09-26-2024 Letter of Interpretation Added - Ergonomic Hazards in Ultrasound Sonography
2024-09-26T05:00:00Z
The following Letter of Interpretation has been added:
The following Letter of Interpretation has been added:
The following Letter of Interpretation has been added:
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The Environmental Protection Agency (EPA) published the Fall 2024 Semiannual Agenda of Regulatory and Deregulatory Actions on December 13, 2024. The agenda reveals the agency’s upcoming regulatory actions and where each action is in the rulemaking process.
The agenda includes major EPA updates, such as:
This article highlights some of the major rules we’re watching closely. You’ll want to review the entire agenda to learn about all the rulemakings on EPA’s docket. Please note that the agenda dates are tentative; they're when the agency seeks to publish the rulemakings in the Federal Register.
Final Rule Stage | |
Projected Publication Date | Title |
December 2024 | New Source Performance Standards (NSPS) and Emission Guidelines (EG) for Large Municipal Waste Combustors (MWCs) |
December 2024 | Removal of Affirmative Defense Provisions From Specified New Source Performance Standards and National Emission Standards for Hazardous Air Pollutants |
January 2025 | Water System Restructuring Assessment Rule |
March 2025 | Regulatory Requirements for New HAP Additions to Part 63 |
July 2025 | Listing of Specific PFAS as Hazardous Constituents |
August 2025 | Clean Water Act Effluent Limitations Guidelines and Standards for the Meat and Poultry Products Point Source Category |
October 2025 | Revisions to Standards for the Open Burning/Open Detonation of Waste Explosives |
November 2025 | Stationary Combustion Turbines New Source Performance Standards (NSPS) Technology Review |
Proposed Rule Stage | |
Projected publication date of Notice of Proposed Rulemaking | Title |
December 2024 | Reconsideration of Standards of Performance for New, Reconstructed and Modified Sources and Emissions Guidelines for Existing Sources: Oil and Natural Gas Sector Climate Review |
January 2025 | National Emission Standards for Hazardous Air Pollutants for the Polyether Polyols Production Industry |
March 2025 | Clean Water Act Effluent Limitations Guidelines and Standards for PFAS Manufacturers Under the Organic Chemicals, Plastics and Synthetic Fibers Point Source Category |
April 2025 | Phasedown of Hydrofluorocarbons: Reconsideration of Technology Transitions Final Rule Under the American Innovation and Manufacturing Act of 2020 |
May 2025 | National Emission Standards for Hazardous Air Pollutants: Stationary Combustion Turbines; Amendments |
June 2025 | Improving Recycling and Management of Renewable Energy Wastes: Universal Waste Regulations for Solar Panels and Lithium Batteries |
June 2025 | PFAS Requirements in NPDES Permit Applications |
June 2025 | Tiered Data Reporting to Inform Prioritization, Risk Evaluation and Risk Management Under the Toxic Substances Control Act (TSCA) |
November 2025 | Revisions to Establish the Sixth Unregulated Contaminant Monitoring Rule (UCMR 6) for Public Water Systems |
November 2025 | Revise/Update the Standards of Performance and Emission Guidelines for Municipal Solid Waste Landfills |
Pre-Rule Stage | |
Projected publication date or other action | Title |
December 2024 (Notice of Proposed Rulemaking) | Lead Wheel Weights; Regulatory Investigation Under the Toxic Substances Control Act (TSCA) |
January 2025 (End Review) | 610 Review of Standards of Performance for New Residential Wood Heaters, New Residential Hydronic Heaters and Forced-Air Furnaces |
January 2025 (Advanced Notice of Proposed Rulemaking Comment Period End) | Regulatory Investigation of N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine ("6PPD") and its Transformation Product, 6PPD-quinone, Under the Toxic Substances Control Act (TSCA) |
Before a new chemical substance can enter the marketplace, it first travels through the New Chemicals Review Program. Section 5 of the Toxic Substances Control Act (TSCA) requires the Environmental Protection Agency (EPA) to review new chemicals for any unreasonable risk of injury they may pose to human or environmental health. The agency determines (a) whether the substances can enter the marketplace and (b) if they require restrictions to manage any unreasonable risk.
To manufacture (including import) a chemical for commercial purposes that’s not on the TSCA Chemical Substance Inventory (i.e., a new chemical), you have to submit a premanufacture notice (PMN) to EPA. In December 2024, EPA finalized the new chemicals review rule. It clarifies that when you submit a PMN, you may not manufacture the new chemical substance until the agency issues a safety determination and completes any associated actions (like developing rules to limit its use).
Start the PMN process by conducting your own review! Evaluate and prepare for the possible determinations EPA will make for your new chemical substance.
Submitting a PMN sparks the beginning of the new chemicals review process. EPA completes the review process by making one of five possible safety determinations for the new chemical.
It’s important to note that three types of determinations fall under the scope of Section 5(e) actions. If EPA makes any determination under Section 5(e), it must issue a Section 5(e) order with requirements that limit or ban the manufacture, processing, distribution in commerce, use, or disposal of the new chemical. Examples include toxicity testing, personal protective equipment for exposed workers, and environmental release restrictions.
Let’s take a look at each one.
In the most straightforward scenario, EPA can find that the new chemical isn’t likely to pose an unreasonable risk.
In this case, the agency will notify you and publish its findings in the Federal Register. Once you receive the Section 5(a)(3)(C) notice from EPA, you may begin manufacturing the new chemical substance, even if the applicable review period isn’t over.
The agency may find that a new chemical presents an unreasonable risk of injury.
It will use Section 5(f) to limit or ban the manufacture, processing, distribution in commerce, use, or disposal of the new chemical through either:
The agency may determine that it doesn’t have enough information to make a “reasoned evaluation” of the new chemical’s impact on health and the environment.
EPA will issue a Section 5(e) order with restrictions to mitigate or eliminate the unreasonable risk.
If EPA doesn’t have enough information, it can alternatively determine that the new chemical poses an unreasonable risk due to insufficient information.
The agency will issue a Section 5(e) order with restrictions to mitigate or eliminate the unreasonable risk.
On the other hand, EPA may determine that the new chemical will be produced in substantial quantities that could (a) be released in large amounts to the environment or (b) result in significant human exposure.
EPA will issue a Section 5(e) order with restrictions to mitigate or eliminate the unreasonable risk.
In December 2024, EPA finalized changes to the rule for new chemical reviews. It clarifies that the agency must make one of five statutory determinations for each PMN, significant new use notice, and microbial commercial activity notice it receives.
The final rule also:
Key to remember: EPA reviews each new chemical and makes one of five possible safety determinations that dictate both if and how the substance can enter the marketplace.
In 2022, the National Institute for Occupational Safety and Health (NIOSH) reported a staggering 658,000 workers were exposed to harmful chemicals, resulting in 839 fatalities. These statistics highlight the significant health and safety risks that an unexpected exposure to a hazardous chemical, or a substantial threat of a hazardous substance release, can pose to workers, organizations, and communities. A thorough understanding of chemical management regulations is crucial to ensure potential hazardous exposures are minimized.
OSHA’s HazCom standard (29 CFR 1910.1200) is designed to inform workers about chemical hazards and how to protect themselves.
Key definitions: A "hazardous chemical" is any chemical which is classified as a physical hazard or a health hazard, a simple asphyxiant, combustible dust, or other hazards not that may not be classified but still pose a serious danger.
Indicators: Any workplace where hazardous chemicals are used, stored, or processed needs a hazard communication program. Labels, safety data sheets (SDSs), and employee training are essential components.
Training requirements: Training must cover how to read and understand labels, the purpose and location of SDSs, and specific protective measures when handling hazardous chemicals. Training must be provided upon initial assignment and updated whenever new chemical hazards are introduced.
The DOT’s hazmat regulations (DOT 49 CFR Parts 171-180) include substances that, if transported improperly, can harm people, property, or the environment. By correctly handling and moving these materials, organizations can avoid accidents and safeguard both public health and the environment.
Key definitions: A "hazardous material" is any substance or material capable of posing an unreasonable risk when transported in commerce. This can include flammable, toxic, and reactive substances.
Indicators: Activities involving the loading, unloading, and handling of hazardous materials require adherence to hazmat regulations. This requirement also applies to organizations that make or maintain packaging, or a part of packaging, that's marked or sold as suitable for transporting hazardous materials commercially.
Training requirements: Workers handling hazmat must undergo specific training on material classification, safe handling, emergency response, and transportation. Training must be provided within 90 days of initial assignment and a refresher at least once every three years. Training must also be documented and retained for a minimum of three years.
The EPA’s hazwaste regulations (40 CFR Parts 260-299) refer to any waste material that could potentially harm the environment or human health if not managed correctly. Additionally, many states have hazardous waste requirements beyond EPA regulations.
Key Definitions: Hazardous waste includes materials classified as toxic, ignitable, corrosive, or reactive, based on specific criteria.
Indicators: Managing hazardous waste follows the material’s entire lifecycle including the generation, transportation, treatment, storage, and disposal, known as "cradle-to-grave." Requirements are based on the quantity of waste generated.
Training requirements: Employees involved in hazardous waste management must receive training on waste handling, storage, labeling, and disposal procedures. Annual training requirements are based on generator quantity status.
OSHA’s HAZWOPER standard (29 CFR 1910.120) protects workers involved in hazardous waste management and emergency response. HAZWOPER covers a wide range of activities, including cleanup operations and responses to hazardous substance releases.
Key definitions: A hazardous substance is any material that can harm health and safety if released into the environment. In the context of HAZWOPER, this includes materials that pose risks in emergencies, such as spills, leaks, or other uncontrolled releases.
Indicators: Workers and organizations tasked with hazardous waste cleanup, spill response, and emergency operations require specialized training, equipment, and procedures.
Training requirements: HAZWOPER training is intensive and includes specific requirements depending on job roles. Training levels include 24-hour, 40-hour, and 8-hour refresher courses for different exposure risks. Employees learn about hazardous substance properties, emergency response procedures, PPE use, and decontamination processes.
OSHA’s PSM standard (29 CFR 1910.119) aims to prevent accidental chemical releases that could seriously harm employees or the environment by including safety measures, risk assessments, and employee training to ensure safe operations. It is especially important in industries handling highly hazardous chemicals including facilities with high-risk chemical processes.
Key definitions: OSHA defines a "highly hazardous chemical" as any substance that poses a significant risk of causing serious harm to people, property, or the environment due to its toxic, reactive, flammable, or explosive properties.
Indicators: Any workplace handling large volumes of hazardous chemicals or using complex chemical processes including chemicals that are specifically listed by OSHA in appendix A of the standard, are present in quantities above specified thresholds, or exhibit properties that make them likely to cause a major incident.
Training requirements: PSM training covers safe operating procedures, hazard analysis, and incident investigation for employees involved in high-risk processes. Training must be provided at initial assignment and a refresher at least once every three years.
Key to remember: Chemical management is a complex task. Understanding what regulatory requirements apply will ensure compliance as well as minimize the chance for dangerous incidents.
December 2024 marks the 40th anniversary of one of history’s worst industrial incidents — the release of a deadly gas at a chemical plant in Bhopal, India. This incident, along with another in West Virginia in 1985, spurred U.S. legislative and regulatory action. However, some might say that work is not finished.
Think of the Emergency Planning and Community Right-to-Know Act (EPCRA) of 1986, the EPA Risk Management Program (RMP) standard, and the OSHA Process Safety Management (PSM) standard, for example. You’ll find roots to the Bhopal disaster.
It was late on December 2, 1984, at a chemical facility. A faulty valve leaked water into a tank of methyl isocyanate (or MIC). This prompted a violent reaction inside the tank. History tells us that at about 1:00 a.m. on that fateful December 3, the failure of a safety valve triggered a massive release. A dense, lethal cloud of MIC and other chemicals drifted over the city of Bhopal.
By dawn, thousands of residents were dead, along with birds, dogs, cows, and other animals. The injured flocked to hospitals in overwhelming numbers. A lack of information about just what the chemicals were, however, compounded the catastrophe.
India officials reported half a million or more chemical exposures. Estimates vary, but as many as 10,000 people perished in the initial few days. Tens of thousands died prematurely in the decades to follow, according to sources.
In August 1985, a chemical release in Institute, West Virginia, showed Americans that a “Bhopal-like” incident could happen here. Aldicarb oxime and other chemicals released from the facility, and over 125 residents landed in the hospital. Again, a lack of available chemical information was noteworthy. Many U.S. citizens began to fear they faced catastrophic risks.
In the wake of the incidents, Congress enacted laws:
Together, they required EPA and OSHA to issue regulations to:
Congress also established the Chemical Safety and Hazard Investigation Board (CSB) to investigate chemical incidents and recommend measures to prevent them. Despite these actions, the U.S. continues to experience serious chemical incidents. A visit to the CSB or National Response Center (NRC) websites reveals countless incident reports since 1990. A look at the 2024 data finds:
Ten years ago, on the 30th anniversary of the Bhopal disaster, CSB posted a six-minute video explaining how the tragedy occurred. The video also examines more recent U.S. incidents. It emphasizes what more could be done to prevent similar incidents.
CSB investigations around the time of the video found deficiencies in design and PSM, similar to those uncovered in Bhopal! CSB Chairperson Rafael Moure-Eraso argued: “Process safety management regulations are in need of reform. There must be more emphasis on preventing the occurrence of major chemical accidents through safer design. Responding to emergencies and punishing people after the fact are not enough.”
Another headline-making incident in April 2013 involved a massive explosion of ammonium nitrate at a fertilizer storage/distribution facility in West, Texas. It fatally injured 12 volunteer firefighters and two members of the public and caused hundreds of injuries. The incident prompted the Executive Order on Improving Chemical Facility Safety and Security (EO 13650) on August 1, 2013. The order directed the federal government to:
The feds held listening sessions and issued a flurry of fact sheets, alerts, and enforcement policy changes (See here and here.). Note that the RMP regulation at 40 CFR 68 was eventually amended this year on March 11, 2024. The PSM standard remains unchanged, despite a request for information on December 9, 2013. In an about-face, Congress allowed the Chemical Facility Anti-Terrorism Standards program (at 6 CFR 27) to expire on July 28, 2023, but many in Congress and industry would like to see its return.
This month marks the 40th anniversary of the Bhopal chemical disaster. It sparked the U.S. Congress to take steps back then to prevent such a disaster from occurring here. Those actions did not spell the end to all chemical disasters in the U.S. In response, a renewed push for regulatory reforms popped up in the last decade.
Leak detection on an underground tank storing petroleum or other hazardous materials can be the factor that prevents a release from turning into a contamination catastrophe. A leak (or release) detection system alerts tank operators and owners of potential releases, allowing them to respond and limit contamination quickly.
The Environmental Protection Agency (EPA) requires regulated underground storage tanks (USTs) to have release detection systems. Here are five things you should know about complying with UST leak detection requirements.
EPA’s release detection requirements (40 CFR Part 280 Subpart D) apply to USTs and any underground piping connected to the tanks.
Owners and operators must equip each regulated UST and piping with leak detection that:
The UST’s date of installation or replacement determines the release detection methods that owners and operators can use for the tank. There are three categories of release detection methods:
Owners and operators of USTs installed on or before April 11, 2016, choose at least one leak detection method from the range of interstitial, internal, and external options (or another method approved by the implementing agency). However, owners and operators of USTs installed or replaced after April 11, 2016, must use secondary containment with interstitial monitoring.
The release detection methods for piping that UST owners and operators can use are based on (a) the date of installation or replacement and (b) the type of piping.
Pressurized piping installed on or before April 11, 2016, must:
Pressurized piping installed or replaced after April 11, 2016, must also have an automatic line leak detector and use secondary containment with interstitial monitoring.
Suction piping installed on or before April 11, 2016, must use monthly monitoring or line testing every three years (unless the piping is exempt from requirements). Suction piping installed or replaced after April 11, 2016, must use secondary containment with interstitial monitoring (unless the piping is exempt from requirements).
EPA revised the UST regulations in 2015, requiring all new and replaced tanks and piping to use secondary containment with interstitial monitoring for release detection. For example, say you have a UST installed before April 11, 2016, but you have to replace its piping. You must use secondary containment with interstitial monitoring for the replaced piping.
Secondary containment refers to a physical barrier between the UST and the environment, such as a double-walled tank or internally fitted liner. If the UST leaks, the barrier holds the leak between the tank and the barrier so it can be detected.
The interstitial monitor detects leaks between the tank and the barrier and alerts owners and operators of a potential leak. Monitoring devices range from physical dipsticks to high-tech pressure and liquid-detecting sensors.
Many states implement the UST regulatory program. State requirements must be at least equal to EPA’s, and in some cases, they may be more stringent.
Whether you have one UST at a facility or several at facilities across the country, it’s vital to check state requirements to ensure you comply with all applicable standards.
UST release detection systems can help your facility prevent potential leaks from turning into environmental — and compliance — disasters.
Key to remember: EPA requires underground storage tanks to have release detection systems that alert owners and operators quickly to potential leaks.
Future emission requirements for certain power plants and other industrial sources across 23 states remain up in the air. The Environmental Protection Agency (EPA) published the Third Final Interim Rule for its Good Neighbor Plan (GNP) in October 2024, officially pausing the federal emissions-control program in all affected states as legal battles continue.
So, the GNP requirements are paused, but what does that mean for the facilities covered by the rule?
The GNP is a federal program for 23 states that requires fossil fuel-fired power plants and other industrial facilities (such as manufacturers and solid waste incinerators) to lower emissions of ozone-forming nitrogen oxides (NOx) that hinder downwind states’ ability to achieve and maintain the 2015 Ozone National Ambient Air Quality Standards (NAAQS).
EPA issued the First and Second Interim Final Rules in 2023 in response to a judicial order to partially stay the agency’s disapproval of State Implementation Plans (SIPs) for implementing the NAAQS. The rules temporarily stopped enforcement of the GNP in 12 states.
In July 2024, the U.S. Supreme Court issued an order of stay for three other states challenging the GNP rule in a separate case. EPA responded to the Supreme Court with the Third Interim Final Rule. Although the Supreme Court’s order addresses only the states involved in the case, the rule pauses the GNP’s requirements for the emissions sources in all remaining 11 states.
Until the GNP rule is settled, power plants and industrial facilities must meet the less stringent 2008 Ozone NAAQS. Two rules address interstate emissions for this standard:
For the interim, power plants in states with previous interstate air pollution requirements for the 2008 Ozone NAAQS are subject to equivalent requirements established by the CSAPR and Revised CSAPR rules:
The interim rules also make allowances interchangeable for power plants in some states for Group 2 trading program compliance, including Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, New Jersey, New York, Ohio, Pennsylvania, Virginia, and West Virginia.
Power plants in Alabama, Arkansas, Mississippi, Missouri, Oklahoma, and Texas retain their banked Group 2 allowances. Also, Kentucky, Louisiana, and West Virginia may convert banked 2021–22 Group 3 allowances to Group 2 allowances.
Power plants in Illinois, Indiana, Maryland, Michigan, New Jersey, New York, Ohio, Pennsylvania, Virginia, and Wisconsin may convert their 2021–23 Group 3 allowances to Group 2 allowances. However, EPA will recall the 2024 Group 3 allowances issued before the stay order.
Power plants in Minnesota, Nevada, and Utah weren’t covered by previous ozone NAAQS requirements, so they maintain the status quo. Additionally, California power plants aren’t subject to GNP requirements.
Most of the GNP’s requirements for industrial facilities don’t begin until the start of the 2026 ozone season (May 1, 2026). EPA won’t enforce the deadlines that occur before then for procedural requirements, such as submitting optional case-by-case emissions limits requests.
For now, the future of the GNP remains unclear due to ongoing litigation. EPA’s administrative stay remains in effect until:
Plus, if a state’s judicial stay order due to SIP disapproval is lifted, the agency won’t remove the stay for the state’s emissions sources until the Supreme Court lifts its stay order.
Key to remember: EPA’s final interim rules establish temporary compliance requirements for power plants and other industrial sources while the Good Neighbor Plan remains paused.
Hi everyone! Welcome to the monthly news roundup video, where we’ll review the most impactful environmental, health, and safety news. Please view the content links in the transcript for more information about the topics I’ll be covering today. Let’s get started!
A Government Accountability Office report says OSHA can do more to protect warehouse and delivery workers from ergonomic injuries. The report recommends several steps for OSHA to consider, including ensuring compliance officers can easily obtain data on when musculoskeletal disorders occurred.
OSHA updated its inspection guidance for animal slaughtering and processing industries. Inspections will focus on several hazards, including sanitation, ergonomics, and machine guarding. Among other changes, compliance officers will conduct inspections during off-shift times and identify workplace activities that impact employees most at risk such as temporary employees.
OSHA urges workers involved in hurricane cleanup and recovery efforts to be mindful of hazards, especially those associated with restoring electricity, removing debris, and trimming trees. Proper training, experience, and familiarity with related equipment helps ensure worker safety.
And finally, turning to environmental news, EPA extended the 2024 Chemical Data Reporting deadline to November 22 due to technical difficulties with its electronic reporting tool. The 2024 report covers activities that occurred between calendar years 2020 and 2023.
Thanks for tuning in to the monthly news roundup. We’ll see you next month!
As the year draws to a close, it’s essential for environmental professionals to take proactive steps to ensure a smooth transition into the new year. As an environmental professional working in the industry, I always took this time to address key tasks to avoid last-minute stress and position my organization for a successful environmental compliance year. Here are a few tips and reminders for you to consider.
It’s a good time to verify expiration dates and to ensure all permits and licenses are current and valid. Identify renewal requirements and gather necessary documentation and information for upcoming renewals. Take corrective actions to rectify any violations or deficiencies.
If Tier II reporting applies to your facility, start gathering information on hazardous chemicals stored or handled on-site. The March 1 deadline will approach quickly, and you’ll want to be prepared.
The end of the year provides an opportunity to review and assess your organization’s environmental performance and identify areas for improvement. Use your experience throughout the year to guide you as you develop corrective action plans. Review and update emergency response plans. Verify that contact information, procedures, and equipment are up to date.
File documents and store all environmental records in a systematic and organized manner. Consider scanning important documents to create electronic copies. Establish guidelines for retaining environmental records to comply with legal requirements.
Things can change rapidly during the year, and much-needed tasks can fall by the wayside. By carving out time at the end of the year to complete these tasks, you can set a strong foundation for a successful and compliant new year.
Are your aboveground storage tanks (ASTs) engineered to avoid overfills during oil transfers? EPA issued a technical alert to highlight the importance of overfill prevention measures. Having these systems is not enough, though. They must be properly designed, operated, maintained, and inspected.
The 13-page alert (EPA 540-S-24-001) aims at owners and operators of “substantial harm oil storage facilities.” These facilities are often covered by 40 CFR 112, including both the oil Spill Prevention, Control, and Countermeasure (SPCC) regulations and oil Facility Response Plan (FRP) regulations.
Implementing overfill prevention is mandated by part 112. That’s because these critical systems alert you to potential container overfills. Overfills are often the cause of oil discharges.
Overfills of large ASTs during high-volume oil transfers have led to:
The alert showcases two headline-making incidents to illustrate the danger:
Overfills can happen, but they are preventable! The alert explains that overfill prevention systems commonly used at facilities monitor liquid levels in tanks. These prevention systems include:
The trouble is, when these systems fail, overfills can still occur. Therefore, it’s critical to take other measures. Adequate system maintenance, inspection, implementation, nighttime security lighting, training, and procedures are examples.
So, oil discharges to the environment and waterways may be prevented and/or minimized with the help of overfill prevention systems. At the same time, however, owners and operators need to implement:
EPA’s technical alert addresses adequately designed, implemented, and maintained overfill prevention systems. The alert explores:
Thirteen references and their links are included. Two worth noting are:
If you have an SPCC- and/or FRP-regulated facility, EPA urges you to review the alert. You should also consider whether more action is needed to address these requirements at your oil storage facility.
EPA issued a technical alert to highlight the importance of overfill prevention measures. The agency says they must be properly designed, operated, maintained, and inspected.
Did you know that the chemicals your facility makes and processes could be subject to additional testing requirements? Through a Section 4 Test Order under the Toxic Substances Control Act (TSCA), the Environmental Protection Agency (EPA) can require manufacturers (including importers) and processors to test and submit information on existing chemicals and mixtures through the agency’s Central Data Exchange (CDX).
For example, EPA issued the fifth TSCA Section 4 Test Order for per- and polyfluoroalkyl substances (PFAS) in October 2024. Five companies must submit information on the PFAS commonly known as 6:2 FTAc (used to manufacture plastics, resins, textiles, apparel, leather, and other chemicals), which the agency found may present an unreasonable risk of injury to human health or the environment.
How will your facility respond if it receives a TSCA Section 4 Test Order? Let’s look at the four response options.
Entities that receive a test order must first submit an identification response within 30 days of the order’s effective date. You can identify as a manufacturer, processor, or both.
If you don’t manufacture or process the chemical or believe EPA mistakenly sent you the order, you may claim that you’re not subject to the order. Provide supporting information with the claim in the identification response.
Companies subject to the test order then submit an initial response to tell EPA how it will comply. There are four response options:
You can choose a different response for every test required by the order. Let’s zoom in on each option.
The most straightforward response is to conduct the test(s) and generate the information. The order contains everything you need to know, including:
Alternatively, if you believe EPA hasn’t considered relevant information, you can submit an existing study and/or other relevant information. Include a rationale document that explains how the existing information you present fulfills the test order’s requirements and which information it covers (i.e., Does it provide parts of or all the needed information?).
If EPA finds any of the existing data you submit acceptable, the agency will remove the obligations in the test order that the existing information fulfills. However, if the agency determines the existing information isn’t acceptable, you must submit a different response option within 10 days of EPA’s rejection.
EPA grants exemptions to avoid duplicating information. You may be exempt from a test order if:
Include with your exemption application a rationale document that identifies:
You must also include a sworn statement of financial responsibility to reimburse the entity(ies) that paid the costs to submit the testing information if your exemption is granted.
EPA allows companies subject to the same test order to form a consortium to share the costs of generating the required information (including testing and fees).
To begin, inform EPA individually of the specific chemicals and tests you plan to address through a consortium. The individual designated as the lead in the consortium then submits the initial response on behalf of all entities in the group.
Organizations interested in joining a consortium must contact EPA’s TSCA Hotline by email (tsca-hotline@epa.gov) or phone call ((202) 554-1404).
Consider these helpful tips when choosing how to respond to a TSCA Section 4 Test Order:
Key to remember: EPA’s TSCA Section 4 Test Orders require manufacturers (including importers) and processors to develop information on existing chemicals. Companies subject to the order have four response options.
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2020-0497; FRL-8215-01-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (20-10.B)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: EPA is issuing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemical substances which were the subject of premanufacture notices (PMNs). This action requires persons to notify EPA at least 90 days before commencing manufacture (defined by statute to include import) or processing of any of these chemical substances for an activity that is designated as a significant new use by this rule. This action further requires that persons not commence manufacture or processing for the significant new use until they have submitted a Significant New Use Notice (SNUN), EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken any risk management actions as are required as a result of that determination.
DATES: This rule is effective on January 14, 2022. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on November 29, 2021.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: William Wysong, New Chemicals Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-4163; email address: wysong.william@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA, which would include the SNUR requirements. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import provisions. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, pursuant to 40 CFR 721.20, any persons who export or intend to export a chemical substance that is the subject of this rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), and must comply with the export notification requirements in 40 CFR part 707, subpart D.
B. How can I access the docket?
The docket includes information considered by the Agency in developing the proposed and final rules. The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2020-0497, is available at https://www.regulations.gov and at the Office of Pollution Prevention and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Please review the visitor instructions and additional information about the docket available at https://www.epa.gov/dockets.
Due to the public health emergency, the EPA Docket Center (EPA/DC) and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.
II. Background
A. What action is the Agency taking?
EPA is finalizing SNURs under TSCA section 5(a)(2) for chemical substances which were the subject of PMNs P-18-289, P-18-330, P-18-334, P-18-335, and P-18-337. These SNURs require persons who intend to manufacture or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.
Previously, in the Federal Register of October 20, 2020 (85 FR 66506) (FRL-10015-28), EPA proposed SNURs for these chemical substances. More information on the specific chemical substances subject to this final rule can be found in the Federal Register document proposing the SNURs. The docket includes information considered by the Agency in developing the proposed and final rules, including public comments and EPA's responses to the public comments received on the proposed rules, as described in Unit IV.
B. What is the Agency's authority for taking this action?
TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four TSCA section 5(a)(2) factors listed in Unit III.
C. Do the SNUR general provisions apply?
General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. Pursuant to 40 CFR 721.1(c), persons subject to these SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA sections 5(b) and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1), 5(h)(2), 5(h)(3), and 5(h)(5) and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination before manufacture or processing for the significant new use can commence. If EPA determines that the significant new use is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the Federal Register , a statement of EPA's findings.
III. Significant New Use Determination
A. Determination Factors
TSCA section 5(a)(2) states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:
In determining what would constitute a significant new use for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, and potential human exposures and environmental releases that may be associated with the substances, in the context of the four bulleted TSCA section 5(a)(2) factors listed in this unit. During its review of these chemicals, EPA identified certain conditions of use that are not intended by the submitters, but reasonably foreseen to occur. EPA is designating those reasonably foreseen conditions of use as well as certain other circumstances of use as significant new uses.
B. Procedures for Significant New Uses Claimed as Confidential Business Information (CBI)
By this rule, EPA is establishing certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI, at 40 CFR 721.1725(b)(1) and has referenced it to apply to other SNURs.
Under these procedures a manufacturer or processor may request EPA to determine whether a specific use would be a significant new use under the rule. The manufacturer or processor must show that it has a bona fide intent to manufacture or process the chemical substance and must identify the specific use for which it intends to manufacture or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture or process the chemical substance, EPA will tell the person whether the use identified in the bona fide submission would be a significant new use under the rule. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers and processors can combine the bona fide submission under the procedure in 40 CFR 721.1725(b)(1) with that under 40 CFR 721.11 into a single step.
If EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the annual production volume limit is not exceeded by the amount identified in the bona fide submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use.
IV. Public Comments
EPA received a public comment from one identifying entity on the proposed rule. The Agency's response is described in a separate Response to Public Comments document that is available in the public docket for this rulemaking. In addition, EPA received three anonymous comments. They were either general in nature and did not pertain to the proposed rule or were broadly supportive of the rule and requested no changes to the rule itself; therefore, no response is required. EPA made no changes to the final rule based on these comments.
V. Substances Subject to This Rule
EPA is establishing significant new use and recordkeeping requirements for chemical substances in 40 CFR part 721, subpart E. In Unit IV. of the proposed SNUR, EPA provided the following information for each chemical substance:
The regulatory text section of these rules specifies the activities designated as significant new uses. Certain new uses, including production volume limits and other uses designated in the rules, may be claimed as CBI.
VI. Rationale and Objectives of the Rule
A. Rationale
During review of the PMNs submitted for the chemical substances that are the subject of these SNURs and as further discussed in Unit IV. of the proposed rule, EPA identified certain other reasonably foreseen conditions of use in addition to those conditions of use intended by the submitter. EPA has determined that the chemical under the intended conditions of use is not likely to present an unreasonable risk. However, EPA has not assessed risks associated with the reasonably foreseen conditions of use. EPA is designating these conditions of use as well as certain other circumstances of use as significant new uses. As a result, those significant new uses cannot occur without going through a separate, subsequent EPA review and determination process associated with a SNUN.
B. Objectives
EPA is issuing these SNURs because the Agency wants:
Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Inventory. Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the internet at https://www.epa.gov/tsca-inventory.
VII. Applicability of the Rules to Uses Occurring Before the Effective Date of the Final Rule
To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule were undergoing premanufacture review at the time of signature of the proposed rule and were not on the TSCA inventory. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for the chemical substances subject to these SNURs, EPA concluded at the time of signature of the proposed rule that the designated significant new uses were not ongoing.
EPA designated October 7, 2020 (the date of web posting of the proposed rule) as the cutoff date for determining whether the new use is ongoing. The objective of EPA's approach is to ensure that a person cannot defeat a SNUR by initiating a significant new use before the effective date of the final rule.
Persons who began commercial manufacture or processing of the chemical substances for a significant new use identified on or after that date will have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and EPA would have to take action under TSCA section 5 allowing manufacture or processing to proceed.
VIII. Development and Submission of Information
EPA recognizes that TSCA section 5 does not require development of any particular new information (e.g., generating test data) before submission of a SNUN. There is an exception: If a person is required to submit information for a chemical substance pursuant to a rule, Order or consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A) requires such information to be submitted to EPA at the time of submission of the SNUN.
In the absence of a rule, Order, or consent agreement under TSCA section 4 covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Unit IV. of the proposed rule lists potentially useful information for all SNURs listed here. Descriptions are provided for informational purposes. The potentially useful information identified in Unit IV. of the proposed rule will be useful to EPA's evaluation in the event that someone submits a SNUN for the significant new use. Companies who are considering submitting a SNUN are encouraged, but not required, to develop the information on the substance, which may assist with EPA's analysis of the SNUN.
EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol election. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing in vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the recommended test data. EPA encourages dialog with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h). For more information on alternative test methods and strategies to reduce vertebrate animal testing, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.
The potentially useful information described in Unit IV. of the proposed rule may not be the only means of providing information to evaluate the chemical substance associated with the significant new uses. However, submitting a SNUN without any test data may increase the likelihood that EPA will take action under TSCA sections 5(e) or 5(f). EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:
IX. SNUN Submissions
According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is available electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
X. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this rule. EPA's complete economic analysis is available in the docket for this rulemaking.
XI. Statutory and Executive Order Reviews
Additional information about these statutes and executive orders can be found at https://www.epa.gov/laws-regulations-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulations and Regulatory Review
This action establishes SNURs for new chemical substances that were the subject of PMNs. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011).
B. Paperwork Reduction Act (PRA)
According to PRA, 44 U.S.C. 3501 et seq., an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable.
The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.
The listing of the OMB control numbers of the collection instruments and their subsequent codification in the table in 40 CFR 9.1 satisfies the display requirements of the PRA and OMB's implementing regulations at 5 CFR part 1320. Since this ICR was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table in 40 CFR part 9, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is “good cause” under section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table in 40 CFR 9.1 without further notice and comment.
C. Regulatory Flexibility Act (RFA)
Pursuant to RFA section 605(b), 5 U.S.C. 601 et seq., I hereby certify that promulgation of this SNUR would not have a significant adverse economic impact on a substantial number of small entities. The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the final rule as a “significant new use.” Because these uses are “new,” based on all information currently available to EPA, it appears that no small or large entities presently engage in such activities. A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. Although some small entities may decide to pursue a significant new use in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemicals, the Agency receives only a small number of notices per year. For example, the number of SNUNs received was seven in Federal fiscal year (FY) 2013, 13 in FY2014, six in FY2015, 12 in FY2016, 13 in FY2017, and 11 in FY2018. Only a fraction of these were from small businesses. In addition, the Agency currently offers relief to qualifying small businesses by reducing the SNUN submission fee from $16,000 to $2,800. This lower fee reduces the total reporting and recordkeeping of cost of submitting a SNUN to about $10,116 for qualifying small firms. Therefore, the potential economic impacts of complying with this SNUR are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented its general determination that final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.
D. Unfunded Mandates Reform Act (UMRA)
Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this action. As such, EPA has determined that this action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq. ).
E. Executive Order 13132: Federalism
This action will not have federalism implications because it is not expected to have a substantial direct effect on States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).
F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments
This action will not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes, significantly or uniquely affect the communities of Indian Tribal governments and does not involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175 (65 FR 67249, November 9, 2000), do not apply to this action.
G. Executive Order 13045: Protection of Children From Environmental Health and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.
H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use
This action is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), because this action is not a significant regulatory action under Executive Order 12866.
I. National Technology Transfer and Advancement Act (NTTAA)
In addition, since this action does not involve any technical standards, NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to this action.
J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations
This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898 (59 FR 7629, February 16, 1994).
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA will submit a rule report containing this rule and other required information to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).
List of Subjects
40 CFR Part 9
Environmental protection, Reporting and recordkeeping requirements.
40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.
Dated: October 26, 2021.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows:
PART 9—OMB APPROVALS UNDER THE PAPERWORK REDUCTION ACT
1. The authority citation for part 9 continues to read as follows:
Authority:
7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a; 31 U.S.C. 9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 9601-9657, 11023, 11048.
2. In §9.1, amend the table by adding entries for §§721.11561 through 721.11565 in numerical order under the undesignated center heading “Significant New Uses of Chemical Substances” to read as follows:
§9.1
OMB approvals under the Paperwork Reduction Act.
* * * * *
40 CFR citation | OMB control No. |
* * * * * | |
Significant New Uses of Chemical Substances | |
* * * * * | |
721.11561 | 2070-0012 |
721.11562 | 2070-0012 |
721.11563 | 2070-0012 |
721.11564 | 2070-0012 |
721.11565 | 2070-0012 |
* * * * * |
* * * * *
PART 721—SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
3. The authority citation for part 721 continues to read as follows:
Authority:
15 U.S.C. 2604, 2607, and 2625(c).
4. Add §§721.11561 through 721.11565 to subpart E to read as follows:
Subpart E—Significant New Uses for Specific Chemical Substances
Sec.
* * * * *
§721.11561 2-[2-(methylcarboxymonocyclic)amino)ethoxy]alcohol (generic).
§721.11562 Formaldehyde, polymer with alkyl aryl ketone (generic).
§721.11563 Propanedioic acid, 1,3-dihexyl ester.
§721.11564 Propanedioic acid, 1,3-dicyclohexyl ester.
§721.11565Propanedioic acid, 2,2-bis(hydroxymethyl)-, 1,3-dicyclohexyl ester.
* * * * *
§721.11561 2-[2-(methylcarboxymonocyclic)amino)ethoxy]alcohol (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 2-[2-(methylcarboxymonocyclic)amino)ethoxy]alcohol (generic).(PMN P-18-289) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(j) and (s). For purposes of §721.80(s), the annual manufacture and importation volume is 80,000 kilograms.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
(3) Determining whether a specific use is subject to this section. The provisions of §721.1725(b)(1) apply to paragraph (a)(2)(i) of this section.
§721.11562 Formaldehyde, polymer with alkyl aryl ketone (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as formaldehyde, polymer with alkyl aryl ketone (PMN P-18-330) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(o).
(ii) Release to water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4), where N=770.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c), (i) and (k) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11563 Propanedioic acid, 1,3-dihexyl ester.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as propanedioic acid, 1,3-dihexyl ester (PMN P-18-334; CAS No. 1431-37-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(g).
(ii) Release to water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4), where N=3.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c), (i) and (k) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11564 Propanedioic acid, 1,3-dicyclohexyl ester.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as propanedioic acid, 1,3-dicyclohexyl ester (PMN P-18-335; CAS No. 1152-57-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(g).
(ii) Release to water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4), where N=6.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c), (i) and (k) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11565Propanedioic acid, 2,2-bis(hydroxymethyl)-, 1,3-dicyclohexyl ester.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as propanedioic acid, 2,2- bis(hydroxymethyl)-, 1,3-dicyclohexyl ester (PMN P-18-337; CAS No. 2222732-46-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4), where N=95.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (c) and (k) are applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
[FR Doc. 2021-24789 Filed 11-12-21; 8:45 am]
BILLING CODE 6560-50-P
Hi everyone! Welcome to the monthly news roundup video, where we’ll review the most impactful environmental, health, and safety news. Please view the content links in the transcript for more information about the topics I’ll be covering today. Let’s get started!
OSHA published its proposed heat illness rule on August 30. It applies to both indoor and outdoor work in general industry, construction, agriculture, and maritime. Comments on the proposal will be accepted until December 30. OSHA encourages both employers and workers to submit comments.
Fall protection for construction remained number one on OSHA’s list of Top 10 violations for the 14th year in a row. There was little movement among the other Top 10 entries, with Hazard Communication at number 2 and ladders at number 3.
OSHA may exclude volunteer emergency response organizations from its proposed emergency response rule. During the rule’s public comment period, the agency received numerous comments that raised serious economic feasibility concerns.
During its silica enforcement inspections, OSHA also found violations of the hazard communication, respiratory protection, and noise standards. Over 200 companies were targeted as part of the agency’s respirable crystalline silica emphasis program.
Employers can view workplace injury and illness trends using OSHA’s Severe Injury Report dashboard. This new online tool allows users to search the agency’s severe injury report database. Severe injuries and illnesses are those that result in inpatient hospitalization, amputation, or loss of an eye.
And finally, turning to environmental news, an EPA final rule impacts facilities that reclassify from major to area source status under the National Emission Standards for Hazardous Air Pollutants program. These facilities must continue to meet the major source emission standards for seven hazardous air pollutants.
Thanks for tuning in to the monthly news roundup. We’ll see you next month!
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 141
[EPA-HQ-OW-2020-0530; FRL-6791-03-OW]
RIN 2040-AF89
Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 5) for Public Water Systems and Announcement of Public Meetings
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule and notice of public meetings.
SUMMARY: The U.S. Environmental Protection Agency (EPA) is finalizing a Safe Drinking Water Act (SDWA) rule that requires certain public water systems (PWSs) to collect national occurrence data for 29 per- and polyfluoroalkyl substances (PFAS) and lithium. Subject to the availability of appropriations, EPA will include all systems serving 3,300 or more people and a representative sample of 800 systems serving 25 to 3,299 people. If EPA does not receive the appropriations needed for monitoring all of these systems in a given year, EPA will reduce the number of systems serving 25 to 10,000 people that will be asked to perform monitoring. This final rule is a key action to ensure science-based decision-making and prioritize protection of disadvantaged communities in accordance with EPA's PFAS Strategic Roadmap. EPA is also announcing plans for public webinars to discuss implementation of the fifth Unregulated Contaminant Monitoring Rule (UCMR 5).
DATES: This final rule is effective on January 26, 2022. The incorporation by reference of certain publications listed in this final rule is approved by the Director of the Federal Register as of January 26, 2022.
ADDRESSES: EPA has established a docket for this action under Docket ID No. EPA-HQ-OW-2020-0530. All documents in the docket are listed on the https://www.regulations.gov website. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available electronically through https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Brenda D. Bowden, Standards and Risk Management Division (SRMD), Office of Ground Water and Drinking Water (OGWDW) (MS 140), Environmental Protection Agency, 26 West Martin Luther King Drive, Cincinnati, Ohio 45268; telephone number: (513) 569-7961; email address: bowden.brenda@epa.gov; or Melissa Simic, SRMD, OGWDW (MS 140), Environmental Protection Agency, 26 West Martin Luther King Drive, Cincinnati, Ohio 45268; telephone number: (513) 569-7864; email address: simic.melissa@epa.gov. For general information, visit the Ground Water and Drinking Water web page at: https://www.epa.gov/ground-water-and-drinking-water.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Summary Information
A. Purpose of the Regulatory Action
1. What action is EPA taking?
2. Does this action apply to me?
3. What is EPA's authority for taking this action?
4. What is the applicability date?
B. Summary of the Regulatory Action
C. Economic Analysis
1. What is the estimated cost of this action?
2. What are the benefits of this action?
II. Public Participation
A. What meetings have been held in preparation for UCMR 5?
B. How do I participate in the upcoming meetings?
1. Meeting Participation
2. Meeting Materials
III. General Information
A. How are CCL, UCMR, Regulatory Determination process, and NCOD interrelated?
B. What are the Consumer Confidence Reporting and Public Notice Reporting requirements for public water systems that are subject to UCMR?
C. What is the UCMR 5 timeline?
D. What is the role of “States” in UCMR?
E. How did EPA consider Children's Environmental Health?
F. How did EPA address Environmental Justice?
G. How did EPA coordinate with Indian Tribal Governments?
H. How are laboratories approved for UCMR 5 analyses?
1. Request To Participate
2. Registration
3. Application Package
4. EPA's Review of Application Package
5. Proficiency Testing
6. Written EPA Approval
I. What documents are being incorporated by reference?
1. Methods From the U.S. Environmental Protection Agency
2. Alternative Methods From American Public Health Association—Standard Methods (SM)
3. Methods From ASTM International
IV. Description of Final Rule and Summary of Responses to Public Comments
A. What contaminants must be monitored under UCMR 5?
1. This Final Rule
2. Summary of Major Comments and EPA Responses
a. Aggregate PFAS Measure
b. Legionella Pneumophila
c. Haloacetonitriles
d. 1,2,3-Trichloropropane
B. What is the UCMR 5 sampling design?
1. This Final Rule
2. Summary of Major Comments and EPA Responses
C. What is the sampling frequency and timing?
1. This Final Rule
2. Summary of Major Comments and EPA Responses
D. Where are the sampling locations and what is representative monitoring?
1. This Final Rule
2. Summary of Major Comments and EPA Responses
E. How long do laboratories and PWSs have to report data?
1. This Final Rule
2. Summary of Major Comments and EPA Responses
F. What are the reporting requirements for UCMR 5?
1. This Final Rule
2. Summary of Major Comments and EPA Responses
a. Data Elements
b. Reporting State Data
G. What are the UCMR 5 Minimum Reporting Levels (MRLs) and how were they determined?
1. This Final Rule
2. Summary of Major Comments and EPA Responses
H. What are the requirements for laboratory analysis of field reagent blank samples?
1. This Final Rule
2. Summary of Major Comments and EPA Responses
I. How will EPA support risk communication for UCMR 5 results?
V. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review
B. Paperwork Reduction Act (PRA)
C. Regulatory Flexibility Act (RFA)
D. Unfunded Mandates Reform Act (UMRA)
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments
G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks
H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use
I. National Technology Transfer and Advancement Act (NTTAA)
J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations
K. Congressional Review Act (CRA)
VI. References
Abbreviations and Acronyms
μg/L Microgram per Liter
11Cl-PF3OUdS 11-chloroeicosafluoro-3-oxaundecane-1-sulfonic Acid
4:2 FTS 1H, 1H, 2H, 2H-perfluorohexane Sulfonic Acid
6:2 FTS 1H, 1H, 2H, 2H-perfluorooctane Sulfonic Acid
8:2 FTS 1H, 1H, 2H, 2H-perfluorodecane Sulfonic Acid
9Cl-PF3ONS 9-chlorohexadecafluoro-3-oxanone-1-sulfonic Acid
ADONA 4,8-dioxa-3H-perfluorononanoic Acid
AES Atomic Emission Spectrometry
ASDWA Association of State Drinking Water Administrators
ASTM ASTM International
AWIA America's Water Infrastructure Act of 2018
CASRN Chemical Abstracts Service Registry Number
CBI Confidential Business Information
CCL Contaminant Candidate List
CCR Consumer Confidence Report
CFR Code of Federal Regulations
CRA Congressional Review Act
CWS Community Water System
DBP Disinfection Byproduct
DWSRF Drinking Water State Revolving Fund
EPA United States Environmental Protection Agency
EPTDS Entry Point to the Distribution System
FR Federal Register
FRB Field Reagent Blank
GW Ground Water
GWRMP Ground Water Representative Monitoring Plan
HFPO-DA Hexafluoropropylene Oxide Dimer Acid (GenX)
HRL Health Reference Level
ICP Inductively Coupled Plasma
ICR Information Collection Request
IDC Initial Demonstration of Capability
LCMRL Lowest Concentration Minimum Reporting Level
LC/MS/MS Liquid Chromatography/Tandem Mass Spectrometry
MDBP Microbial and Disinfection Byproduct
MRL Minimum Reporting Level
NAICS North American Industry Classification System
NCOD National Contaminant Occurrence Database
NDAA National Defense Authorization Act for Fiscal Year 2020
NEtFOSAA N-ethyl Perfluorooctanesulfonamidoacetic Acid
NFDHA Nonafluoro‐3,6‐dioxaheptanoic Acid
ng/L Nanogram per Liter
NMeFOSAA N-methyl Perfluorooctanesulfonamidoacetic Acid
NPDWR National Primary Drinking Water Regulation
NTNCWS Non-transient Non-community Water System
NTTAA National Technology Transfer and Advancement Act
NTWC National Tribal Water Council
OGWDW Office of Ground Water and Drinking Water
OMB Office of Management and Budget
PFAS Per- and Polyfluoroalkyl Substances
PFBA Perfluorobutanoic Acid
PFBS Perfluorobutanesulfonic Acid
PFDA Perfluorodecanoic Acid
PFDoA Perfluorododecanoic Acid
PFEESA Perfluoro (2‐ethoxyethane) Sulfonic Acid
PFHpA Perfluoroheptanoic Acid
PFHpS Perfluoroheptanesulfonic Acid
PFHxA Perfluorohexanoic Acid
PFHxS Perfluorohexanesulfonic Acid
PFMBA Perfluoro‐4‐methoxybutanoic Acid
PFMPA Perfluoro‐3‐methoxypropanoic Acid
PFNA Perfluorononanoic Acid
PFOA Perfluorooctanoic Acid
PFOS Perfluorooctanesulfonic Acid
PFPeA Perfluoropentanoic Acid
PFPeS Perfluoropentanesulfonic Acid
PFTA Perfluorotetradecanoic Acid
PFTrDA Perfluorotridecanoic Acid
PFUnA Perfluoroundecanoic Acid
PN Public Notice
PRA Paperwork Reduction Act
PT Proficiency Testing
PWS Public Water System
QC Quality Control
RFA Regulatory Flexibility Act
SBA Small Business Administration
SBREFA Small Business Regulatory Enforcement Fairness Act
SDWA Safe Drinking Water Act
SDWARS Safe Drinking Water Accession and Review System
SDWIS/Fed Safe Drinking Water Information System Federal Reporting Services
SM Standard Methods for the Examination of Water and Wastewater
SOP Standard Operating Procedure
SPE Solid Phase Extraction
SRMD Standards and Risk Management Division
SW Surface Water
SWTR Surface Water Treatment Rule
TNCWS Transient Non-community Water System
TOF Total Organic Fluorine
TOP Total Oxidizable Precursors
UCMR Unregulated Contaminant Monitoring Rule
UMRA Unfunded Mandates Reform Act of 1995
U.S. United States
USEPA United States Environmental Protection Agency
I. Summary Information
A. Purpose of the Regulatory Action
1. What action is EPA taking?
This final rule requires certain public water systems (PWSs), described in section I.A.2 of this preamble, to collect national occurrence data for 29 PFAS and lithium. PFAS and lithium are not currently subject to national primary drinking water regulations, and EPA is requiring collection of data under UCMR 5 to inform EPA regulatory determinations and risk-management decisions. Consistent with EPA's PFAS Strategic Roadmap, UCMR 5 will provide new data critically needed to improve EPA's understanding of the frequency that 29 PFAS (and lithium) are found in the nation's drinking water systems and at what levels. This data will ensure science-based decision-making and help prioritize protection of disadvantaged communities.
2. Does this action apply to me?
This final rule applies to PWSs described in this section. PWSs are systems that provide water for human consumption through pipes, or constructed conveyances, to at least 15 service connections or that regularly serve an average of at least 25 individuals daily at least 60 days out of the year. A community water system (CWS) is a PWS that has at least 15 service connections used by year-round residents or regularly serves at least 25 year-round residents. A non-transient non-community water system (NTNCWS) is a PWS that is not a CWS and that regularly serves at least 25 of the same people over 6 months per year. Under this final rule, all large CWSs and NTNCWSs serving more than 10,000 people are required to monitor. In addition, small CWSs and NTNCWSs serving between 3,300 and 10,000 people are required to monitor (subject to available EPA appropriations and EPA notification of such requirement) as are the PWSs included in a nationally representative sample of CWSs and NTNCWSs serving between 25 and 3,299 people (see “Selection of Nationally Representative Public Water Systems for the Unregulated Contaminant Monitoring Rule: 2021 Update” for a description of the statistical approach for EPA's selection of the nationally representative sample (USEPA, 2021a), available in the UCMR 5 public docket). EPA expects to clarify the monitoring responsibilities for affected small systems by approximately July 1 of each year preceding sample collection, based on the availability of appropriations each year.
As in previous UCMRs, transient non-community water systems (TNCWSs) ( i.e., non-community water systems that do not regularly serve at least 25 of the same people over 6 months per year) are not required to monitor under UCMR 5. EPA leads UCMR 5 monitoring as a direct-implementation program. States, Territories, and Tribes with primary enforcement responsibility (primacy) to administer the regulatory program for PWSs under SDWA (hereinafter collectively referred to in this document as “states”), can participate in the implementation of UCMR 5 through voluntary Partnership Agreements (see discussion of Partnership Agreements in Section III.D of this preamble). Under Partnership Agreements, states can choose to be involved in various aspects of UCMR 5 monitoring for PWSs they oversee; however, the PWS remains responsible for compliance with the final rule. Potentially regulated categories and entities are identified in the following table.
Category | Examples of potentially regulated entities | NAICS * |
---|---|---|
* NAICS = North American Industry Classification System. | ||
State, local, & Tribal governments | State, local, and Tribal governments that analyze water samples on behalf of PWSs required to conduct such analysis; State, local, and Tribal governments that directly operate CWSs and NTNCWSs required to monitor | 924110 |
Industry | Private operators of CWSs and NTNCWSs required to monitor | 221310 |
Municipalities | Municipal operators of CWSs and NTNCWSs required to monitor | 924110 |
This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. This table lists the types of entities that EPA is aware could potentially be regulated by this action. Other types of entities not listed in the table could also be regulated. To determine whether your entity is regulated by this action, you should carefully examine the definition of PWS found in Title 40 in the Code of Federal Regulations (CFR) at 40 CFR 141.2 and 141.3, and the applicability criteria found in 40 CFR 141.40(a)(1) and (2). If you have questions regarding the applicability of this action to a particular entity, please consult the contacts listed in the preceding FOR FURTHER INFORMATION CONTACT section of this preamble.
3. What is EPA's authority for taking this action?
As part of EPA's responsibilities under SDWA, the agency implements section 1445(a)(2), Monitoring Program for Unregulated Contaminants. This section, as amended in 1996, requires that once every five years, beginning in August 1999, EPA issue a list of not more than 30 unregulated contaminants to be monitored by PWSs. SDWA requires that EPA enter the monitoring data into the agency's publicly available National Contaminant Occurrence Database (NCOD) at https://www.epa.gov/sdwa/national-contaminant-occurrence-database-ncod.
EPA must vary the frequency and schedule for monitoring based on the number of people served, the source of supply, and the contaminants likely to be found. EPA is using SDWA Section 1445(a)(2) authority as the basis for monitoring the unregulated contaminants under this final rule.
Section 2021 of America's Water Infrastructure Act of 2018 (AWIA) (Pub. L. 115-270) amended SDWA and specifies that, subject to the availability of EPA appropriations for such purpose and sufficient laboratory capacity, EPA's UCMR program must require all PWSs serving between 3,300 and 10,000 people to monitor for the contaminants in a particular UCMR cycle, and ensure that only a nationally representative sample of systems serving between 25 and 3,299 people are required to monitor for those contaminants. EPA has developed this final rule anticipating that necessary appropriations will become available; however, to date, Congress has not appropriated additional funding ( i.e., funding in addition to the $2.0 million that EPA has historically set aside each year from the Drinking Water State Revolving Fund, using SDWA authority, to support UCMR monitoring at small systems) to cover monitoring expenses for all PWSs serving between 3,300 and 10,000 people. Provisions in the final rule enable the agency to adjust the number of these systems that must monitor based upon available appropriations.
AWIA did not amend the original SDWA requirements for large PWSs. Therefore, PWSs serving a population larger than 10,000 people continue to be responsible for participating in UCMR.
Section 7311 of the National Defense Authorization Act for Fiscal Year 2020 (NDAA) (Pub. L. 116-92) amended SDWA and specifies that EPA shall include all PFAS in UCMR 5 for which a drinking water method has been validated by the Administrator and that are not subject to a national primary drinking water regulation.
4. What is the applicability date?
The applicability date represents an internal milestone used by EPA to determine if a PWS is included in the UCMR program and whether it will be treated as small ( i.e., serving 25 to 10,000 people) or large ( i.e., serving more than 10,000 people). It does not represent a date by which respondents need to take any action. The determination of whether a PWS is required to monitor under UCMR 5 is based on the type of system ( e.g., CWS, NTNCWS, etc.) and its retail population served, as indicated by the Safe Drinking Water Information System Federal Reporting Services (SDWIS/Fed) inventory on February 1, 2021. SDWIS/Fed can be accessed at https://www.epa.gov/ground-water-and-drinking-water/safe-drinking-water-information-system-sdwis-federal-reporting. Examining water system type and population served as of February 1, 2021 allowed EPA to develop a draft list of PWSs tentatively subject to UCMR 5 and share that list with the states during 2021 for their review. This advance planning and review then allowed EPA to load state-reviewed PWS information into EPA's reporting system so that those PWSs can be promptly notified upon publication of this final rule. If a PWS receives such notification and believes it has been erroneously included in UCMR 5 based on an incorrect retail population, the system should contact their state authority to verify its population served as of the applicability date. If an error impacting rule applicability is identified, the state or the PWS may contact EPA to address the error. The 5-year UCMR 5 cycle spans January 2022 through December 2026, with preparations in 2022, sample collection between January 1, 2023, and December 31, 2025, and completion of data reporting in 2026. By approximately July 1 of the year prior to each year's sample collection ( i.e., by July 1, 2022 for 2023 sampling; by July 1, 2023 for 2024 sampling; and by July 1, 2024 for 2025 sampling) EPA expects to determine whether it has received necessary appropriations to support its plan to monitor at all systems serving between 3,300 and 10,000 people and at a representative group of 800 smaller systems. As EPA finalizes its small-system plan for each sample collection year, the agency will notify the small PWSs accordingly.
B. Summary of the Regulatory Action
EPA is requiring certain PWSs to collect occurrence data for 29 PFAS and lithium. This document addresses key aspects of UCMR 5, including the following: Analytical methods to measure the contaminants; laboratory approval; monitoring timeframe; sampling locations; data elements ( i.e., information required to be collected along with the occurrence data); data reporting timeframes; monitoring cost; public participation; conforming and editorial changes, such as those necessary to remove requirements solely related to UCMR 4; and EPA responses to public comments on the proposed rule. This document also discusses the implication for UCMR 5 of the AWIA Section 2021(a) requirement that EPA collect monitoring data from all systems serving more than 3,300 people “subject to the availability of appropriations.”
Regardless of whether EPA is able to carry out the small-system monitoring as planned, or instead reduces the scope of that monitoring, the small-system data collection, coupled with data collection from all systems serving more than 10,000 people under this action, will provide scientifically valid data on the national occurrence of 29 PFAS and lithium in drinking water. The UCMR data are the primary source of national occurrence data that EPA uses to inform regulatory and other risk management decisions for drinking water contaminant candidates.
EPA is required under SDWA Section 1445(a)(2)(C)(ii) to pay the “reasonable cost of such testing and laboratory analysis” for all applicable PWSs serving 25 to 10,000 people. Consistent with AWIA, EPA will require monitoring at as many systems serving 3,300 to 10,000 people as appropriations support (see Section IV.B of this preamble for more information on the agency's sampling design).
The agency received several public comments expressing concern that significant laboratory capacity will be needed to support the full scope envisioned for UCMR 5 PFAS monitoring. EPA anticipates that sufficient laboratory capacity will exist to support the expanded UCMR 5 scope. EPA's experience over the first four cycles of UCMR implementation has been that laboratory capacity quickly grows to meet UCMR demand. EPA also notes that the number of laboratories successfully participating in the early stages of the UCMR 5 laboratory approval program is a good indicator that there will be a robust national network of laboratories experienced in PFAS drinking water analysis.
By early 2022, EPA will notify all small CWSs and NTNCWSs serving between 3,300 and 10,000 people of their anticipated requirement to monitor, which EPA expects to confirm and schedule by July 1 preceding each collection year based on the availability of appropriations. The nationally representative sample of smaller PWSs described in Section I.A of this preamble will be similarly notified and advised of their schedules.
This final rule addresses the requirements of the NDAA by including all 29 PFAS that are within the scope of EPA Methods 533 and 537.1. Both of these methods have been validated by EPA for drinking water analysis.
C. Economic Analysis
1. What is the estimated cost of this action?
EPA estimates the total average national cost of this action would be $21 million per year over the 5-year effective period of the final rule (2022-2026) assuming EPA collects information from all systems serving between 3,300 and 10,000 people. All of these costs are associated with paperwork burden under the Paperwork Reduction Act (PRA). EPA discusses the expected costs as well as documents the assumptions and data sources used in the preparation of this estimate in the “Information Collection Request for the Final Unregulated Contaminant Monitoring Rule (UCMR 5)” (USEPA, 2021b). Costs are incurred by large PWSs (for sampling and analysis); small PWSs (for sampling); state regulatory agencies ( i.e., those who volunteer to assist EPA with oversight and implementation support); and EPA (for regulatory support and oversight activities, and analytical and shipping costs for samples from small PWSs). These costs are also summarized in Exhibit 1 of this preamble. EPA's estimates are based on executing the full monitoring plan for small systems ( i.e., including all systems serving 3,300 to 10,000 people and a representative group of 800 smaller systems). As such, those estimates represent an upper bound. If EPA does not receive the necessary appropriations in one or more of the collections years—and thus collects data from fewer small systems—the actual costs would be lower than those estimated here.
EPA received several comments on the cost of monitoring. EPA has accounted for the cost/burden associated with all of the PWS activities as part of the comprehensive cost/burden estimates. In order to provide the most accurate and updated cost estimate, EPA re-examined labor burden estimates for states, EPA, and PWS activities and updated costs of laboratory services for sample analysis, based on consultations with national drinking water laboratories, when developing this final rule.
The costs for a particular UCMR cycle are heavily influenced by the selection of contaminants and associated analytical methods. EPA identified three EPA-developed analytical methods (and, in the case of lithium, multiple optional alternative methods) to analyze samples for UCMR 5 contaminants. EPA's estimate of the UCMR 5 analytical cost is $740 per sample set ( i.e., $740 to analyze a set of samples from one sample point and one sample event for the 30 UCMR 5 contaminants).
Exhibit 1 of this preamble details the EPA-estimated annual average national costs (accounting for labor and non-labor expenses). Laboratory analysis and sample shipping account for approximately 65 percent of the estimated total national cost for the implementation of UCMR 5. EPA estimated laboratory costs based on consultations with multiple commercial drinking water testing laboratories. EPA's cost estimates for the laboratory methods include shipping and analysis.
EPA expects that states will incur modest labor costs associated with voluntary assistance with the implementation of UCMR 5. EPA estimated state costs using the relevant assumptions from the State Resource Model developed by the Association of State Drinking Water Administrators (ASDWA) (ASDWA, 2013) to help states forecast resource needs. Model estimates were adjusted to account for actual levels of state participation under UCMR 4. State assistance with EPA's implementation of UCMR 5 is voluntary; thus, the level of effort is expected to vary among states and will depend on their individual agreements with EPA.
EPA assumes that one-third of the systems will collect samples during each of the three sample-collection years from January 2023 through December 2025.
Entity | Average annual cost (million) (2022-2026) 2 |
---|---|
1 Based on the scope of small-system monitoring described in AWIA. | |
2 Totals may not equal the sum of components due to rounding. | |
3 Labor costs pertain to PWSs, states, and EPA. Costs include activities such as reading the final rule, notifying systems selected to participate, sample collection, data review, reporting, and record keeping. | |
4 Non-labor costs will be incurred primarily by EPA and by large and very large PWSs. They include the cost of shipping samples to laboratories for testing and the cost of the laboratory analyses. | |
5 For a typical UCMR program that involves the expanded scope prescribed by AWIA, EPA estimates an average annual cost to the agency of $17M/year (over a 5-year cycle) ($2M/year for the representative sample of 800 PWSs serving between 25 and 3,299 people and $15M/year for all PWSs serving between 3,300 and 10,000 people). The projected cost to EPA for UCMR 5 implementation is lower than for a typical UCMR program because of lower sample analysis expenses. Those lower expenses are a result of analytical method efficiencies ( i.e., being able to monitor for 30 chemicals with only three analytical methods). | |
Small PWSs (25-10,000), including labor 3 only (non-labor costs 4 paid for by EPA) | $0.3 |
Large PWSs (10,001-100,000), including labor and non-labor costs | 7.0 |
Very Large PWSs (100,001 and greater), including labor and non-labor costs | 2.2 |
States, including labor costs related to implementation coordination | 0.8 |
EPA, including labor for implementation and non-labor for small system testing | 5 10.5 |
Average Annual National Total | 20.8 |
Additional details regarding EPA's cost assumptions and estimates can be found in the Information Collection Request (ICR) (USEPA, 2021b), ICR Number 2040-0304, which presents estimated cost and labor hours for the 5-year UCMR 5 period of 2022-2026. Copies of the ICR may be obtained from the EPA public docket for this final rule under Docket ID No. EPA-HQ-OW-2020-0530.
2. What are the benefits of this action?
The public benefits from the information about whether or not unregulated contaminants are present in their drinking water. If contaminants are not found, consumer confidence in their drinking water should improve. If contaminants are found, related health effects may be avoided when subsequent actions, such as regulations, are implemented, reducing or eliminating those contaminants.
II. Public Participation
A. What meetings have been held in preparation for UCMR 5?
EPA held three public meetings on UCMR 5 over the period of 2018 through 2021. EPA held a meeting focused on drinking water methods for unregulated contaminants on June 6, 2018, in Cincinnati, Ohio. Representatives from state agencies, laboratories, PWSs, environmental organizations, and drinking water associations joined the meeting via webinar and in person. Meeting topics included an overview of regulatory process elements (including the Contaminant Candidate List (CCL), UCMR, and Regulatory Determination), and drinking water methods under development (see USEPA, 2018 for presentation materials). EPA held a second meeting on July 16, 2019, in Cincinnati, Ohio. Representatives from State agencies, Tribes, laboratories, PWSs, environmental organizations, and drinking water associations participated in the meeting via webinar and in person. Meeting topics included the impacts of AWIA, analytical methods and contaminants being considered by EPA, potential sampling design, and other possible aspects of the UCMR 5 approach (see USEPA, 2019a for meeting materials). EPA held two identical virtual meetings on April 6 and 7, 2021, during the public comment period for the proposed rule (see USEPA, 2021c for presentation materials). Topics included the proposed UCMR 5 monitoring requirements, analyte selection and rationale, analytical methods, the laboratory approval process, and ground water representative monitoring plans (GWRMPs). Representatives of state agencies, laboratories, PWSs, environmental organizations, and drinking water associations participated in the meeting via webinar. In Section II.B of this preamble, the agency is announcing additional meetings to be held in 2022, which will assist with implementation.
B. How do I participate in the upcoming meetings?
EPA will hold multiple virtual meetings during 2022 to discuss UCMR 5 implementation planning, data reporting using Safe Drinking Water Accession and Review System (SDWARS), and best practices for sample collection. Dates and times of the upcoming meetings will be posted on EPA's website at https://www.epa.gov/dwucmr/unregulated-contaminant-monitoring-rule-ucmr-meetings-and-materials. EPA anticipates hosting the meetings focused on implementation planning in spring 2022, and the SDWARS and sample-collection meetings in fall 2022. Stakeholders who have participated in past UCMR meetings and/or those who register to use SDWARS will receive notification of these events. Other interested stakeholders are also welcome to participate.
1. Meeting Participation
Those who wish to participate in the public meetings, via webinar, can find information on how to register at https://www.epa.gov/dwucmr/unregulated-contaminant-monitoring-rule-ucmr-meetings-and-materials. The number of webinar connections available for the meetings are limited and will be available on a first-come, first-served basis. If stakeholder interest results in exceeding the maximum number of available connections for participants in upcoming webinar offerings, EPA may schedule additional webinars, with dates and times posted on EPA's Unregulated Contaminant Monitoring Program Meetings and Materials web page at https://www.epa.gov/dwucmr/unregulated-contaminant-monitoring-rule-ucmr-meetings-and-materials.
2. Meeting Materials
EPA expects to send meeting materials by email to all registered participants prior to the meeting. The materials will be posted on EPA's website at https://www.epa.gov/dwucmr/unregulated-contaminant- monitoring-rule-ucmr-meetings-and-materials for people who do not participate in the webinar.
III. General Information
A. How are CCL, UCMR, Regulatory Determination process, and NCOD interrelated?
Under the 1996 amendments to SDWA, Congress established a multi-step, risk-based approach for determining which contaminants would become subject to drinking water standards. Under the first step, EPA is required to publish a CCL every five years that identifies contaminants that are not subject to any proposed or promulgated drinking water regulations, are known or anticipated to occur in PWSs, and may require future regulation under SDWA. EPA published the draft CCL 5 in the Federal Register on July 19, 2021 (86 FR 37948, July 19, 2021 (USEPA, 2021d)). Under the second step, EPA must require, every five years, monitoring of unregulated contaminants as described in this action. The third step requires EPA to determine, every five years, whether or not to regulate at least five contaminants from the CCL. Under Section 1412(b)(1)(A) of SDWA, EPA regulates a contaminant in drinking water if the Administrator determines that:
(1) The contaminant may have an adverse effect on the health of persons;
(2) The contaminant is known to occur or there is substantial likelihood that the contaminant will occur in PWSs with a frequency and at levels of public health concern; and
(3) In the sole judgment of the Administrator, regulation of such contaminant presents a meaningful opportunity for health risk reduction for persons served by PWSs.
For the contaminants that meet all three criteria, SDWA requires EPA to publish national primary drinking water regulations (NPDWRs). Information on the CCL and the regulatory determination process can be found at: https://www.epa.gov/ccl.
The data collected through the UCMR program are made available to the public through the National Contaminant Occurrence Database (NCOD) for drinking water. EPA developed the NCOD to satisfy requirements in SDWA Section 1445(g), to assemble and maintain a drinking water contaminant occurrence database for both regulated and unregulated contaminants in drinking water systems. NCOD houses data on unregulated contaminant occurrence; data from EPA's “Six-Year Review” of national drinking water regulations; and ambient and/or source water data. Section 1445(g)(3) of SDWA requires that EPA maintain UCMR data in the NCOD and use the data when evaluating the frequency and level of occurrence of contaminants in drinking water at a level of public health concern. UCMR results can be viewed by the public via NCOD ( https://www.epa.gov/sdwa/national-contaminant-occurrence-database-ncod ) or via the UCMR web page at: https://www.epa.gov/dwucmr.
B. What are the Consumer Confidence Reporting and Public Notice Reporting requirements for public water systems that are subject to UCMR?
In addition to reporting UCMR monitoring data to EPA, PWSs are responsible for presenting and addressing UCMR results in their annual Consumer Confidence Reports (CCRs) (40 CFR 141.153) and must address Public Notice (PN) requirements associated with UCMR (40 CFR 141.207). More details about the CCR and PN requirements can be viewed by the public at: https://www.epa.gov/ccr and https://www.epa.gov/dwreginfo/public-notification-rule, respectively.
C. What is the UCMR 5 timeline?
This final rule identifies a UCMR 5 sampling period of 2023 to 2025. Prior to 2023 EPA will coordinate laboratory approval, tentatively select representative small systems (USEPA, 2021a), organize Partnership Agreements, develop State Monitoring Plans (see Section III.D of this preamble), establish monitoring schedules and inventory, and conduct outreach and training. Exhibit 2 of this preamble illustrates the major activities that EPA expects will take place in preparation for and during the implementation of UCMR 5.
BILLING CODE 6560-50-P
BILLING CODE 6560-50-C
D. What is the role of “States” in UCMR?
UCMR is a direct implementation rule ( i.e., EPA has primary responsibility for its implementation) and state participation is voluntary. Under the previous UCMR cycles, specific activities that individual states agreed to carry out or assist with were identified and established exclusively through Partnership Agreements. Through Partnership Agreements, states can help EPA implement UCMR and help ensure that the UCMR data are of the highest quality possible to best support the agency decision making. Under UCMR 5, EPA will continue to use the Partnership Agreement process to determine and document the following: The process for review and revision of the State Monitoring Plans; replacing and updating PWS information, including inventory ( i.e., PWS identification codes (PWSID), facility identification code along with associated facility types and water source type, etc.); review of proposed GWRMPs; notification and instructions for systems; and compliance assistance. EPA recognizes that states often have the best information about their PWSs and encourages them to partner in the UCMR 5 program.
E. How did EPA consider Children's Environmental Health?
By monitoring for unregulated contaminants that may pose health risks via drinking water, UCMR furthers the protection of public health for all citizens, including children. Children consume more water per unit of body weight compared to adults. Moreover, formula-fed infants drink a large amount of water compared to their body weight; thus, children's exposure to contaminants in drinking water may present a disproportionate health risk (USEPA, 2011). The objective of UCMR 5 is to collect nationally representative drinking water occurrence data on unregulated contaminants for future regulatory consideration. Information on the prioritization process, as well as contaminant-specific information ( e.g., source, use, production, release, persistence, mobility, health effects, and occurrence), that EPA used to select the analyte list, is contained in “Information Compendium for Contaminants for the Final Unregulated Contaminant Monitoring Rule (UCMR 5)” (USEPA, 2021e), available in the UCMR 5 public docket.
Since this is a final rule to monitor for contaminants and not to reduce their presence in drinking water to an acceptable level, the rule does not concern environmental health or safety risks presenting a disproportionate risk to children that would be addressed by this action (See Section V.G Executive Order 13045 of this preamble). Therefore, Executive Order 13045 does not apply to UCMR. However, EPA's Policy on Evaluating Health Risks to Children, which ensures that the health of infants and children is explicitly considered in the agency's decision making, is applicable, see: https://www.epa.gov/children/epas-policy-evaluating-risk-children.
EPA considered children's health risks during the development of UCMR 5. This included considering public comments about candidate contaminant priorities. Many commenters supported the agency's inclusion of PFAS and lithium in UCMR 5. Some commenters requested that EPA consider children and infant health risks in its risk communication for UCMR 5.
Using quantitation data from multiple laboratories, EPA establishes statistically-based UCMR reporting levels the agency considers feasible for the national network of approved drinking water laboratories. EPA generally sets the reporting levels as low as is technologically practical for measurement by that national network of laboratories, even if that level is well below concentrations that are currently associated with known or suspected health effects. In doing so, EPA positions itself to better address contaminant risk information in the future, including that associated with unique risks to children.
F. How did EPA address Environmental Justice (EJ)?
EPA has concluded that this action is not subject to Executive Order 12898 because it does not establish an environmental health or safety standard (see Section V.J Executive Order 12898 of this preamble). EPA Administrator Regan issued a directive to all EPA staff to incorporate environmental justice (EJ) into the agency's work, including regulatory activities, such as integrating EJ considerations into the regulatory development processes and considering regulatory options to maximize benefits to communities that “continue to suffer from disproportionately high pollution levels and the resulting adverse health and environmental impacts.” In keeping with this directive, and consistent with AWIA, EPA will, subject to the availability of sufficient appropriations, expand UCMR 5 to include all PWSs serving between 3,300 and 10,000 people as described in Sections I.A.4 and IV.B of this preamble. If there are sufficient appropriations, the expansion in the number of participating PWSs will provide a more comprehensive assessment of contaminant occurrence data from small and rural communities, including disadvantaged communities.
By developing a national characterization of unregulated contaminants that may pose health risks via drinking water from PWSs, UCMR furthers the protection of public health for all citizens. If EPA receives the needed appropriations, the expansion in monitoring scope reflected in UCMR 5 ( i.e., including all PWSs serving 3,300 to 10,000 people) will better support state and regional analyses and determination of potential EJ-related issues that need to be addressed. EPA structured the UCMR 5 rulemaking process to allow for meaningful involvement and transparency. EPA organized public meetings and webinars to share information regarding the development and implementation of UCMR 5; consulted with Tribal governments; and convened a workgroup that included representatives from several states. EPA will support stakeholder interest in UCMR 5 results by making them publicly available, as described in Section III.A of this preamble, and by developing additional risk-communication materials to help individuals and communities understand the significance of contaminant occurrence.
EPA received multiple comments on environmental justice considerations. Commenters expressed support for the continued collection of U.S. Postal Service Zip Codes for each PWS's service area and requested that EPA provide multilingual UCMR materials. EPA will continue to collect Zip Codes for UCMR 5, as collected under UCMR 3 and UCMR 4, to support potential assessments of whether or not certain communities are disproportionately impacted by particular drinking water contaminants. EPA also intends to develop the sampling instructions, fact sheets, and data summaries in both English and Spanish.
G. How did EPA coordinate with Indian Tribal Governments?
EPA has concluded that this action has Tribal implications. However, it will neither impose substantial direct compliance costs on federally recognized Tribal governments, nor preempt Tribal law. (See section V.F Executive Order 13175 of this preamble).
EPA consulted with Tribal officials under the EPA Policy on Consultation and Coordination with Indian Tribes early in the process of developing this action to ensure meaningful and timely input into its development. EPA initiated the Tribal consultation and coordination process before proposing the rule by mailing a “Notification of Consultation and Coordination” letter on June 26, 2019, to the Tribal leadership of the then 573 federally recognized Tribes. The letter invited Tribal leaders and representatives of Tribal governments to participate in an August 6, 2019, UCMR 5 Tribal consultation and coordination informational meeting. Presentation topics included an overview of the UCMR program, potential approaches to monitoring and implementation for UCMR 5, and the UCMR 5 contaminants and analytical methods under consideration. After the presentation, EPA provided an opportunity for input and questions on the action. Eight representatives from five Tribes attended the August meeting. Tribal representatives asked clarifying questions regarding program costs to PWSs and changes in PWS participation per AWIA. EPA addressed the questions during the meeting. Following the meeting, EPA received and addressed one additional clarifying question from a Tribal representative during the Tribal consultation process. No other Tribal representatives submitted written comments during the UCMR 5 consultation comment period that ended September 1, 2019.
Prior to the August 2019 meeting, EPA provided additional opportunities for Tribal officials to provide meaningful and timely input into the development of the proposed rule. On July 10, 2019, EPA participated in a monthly conference call with the National Tribal Water Council (NTWC). EPA shared a brief summary of UCMR statutory requirements with the Council and highlighted the upcoming official Tribal meeting. EPA also invited Tribal leaders and representatives to participate in a public meeting, held on July 16, 2019, to discuss the development of the proposed rule. Representatives from six Tribes participated in the public meeting. Following the publication of the proposal, EPA advised the Indian Health Services of the 60-day public comment period to assist with facilitating additional Tribal comments on the proposed rule. EPA received no public comments from Tribal officials.
A complete summary of the consultation, titled, “Summary of the Tribal Coordination and Consultation Process for the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” is provided in the UCMR 5 public docket listed in the ADDRESSES section of this preamble.
H. How are laboratories approved for UCMR 5 analyses?
Consistent with prior UCMRs, this action maintains the requirement that PWSs use laboratories approved by EPA to analyze UCMR 5 samples. Interested laboratories are encouraged to apply for EPA approval as early as possible. The UCMR 5 laboratory approval process, which began with the publication of the UCMR 5 proposal, is designed to assess whether laboratories possess the required equipment and can meet laboratory-performance and data-reporting criteria described in this action.
EPA expects demand for laboratory support to increase significantly based on the greater number of PWSs expected to participate in UCMR 5. EPA anticipates that the number of participating small water systems will increase from the typical 800 to approximately 6,000 (see Exhibit 5 in Section IV.B of this preamble). In preparation for this increase, EPA will solicit proposals and award contracts to laboratories to support small system monitoring prior to the end of the proficiency testing (PT) program. As in previous UCMR programs, EPA expects that laboratories awarded contracts by EPA will be required to first be approved to perform all methods. The requirements for the laboratory approval process are described in steps 1 through 6 of the following paragraphs.
EPA will require laboratories seeking approval to: (1) Provide EPA with data documenting an initial demonstration of capability (IDC) as outlined in each method; (2) verify successful performance at or below the minimum reporting levels (MRLs) as specified in this action; (3) provide information about laboratory standard operating procedures (SOPs); and (4) participate in two EPA PT studies for the analytes of interest. Audits of laboratories may be conducted by EPA prior to and/or following approval, and maintaining approval is contingent on timely and accurate reporting. The “UCMR 5 Laboratory Approval Manual” (USEPA, 2021f), available in the UCMR 5 public docket, provides more specific guidance on EPA laboratory approval program and the specific method acceptance criteria. EPA has included sample-collection procedures that are specific to the methods in the “UCMR 5 Laboratory Manual,” and will address these procedures in our outreach to the PWSs that will be collecting samples.
The UCMR 5 laboratory approval program will provide an assessment of the ability of laboratories to perform analyses using the methods listed in 40 CFR 141.40(a)(3), Table 1 of this preamble. Laboratory participation in the program is voluntary. However, as in the previous UCMRs, EPA will require PWSs to exclusively use laboratories that have been approved under the program. EPA will post a list of approved UCMR 5 laboratories to https://www.epa.gov/dwucmr and will bring this to the attention of the PWSs in our outreach.
1. Request To Participate
Laboratories interested in the UCMR 5 laboratory approval program first email EPA at: UCMR_Lab_Approval@epa.gov to request registration materials. EPA began accepting requests beginning with the publication of the proposal in the Federal Register .
2. Registration
Laboratory applicants provide registration information that includes laboratory name, mailing address, shipping address, contact name, phone number, email address, and a list of the UCMR 5 methods for which the laboratory is seeking approval. This registration step provides EPA with the necessary contact information and ensures that each laboratory receives a customized application package.
3. Application Package
Laboratory applicants will complete and return a customized application package that includes the following: IDC data, including precision, accuracy, and results of MRL studies; information regarding analytical equipment and other materials; proof of current drinking water laboratory certification (for select compliance monitoring methods); method-specific SOPs; and example chromatograms for each method under review.
As a condition of receiving and maintaining approval, the laboratory must promptly post UCMR 5 monitoring results and quality control data that meet method criteria (on behalf of its PWS clients) to EPA's UCMR electronic data reporting system, SDWARS.
Based on the January 1, 2023 start for UCMR 5 sample collection, the deadline for a laboratory to submit the necessary registration and application information is August 1, 2022.
4. EPA's Review of Application Package
EPA will review the application packages and, if necessary, request follow-up information. Laboratories that successfully complete the application process become eligible to participate in the UCMR 5 PT program.
5. Proficiency Testing
A PT sample is a synthetic sample containing a concentration of an analyte or mixture of analytes that is known to EPA, but unknown to the laboratory. To be approved, a laboratory must meet specific acceptance criteria for the analysis of a UCMR 5 PT sample(s) for each analyte in each method, for which the laboratory is seeking approval. EPA offered three PT studies between publication of the proposed rule and final rule, and anticipates offering at least two additional studies. Interested laboratories must participate in and report data for at least two PT studies. This allows EPA to collect a robust dataset for PT results, and provides laboratories with extra analytical experience using UCMR 5 methods. Laboratories must pass a PT for every analyte in the method to be approved for that method and may participate in multiple PT studies in order to produce passing results for each analyte. EPA has taken this approach in UCMR 5, recognizing that EPA Method 533 contains 25 analytes. EPA does not expect to conduct additional PT studies after the start of PWS monitoring; however, EPA expects to conduct laboratory audits (remote and/or on-site) throughout the implementation of UCMR 5 on an as needed and/or random basis. Initial laboratory approval is contingent on successful completion of PT studies, which includes properly uploading the PT results to SDWARS. Continued laboratory approval is contingent on successful completion of the audit process and satisfactorily meeting all the other stated conditions.
6. Written EPA Approval
For laboratories that have already successfully completed steps 1 through 5, EPA sent the laboratory a notification letter listing the methods for which approval was “pending” ( i.e., pending promulgation of this final rule). Because no changes have been made to the final rule that impact the laboratory approval program, laboratories that received pending-approval letters will be notified of full approval without further action on their part. Approval actions for additional laboratories that successfully complete steps 1 through 5 will also be documented by EPA in writing.
I. What documents are being incorporated by reference?
The following methods are being incorporated by reference into this section for UCMR 5 monitoring. All method material is available for inspection electronically at https://www.regulations.gov (Docket ID No. EPA-HQ-OW-2020-0530), or from the sources listed for each method. The methods that may be used to support monitoring under this final rule are as follows:
1. Methods From the U.S. Environmental Protection Agency
The following methods are available at EPA's Docket No. EPA-HQ-OW-2020-0530.
(i) EPA Method 200.7 “Determination of Metals and Trace Elements in Water and Wastes by Inductively Coupled Plasma-Atomic Emission Spectrometry,” Revision 4.4, 1994. Available at https://www.epa.gov/esam/method-2007-determination-metals-and-trace-elements-water-and-wastes-inductively-coupled-plasma. This is an EPA method for the analysis of metals and trace elements in water by ICP-AES and may be used to measure lithium during UCMR 5. See also the discussion of non-EPA alternative methods for lithium in this section.
(ii) EPA Method 533 “Determination of Per- and Polyfluoroalkyl Substances in Drinking Water by Isotope Dilution Anion Exchange Solid Phase Extraction and Liquid Chromatography/Tandem Mass Spectrometry,” November 2019, EPA 815-B-19-020. Available at https://www.epa.gov/dwanalyticalmethods/analytical-methods-developed-epa-analysis-unregulated-contaminants. This is an EPA method for the analysis PFAS in drinking water using SPE and LC/MS/MS and is to be used to measure 25 PFAS during UCMR 5 (11Cl-PF3OUdS, 8:2 FTS, 4:2 FTS, 6:2 FTS, ADONA, 9Cl-PF3ONS, HFPO-DA (GenX), NFDHA, PFEESA, PFMPA, PFMBA, PFBS, PFBA, PFDA, PFDoA, PFHpS, PFHpA, PFHxS, PFHxA, PFNA, PFOS, PFOA, PFPeS, PFPeA, and PFUnA).
(iii) EPA Method 537.1 “Determination of Selected Per- and Polyfluorinated Alkyl Substances in Drinking Water by Solid Phase Extraction and Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS),” Version 2.0, March 2020, EPA/600/R-20/006. Available at https://www.epa.gov/dwanalyticalmethods/analytical-methods-developed-epa-analysis-unregulated-contaminants. This is an EPA method for the analysis of PFAS in drinking water using SPE and LC/MS/MS and is to be used to measure four PFAS during UCMR 5 (NEtFOSAA, NMeFOSAA, PFTA, and PFTrDA).
2. Alternative Methods From American Public Health Association—Standard Methods (SM)
The following methods are from American Public Health—Standard Methods (SM), 800 I Street NW, Washington, DC 20001-3710.
(i) “Standard Methods for the Examination of Water & Wastewater,” 23rd edition (2017).
(a) SM 3120 B, “Metals by Plasma Emission Spectroscopy (2017): Inductively Coupled Plasma (ICP) Method.” This is a Standard Method for the analysis of metals in water and wastewater by emission spectroscopy using ICP and may be used for the analysis of lithium.
(ii) “Standard Methods Online,” approved 1999. Available for purchase at https://www.standardmethods.org.
(a) SM 3120 B, “Metals by Plasma Emission Spectroscopy: Inductively Coupled Plasma (ICP) Method, Standard Methods Online,” revised December 14, 2020. This is a Standard Method for the analysis of metals in water and wastewater by emission spectroscopy using ICP and may be used for the analysis of lithium.
3. Methods From ASTM International
The following methods are from ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959.
(i) ASTM D1976-20, “Standard Test Method for Elements in Water by Inductively-Coupled Plasma Atomic Emission Spectroscopy,” approved May 1, 2020. Available for purchase at https://www.astm.org/Standards/D1976.htm. This is an ASTM method for the analysis of elements in water by ICP-AES and may be used to measure lithium.
IV. Description of Final Rule and Summary of Responses to Public Comments
EPA published “Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 5) for Public Water Systems and Announcement of Public Meeting;” Proposed Rule, on March 11, 2021 (86 FR 13846, (USEPA, 2021g)). The UCMR 5 proposal identified three EPA analytical methods, and multiple alternative methods, to support water system monitoring for 30 UCMR 5 contaminants (29 PFAS and lithium) and detailed other potential changes relative to UCMR 4. Among the other changes reflected in the UCMR 5 proposal were the following: Requirement for water systems serving 3,300 to 10,000 people to monitor per AWIA requirements “subject to the availability of appropriations”; provisions for sampling frequency, timing, and locations; submission timeframe for GWRMPs; data reporting timeframes; and reporting requirements.
EPA received 75 sets of comments from 72 public commenters, including other federal agencies, state and local governments, utilities and utility stakeholder organizations, laboratories, academia, non-governmental organizations, and other interested stakeholders. After considering the comments, EPA developed the final UCMR 5 as described in Exhibit 3 of this preamble. Except as noted, the UCMR 5 final rule approach is consistent with the proposed rule. A track-changes version of the rule language, comparing UCMR 4 to UCMR 5, (“Revisions to 40 CFR 141.35 and 141.40” (USEPA, 2021h)), is included in the electronic docket listed in the ADDRESSES section of this preamble.
This section summarizes key aspects of this final rule and the associated comments received in response to the proposed rule. EPA has compiled all public comments and EPA's responses in the “Response to Comments on the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” (USEPA, 2021i), which can be found in the electronic docket listed in the ADDRESSES section of this preamble.
Number | Title | ||
---|---|---|---|
CFR rule section | Description of section | Corresponding preamble section | |
Number | Title | ||
40 CFR 141.40(a)(3) | Contaminants in UCMR 5 | Maintains proposed list of 29 PFAS and lithium for monitoring | IV.A |
40 CFR 141.35(d), 40 CFR 141.40(a)(2)(ii), and 40 CFR 141.40(a)(4)(ii) | Scope of UCMR 5 applicability | Revises the scope of UCMR 5 to reflect that small CWSs and NTNCWSs serving 25 to 10,000 people will monitor (consistent with AWIA), if they are notified by the agency | IV.B |
40 CFR 141.40(a)(i)(B) | Sampling frequency and timing | Maintains proposed sample frequency (four sample events for SW, two sample events for GW) | IV.C |
40 CFR 141.35(c)(3) | Sampling locations and Ground Water Representative Monitoring Plans (GWRMPs) | Maintains proposed flexibility for PWSs to submit a GWRMP proposal to EPA | IV.D |
40 CFR 141.35(c)(6)(ii) and 40 CFR 141.40(a)(5)(vi) | Reporting timeframe | Maintains proposed timeframe (“within 90 days from the sample collection date”) for laboratories to post and approve analytical results in EPA's electronic data reporting system (for review by the PWS). Maintains proposed timeframe (“30 days from when the laboratory posts the data to EPA's electronic data reporting system”) for PWSs to review, approve, and submit data to the state and EPA | IV.E |
40 CFR 141.35(e) | Reporting requirements | Removes one proposed data element, maintains 27 proposed data elements, and clarifies the use of state data | IV.F |
40 CFR 141.40(a)(3) | Minimum reporting levels (MRL) | Maintains proposed MRLs for contaminants | IV.G |
A. What contaminants must be monitored under UCMR 5?
1. This Final Rule
EPA is maintaining the proposed list of UCMR 5 contaminants and the methods associated with analyzing those contaminants (see Exhibit 4 of this preamble). Further information on the prioritization process, as well as contaminant-specific information ( e.g., source, use, production, release, persistence, mobility, health effects, and occurrence), that EPA used to select the analyte list, is contained in “Information Compendium for Contaminants for the Final Unregulated Contaminant Monitoring Rule (UCMR 5)” (USEPA, 2021e). This Information Compendium can be found in the electronic docket listed in the ADDRESSES section of this preamble.
1 EPA Method 533 (Solid phase extraction (SPE) liquid chromatography/tandem mass spectrometry (LC/MS/MS)) (USEPA, 2019b). | |
2 EPA Method 537.1 Version 2.0 (Solid phase extraction (SPE) liquid chromatography/tandem mass spectrometry (LC/MS/MS)) (USEPA, 2020). | |
3 EPA Method 200.7 (Inductively coupled plasma-atomic emission spectrometry (ICP-AES)) (USEPA, 1994). | |
4 Standard Methods (SM) 3120 B (SM, 2017) or SM 3120 B-99 (SM Online, 1999). | |
5 ASTM International (ASTM) D1976-20 (ASTM, 2020). | |
Twenty-five Per- and Polyfluoroalkyl Substances (PFAS) using EPA Method 533 (SPE LC/MS/MS): | |
11-chloroeicosafluoro-3-oxaundecane-1-sulfonic acid (11Cl-PF3OUdS) | perfluorodecanoic acid (PFDA). |
1H, 1H, 2H, 2H-perfluorodecane sulfonic acid (8:2 FTS) | perfluorododecanoic acid (PFDoA). |
1H, 1H, 2H, 2H-perfluorohexane sulfonic acid (4:2 FTS) | perfluoroheptanesulfonic acid (PFHpS). |
1H, 1H, 2H, 2H-perfluorooctane sulfonic acid (6:2 FTS) | perfluoroheptanoic acid (PFHpA). |
4,8-dioxa-3H-perfluorononanoic acid (ADONA) | perfluorohexanesulfonic acid (PFHxS). |
9-chlorohexadecafluoro-3-oxanone-1-sulfonic acid (9Cl-PF3ONS) | perfluorohexanoic acid (PFHxA). |
hexafluoropropylene oxide dimer acid (HFPO-DA) (GenX) | perfluorononanoic acid (PFNA). |
nonafluoro‐3,6‐dioxaheptanoic acid (NFDHA) | perfluorooctanesulfonic acid (PFOS). |
perfluoro (2‐ethoxyethane) sulfonic acid (PFEESA) | perfluorooctanoic acid (PFOA). |
perfluoro‐3‐methoxypropanoic acid (PFMPA) | perfluoropentanesulfonic acid (PFPeS). |
perfluoro‐4‐methoxybutanoic acid (PFMBA) | perfluoropentanoic acid (PFPeA). |
perfluorobutanesulfonic acid (PFBS) | perfluoroundecanoic acid (PFUnA). |
perfluorobutanoic acid (PFBA) | |
Four Per- and Polyfluoroalkyl Substances (PFAS) using EPA Method 537.1 (SPE LC/MS/MS): | |
n-ethyl perfluorooctanesulfonamidoacetic acid (NEtFOSAA) | perfluorotetradecanoic acid (PFTA). |
n-methyl perfluorooctanesulfonamidoacetic acid (NMeFOSAA) | perfluorotridecanoic acid (PFTrDA). |
One Metal/Pharmaceutical using EPA Method 200.7 (ICP-AES) or alternate SM or ASTM: | |
lithium |
2. Summary of Major Comments and EPA Responses
Those who expressed an opinion about the proposed UCMR 5 analytes were supportive of EPA's inclusion of the 29 PFAS and lithium. Commenters expressed mixed opinions on the consideration of additional contaminants, particularly “aggregate PFAS,” Legionella pneumophilia, haloacetonitriles, and 1,2,3-trichloropropane. The major comments and EPA responses regarding these contaminants are summarized in the discussion that follows.
a. Aggregate PFAS Measure
EPA received multiple comments encouraging the agency to validate and include a total organic fluorine (TOF) and/or total oxidizable precursors (TOP) technique in UCMR 5 as a screening tool to determine “total PFAS.” EPA also received comments expressing concern for the limitations of the analytical methodologies, including a lack of sensitivity and specificity for PFAS using TOF.
EPA has not identified a complete, validated, peer-reviewed aggregate PFAS method with the appropriate specificity and sensitivity to support UCMR 5 monitoring. EPA's Office of Water and Office of Research and Development are currently developing and evaluating methodologies for broader PFAS analysis in drinking water, however, the measurement approaches are subject to significant technical challenges. The sensitivity of TOF is currently in the low μg/L range, as opposed to the low ng/L range of interest required for PFAS analysis in drinking water. TOF is also not specific to PFAS. TOP, while focusing on PFAS, is limited to measuring compounds that can be detected by LC/MS/MS and the technique requires two LC/MS/MS analyses; one before oxidation and one after oxidation. EPA is evaluating the TOP approach to understand the degree to which certain precursors are oxidized, and subsequently measurable by LC/MS/MS, as well as the degree to which PFAS that were measured in the pre-oxidation sample are still measured post-oxidation.
EPA is also monitoring progress by commercial laboratories and academia. In 2020 and 2021, EPA contacted commercial laboratories that advertised TOF capability, and these laboratories indicated that they had not yet commercialized the TOF method (see Appendix 4 in “Response to Comments on the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” (USEPA, 2021i), which can be found in the electronic docket listed in the ADDRESSES section of this preamble). TOP has been more widely commercialized but is often used as an exploratory tool to estimate precursors.
In summary, there are still analytical challenges leading to uncertainties in the results using the TOF and TOP techniques. More research and method refinement are needed before a peer-reviewed validated method that meets UCMR quality control needs is available to address PFAS more broadly.
b. Legionella Pneumophila
Some comments supported EPA's proposal to not include Legionella pneumophila in UCMR 5, while others encouraged EPA to add it. EPA has decided not to include Legionella pneumophila in the final UCMR 5.
Under EPA's Surface Water Treatment Rule (SWTR), EPA established NPDWRs for Giardia, viruses, Legionella, turbidity and heterotrophic bacteria and set maximum contaminant level goals of zero for Giardia lamblia, viruses and Legionella pneumophila (54 FR 27486, June 29, 1989 (USEPA, 1989)). EPA is currently examining opportunities to enhance protection against Legionella pneumophila through revisions to the suite of Microbial and Disinfection Byproduct (MDBP) rules. In addition to the SWTR, the MDBP suite includes the Stage 1 and Stage 2 Disinfectants and Disinfection Byproduct Rules; the Interim Enhanced Surface Water Treatment Rule; and the Long Term 1 Enhanced Surface Water Treatment Rule.
As stated in the conclusions from EPA's third “Six-Year Review of Drinking Water Standards” (82 FR 3518, January 11, 2017 (USEPA, 2017)), “EPA identified the following NPDWRs under the SWTR as candidates for revision, because of the opportunity to further reduce residual risk from pathogens (including opportunistic pathogens such as Legionella ) beyond the risk addressed by the current SWTR.” In accordance with the dates in the Settlement Agreement between EPA and Waterkeeper Alliance ( Waterkeeper Alliance, Inc. v. U.S. EPA, No. 1:19-cv-00899-LJL (S.D.N.Y. Jun. 1, 2020)), the agency anticipates signing a proposal for revisions to the MDBP rules and a final action on the proposal by July 31, 2024 and September 30, 2027, respectively. EPA has concluded that UCMR 5 data collection for Legionella pneumophila would not be completed in time to meaningfully inform MDBP revision and that UCMR 5 data for Legionella pneumophila would soon lack significance because it would not reflect conditions in water systems after any regulatory revisions become effective (because water quality would be expected to change as a result of PWSs complying with such regulatory revisions).
EPA estimates that Legionella pneumophila monitoring under UCMR 5 would have added $10.5 million in new expenses for large PWSs, $20 million in new expenses for the agency for small system monitoring, and $0.5 million in new expenses for small PWSs and states over the 5-year UCMR period. Because the data would not be available in time to inform MDBP regulatory revisions and because MDBP revisions could change the presence of Legionella pneumophila in drinking water distribution systems ( Legionella occurrence may change, for example, if the required minimum disinfectant residual concentration is higher following MDBP revisions), EPA concluded that the expense of this monitoring is not warranted given the limited utility of the data.
c. Haloacetonitriles
Some commenters agreed with EPA's rationale for not including the four unregulated haloacetonitrile disinfection byproducts (DBPs) in UCMR 5, while others encouraged EPA to include them. EPA has decided not to include haloacetonitrile DBPs in the final UCMR 5.
As was the case with Legionella pneumophila, EPA has concluded that UCMR 5 data collection for haloacetonitriles would not be completed in time to meaningfully inform MDBP revision and that UCMR 5 data would not reflect conditions in water systems after any regulatory revisions become effective (haloacetonitrile occurrence may change, for example, if the required minimum disinfectant residual concentration is higher following MDBP revisions).
As with Legionella pneumophila, inclusion of haloacetonitriles in UCMR 5 would introduce significant monitoring and reporting complexity and cost compared to the sampling design for PFAS and lithium. If haloacetonitriles were to be added to UCMR 5, most of the additional expenses would be borne by large PWSs (for analysis of their samples) and EPA (for analysis of samples from small PWSs). EPA estimates this would result in $13 million in new expenses for large PWSs, $19 million in new expenses for the agency, and $0.5 million in new expenses for small PWSs and states over the 5-year UCMR period.
Because the data would not be available in time to inform MDBP regulatory revisions and because MDBP revisions could change the presence of haloacetonitriles in drinking water distribution systems, EPA concluded that the expense of this monitoring is not warranted given the limited utility of the data.
d. 1,2,3-Trichloropropane
EPA received some comments that support the agency's proposed decision to not include 1,2,3-trichloropropane (1,2,3-TCP) monitoring in UCMR 5, and others recommending that 1,2,3-TCP be included. EPA concluded that appropriate analytical methods are not currently available to support additional UCMR data collection ( i.e., above and beyond the data collection under UCMR 3 (USEPA, 2019c)).
Several commenters suggested that EPA consider analytical methods to monitor for 1,2,3-trichloropropane at lower levels. They suggested, for example, that the agency use California method SRL-524M (California DHS, 2002), which is prescribed by the state for compliance monitoring at 0.005 μg/L (5 ng/L). EPA has reviewed SRL 524M and determined that the associated quality control (QC) and IDC criteria do not meet the EPA's needs for drinking water analysis. See also EPA's “Response to Comments on the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” (USEPA, 2021i), which can be found in the electronic docket listed in the ADDRESSES section of this preamble.
Occurrence data collected during UCMR 3 (77 FR 26072, May 2, 2012 (USEPA, 2012)) for 1,2,3-trichloropropane may be found at https://www.epa.gov/dwucmr/occurrence-data-unregulated-contaminant-monitoring-rule#3.
B. What is the UCMR 5 sampling design?
1. This Final Rule
EPA has utilized up to three different tiers of contaminant monitoring, associated with three different “lists” of contaminants, in past UCMRs. EPA designed the monitoring tiers to reflect the availability and complexity of analytical methods, laboratory capacity, sampling frequency, and cost. The Assessment Monitoring tier is the largest in scope and is used to collect data to determine the national occurrence of “List 1” contaminants for the purpose of estimating national population exposure. Assessment Monitoring has been used in the four previous UCMRs to collect occurrence data from all systems serving more than 10,000 people and a representative sample of 800 smaller systems. Consistent with AWIA, the Assessment Monitoring approach was redesigned for UCMR 5 and reflects the plan, subject to additional appropriations being made available for this purpose, that would require all systems serving 3,300 or more people and a representative sample of systems serving 25 to 3,299 people to perform monitoring (USEPA, 2021a). The population-weighted sampling design for the nationally representative sample of small systems (used in previous UCMR cycles to select 800 systems serving 25 to 10,000 people and used in UCMR 5 to select 800 systems serving 25 to 3,299 people) calls for the sample to be stratified by water source type (ground water or surface water), service size category, and state (where each state is allocated a minimum of two systems in its State Monitoring Plan). The allowable margin of error at the 99 percent confidence level is ±1 percent for an expected contaminant occurrence of 1 percent at the national level. Assessment Monitoring is the primary tier used for contaminants and generally relies on analytical methods that use more common techniques that are expected to be widely available. EPA has used an Assessment Monitoring tier for 72 contaminants and contaminant groups over the course of UCMR 1 through UCMR 4. The agency is exclusively requiring Assessment Monitoring in UCMR 5. This monitoring approach yields the most complete set of occurrence data to support EPA's decision making.
2. Summary of Major Comments and EPA Responses
Many commenters expressed support for the increase in small system Assessment Monitoring, with no opposition to the inclusion of all PWSs serving 3,300 to 10,000 people in UCMR 5. The U.S. Small Business Administration asked that EPA clarify small-system responsibilities in the event of inadequate EPA funding to fully support the envisioned monitoring.
Recognizing the uncertainty in funding from year-to-year, the agency will implement a “monitor if notified” approach for PWSs serving 25 to 10,000 people. In 2022, EPA will notify the approximately 6,000 small PWSs tentatively selected for the expanded UCMR 5 (all PWSs serving 3,300 to 10,000 people and a statistically-based, nationally representative set of 800 PWSs serving 25 to 3,299 people) of their anticipated UCMR 5 monitoring requirements; that initial notification will specify that monitoring is conditioned on EPA having sufficient funds and will be confirmed in a second notification. Upon receiving appropriations for a particular year, EPA will determine the number of small PWSs whose monitoring is covered by the appropriations, and notify the included small PWSs of their upcoming requirements at least six months prior to their scheduled monitoring. EPA has made minor edits to 40 CFR 141.35 and 40 CFR 141.40 for consistency with this approach.
Additionally, to ensure that EPA has access to a nationally representative set of small-system data, even in the absence of sufficient appropriations to support the planned monitoring by small systems, a statistically-based nationally representative set of 800 PWSs will also be selected from among the PWSs serving 25 to 10,000 people. An updated description of the statistical approach for the nationally representative samples for UCMR 5 is available in the docket as “Selection of Nationally Representative Public Water Systems for the Unregulated Contaminant Monitoring Rule: 2021 Update” (USEPA 2021a).
To minimize the impact of the final rule on small systems (those serving 25 to 10,000 people), EPA pays for their sample kit preparation, sample shipping fees, and sample analysis. Large systems (those serving more than 10,000 people) pay for all costs associated with their monitoring. Exhibit 5 of this preamble shows a summary of the estimated number of PWSs subject to monitoring.
List 1 chemicals | ||
---|---|---|
1 EPA pays for all analytical costs associated with monitoring at small systems. | ||
2 Counts for small PWSs serving 3,300-10,000 people are approximate. | ||
3 Large system counts are approximate. | ||
4 In the absence of appropriations to support monitoring at all PWSs serving 3,300 to 10,000 people, EPA could instead include as few as 400 PWSs serving 25 to 3,299 people and 400 PWSs serving 3,300 to 10,000 people (for a representative sample of 800 PWSs serving 25 to 10,000 people). | ||
System size (number of people served) | National sample: Assessment monitoring design | Total number of systems per size category |
List 1 chemicals | ||
Small Systems1 (25-3,299) | 800 randomly selected systems (CWSs and NTNCWSs) | 4 800 |
Small Systems12 (3,300-10,000) | All systems (CWSs and NTNCWSs) subject to the availability of appropriations | 4 5,147 |
Large Systems3 (10,001 and over) | All systems (CWSs and NTNCWSs) | 4,364 |
Total | 10,311 |
C. What is the sampling frequency and timing?
1. This Final Rule
This final rule maintains the proposed sampling frequency and timeframe for Assessment Monitoring. On a per-system basis, the anticipated number of samples collected by each system is consistent with sample collection during prior UCMR cycles (although, as described elsewhere in this document, the number of water systems expected to participate in UCMR 5 is significantly greater under this final rule per AWIA). Water systems will be required to collect samples based on the typical UCMR sampling frequency and timeframe as follows: For surface water, ground water under the direct influence of surface water, and mixed locations, sampling will take place for four consecutive quarters over the course of 12 months (total of 4 sampling events). Sampling events will occur three months apart. For example, if the first sample is taken in January, the second will then occur anytime in April, the third will occur anytime in July, and the fourth will occur anytime in October. For ground water locations, sampling will take place twice over the course of 12 months (total of 2 sampling events). Sampling events will occur five to seven months apart. For example, if the first sample is taken in April, the second sample will then occur anytime in September, October, or November.
EPA, in conjunction with the states, will initially determine schedules (year and months of monitoring) for large water systems. Thereafter, large PWSs will have an opportunity to modify this initial schedule for planning purposes or other reasons ( e.g., to spread costs over multiple years, if a sampling location will be closed during the scheduled month of monitoring, etc.). EPA will schedule and coordinate small system monitoring (for PWSs serving 3,300 to 10,000 people and for the nationally representative sample of smaller PWSs) by working closely with partnering states. State Monitoring Plans provide an opportunity for states to review and revise the initial sampling schedules developed by EPA (see discussion of State Monitoring Plans in Section III.D of this preamble).
2. Summary of Major Comments and EPA Responses
EPA received two comments recommending that the agency reduce the sampling frequency for both ground water (GW) and surface water (SW) systems, including a suggestion that UCMR 5 require only one sample per system. EPA concluded that less frequent data collection would affect the integrity of the data and result in insufficient data to fulfill the needs envisioned by the 1996 SDWA Amendments, particularly with regard to supporting the Administrator's regulatory determinations and drinking water regulation development. Maintaining the proposed sampling frequency allows the resulting contaminant data to be analyzed for temporal variability, in addition to between-system variability. These analyses are not possible with a single-sample structure. When making regulatory determinations, EPA evaluates the number of systems (and populations) with means or single measured values above health levels of concern, as both values provide important information.
EPA acknowledges that based on UCMR 3 (77 FR 26072, May 2, 2012 (USEPA, 2012)) data, the correlation between results from multiple sample events can be high; however, the approach suggested by commenters would yield less accurate data for several reasons. EPA's assessment of sampling frequency using UCMR 3 and UCMR 4 data (see Appendix 2 in “Response to Comments on the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” (USEPA, 2021i), which can be found in the electronic docket listed in the ADDRESSES section of this preamble) shows that for both SW and GW systems, there are numerous cases where occurrence is notably different between sample events. Focusing first on UCMR 3 results for PWS with SW sources, the number of sample points at which PFOS was measured at or above the MRL was 108 percent greater when considering multiple sample events, versus only considering the first sample event. There were multiple occasions where the results from the first sample event were below the health-based reference concentration while subsequent results were above it. Looking at UCMR 3 results for PWSs with GW sources, PFOS was measured at or above the MRL at 26 percent more sample points in the second sample event relative to the first. Similar to the UCMR 3 results for SW systems, there were multiple occasions where the second result from a GW system exceeded the reference concentration while the first result did not.
Some commenters suggested that between-system variability is much greater for PFAS than within-system variability. While it may be less than between-system variability, within-system variability can still be important. Shifting to a single sample prevents reasonable assessments of within-system variability and limits the ability to observe between-system variability estimates. This would then drastically reduce the ability to characterize uncertainty.
Additionally, although the provisions of AWIA could include the addition of approximately 5,200 more PWSs to UCMR 5 relative to earlier cycles and thus capture more spatial variation in the resulting dataset, it is important to note that spatial variation is different than temporal or seasonal variation. Capturing more of one does not diminish the influence of the others on national occurrence data and reducing the frequency of sampling eliminates the possibility of analyzing the resulting data for temporal variation. In addition, statistical means based on two measurements have considerably less error than a single measurement per system, and provide a more robust dataset for future regulatory decisions. Having more than one sample event also greatly reduces the chance of underestimating the true proportion of occurrence of the contaminant in drinking water ( i.e., exposure).
Regarding monitoring frequency and burden, EPA notes that the agency allows large GW systems the opportunity to reduce monitoring burden by using approved representative entry points (40 CFR 141.35(c)(3)) as described in Section IV.D of this preamble. Representative monitoring plans will result in fewer samples and thus time and cost savings to the PWS. Consecutive systems with multiple connections from a particular wholesaler are also permitted to choose one entry point as representative, thus reducing burden.
D. Where are the sampling locations and what is representative monitoring?
1. This Final Rule
Consistent with past UCMR cycles, sample collection for UCMR 5 contaminants will take place at the entry point to the distribution system (EPTDS). As during past UCMRs and as described in 40 CFR 141.35(c)(3) of this preamble, this final rule will allow large ground water systems (or large surface water systems with ground water sources) that have multiple ground water EPTDSs to request approval to sample at representative monitoring locations rather than at each ground water EPTDS. GWRMPs approved under prior UCMRs may be used for UCMR 5, presuming no significant changes in the configuration of the ground water EPTDSs since the prior approval. Water systems that intend to use a previously approved plan must send EPA a copy of the approval documents received under prior UCMRs from their state (if reviewed by the state) or EPA.
Relative to the rules for prior UCMR cycles, this final rule provides greater flexibility to PWSs in submitting GWRMPs to EPA. Plans must be submitted to EPA six months prior to the PWS's scheduled sample collection, instead of by a specified date; those PWSs scheduled to collect samples in 2024 or 2025 will have significant additional time to develop and propose representative plans. PWSs, particularly those scheduled for sample collection in 2023, are encouraged to submit proposals for a new GWRMP by December 31, 2022, to allow time for review by EPA and, as appropriate, the state. EPA will work closely with the states to coordinate the review of GWRMPs in those cases where such review is part of the state's Partnership Agreement. Changes to inventory data in SDWARS that impact a PWS's representative plan before or during the UCMR sampling period must be reported within 30 days of the change. EPA will collaborate with small systems (particularly those with many ground water locations) to develop a GWRMP when warranted, recognizing that EPA pays for the analysis of samples from small systems.
2. Summary of Major Comments and EPA Responses
EPA received multiple comments regarding GWRMPs and representative sampling for wholesale systems and consecutive connections. Generally, commenters supported the continued use of GWRMPS and the use of previously approved monitoring plans. An additional supporting document, titled, “Instructions for Preparing a Ground Water Representative Monitoring Plan for the Unregulated Contaminant Monitoring Rule,” (USEPA, 2021j) has been placed in the electronic docket listed in the ADDRESSES section of this preamble.
Several commenters recommended that EPA not require monitoring by consecutive systems that purchase 100 percent of their water from wholesale systems that are already subject to UCMR 5 monitoring. They requested that EPA instead require wholesalers to identify the PWSIDs of consecutive systems receiving water from the wholesaler, and that EPA rely on wholesaler monitoring in lieu of monitoring by the consecutive systems. EPA has decided to require monitoring by consecutive systems to conduct monitoring in accordance with UCMR 5. Previous UCMR data demonstrate that wholesalers and purchasers can have different analytical results (see Appendix 3 in “Response to Comments on the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” (USEPA, 2021i), which can be found in the electronic docket listed in the ADDRESSES section of this preamble). For example, pairing the results from wholesaler to consecutive connections for 190 manganese results from UCMR 4 (81 FR 92666, December 20, 2016 (USEPA, 2016)), one-third of the results are higher at the wholesaler and one-third of the results are higher at the consecutive connection, with one-third of all results being comparable [±0.4 μg/L]. The agency therefore elected to maintain the proposed approach in which all eligible consecutive systems must monitor, irrespective of monitoring being conducted by the wholesale system from which they purchase drinking water.
E. How long do laboratories and PWSs have to report data?
1. This Final Rule
EPA is maintaining the revised reporting timeframes for laboratories and PWSs as proposed. For UCMR 5, laboratories have 90 days (versus 120 days in prior UCMR cycles) from the sample collection date to post and approve analytical results in SDWARS for PWS review. Large PWSs have 30 days (versus 60 days in prior UCMR cycles) to review and approve the analytical results posted to SDWARS. As with the UCMR 4 requirements, data will be considered approved and available for state and EPA review if the PWS takes no action within their allotted review period.
In the proposed rule for UCMR 5, EPA noted that multiple states have expressed an interest in earlier access to UCMR data (see Docket ID No. EPA-HQ-OW-2020-0530). EPA believes that the shorter timeframes for posting and approving data are feasible and reasonable based on our experience with UCMR reporting to date.
2. Summary of Major Comments and EPA Responses
Commenters generally agreed with the revised timeframes for laboratories to post and approve analytical results in SDWARS. The 90-day laboratory timeframe makes UCMR results more readily available to interested stakeholders and states. Some commenters supported the timely reporting of data by laboratories to ensure that PWSs have adequate time to reconcile QC issues, especially those that may require a PWS to resample. Some expressed concerns that the revised timeframe could be challenging for laboratories. Some suggested that the shorter timeframe be conditioned on consistent functionality and availability of SDWARS.
Commenters generally agreed with the changes in the timeframes for large PWSs to review and approve analytical results posted to SDWARS, though several requested that EPA maintain the 60-day review period.
EPA has observed that many laboratories are routinely posting data to SDWARS within 90 days of sample collection and that many large PWSs are approving and submitting data within 30 days of their laboratory posting the data. Judging by reporting for 2020 monitoring under UCMR 4 (81 FR 92666, December 20, 2016 (USEPA, 2016)), more than 75 percent of laboratories posted and approved data within 90 days, and more than 85 percent of large PWSs who chose to act on their data, did so within 30 days of the laboratory posting it. During UCMR 3 and UCMR 4, less than half of large PWSs chose to actively review and approve their data, as opposed to letting the results default to “approved” status after the review period. The many large PWSs that have routinely chosen to not review and approve their data will not be impacted by the revised timeframe for PWS data review for UCMR 5. See also Appendix 5 in “Response to Comments on the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” (USEPA, 2021i), which can be found in the electronic docket listed in the ADDRESSES section of this preamble.
EPA does not anticipate functionality or availability issues with SDWARS during UCMR 5 but is prepared to make case-by-case exceptions for reporting timeframes should significant issues occur with the reporting system.
F. What are the reporting requirements for UCMR 5?
1. This Final Rule
Today's final rule removes 1 of the proposed data elements (“Direct Potable Reuse Water Information”) and maintains the 27 others described in the proposed rule. EPA has updated some of the data-element definitions for clarity and consistency in the reporting requirements. Please see Table 1 of 40 CFR 141.35(e) of this preamble for the complete list of data elements, definitions and drop-down options that will be provided in the data reporting system.
2. Summary of Major Comments and EPA Responses
a. Data Elements
EPA received multiple comments on the proposed contaminant-specific data elements, with some commenters questioning the quality, reliability, and utility of some of the data that would be provided to the agency per the proposed data element requirements. Several commenters requested that EPA include rationale explaining the intended use of such data. EPA has updated the data elements for clarity ( e.g., clarifying treatment types, and abbreviations for them; adding the treatment option “NMT = not modified after testing”) and has provided additional rationale (including describing how the information could impact regulatory decision making and risk-management strategies) in the “Response to Comments on the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” (USEPA, 2021i), available in the UCMR 5 public docket (see the ADDRESSES section of this preamble). EPA acknowledges the data collected will have some limitations but believes that the collection of the information is still valuable. In addition, EPA notes the modest burden associated with the collection.
b. Reporting State Data
EPA received several comments suggesting that PWSs be permitted to submit occurrence data collected under state-based monitoring, in lieu of conducting UCMR 5 monitoring, to reduce the monitoring burden. In those cases where the monitoring required by a state is aligned with the requirements of UCMR 5, PWSs may be able to conduct PFAS monitoring that meets the needs of their state and UCMR 5, with the understanding that UCMR 5 requirements must be met. This includes the requirement that PFAS samples be analyzed by a UCMR 5-approved laboratory using EPA Method 533 and Method 537.1. EPA offers flexibility for PWSs to reschedule their UCMR 5 monitoring, and PWSs may do so to coordinate it with their state-required monitoring. PWSs wishing to conduct “dual purpose” monitoring ( i.e., concurrently meeting the state and UCMR 5 needs) may contact their state or EPA, as appropriate, if there are questions about whether the state and UCMR 5 requirements are being met.
G. What are the UCMR 5 Minimum Reporting Levels (MRLs) and how were they determined?
1. This Final Rule
EPA is maintaining the proposed minimum reporting levels for the UCMR 5 contaminants. EPA establishes MRLs to ensure consistency in the quality of the information reported to the agency. As defined in 40 CFR 141.40(a)(5)(iii) of this preamble, the MRL is the minimum quantitation level that, with 95 percent confidence, can be achieved by capable analysts at 75 percent or more of the laboratories using a specified analytical method. More detailed explanation of the MRL calculation is in the “Technical Basis for the Lowest Concentration Minimum Reporting Level (LCMRL) Calculator” (USEPA, 2010), available at ( https://www.epa.gov/dwanalyticalmethods/lowest-concentration-minimum-reporting-level-lcmrl-calculator ).
EPA requires each laboratory interested in supporting UCMR analyses to demonstrate that they can reliably make quality measurements at or below the established MRL to ensure that high quality results are being reported by participating laboratories. EPA established the proposed MRLs in 40 CFR 141.40(a)(3), Table 1 of this preamble, for each analyte/method by obtaining data from at least three laboratories that performed “lowest concentration minimum reporting level” (LCMRL) studies. The results from these laboratory LCMRL studies can be found in the “UCMR 5 Laboratory Approval Manual” (USEPA, 2021f), available in the electronic docket (see the ADDRESSES section of this preamble).
The multiple laboratory LCMRLs were then processed through a statistical routine to derive an MRL that, with 95 percent confidence, is predicted to be attainable by 75 percent of laboratories using the prescribed method. EPA considers these to be the lowest reporting levels that can practically and consistently be achieved on a national basis (recognizing that individual laboratories may be able to measure at lower levels).
2. Summary of Major Comments and EPA Responses
Some commenters recommended that EPA establish lower MRLs for the 29 PFAS in UCMR 5. MRLs used for the UCMR program are based on calculations that account for the ability of laboratories to report accurate and precise measurements with a specific statistical confidence. Based on the results from multiple laboratories that participated in MRL-setting studies, EPA concluded that the proposed MRLs represent the lowest feasible levels for a national MRL measure. Sensitivity ( i.e., quantitation limit) may improve with time, experience, and instrumentation advances.
H. What are the requirements for laboratory analysis of field reagent blank samples?
1. This Final Rule
EPA initially proposed that laboratories analyze all field reagent blank (FRB) samples, along with the corresponding field samples, to reduce the possibility of invalidating a positive field sample result ( i.e., a field sample result at or above the MRL) because of FRB hold times being exceeded.
2. Summary of Major Comments and EPA Responses
EPA did not receive any comments expressing concerns with the laboratory approval process; however, the agency did receive a comment on the FRB sample analysis criteria, suggesting that the agency not require analysis of every FRB sample. EPA Method 537.1 and Method 533, used for PFAS analysis, require collection of a corresponding FRB sample from each unique sampling location for each sampling event. The methods require that the FRB be analyzed if there is a positive result for a PFAS analyte in a corresponding field sample. Based on further consideration, EPA is now providing laboratories with discretion as to whether they analyze every FRB sample proactively or only those associated with positive field sample results. This is with the understanding that laboratories must analyze field samples promptly enough such that the corresponding FRB analyses, if needed, may be completed within the prescribed hold time. Compliance with the method hold-time requirements, and other provisions of the methods, is a condition of maintaining laboratory approval. EPA is studying the possibility of extending the FRB hold times for EPA Method 537.1 and Method 533, and will communicate the results of the studies with the approved laboratories.
I. How will EPA support risk communication for UCMR 5 results?
EPA received comments requesting that the agency develop and provide risk communication materials to support interpretation and characterization of UCMR 5 results. EPA intends to publish a “reference concentration” summary document with available EPA health values; provide a template for PWSs to consider using in communicating with their customers about the detection of PFAS in drinking water; and provide other supporting material as risk-related information becomes available.
V. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review
This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review. Any changes made in response to OMB recommendations have been documented in the docket. A full analysis of potential costs associated with this action, the “Information Collection Request for the Final Unregulated Contaminant Monitoring Rule (UCMR 5),” (USEPA, 2021b) ICR Number 2040-0304, is also available in the docket (Docket ID No. EPA-HQ-OW-2020-0530). A summary of the ICR can be found in Section I.C of this preamble.
B. Paperwork Reduction Act (PRA)
The information collection activities in this final rule have been submitted for approval to the Office of Management and Budget (OMB) under the PRA. The Information Collection Request (ICR) document (USEPA, 2021b) that EPA prepared has been assigned EPA ICR number ICR 2683.02. You can find a copy of the ICR in the docket for this final rule, and it is briefly summarized here. The information collection requirements are not enforceable until OMB approves them.
The information that EPA will collect under this final rule fulfills the statutory requirements of Section1445(a)(2) of SDWA, as amended in 1996, 2018, and 2019. The data will describe the source of the water, location, and test results for samples taken from public water systems (PWSs) as described in 40 CFR 141.35(e). The information collected will support EPA's decisions as to whether or not to regulate particular contaminants under SDWA. Reporting is mandatory. The data are not subject to confidentiality protection.
The 5-year UCMR 5 period spans 2022-2026. UCMR 5 sample collection begins in 2023 and continues through 2025. Since ICRs cannot be approved by OMB for a period longer than three years pursuant to 5 CFR 1320.10, the primary analysis in the ICR only covers the first three years of the UCMR 5 period ( i.e., 2022-2024). Prior to expiration of the initial UCMR 5 ICR, EPA will seek to extend the ICR and thus receive approval to collect information under the PRA in the remaining two years of the UCMR 5 period (2025-2026).
EPA received several comments regarding cost and burden of the proposed rule. Those comments recommended that EPA provide more accurate cost estimates. EPA's response is detailed more fully in the “Response to Comments on the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” (USEPA, 2021i), which can be found in the electronic docket listed in the ADDRESSES section of this preamble.
EPA has reviewed and, as appropriate, revised the cost and burden figures for UCMR 5; this includes using updated unit cost estimates for sample analysis. The annual burden and cost estimates described in this section are based on the implementation assumptions described in Section III of this preamble, among them the inclusion of all systems serving 3,300 to 10,000 people and a representative sample of smaller systems. As such, those estimates represent an upper bound. If EPA does not receive the necessary appropriations in one or more of the collections years—and thus collects data from fewer small systems—the actual costs would be lower than those estimated here. In general, burden hours were calculated by:
1. Determining the activities that PWSs and states would complete to comply with UCMR activity;
2. Estimating the number of hours per activity;
3. Estimating the number of respondents per activity; and
4. Multiplying the hours per activity by the number of respondents for that activity.
Respondents/affected entities: The respondents/affected entities are small PWSs (those serving 25 to 10,000 people); large PWSs (those serving 10,001 to 100,000 people); very large PWSs (those serving more than 100,000 people); and states.
Respondent's obligation to respond: Mandatory (40 CFR 141.35).
Estimated number of respondents: Respondents to UCMR 5 include 5,947 small PWSs, 4,364 large PWSs, and the 56 primacy agencies (50 States, one Tribal nation, and five Territories) for a total of 10,367 respondents.
Frequency of response: The frequency of response varies across respondents and years. Across the initial 3-year ICR period for UCMR 5, small PWSs will sample an average of 2.8 times per PWS ( i.e., number of responses per PWS); large PWSs will sample and report an average of 3.2 times per PWS; and very large PWSs will sample and report an average of 3.7 times per PWS.
Total estimated burden: 48,469 hours (per year). Burden is defined at 5 CFR 1320.3(b).
Total estimated cost: $9,404,007 annualized capital or operation & maintenance costs.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the EPA's regulations in 40 CFR are listed in 40 CFR part 9. When OMB approves this ICR, the agency will announce that approval in the Federal Register and publish a technical amendment to 40 CFR part 9 to display the OMB control number for the approved information collection activities contained in this final rule.
C. Regulatory Flexibility Act (RFA)
For purposes of assessing the impacts of this final rule on small entities, EPA considered small entities to be PWSs serving 25 to 10,000 people. As required by the RFA, EPA proposed using this alternative definition in the Federal Register (63 FR 7606, February 13, 1998 (USEPA, 1998a)), sought public comment, consulted with the Small Business Administration (SBA) Office of Advocacy, and finalized the alternative definition in the Consumer Confidence Reports rulemaking (63 FR 44512, August 19, 1998 (USEPA, 1998b)). As stated in that document, the alternative definition applies to this regulation.
1 In the absence of appropriations to support monitoring at all PWSs serving 3,300 to 10,000 people, EPA could instead include as few as 400 PWSs serving 25 to 3,299 people and 400 PWSs serving 3,300 to 10,000 people (for a representative sample of 800 PWSs serving 25 to 10,000 people). | |||
2 PWS counts were adjusted to display as whole numbers in each size category. | |||
System size (number of people served) | Publicly-owned | Privately-owned | Total 2 |
Ground Water | |||
500 and under | 42 | 126 | 168 |
501 to 3,300 | 320 | 121 | 441 |
3,301 to 10,000 | 2,334 | 541 | 2,875 |
Subtotal Ground Water | 2,696 | 788 | 3,484 |
Surface Water (and Ground Water Under the Direct Influence of Surface Water) | |||
500 and under | 9 | 11 | 20 |
501 to 3,300 | 126 | 45 | 171 |
3,301 to 10,000 | 1,762 | 510 | 2,272 |
Subtotal Surface Water | 1,897 | 566 | 2,463 |
Total of Small Water Systems | 4,593 | 1,354 | 5,947 |
The basis for the UCMR 5 RFA certification is as follows: For the 5,947 small water systems that EPA anticipates will be affected, per the planned monitoring, the average annual cost for complying with this final rule represents an average of 0.02 percent of system revenues. The average yearly cost to small systems to comply with UCMR 5 over the 5-year period of 2022-2026, is approximately $0.3 million. EPA anticipates that approximately one third of the 5,947 small PWSs will collect samples in each of three years (2023, 2024, and 2025).
PWS costs are attributed to the labor required for reading about UCMR 5 requirements, monitoring, reporting, and record keeping. The estimated average annual burden across the 5-year UCMR 5 implementation period of 2022-2026 is 1.3 hours at $52 per small system. By assuming all costs for laboratory analyses, shipping and quality control for small entities, EPA incurs the entirety of the non-labor costs associated with UCMR 5 small system monitoring, or 96 percent of total small system testing costs. Exhibit 7 and Exhibit 8 of this preamble present the estimated economic impacts in the form of a revenue test for publicly- and privately-owned systems.
System size (number of people served) | Annual number of systems impacted 2 | Average annual hours per system | Average annual cost per system | SBREFA criteria- revenue test 3 (%) |
---|---|---|---|---|
1 In the absence of appropriations to support monitoring at all PWSs serving 3,300 to 10,000 people, EPA could instead include as few as 400 PWSs serving 25 to 3,299 people and 400 PWSs serving 3,300 to 10,000 people (for a representative sample of 800 PWSs serving 25 to 10,000 people). | ||||
2 PWS counts were adjusted to display as whole numbers in each size category. Includes the publicly-owned portion of small systems subject to UCMR 5. | ||||
3 Costs are presented as a percentage of median annual revenue for each size category. | ||||
Ground Water Systems | ||||
500 and under | 8 | 1.0 | $40.65 | 0.09 |
501 to 3,300 | 64 | 1.1 | 43.37 | 0.02 |
3,301 to 10,000 | 467 | 1.3 | 49.92 | 0.01 |
Surface Water (and Ground Water Under the Direct Influence of Surface Water) Systems | ||||
500 and under | 2 | 1.4 | 54.39 | 0.07 |
501 to 3,300 | 25 | 1.4 | 56.19 | 0.02 |
3,301 to 10,000 | 353 | 1.5 | 57.39 | 0.004 |
System size (number of people served) | Annual number of systems impacted 2 | Average annual hours per system | Average annual cost per system | SBREFA criteria- revenue test 3 (%) |
---|---|---|---|---|
1 In the absence of appropriations to support monitoring at all PWSs serving 3,300 to 10,000 people, EPA could instead include as few as 400 PWSs serving 25 to 3,299 people and 400 PWSs serving 3,300 to 10,000 people (for a representative sample of 800 PWSs serving 25 to 10,000 people). | ||||
2 PWS counts were adjusted to display as whole numbers in each size category. Includes the privately-owned portion of small systems subject to UCMR 5. | ||||
3 Costs are presented as a percentage of median annual revenue for each size category. | ||||
Ground Water Systems | ||||
500 and under | 25 | 1.0 | $40.65 | 0.48 |
501 to 3,300 | 24 | 1.1 | $43.37 | 0.03 |
3,301 to 10,000 | 108 | 1.3 | $49.92 | 0.004 |
Surface Water (and Ground Water Under the Direct Influence of Surface Water) Systems | ||||
500 and under | 2 | 1.4 | $54.39 | 0.11 |
501 to 3,300 | 9 | 1.4 | $56.19 | 0.02 |
3,301 to 10,000 | 102 | 1.5 | $57.39 | 0.004 |
Up to 9.4 percent of all small systems ( i.e., up to 5,947 small PWSs serving 25 to 10,000 people) will participate in UCMR 5 if EPA receives the necessary appropriations to support its plan. EPA has determined that participating small systems will experience an average impact of 0.02 percent of revenues. This accounts for small PWSs familiarizing themselves with the regulatory requirements; reading sampling instructions; traveling to the sampling location; collecting and shipping the samples; and maintaining their records. The 5,947 small PWSs are comprised of all 5,147 systems serving between 3,300 and 10,000 people, and the representative group of 800 systems serving between 25 and 3,299 people; the remainder of small systems will not participate in UCMR 5 monitoring and will not be impacted.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. The small entities subject to the requirements of this action along with a description of the very minor impacts are previously addressed in this section. Although this final rule will not have a significant economic impact on a substantial number of small entities, EPA has attempted to reduce impacts by assuming all costs for analyses of the samples, and for shipping the samples from small systems to laboratories contracted by EPA to analyze the UCMR 5 samples (the cost of shipping is included in the cost of each analytical method). EPA has historically set aside $2.0 million each year from the Drinking Water State Revolving Fund (DWSRF) with its authority to use DWSRF monies for the purposes of implementing this provision of SDWA. EPA anticipates drawing on these and additional funds, if available, to implement the plan and carry out the expanded UCMR monitoring approach outlined in AWIA. We have therefore concluded that this action will have no significant impact on any directly regulated small entities.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action implements mandate(s) specifically and explicitly set forth in SDWA Section 1445(a)(2), Monitoring Program for Unregulated Contaminants.
E. Executive Order 13132: Federalism
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments
This action has Tribal implications. However, it will neither impose substantial direct compliance costs on federally recognized Tribal governments, nor preempt Tribal law. As described previously in this document, this final rule requires monitoring by all large PWSs. Information in the SDWIS/Fed water system inventory indicates there are approximately 27 large Tribal PWSs (serving 10,001 to 40,000 people). EPA estimates the average annual cost to each of these large PWSs, over the 5-year rule period, to be $1,783. This cost is based on a labor component (associated with the collection of samples), and a non-labor component (associated with shipping and laboratory fees). As planned, UCMR 5 is expected to also require monitoring by all small PWSs serving 3,300 to 10,000 people and a nationally representative sample of small PWSs serving 25 to 3,299 people. Information in the SDWIS/Fed water system inventory indicates there are approximately 75 small Tribal PWSs (serving 3,300 to 10,000 people). EPA estimates that less than 2 percent of small Tribal systems serving 25 to 3,299 people will be selected as part of the nationally representative sample. EPA estimates the average annual cost to small Tribal systems over the 5-year rule period to be $52. Such cost is based on the labor associated with collecting a sample and preparing it for shipping. All other small-PWS expenses (associated with shipping and laboratory fees) are paid by EPA.
EPA consulted with Tribal officials under the EPA Policy on Consultation and Coordination with Indian Tribes early in the process of developing this regulation to permit them to have meaningful and timely input into its development. A summary of that consultation, titled, “Summary of the Tribal Coordination and Consultation Process for the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” is provided in the electronic docket listed in the ADDRESSES section of this preamble.
As required by section 7(a), the EPA's Tribal Consultation Official has certified that the requirements of the executive order have been met in a meaningful and timely manner. A copy of the certification is included in the docket for this action.
G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks
EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern such an environmental health risk or safety risk.
H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use
This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution or use of energy and has not otherwise been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. This is a national drinking water occurrence study that was submitted to OMB for review.
I. National Technology Transfer and Advancement Act (NTTAA)
This action involves technical standards. EPA has identified options that involve using analytical methods developed by the agency and three major voluntary consensus method organizations to support UCMR 5 monitoring. The voluntary consensus method organizations are Standard Methods for the Examination of Water and Wastewater, and ASTM International. EPA identified acceptable consensus method organization standards for the analysis of lithium. A summary of each method along with how the method specifically applies to UCMR 5 can be found in Section III.I of this preamble.
All of these standards are reasonably available for public use. EPA methods are free for download on the agency's website. The methods in the Standard Methods for the Examination of Water and Wastewater 23rd edition are consensus standards, available for purchase from the publisher, and are commonly used by the drinking water laboratory community. The methods in the Standard Methods Online are consensus standards, available for purchase from the publisher's website, and are commonly used by the drinking water laboratory community. The methods from ASTM International are consensus standards, are available for purchase from the publisher's website, and are commonly used by the drinking water laboratory community.
J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations
EPA believes that this action is not subject to Executive Order 12898 (59 FR 7629, February 16, 1994) because it does not establish an environmental health or safety standard. Background information regarding EPA's consideration of Executive Order 12898 in the development of this final rule is provided in Section III.F of this preamble, and an additional supporting document, titled, “Summary of Environmental Justice Considerations for the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal,” has been placed in the electronic docket listed in the ADDRESSES section of this preamble.
K. Congressional Review Act (CRA)
This action is subject to the CRA, and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).
VI. References
(i) ASDWA. 2013. Insufficient Resources for State Drinking Water Programs Threaten Public Health: An Analysis of State Drinking Water Programs' Resources and Needs. December 2013. Available at https://www.asdwa.org/asdwa-reports/.
(ii) ASTM. 2020. ASTM D1976-20— Standard Test Method for Elements in Water by Inductively-Coupled Plasma Atomic Emission Spectroscopy. ASTM, 100 Barr Harbor Drive, West Conshohocken, PA, 19428. Approved May 1, 2020. Available for purchase at https://www.astm.org/Standards/D1976.htm.
(iii) California DHS. 2002. California Department of Health Services. Determination of 1,2,3-Trichloropropane in Drinking Water by Purge and Trap Gas Chromatography/Mass Spectrometry. Division of Drinking Water and Environmental Management, Sanitation and Radiation Laboratories Branch, Berkeley, CA. Available at https://www.waterboards.ca.gov/drinking_water/certlic/drinkingwater/documents/123-tcp/tcp_by_pt_gcms.pdf.
(iv) Settlement Agreement, Waterkeeper Alliance, Inc. v. U.S. EPA, No. 1:19-cv-00899-LJL (S.D.N.Y. Jun. 1, 2020).
(v) SM. 2017. 3120B—Metals by Plasma Emission Spectroscopy (2017): Inductively Coupled Plasma (ICP) Method. Standard Methods for the Examination of Water and Wastewater, 23rd edition. American Public Health Association, 800 I Street NW, Washington, DC 20001-3710.
(vi) SM Online. 1999. 3120B-99—Metals by Plasma Emission Spectroscopy: Inductively Coupled Plasma (ICP) Method (Editorial Revisions, 2020). Standard Methods Online. Available for purchase at http://www.standardmethods.org.
(vii) USEPA. 1989. National Primary Drinking Water Regulations; Filtration, Disinfection; Turbidity, Giardia lamblia, Viruses, Legionella, and Heterotrophic Bacteria; Final Rule. Federal Register . Vol. 54, No. 124, p. 27486, June 29, 1989.
(viii) USEPA. 1994. EPA Method 200.7—Determination of Metals and Trace Elements in Water and Wastes by Inductively Coupled Plasma-Atomic Emission Spectrometry, Revision 4.4. Office of Research and Development, Cincinnati, OH. Available at https://www.epa.gov/esam/method-2007-determination-metals-and-trace-elements-water-and-wastes-inductively-coupled-plasma.
(ix) USEPA. 1998a. National Primary Drinking Water Regulations: Consumer Confidence Reports; Proposed Rule. Federal Register . Vol. 63, No. 30, p. 7606, February 13, 1998.
(x) USEPA. 1998b. National Primary Drinking Water Regulation: Consumer Confidence Reports; Final Rule. Federal Register . Vol. 63, No. 160, p. 44512, August 19, 1998.
(xi) USEPA. 2010. Technical Basis for the Lowest Concentration Minimum Reporting Level (LCMRL) Calculator. EPA 815-R-11-001. Office of Water. December 2010. Available at https://www.epa.gov/dwanalyticalmethods.
(xii) USEPA. 2011. Exposure Factors Handbook 2011 Edition (Final Report). U.S. EPA, Washington, DC, EPA/600/R-09/052F. Office of Research and Development, Washington, DC. September 2011. Available at https://www.epa.gov/expobox/about-exposure-factors-handbook.
(xiii) USEPA. 2012. Revisions to the Unregulated Contaminant Monitoring Regulation (UCMR 3) for Public Water Systems; Final Rule. Federal Register . Vol. 77, No. 85, p. 26072, May 2, 2012.
(xiv) USEPA. 2016. Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) for Public Water Systems and Announcement of Public Meeting. Federal Register . Vol. 81, No. 244, p. 92666, December 20, 2016.
(xv) USEPA. 2017. National Primary Drinking Water Regulations; Announcement of the Results of EPA's Review of Existing Drinking Water Standards and Request for Public Comment and/or Information on Related Issues. Federal Register . Vol. 82, No. 7, p. 3518, January 11, 2017.
(xvi) USEPA. 2018. Method Development for Unregulated Contaminants in Drinking Water: Public Meeting and Webinar. EPA 815-A-18-001. Office of Water. June 2018. Available at https://www.epa.gov/dwanalyticalmethods.
(xvii) USEPA. 2019a. Development of the Proposed Unregulated Contaminant Monitoring Rule for the Fifth Monitoring Cycle (UCMR 5). Presentation Slides. EPA 815-A-19-001. Office of Water. Available at https://www.epa.gov/dwucmr/unregulated-contaminant-monitoring-rule-ucmr-meetings-and-materials.
(xviii) USEPA. 2019b. EPA Method 533—Determination of Per- and Polyfluoroalkyl Substances in Drinking Water by Isotope Dilution Anion Exchange Solid Phase Extraction and Liquid Chromatography/Tandem Mass Spectrometry. EPA 815-B-19-020. Office of Water, Cincinnati, OH. November 2019. Available at https://www.epa.gov/dwanalyticalmethods.
(xix) USEPA. 2019c. Appendix C: 1,2,3-Trichloropropane in Regulatory Determination 4 Support Document for Selected Contaminants from the Fourth Drinking Water Contaminant Candidate List (CCL 4). EPA 815-R-19-006. Docket ID EPA-HQ-OW-2019-0583. Available at https://www.regulations.gov.
(xx) USEPA. 2020. EPA Method 537.1—Determination of Selected Per- and Polyfluorinated Alkyl Substances in Drinking Water by Solid Phase Extraction and Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS). Version 2.0. EPA/600/R-20/006. Office of Research and Development, Cincinnati, OH. March 2020. Available at https://www.epa.gov/dwanalyticalmethods.
(xxii) USEPA. 2021a. Selection of Nationally Representative Public Water Systems for the Unregulated Contaminant Monitoring Rule: 2021 Update. EPA 815-B-21-012. Office of Water. December 2021.
(xxiii) USEPA. 2021b. Information Collection Request for the Final Unregulated Contaminant Monitoring Rule (UCMR 5). EPA 815-B-21-008. Office of Water. December 2021.
(xxiv) USEPA. 2021c. Revisions to the Unregulated Contaminant Monitoring Rule for the Fifth Monitoring Cycle (UCMR 5): Public Meeting and Webinar. Presentation Slides. EPA 815-A-21-001. Office of Water. April 2021. Available at https://www.epa.gov/dwucmr/unregulated-contaminant-monitoring-rule-ucmr-meetings-and-materials.
(xxv) USEPA. 2021d. Drinking Water Contaminant Candidate List 5—Draft. Federal Register . Vol. 86, No. 135 p. 37948, July 19, 2021.
(xxvi) USEPA. 2021e. Information Compendium for Contaminants for the Final Unregulated Contaminant Monitoring Rule (UCMR 5). EPA 815-B-21-009. Office of Water. December 2021.
(xxvii) USEPA. 2021f. UCMR 5 Laboratory Approval Manual. EPA 815-B-21-010. Office of Water. December 2021.
(xxviii) USEPA. 2021g. Revisions to the Unregulated Contaminant Monitoring Rule for Public Water Systems and Announcement of Public Meeting; Proposed Rule and Notice of Public Meeting. Federal Register . Vol. 86, No. 46, p. 13846, March 11, 2021.
(xxix) USEPA. 2021h. Revisions to 40 CFR 141.35 and 141.40. EPA 815-B-21-011. Office of Water. December 2021. Available in EPA's public docket (under Docket ID No. EPA-HQ-OW-2020-0530) at https://www.regulations.gov.
(xxx) USEPA. 2021i. Response to Comments on the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) Proposal. EPA 815-R-21-008. Office of Water. December 2021.
(xxi) USEPA. 2021j. Instructions for Preparing a Ground Water Representative Monitoring Plan for the Unregulated Contaminant Monitoring Rule. EPA 815-B-21-013. Office of Water. December 2021.
List of Subjects in 40 CFR Part 141
Environmental protection, Chemicals, Incorporation by reference, Indian—lands, Intergovernmental relations, Reporting and recordkeeping requirements, Water supply.
Michael S. Regan,
Administrator.
For the reasons set forth in the preamble, EPA amends 40 CFR part 141 as follows:
PART 141—NATIONAL PRIMARY DRINKING WATER REGULATIONS
1. The authority citation for part 141 continues to read as follows:
Authority:
42 U.S.C. 300f, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-4, 300j-9, and 300j-11.
Subpart D—Reporting and Recordkeeping
2. Amend §141.35 as follows:
a. In paragraph (a), revise the fourth sentence;
b. In paragraph (c)(1), remove the text “December 31, 2017” and add, in its place the text “December 31, 2022”;
c. Revise paragraphs (c)(2), (c)(3)(i) through (iii), (c)(4), (c)(5)(i), and (c)(6)(ii);
d. In paragraph (d)(2), revise the first, second, and third sentences; and
f. Revise paragraph (e).
The revisions read as follows:
§141.35 Reporting for unregulated contaminant monitoring results.
(a) * * * For the purposes of this section, PWS “population served” is the retail population served directly by the PWS as reported to the Federal Safe Drinking Water Information System (SDWIS/Fed). * * *
* * * * *
(c) * * *
(2) Sampling location inventory information. You must provide your inventory information by December 31, 2022, using EPA's electronic data reporting system, as specified in paragraph (b)(1) of this section. You must submit, verify, or update data elements 1-9 (as defined in Table 1 of paragraph (e) of this section) for each sampling location, or for each approved representative sampling location (as specified in paragraph (c)(3) of this section) regarding representative sampling locations. If this information changes, you must report updates, including new sources, and sampling locations that are put in use before or during the UCMR sampling period, to EPA's electronic data reporting system within 30 days of the change.
(3) * * *
(i) Qualifications. Large PWSs that have EPA- or State-approved representative EPTDS sampling locations from a previous UCMR cycle, or as provided for under 40 CFR 141.23(a)(1), 40 CFR 141.24(f)(1), or 40 CFR 141.24(h)(1), may submit a copy of documentation from your State or EPA that approves your representative sampling plan. PWSs that do not have an approved representative EPTDS sampling plan may submit a proposal to sample at representative EPTDS(s) rather than at each individual EPTDS if: You use ground water as a source; all of your well sources have either the same treatment or no treatment; and you have multiple EPTDSs from the same source ( i.e., same aquifer). You must submit a copy of the existing or proposed representative EPTDS sampling plan, as appropriate, at least six months prior to your scheduled sample collection, as specified in paragraph (b)(1) of this section. If changes to your inventory that impact your representative plan occur before or during the UCMR sampling period, you must report updates within 30 days of the change.
(ii) Demonstration. If you are submitting a proposal to sample at representative EPTDS(s) rather than at each individual EPTDS, you must demonstrate that any EPTDS that you propose as representative of multiple wells is associated with a well that draws from the same aquifer as the wells it will represent. The proposed well must be representative of the highest annual volume and most consistently active wells in the representative array. If that representative well is not in use at the scheduled sampling time, you must select and sample an alternative representative well. You must submit the information defined in Table 1, paragraph (e) of this section for each proposed representative sampling location. You must also include documentation to support your proposal that the specified wells are representative of other wells. This documentation can include system-maintained well logs or construction drawings indicating that the representative well(s) is/are at a representative depth, and details of well casings and grouting; data demonstrating relative homogeneity of water quality constituents ( e.g., pH, dissolved oxygen, conductivity, iron, manganese) in samples drawn from each well; and data showing that your wells are located in a limited geographic area ( e.g., all wells within a 0.5 mile radius) and/or, if available, the hydrogeologic data indicating the ground water travel time between the representative well and each of the individual wells it represents ( e.g., all wells within a five-year time of travel delineation). Your proposal must be sent in writing to EPA, as specified in paragraph (b)(1) of this section.
(iii) Approval. EPA or the State (as specified in the Partnership Agreement reached between the State and EPA) will review your proposal and coordinate any necessary changes with you. Your plan will not be final until you receive written approval from EPA, identifying the final list of EPTDSs where you will be required to monitor.
(4) Contacting EPA if your PWS has not been notified of requirements. If you believe you are subject to UCMR requirements, as defined in 40 CFR 141.40(a)(1) and (a)(2)(i), and you have not been contacted by either EPA or your State by April 26, 2022, you must send a letter to EPA, as specified in paragraph (b)(1) of this section. The letter must be from your PWS Official and must include an explanation as to why the UCMR requirements are applicable to your system along with the appropriate contact information. A copy of the letter must also be submitted to the State as directed by the State. EPA will make an applicability determination based on your letter, and in consultation with the State when necessary and will notify you regarding your applicability status and required sampling schedule. However, if your PWS meets the applicability criteria specified in 40 CFR 141.40(a)(2)(i), you are subject to the UCMR monitoring and reporting requirements, regardless of whether you have been contacted by the State or EPA.
(5) * * *
(i) General rescheduling notification requirements. Large systems may independently change their monitoring schedules up to December 31, 2022, using EPA's electronic data reporting system, as specified in paragraph (b)(1) of this section. After this date has passed, if your PWS cannot sample according to your assigned sampling schedule ( e.g., because of budget constraints, or if a sampling location will be closed during the scheduled month of monitoring), you must mail or email a letter to EPA, as specified in paragraph (b)(1) of this section, prior to the scheduled sampling date. You must include an explanation of why the samples cannot be taken according to the assigned schedule, and you must provide the alternative schedule you are requesting. You must not reschedule monitoring specifically to avoid sample collection during a suspected vulnerable period. You are subject to your assigned UCMR sampling schedule or the schedule that you revised on or before December 31, 2022, unless and until you receive a letter from EPA specifying a new schedule.
* * * * *
(6) * * *
(ii) Reporting schedule. You must require your laboratory, on your behalf, to post and approve the data in EPA's electronic data reporting system, accessible at https://www.epa.gov/dwucmr, for your review within 90 days from the sample collection date (sample collection must occur as specified in 40 CFR 141.40(a)(4)). You then have 30 days from when the laboratory posts and approves your data to review, approve, and submit the data to the State and EPA via the agency's electronic data reporting system. If you do not electronically approve and submit the laboratory data to EPA within 30 days of the laboratory posting approved data, the data will be considered approved by you and available for State and EPA review.
* * * * *
(d) * * *
(2) Sampling location inventory information. You must provide your inventory information by December 31, 2022, using EPA's electronic data reporting system, as specified in paragraph (b)(1) of this section. If this information changes, you must report updates, including new sources, and sampling locations that are put in use before or during the UCMR sampling period, to EPA's electronic data reporting system within 30 days of the change, as specified in paragraph (b)(1) of this section. * * *
(e) Data elements. Table 1 defines the data elements that must be provided for UCMR monitoring.
Data element | Definition |
---|---|
1. Public Water System Identification (PWSID) Code | The code used to identify each PWS. The code begins with the standard 2-character postal State abbreviation or Region code; the remaining 7 numbers are unique to each PWS in the State. The same identification code must be used to represent the PWS identification for all current and future UCMR monitoring. |
2. Public Water System Name | Unique name, assigned once by the PWS. |
3. Public Water System Facility Identification Code | An identification code established by the State or, at the State's discretion, by the PWS, following the format of a 5-digit number unique within each PWS for each applicable facility (i.e., for each source of water, treatment plant, distribution system, or any other facility associated with water treatment or delivery). The same identification code must be used to represent the facility for all current and future UCMR monitoring. |
4. Public Water System Facility Name | Unique name, assigned once by the PWS, for every facility ID ( e.g., Treatment Plant). |
5. Public Water System Facility Type | That code that identifies that type of facility as either: CC = Consecutive connection. SS = Sampling station. TP = Treatment plant. OT = Other. |
6. Water Source Type | The type of source water that supplies a water system facility. Systems must report one of the following codes for each sampling location: |
SW = Surface water (to be reported for water facilities that are served entirely by a surface water source during the 12-month period). | |
GU = Ground water under the direct influence of surface water (to be reported for water facilities that are served all or in part by ground water under the direct influence of surface water at any time during the 12-month sampling period), and are not served at all by surface water during this period. | |
MX = Mixed water (to be reported for water facilities that are served by a mix of surface water, ground water, and/or ground water under the direct influence of surface water during the 12-month period). | |
GW = Ground water (to be reported for water facilities that are served entirely by a ground water source during the 12-month period). | |
7. Sampling Point Identification Code | An identification code established by the State, or at the State's discretion, by the PWS, that uniquely identifies each sampling point. Each sampling code must be unique within each applicable facility, for each applicable sampling location (i.e ., entry point to the distribution system). The same identification code must be used to represent the sampling location for all current and future UCMR monitoring. |
8. Sampling Point Name | Unique sample point name, assigned once by the PWS, for every sample point ID ( e.g., Entry Point). |
9. Sampling Point Type Code | A code that identifies the location of the sampling point as: EP = Entry point to the distribution system. |
10. Disinfectant Type | All of the disinfectants/oxidants that have been added prior to and at the entry point to the distribution system. Please select all that apply: |
PEMB = Permanganate. | |
HPXB = Hydrogen peroxide. | |
CLGA = Gaseous chlorine. | |
CLOF = Offsite generated hypochlorite (stored as a liquid form). | |
CLON = Onsite generated hypochlorite. | |
CAGC = Chloramine (formed with gaseous chlorine). | |
CAOF = Chloramine (formed with offsite hypochlorite). | |
CAON = Chloramine (formed with onsite hypochlorite). | |
CLDB = Chlorine dioxide. | |
OZON = Ozone. | |
ULVL = Ultraviolet light. | |
OTHD = All other types of disinfectant/oxidant. | |
NODU = No disinfectant/oxidant used. | |
11. Treatment Information | Treatment information associated with the sample point. Please select all that apply. |
CON = Conventional (non-softening, consisting of at least coagulation/sedimentation basins and filtration). | |
SFN = Softening. | |
RBF = River bank filtration. | |
PSD = Pre-sedimentation. | |
INF = In-line filtration. | |
DFL = Direct filtration. | |
SSF = Slow sand filtration. | |
BIO = Biological filtration (operated with an intention of maintaining biological activity within filter). | |
UTR = Unfiltered treatment for surface water source. | |
GWD = Groundwater system with disinfection only. | |
PAC = Application of powder activated carbon. | |
GAC = Granular activated carbon adsorption (not part of filters in CON, SFN, INF, DFL, or SSF). | |
AIR = Air stripping (packed towers, diffused gas contactors). | |
POB = Pre-oxidation with chlorine (applied before coagulation for CON or SFN plants or before filtration for other filtration plants). | |
MFL = Membrane filtration. | |
IEX = Ionic exchange. | |
DAF = Dissolved air floatation. | |
CWL = Clear well/finished water storage without aeration. | |
CWA = Clear well/finished water storage with aeration. | |
ADS = Aeration in distribution system (localized treatment). | |
OTH = All other types of treatment. | |
NTU = No treatment used. | |
DKN = Do not know. | |
12. Sample Collection Date | The date the sample is collected, reported as 4-digit year, 2-digit month, and 2-digit day (YYYYMMDD). |
13. Sample Identification Code | An alphanumeric value up to 30 characters assigned by the laboratory to uniquely identify containers, or groups of containers, containing water samples collected at the same sampling location for the same sampling date. |
14. Contaminant | The unregulated contaminant for which the sample is being analyzed. |
15. Analytical Method Code | The identification code of the analytical method used. |
16. Extraction Batch Identification Code | Laboratory assigned extraction batch ID. Must be unique for each extraction batch within the laboratory for each method. For CCC samples report the Analysis Batch Identification Code as the value for this field. For methods without an extraction batch, leave this field null. |
17. Extraction Date | Date for the start of the extraction batch (YYYYMMDD). For methods without an extraction batch, leave this field null. |
18. Analysis Batch Identification Code | Laboratory assigned analysis batch ID. Must be unique for each analysis batch within the laboratory for each method. |
19. Analysis Date | Date for the start of the analysis batch (YYYYMMDD). |
20. Sample Analysis Type | The type of sample collected and/or prepared, as well as the fortification level. Permitted values include: CCCL = MRL level continuing calibration check; a calibration standard containing the contaminant, the internal standard, and surrogate analyzed to verify the existing calibration for those contaminants. |
CCCM = Medium level continuing calibration check; a calibration standard containing the contaminant, the internal standard, and surrogate analyzed to verify the existing calibration for those contaminants. | |
CCCH = High level continuing calibration check; a calibration standard containing the contaminant, the internal standard, and surrogate analyzed to verify the existing calibration for those contaminants. | |
FS = Field sample; sample collected and submitted for analysis under this final rule. | |
LFB = Laboratory fortified blank; an aliquot of reagent water fortified with known quantities of the contaminants and all preservation compounds. | |
LRB = Laboratory reagent blank; an aliquot of reagent water treated exactly as a field sample, including the addition of preservatives, internal standards, and surrogates to determine if interferences are present in the laboratory, reagents, or other equipment. | |
LFSM = Laboratory fortified sample matrix; a UCMR field sample with a known amount of the contaminant of interest and all preservation compounds added. | |
LFSMD = Laboratory fortified sample matrix duplicate; duplicate of the laboratory fortified sample matrix. | |
QCS = Quality control sample; a sample prepared with a source external to the one used for initial calibration and CCC. The QCS is used to check calibration standard integrity. | |
FRB = Field reagent blank; an aliquot of reagent water treated as a sample including exposure to sampling conditions to determine if interferences or contamination are present from sample collection through analysis. | |
21. Analytical Result—Sign | A value indicating whether the sample analysis result was: (<) “less than” means the contaminant was not detected, or was detected at a level below the Minimum Reporting Level. (=) “equal to” means the contaminant was detected at the level reported in “Analytical Result— Measured Value.” |
22. Analytical Result—Measured Value | The actual numeric value of the analytical results for: Field samples; laboratory fortified matrix samples; laboratory fortified sample matrix duplicates; and concentration fortified. |
23. Additional Value | Represents the true value or the fortified concentration for spiked samples for QC Sample Analysis Types (CCCL, CCCM, CCCH, QCS, LFB, LFSM, and LFSMD). |
24. Laboratory Identification Code | The code, assigned by EPA, used to identify each laboratory. The code begins with the standard two-character State postal abbreviation; the remaining five numbers are unique to each laboratory in the State. |
25. Sample Event Code | A code assigned by the PWS for each sample event. This will associate samples with the PWS monitoring plan to allow EPA to track compliance and completeness. Systems must assign the following codes: |
SE1, SE2, SE3, and SE4—Represent samples collected to meet UCMR Assessment Monitoring requirements; where “SE1” and “SE2” represent the first and second sampling period for all water types; and “SE3” and “SE4” represent the third and fourth sampling period for SW, GU, and MX sources only. | |
26. Historical Information for Contaminant Detections and Treatment | A yes or no answer provided by the PWS for each entry point to the distribution system. Question: Have you tested for the contaminant in your drinking water in the past? YES = If yes, did you modify your treatment and if so, what types of treatment did you implement? Select all that apply. |
PAC = Application of powder activated carbon. | |
GAC = Granular activated carbon adsorption (not part of filters in CON, SFN, INF, DFL, or SSF). | |
IEX = Ionic exchange. | |
NRO = Nanofiltration and reverse osmosis. | |
OZN = Ozone. | |
BAC = Biologically active carbon. | |
MFL = Membrane filtration. | |
UVL = Ultraviolet light. | |
OTH = Other. | |
NMT = Not modified after testing. | |
NO = Have never tested for the contaminant. | |
DK = Do not know. | |
27. Potential PFAS Sources | A yes or no answer provided by the PWS for each entry point to the distribution system. Question: Are you aware of any potential current and/or historical sources of PFAS that may have impacted the drinking water sources at your water system? |
YES = If yes, select all that apply: | |
MB = Military base. | |
FT = Firefighting training school. | |
AO = Airport operations. | |
CW = Car wash or industrial launderers. | |
PS = Public safety activities ( e.g., fire and rescue services). | |
WM = Waste management. | |
HW = Hazardous waste collection, treatment, and disposal. | |
UW = Underground injection well. | |
SC = Solid waste collection, combustors, incinerators. | |
MF = Manufacturing. | |
FP = Food packaging. | |
TA = Textile and apparel ( e.g., stain- and water-resistant, fiber/thread, carpet, house furnishings, leather). | |
PP = Paper. | |
CC = Chemical. | |
PR = Plastics and rubber products. | |
MM = Machinery. | |
CE = Computer and electronic products. | |
FM = Fabricated metal products (e.g., nonstick cookware). | |
PC = Petroleum and coal products. | |
FF = Furniture. | |
OG = Oil and gas production. | |
UT = Utilities (e.g ., sewage treatment facilities). | |
CT = Construction (e.g ., wood floor finishing, electrostatic painting). | |
OT = Other. | |
NO = Not aware of any potential current and/or historical sources. | |
DK = Do not know. |
Subpart E—Special Regulations, Including Monitoring Regulations and Prohibition on Lead Use
3. Amend §141.40 as follows:
a. In paragraph (a) introductory text, remove the text “December 31, 2015” and add in its place the text “February 1, 2021 or subsequent corrections from the State”;
b. Revise paragraphs (a)(2)(ii) introductory text, (a)(2)(ii)(A), and (a)(3);
c. In paragraph (a)(4)(i) introductory text, remove the text “December 31, 2017” and add in its place the text “December 31, 2022”;
d. Revise paragraphs (a)(4)(i)(A) through (C), (a)(4)(ii) introductory text, and the first sentence in paragraph (a)(4)(ii)(A);
e. Remove paragraph (a)(4)(iii);
f. In paragraph (a)(5)(ii), revise the fifth and sixth sentences;
g. Revise paragraph (a)(5)(iii) introductory text;
h. Remove and reserve paragraph (a)(5)(iv); and
i. Revise paragraphs (a)(5)(v) and (vi) and paragraph (c).
The revisions read as follows:
§141.40 Monitoring requirements for unregulated contaminants.
(a) * * *
(2) * * *
(ii) Small systems. EPA will provide sample containers, provide pre-paid air bills for shipping the sampling materials, conduct the laboratory analysis, and report and review monitoring results for all small systems selected to conduct monitoring under paragraphs (a)(2)(ii)(A) through (C) of this section. If you own or operate a PWS (other than a transient non-community water system) that serves a retail population of 10,000 or fewer people and you are notified of monitoring requirements by the State or EPA, you must monitor as follows:
(A) Assessment Monitoring. You must monitor for the contaminants on List 1 per table 1 to paragraph (a)(3) if you are notified by your State or EPA that you are part of the State Monitoring Plan for Assessment Monitoring.
* * * * *
(3) Analytes to be monitored. Lists 1, 2, and 3 contaminants are provided in table 1 to paragraph (a)(3):
1—Contaminant | 2—CASRN | 3—Analytical methods a | 4—Minimum reporting level b | 5—Sampling location c | 6—Period during which sample collection to be completed |
---|---|---|---|---|---|
Column headings are: | |||||
1—Contaminant: The name of the contaminant to be analyzed. | |||||
2—CASRN (Chemical Abstracts Service Registry Number) or Identification Number: A unique number identifying the chemical contaminants. | |||||
3—Analytical Methods: Method numbers identifying the methods that must be used to test the contaminants. | |||||
4—Minimum Reporting Level (MRL): The value and unit of measure at or above which the concentration of the contaminant must be measured using the approved analytical methods. If EPA determines, after the first six months of monitoring that the specified MRLs result in excessive resampling, EPA will establish alternate MRLs and will notify affected PWSs and laboratories of the new MRLs. N/A is defined as non-applicable. | |||||
5—Sampling Location: The locations within a PWS at which samples must be collected. | |||||
6—Period During Which Sample Collection to be Completed: The time period during which the sampling and testing will occur for the indicated contaminant. | |||||
a The analytical procedures shall be performed in accordance with the documents associated with each method, see paragraph (c) of this section. | |||||
b The MRL is the minimum concentration of each analyte that must be reported to EPA. | |||||
c Sampling must occur at your PWS's entry points to the distribution system (EPTDSs), after treatment is applied, that represent each non-emergency water source in routine use over the 12-month period of monitoring. Systems that purchase water with multiple connections from the same wholesaler may select one representative connection from that wholesaler. The representative EPTDS must be a location within the purchaser's water system. This EPTDS sampling location must be representative of the highest annual volume connections. If the connection selected as the representative EPTDS is not available for sampling, an alternate highest volume representative connection must be sampled. See 40 CFR 141.35(c)(3) for an explanation of the requirements related to the use of representative GW EPTDSs. | |||||
List 1: Assessment Monitoring | |||||
Per- and Polyfluoroalkyl Substances (PFAS) | |||||
11-chloroeicosafluoro-3-oxaundecane-1-sulfonic acid (11Cl-PF3OUdS) | 763051-92-9 | EPA 533 | 0.005 µg/L | EPTDS | 1/1/2023-12/31/2025 |
1H, 1H, 2H, 2H-perfluorodecane sulfonic acid (8:2 FTS) | 39108-34-4 | EPA 533 | 0.005 µg/L | EPTDS | 1/1/2023-12/31/2025 |
1H, 1H, 2H, 2H-perfluorohexane sulfonic acid (4:2 FTS) | 757124-72-4 | EPA 533 | 0.003 µg/L | EPTDS | 1/1/2023-12/31/2025 |
1H, 1H, 2H, 2H-perfluorooctane sulfonic acid (6:2 FTS) | 27619-97-2 | EPA 533 | 0.005 µg/L | EPTDS | 1/1/2023-12/31/2025 |
4,8-dioxa-3H-perfluorononanoic acid (ADONA) | 919005-14-4 | EPA 533 | 0.003 µg/L | EPTDS | 1/1/2023-12/31/2025 |
9-chlorohexadecafluoro-3-oxanone-1-sulfonic acid (9Cl-PF3ONS) | 756426-58-1 | EPA 533 | 0.002 µg/L | EPTDS | 1/1/2023-12/31/2025 |
hexafluoropropylene oxide dimer acid (HFPO-DA) (GenX) | 13252-13-6 | EPA 533 | 0.005 µg/L | EPTDS | 1/1/2023-12/31/2025 |
nonafluoro‐3,6‐dioxaheptanoic acid (NFDHA) | 151772-58-6 | EPA 533 | 0.02 µg/L | EPTDS | 1/1/2023-12/31/2025 |
perfluoro (2‐ethoxyethane) sulfonic acid (PFEESA) | 113507-82-7 | EPA 533 | 0.003 µg/L | EPTDS | 1/1/2023-12/31/2025 |
perfluoro‐3‐methoxypropanoic acid (PFMPA) | 377-73-1 | EPA 533 | 0.004 µg/L | EPTDS | 1/1/2023-12/31/2025 |
perfluoro‐4‐methoxybutanoic acid (PFMBA) | 863090-89-5 | EPA 533 | 0.003 µg/L | EPTDS | 1/1/2023-12/31/2025 |
perfluorobutanesulfonic acid (PFBS) | 375-73-5 | EPA 533 | 0.003 µg/L | EPTDS | 1/1/2023-12/31/2025 |
perfluorobutanoic acid (PFBA) | 375-22-4 | EPA 533 | 0.005 µg/L | EPTDS | 1/1/2023-12/31/2025 |
perfluorodecanoic acid (PFDA) | 335-76-2 | EPA 533 | 0.003 µg/L | EPTDS | 1/1/2023-12/31/2025 |
perfluorododecanoic acid (PFDoA) | 307-55-1 | EPA 533 | 0.003 µg/L | EPTDS | 1/1/2023-12/31/2025 |
perfluoroheptanesulfonic acid (PFHpS) | 375-92-8 | EPA 533 | 0.003 µg/L | EPTDS | 1/1/2023-12/31/2025 |
perfluoroheptanoic acid (PFHpA) | 375-85-9 | EPA 533 | 0.003 µg/L | EPTDS | 1/1/2023-12/31/2025 |
perfluorohexanesulfonic acid (PFHxS) | 355-46-4 | EPA 533 | 0.003 µg/L | EPTDS | 1/1/2023-12/31/2025 |
perfluorohexanoic acid (PFHxA) | 307-24-4 | EPA 533 | 0.003 µg/L | EPTDS | 1/1/2023-12/31/2025 |
perfluorononanoic acid (PFNA) | 375-95-1 | EPA 533 | 0.004 µg/L | EPTDS | 1/1/2023-12/31/2025 |
perfluorooctanesulfonic acid (PFOS) | 1763-23-1 | EPA 533 | 0.004 µg/L | EPTDS | 1/1/2023-12/31/2025 |
perfluorooctanoic acid (PFOA) | 335-67-1 | EPA 533 | 0.004 µg/L | EPTDS | 1/1/2023-12/31/2025 |
perfluoropentanesulfonic acid (PFPeS) | 2706-91-4 | EPA 533 | 0.004 µg/L | EPTDS | 1/1/2023-12/31/2025 |
perfluoropentanoic acid (PFPeA) | 2706-90-3 | EPA 533 | 0.003 µg/L | EPTDS | 1/1/2023-12/31/2025 |
perfluoroundecanoic acid (PFUnA) | 2058-94-8 | EPA 533 | 0.002 µg/L | EPTDS | 1/1/2023-12/31/2025 |
n-ethyl perfluorooctanesulfonamidoacetic acid (NEtFOSAA) | 2991-50-6 | EPA 537.1 | 0.005 µg/L | EPTDS | 1/1/2023-12/31/2025 |
n-methyl perfluorooctanesulfonamidoacetic acid (NMeFOSAA) | 2355-31-9 | EPA 537.1 | 0.006 µg/L | EPTDS | 1/1/2023-12/31/2025 |
perfluorotetradecanoic acid (PFTA) | 376-06-7 | EPA 537.1 | 0.008 µg/L | EPTDS | 1/1/2023-12/31/2025 |
perfluorotridecanoic acid (PFTrDA) | 72629-94-8 | EPA 537.1 | 0.007 µg/L | EPTDS | 1/1/2023-12/31/2025 |
Metal/Pharmaceutical | |||||
Lithium | 7439-93-2 | EPA 200.7, SM 3120 B, ASTM D1976-20 | 9 µg/L | EPTDS | 1/1/2023-12/31/2025 |
List 2: Screening Survey | |||||
Reserved | Reserved | Reserved | Reserved | Reserved | Reserved |
List 3: Pre-Screen Testing | |||||
Reserved | Reserved | Reserved | Reserved | Reserved | Reserved |
(4) * * *
(i) * * *
(A) Sample collection period. You must collect the samples in one continuous 12-month period for List 1 Assessment Monitoring, and, if applicable, for List 2 Screening Survey, or List 3 Pre-Screen Testing, during the timeframe indicated in column 6 of table 1 to paragraph (a)(3) of this section. EPA or your State will specify the month(s) and year(s) in which your monitoring must occur. As specified in 40 CFR 141.35(c)(5), you must contact EPA if you believe you cannot collect samples according to your schedule.
(B) Frequency. You must collect the samples within the timeframe and according to the frequency specified by contaminant type and water source type for each sampling location, as specified in table 2 to this paragraph (a)(4)(i)(B). For the second or subsequent round of sampling, if a sample location is non-operational for more than one month before and one month after the scheduled sampling month ( i.e., it is not possible for you to sample within the window specified in table 2), you must notify EPA as specified in 40 CFR 141.35(c)(5) to reschedule your sampling.
Contaminant type | Water source type | Timeframe | Frequency 1 |
---|---|---|---|
1 Systems must assign a sample event code for each contaminant listed in Table 1. Sample event codes must be assigned by the PWS for each sample event. For more information on sample event codes see 40 CFR 141.35(e) Table 1. | |||
List 1 Contaminants | Surface water, Mixed, or GWUDI | 12 months | You must monitor for four consecutive quarters. Sample events must occur three months apart. (Example: If first monitoring is in January, the second monitoring must occur any time in April, the third any time in July, and the fourth any time in October). |
Ground water | 12 months | You must monitor twice in a consecutive 12-month period. Sample events must occur 5-7 months apart. (Example: If the first monitoring event is in April, the second monitoring event must occur any time in September, October, or November.) |
(C) Location. You must collect samples for each List 1 Assessment Monitoring contaminant, and, if applicable, for each List 2 Screening Survey, or List 3 Pre-Screen Testing contaminant, as specified in table 1 to paragraph (a)(3) of this section. Samples must be collected at each sample point that is specified in column 5 and footnote c of table 1 to paragraph (a)(3) of this section. If you are a GW system with multiple EPTDSs, and you request and receive approval from EPA or the State for sampling at representative EPTDS(s), as specified in 40 CFR 141.35(c)(3), you must collect your samples from the approved representative sampling location(s).
* * * * *
(ii) Small systems. If you serve a population of 10,000 or fewer people and are notified that you are part of the State Monitoring Plan, you must comply with the requirements specified in paragraphs (a)(4)(ii)(A) through (H) of this section. If EPA or the State informs you that they will be collecting your UCMR samples, you must assist them in identifying the appropriate sampling locations and in collecting the samples.
(A) Sample collection and frequency. You must collect samples at the times specified for you by the State or EPA. Your schedule must follow both the timing of monitoring specified in table 1 to paragraph (a)(3) of this section, List 1, and, if applicable, List 2, or List 3, and the frequency of monitoring in table 2 to paragraph (a)(4)(i)(B) of this section.
* * * * *
(5) * * *
(ii) * * * To participate in the UCMR Laboratory Approval Program, the laboratory must register and complete the necessary application materials by August 1, 2022. Correspondence must be addressed to: UCMR Laboratory Approval Coordinator, USEPA, Technical Support Center, 26 West Martin Luther King Drive, (MS 140), Cincinnati, Ohio 45268; or emailed to EPA at: UCMR_Lab_Approval@epa.gov.
(iii) Minimum Reporting Level. The MRL is defined by EPA as the quantitation limit achievable, with 95 percent confidence, by 75 percent of laboratories nationwide, assuming the use of good instrumentation and experienced analysts.
* * * * *
(v) Method defined quality control. You must ensure that your laboratory analyzes Laboratory Fortified Blanks and conducts Laboratory Performance Checks, as appropriate to the method's requirements, for those methods listed in column 3 in table 1 to paragraph (a)(3) of this section. Each method specifies acceptance criteria for these QC checks.
(vi) Reporting. You must require your laboratory, on your behalf, to post and approve these data in EPA's electronic data reporting system, accessible at https://www.epa.gov/dwucmr, for your review within 90 days from the sample collection date. You then have 30 days from when the laboratory posts and approves your data to review, approve, and submit the data to the State and EPA, via the agency's electronic data reporting system. If you do not electronically approve and submit the laboratory data to EPA within 30 days of the laboratory posting approved data, the data will be considered approved by you and available for State and EPA review.
* * * * *
(c) Incorporation by reference. The standards required in this section are incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available for inspection at U.S. Environmental Protection Agency, Water Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave. NW, Washington, DC 20004, (202) 566-1744, email Docket-customerservice@epa.gov, or go to https://www.epa.gov/dockets/epa-docket-center-reading-room, and is available from the sources indicated elsewhere in this paragraph. The material is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email fr.inspection@nara.gov, or go to www.archives.gov/federal-register/cfr/ibr-locations.html.
(1) U.S. Environmental Protection Agency, EPA West, Room 3334, 1301 Constitution Ave. NW, Washington, DC 20004; telephone: (202) 566-1744.
(i) Method 200.7, “Determination of Metals and Trace Elements in Water and Wastes by Inductively Coupled Plasma-Atomic Emission Spectrometry,” Revision 4.4, EMMC Version, 1994. Available at https://www.epa.gov/esam/method-2007-determination-metals-and-trace-elements-water-and-wastes-inductively-coupled-plasma.
(ii) Method 537.1, “Determination of Selected Per- and Polyfluorinated Alkyl Substances in Drinking Water by Solid Phase Extraction and Liquid Chromatography/Tandem Mass Spectrometry,” Version 2.0, 2020. Available at https://www.epa.gov/water-research/epa-drinking-water-research-methods.
(iii) Method 533, “Determination of Per- and Polyfluoroalkyl Substances in Drinking Water by Isotope Dilution Anion Exchange Solid Phase Extraction and Liquid Chromatography/Tandem Mass Spectrometry,” November 2019, EPA 815-B-19-020. Available at https://www.epa.gov/dwanalyticalmethods.
(2) American Public Health Association, 800 I Street NW, Washington, DC 20001-3710; telephone: (202) 777-2742; email: comments@apha.org; www.apha.org.
(i) “Standard Methods for the Examination of Water & Wastewater,” 23rd edition (2017).
(A) SM 3120 B, “Metals by Plasma Emission Spectroscopy (2017): Inductively Coupled Plasma (ICP) Method.”
(B) [Reserved]
(ii) “Standard Methods Online,” approved 1999; https://www.standardmethods.org.
(A) SM 3120 B, “Metals by Plasma Emission Spectroscopy: Inductively Coupled Plasma (ICP) Method,” revised December 14, 2020.
(B) [Reserved]
(3) ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959; telephone: (610) 832-9500; email: service@astm.org; www.astm.org.
(i) ASTM D1976-20, “Standard Test Method for Elements in Water by Inductively-Coupled Plasma Atomic Emission Spectroscopy,” approved May 1, 2020.
(ii) [Reserved]
[FR Doc. 2021-27858 Filed 12-23-21; 8:45 am]
BILLING CODE 6560-50-P
The Environmental Protection Agency (EPA) regulates emissions from motor vehicles, engines, and the fuels used to operate them. The agency requires vehicle manufacturers to install control devices that limit the amount of air pollutants a vehicle may emit. However, defeat devices attempt to detour around these controls and allow emissions beyond federal limits.
Excess vehicle emissions can threaten the health of others, impair state and local efforts to maintain national air quality standards, and — as one company and its owner learned — subject you and your business to steep monetary penalties.
Steer clear of defeat devices to ensure a smooth regulatory road.
EPA and the U.S. Department of Justice reached a settlement agreement with a North Carolina automotive parts company and its owner for violating the Clean Air Act (CAA) requirements for mobile sources by:
The company and its owner face civil and criminal consequences and will pay a total of $10 million in fees and penalties.
Civil enforcement
A July 2024 consent decree (pending court approval) requires both parties to pay a combined $7 million penalty. It also bans the company and owner from:
Criminal enforcement
Both the company and owner pleaded guilty to conspiring to violate the CAA. The federal court ordered the company to pay a $2.4 million fine and complete three years of organizational probation. It also ordered the owner to pay a $600,000 fine and serve three years of probation.
A defeat device is any component that “bypasses, impairs, defeats, or disables the control of emissions of any regulated pollutant” (40 CFR 1068.101(b)(2)). Put simply, it’s an illegal device that removes or disables a vehicle’s emissions controls.
There are generally two types of defeat devices: hardware (such as modified automotive parts) and software (like delete tuners). In fact, many of the devices consist of both types that work in tandem. Federal law (and EPA regulations at 1068.101(b)) bans defeat devices used to swerve around vehicle emissions controls. Section 203(a)(3) of the CAA prohibits anyone from:
Common emission control devices include:
The prohibition on defeat devices applies to everyone, from the original equipment manufacturer that installs the vehicle emissions controls to the vehicle owner and operators.
The 1990 CAA Amendments expanded the tampering provision in Section 203(a)(3) to include “any person.” Further, EPA’s regulations at 1068.101(b) “apply to everyone,” such as:
Consider these helpful suggestions for maintaining compliance:
The case against this automotive parts company and owner serves as a multimillion-dollar reminder about making, selling, installing, or using defeat devices — steer clear!
Key to remember: Steer clear of defeat devices that try to detour around EPA’s vehicle emissions controls to ensure a smooth regulatory road.
Implementation of the Clean Air Act in 1970 has fueled impressive long-term emissions reductions, improving the air we breathe. Still, approximately 140 million Americans live in counties where air quality concentrations are above set levels. While long-term trends continue to improve, the Environmental Protection Agency (EPA) states that there’s still work to be done.
The Clean Air Act requires EPA to set National Ambient Air Quality Standards (NAAQS) for six principal pollutants called criteria air pollutants, which can be harmful to public health and the environment.
Between 1970 and 2023, the combined emissions of these criteria pollutants have dropped by 78 percent. This is of particular significance due to the continued growth of the U.S. economy by 320 percent over that same period of time. Since 1990, air pollutant concentrations of these six key pollutants have declined as follows:
The link between air pollution and these criteria air pollutants contributes to a variety of health problems and impacts on the environment. Breathing elevated levels of CO can decrease the amount of oxygen reaching a person's organs and tissues. Lead exposure can harm the development of children, leading to lower IQs, learning deficits, and behavioral problems. Short-term exposure to NO2 can aggravate asthma and other respiratory diseases. The environmental effects of ozone include damage to vegetation by injuring leaves, which reduces photosynthesis, therefore impairing growth and decreasing crop yields. Particulate matter in the air is the main cause of reduced visibility in parts of the U.S. It can settle on soils and surface waters, which can change the pH, deplete nutrients, and negatively affect ecosystems.
EPA and states continue to track emissions data from industry, state, tribal, and local agencies from sources in their jurisdictions, including:
The government continues to invest in climate pollution action efforts to improve the economic and public health of those living in the country, including:
Key to remember: While long-term trends continue to show an improvement in the air we breathe, EPA states that there’s still work to be done.
The Environmental Protection Agency (EPA) has extended the submission period for the Chemical Data Reporting (CDR) report. The submission period opened on June 1, and EPA has pushed the submission deadline from September 30 to November 22, 2024.
Who’s impacted?
Under the Toxic Substances Control Act (TSCA), EPA’s CDR rule requires manufacturers (including importers) of chemicals on TSCA’s Chemical Substance Inventory to report information on the production and use of the chemicals in commerce if they meet certain production volume thresholds at any one site.
Why the delay?
The deadline extension is due to technical errors with e-CDRweb, the electronic reporting tool on EPA’s Central Data Exchange system that reporters use to submit the CDR report (Form U). The specific issue only impacts submissions with multiple confidential business information (CBI) claims for chemical identity.
The tool’s copy function fails to properly capture the substantiations submitted by facilities making multiple CBI claims, leaving out some of the questions and answers. Additionally, it doesn’t let submitters who used the copy function add the missing information.
EPA expects to fix the reporting tool by the end of September.
About the 2024 CDR report
The CDR report is submitted to EPA every four years. The 2024 CDR report covers activities that occurred between the calendar years 2020 and 2023. Note that this extension applies only to the 2024 CDR submission period.
Key to remember: Due to technical difficulties with the electronic reporting tool, EPA has extended the 2024 Chemical Data Reporting submission deadline to November 22, 2024.
It’s no secret that the healthcare industry is swamped by government requirements from a host of federal, state, and local agencies. New survey results put three agencies in a near tie for the “greatest compliance challenge” category for leaders, managers, and others in healthcare.
Two of the agencies may be no surprise — the Centers for Medicare & Medicaid Services (CMS), and the Centers for Disease Control and Prevention (CDC). However, some might be taken aback to learn that the Occupational Safety and Health Administration (OSHA) ranked just as challenging to comply with for the healthcare industry.
The lion’s share of the attention in healthcare has long been on patient care and safety. Therefore, to discover that OSHA — a worker safety and health agency — weighed in as a huge pain point with the other two agencies should raise eyebrows.
An August 2024 survey report from the J. J. Keller Center for Market Insights recently tapped 220 professionals from healthcare. This included respondents from clinics/offices; hospitals; ambulatory, nursing, and home care services; outpatient facilities; behavioral health services; medical/dental labs; and other healthcare service types.
As stated, the CMS, CDC, and OSHA each took over 20 percent of the findings in answer to the question, “What government entity’s standards pose the greatest compliance challenge(s) to your organization?” Together, these three stand out from any others for that survey question. In total, they racked up 75 percent of the results!
Other agencies and organizations made up another 10 percent in aggregate, while “none of the above” garnered 14 percent.
OSHA’s mission is “to assure America’s workers have safe and healthful working conditions.” While patient safety is not part of that mission, worker safety and health efforts can spill over into that space. For example, ensuring that workers have proper means of egress and fire protections relates to patient safety. In fact, patient safety efforts may not succeed without safe healthcare workers.
OSHA requires private-sector healthcare employers to provide workers with a safe and healthful work setting free of known serious hazards. The agency has over 1,600 pages of regulations covering general industry, and that includes healthcare. These regulations are complex, but healthcare employers must comply with all applicable requirements.
Healthcare organizations have well over 100 applicable OSHA regulations. The top-cited OSHA regulations for hospitals in fiscal year 2023 include:
OSHA’s Healthcare topic page also showcases regulations for personal protective equipment, formaldehyde, ethylene oxide, ionizing radiation, chemical hazard communication, and laboratories.
Yet, the agency’s reach can go beyond regulations. Hazards related to ergonomics, workplace violence, and infectious diseases may be cited. The citations point to section 5(a)(1) of the Occupational Safety and Health Act, which calls for worker protections from serious, recognized hazards. Also, OSHA officers follow the agency’s “Inspection Guidance for Inpatient Healthcare Settings,” which targets lifting-related musculoskeletal disorders, workplace violence, tuberculosis, and other hazards.
OSHA and state-plan state inspections are unannounced — they can happen at any time! In addition, an OSHA penalty can reach over $161,000 per violation.
Statistics show that healthcare settings are hazardous places to work! The injury/illness incidence rates for hospitals and nursing and residential care facilities are higher than in the construction industry!
Note that the Bureau of Labor Statistics reveals that the leading injury/illness events with days away from work in hospitals in 2021 and 2022 were:
Because of the severity of some injuries/illnesses and the potential for a worker to suffer one, it’s critical to meet OSHA regulations and beyond. Worker injuries/illnesses come at a high cost that most healthcare facilities likely cannot afford.
The good news is OSHA compliance can lead to a marked decline in worker injuries/illnesses. Even accreditation organizations like The Joint Commission expect to see compliance with applicable OSHA regulations. That’s because meeting OSHA worker safety and health regulations has been discovered to have a positive effect on patient safety. A stable workforce with few worker injuries/illnesses creates a setting conducive to patient confidence and satisfaction.
OSHA has resources such as a small business handbook, quick start page, and Hospitals eTool. However, given the importance of OSHA compliance and the challenges it poses to healthcare, it may be wise to have a third party do a comprehensive OSHA compliance audit of each healthcare facility. This is particularly true if leadership is new to workplace safety or does not have the in-house expertise. This baseline may help the facility spot the major hazards and flag OSHA requirements for the site.
The agency recommends that employers conduct compliance inspections at least quarterly. This would be more often if conditions change frequently.
OSHA, along with the CMS and CDC, top the list of compliance challenges for healthcare. A third-party audit or inspection may help these facilities get a handle on the requirements.
No organization wants to throw away the chance to improve operational efficiency. Yet, many businesses unknowingly discard such opportunities by overlooking a process that happens every day: nonhazardous (solid) waste management. That’s where a waste assessment comes in; it’s a tool that can help your facility avoid wasted opportunities.
The ultimate goal of a solid waste assessment is to achieve operational efficiency by cutting the amount of waste a facility generates and improving management practices for waste that can’t be eliminated. As a result, facilities send less waste to landfills (minimizing environmental impact) and require fewer resources for waste management (cutting costs).
Through a waste assessment, your facility can:
The Environmental Protection Agency (or EPA) identifies three leading methods for conducting waste assessments: records examinations, walkthroughs, and sorts.
A records examination answers two questions: How does your facility remove solid waste (landfill vs. recycling), and how much does it cost your facility to remove it?
First, calculate the total amount of waste removed (typically in pounds) and total costs for:
Next, using the same measurement units, sum up the number of recyclables collected and recycling costs for:
Finally:
A facility walkthrough requires physical observation of the processes that generate waste and the types of waste they create.
Each facility can tailor the walkthrough process to its unique objectives. However, effective walkthroughs generally incorporate these elements:
Sometimes, the most effective assessment requires a hands-on approach, and that’s what a waste sort delivers. It enables you to estimate how much each type of waste contributes to the total amount of generated waste.
Remember to weigh the containers when they’re empty. Subtract the weight of the empty containers from the weight of waste to obtain each subcategory’s net component weight. Add these measurements to obtain the total weight of waste generated.
The “right” waste assessment is unique to each facility. You can use one method or a combination. When selecting the waste assessment(s) to use, consider these factors:
Key to remember: Waste assessments help facilities improve operational efficiency by identifying ways to reduce waste and enhance waste management practices.
The "Review of Final Rule Reclassification of Major Sources as Area Sources Under Section 112 of the Clean Air Act” rule allows certain major sources to reclassify as area sources under specific conditions. The reclassification process typically involves a review of the source's emissions profile, its location within a specific air quality nonattainment area, and other relevant factors. If it’s determined that a major source isn’t making a substantial contribution to air quality problems, it may be eligible for reclassification as an area source. Under this rule (finalized on August 30, 2024), the Environmental Protection Agency (EPA) allows a major source of hazardous air pollutants (HAPs) to reclassify as an area source after acting to limit emissions under the National Emission Standards for Hazardous Air Pollutants (NESHAP) program. However, sources of persistent and bioaccumulative HAPs listed in Clean Air Act (CAA) Section 112(c)(6) must continue to comply with certain major source emission standards under Sections 112(d)(2) or 112(d)(4) even if these sources reclassify as area sources.
The seven persistent and bioaccumulative HAPs include:
The following subparts are included in the list of NESHAPs (see 40 CFR 63.1(c)(6)(iii)) that cannot be avoided through reclassification:
• Continued compliance: Facilities that have already reclassified from major to area source status and fall under one of the listed subparts will need to continue to comply with the associated maximum achievable control technology (MACT) requirements, including monitoring, recordkeeping, testing, and reporting. MACT standards are performance criteria that apply to major sources.
• Potential challenges: Reclassification may have been a strategy to reduce regulatory burden. However, the new limitations could increase the compliance costs and operational challenges for affected facilities.
• Stationary combustion turbines: The NESHAP for stationary combustion turbines isn’t included in the list of affected subparts, providing some relief for facilities using this technology.
• Retroactive applicability: The final rule doesn’t specifically address whether the effective date of reclassification is the revised permit, notification to EPA or date of change in potential emissions. This uncertainty could impact facilities that have recently reclassified.
Overall, the new reclassification limitations will have significant implications for facilities operating under the affected NESHAP subparts. It’s essential for affected facilities to carefully review the specific requirements and consider the potential impacts on their operations.
Key to remember: EPA finalized requirements for sources that reclassify from major source status to area source status under the National Emission Standards for Hazardous Air Pollutants (NESHAP) program. Sources subject to certain major source NESHAPs for seven specific pollutants must remain subject to those NESHAPs even if the sources reclassify to area source status.
A final rule issued by the Environmental Protection Agency (EPA) in September 2024 requires facilities that reclassify from major to area source status under the National Emission Standards for Hazardous Air Pollutants (NESHAP) program to continue to meet the major source emission standards for seven persistent and bioaccumulative hazardous air pollutants (HAPs).
Who does this impact?
The final rule applies to facilities subject to any of the seven major source NESHAPs that reclassify from major to area source status. The major and area source categories differ based on the emissions and/or potential to emit (PTE) certain hazardous air pollutants. Major sources emit or have the PTE:
Area sources are facilities with actual and/or potential emissions below these thresholds.
Which HAPs are affected?
The final rule targets seven HAPs:
What are the notification changes?
The final rule also made minor adjustments to the reclassification notification requirements. Specifically, the agency clarifies that facilities must:
EPA also added electronic submission procedures for confidential business information.
Key to remember: Facilities that reclassify from major to area source status under EPA’s NESHAP program must continue complying with the major source emission standards for seven hazardous air pollutants.
OSHA requires employers to provide all workers with immediately available and sanitary restroom or toilet facilities. But does this include truckers and delivery drivers that stop at your facilities? The sanitation standards (1910.141, 1926.51, and 1928.110) are meant to protect all workers from adverse health effects from unsanitary toilets facilities, or the unavailability of facilities when needed.
Bipartisan legislation has recently been introduced in the House that would require businesses to provide restroom access to truckers who are loading or delivering cargo at their warehouses, manufacturers, distribution centers, retailers, and ports.
Supported by leading organizations in the trucking industry, the Trucker Bathroom Access Act (H.R. 9592) was introduced on Dec. 15, 2022. The bill requires retailers, warehouses, and other establishments with existing restrooms to provide access to drivers who are loading or delivering cargo. Additionally, operators of ports and marine terminals must provide access for drayage and parking while accessing such restrooms.
This amendment to Title 49 would exempt some employers from the bill including filling and service stations, and restaurants 800-square feet or smaller with restrooms intended for employee use only. The bill doesn’t require employers to construct new restrooms but to give truck drivers the same access as employees or customers.
Commercial truckers and delivery drivers are the lifeline of our supply chain of supplies, products, and consumables. Working tirelessly all hours, during holidays and weekends, and throughout the pandemic, they continue to deliver critical food and emergency supplies to companies everywhere. Employers have the privilege of demonstrating gratitude to truckers and delivery drivers with a positive work environment.
The benefits of allowing truckers and delivery drivers the convenience and safety of readily available, sanitary restroom facilities are plenty. They’re able to rest and reset when necessary, which keeps them and others safer on the roads. Equally important, restroom availability prevents drivers from having to search for available facilities elsewhere, allowing them to keep a timely delivery schedule, limit supply chain delays, and ultimately lower costs for employers and customers.
The proposed Trucker Bathroom Access Act will require retailers, warehouses, and other establishments with existing restrooms to provide access to truckers and delivery drivers who are loading or delivering cargo. Access to restrooms keeps them refreshed and ready to deliver essential supplies to companies across the country.
The Environmental Protection Agency (EPA) published the Fall 2024 Semiannual Agenda of Regulatory and Deregulatory Actions on December 13, 2024. The agenda reveals the agency’s upcoming regulatory actions and where each action is in the rulemaking process.
The agenda includes major EPA updates, such as:
This article highlights some of the major rules we’re watching closely. You’ll want to review the entire agenda to learn about all the rulemakings on EPA’s docket. Please note that the agenda dates are tentative; they're when the agency seeks to publish the rulemakings in the Federal Register.
Final Rule Stage | |
Projected Publication Date | Title |
December 2024 | New Source Performance Standards (NSPS) and Emission Guidelines (EG) for Large Municipal Waste Combustors (MWCs) |
December 2024 | Removal of Affirmative Defense Provisions From Specified New Source Performance Standards and National Emission Standards for Hazardous Air Pollutants |
January 2025 | Water System Restructuring Assessment Rule |
March 2025 | Regulatory Requirements for New HAP Additions to Part 63 |
July 2025 | Listing of Specific PFAS as Hazardous Constituents |
August 2025 | Clean Water Act Effluent Limitations Guidelines and Standards for the Meat and Poultry Products Point Source Category |
October 2025 | Revisions to Standards for the Open Burning/Open Detonation of Waste Explosives |
November 2025 | Stationary Combustion Turbines New Source Performance Standards (NSPS) Technology Review |
Proposed Rule Stage | |
Projected publication date of Notice of Proposed Rulemaking | Title |
December 2024 | Reconsideration of Standards of Performance for New, Reconstructed and Modified Sources and Emissions Guidelines for Existing Sources: Oil and Natural Gas Sector Climate Review |
January 2025 | National Emission Standards for Hazardous Air Pollutants for the Polyether Polyols Production Industry |
March 2025 | Clean Water Act Effluent Limitations Guidelines and Standards for PFAS Manufacturers Under the Organic Chemicals, Plastics and Synthetic Fibers Point Source Category |
April 2025 | Phasedown of Hydrofluorocarbons: Reconsideration of Technology Transitions Final Rule Under the American Innovation and Manufacturing Act of 2020 |
May 2025 | National Emission Standards for Hazardous Air Pollutants: Stationary Combustion Turbines; Amendments |
June 2025 | Improving Recycling and Management of Renewable Energy Wastes: Universal Waste Regulations for Solar Panels and Lithium Batteries |
June 2025 | PFAS Requirements in NPDES Permit Applications |
June 2025 | Tiered Data Reporting to Inform Prioritization, Risk Evaluation and Risk Management Under the Toxic Substances Control Act (TSCA) |
November 2025 | Revisions to Establish the Sixth Unregulated Contaminant Monitoring Rule (UCMR 6) for Public Water Systems |
November 2025 | Revise/Update the Standards of Performance and Emission Guidelines for Municipal Solid Waste Landfills |
Pre-Rule Stage | |
Projected publication date or other action | Title |
December 2024 (Notice of Proposed Rulemaking) | Lead Wheel Weights; Regulatory Investigation Under the Toxic Substances Control Act (TSCA) |
January 2025 (End Review) | 610 Review of Standards of Performance for New Residential Wood Heaters, New Residential Hydronic Heaters and Forced-Air Furnaces |
January 2025 (Advanced Notice of Proposed Rulemaking Comment Period End) | Regulatory Investigation of N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine ("6PPD") and its Transformation Product, 6PPD-quinone, Under the Toxic Substances Control Act (TSCA) |
December 2024 marks the 40th anniversary of one of history’s worst industrial incidents — the release of a deadly gas at a chemical plant in Bhopal, India. This incident, along with another in West Virginia in 1985, spurred U.S. legislative and regulatory action. However, some might say that work is not finished.
Think of the Emergency Planning and Community Right-to-Know Act (EPCRA) of 1986, the EPA Risk Management Program (RMP) standard, and the OSHA Process Safety Management (PSM) standard, for example. You’ll find roots to the Bhopal disaster.
It was late on December 2, 1984, at a chemical facility. A faulty valve leaked water into a tank of methyl isocyanate (or MIC). This prompted a violent reaction inside the tank. History tells us that at about 1:00 a.m. on that fateful December 3, the failure of a safety valve triggered a massive release. A dense, lethal cloud of MIC and other chemicals drifted over the city of Bhopal.
By dawn, thousands of residents were dead, along with birds, dogs, cows, and other animals. The injured flocked to hospitals in overwhelming numbers. A lack of information about just what the chemicals were, however, compounded the catastrophe.
India officials reported half a million or more chemical exposures. Estimates vary, but as many as 10,000 people perished in the initial few days. Tens of thousands died prematurely in the decades to follow, according to sources.
In August 1985, a chemical release in Institute, West Virginia, showed Americans that a “Bhopal-like” incident could happen here. Aldicarb oxime and other chemicals released from the facility, and over 125 residents landed in the hospital. Again, a lack of available chemical information was noteworthy. Many U.S. citizens began to fear they faced catastrophic risks.
In the wake of the incidents, Congress enacted laws:
Together, they required EPA and OSHA to issue regulations to:
Congress also established the Chemical Safety and Hazard Investigation Board (CSB) to investigate chemical incidents and recommend measures to prevent them. Despite these actions, the U.S. continues to experience serious chemical incidents. A visit to the CSB or National Response Center (NRC) websites reveals countless incident reports since 1990. A look at the 2024 data finds:
Ten years ago, on the 30th anniversary of the Bhopal disaster, CSB posted a six-minute video explaining how the tragedy occurred. The video also examines more recent U.S. incidents. It emphasizes what more could be done to prevent similar incidents.
CSB investigations around the time of the video found deficiencies in design and PSM, similar to those uncovered in Bhopal! CSB Chairperson Rafael Moure-Eraso argued: “Process safety management regulations are in need of reform. There must be more emphasis on preventing the occurrence of major chemical accidents through safer design. Responding to emergencies and punishing people after the fact are not enough.”
Another headline-making incident in April 2013 involved a massive explosion of ammonium nitrate at a fertilizer storage/distribution facility in West, Texas. It fatally injured 12 volunteer firefighters and two members of the public and caused hundreds of injuries. The incident prompted the Executive Order on Improving Chemical Facility Safety and Security (EO 13650) on August 1, 2013. The order directed the federal government to:
The feds held listening sessions and issued a flurry of fact sheets, alerts, and enforcement policy changes (See here and here.). Note that the RMP regulation at 40 CFR 68 was eventually amended this year on March 11, 2024. The PSM standard remains unchanged, despite a request for information on December 9, 2013. In an about-face, Congress allowed the Chemical Facility Anti-Terrorism Standards program (at 6 CFR 27) to expire on July 28, 2023, but many in Congress and industry would like to see its return.
This month marks the 40th anniversary of the Bhopal chemical disaster. It sparked the U.S. Congress to take steps back then to prevent such a disaster from occurring here. Those actions did not spell the end to all chemical disasters in the U.S. In response, a renewed push for regulatory reforms popped up in the last decade.
Quick action using cardiopulmonary resuscitation (CPR) and automated external defibrillators(AEDs) can save the lives of the nearly 350,000 cardiac event victims each year outside of a hospital setting. But what does OSHA require for the workplace? What you didn’t know about OSHA regulations regarding AEDs may surprise you.
For every minute a patient is in cardiac arrest, their chances of survival decrease dramatically. When a patient doesn’t have a pulse and isn’t breathing, CPR should be performed until an AED is available. It’s important to note that CPR alone does not restart the heart. CPR is an oxygen circulation procedure. AEDs, on the other hand, are meant for lifesaving intervention.
CPR and early defibrillation are vital components of the emergency medical services (EMS) chain of survival that increases the odds of cardiac patient survival. However, according to the American Heart Association (AHA), even the best CPR can’t provide enough circulation of oxygen to the brain and heart for more than a few minutes. In fact, a patient whose brain is deprived of oxygen for 10 minutes or more seldom recovers.
Just like a reliable vehicle, the circulatory system is the human body’s blood transportation system, and the heart is the engine. Amazingly, the heart generates its own electrical impulses, pumping in a regular, rhythmic manner. As with any engine, the heart requires a certain amount of pressure to function and doesn’t work well when clogged with grease or debris. The most common causes of sudden cardiac arrest include a heart attack, electrocution, and asphyxiation — all of which could occur in the workplace. Common signs and symptoms include:
CPR provides the pressure for the body’s “engine” to oxygen circulating, while an AED provides the electrical impulses to keep the engine pumping.
OSHA 1910.151 requires first aid treatment be provided in the absence of an infirmary, clinic, or hospital in near proximity to the workplace used to treat injured employees. This may include assisting a victim of cardiac arrest using CPR or defibrillation.
OSHA requirements for CPR and defibrillation differ considerably. Standards requiring CPR include:
OSHA recommends basic adult CPR refresher training and retesting every year, and first aid training at least once every three years. CPR training include facilitated discussion along with ’hands-on’ skills training that uses mannequins and partner practice.
Though OSHA recognizes AEDs as important lifesaving technology that plays a role in treating cardiac arrest, the agency doesn’t currently require their use in the workplace. Instead, OSHA wants employers to assess their own requirements for AEDs as part of their first aid response.
AEDs are considered Class III medical devices which means the Food and Drug Administration (FDA) has some oversight on their use. Almost all AEDs require the purchaser to obtain a prescription from a physician under FDA regulations. The prescription process is meant as a quality control mechanism to ensure AEDs are properly maintained, that all designated responders are properly trained, and assist employers with establishing an emergency response plan for their workplace AED program.
The AHA requires AED operators to also receive CPR training as an “integral part of providing lifesaving aid to people suffering sudden cardiac arrest.” Though easy to use, each AED is slightly different, so training helps users understand the unique traits and supplies for the individual units at their workplace. Additionally, AED users must be trained to understand the signs of a sudden cardiac arrest, when to activate the EMS system, and how to perform CPR.
AEDs are light, portable, easy to use, and inexpensive. They’re best placed near high-hazard areas such as confined spaces, near electrical energy, or in remote work areas. Response time to reach AEDs should be kept within 3–5-minutes.
Need more information on defibrillators in the workplace? See our ezExplanation on AEDs. |
Many states require or encourage CPR and AED training from nationally recognized organizations. Any AED training should include CPR training. OSHA doesn’t offer first aid or CPR training, nor certify trainers. Training by a nationally recognized organization, such as AHA, the American Red Cross, or National Safety Council is recommended.
While OSHA doesn’t currently require the use of AEDs in the workplace, they do expect employers to assess their own AED requirements as part of their first aid response. AED training is required by most states and should include CPR with a hands-on practical component.
In 2022, the National Institute for Occupational Safety and Health (NIOSH) reported a staggering 658,000 workers were exposed to harmful chemicals, resulting in 839 fatalities. These statistics highlight the significant health and safety risks that an unexpected exposure to a hazardous chemical, or a substantial threat of a hazardous substance release, can pose to workers, organizations, and communities. A thorough understanding of chemical management regulations is crucial to ensure potential hazardous exposures are minimized.
OSHA’s HazCom standard (29 CFR 1910.1200) is designed to inform workers about chemical hazards and how to protect themselves.
Key definitions: A "hazardous chemical" is any chemical which is classified as a physical hazard or a health hazard, a simple asphyxiant, combustible dust, or other hazards not that may not be classified but still pose a serious danger.
Indicators: Any workplace where hazardous chemicals are used, stored, or processed needs a hazard communication program. Labels, safety data sheets (SDSs), and employee training are essential components.
Training requirements: Training must cover how to read and understand labels, the purpose and location of SDSs, and specific protective measures when handling hazardous chemicals. Training must be provided upon initial assignment and updated whenever new chemical hazards are introduced.
The DOT’s hazmat regulations (DOT 49 CFR Parts 171-180) include substances that, if transported improperly, can harm people, property, or the environment. By correctly handling and moving these materials, organizations can avoid accidents and safeguard both public health and the environment.
Key definitions: A "hazardous material" is any substance or material capable of posing an unreasonable risk when transported in commerce. This can include flammable, toxic, and reactive substances.
Indicators: Activities involving the loading, unloading, and handling of hazardous materials require adherence to hazmat regulations. This requirement also applies to organizations that make or maintain packaging, or a part of packaging, that's marked or sold as suitable for transporting hazardous materials commercially.
Training requirements: Workers handling hazmat must undergo specific training on material classification, safe handling, emergency response, and transportation. Training must be provided within 90 days of initial assignment and a refresher at least once every three years. Training must also be documented and retained for a minimum of three years.
The EPA’s hazwaste regulations (40 CFR Parts 260-299) refer to any waste material that could potentially harm the environment or human health if not managed correctly. Additionally, many states have hazardous waste requirements beyond EPA regulations.
Key Definitions: Hazardous waste includes materials classified as toxic, ignitable, corrosive, or reactive, based on specific criteria.
Indicators: Managing hazardous waste follows the material’s entire lifecycle including the generation, transportation, treatment, storage, and disposal, known as "cradle-to-grave." Requirements are based on the quantity of waste generated.
Training requirements: Employees involved in hazardous waste management must receive training on waste handling, storage, labeling, and disposal procedures. Annual training requirements are based on generator quantity status.
OSHA’s HAZWOPER standard (29 CFR 1910.120) protects workers involved in hazardous waste management and emergency response. HAZWOPER covers a wide range of activities, including cleanup operations and responses to hazardous substance releases.
Key definitions: A hazardous substance is any material that can harm health and safety if released into the environment. In the context of HAZWOPER, this includes materials that pose risks in emergencies, such as spills, leaks, or other uncontrolled releases.
Indicators: Workers and organizations tasked with hazardous waste cleanup, spill response, and emergency operations require specialized training, equipment, and procedures.
Training requirements: HAZWOPER training is intensive and includes specific requirements depending on job roles. Training levels include 24-hour, 40-hour, and 8-hour refresher courses for different exposure risks. Employees learn about hazardous substance properties, emergency response procedures, PPE use, and decontamination processes.
OSHA’s PSM standard (29 CFR 1910.119) aims to prevent accidental chemical releases that could seriously harm employees or the environment by including safety measures, risk assessments, and employee training to ensure safe operations. It is especially important in industries handling highly hazardous chemicals including facilities with high-risk chemical processes.
Key definitions: OSHA defines a "highly hazardous chemical" as any substance that poses a significant risk of causing serious harm to people, property, or the environment due to its toxic, reactive, flammable, or explosive properties.
Indicators: Any workplace handling large volumes of hazardous chemicals or using complex chemical processes including chemicals that are specifically listed by OSHA in appendix A of the standard, are present in quantities above specified thresholds, or exhibit properties that make them likely to cause a major incident.
Training requirements: PSM training covers safe operating procedures, hazard analysis, and incident investigation for employees involved in high-risk processes. Training must be provided at initial assignment and a refresher at least once every three years.
Key to remember: Chemical management is a complex task. Understanding what regulatory requirements apply will ensure compliance as well as minimize the chance for dangerous incidents.
The Environmental Protection Agency (EPA) has extended the submission period for the Chemical Data Reporting (CDR) report. The submission period opened on June 1, and EPA has pushed the submission deadline from September 30 to November 22, 2024.
Who’s impacted?
Under the Toxic Substances Control Act (TSCA), EPA’s CDR rule requires manufacturers (including importers) of chemicals on TSCA’s Chemical Substance Inventory to report information on the production and use of the chemicals in commerce if they meet certain production volume thresholds at any one site.
Why the delay?
The deadline extension is due to technical errors with e-CDRweb, the electronic reporting tool on EPA’s Central Data Exchange system that reporters use to submit the CDR report (Form U). The specific issue only impacts submissions with multiple confidential business information (CBI) claims for chemical identity.
The tool’s copy function fails to properly capture the substantiations submitted by facilities making multiple CBI claims, leaving out some of the questions and answers. Additionally, it doesn’t let submitters who used the copy function add the missing information.
EPA expects to fix the reporting tool by the end of September.
About the 2024 CDR report
The CDR report is submitted to EPA every four years. The 2024 CDR report covers activities that occurred between the calendar years 2020 and 2023. Note that this extension applies only to the 2024 CDR submission period.
Key to remember: Due to technical difficulties with the electronic reporting tool, EPA has extended the 2024 Chemical Data Reporting submission deadline to November 22, 2024.
The 150 air-mile exemptions, which are in the regulations at 395.1(e)(1) and (2), allow a driver to use a time record in place of a log, provided that certain conditions are met. While this is possibly the most widely used hours-of-service exemption, it may be the most commonly misused exemption, as well.
To be able to use this logging exemption in 395.1(e)(1), the driver must:
The company must retain the time record and have it available for inspection for six months.
Need more info? View our ezExplanation on the 150 air-mile exception. |
If the driver cannot meet the terms of the exemption (he or she goes too far or works too many hours), the driver must complete a regular driver’s log for the day as soon as the exemption no longer applies.
If the driver has had to complete a log 8 or fewer days out of the last 30 days, the driver can use a paper log for the day. If the driver had to complete a log more than 8 days out of the last 30 days, the driver needs to use an electronic log for the day (unless one of the ELD exemptions applies, such as operating a vehicle older than model year 2000).
When a property-carrying driver is operating under the 150 air-mile exemption, the driver is also exempt from having to take the required 30-minute break (see 395.3(a)(3)(ii)).
If the driver began the day as a 150 air-mile driver and has driven more than 8 consecutive hours without a break, and something unexpected happens and the driver can no longer use the 150 air-mile exemption, the driver must stop and immediately take the 30-minute break as well as start logging. If the driver went outside of the 150 air-mile area before the driver had 8 hours of driving without a break from driving, the driver would be expected to take the break at the appropriate time.
Here are some of the common myths and misunderstandings about the 150 air-mile exemption:
The 150 air-mile exemption at 395.1(e)(2) only applies to drivers that: Operate property-carrying vehicles that do not require a CDL to operate, and Stay within the 150 air-miles of their work reporting location.
If the driver stays within the 150 air-mile radius of the work reporting location, and returns to the work reporting location within 14 hours on 5 of the last 7 days, and 16 hours on 2 of the last seven days, the driver is allowed to use a time record in place of a log.
If the driver does not meet the terms of the exception, the driver will need to complete a log for the day. If the driver had to log more than 8 days out of the last 30 days, the driver will need to use an electronic log for the day. All of the other issues discussed above would apply to these drivers as well.
If you have drivers that use these exemptions, you will need to check time records to make sure they are complying with the appropriate time limits. You will also need to check movement records to verify that the drivers using these exemptions are staying within the mandated area (within 150 air-miles of the work reporting location for the day).
If a driver is over the hours limit, or has gone too far, you need to verify that the submitted a log for the day, either paper or electronic, depending on how many days the driver had to log out of the previous 30 days.
During an audit, if it is discovered that your drivers are using these exemptions incorrectly, you will be cited for not having drivers’ logs when required. Each day this occurred will be another violation, so the fine could be rather large if you are not managing the use of these exemptions!
Do your drivers dread training sessions? Do they view these sessions as unnecessary or an inconvenience? Do you sense a negative or indifferent attitude among your drivers when it comes to training?
Preparing your drivers - making sure they know what will happen during the session - is one way to promote a positive attitude.
Preparation should include distributing an agenda prior to the training session. An agenda lets everyone involved know exactly what will happen during the training session. It also shows that your session is organized and well thought out.
As well as giving your drivers an idea of what will be covered, it shows that you value the time being taken out of your drivers’ busy schedules for this training session.
The agenda should include:
Briefly review the agenda with your drivers at the start of the training session. Explain why you are doing the training and how each of the topic(s) covered will apply to their work.
When drafting a brief explanation of the training session, consider what is important and/or of interest to your drivers.
Imagine you are a driver attending the session. Ask yourself the following questions:
Key to remember: Promoting a positive attitude by keeping your drivers informed can go a long way when it comes to a successful training program.
Interstate regulated for-hire and private carriers sometimes experience serious difficulties due to lack of maintenance of their major operating credentials. The most serious result can be an "Out of Service" ruling and being shut down.
Once obtained, credentials must be kept up to date to reflect changes in your information. The most common errors are caused by:
None of these have simple fixes; each may require multiple filings. The following checklists include common credentials to consider.
Name change checklist | ||
For-hire carrier | Private carrier | Action |
X | X | Obtain state/provincial name change documentation. |
X | File carrier name change information with the Federal Motor Carrier Safety Administration (FMCSA) for operating authority certificate/permit. See 365.413. The motor carrier (MC) number will not change. A new Certificate of Authority or Permit will not be issued, but a “Re-entitlement Decision” will be provided. This document should be attached to original operating authority. Online filing not available. | |
X | File updated Form BOC 3 with FMCSA (designate process agents). | |
X | X | Insurance company to file updated insurance document with FMCSA. All for-hire and hazardous material private carriers obtain updated MCS90/90B per 387.9. |
X | X | File modification of USDOT number (MCS 150 or MCS 150B hazmat safety permit). Online filing available. 1 |
X | X | Transfer DOT drug/alcohol testing service to reflect new name. |
X | X | Obtain/transfer International Registration Plan (IRP) account. |
X | X | Obtain/transfer International Fuel Tax Agreement (IFTA) account. |
X | X | Obtain/transfer CT, NY, KY, NM, OR weight/distance tax accounts. |
X | X | Change name on other state accounts (intrastate authority, etc.) if applicable. |
X | X | Change name on provincial safety registration(s) if applicable. |
X | X | Change name on vehicle(s). |
X | X | Placarded hazmat carriers required to register with the Pipeline and Hazardous Materials Safety Administration (PHMSA) must submit an amended registration statement to PHMSA within 30 days of name change. |
Address change checklist | ||
For-hire carrier | Private carrier | Action |
X | File carrier address change information with FMCSA (365.413 authority). Online filing not available. | |
X | File updated Form BOC 3 with FMCSA (designate process agents). | |
X | X | File modification of USDOT number (MCS150 or MCS150B). Online filing available. 1 |
X | X | Notify DOT drug/alcohol testing service of new address. |
X | X | Modify IRP account. |
X | X | Modify IFTA account. |
X | X | Modify CT, NY, KY, NM, OR weight/distance tax accounts. |
X | X | Change address on other state accounts (intrastate authority, etc.) if applicable. |
X | X | Change address on provincial safety registration if applicable. |
X | X | Placarded hazmat carriers required to register with PHMSA must submit an amended registration statement to PHMSA within 30 days of address change. |
Ownership change checklist | ||
For-hire carrier | Private carrier | Action |
X | File authority transfer information with FMCSA (Subpart D of Part 365). | |
X | File OP-1 form with required attachments (per 365.405). 2 | |
X | X | File new insurance (for hire BMC91/91X, BMC 34). All for-hire and hazardous material private carriers obtain updated MCS 90/90B per 387.9. |
X | Update Form BOC 3 with FMCSA (designate process agents). | |
X | X | Obtain new USDOT number if acquiring owner does not have one. |
X | X | Obtain Unified Carrier Registration (UCR) registration (if acquiring owner not registered under new US DOT number). |
X | X | Transfer DOT drug/alcohol testing service to reflect new USDOT number. |
X | X | Check with base jurisdiction regarding need for new IRP/IFTA accounts. Change in Federal Employer Identification Number (FEIN) usually requires new accounts. |
X | X | Obtain/transfer CT, NY, KY, NM, OR weight/distance tax accounts. |
X | X | Obtain other state accounts as necessary (intrastate authority, etc.). |
X | X | Obtain necessary provincial safety registration. |
X | X | Change name/US DOT number on vehicle. |
1The MCS-150 form(s) may be discontinued in 2025, if/when a new online process is implemented.
2The OP-1 form may be discontinued in 2025, if/when a new online process is implemented.
Key to remember: Be sure to regularly check and update your credentials, especially after a change in your company name, address, or ownership.
If you’re planning to start a motor carrier operation or add a different type of service to an existing business, you need to know what type of carrier you will be. Motor carriers are considered either a for-hire carrier or a private carrier. To be a private carrier, 100 percent of the company’s movements must be to support its own operation. If the carrier is engaged in any for-hire activities, the Federal Motor Carrier Safety Administration (FMCSA) considers them a for-hire carrier.
For-hire carriers use vehicles to transport people or property and are paid for their service. The fee could be a direct fee like a fare or a rate but could also be other indirect forms of compensation. Examples of for-hire operations include a trucking company that hauls other people’s property for a fee (direct compensation) or a hotel that includes in its service the transportation to and from the airport to the hotel (indirect compensation).
Private carriers, on the other hand, transport only their own goods or people. Examples include a manufacturer that uses its own commercial vehicles to transport its product, a construction or landscaping company that uses commercial vehicles to transport equipment and employees to job sites, or a utility company that operates commercial vehicles in support of its operations.
While private carriers are not required to obtain operating authority from the FMCSA, for-hire carriers are required to get authority to move property or people that belong to somebody else and get paid for their service. Having authority is often referred to as having an MC Number.
The most common types of authority are:
If a company never operates a commercial motor vehicle (CMV), it is possible to have authority, but not have a USDOT number. For example, straight brokers or freight forwarders.
As part of obtaining for-hire authority, carriers must designate process agents and demonstrate financial responsibility (have proper insurance coverage).
Authorities are not all-inclusive. Separate authority is needed for each type of service offered. For instance, a for-hire, over-the-road carrier that also wants to be able to resell its extra demand will need both for-hire and brokerage authorities. A company is required to pay a $300 one-time fee for each type of authority needed.
There are no temporary permits available to substitute for authority. For-hire operations may not be performed until the proper authority has been granted. It’s not uncommon for otherwise private carriers to become for-hire carriers to generate revenue on back-hauls or help balance capacity and demand during slow periods or seasons.
Carriers need to get it right when it comes to authority. Carriers required to have authority — but don’t and operate anyway — can get themselves into trouble. Penalties for operating without proper authority can get expensive and can result in out-of-service orders.
Key to remember: Carriers are either for-hire or private, with for-hire carriers being paid for their services while private carriers transport only their own goods or people.
Related article: Process agents — what are they and do you need them?
One question that comes up when reviewing roadside inspection reports is, “What is the meaning of the letters that follow a violation of 392.2 on a roadside inspection report?”
A violation of 392.2 is a violation of a local or state law, regulation, or ordinance. These must be obeyed due to 392.2, which reads, “Every commercial motor vehicle must be operated in accordance with the laws, ordinances, and regulations of the jurisdiction in which it is being operated.”
The confusion is that there are no paragraphs in 392.2, so there technically should be no letters following that section. However, to inform the driver, carrier, and the Federal Motor Carrier Safety Administration (FMCSA) what particular state or local law or regulation was involved, FMCSA has developed a system of suffix codes. The letters following “392.2” – the “suffix” — show which state or local law or regulation was involved.
When one of these codes is used, the officer should include a description of the specific violation in the “violation details” area on the actual inspection report. FYI: Summary roadside inspection reports (such as the ones visible in CSA’s SMS) do not show these details.
For more information, see our ezExplanation on Roadside Inspections. |
Not all of these state and local law or regulation violations are used by the FMCSA for scoring purposes. The Compliance, Safety, Accountability (CSA) Safety Measurement System (SMS) does not use the 392.2 violations that cannot be tied to crash causation. Here are a couple of examples: 392.2UCR Failure to pay UCR fee and 392.2W Size and weight are not used.
Below are the top 10392.2violations written during 2021. All of these violations are safety-related, and therefore used in the CSA SMS for scoring. The BASIC within the SMS the violation is scored in is shown following the violation description.
In general, FMCSA does not write traffic codes. They rely on local and state agencies to do that. When state or local traffic codes are violated, it appears on a roadside inspection report as a violation of 392.2, with a suffix indicating which traffic code was involved.
A “yard move” (YM) is an electronic logging device (ELD) special driving category, which carriers have the option to authorize. Putting an ELD in the YM status can give a yard or road driver added flexibility or another avenue for falsification.
To avoid violations and increased risk, ensure that your drivers, dispatchers, and safety personnel know the answers to these frequently asked questions (FAQs).
1. What falls under the definition of a “yard”?
The Federal Motor Carrier Safety Administration (FMCSA) does not officially define a yard. Still, it is generally accepted an area that is not open to public travel due to being restricted by signs or gates.
A carrier’s terminal, a customer’s facility, or a rail yard can be a yard if the area cannot be defined as a highway per 390.5. A driver may also cross a public road to reach another part of private property under yard-move time if traffic controls (i.e., flagger) for the public are in place.
Malls, truck stops, and parking lots the public can access, however, are all examples of places that cannot be a yard for ELD and on-duty (not driving) purposes.
2. Is a yard driver subject to federal regulations?
Commercial motor vehicles (CMVs) are federally regulated at 10,001 pounds or greater — rated or actual, alone or in combination with a trailer. State definitions of a CMV vary.
Suppose a yard truck met the definition of a CMV and operates in an area open to public travel in interstate commerce. In that case, the yard driver must be qualified under Part 391 and is subject to all other applicable federal regulations. If the yard truck and trailer meet the definition of a CDL vehicle in 383.5 as most do, the driver is also subject to drug and alcohol testing and CDL requirements.
Yard drivers might not be required by their carrier to use an ELD to create a log. They are stillsubject to the hours-of-service limits in 395.3 and the same rules for on-duty (not driving) time in a yard or on-duty driving (Line-3) on a public roadway.
A carrier may allow the use of a time record instead of an ELD to track a yard driver’s time under the 150 air-mile exception in 395.1(e). If the yard driver uses an ELD, the carrier can designate the driver as “Exempt” (exempt from grid logs only) in the ELD back-office system.
3. How is a yard move recorded on an ELD?
YM time is visible in the ELD grid as driving time with a dashed or dotted line. Before using YM time, the driver must select the “YM” special driving category and annotate the ELD record describing the reason for the activity.
According to federal hours-of-service rules, a driver cannot use “Line-3” or on-duty driving time after 14 consecutive hours from the start of on-duty time for the day. However, yard moves are recorded as “Line-4 time” or on-duty not (driving) time. Therefore, YM time doesn’t stop the 14-hour clock, but can be appropriately used beyond the 14-hour or other driving limits.
4. Does a yard move count toward the 30-minute break from eight total hours of on-duty driving?
Yes. Because a YM is on-duty (not driving), it counts toward the 30-consecutive minute break from on-duty driving required after eight total hours of on-duty driving. (see 395.3(a)(3))However, if a driver is involved in a fatigue-related crash, driving in a yard to satisfy a break from driving requirement will not look prudent to a jury.
5. What if a driver forgets to change the driving status, and the ELD remains in YM-status after they leave the yard?
The time will be incorrectly captured as Yard Move (on-duty yard time rather than on-duty driving time) and could be considered a false log. To address this, the driver should attach a comment to the log explaining the error as soon as safely possible.
The driver’s log must be manually edited to the correct driving time if the ELD system allows the off-yard time to be changed to on-duty driving time. Otherwise, an annotation must be made noting the correct on-duty (not driving) and on-duty driving time.
6. How are yard moves audited?
Verify the location at the time of the YM with the location description or the longitude and latitude data from the ELD or vehicle tracking device. If the driver was not in a yard at the time of the YM, the driver falsified the record.
A driver using a public road in YM status to get fuel or take the truck in for maintenance is considered falsification. If the driver was over the 11-hour driving limit, 14-consecutive on-duty period, or the 60- or 70-hour limit, they now have an out-of-service violation and a false log.
Carriers can define a geo-fence or virtual boundary of the yard if the system allows that feature to indicate a departure from the yard.
Keys to remember:
Carriers must train their team to understand when the Yard Move status or on-duty (not driving) can and can’t be used when operating a CMV. Audit yard moves to ensure this ELD special driving category, or duty status for drivers on time records, is not used to falsify logs.
Most employers that deal with employee leave know that employees get 12 weeks of job-protected, unpaid leave under the federal Family and Medical Leave Act (FMLA). But how does that break down for part-time employees?
Employees must meet the eligibility criteria to take FMLA leave. This doesn’t require employees to work a full-time schedule, but they must:
The 1,250 hours equates to someone working a little more than 26 hours per week, so part-time employees can be eligible to take FMLA leave.
Once employees meet all three eligibility criteria, they may take up to 12 of their workweeks of leave in a 12-month leave year period for FMLA-qualifying reasons. The workweek is the basis of leave entitlement.
If, therefore, Joe Employee normally works 30 hours per week, he gets 12 of his 30-hour workweeks of leave. This translates into 360 leave hours. Part-time employees still get 12 workweeks of FMLA, but the number of hours in their leave “bucket” is smaller.
To help illustrate this, if Joe Employee needed seven weeks of continuous leave beginning December 12, 2024, his seven weeks of leave would end on January 30, 2025. The employer would simply count the weeks, as Joe would get seven of his 30-hour workweeks of leave. Joe would have five weeks of FMLA leave remaining in the 12-month leave year period.
If, however, Joe Employee needed intermittent leave, the employer would count only the days (or hours) that Joe took leave. Employers like to think of these 12 weeks through the lens of how many hours of FMLA leave are available. Employees who normally work 40 hours per week get 480 hours of FMLA leave. Part-time employees who work less than 40 hours per week get fewer hours of FMLA leave.
Key to remember: Part-time employees can be entitled to FMLA leave as long as they meet the eligibility criteria, but they have fewer hours of FMLA leave.
The wait is over! OSHA has just finalized a new rule on personal protective equipment (PPE) that promises to enhance worker safety in the construction industry. Published on December 12 and set to take effect on January 13, 2025, this rule requires that employers take an inclusive approach to PPE to ensure it "properly fits" their workforce.
The new OSHA rule on personal protective equipment (PPE) for construction introduces several key changes from the previous regulation including:
You might be wondering, "What do I need to do to ensure I'm compliant with the new rule?" By following these steps, you'll not only meet OSHA's requirements but also enhance the safety and well-being of your team:
Properly fitting PPE is crucial for keeping workers safe. If it doesn't fit right, it can leave workers exposed to dangers or even create new hazards. Here's why fit matters for different types of PPE:
Ensuring a proper fit means taking each worker's unique needs into account, which helps prevent these issues and keeps everyone safe and productive.
Key to remember: OSHA's new PPE rule for construction takes effect on January 13, 2025. Now is the time to update your programs and training to ensure the proper fit of PPE for your workers, ensuring compliance and enhancing workforce safety.
The U.S. Bureau of Labor statistics reported in July 2024 that there are 8.2 million job openings in the U.S., but only 7.2 million unemployed workers.
With that in mind, employers might choose to hang onto employees even if they’re under performing. But what about when complaints are rolling in from different angles? Take, for example, a lackluster supervisor who’s annoying employees and disappointing customers.
An employer could be hesitant to let the supervisor go, especially if there’s no documentation backing up claims of misconduct. The employer must weigh their options to decide if putting the supervisor on a performance improvement plan (PIP) or moving right to termination is the ideal choice.
At-will employment
For starters, in most states employers may terminate an employee at-will, meaning they can fire employees for pretty much any reason as long as it doesn’t discriminate against someone in a protected class based on sex, age, race, religion, etc. Employers also cannot terminate in retaliation for an employee making a claim of harassment, discrimination, or safety concerns.
Aside from these limits, employers can terminate employees for good cause, bad cause, or no cause at all.
PIP or terminate
Deciding whether to put an employee on a PIP or terminate must be decided on a case-by-case basis.
A PIP is usually for job performance issues (hence, performance improvement plan). This could mean anything from not making enough sales to being inept at the job’s essential functions. If job performance doesn’t improve under the PIP, termination may be the end result depending on company policies and practices.
Even if an employee has job performance issues, the employer can terminate without going through the PIP process first, unless the usual process is to implement a PIP with employees who have had similar problems. In that case, not doing a PIP could be seen as discrimination against an employee, especially if the person falls into a protected class.
Workplace misconduct, however, is another situation altogether. This could be anything from a one-off poor joke to pervasive harassment. Snapping at customers or coworkers (or worse), for example, is a conduct issue. An employer could issue a warning or move right to termination if the behavior is clearly illegal or a serious threat to workplace safety.
Read more: ezExplanation on discharging employees |
Termination tips
If an employer decides to terminate, they should treat the employee as respectfully as possible during the termination process. Also, an employer should carefully and clearly communicate the job-related reasons for the termination to avoid any hint of discrimination. Lastly, an employer should document the reasons and reiterate the steps taken leading up to the termination and keep those records handy in case the employee files a wrongful termination lawsuit.
Key to remember: Employers sometimes struggle when making termination decisions. Having a process in place and documenting steps along the way can help if a case lands in court.
Captive-audience meetings, where an employer holds a mandatory meeting to express its views on unionization, have been receiving a great deal of attention.
The National Labor Relations Board (NLRB) ruled on November 13 that these meetings are unlawful, as they violate employee rights under the National Labor Relations Act (NLRA). The board determined that they interfere with an employee’s right to freely decide how to participate in a conversation about unionization.
A number of states have also passed laws banning captive-audience meetings. Employers in these states must make sure any meetings about unionization comply with both NLRB guidelines and state laws.
Some state captive-audience-meeting laws also require employers to do one more thing: Make workers aware of their rights by posting information about the law in the workplace. In some cases, states provide a standardized poster. When a standardized poster is not available, employers can post the text of the law to comply with the posting requirement.
The posting requirements for captive meeting laws vary by state:
Illinois: Post information about the Worker Freedom of Speech law as of January 1, 2025.
Maine: Display information about the state’s Captive Audience statute after a standardized posting is made available by the state.
Minnesota: Display the Employer-Sponsored Meetings posting from the state.
New York: Post the text of the state’s Discrimination Against Engagement in Certain Activities law.
Oregon: Display the Captive Audiences poster from the state.
Washington: Display the text of the state’s Free Choice Act or a posting from the state when one is made available.
Alaska, California, Connecticut, Hawaii, and Vermont have captive-audience meeting laws, but do not require employers to display related information .
Key to remember: Employers in some states need to display a captive-audience meeting posting to make employees aware of their rights.
Employers sometimes get tripped up on how to calculate the 1,250 hours worked eligibility criterion when employees need leave under the Family and Medical Leave Act (FMLA).
Does working overtime count toward the 1,250?
Recently, someone asked if overtime hours counted toward the 1,250 hours worked requirement (it does).
All hours actually worked apply to the 1,250, whether overtime or regular time, even if the overtime is not mandatory.
The 1,250 hours is calculated in relation to when the leave will begin, not when the employee puts an employer on notice of the need for leave.
Whether an employee is allowed to work overtime, however, is generally up to company policy. As far as pay goes, remember, if the employee is nonexempt (“hourly”) and works any overtime (mandatory or voluntary) the employee must be paid time and one-half for all hours worked over 40 within the workweek.
More about FMLA leave requirements
To be eligible to take FMLA leave, employees must:
Whether an employee has worked the minimum 1,250 hours is calculated based on determining compensable hours or work under the Fair Labor Standards Act (FLSA).
Calculating the 1,250 hours worked
When it comes to figuring out if an employee has worked at least 1,250 hours, it can get tricky. As was mentioned above, all hours worked, regular and overtime, must be counted.
Hours not worked should not be counted. The “not worked hours” include such time off as vacation time, sick leave, paid or unpaid holidays, or any other time in which an employee isn’t actually working — which can include disability, bereavement, FMLA and other forms of leave.
Once an employee meets the three eligibility criteria, including the 1,250 hours worked, for a particular leave reason, the employee remains eligible for the duration of the 12-month leave year period.
If the employee needs leave for another, different reason, eligibility would be recalculated.
Key to remember: All hours worked must be included in the 1,250 hours criterion when determining whether an employee is eligible for FMLA leave. Hours that aren’t worked (like vacation) are not included.
Did you hear that? It sounded like a gunshot. Unfortunately, these chilling words have become all too common in recent years. According to an FBI study, between 2000 and 2019, there were 62 active shooter events in educational institutions, resulting in 419 casualties. To prevent these institutions from becoming another statistic, leaders must shift their mindset to be prepared for when, not if, such a tragedy could occur.
Being prepared is crucial to responding in any emergency situation, and active shooter safety is at the top part of the list. Here are some key points to consider ensuring your organization is prepared:
Good news is there are many resources available to guide organizations in their overall preparedness. Here are some additional sources and resources for active shooter preparedness in schools:
Key to remember: To keep educational institutions safe from active shooter threats, leaders need to be proactive. This means having emergency plans, regular training, and working closely with law enforcement. Being prepared can save lives.
Ever since OSHA published its Trade Release on December 11, 2023, people have been scratching their heads about the “new” PPE requirement.
But here’s the thing. There isn’t a new requirement for “helmets” instead of hard hats.
So where’s the confusion? And what is actually required?
OSHA released a Safety and Health Bulletin (SHIB 11-22-2023) on November 22, 2023, detailing the key differences and benefits of using modern safety helmets over traditional hard hats.
And just a few weeks later, in the December 11, 2023 Trade Release, the Agency announced it would now require its inspectors to wear Type II head protection, which is also commonly referred to as safety helmets.
The November 22, 2023 SHIB discussed two main benefits of choosing modern safety helmets over traditional hard hats -- the construction of materials and the use of chinstraps.
Construction of Materials: | The SHIB first explained that one of the benefits of safety helmets lies in their construction materials. While hard hats are made from hard plastics, safety helmets incorporate a combination of materials, including lightweight composites, fiberglass, and advanced thermoplastics. Such materials can help enhance the impact resistance of the helmets but also include the added benefit of reducing the overall weight of the helmet. This reduces neck strain and improves comfort during extended use. |
Use of Chinstraps: | The SHIB also discussed the potential benefits of chinstraps used in conjunction with Type II safety helmets. The general idea here is that chinstraps can be helpful in maintaining the position of the safety helmet and protecting the worker’s head in the event of a slip, trip, or fall. According to data from the Bureau of Labor Statistics, head injuries accounted for nearly 6% of non-fatal occupational injuries involving days away from work. About 20% of those were caused by slips, trips, and falls. |
And while OSHA has recognized the benefits of Type II safety helmets, and is actively taking steps to protect its own employees, it’s important to understand that there is not a new requirement for employers to make the switch to safety helmets.
That being said, a growing number of employers have recognized the benefits of added head protection and are choosing to use Type II helmets for their workers. In addition, some clients are starting to contractually require their construction contractors to make the switch as well.
Hard hats will have a Type I or Type II rating on the manufacturer’s sticker. These markings are based on ANSI Z89.1’s impact ratings.
Type I hard hats protect from objects or impacts from the top center area of the hard hat and are often used in work areas with no lateral head impact hazards.
Type II hard hats, on the other hand, offers protection from both top and lateral impacts and objects and is often found on construction job sites or complex general industry settings where workers face multiple head contact exposures.
Hard hats are classified based on their level of voltage protection. See the chart below.
Class G – (General) low voltage protection. Class E – (Electrical) high voltage protection. Class C – (Conductive) no voltage protection. |
Employers should conduct a job hazard analysis and/or a PPE assessment to determine which style hard hat is best for their workers. In general, OSHA recommends the use of Type II safety helmets at the following locations:
1. Construction Sites: For construction sites, especially those with high risks of falling objects and debris, impacts from equipment, or slips, trips, and falls, safety helmets have enhanced impact resistance and additional features that offer superior protection compared to the components and construction of traditional hard hats.
2. Oil and Gas Industry: In these sectors where workers face multiple hazards, including potential exposure to chemicals and severe impacts, safety helmets with additional features can provide comprehensive protection.
3. Working from Heights: For tasks or jobs that involve working from heights, safety helmets offer protection of the entire head and include features that prevent the safety helmet from falling off.
4. Electrical Work: For tasks involving electrical work or proximity to electrical hazards, safety helmets with non-conductive materials (Class G and Class E) provide protection to prevent electrical shocks. However, some traditional hard hats also offer electrical protection.
5. High-Temperature Environments: In high temperatures or where there is exposure to molten materials, safety helmets with advanced heat-resistant properties can provide additional protection to workers.
Key to remember: While there isn’t a new requirement for safety helmets, employers should review their workplace hazards to determine which style of hard hat will best protect their employees.
If one of your employees walked into the breakroom and saw a coworker being bullied, would the employee know what to do? In that moment, the employee (who has now taken on the role of being a “bystander”) has three choices to make:
The employee’s split-second decision could impact your workplace safety and culture in a positive or negative way. Choosing to intervene safely is the right choice. But your employees need to be trained in recognizing workplace bullying and how to stop it.
Workplace bullying is repeated, unwelcome behavior that humiliates or intimidates a coworker or sabotages the person’s performance. Even if employees are working remotely, bullying can still occur through emails, chat messages, texts, and calls.
Bullying can have significant psychological effects. When it comes to prevention, a bystander can take an active role and intervene. A bystander to bullying is anyone who witnesses bullying either in person or in digital forms. Bystanders have the potential to make a positive difference in a bullying situation.
As you prepare for 2025, consider adding bystander training to your workplace violence prevention plan. Share the following tactics for employees to use should they become bystanders:
Another option for a bystander is to be direct and tell the bully to stop. This could be a risky move, however, and the bystander should first consider whether it might escalate matters.
Key to remember: Teach employees what to do if they witness bullying behaviors and how to be helpful bystanders.
OSHA’s Fall 2024 regulatory agenda, released December 13, shows many rulemakings have been pushed into the first half of 2025, with a few proposed rules even moving into the third quarter of the year. Very few entries moved out of the stage they were in in Spring 2024.
Two entries moved to the pre-rule stage. Process Safety Management (PSM), which moved from the proposed rulemaking stage, has a projected December 2024 date to analyze stakeholder comments. The mechanical power presses update moved from the list of long-term actions, with stakeholder comments projected to be analyzed in July 2025.
COVID-19 vaccination and testing emergency temporary standard rulemaking moved off the rulemaking list altogether.
[Note: Bold denotes entries new to that rulemaking stage.]
Final Rule Stage | |
Projected publication date | Title |
December 12, 2024; effective January 13, 2025 | • Personal Protective Equipment in Construction |
January 2025 | • COVID-19 in Healthcare Settings • Procedures for Handling of Retaliation Complaints Under the Whistleblower Protection Statutes • Procedures for the Handling of Retaliation Complaints Under the Anti-Money Laundering Act |
February 2025 | • Powered Industrial Trucks Design Standard Update |
March 2025 | • Procedures for the Handling of Retaliation Complaints Under the Criminal Antitrust Anti-Retaliation Act |
June 2025 | • Procedures for the Use of Administrative Subpoenas |
Proposed Rule Stage | |
Projected publication date | Title |
December 2024 (re-open rulemaking record) | • Walking-Working Surfaces |
January 2025 | • Infectious Diseases |
Comment period extended to January 14, 2025 | • Heat Illness Prevention in Outdoor and Indoor Work Settings |
April 2025 | • Tree Care Standard |
May 2025 | • Welding in Construction Confined Spaces |
June 2025 (analyze comments) | • Emergency Response |
June 2025 | • Prevention of Workplace Violence in Health Care and Social Assistance • Rapid REDON Fit-Testing Protocol: Amendment to Respiratory Protection Standard Appendix A • Amendments to the Cranes and Derricks in Construction Standard |
August 2025 | • Shipyard Fall Protection - Scaffolds, Ladders and Other Working Surfaces |
September 2025 | • Occupational Exposure to Crystalline Silica: Revisions to Medical Surveillance Provisions for Medical Removal Protection • Lockout/Tagout Update |
October 2025 | • Communication Tower Safety |
Pre-rule Stage | |
Projected publication date or other action | Title |
December 2024 (analyze comments) | • Process Safety Management and Prevention of Major Chemical Accidents |
June 2025 (analyze comments) | • Blood Lead Level for Medical Removal |
July 2025 (analyze comments) | • Mechanical Power Presses Update |
Long-term actions | |
• Occupational Injury and Illness Recording and Recordkeeping Requirements – Musculoskeletal Disorders (MSD) Column • Powered Industrial Trucks • Occupational Exposure to Crystalline Silica: Revisions to Table 1 in the Standard for Construction |
The COVID-19 outbreak created a shortage of latex and nitrile gloves in many workplaces.
Latex and nitrile gloves are used extensively in health care, and their disposable (single use) nature meant that large quantities were consumed during the peak of the pandemic. The shortage was also worsened because of hoarding by some consumers. In addition, certain businesses and government agencies began using these gloves to protect employees, even if their workers didn’t normally require gloves on the job.
If you have trouble obtaining your staff’s usual gloves, be prepared to identify feasible alternatives. You don’t want to endanger them by having them wear any old gloves they find lying around.
To identify alternatives for workers who rely on latex or nitrile gloves as PPE, you must know which chemicals workers handle or come in contact with. That’s because all glove materials are not suitable for all hazards.
Evaluate which materials offer appropriate protection from the specific chemicals that workers handle to select appropriate alternative gloves.
Here’s a summary of glove types and the protection given to help evaluate alternatives.
Butyl gloves protect against a variety of chemicals such as peroxide, highly corrosive acids, strong bases, alcohols, aldehydes, ketones, esters and nitrocompounds. Butyl gloves also resist oxidation, ozone corrosion and abrasion, and remain flexible at low temperatures. However, they do not perform well with aliphatic and aromatic hydrocarbons and halogenated solvents.
Natural (latex) rubber gloves have good elasticity and temperature resistance, and resist abrasions well. They protect against most water solutions of acids, alkalis, salts, and ketones. Latex gloves may cause allergic reactions and may not be appropriate for all employees. Hypoallergenic gloves, glove liners, and powderless gloves are possible alternatives for employees who are allergic.
Neoprene gloves protect against hydraulic fluids, gasoline, alcohols, organic acids, and alkalis. Their chemical and wear resistance are generally better than gloves of natural rubber.
Nitrile gloves are intended for jobs requiring dexterity, and they stand up even after prolonged exposure to substances that cause other gloves to deteriorate. They offer protection when working with greases, oils, acids, caustics, and alcohols but are not recommended for use with strong oxidizing agents, aromatic solvents, ketones, and acetates.
Employer expenditures regarding worker protection are substantial. When you consider personal protective equipment (PPE) per employee in identified high-hazard sectors, the cost is even higher. The price of PPE can skyrocket depending on the quality and quantity being purchased and consumed by the employee. As a cost savings strategy, employers may need to tighten up their PPE Program and clarify employee responsibility for the care of such equipment. While employers must supply required PPE at no cost, according to OSHA, the employer is not required to replace PPE when the employee has lost or intentionally damaged the PPE.
More often than not, employers are finding that some employees inadvertently mismanage the very equipment meant to protect them. Whether losing, misplacing, or simply not taking care of supplied PPE, the expectation of the uninformed employee is to request new PPE with little to no regard for who pays for that equipment. This blatant mismanagement of PPE may find employers looking at the bottom line and developing and implementing workplace rules. This may include reasonable and appropriate disciplinary policies, replacement schedules, and allowances to ensure that employees have and use the PPE that the employer provided.
Employers do not have to bear the cost of replacing PPE that the employee has lost, even if it is a single instance. The PPE may be considered “lost” if the employee comes to work without the issued PPE. The rule does not prohibit employers from sending employees home to retrieve the PPE or from charging an employee for replacement PPE when the employee fails to bring the PPE back to the workplace.
While not required for general industry nor construction, writing a “overall” PPE program documenting PPE usage and responsibilities makes it easier to:
The basic element of any PPE Program should be an in-depth evaluation of the equipment needed to protect against hazards in the workplace. This is the initial hazard assessment for which written documentation is required. The two basic objectives of any PPE Program should be to protect the wearer from safety and health hazards and to prevent injury and illness to the wearer from incorrect use and/or malfunction of the PPE. Management can then use this assessment and PPE Program to develop standard operating procedures for employees, and train them to use, maintain, and clean/care for provided PPE while identifying expectations should an employee lose or intentionally damage PPE.
OSHA first issued a proposed rule for employer payment of PPE in March 1999. After almost nine years of public hearings and comment periods, in February 2008, OSHA worked to develop a standard that provides clarity and fairness for employers and employees. OSHA standard 1910.132 clarifies the responsibilities of employers in a way that sets a reasonable PPE payment policy.
Key to remember: The standard states that the employer is required to pay for PPE used to comply with OSHA standards, except when the employee has lost or intentionally damages the PPE.
Pallet racks are utilized to house millions of pounds of material each day. How much weight a racking system can hold depends on a number of factors. While OSHA does not specifically require posting the load capacity rating on steel racking, they are consistently citing employers for not displaying it.
Aside from a very general “stored items must be secured” mention in 1910.176(b), OSHA has no specific racking safety standards or guidelines. Because of this, they typically cite racking hazards under the General Duty Clause of the OSH Act, which simply states that each employer must provide a workplace that is free from recognized hazards.
Exact loads can vary depending on the configuration of the pallet rack and the types of pallets used. If workers are placing loads in racks, they need to be trained to understand the weight of the load and whether or not the rack can handle it. Employers should have systems in place that include weighing pallets and materials prior to placement on the racking system. They should also maintain, and continually update, a weight inventory of all materials being stored and/or removed from the racks.
During enforcement actions, OSHA can reference other standards that could be used in times of abatement. In the case of load capacity rating, they often reference the industry standard ANSI MH16.1.
About ANSI MH16.1
Industrial steel storage racks, moveable shelf racks, rack-supported systems, and stacker racks made of hot-rolled and/or cold-formed steel structural members are covered by the MH16.1 standard. The standard is intended to be applied to the design of the storage rack structure.
One particular section (1.4.2 – Plaque) requires displaying one or more permanent plaques that contain information including:
This is not to say that employers need to display a plaque on every section of steel racking. What they should pay particular attention to is where the standard mentions displaying the maximum total load per bay.
Inspectors reference section 1.4.2 of the MH16.1 standard when identifying racking hazards. For example, OSHA may state that one way to abate a racking hazard would be to include the wording on a rack label that communicates the load capacity so employees don’t overload the racking.
Other considerations
If an OSHA inspector is on site to review your racking system, they may also look for hazards associated with anchoring of the system, as well as inspection and maintenance.
It is recommended that the bottom of all columns be furnished with column base plates and be anchored to the floor with anchor bolts capable of resisting the forces caused by the loads on the rack.
Storage racks should also be inspected regularly, with sufficient clearance around them, and should not be damaged, out of plumb, or overloaded. An effective maintenance and inspection program will bring awareness to things such as keeping aisles clear and providing sufficient clearance for material handling equipment; ensuring racks are properly aligned, plumb, and level, per manufacturer’s instructions; and encourage employees to promptly report any damage to racks.
The OSHA requirements for steel racking are vague. Even though there are no specific standards that require displaying the load rating on racking, being anchored to the floor, or inspected, citations have and will be given under the General Duty Clause if discovered.
Keep in mind also, OSHA may reference other standards during enforcement actions — sometimes there are other means of abatement, so an employer doesn’t have to follow the ANSI standard, but other times, there isn’t much alternative.
Key to remember: Steel storage racks should display the maximum load capacity rating, be bolted to the floor, and inspected.