PFOA and PFAS Take Another Step Towards Becoming Full-Fledged Members of the CERCLA Family of Hazardous Substances
By Steven M. Siros, Co-Chair, Environmental and Workplace Health & Safety Law Practice
On January 10, 2022, U.S. EPA forwarded to the White House Office of Management and Budget (OMB) a proposed rule that seeks to designate perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) as “hazardous substances” under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA). Although not unexpected since this was of the key elements of U.S. EPA’s PFAS Strategic Roadmap, U.S. EPA’s proposed rule is unique in that it represents one of the first times that U.S. EPA has by rule sought to designate a chemical as a CERCLA hazardous substance. U.S. EPA's actions in sending the proposed rule to OMB may also be foreshadowing for a similar effort to designate PFOA and PFOS as "hazardous wastes" under the Resource Conservation and Recovery Act (RCRA) which would subject these substances to RCRA's cradle to grave regulatory scheme.
The effect of listing PFOA and PFOS as CERCLA “hazardous substances” is significant for the following reasons:
- New Sites: By designating PFOA and PFOS as CERCLA “hazardous substances”, due to the ubiquitous nature of these contaminants in the environment, hundreds of sites could become CERCLA Superfund sites. For example, PFAS chemicals can be found in the soil and groundwater at sites that historically used firefighting foams, including airports, refineries, and military installations. It is also a contaminant of concern at manufacturing operations associated with cookware, stain-resistant clothing, and various packaging products. Finally, it may be a concern at municipal landfills and wastewater treatment facilities. There may also be trickle-down effects at the state level since many states automatically include federally-designated substances in the state definition of hazardous substances.
- Existing/Closed Sites: Moreover, at existing Superfund sites (including sites where a final remedy has been selected and is being implemented), U.S. EPA can require that the sites be investigated for PFOA and PFOS. If found, U.S. EPA can require that existing remedial strategies be modified to address these contaminants in the soil or groundwater. Similarly, even at sites where remedial measures have been completed, U.S. EPA could still seek to reopen the sites and require that these newly designated hazardous substances be remediated.
- Cost-Recovery Claims: Designation of PFOA and PFOS as CERCLA hazardous substances would open the door for both U.S. EPA and private-party PRPs to bring CERCLA cost recovery and/or contribution claims to pay for the costs to investigate and remediate these chemicals. In light of the increased scrutiny of these compounds in drinking water supplies, one could expect numerous CERCLA cost-recovery lawsuits by drinking water providers to recover the costs to treat public drinking water system.
- Reporting Requirements: Designation as a CERCLA hazardous substance also triggers release reporting under CERCLA. CERCLA § 103 (42 U.S.C. § 9603) requires that releases of “reportable quantities” (RQ) of CERCLA hazardous substances be reported to the National Response Center. Until such time as U.S. EPA promulgates a specific RQ for PFOA and PFOS, the default RQ for these chemicals will be one pound. Although many states are moving towards banning the use of fire-fighting foam that contains per- and polyfluoroalkyl substances, if PFOA and/or PFOS are designated as CERCLA "hazardous substances", it is likely that any use of fire-fighting foam containing these substances would trigger CERCLA release reporting.
Once U.S. EPA receives the review back from OMB and publishes the proposed rule for comment in the Federal Register, U.S.EPA can expect to receive robust comments both against and in favor of the designation. We will continue to follow U.S. EPA’s efforts to designate PFOA and PFOS as CERCLA “hazardous substances” at the Corporate Environmental Lawyer blog.
By Steven M. Siros, Co-Chair, Environmental and Workplace Health & Safety Law Practice
On December 20, 2021, U.S. EPA finalized its Fifth Unregulated Contaminant Monitoring Rule (UCMR) that will require public water systems (PWS) to collect monitoring data for 29 per- and polyfluoroalkyl substances (PFAS) and lithium in drinking water. Every five years, the Safe Drinking Water Act (SDWA) requires U.S. EPA to publish a new list of unregulated contaminants that will be monitored by PWS. UCMR 5 focuses almost exclusively on PFAS and targets 29 of the more than 4,700 PFAS that have been identified to date.
Starting in 2023, all PWSs serving more than 10,000 customers are obligated to monitor for these UCMR 5 contaminants while smaller PWSs (those serving less than 10,000 customers) must monitor subject to availability of appropriations (U.S. EPA is responsible for all analytical costs associated with PWSs serving less than 10,000 customers) and laboratory capacity. In response to comments on the draft UCMR 5 expressing concern about the lack of laboratory capacity to support the PFAS monitoring, the final rule notes that U.S. EPA expects laboratory capacity to quickly grow to meet UCMR demand. The final rule identifies applicable U.S. EPA test methods for each of the 29 targeted PFAS compounds. However, some commenters were critical that the final rule did not identify a testing technique to determine “total PFAS” in drinking water. The final rule acknowledges this issue but notes that U.S. EPA “has not identified a complete, validated peer-reviewed aggregate PFAS method” at this time.
The data collected is expected to inform U.S. EPA as it evaluates whether to set a specific drinking water limit or treatment standard under the SDWA for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS). U.S. EPA has committed to establishing a national drinking water regulation for PFOA and PFOS by the fall of 2023 and it is likely that additional PFAS will be in the SDWA regulatory pipeline in the near future.
We will continue to track U.S. EPA regulatory agenda at the Corporate Environmental Lawyer blog.
By Steven M. Siros, Co-Chair, Environmental and Workplace Health & Safety Law Practice
As part of the infrastructure package that was just approved on a bi-partisan basis by the Senate and is now moving on to the House, the Great Lakes Restoration Initiative (“GLRI”) could receive approximately $1 billion for the remediation of impacted site and waterways in the Great Lakes region.
Since its inception in 2010, the GLRI has provided funding to 16 federal organizations to strategically target the biggest threats to the Great Lakes ecosystem and to accelerate progress toward achieving long term goals:
- Fish safe to eat;
- Water safe for recreation;
- Safe source of drinking water;
- All Areas of Concern delisted;
- Harmful/nuisance algal blooms eliminated;
- No new self-sustaining invasive species;
- Existing invasive species controlled; and
- Native habitat protected and restored to sustain native species.
One of the primary areas of focus of GRLI’s most recent action plan is the remediation of “Areas of Concern” (“AOCs”) that are defined as "geographic areas designated by the Parties where significant impairment of beneficial uses has occurred as a result of human activities at the local level." There are currently more than 26 AOCs in the Great Lakes basin that could be cleaned up using monies appropriated in the current version of the infrastructure bill.
We will continue to track the progress of the infrastructure bill and the availability of funds to address AOCs in the Great Lake basin at the Corporate Environmental Lawyer.
In a unanimous decision authored by Justice Thomas, the Supreme Court of the United States ruled in the case of Guam v. United States, No. 20-382, 593 U.S. __ (2021), that a party must resolve “CERCLA-specific liability” in order to trigger contribution rights under § 113(f)(3)(B) of the Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA”).
The question before the Court was whether a settlement between Guam and the United States that resolved claims under the Clean Water Act could be the basis for a contribution claim under § 113(f)(3)(B) of CERCLA. In this case, Guam and the U.S. EPA had entered into a Consent Decree following a Clean Water Act lawsuit, settling the United States’ Clean Water Act claims against Guam and requiring Guam take actions to close and cover a dump site. Thirteen years later Guam sued the United States under CERCLA for cost recovery and contribution, claiming the United States’ earlier use of the dump site exposed it to liability. The district court, in a ruling affirmed by the court of appeals, ruled that Guam had a contribution claim at one point, based on its Clean Water Act Consent Decree because that Decree required remedial measures and provided a conditional release, which sufficiently resolved Guam’s liability for the dump site and triggered a CERCLA contribution claim under § 113(f)(3)(B). However, the Decree also triggered the three-year statute of limitations, which had expired, leaving Guam without any viable claims.
The Supreme Court reversed the lower courts, rejecting the notion that the Clean Water Act Consent Decree was sufficiently similar to a CERCLA settlement to trigger contribution liability. The Court focused on a textual analysis of the statute, which states in relevant part that:
A person who has resolved its liability to the United States or a State for some or all of a response action or for some or all of the costs of such action in an administrative or judicially approved settlement may seek contribution from any person who is not party to a [qualifying] settlement.
42 U.S.C. § 9613(f)(3)(B).
Of particular note to the Court was the reference in § 113(f)(3)(B) to “response action”, which is a term of art in CERCLA, and appears throughout the Act. The Court reasoned that this language “is best ‘understood only with reference’ to the CERCLA regime.” Guam, slip op. at 6, quoting United States v. Atlantic Research Corp., 551 U. S. 128, 135 (2007). Thus, according to the Court’s reasoning, to resolve liability for a “response action,” a party must engage in a CERCLA-specific settlement, not “settle an environmental liability that might have been actionable under CERCLA.” Id. at 7.
In conclusion, the Court held that “[t]he most natural reading of §113(f)(3)(B) is that a party may seek contribution under CERCLA only after settling a CERCLA-specific liability.” Id. at 9.
Like most major CERCLA decisions, the Court’s ruling answers one question but raises many more. We can expect future litigation on the precise bounds of how specific a settlement need be to qualify as “CERCLA-specific” under the Court’s holding. There will also likely be litigation regarding how this ruling may apply to other provision of CERCLA beyond §113(f )(3)(B). As always, the Corporate Environmental Lawyer Blog will be monitoring these important developments and reporting on what you need to know.
On Friday, April 30, 2021, the Biden Administration’s Environmental Protection Agency (EPA) announced significant steps the agency intends to take under the Toxics Release Inventory (TRI) Program to implement expanded reporting requirements for companies that store and utilize hazardous chemicals, including new obligations to report the storage, use and any releases of ethylene oxide, a commonly used industrial chemical and sterilant for medical equipment and supplies. The TRI Program, which was established under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA), serves as a resource for the public to learn about annual chemical releases, waste management, and pollution prevention activities reported by nearly 22,000 industrial and federal facilities. Under the TRI Program, U.S. facilities operating in various industry sectors must report annually the quantity of certain chemicals they release to the environment and/or manage through recycling, energy recovery and treatment. A “release” of a chemical in the context of the TRI Program means that the chemical is emitted to the air or water, or placed in some type of land disposal.
A major component of EPA’s announcement is the agency’s intent to regulate ethylene oxide. The use and release of ethylene oxide by medical device sterilization companies have prompted a number of recent high-profile lawsuits alleging that releases of the chemical into the environment have caused increased cancer rates in communities adjacent to the facilities. EPA’s announcement notes that many existing sterilization facilities “are located near areas with Environmental Justice concerns,” and that individuals living adjacent to these facilities may be at a heightened risk from exposure to ethylene oxide. “Every person in the United States has a right to know about what chemicals are released into their communities,” EPA Administrator Michael S. Regan stated. “By requiring new and more data on chemical releases from facilities, EPA and its partners will be better equipped to protect the health of every individual, including people of color and low-income communities that are often located near these facilities but have been left out of the conversation for too long.” In the coming months, EPA will provide further details regarding the specific actions the agency intends to take to require sterilization facilities that use ethylene oxide to report under the TRI Program.
In addition to implementing new reporting requirements for companies utilizing ethylene oxide, EPA announced several other steps the agency plans to take that will increase reporting and public access to information under the TRI Program, including:
- Finalizing a longstanding proposed rule that will add natural gas processing facilities to the industry sectors covered under the TRI Program thereby increasing the publicly available information on chemical releases and other waste management activities of TRI-listed chemicals from this sector;
- Continuing to add new per- and polyfluoroalkyl substances (“PFAS”) to the list of chemicals that require reporting under the TRI Program, including the addition of perfluorobutane sulfonic acid (PFBS) following EPA’s toxicity assessment of the substance;
- Proposing a new rule to add high-priority substances under the Toxic Substances Control Act (TSCA) and chemicals included in the TSCA workplan to the list of chemicals that require reporting under the TRI Program; and
- Increasing public access to TRI data through improved search functionality and improved website interface.
EPA’s announcement marks the most recent step by the agency to implement the Biden Administration’s focus on environmental justice as a top priority of its environmental agenda. On the same day that EPA announced the agency’s updated TRI policy, EPA circulated a memorandum to all EPA-staff, indicating the additional actions the agency intends to take to fulfill its environmental justice commitment. These actions include: (1) increasing inspections of facilities that pose the most serious threats to overburdened communities; (2) focusing on implementing remedies that benefit communities, including through the incorporation of supplemental environmental projects; (3) increasing communications with overburdened communities to develop improved cleanup and non-compliance solutions; and (4) identifying locations where state regulators are not adequately protecting local communities and taking increased enforcement actions to “pick up the slack” if state regulators have not taken appropriate or timely actions.
The Corporate Environmental Blog will continue to follow developments on this issue in the coming months as EPA provides additional details on the specific actions it intends to take to expand the TRI Program.
The North Carolina Department of Environmental Quality (DEQ) is continuing to investigate an unexplained source of per-fluorinated compounds (PFAS) contamination that may be associated with the deployment of a fire-fighting compound in response to a major gasoline release by the Colonial Pipeline system on August 14, 2020. The Colonial Pipeline, which spans 5,500 miles from Houston, Texas, to Linden, New Jersey, runs through a number of southern and mid-Atlantic states, including North Carolina. The active pipeline delivers an average of 100 million gallons of liquid petroleum products each day. On August 14, 2020, a leak in the pipeline resulted in the release of approximately 1.2 million gallons of gasoline into the environment near the town of Huntersville, North Carolina. The release was the largest onshore gasoline spill in the United States in over 20 years and in connection with Colonial Pipeline’s emergency response to that release, Colonial Pipeline sprayed a commonly used fire suppressant known as F-500 encapsulate on the contaminated land to minimize the risk that vapors from the release would ignite.
However, following Colonial Pipeline’s initial emergency response, new questions have emerged regarding PFAS that was detected at the release site. As part of the ongoing efforts to investigate the nature and extent of the gasoline release, DEQ directed Colonial Pipeline to collect samples from the F-500 encapsulate and test that encapsulate for various PFAS formations. The resulting test data found elevated levels—as high as 22,600 parts per trillion (“ppt”)—of at least three different PFAS compounds. Samples of a nearby surface water showed PFAS concentrations ranging from 1 ppt to 14.9 ppt.
The source of the PFAS is not readily apparent, however, because as verified by the Safety Data Sheet , F-500 is not known to contain PFAS compounds. In fact, F-500 acts differently than aqueous film forming foam (AFFF) to fight fires. AFFF is intended to separate oxygen from the fuel while F-500 works by removing the heat, neutralizing the fuel, and interrupting the free radical chain reaction. As such, it does not rely on fluorine compounds for effectiveness.
It is possible that the source of the PFAS identified by Colonial Pipeline was a result of residual AFFF residing in the storage tank or in the fire-fighting equipment that was used to dispense the F-500 encapsulating agent. The F-500 was transported to the site by the Pelham Alabama fire department and the fire-fighting equipment that sprayed the F-500 was supplied by the Hunterville Fire Department. However, notwithstanding that the equipment was supplied by the municipal fire departments and that the F-500 is not known to contain PFAS compounds, DEQ has still requested that Colonial Pipeline provide data demonstrating that there have been no PFAS impacts to soil or groundwater as a result of the emergency response.
This a cautionary tale for environmental health and safety professionals charged with maintaining emergency spill response materials, including fire suppressant products, for their respective organizations. Such professionals are faced with a unique challenge of ensuring that products maintained for spill containment or remediation purposes are not only fit for these purposes, but also that these products do not contain chemicals that pose a potential threat to human health or the environment. This challenge is particularly acute with PFAS, of which there are over 5,000 different formulations which can be found in a large variety of different consumer and industry products. Even if a decision is made to swap out one product that may historically contained PFAS with a new product that is purportedly PFAS-free, care should be taken to ensure that product distribution equipment is PFAS-free. Otherwise, one might find oneself in the unfortunate position of having to defend against claims relating to PFAS impacts in the environment.
OSHA under Deadline for a Nationwide COVID 19 Workplace Safety Rule: Four States’ Existing Laws and New Federal Guidance and Orders Foretell the Future
By Gabrielle Sigel, Co-Chair, Environmental and Workplace Health and Safety Law Practice
On his first full day in office, President Biden issued an Executive Order on Protecting Worker Health and Safety, which required OSHA to “consider whether any emergency temporary standards on COVID‑19, including with respect to masks in the workplace, are necessary,” and if so, to issue such emergency temporary standards (ETS) by March 15, 2021. Executive Order 13999, § 2(b) (Jan. 21, 2021), 86 FR 7211 (Jan. 26, 2021). An ETS, which skips the initial notice and comment process before it is in effect, can be issued pursuant to Section 6(c) of the OSH Act if OSHA determines that employees are exposed to “grave danger” and that an emergency standard is necessary to protect them from the grave danger. 29 U.S.C. § 655(c).
Putting aside that OSHA has not successfully issued an ETS since 1978, including that the last attempt to issue an ETS, regulating asbestos exposure, was invalidated by the US Court of Appeals in 1984, OSHA now has several models for a COVID‑19 ETS from which it may draw. Specifically, California, Michigan, Oregon, and Virginia are among the 22 states and territories that administer and enforce their own state-plan OSHA, rather than rely solely on federal standards and enforcement. These four states have developed their own COVID‑19 safety regulations that apply to most, if not all, workplaces in their respective states, and have both distinctive features and commonalities. Employers would be well-advised to be aware of each of the states’ specific standards, not only to comply with regulatory requirements in that state, but to consider whether their workplace is ready for potential, nationwide regulations which may incorporate elements of these states’ approaches.
With OSHA under a Presidential deadline to issue a nationwide COVID-19 safety regulation, we review the current status of OSHA guidance; describe the basic elements of the four states’ regulations; and look at recent federal orders by other agencies to anticipate what employers nationwide may soon be facing.
US OSHA: COVID‑19 Regulation and Guidance in the Prior Administration
On February 5, 2021, the U.S. Occupational Safety and Health Administration (OSHA) issued a proposed rule updating its Hazard Communication (“Haz Com”) Standard to align its rules with those in the seventh version of the United Nation’s Globally Harmonized System of Classification and Labeling of Chemicals (GHS), published in 2017. OSHA’s proposed regulatory update is being issued as the United States’ major international trading partners, including Canada, Australia, New Zealand, and those in Europe, similarly prepare to align their own hazard communications rules with the seventh version of the GHS.
Originally established in 1983, OSHA’s Haz Com Standard provides a systematized approach to communicating workplace hazards associated with exposure to hazardous chemicals. Under the Haz Com Standard, chemical manufacturers and/or importers are required to classify the hazards of chemicals which they produce or import into the United States, and all employers are required to provide information to their employees about the hazardous chemicals to which they are exposed, by means of a hazard communication program, labels and other forms of warning, safety data sheets, and information and training. At an international level, the GHS provides a universally harmonized approach to classifying chemicals and communicating hazard information. Core tenants of the GHS include universal standards for hazard testing criteria, warning pictograms, and safety data sheets for hazardous chemicals.
In a pre-published version of the proposed rule, OSHA’s proposed modifications to the Haz Com Standard include codifying enforcement policies currently in OSHA’s compliance directive, clarifying requirements related to the transport of hazardous chemicals, adding alternative labeling provisions for small containers and adopting new requirements related to preparation of Safety Data Sheets. Key modifications included in the proposed rule, include:
- New flexibility for labeling bulk shipments of hazardous chemicals, including allowing labels to be placed on the immediate container or transmitted with shipping papers, bills of lading, or by other technological or electronic means that are immediately available to workers in printed form on the receiving end of the shipment;
- New alternative labeling options where a manufacturer or importer can demonstrate that it is not feasible to use traditional pull-out labels, fold-back labels, or tags containing the full label information normally required under the Haz Com Standard, including specific alternative requirements for containers less than or equal to 100ml capacity and for containers less than or equal to 3ml capacity; and
- New requirements to update the labels on individual containers that have been released for shipment but are awaiting future distribution where the manufacturer, importer or distributer becomes aware of new significant information regarding the hazards of the chemical.
OSHA last updated its Haz Com Standard in 2012, to align the standard with the then recently published third version of GHS. In its newly proposed rule, OSHA clarifies that it is “not proposing to change the fundamental structure” of its Haz Com Standard, but instead seeking to “address specific issues that have arisen since the 2012 rulemaking” and to provide better alignment with international trading partners. According to OSHA, its proposed modifications to the Haz Com Standard “will increase worker protections, and reduce the incidence of chemical-related occupational illnesses and injuries by further improving the information on the labels and Safety Data Sheets for hazardous chemicals.”
OSHA is currently accepting comments on its proposed rule until April 19, 2021. Comments may be submitted electronically to Docket No. OSHA-2019-0001at http://www.regulations.gov, which is the Federal e-Rulemaking Portal.
By Steven M. Siros, Co-Chair, Environmental and Workplace Health and Safety Law Practice
The Trump administration continues its efforts to issue new regulations in advance of January 20, 2021, with the Department of Energy (DOE) issuing a final rule that will exempt certain liquefied natural gas (LNG) projects from National Environmental Protection Act (NEPA) review. The final rule, published in the Federal Register on December 4, updates DOE’s NEPA implementing procedures with respect to authorizations issued under the Natural Gas Act in accordance with the recent revisions to the NEPA regulations as further described below.
According to DOE, the focus of the new rule is to clarify the scope of DOE’s NEPA obligations with respect to LNG projects and more specifically, to eliminate from the scope of DOE’s NEPA review potential environmental effects that the agency has no authority to prevent. Because DOE’s discretionary authority under Section 3 of the Natural Gas Act is limited to the authorization of exports of natural gas to non-free trade agreement countries, the rule limits the scope of environmental impacts that DOE must consider to the impacts associated with the marine transport of the LNG commencing at the point of export.
To that end, the final rule revises DOE’s existing Categorical Exclusions (CATEX) to reflect that the only elements of LNG projects subject to NEPA review is the following:
B5.7 Export of natural gas and associated transportation by marine vessel.
Approvals or disapprovals of new authorizations or amendments of existing authorizations to export natural gas under section 3 of the Natural Gas Act and any associated transportation of natural gas by marine vessel.
Based on prior NEPA reviews and technical reports, DOE has determined that the transport of natural gas by marine vessel normally does not pose the potential for significant environmental impacts and therefore qualifies for a CATEX. As such, the only reason that DOE would be obligated to engage in a NEPA review of a LNG project would be if “extraordinary circumstances” were deemed to be present that could not be mitigated and therefore would preclude DOE's reliance on this CATEX.
The revised CATEX also removes the reference to import authorizations from CATEX B5.7 because DOE has no discretion with respect to such approvals. Finally, the final rule also removes and reserves CATEX B5.8 and classes of actions C13, D8, D9 because these actions are outside of the scope of DOE’s authority or are covered by the revised CATEX B5.7.
Interestingly, although the Federal Energy Regulatory Commission (FERC) has responsibility for approving the construction of LNG export terminals, it has previously declined to analyze the greenhouse emissions associated with such projects, noting that DOE is the appropriate agency to consider such impacts. However, with DOE now concluding that these projects are categorically excluded from such reviews, it remains to be seen if FERC will reconsider its approach to these operations.
The final rule is scheduled to take effect on January 4, 2021 and it remains to be seen what if any action a new Biden administration might take in response to this rule. Assuming that the Republicans retain control of the Congress, DOE would be required to go through the formal withdrawal process. Alternatively, if the Democrats take control of the Senate, the regulation could be repealed pursuant to the Congressional Review Act.
We will continue to track the Trump administration’s ongoing effort to finalize regulations in advance of January 20th as well as efforts by any new administration to rollback these regulations on the Corporate Environmental Lawyer.
The chemical industry has received some relief from a November 30th deadline to submit information to U.S. EPA pursuant to the Chemical Data Reporting Rule (“CDR”). Section 8(a) of the Toxic Substances Control Act (“TSCA”) authorizes U.S. EPA to promulgate rules pursuant to which manufacturers and processors of chemical substances must maintain records and submit information to U.S. EPA. To that end, U.S. EPA promulgated the CDR that requires entities that manufacture certain chemicals listed on the TSCA inventory in excess of 25,000 pounds annually (lower thresholds apply for certain listed chemicals) to report basic production information to U.S. EPA every four years. The 2020 reporting deadline had been November 30, 2020.
U.S. EPA recently revised the CDR to comply with the 2016 TSCA amendments. These revisions were intended to improve the reliability and usefulness of the data collected and reduce the overall reporting burden on regulated entities. For example, the revised rule allows for the use of data and processing codes based on those already in use by the Organization for Economic Cooperation and Development. The rule also incorporates exemptions for certain byproducts and amends the requirements to claim that the submitted data constitutes confidential business information (“CBI”) (requiring the upfront substantiation of all CBI claims).
On October 26th, the American Chemical Council requested a 60-day extension from the November 30th deadline, noting significant technical issues with the electronic CDR submission platform. Notwithstanding objections from a variety of environmental groups, U.S. EPA has extended the CDR reporting deadline to January 29, 2021. The extension is good news for the regulated community as it works to compile the substantial information necessary to comply with the CDR requirements.
We will continue to track and provide updates on the CDR and other reporting obligations for chemical manufacturer on Jenner & Block’s Corporate Environmental Lawyer blog.
CDC Changes Definition of “Close Contacts” for Contact Tracing Purposes: What Does This Mean for Employers?
By Gabrielle Sigel, Co-Chair, Environmental and Workplace Health and Safety Law Practice
I. The New CDC Definition of Close Contacts
On October 21, 2020, the CDC published a new definition of “Close Contact” for contact tracing purposes. This new definition will affect how employers determine Close Contacts for purposes of internal contract tracing to limit and prevent exposures and spread of the coronavirus within the workplace. The new CDC definition can be found here: https://www.cdc.gov/coronavirus/2019-ncov/php/contact-tracing/contact-tracing-plan/appendix.html#contact Quoting from the CDC link:
“Someone who was within 6 feet of an infected person for a cumulative total of 15 minutes or more over a 24-hour period* starting from 2 days before illness onset (or, for asymptomatic patients, 2 days prior to test specimen collection) until the time the patient is isolated.
* Individual exposures added together over a 24-hour period (e.g., three 5-minute exposures for a total of 15 minutes). Data are limited, making it difficult to precisely define “close contact;” however, 15 cumulative minutes of exposure at a distance of 6 feet or less can be used as an operational definition for contact investigation. Factors to consider when defining close contact include proximity (closer distance likely increases exposure risk), the duration of exposure (longer exposure time likely increases exposure risk), whether the infected individual has symptoms (the period around onset of symptoms is associated with the highest levels of viral shedding), if the infected person was likely to generate respiratory aerosols (e.g., was coughing, singing, shouting), and other environmental factors (crowding, adequacy of ventilation, whether exposure was indoors or outdoors). Because the general public has not received training on proper selection and use of respiratory PPE, such as an N95, the determination of close contact should generally be made irrespective of whether the contact was wearing respiratory PPE. At this time, differential determination of close contact for those using fabric face coverings is not recommended.”
Previously, CDC had defined “Close Contact” to mean someone who spent at least 15 consecutive minutes within six feet of a person confirmed to be have COVID-19, the disease caused by SARS-CoV-2.
II. What Does the New Definition Mean for Employers (Outside the Healthcare Industry)
Under CDC guidance, an employer should quarantine any Close Contact employee, i.e., the Close Contact employee should not be allowed on the worksite and should be told to quarantine per CDC guidance. If the Close Contact develops symptoms or tests positive, in which case the Close Contact becomes an infected person who is in isolation per CDC guidance. Notably, the CDC also states that, at this time, whether an infected person or the exposed person was wearing a mask during the exposure period does not affect the determination of a Close Contact for these purposes. However, the CDC does recognize that the determination of a Close Contact is “difficult to precisely define” and suggests that other factors may be considered, such as whether the infected person had symptoms at the time of exposure, whether the infected person was engaged in activities “likely to generate respiratory aerosols,” and environmental conditions, such as whether the exposure occurred indoors and the adequacy of indoor ventilation.
Per CDC guidance, the quarantine period is for 14 days, which typically means that the employee is not at the worksite, but can work remotely if their circumstances, including any labor agreement, so allows. The CDC recognizes, however, that a mandatory worksite quarantine period for Close Contacts could cause severe consequences for employers of “Critical Infrastructure Workers,” typically as defined by the Cybersecurity & Infrastructure Security Agency (“CISA”). Thus, the CDC provides an exception to the 14-day worksite quarantine for asymptomatic Critical Infrastructure Workers – they may continue to work at the standard workplace(s) if they adhere to protective measures prior to and during their work shift, including: pre-screening and regular monitoring for fever and other symptoms; wearing a face mask “at all times while in the workplace;” maintaining at 6-foot distance and practice social distancing “as work duties permit;” and working in areas that are frequently cleaned, including common areas and commonly shared equipment.
Although the CDC suggests that determinations of close contact can be affected by factors other than proximity and duration of exposure, it provides no guidance on how to account for those other factors in the course of the determination. Most employers are going to need to rely on clearly defined and easily understood rules, so that a workplace contact tracing program can be appropriately administered. Thus, most employers likely will continue to rely only on the more easily determined proximity and duration factors.
As a result of CDC’s change to the definition of Close Contact to include anyone in close proximity within a cumulative 15-minute period, rather than a consecutive 15-minute period, more employees may be designated as Close Contacts and, therefore, more employees may need to be precluded from working on-site, particularly those who cannot be classified as Critical Infrastructure Workers. Although an employer typically cannot prevent an exposure from occurring outside the workplace, an employer’s best “defense” to potential coronavirus exposure in the workplace, and the resulting Close Contact designation, is adherence to and enforcement of 6-foot distancing for all workplace activities, both during more social activities (such as in breakrooms, cafeterias, restrooms) and during job tasks.
Other Related CDC Sites:
Jenner & Block’s Corporate Environmental Lawyer will continue to update on these matters, as well as other important COVID‑19 related guidance, as they unfold.
On August 30, 2020, the California legislature passed the Toxic Free Cosmetics Act making California the first state to ban certain chemicals from cosmetics. Governor Newson signed the bill into law on October 1, 2020. The new law amends existing regulatory programs in California and provides that cosmetics containing any of a specific list of 24 chemicals will be considered “adulterated” and therefore unable to be sold in California. The specific list of chemicals includes certain phthalates and formaldehyde. However, the chemicals that have received the most attention are various per- and polyfluoroalkyl (PFAS) substances. Although some states have previously implemented legislation banning certain chemicals in cosmetic products (Minnesota banned formaldehyde in certain children’s personal care products; Washington requires that certain chemicals in children’s products be reported), California has become the first state to implement such a broad ban on these listed chemicals in cosmetics generally.
The ban will take effect on January 1, 2025 providing companies with time to take the necessary steps to eliminate any of the 24 listed chemicals from their cosmetic products. Of course, many companies have already taken steps to eliminate these chemicals from their products especially since many of these chemicals are already on California’s Proposition 65 list. However, unlike with Proposition 65 where compliance can be demonstrated by the provision of the requisite warnings, the Toxic Free Cosmetics Act will require elimination of these chemicals (with the exception of unavoidable trace quantities).
We will continue to provide regulatory updates as more states are likely to follow California’s lead in regulating these chemicals in various personal care products.