By Lynn L. Bergeson
On September 14, 2020, the U.S. Environmental Protection Agency (EPA) released a pre-publication version of a final rule establishing the procedures and requirements for how EPA will manage the issuance of guidance documents consistent with Executive Order (EO) 13891, “Promoting the Rule of Law Through Improved Agency Guidance Documents.” The final regulation provides a definition of guidance document for the purposes of this rule, establishes general requirements and procedures for certain guidance documents issued by EPA, and incorporates additional requirements for guidance documents determined to be significant guidance. EPA notes that the regulation, consistent with the EO, also provides procedures for the public to petition for the modification or withdrawal of active guidance documents as defined by the rule or to petition for the reinstatement of a rescinded guidance document. EPA states that the regulation is intended to increase the transparency of its guidance practices and improve the process used to manage its guidance documents. The final rule will be effective 30 days after the publication in the Federal Register. Further details and a Bergeson & Campbell, P.C. (B&C®) commentary are available here.
By Lynn L. Bergeson
On September 24, 2020, EPA announced the 2020 Safer Choice Partner of the Year award winners. EPA recognized 18 Safer Choice Partner of the Year award winners across ten states and the District of Columbia for achievement in the design, manufacture, selection, and use of products with safer chemicals that further outstanding or innovative source reduction. EPA states that the Safer Choice program helps consumers and purchasers for facilities, such as schools and office buildings, find products that perform and are safer for human health and the environment. According to EPA, the 2020 Partner of the Year award winners represent businesses, including woman-owned and small- and medium-sized; federal and local government; and associations. The following organizations from eight EPA regions are being awarded this year:
- Apple -- Cupertino, California;
- BASF Home Care and I&I Cleaning Solutions -- Florham Park, New Jersey;
- Berkley Green -- Uniontown, Pennsylvania;
- The Clorox Company -- Oakland, California;
- Defunkify -- Eugene, Oregon;
- DuPont Nutrition & Biosciences -- Palo Alto, California;
- ECOS -- Cypress, California;
- Grove Collaborative -- San Francisco, California;
- Hazardous Waste Management Program -- King County, Washington;
- Household & Commercial Products Association -- Washington, D.C.;
- Jelmar, LLC -- Skokie, Illinois;
- Lemi Shine -- Austin, Texas;
- Naval Supply Systems Command Weapons System Support -- Mechanicsburg, Pennsylvania;
- PROSOCO -- Lawrence, Kansas;
- PurposeBuilt Brands -- Gurnee, Illinois;
- Sea Mar Community Health Centers -- Seattle, Washington;
- Seventh Generation -- Burlington, Vermont; and
- Wegmans Food Markets -- Rochester, New York.
More information is available on EPA’s website.
By Lynn L. Bergeson
On June 30, 2020, EPA’s Office of Inspector General (OIG) released a report on its audit to determine whether the Safer Choice program effectively meets its goals and whether the program achieves quality standards through its product qualification, renewal, and required audit processes. OIG states that EPA’s Safer Choice program does not have formal goals included in the FY 2018-2022 EPA Strategic Plan, and the program has not reported results for FYs 2018-2019. The program does have internal, non-outcome-oriented goals, however, which it is generally achieving. The Safer Choice program’s goal is to add 200 Safer Choice products to the program and 25 chemicals to the Safer Chemical Ingredients List each year. According to OIG, in FY 2019, EPA added 265 products and 24 chemicals. OIG states that by not including formal goals for the Safer Choice program in EPA reports while continuing to receive Congressional funding and support, EPA limits not only accountability to Congress and the public, but also the extent that the program can use performance management information to make policy, budget, and management decisions. OIG notes that the Safer Choice program has general controls in place for the required Safer Choice audit process, and EPA reviews audit summaries and corrective actions provided by third-party profilers (TPP). EPA does not routinely review all supporting documentation, however, relying on TPPs to review and retain these documents. Additionally, the Safer Choice program does not have procedures in place to conduct any formal performance reviews of TPPs or oversight reviews of TPP partner audits. According to OIG, without periodic audit oversight, including full reviews of supporting documents and formal performance reviews of TPPs, EPA risks approving products that do not comply with the Safer Choice Standard. OIG recommends that the Assistant Administrator for Chemical Safety and Pollution Prevention develop and publish adequate Safer Choice program goals and performance measures, establish and implement procedures for formal audit oversight of TPPs, amend its memorandums of understanding with TPPs to require performance reviews conducted by EPA, and collect and document TPP audit supporting information.
By Lynn L. Bergeson
On May 29, 2020, the U.S. Environmental Protection Agency (EPA) issued a pre-publication version of a proposed anti-backsliding determination that no additional measures are necessary pursuant to the Clean Air Act (CAA) Section 211(v) to mitigate the adverse air quality impacts of renewable fuel volumes required under CAA Section 211(o). The proposed determination will be published in the Federal Register for a 30-day comment period. CAA Section 211 requires EPA to take two actions. The first action is for EPA to complete a study to determine whether renewable fuel volumes required under CAA Section 211(o) will adversely impact air quality given changes of vehicle and engine emissions of air pollutants. This study is often referred to as the anti-backsliding study and must include consideration of various blend levels, types of renewable fuels, and available vehicle technologies. The study must also include appropriate national, regional, and local air quality control measures. EPA has completed the study, which is available here.
The second action requires EPA to make a decision on whether it should proceed down one of the following paths:
- Promulgation of fuel regulations to implement appropriate measures to mitigate any adverse impacts on air quality as a result of the renewable volumes required by Section 211; or
- Determination that no such measures are required.
In this case, EPA is proposing a determination “that no additional appropriate fuel control measures are necessary to mitigate adverse air quality impacts of required renewable fuel volumes.”
By Lynn L. Bergeson
On April 10, 2020, the U.S. Environmental Protection Agency (EPA) published a quarterly update of the Toxic Substances Control Act (TSCA) confidential business information (CBI) review statistics. The data summarize the number of CBI cases under review and results of completed reviews through March 1, 2020. In addition, a spreadsheet showing the details of completed TSCA CBI determinations through March 1, 2020, is available. EPA states that making this information publicly available “continues to demonstrate the agency’s commitment to transparency while fulfilling its responsibilities under the Lautenberg Act amendments to TSCA.” According to EPA, it has established “numerous new processes, systems, and procedures to enable submitters to provide the information required when making confidentiality claims and to facilitate EPA’s review, and where applicable, determinations on these claims.” The updated statistics show EPA’s progress toward meeting these requirements.
By Lynn L. Bergeson
EPA announced on April 2, 2020, that it sent a letter to all members of Congress to correct the record on its temporary policy regarding enforcement of environmental legal obligations during the COVID-19 pandemic. EPA states that “[a]s should be apparent to anyone who reads the policy, allegations that EPA ‘will cease all enforcement actions during the coronavirus pandemic’ and that the temporary policy ‘absolves polluters of all responsibility’ are simply not true.” According to EPA, it expects regulated entities to comply with all obligations, and if they do not, EPA emphasizes that the policy states EPA will consider the pandemic, on a case-by-case basis, when determining an appropriate response. Furthermore, in cases that may involve acute risks, or imminent threats, or failure of pollution control or other equipment that may result in exceedances, “EPA’s willingness to provide even that consideration is conditioned on the facility contacting the appropriate EPA region, or authorized state or tribe, to allow regulators to work with that facility to mitigate or eliminate such risks or threats.”
EPA states that it is “not unusual for EPA to exercise enforcement discretion to address emergency situations that disrupt normal operations, such as hurricanes. What is unusual is that the current crisis caused by the COVID-19 pandemic affects the entire nation,” rather than a discrete geographic area. According to EPA, it developed the temporary policy to allow it to prioritize its resources to respond to acute risks and imminent threats, rather than making case-by-case determinations regarding routine monitoring and reporting. EPA notes that the development of the policy was a group effort, involving “multiple calls” and with “drafts shared among EPA staff and managers, both career and political, at both headquarters and in the regions.” Once the COVID-19 threat has ended, “EPA expects regulated facilities to comply with regulatory requirements, where reasonably practicable, and to return to compliance as quickly as possible.” Additionally, according to EPA, “the policy makes clear that EPA expects operators of public water systems to continue normal operations and maintenance during this time, as well as required sampling, to ensure the safety of vital drinking water supplies.”
More information on EPA’s temporary policy is available in our March 27, 2020, blog item, “EPA Announces Temporary Enforcement Discretion Policy.”
By Lynn L. Bergeson
EPA announced on March 26, 2020, a temporary policy regarding enforcement of environmental legal obligations during the COVID-19 pandemic. EPA states that its temporary enforcement discretion policy applies to civil violations during the COVID-19 outbreak. The policy addresses different categories of noncompliance differently. For example, according to EPA, it “does not expect to seek penalties for noncompliance with routine monitoring and reporting obligations that are the result of the COVID-19 pandemic but does expect operators of public water systems to continue to ensure the safety of our drinking water supplies.” The policy describes the steps that regulated facilities should take to qualify for enforcement discretion. To be eligible for enforcement discretion, the policy requires facilities to document decisions made to prevent or mitigate noncompliance and demonstrate how the noncompliance was caused by the COVID-19 pandemic.
EPA notes that its policy does not provide leniency for intentional criminal violations of law and that it does not apply to activities that are carried out under Superfund and Resource Conservation and Recovery Act (RCRA) Corrective Action enforcement instruments. EPA states that it will address these matters in separate communications. The policy states that it does not apply to imports. According to the policy, EPA is “especially concerned about pesticide products entering the United States, or produced, manufactured, distributed in the United States, that claim to address COVID-19 impacts.” EPA “expects to focus on ensuring compliance with requirements applicable to these products to ensure protection of public health.”
The policy will apply retroactively beginning on March 13, 2020. EPA will assess the continued need for and scope of this temporary policy on a regular basis and will update it if EPA determines modifications are necessary. To provide fair and sufficient notice to the public, EPA states that it will post a notification on its website at least seven days prior to terminating the temporary policy.
On March 30, 2020, the EPA issued a Press Release to clarify this Temporary Policy. The impetus for the Press Release was based, according to EPA, on the “reckless propaganda” by certain news outlets that provided erroneous or exaggerated information about the Temporary Policy, particularly that the Temporary Policy is providing a blanket waiver of environmental requirements or is creating a presumption that the COVID-19 pandemic is the cause of noncompliance.
EPA’s Press Release outlines certain elements of the Temporary Policy that should not be overlooked:
- The Temporary Policy states that EPA will not seek penalties for noncompliance with routine monitoring and reporting requirements, if, on a case-by-case basis, EPA agrees that such noncompliance was caused by the COVID-19 pandemic. The Policy is not intended to cover:
- Exceedances of pollutant limitations in permits, regulations, and statutes.
- Cases which may involve acute risks or imminent threats, or failure of pollution control or other equipment that may result in exceedances, except in possible circumstances where the facility contacts the appropriate EPA region, or authorized state or tribe, and allows regulators to work with that facility to mitigate or eliminate such risks or threats.
- Normal operations and maintenance of public water systems and required sampling of vital drinking water supplies.
- Regulated parties must document the basis for any claim that the pandemic prevented them from conducting that routine monitoring and reporting and present it to EPA upon request. EPA states that it is using this approach to allow EPA to prioritize its resources and respond to acute risks and imminent threats, rather than making up-front case-by-case determinations regarding routine monitoring and reporting requirements.
EPA notes that it expects regulated facilities to comply with regulatory requirements, where reasonably practicable, and to return to compliance as quickly as possible, once the COVID-19 threat is over. EPA states that it plans to lift the measures of the Temporary Policy as soon as normal operations can resume, which may occur sooner in some locations than others.
By Lynn L. Bergeson
Effective March 29, 2020, Yvette T. Collazo will be the new Director of EPA’s Office of Pollution Prevention and Toxics (OPPT). Ms. Collazo previously worked for the U.S. Department of Energy (DOE), where she led activities related to federal contracts and agreements of more than $250 million for the cleanup of radiological, industrial, and groundwater hazards resulting from decades of nuclear material production at DOE’s Savannah River facility. Ms. Collazo also served as Senior Advisor and Director for the Office of Technology Innovation and Development at DOE’s Office of Environmental Management. In this capacity, she led the identification and advancement of technologies, processes, and technical practices that improved the performance of waste processing, groundwater and soil, facility decontamination and decommissioning, and nuclear materials projects over their life cycles, from planning to disposal. Starting in 2013, Ms. Collazo served as District Director of the U.S. Small Business Administration (SBA) Puerto Rico and Virgin Islands District Office. As District Director, she was responsible for the delivery of the SBA’s financial assistance, business counseling, entrepreneurial training, and federal contracting programs throughout the District. Ms. Collazo has a Master of Science in Environmental Management from the Illinois Institute of Technology and a Bachelor of Science in Mechanical Engineering from the University of Puerto Rico, Mayagüez Campus.
By Lynn L. Bergeson
On March 18, 2020, EPA published its supplemental notice of proposed rulemaking (SNPRM) titled “Strengthening Transparency in Regulatory Science” in the Federal Register. Per last week’s Bergeson & Campbell, P.C. (B&C®) blog post, the supplemental notice proposes the following changes to the 2018 proposed rulemaking:
- A scope that applies to influential scientific information and significant regulatory decisions;
- A modified approach to the availability provisions for data and models that would underlie influential scientific information and significant regulatory decisions as well as an alternate approach;
- Clarification on the ability of the EPA Administrator to grant exemptions; and
- Definitions and clarifications that the proposed rule applies to data and models underlying both pivotal science and pivotal regulatory science.
EPA is seeking comment on each of the proposed changes by April 17, 2020. In particular, EPA is asking for feedback on whether this approach may improve consistency between this proposed rulemaking and certain provisions of those statutes that refer to standards for data availability. Interested parties may also wish to review B&C’s March 9, 2020, memorandum on the SNPRM.