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or withdrawal of active guidance documents as defined by the rule or to petition for the reinstatement of a rescinded guidance document.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 and Carla N. Hutton
On June 16, 2020, the U.S. Environmental Protection Agency (EPA) announced the winners of the 2020 Green Chemistry Challenge Awards. EPA states that this year’s winners “have developed new and innovative green chemistry technologies that turn potential environmental challenges into business opportunities, spurring innovation and economic development.” The 2020 winners and their innovative technologies are:
- Genomatica, San Diego, California, for creating Brontide™, a new brand of 1,3-butylene glycol, commonly used in cosmetics for moisture retention and as a carrier for plant extracts. Butylene glycol is traditionally produced from fossil fuels. Brontide™ is produced by fermenting E. coli using renewable sugars in a one-step production process, however. This method reduces greenhouse gas emissions and avoids the use of hazardous chemicals in the production process.
- Merck, Rahway, New Jersey, for improving the process used to produce certain antiviral drugs used for the treatment of diseases including hepatitis C and HIV. According to EPA, the new process improved manufacturing efficiency and sustainability of one important antiviral by more than 85 percent. This method reduces waste and hazards associated with the existing process and results in substantial cost savings.
- Johns Manville, Littleton, Colorado, for developing a biobased, formaldehyde-free thermoset binder for fiberglass reinforcement applications. Thermoset binders are used to bind glass fibers of fiberglass mats used in carpet tile backing. EPA states that this technology eliminates the use of hazardous chemicals, reduces water and energy use, and produces a product with a longer shelf life.
- Professor Steven Skerlos, University of Michigan and Fusion Coolant Systems, for creating Pure-Cut™, an alternative to traditional metalworking fluids that uses high-pressure carbon dioxide instead of oil-based lubricants. According to EPA, Pure-Cut™ can improve performance and machining tool life span compared to traditional metalworking fluids, while greatly reducing hazards to the environment and worker health.
- Vestaron, Kalamazoo, Michigan, for producing a new biopesticide called Spear®. This pesticide is based on a naturally occurring component inspired by spider venom that can effectively control target pests while showing no adverse effects on people, the environment, and non-target wildlife, such as fish and bees. EPA notes that Spear® should provide growers with a new pest management tool that also lessens environmental impacts.
EPA plans to recognize the winners at a ceremony in Washington, D.C., later this year. EPA and the American Chemical Society co-sponsor the awards. An independent panel of technical experts convened by the American Chemical Society Green Chemistry Institute formally judged the 2020 submissions and made recommendations to EPA for the 2020 winners.
By Lynn L. Bergeson
On June 11, 2020, the U.S. Environmental Protection Agency (EPA) announced that its Pollution Prevention (P2) Awards Program is planning to submit an information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval. Before proceeding with the ICR, however, EPA is soliciting public comments on specific aspects of the proposed ICR. EPA’s P2 Program consists of a voluntary program that encourages businesses and facilities to adopt P2 projects that reduce financial costs associated with waste management and cleanup, as well as environmental costs associated with health and environmental problems. Comments must be submitted on or before August 10, 2020.
Register now for the American Bar Association (ABA) webinar “Navigating the Jurisdictional Tightrope Between Biopesticides, Biostimulants, and Related Emerging Technologies” with Bergeson & Campbell P.C. (B&C®) professionals deconstructing the jurisdictional boundaries distinguishing pesticides, biopesticides, plant regulators, biostimulants, and related technologies. The webinar will focus on draft EPA guidance intended to clarify the lines between and among those products that are subject to FIFRA registration as plant regulators and those biostimulant products not subject to FIFRA registration. The webinar also will focus on new and evolving chemistry and technology issues that may blur some jurisdictional lines or potentially move products from one category to another. Lynn L. Bergeson, Managing Partner, B&C; Lisa R. Burchi, Of Counsel, B&C; and Sheryl Dolan, Senior Regulatory Consultant, B&C, will present.
By Lynn L. Bergeson
On March 3, 2020, EPA announced the availability of a supplemental notice of proposed rulemaking (SNPRM) to the Strengthening Transparency in Regulatory Science proposed rule. EPA notes that the SNPRM “is not a new rulemaking; rather, it provides clarifications on certain terms and aspects of the 2018 proposed rule.” The SNPRM:
- Proposes that the scope of the rulemaking applies to influential scientific information, as well as significant regulatory decisions;
- Defines and clarifies that the proposed rule applies to data and models underlying both pivotal science and pivotal regulatory science;
- Proposes 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; and
- Clarifies the ability of the Administrator to grant exemptions.
EPA published the SNPRM in the Federal Register on March 18, 2020. 85 Fed. Reg. 15396. EPA states that it “is taking comment on whether to use its housekeeping authority independently or in conjunction with appropriate environmental statutory provisions as authority for taking this action.” On April 2, 2020, EPA announced that it would extend the comment period to May 18, 2020. EPA anticipates promulgating a final rule later in 2020. More information is available in our March 9, 2020, memorandum, “EPA Releases Supplemental Proposed Rule to the Proposed Rule on Strengthening Transparency in Regulatory Science.”
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 and Ligia Duarte Botelho, M.A.
On April 1, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is now accepting nominations of scientific experts to be considered for appointment to its Science Advisory Board (SAB) and four SAB standing committees. EPA is seeking candidates from a wide range of disciplines including analytical chemistry, forestry, modeling, toxicology, and benefit-cost analysis, among many others. The four SAB standing committees seeking experts are:
- The Agricultural Science Committee (ASC) – It provides advice to the chartered SAB on matters that have been determined to have a significant direct impact on farming and agriculture-related industries;
- The Chemical Assessment Advisory Committee (CAAC) – It provides advice through the chartered SAB regarding selected toxicological reviews of environmental chemicals;
- The Drinking Water Committee (DWC) – It provides advice on the scientific and technical aspects of EPA’s national drinking water program; and
- The Radiation Advisory Committee (RAC) – It provides advice on radiation protection, radiation science, and radiation risk assessment.
Nominations will be accepted until May 1, 2020.