The Biobased and Renewable Products Advocacy Group (BRAG) helps members develop and bring to market their innovative biobased and renewable chemical products through insightful policy and regulatory advocacy. BRAG is managed by B&C® Consortia Management, L.L.C., an affiliate of Bergeson & Campbell, P.C.

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.

Tags: SAB

 

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.

Tags: EPA, OPPT

 

By Lynn L. Bergeson

EPA published a Federal Register notice on March 23, 2020, announcing that the EPA Safer Choice program is accepting submissions for its 2020 Safer Choice Partner of the Year Awards. 85 Fed. Reg. 16334. EPA states that it developed the Partner of the Year Awards to recognize the leadership contributions of Safer Choice partners and stakeholders who, over the past year, have shown achievement in the design, manufacture, selection, and use of products with safer chemicals, furthering outstanding or innovative source reduction. All Safer Choice stakeholders and program participants in good standing are eligible for recognition. Interested parties who would like to be considered for this award should submit to EPA information about their accomplishments and contributions during 2019. EPA notes that there is no form associated with this year’s application. EPA will recognize award winners at a Safer Choice Partner of the Year Awards ceremony that is being planned for fall 2020. Submissions are due May 31, 2020.


 

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.


 

By Lynn L. Bergeson

On March 3, 2020, EPA announced that a supplemental notice of the proposed rulemaking (SNPRM) titled “Strengthening Transparency in Regulatory Science” will be published in the Federal Register in the near future. While the notice would only modify EPA internal procedures, industry stakeholders are asked to comment on the proposed rule during a 30-day period after the date of publication in the Federal Register. 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.

These proposed modifications are in response to some of the public comments received by EPA on the 2018 proposed rulemaking. Under the alternate approach to the use of data and models, EPA will also use restricted studies that are not available to the public. The proposal would apply to reviews of data, models, and studies regardless of when the data and models were generated. EPA plans to identify studies that are given greater consideration and provide a short explanation of why greater consideration was given.

EPA is seeking comment on each of the proposed changes. 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.

EPA’s announcement includes a pre-publication version of the proposed supplemental rulemaking, which can be accessed here. Interested parties may wish to review Bergeson & Campbell, P.C.’s (B&C®) March 9, 2020, memorandum on the SNPRM.


 

By Lynn L. Bergeson

On February 28, 2020, the U.S. Environmental Protection Agency (EPA) announced that, in support of President Trump’s (R) Executive Order to promote transparency, EPA launched a new guidance portal that provides public access to its guidance documents. According to EPA, the new searchable database will make it easier for the regulated community to find and follow agency guidance. On October 9, 2019, President Trump issued Executive Order 13891, Promoting the Rule of Law Through Improved Agency Guidance Documents, to promote transparency by ensuring that all active guidance documents are made available to the public. The portal provides an indexed database that allows the public to search for documents based on a range of criteria that include date of issuance, general subject matter, and summary of contents. EPA states that prior to the launch of the portal, it conducted an exhaustive review of its current guidance documents and withdrew those documents that it determined to be no longer relevant. The guidance portal also provides a mechanism for the public to request modification or withdrawal of any documents. EPA notes that it uses guidance documents “to clarify existing obligations for interested parties, but not as a vehicle for implementing new, binding requirements on the public.” According to EPA, it will release by August 28, 2020, a regulation that establishes the processes and procedures for issuance of new guidance documents.


 
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