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.
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By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On April 6, 2020, 15 United States Senators submitted a bipartisan letter to the U.S. Department of Agriculture (USDA) Secretary, Sonny Perdue, requesting the use of its authority to assist the biofuels industry’s economic circumstances brought by the COVID-19 pandemic. Highlighting the negative impacts of the pandemic on farmers and producers who will bear the impact of the decrease in consumption, in the letter, the Senators have also taken the opportunity to criticize the U.S. Environmental Protection Agency (EPA) for failing to implement the Renewable Fuel Standard (RFS). Specifically, the letter states that EPA has failed “to implement the RFS in accordance with the law, including its issuance of illegal small refinery waivers and enforcement of ethanol blending requirements.” The lack of proper implementation of RFS combined with the COVID-19 crisis, according to the Senators, further negatively impact the rural communities and employment rates in their respective home states.

Given these circumstances, the 15 signatories of the letter ask that USDA considers the allocation of additional funds provided to the Commodity Credit Corporation (CCC) by the Coronavirus Aid, Relief, and Economic Stabilization (CARES) Act to assist the biofuels industry sector. Assistance would be helpful in the format of reimbursements for feedstocks and additional CCC funds to the Higher-Blends Infrastructure Incentive Program to drive future biofuel demand. Although, Secretary Purdue has not yet responded to the aforementioned request, the biofuels industry is hopeful.


 
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By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On April 9, 2020, EPA issued a final rule amending the Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) regulations by extending the 2020 report submission deadline to November 30, 2020. The extension applies to the 2020 submission period only. As many are aware, CDR regulations require manufacturers (including importers) of certain chemical substances to report data on the manufacturing, processing, and use of the chemical substances. This final rule is effective as of April 9, 2020.

This final rule has been published alongside EPA’s CDR Revisions final rule, which includes several changes to make regulatory updates that align with new statutory requirements of TSCA, improve the data collected, and potentially reduce the burden for chemical reporters. The CDR Revisions final rule will be effective on May 11, 2020.

Given the changes to become effective, The Acta Group (Acta®) announced on April 1, 2020, the launch of CDR Cross-Check™, an ingenious yet simple tool developed and offered by Acta to assist companies in preparing for the 2020 CDR required by EPA. CDR Cross-Check utilizes the most recent CDR listing information publicly available provided by EPA (currently, 2016 lists) to identify whether all or some of a company’s inventory of chemical substances are subject to CDR under TSCA and, if so, at what reporting threshold. CDR Cross-Check will make CDR reporting easier. CDR Cross-Check will identify whether chemicals are listed on the TSCA Inventory and, if so,

  • whether they are listed as active or inactive;
  • whether they were subject to specific TSCA regulatory actions in 2016;
  • whether they are exempt; and
  • what the 2020 reporting thresholds would be based on the 2016 data.

Visit the CDR Cross-Check website, https://cdr-cross-check.actagroup.com/, for more information and to order a CDR Cross-Check report.

The Acta Group is a global scientific and regulatory consulting firm that assists companies with strategic commercialization planning and complex product registration and compliance matters in North America, South America, Europe, the Middle East, and Asia. Acta is the consulting affiliate of Washington, D.C., law firm Bergeson & Campbell, P.C. (B&C®).

Tags: TSCA, CDR

 
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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.”


 
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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.”


 
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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

 

 
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By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On March 31, 2020, the U.S. Department of Energy’s (DOE) Office of Energy Efficiency and Renewable Energy (EERE) announced its intention to replace eXCHANGE for a new system for funding opportunity announcements (FOA) and application submissions. Starting in Fiscal Year 2021, parties interested in responding to EERE’s opportunities will use the EERE Program Information Center (EPIC). As DOE EERE transitions into EPIC, it is currently looking for volunteers to test the new system and provide feedback. Pilot testing will be from May through June 2020.

Interested parties will have a chance to register early and experience EPIC and how the submission process is changing. According to EERE, the most prominent change to the registration process is that parties must register before their individual applicant accounts can be created. The pilot is open to any organization. Volunteers will be asked to register in EPIC and submit a test application. Training videos will be available, and volunteers will be asked to provide feedback on the new system. Two roles are needed to register for the pilot: (1) the organization’s Government Business Point of Contact (from www.sam.gov), and (2) Technical Points of Contact, such as Principle Investigators or individuals who prepare, review, or submits applications for FOAs.

Organizations interested in volunteering for the pilot test should e-mail .(JavaScript must be enabled to view this email address) by May 1, 2020. Further details are available here. Participation is limited and volunteers will be selected on a first-come-first-serve basis.

Tags: DOE, EERE, FOA

 
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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.


 
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The Acta Group (Acta®) announced today the launch of CDR Cross-Check™, an ingenious yet simple tool developed and offered by Acta to assist companies in preparing for the 2020 Chemical Data Reporting (CDR) required by the U.S. Environmental Protection Agency (EPA). CDR Cross-Check utilizes the most recent CDR listing information publicly available provided by EPA (currently, 2016 lists) to identify whether all or some of a company’s inventory of chemical substances are subject to CDR under the Toxic Substances Control Act (TSCA) and, if so, at what reporting threshold. CDR Cross-Check will make CDR reporting easier.

CDR Cross-Check will identify whether chemicals are listed on the TSCA Inventory and, if so,

  • whether they are listed as active or inactive;
     
  • whether they were subject to specific TSCA regulatory actions in 2016;
     
  • whether they are exempt; and
     
  • what the 2020 reporting thresholds would be based on the 2016 data.

Sample CDR Cross-Check™ Report:

(Click image to enlarge.)

A CDR Cross-Check report prepared at this time will be extremely useful as a preliminary check in preparation for the 2020 CDR reporting. It will confirm regulatory statuses from the 2016 reporting cycle, so for those chemicals, users will know what the reporting threshold will be for 2020 and can determine now whether reporting is needed. It will also give users time to address potential issues well before the 2020 reports are due.

To access CDR Cross-Check, a customer will upload the list of chemicals to be evaluated by the CDR Cross-Check tool and pay the appropriate fee based on the number of chemicals to be evaluated. Fees are $3.00 (USD) per chemical for the first 750 chemicals plus $2.00 (USD) per chemical for additional chemicals over 750. The minimum fee is $400 (USD).

Acta anticipates that additional chemicals will be added to the regulatory lists in June 2020 that may result in lower reporting thresholds. The CDR Cross-Check will be updated at that time to include the new lists. Customers that have already used the CDR Cross-Check prior to the 2020 updates will receive a 50% discount for an updated list.

Visit the CDR Cross-Check website, https://cdr-cross-check.actagroup.com/, for more information and to order a CDR Cross-Check report.

More information on recent CDR developments is available in Acta’s March 19, 2020, memorandum “EPA Releases Final Amendments to CDR Rule, Extends Reporting Period.”

The Acta Group is a global scientific and regulatory consulting firm that assists companies with strategic commercialization planning and complex product registration and compliance matters in North America, South America, Europe, the Middle East, and Asia. Acta is the consulting affiliate of Washington, D.C., law firm Bergeson & Campbell, P.C.


 
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By Lynn L. Bergeson

On March 25, 2020, the U.S. Department of Energy (DOE) announced a meeting of the Biological and Environmental Research Advisory Committee (BERAC). The meeting will be held digitally via webcast on April 16, 2020, from 9:00 a.m. to 5:00 p.m. (EDT). Information on how to access the meeting will be posted here. Tentative agenda topics include:

  • BERAC business and discussion;
  • News from the Biological Systems Science and Climate and Environmental Sciences Divisions;
  • News from the Office of Biological and Environmental Research (BER);
  • Report brief(s); and
  • Public comment.

The virtual meeting is open to the public. Both written and oral statements regarding agenda items will be accepted.

Tags: DOE, BERAC

 
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By Lynn L. Bergeson

The U.S. Environmental Protection Agency (EPA) announced on March 25, 2020, that it will consider a proposed rule that would look at providing exemptions to the Toxic Substances Control Act (TSCA) fees rule in response to stakeholder concerns about implementation challenges. EPA states that by considering a proposal to narrow the broad scope of the current requirements, it “could significantly reduce burden on potentially thousands of businesses across the country while maintaining the ability to successfully implement the Lautenberg Act amendments” to TSCA to protect human health and the environment. According to EPA, it plans to initiate a new rulemaking process to consider proposing exemptions to the current rule’s self-identification requirements associated with EPA-initiated risk evaluations for manufacturers that:

  • Import the chemical substance in an article;
  • Produce the chemical substance as a byproduct; or
  • Produce or import the chemical substance as an impurity.

EPA states that it may also consider proposing other changes to the rule during this process consistent with TSCA’s requirement to reevaluate the fees rule every three years. EPA notes that it believes that considering exempting certain entities from self-identification requirements will not impede the ability to collect fully the necessary fees and will still allow it to achieve the ultimate objective of the TSCA fees rule and the statute -- “to defray a portion of EPA’s TSCA implementation costs.” EPA intends to issue proposed amendments to the current fees rule later in 2020, with the goal of promulgating the amendments in 2021.

EPA states that additionally, “in light of the extremely unusual circumstances of this situation and the undue hardship imposed on certain businesses who would be required to collect and report information” under the TSCA fees rule, EPA issued a “no action assurance” for the three categories of manufacturers at this time. More specifically, EPA “will exercise its enforcement discretion regarding the self-identification requirement for the three categories of manufacturers” for which EPA intends to propose an exemption.

EPA suggests that businesses that are erroneously on the preliminary lists of fee payers or fall into one of the three categories discussed above should see its frequently asked questions (FAQ) for more information about how to certify as such to EPA and to avoid fee obligations. EPA posted more information on its announcement, as well as a copy of the no-action assurance, on its website. More information is available in our March 9, 2020, blog item, “EPA Extends Deadline to Self-Identify as a Manufacturer or Importer of a High-Priority Chemical to May 27.”


 
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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

 
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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.


 
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By Lynn L. Bergeson

EPA published a Federal Register notice on March 20, 2020, inviting the public to nominate scientific experts from a diverse range of disciplines to be considered for appointment to the TSCA Science Advisory Committee on Chemicals (SACC). 85 Fed. Reg. 16094. EPA is seeking nominations of individuals who have demonstrated high levels of expertise in scientific and/or technical fields relevant to chemical safety and risk assessment, including, but not limited to: human health and ecological risk assessment, biostatistics, epidemiology, pediatrics, physiologically based pharmacokinetics, toxicology and pathology, and the relationship of chemical exposures to women, children, and other potentially exposed or susceptible subpopulations. In addition, nominees should have backgrounds and experiences that would contribute to the diversity of scientific viewpoints on the committee, including professional experiences in government, labor, public health, public interest, animal protection, industry, and other groups, as the EPA Administrator determines to be advisable (e.g., geographic location, social and cultural backgrounds, and professional affiliations). Any interested person or organization may nominate qualified persons to be considered for appointment to SACC. Individuals also may self-nominate. The preferred method for submitting nominations is via e-mail to Steven Knott, the SACC’s Designated Federal Officer (.(JavaScript must be enabled to view this email address)). Nominations are due no later than April 20, 2020.

Tags: TSCA, SACC

 
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By Lynn L. Bergeson

On March 17, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a final rule amending the Chemical Data Reporting (CDR) rule. According to EPA, the amendments are intended to reduce the burden for certain CDR reporters, improve the quality of CDR data collected, and align reporting requirements with the Frank R. Lautenberg Chemical Safety for the 21st Century Act’s (Lautenberg Act) amendments to the Toxic Substances Control Act (TSCA). EPA states that some of the key revisions include:

  • Simplifying reporting, including allowing manufacturers to use certain processing and use data codes already in use by many chemical manufacturers as part of international codes developed through the Organization for Economic Cooperation and Development (OECD);
     
  • Updating requirements for making confidentiality claims to align with the requirements in amended TSCA; and
     
  • Adding reporting exemptions for specific types of byproducts manufactured in certain equipment.
     

Additionally, EPA is extending the reporting period for CDR data submitters from September 30, 2020, to November 30, 2020, to provide additional time for the regulated community to familiarize themselves with the amendments and to allow time for reporters to familiarize themselves with an updated public version of the reporting tool. The reporting period will still begin on June 1, 2020. EPA will host a webinar on Tuesday, March 31, 2020, to discuss the revised reporting requirements, provide an overview of the 2020 CDR submission period, and to give an introduction to the updated e-CDR web reporting tool. EPA has posted pre-publication versions of the final rules amending the CDR rule and extending the reporting period. More information will be available in a forthcoming memorandum that will be posted on our website.

Tags: CDR, TSCA

 
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