Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

By Lynn L. Bergeson and Richard E. Engler, Ph.D.

On May 20, 2019, the U.S. Environmental Protection Agency (EPA) announced that on May 30, 2019, it will begin publishing Toxic Substances Control Act (TSCA) Section 5 notices including premanufacture notices (PMN), microbial commercial activity notices (MCAN), and significant new use notices (SNUN), their attachments, including any health and safety studies, any modifications thereto, and all other associated information in ChemView -- in the form they are received by EPA, without review by EPA.  EPA states that it will not be reviewing confidential business information (CBI)-sanitized filings before publishing.  EPA states that this announcement will be the first of several reminders that EPA sends and, in addition, EPA has incorporated a reminder to check accompanying sanitized submissions as part of the Central Data Exchange (CDX) reporting module for TSCA Section 5 notices.

EPA’s announcement states the following as guidance for submitters to take heed of before submitting their TSCA Section 5 notices:

  1. Verify the asserted CBI claims are correct and consistent; and
  2. Verify the sanitized versions of the form, attachments, and file names are checked for proper and consistent CBI redactions and that watermarks or stamps indicating CBI are removed.  

Commentary

EPA does not specify how long after submission the documents may be posted, but submitters should expect a very short turn-around.  Bergeson & Campbell, P.C. (B&C®) has addressed the topic of CBI before, most recently on our podcast, All Things Chemical™.  When completing a PMN, a submitter must take care to ensure that all information that must be protected as CBI is marked as such.  A submitter cannot expect EPA to extrapolate a claim for CBI in one part of a form to the rest of the document and its attachments.  B&C strongly suggests that a submitter review the sanitized form of an entire document (e.g., a PMN and its attachments) to ensure that all sensitive information is redacted before submitting the document to EPA.

Do not wait until May 30.  Begin developing and practicing good CBI practices today.


 

By Lynn L. Bergeson and Margaret R. Graham, M.S.

On May 16, 2019, the U.S. Environmental Protection Agency (EPA) announced that it has updated its Statistics for the New Chemicals Review Program under TSCA web page, which is under EPA’s Reviewing New Chemicals under the Toxic Substances Control Act (TSCA) section, to make it easier to find and understand how many chemicals are in each stage of the new chemicals review process.  The revised web page now includes a flow chart showing the number of new chemicals cases (premanufacture notices (PMN), significant new use notices (SNUN), and microbial commercial activity notices (MCAN)) at each stage of review and detailed descriptions of each step in the process.

EPA states that these changes “are the first step in a larger effort to increase the transparency of the new chemicals program and ensure stakeholders and the public can quickly and easily view EPA’s progress in reviewing new chemicals submissions as the Agency receives them.”  EPA Assistant Administrator Alexandra Dunn has repeatedly expressed her and EPA’s commitment to enhance the transparency of EPA’s operations, and this latest development reflects that commitment.


 

By Lynn L. Bergeson

The U.S. Environmental Protection Agency (EPA) released on March 20, 2019, a list of 20 chemicals that EPA has suggested as candidates for high priority designation under the Toxic Substances Control Act (TSCA), as reported in our March 22, 2019, memorandum "EPA Releases List of 40 Chemicals Undergoing Prioritization for Risk Evaluation."  Should those chemicals go forward as high priority, they will be subject to risk evaluation under TSCA Section 6.  Industry stakeholder responses to this candidate list proposal and follow up actions with EPA related to risk evaluation work optimally will be conducted under existing or potentially newly formed chemical consortia.  But what if your chemical is not on the list of 20?  If you want to protect or even increase your business market advantage, consider inviting your commercial rivals to join an industry advocacy group anyway.  This is particularly important if you have a chemical of commercial interest on the TSCA Work Plan Chemicals list.  For more information on this issue, please see our full memorandum.


 

By Lynn L. Bergeson and Margaret R. Graham, M.S.

On May 9, 2019, the U.S. Environmental Protection Agency (EPA) announced that it would soon be making available a signed action signed on May 6, 2019, that identifies chemical substances for inactive designation according to the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements rule.  The pre-publication version of the notice is available here.  Specifically, EPA states that the signed action is a companion to the first version of the TSCA Chemical Substance Inventory with all listings designated as active or identified as inactive, which was posted on the EPA TSCA Inventory web page on February 19, 2019, and it will initiate a 90-day period after which substances identified as inactive will be designated as inactive.  Because the action was signed on May 6, 2019, inactive designations will become effective on Monday, August 5, 2019.  

Starting on August 5, 2019, manufacturers and processors are required to notify EPA before reintroducing into commerce a substance designated as inactive on the TSCA Inventory.  Manufacturers and processors can notify EPA via a Notice of Activity Form B, found in EPA's Central Data Exchange (CDX).  Upon receiving such notification, EPA will change the designation of substances from inactive to active.

For more information, visit EPA’s TSCA Inventory Notification (Active-Inactive) Rule site.


 

By Lynn L. Bergeson and Carla N. Hutton

On May 1, 2019, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) sent a memorandum to Alexandria Dapolito Dunn, Assistant Administrator, Office of Chemical Safety and Pollution Prevention, announcing that it “plans to begin preliminary research on the Office of Pollution Prevention and Toxics processes to implement the work to meet statutory deadlines of the Lautenberg Act.”  OIG’s objectives are to determine whether EPA has met the deadlines imposed by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) and whether EPA has the staff, resources, and management controls in place to meet future statutory deadlines.

As reported in our March 6, 2019, memorandum, “GAO Reviews EPA’s IRIS Assessment Efforts and Implementation of TSCA Reforms,” the U.S. Government Accountability Office (GAO) recently assessed whether EPA has demonstrated progress implementing the Toxic Substances Control Act (TSCA) as amended by the Lautenberg Act.  In its report, Chemical Assessments:  Status of EPA’s Efforts to Produce Assessments and Implement the Toxic Substances Control Act, GAO found that while EPA has responded to the initial statutory deadlines in TSCA, as amended by the Lautenberg Act, challenges remain.  As stated in our memorandum, the report draws attention to the challenges facing EPA, including:

  • Pending litigation by environmental groups against many of the final rules;
  • Ensuring appropriate resources and staffing to meet the increased workload required under amended TSCA;
  • Need for development of internal guidance documents to ensure consistency in EPA’s approaches;
  • Ensuring that new chemical review is efficient and predictable, and
  • Attempting to move forward with a major reorganization of the Office of Pollution Prevention and Toxics.

More information is available in our memorandum.


 

By Lynn L. Bergeson and Margaret R. Graham, M.S.

On April 26, 2019, the U.S. Court of Appeals for the D.C. Circuit (D.C. Circuit) issued its order on petition for review of the U.S. Environmental Protection Agency’s (EPA) final rule on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements (82 Fed. Reg. 37520 (Aug. 11, 2017)), which denied the petition for review on all but one claim.  Petitioner Environmental Defense Fund (EDF) challenged five distinct features of the Inventory final rule:  (i) EPA’s exclusion of substantiation questions regarding reverse engineering; (ii) the final rule’s criteria for “maintaining” a confidentiality claim; (iii) EPA’s choice not to incorporate certain regulatory requirements into the final rule; (iv) EPA’s failure to implement the Act’s “unique identifier” requirements in this rulemaking; and (v) the final rule’s exemption of exported chemicals from its notification requirements. 

The D.C. Circuit’s order states that only the first claim succeeds past the standard of review required under both the Administrative Procedure Act (APA) and TSCA, however; specifically, EPA acted arbitrarily and capriciously via its “omission of any inquiry into a chemical identity’s susceptibility to reverse engineering [which] effectively excised a statutorily required criterion from the substantiation process.”  Even though EPA included several substantiation questions to address reverse engineering in the proposed rule, EPA did not include any “substantiation questions related to the requirement that a substance’s chemical identity not be susceptible to reverse engineering” and declined altogether to “‘secure answers’ substantiating a company’s ‘assertion’ that its chemical product cannot be reverse engineered” in the final rule.  The court states that this error was “fatal” and remands this issue back to EPA for EPA to “address its arbitrary elimination of substantiation questions regarding reverse engineering.”

Regarding the other four claims that it denied, EPA made the following statements:

  1. “EPA acted well within its discretion in concluding that, as part of the Inventory update, any manufacturer or processor of a chemical substance can file a claim to maintain the chemical substance’s confidentiality”;
  2. “There is nothing facially troubling about the failure to copy every relevant statutory obligation into the regulation”;
  3. “Agencies need not address all regulatory obligations ‘in one fell swoop’ … nothing in [TSCA] requires the EPA to develop and implement the unique identifier system alongside its Inventory review process”; and
  4. “EPA’s decision [to exclude export-only chemicals from the final rule’s requirement that chemical companies notify EPA of chemical substances being manufactured or processed] reflected a reasonable interpretation of [TSCA].”

 

By Lynn L. Bergeson, Kathleen M. Roberts, and Carla N. Hutton

On April 25, 2019, the U.S. Environmental Protection Agency (EPA) issued a proposed rule that would amend the Toxic Substances Control Act (TSCA) Section 8(a) Chemical Data Reporting (CDR) requirements and the TSCA Section 8(a) size standards for small manufacturers.  84 Fed. Reg. 17692.  The current CDR rule requires manufacturers (including importers) of certain chemical substances listed on the TSCA Chemical Substance Inventory (TSCA Inventory) to report data on chemical manufacturing, processing, and use every four years.  EPA is proposing several changes to the CDR rule to make regulatory updates to align with new statutory requirements of TSCA, improve the CDR data collected as necessary to support the implementation of TSCA, and potentially reduce the burden for certain CDR reporters.  Proposed updates to the definition for small manufacturers, including a new definition for small governments, are being made in accordance with TSCA Section 8(a)(3)(C) and impact certain reporting and recordkeeping requirements for TSCA Section 8(a) rules, including CDR.  EPA states that the definitions may reduce the burden on chemical manufacturers by increasing the number of manufacturers considered small.  Overall, according to EPA, the regulatory modifications may better address EPA and public information needs by providing additional information that is currently not collected; improve the usability and reliability of the reported data; and ensure that data are available in a timely manner.  Comments are due by June 24, 2019.  More information on the proposed rule is available in our full memorandum.


 

By Lynn L. Bergeson, Charles M. Auer, Richard E. Engler, Ph.D., and Carla N. Hutton

On April 23, 2019, the U.S. Environmental Protection Agency (EPA) issued a proposed rule regarding its plan to review certain confidential business information (CBI) claims to protect the specific chemical identities of substances on the confidential portion of the Toxic Substances Control Act (TSCA) Inventory.  84 Fed. Reg. 16826.  The CBI claims that would be reviewed under this plan are those that were asserted on Notice of Activity (NOA) Form A’s filed in accordance with the requirements in the Active-Inactive rule.  Comments are due June 24, 2019See the full memorandum for more information on the proposed rule. 


 

By Lynn L. Bergeson and Margaret R. Graham, M.S.

On April 11, 2019, the U.S. Environmental Protection Agency (EPA) announced that it was partnering with the Physicians Committee for Responsible Medicine (PCRM) and the People for the Ethical Treatment of Animals (PETA) International Science Consortium to host a public webinar related to meeting the goal of reducing, refining, or replacing vertebrate animal testing as stipulated in the Frank R. Lautenberg Chemical Safety for the 21st Century Act that amended the Toxic Substances Control Act (TSCA), specifically New Approaches for Respiratory Sensitization, set for April 24, 2019, at 10:00 a.m. (EDT)Registration is required.  The speakers are Steve Enoch, Ph.D., Liverpool John Moores University, who will be presenting “Chemistry-based Approaches for Identifying Respiratory Sensitizers”; and Arno Gutleb, Ph.D., Luxembourg Institute of Science and Technology, who will be presenting “In Vitro Models to Identify Respiratory Sensitizers.”

The two other webinars in this Webinar Series on the Use of New Approach Methodologies (NAM) in Risk Assessment already took place; the first one was Skin Sensitization Testing and the second one was MPPD and CFD Modeling to Predict Dosimetry of Inhaled Substances.  EPA states that these webinars on the use of New Approach Methodologies (NAMs) in Risk Assessment are part of EPA meeting commitments identified in EPA’s Strategic Plan to Promote the Development and Implementation of Alternative Test Methods, required by amended TSCA.


 

By Lynn L. Bergeson and Margaret R. Graham, M.S.

On March 11, 2019, the U.S. Environmental Protection Agency (EPA) released its Fiscal Year (FY) 2020 Justification of Appropriation Estimates for the Committee on Appropriations.  EPA’s budget request reduces the overall budget by $2.76 billion (31 percent), to $6.068 billion, but requests $66.418 million to support its Chemical Risk Review and Reduction (CRRR) program, an increase of $5.313 million. 

EPA zeros out the other programs under Toxics Risk Review and Prevention, however, including the Endocrine Disruptor Screening Program (EDSP), the Pollution Prevention (P2) program, and the Lead Risk Reduction Program.  EPA states that it will “absorb the remaining functions [of the EDSP] within the Pesticides Program using the currently available tiered testing battery,”  “continue to meet core statutory requirements under the Pollution Prevention Act of 1990 in other programs,” and that “lead paint certifications will continue under the [CRRR] Program.”

In its budget, EPA states that “the resources requested by EPA will support continued implementation of the amendments to [the Toxic Substances Control Act (TSCA)], with emphasis on the critical mandates and timelines applicable to pre-market review of new chemicals, chemical risk evaluation and management, review and determinations on incoming [confidential business information (CBI)] claims, and other statutory priorities.”  EPA anticipates an increased workload to support these efforts in FY 2020 as the Agency reaches statutory deadlines to conclude the first ten risk evaluations for existing chemicals, and initiate risk management regulatory actions as necessary.  As part of this work load, EPA lists its primary TSCA implementation activities under Sections 4, 5, 6, 14; its other TSCA mandates and activities under Section 8; and the information technology systems being developed in support of TSCA implementation, all of which are extensive.


 
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