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 Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) released on February 21, 2020, the draft risk evaluation for trichloroethylene (TCE), “a chemical used as a solvent and an intermediate for refrigerant manufacture in industrial and commercial processes, and with limited consumers uses like as a spot cleaner in dry cleaning facilities.”  EPA assessed 54 conditions of use of TCE, and the draft risk evaluation includes the following findings:

  • EPA did not find risk to the environment; and
  • EPA’s draft risk evaluation preliminarily found unreasonable risk associated with dermal and inhalation exposure for workers, occupational non-users, consumers, and bystanders.

EPA notes that the draft risk evaluation and the initial risk determinations are not a final action.  The draft represents EPA’s preliminary conclusions, findings, and determinations on TCE and will be peer reviewed by independent scientific experts.  According to EPA, the draft risk evaluation includes input from other EPA offices, as well as other federal agencies.
 
The TSCA Science Advisory Committee on Chemicals (SACC) will meet on March 24-26, 2020, to peer review the draft risk evaluation of TCE’s conditions of use.  EPA asks that comments on the draft risk evaluation be submitted by March 18, 2020, to allow SACC time to review and consider them before the peer review meeting.  EPA states that comments received after March 18, 2020, and prior to the end of the oral public comment period during the meeting will still be provided to SACC for their consideration.  EPA will hold a preparatory virtual meeting on March 3, 2020, for SACC and the public to comment on the clarity and scope of the draft charge questions for the March 24-26, 2020, meeting.
 
EPA will publish a notice in the Federal Register announcing the availability of the draft risk evaluation and beginning a 60-day comment period.  More information on the draft risk evaluation will be available in a forthcoming memorandum that will be posted on our website.

 

Try our new TSCA Tutor™ online e-training platform, offering expert, efficient, essential TSCA training.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) released on February 20, 2020, a proposed supplemental significant new use rule (SNUR) issued under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances to make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of surface coatings on articles.  Under the proposed supplemental SNUR, this subset of LCPFAC chemical substances also includes the salts and precursors of these perfluorinated carboxylates.  The supplemental proposal would require importers to notify EPA at least 90 days before commencing the import of these chemical substances in certain articles for the significant new use described in the proposed SNUR.  The required significant new use notification would initiate EPA’s evaluation of the conditions of use associated with the intended significant new use.  Manufacturing (including import) or processing for the significant new use would be prohibited from commencing until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination.  EPA posted a pre-publication version of the proposed supplemental SNUR on its website.  Once EPA publishes the proposed supplemental SNUR in the Federal Register, a 45-day comment period will begin.
 
In a January 21, 2015, proposed LCPFAC SNUR, EPA proposed to require notification of significant new uses from persons who import a subset of LCPFAC chemical substances as part of all articles.  The supplemental proposal narrows the category of articles to which the proposed LCPFAC SNUR would apply to those where the subset of LCPFAC chemicals are part of a surface coating.  EPA states that it is proposing this action to be responsive to the article consideration provision at Section 5(a)(5), added with the passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which states that articles can be subject to notification requirements as a significant new use provided that EPA makes an affirmative finding in a rule that the reasonable potential for exposure to a chemical from an article or category of articles justifies notification.
 
More information on the supplemental proposal will be available in a forthcoming memorandum that will be posted on our website.

 

Try our new TSCA Tutor™ online e-training platform, offering expert, efficient, essential TSCA training.


 

By Lynn L. Bergeson and Carla N. Hutton

On February 20, 2020, the U.S. Environmental Protection Agency (EPA) published a list of 20 chemical substances identified as low-priority for risk evaluation under the amended Toxic Substances Control Act (TSCA), completing another TSCA requirement.  EPA notes that a final designation as “low-priority” means that risk evaluations are not warranted at this time.  EPA states that it considered reasonably available information for each chemical substance under its conditions of use as specified in TSCA.  Additionally, according to EPA, these 20 low-priority chemicals are on its Safer Chemical Ingredients List, which includes chemicals that meet strict criteria for both human health and the environment.  The 20 chemicals are

  1. 1-Butanol, 3-methoxy-, 1-acetate;
  2. D-gluco-Heptonic acid, sodium salt (1:1), (2.xi.)-;
  3. D-Gluconic acid;
  4. D-Gluconic acid, calcium salt (2:1);
  5. D-Gluconic acid, .delta.-lactone;
  6. D-Gluconic acid, potassium salt (1:1);
  7. D-Gluconic acid, sodium salt (1:1);
  8. Decanedioic acid, 1,10-dibutyl ester;
  9. 1-Docosanol;
  10. 1-Eicosanol;
  11. 1,2-Hexanediol;
  12. 1-Octadecanol;
  13. Propanol, [2-(2-butoxymethylethoxy)methylethoxy]-;
  14. Propanedioic acid, 1,3-diethyl ester;
  15. Propanedioic acid, 1,3-dimethyl ester;
  16. Propanol, 1(or 2)-(2-methoxymethylethoxy)-, acetate;
  17. Propanol, [(1-methyl-1,2-ethanediyl)bis(oxy)]bis-;
  18. 2-Propanol, 1,1'-oxybis-;
  19. Propanol, oxybis-; and
  20. Tetracosane, 2,6,10,15,19,23-hexamethyl-.

EPA has posted a pre-publication version of the Federal Register notice announcing the final designation of low-priority substances.  As reported in our December 20, 2019, blog item, in December 2019, EPA designated 20 chemicals as high-priority under TSCA, and those chemicals are now in the risk evaluation process.  More information on the final list of low-priority chemicals will be available in a forthcoming memorandum that will be posted on our website


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) released on February 19, 2020, a final rule concerning the process companies must follow to make certain confidential business information (CBI) claims and EPA’s plan for reviewing those claims.  EPA describes its final rule as creating “an efficient process” for fulfilling the CBI requirements under the Toxic Substances Control Act (TSCA) and providing clarity for affected stakeholders.  Following the procedures set forth in the final rule, EPA states that it will review CBI claims made for chemical substance identity for chemicals on the “active” portion of the TSCA Inventory.  These procedures and requirements are intended to help ensure that when a company claims the identity of a chemical as CBI, that claim meets the criteria laid out in TSCA.
 
The final rule is a follow-on to EPA’s 2017 TSCA Inventory Notification (Active-Inactive) Rule and amends certain substantiation provisions of that rule in response to a recent federal court decision.  The final rule applies to manufacturers and processors who made CBI claims for specific chemical identities for chemicals reported as “active” in response to the TSCA Inventory (Active-Inactive) Notification Rule.  The final rule describes the procedures and deadlines for substantiating these CBI claims, including provisions for supplementing certain previously filed substantiations.
 
The final rule also describes EPA’s plan to review these CBI claims for “active” chemicals, including procedures for its publication of annual review goals and results.  Manufacturers that amend, update, or file new CBI substantiations consistent with the new requirements must do so electronically via EPA’s Central Data Exchange.  According to EPA, providing this information electronically supports more efficient data transmittal, improves data quality, and minimizes respondent burden and EPA administrative costs associated with information submission and recordkeeping.
 
More information on the final rule will be available in a forthcoming memorandum that will be posted on our website.  Information on EPA’s 2017 TSCA Inventory Notification (Active-Inactive) Rule is available in our June 26, 2017, memorandum, “EPA Issues Final TSCA Framework Rules.”

 

Try our new TSCA Tutor™ online e-training platform, offering expert, efficient, essential TSCA training.

Tags: CBI, Inventory

 

By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our October 1, 2019, blog item, on September 25, 2019, the U.S. Environmental Protection Agency (EPA) submitted a proposed significant new use rule (SNUR) on long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate (PFAS) chemical substances to the Office of Management and Budget (OMB) for review.  According to OMB’s website, OMB completed its review on February 14, 2020.  EPA has not yet publicly released the proposed rule.
 
According to the item on the rulemaking in EPA’s fall 2019 Unified Agenda, EPA is developing a supplemental proposal to its 2015 proposed LCPFAC SNUR amendments.  EPA states that the supplemental proposal would make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of certain articles.  According to EPA, this supplemental proposal is necessary to be responsive to the article consideration provision in Section 5(a)(5) of the Toxic Substances Control Act (TSCA) that was added with the 2016 amendments to TSCA.  Under the provision, articles can be subject to notification requirements as a significant new use provided that EPA makes an affirmative finding in a rule that the reasonable potential for exposure to a chemical from an article or category of articles justifies notification.  Insofar as this new provision has not been used previously for chemical substances with a history of prior import in articles, EPA’s approach to and its arguments in making this required affirmative finding will be important for all stakeholders to consider carefully.

 

Try our new TSCA Tutor™ online e-training platform, offering expert, efficient, essential TSCA training.

Tags: OMB, SNUR, PFAS, LCPFAC

 

By Lynn L. Bergeson and Carla N. Hutton
 

The U.S. Environmental Protection Agency (EPA) will host a conference call on February 24, 2020, from 12:30 to 1:00 p.m. (EST) to review certain provisions of the final rule on fees for the administration of the Toxic Substances Control Act (TSCA).  In light of the recent publication of the preliminary list of manufacturers/importers subject to risk evaluation fees, as reported in our January 29, 2020, blog item, EPA states that it will give a brief overview of the fees associated with an EPA-initiated risk evaluation, the entities subject to fees, requirements for self-identification, and how fees will be divided among those identified on final lists.  The publication of the lists has inspired considerable confusion and the call is intended to address as many as possible of them.  Questions can be submitted in advance to Ryan Schmit at .(JavaScript must be enabled to view this email address).  Additional questions will be answered as time permits.  To attend, call the following number and enter the conference ID:

Call-in Number: (877) 317-0679
Conference ID: 3372249

The preliminary list of manufacturers/importers subject to risk evaluation fees is available in Docket EPA-HQ-OPPT-2019-0677.  Reference 9 from the final rule on fees, TSCA Fee Reporting Notice (Sept. 2018), is available in the docket for the final rule at https://www.regulations.gov/document?D=EPA-HQ-OPPT-2016-0401-0079.  More information about TSCA fees is available on EPA’s website at http://www.epa.gov/TSCA-fees.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) Pollution Prevention (P2) Grant Program has announced the availability of funds to provide technical assistance (e.g., information, training, tools) to businesses to encourage the development and implementation of source reduction practices.  EPA states that source reduction practices can help businesses save money by reducing resource use, expenditures, waste, and liability costs, while at the same time reducing their environmental footprint and helping to protect human health and the environment.  Applications for fiscal years (FY) 2020 and 2021 are due March 31, 2020.
 
EPA states that it anticipates awarding approximately $9.38 million in total federal pollution prevention grant funding over a two-year funding cycle ($4.69 million in FY 2020 funds and approximately $4.69 million in FY 2021 funds).  According to EPA, P2 grants are expected to be awarded in each EPA region and will be funded in the form of grants or cooperative agreements.  EPA provides the following “quick facts” for P2 grants:

  • Eligibility:  State governments, colleges, and universities (recognized as instrumentalities of the state), federally recognized tribes, and intertribal consortia;
  • Match requirement:  50 percent match; for tribal governments that place P2 grant activities into a performance partnership grant (PPG) agreement, the match for the tribe is reduced to five percent;
  • Review of applications:  Along with other requirements that are noted in the Request for Applications (RFA), applications must address one of the following statutory/regulatory criteria to merit further review:
    • Provide technical assistance and/or training to businesses/facilities about source reduction techniques to help them adopt and implement source reduction approaches and to increase the development, adoption, and market penetration of greener products and sustainable manufacturing practices; and
    • Identify, develop, document, and share P2 best management practices and innovations so this information may inform future technical assistance and these P2 approaches and outcomes may be replicated by others;
  • Range of awards:  Individual grant awards may potentially be in the range of $40,000-$500,000 for the two-year funding period (between $20,000 and $250,000 incrementally funded per year).  Some EPA regions may have lower award caps, however; and
  • Average number of grants issued: 40.

 
EPA will hold an informational webinar on February 19, 2020, from 2:00 p.m. to 3:30 p.m. (EST).


 

By Lynn L. Bergeson and Carla N. Hutton
 
The New York State Department of Environmental Conservation (NYSDEC) will hold a public meeting on February 24, 2020, at 1 p.m. (EST) in Albany, New York, “to discuss amendments to the household cleansing product rules that are being considered for adoption.”  According to NYSDEC, amendments include specifying what information must be reported about covered products and their ingredients, how information should be shared with NYSDEC for the public record, the type of studies that must be reported, and how confidential business information (CBI) should be handled.  NYSDEC states that during the meeting, it “is looking for input on disclosure of nonfunctional ingredients, issues around confidential information, and how to disclose when a product’s formulation temporarily changes, as well as other regulatory concerns.”  Registration is required to attend the meeting.  NYSDEC notes that it “will hold a formal public comment period at a later date once it officially proposes the regulations.”
 
As reported in our September 4, 2019, blog item, on August 27, 2019, the State of New York Supreme Court invalidated the Household Cleansing Product Information Disclosure Program (Disclosure Program).  Information related to NYSDEC’s prior delay of its enforcement of its Disclosure Program is available here, and general information regarding the Program and its extensive requirements for manufacturers of certain consumer cleaning products to disclose information regarding the ingredients in those products is available here.  The court found that the Disclosure Program was established in violation of the State Administrative Procedure Act (SAPA) and the New York State Constitution.  In making this finding, the court held that the Program was a “rule” as argued by Petitioners and not “guidance” for which adherence to SAPA was not required, as argued by NYSDEC.  A more detailed analysis and commentary are available in our August 30, 2019, memorandum, “NY Department of Environmental Conservation Household Cleansing Product Information Disclosure Program Ruled ‘Null and Void.’


 

By Lynn L. Bergeson and Carla N. Hutton
 
On January 24, 2020, the U.S. Environmental Protection Agency (EPA) released the draft risk evaluation of carbon tetrachloride, “a solvent primarily used in the manufacturing of chlorinated compounds and petrochemicals.”  Carbon tetrachloride is the seventh of the first ten chemicals to undergo risk evaluation under the amended Toxic Substances Control Act (TSCA).  EPA published a Federal Register notice on January 27, 2020, announcing the availability of the draft risk evaluation and beginning a 60-day comment period.  85 Fed. Reg. 4658.  The TSCA Science Advisory Committee on Chemicals (SACC) will hold a preparatory virtual meeting on February 4, 2020, to consider the scope and clarity of the draft charge questions for the peer review.  On February 25-26, 2020, SACC will hold an in-person public meeting to consider and review the draft risk evaluation.  EPA will provide comments submitted on the draft risk evaluation on or before February 19, 2020, to SACC for their consideration before the meeting.  Comments received after February 19, 2020, and prior to the oral public comment period during the meeting will be available to the SACC for their consideration during the meeting.  Comments on the draft risk evaluation are due March 27, 2020.
 
EPA states that it “reviewed 15 potential uses, all of which are associated with industrial and commercial work and are primarily associated with the manufacturing process of other chemicals.”  According to EPA, there are no consumer uses of carbon tetrachloride.  EPA made the following initial determinations on risk:

  • EPA did not find risk to the environment or workers.  For all the conditions of use included in the draft risk evaluation, EPA states that it has preliminarily found no unreasonable risks to the environment under any of the conditions of use or to workers when appropriate personal protective equipment is used; and
     
  • EPA’s draft risk evaluation preliminarily found unreasonable risks associated with chronic inhalation exposure for occupational non-users (ONU).  EPA found that ONUs -- those workers in the vicinity of carbon tetrachloride’s use but not directly working with the chemical -- could be adversely affected by carbon tetrachloride under certain conditions of use.

More information, including an insightful commentary, is available in our January 27, 2020, memorandum, “EPA Releases Draft Risk Evaluation of Carbon Tetrachloride.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on January 27, 2020, identifying the preliminary lists of manufacturers (including importers) of the 20 chemical substances that EPA designated as high-priority substances for risk evaluation and for which fees will be charged.  85 Fed. Reg. 4661.  During the comment period, manufacturers (including importers) are required to self-identify as manufacturers of a high-priority substance irrespective of whether they are included on the preliminary lists identified by EPA.  EPA states that where appropriate, entities may also avoid or reduce fee obligations by making certain certifications consistent with the final rule on fees for the administration of the Toxic Substances Control Act (TSCA).  The comment period also provides the public an opportunity to correct errors or provide comments on the preliminary lists.  According to the notice, EPA expects to publish final lists of manufacturers (including importers) subject to fees no later than concurrently with the publication of the final scope document for risk evaluations of the 20 high-priority substances.  Manufacturers (including importers) identified on the final lists will be subject to applicable fees.
 
The preliminary lists are available in Docket EPA-HQ-OPPT-2019-0677 and on EPA’s website at http://www.epa.gov/TSCA-fees.  EPA states that it developed each preliminary list “using the most up-to-date information available, including information submitted to the Agency (e.g., information submitted under TSCA section 8(a) (including the Chemical Data Reporting (CDR) Rule) and section 8(b), and to the Toxics Release Inventory (TRI)).”  According to the notice, EPA considered using other sources of information, such as publicly available information or information submitted to other agencies to which EPA has access, but EPA “concluded that data quality limitations would create more false positives than appropriate additions to the lists.”  Additionally, EPA notes that it believes the Self-Identification process, established by 40 C.F.R. Section 700.45(b)(5), will be sufficient to identify additional manufacturers (including importers), as appropriate.  To include the two most recent CDR reporting cycle data (collected every four years) and to account for annual or other typical fluctuations in manufacturing (including import), EPA states that it used six years of data submitted or available to it under CDR and TRI to create the preliminary lists (2012-2018).
 
More information on the 20 substances designated as high-priority substances is available in our December 20, 2019, memorandum, “Final List of High-Priority Chemicals Will Be Next to Undergo Risk Evaluation under TSCA.”  More information on the final TSCA fees rule is available in our September 28, 2018, memorandum, “EPA Issues Final TSCA Fees Rule.”


 
 1 2 3 >  Last ›