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
 
On March 3, 2020, the U.S. Environmental Protection Agency (EPA) published in the Federal Register 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.  85 Fed. Reg. 12479.  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.  Comments on the proposed supplemental SNUR are due April 17, 2020.  More information is available in our February 28, 2020, memorandum, “Proposed Supplemental SNUR Would Remove Exemption for LCPFAC Chemical Substances Used as Surface Coatings on Articles.”

 

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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.

 

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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.

 

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Tags: OMB, SNUR, PFAS, LCPFAC

 

On November 13, 2019, Bergeson & Campbell, P.C. (B&C®), presented “Value Chain Communications Required under TSCA Consent Orders and SNURs:  How to Formulate Them and Optimize Their Value,” a complimentary webinar for our clients and friends.  Richard E. Engler, Ph.D., Director of Chemistry, B&C, outlined the categories of legally required risk communications to value chain participants required under TSCA Consent Orders and significant new use rules (SNUR).  Lynn L. Bergeson, Managing Partner, B&C, discussed the considerable value of formulating these communications with a view toward developing a consistent and positive product narrative that resonates far beyond Toxic Substances Control Act (TSCA) compliance.  A recording of this webinar is available now.


 

By Lynn L. Bergeson, Charles M. Auer, and Carla N. Hutton
 
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.  The item on the rulemaking in EPA’s Spring 2019 Regulatory Agenda states that in 2015, EPA proposed amending the SNURs under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for LCPFAC chemical substances and for perfluorooctanoic acid (PFOA) or its salts.  80 Fed. Reg. 2885 (Jan. 21, 2015).  Specifically, EPA proposed to amend the SNUR for LCPFAC chemical substances by designating as a significant new use manufacturing (including importing) or processing of an identified subset of LCPFAC chemical substances for any use that will not be ongoing after December 31, 2015, and all other LCPFAC chemical substances for which there are currently no ongoing uses.  EPA also proposed to make inapplicable the exemption for persons who import LCPFAC chemical substances as part of articles.  In addition, EPA proposed to amend the SNUR for PFAS chemical substances that would make inapplicable the exemption for persons who import PFAS chemical substances as part of carpets.  Persons subject to these SNURs would be required to notify EPA at least 90 days before commencing such manufacture or processing.  The required notifications would initiate EPA’s evaluation of the intended use within the applicable review period.  Manufacture and processing for the significant new use would be unable to commence 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 states that it is developing a supplemental proposal for the LCPFAC SNUR amendments to 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 TSCA Section 5(a)(5) 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.


 

By Lynn L. Bergeson and Carla N. Hutton

On August 20, 2019, the U.S. Environmental Protection Agency (EPA) published in the Federal Register final significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 145 chemical substances that are the subject of premanufacture notices (PMN).  84 Fed. Reg. 43266.  According to EPA, the chemical substances are subject to orders issued by EPA pursuant to TSCA Section 5(e).  The final SNURs require persons who intend to manufacture (defined by statute to include import) or process any of the 145 chemical substances for an activity that is designated as a significant new use by the rule to notify EPA at least 90 days before commencing that activity.  The required notification initiates EPA’s evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period.  Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required by that determination.  The final SNURs will take effect October 21, 2019.

EPA notes that the final SNURs may also affect certain entities through pre-existing import certification and export notification rules under TSCA.  Chemical importers are subject to TSCA Section 13 import certification requirements.  Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA.  Importers of chemicals subject to the SNURs must certify their compliance with the SNUR requirements. Any persons who export or intend to export a chemical substance that is the subject of the SNURs on or after September 19, 2019, are subject to the export notification provisions of TSCA Section 12(b) and must comply with export notification requirements.

Tags: SNUR

 

By Lynn L. Bergeson and Carla N. Hutton
 
Section 5(g) of the Toxic Substances Control Act (TSCA) requires the U.S. Environmental Protection Agency (EPA) to publish a statement of its findings after its review of TSCA Section 5(a) notices when EPA makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment.  On August 12, 2019, EPA published a statement of its findings for June 2019.  84 Fed. Reg. 39828.  EPA notes that such statements apply to premanufacture notices (PMN), microbial commercial activity notices (MCAN), and significant new use notices (SNUN) submitted to EPA under TSCA Section 5.  In the Federal Register notice, EPA provides the following information (to the extent that such information is not claimed as confidential business information (CBI)) on the PMNs, MCANs, and SNUNs for which, during this period, EPA has made findings under TSCA Section 5(a)(3)(C) that the new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment:  EPA case number assigned to the TSCA Section 5(a) notice; chemical identity (generic name, if the specific name is claimed as CBI); and website link to EPA’s decision document describing the basis of the “not likely to present an unreasonable risk” finding made by EPA under TSCA Section 5(a)(3)(C). 


 

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

On April 5, 2019, the U.S. Environmental Protection Agency (EPA) issued a final rule that will establish final significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 13 chemical substances that are the subject of premanufacture notices (PMN).  84 Fed. Reg. 13531. The final rule is significant because the 13 chemical substances are not also subject to consent orders.  During the review, EPA identified certain reasonably foreseen conditions of use that it designated as significant new uses in the final SNURs.  The final SNURs effectively prohibit the designated new use unless a person submits a notice to EPA, EPA makes a determination, and it takes any necessary action to mitigate any identified potential risk.  The final rule will become effective on June 4, 2019.  Please see our full memorandum for more information on this final rule.


 

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

The U.S. Environmental Protection Agency (EPA) issued on October 16, 2018, a proposed rule that would establish significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 13 chemical substances that are the subject of premanufacture notices (PMN).  83 Fed. Reg. 52179.  The proposed rule is significant.  Unlike other recent SNURs (i.e., those enacted since entry into force of amended TSCA), the 13 chemical substances are not also subject to consent orders.  For this reason, the preamble contains novel language to address the new circumstances and legal issues encountered in the proposed rule.  The proposed SNURs would require persons who intend to manufacture (defined by statute to include import) or process any of the 13 chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.  The required notification will initiate EPA’s evaluation of the intended use within the applicable review period.  Persons may not commence the manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.  Comments on the proposed SNURs are due November 15, 2018.

Please see the full memorandum for more information on the proposed rule and an illuminating commentary.


 

By Lynn L. Bergeson and Carla N. Hutton

On August 27, 2018, the U.S. Environmental Protection Agency (EPA) issued two direct final rules promulgating significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA).  The first direct final rule promulgates SNURs for ten chemical substances that were the subject of premanufacture notices (PMN).  83 Fed. Reg. 43527.  The second direct final rule promulgates SNURs for 19 chemical substances that were the subject of PMNs.  83 Fed. Reg. 43538.  In each rule, EPA notes that the chemical substances are subject to consent orders issued by EPA pursuant to TSCA Section 5(e).  The direct final rules require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.  The required notification will initiate EPA’s evaluation of the intended use within the applicable review period.  Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.  Both direct final rules will be effective on October 26, 2018.  Written adverse comments on one or more of the SNURs must be received by September 26, 2018.  If EPA receives written adverse comments, on one or more of these SNURs before September 26, 2018, EPA will withdraw the relevant sections of the direct final rules before their effective date.  In addition to the direct final rules, EPA published proposed rules for both the direct final rules.  83 Fed. Reg. 43606, 83 Fed. Reg. 43607.  Comments on the proposed rules are due September 26, 2018.


 
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