EPA First Webinar on Strategy for Reviewing MMOs CAMs

On November 17, 2022, the U.S. Environmental Safety Company (EPA) held the primary of a two-part webinar collection on EPA’s new standardized course of to evaluate threat and apply mitigation measures, as acceptable, for blended metallic oxides (MMO), together with new and modified cathode lively supplies (CAM). Below the Poisonous Substances Management Act (TSCA), EPA opinions new chemical substances earlier than they enter {the marketplace} to make sure they don’t current unreasonable threat to human well being or the surroundings. In October 2022, EPA introduced an “modern effort” to assist make its evaluate of recent MMOs, together with new and modified CAMs, extra environment friendly. Extra data on the initiative is out there in our October 11, 2022, memorandum.

The webinar slides state that the aim of the webinar was to:

  • Guarantee readability to the regulated group about TSCA Part 5 regulation of MMOs, together with CAMs, as acknowledged within the October 2022 compliance advisory;

  • Present an introduction to EPA’s initiative to standardize new chemical opinions for MMOs, together with CAMs; and

  • Make sure the regulated group understands the steps for navigating the brand new submission course of, together with in relation to the TSCA Stock, nomenclature, and the bona fide course of.

The second webinar, at the moment focused for early winter 2023, will go into higher element on the standardized threat evaluation method; current new options, together with a threat calculator and choice tree; and current varied case situations.

In line with EPA’s slides, MMOs have quite a few electrical functions in batteries, together with lithium-ion batteries utilized in electrical automobiles and renewable power storage, sensors, biosensors, superconductors, and semiconductors, in addition to use as catalysts, adsorbents, and in ceramics. The slides notice {that a} vital part of battery know-how is the uncooked materials that makes up the cathode of the battery, known as the CAM. The slides state that as a chemical uncooked materials, a CAM “should be compliant with TSCA to be commercially manufactured (together with imported) in the USA and processed for functions of making the cathode part of a battery.”

EPA issued the October 2022 compliance advisory to affirm that CAMs and modified CAMs that aren’t on the TSCA Stock are chemical substances topic to TSCA new chemical necessities and have been topic to such necessities since 1976. EPA additionally reaffirmed that changed CAMs will not be thought-about mixtures and are chemical substances topic to TSCA. In line with the slides, EPA has reviewed “lots of” of TSCA Part 5 submissions for MMOs, together with CAMs and modified CAMs, beneath the TSCA New Chemical compounds Program for the reason that Nineteen Eighties, lots of which had been subsequently listed on the TSCA Stock. The slides state that this means that “it’s already broadly understood inside trade that the doubtless limitless variety of deliberately generated metallic oxide substances that might be synthesized from a specific set of atoms will not be all equal to a single combination of straightforward, particular person metallic oxides.”

In line with the slides, EPA has “lengthy interpreted” the exemption beneath 40 C.F.R. Part 720.30(h)(7) (the “h7 exemption”) as restricted to a chemical substance that:

  • Is fashioned from a chemical response that entails using a chemical substance of the sort described in 40 C.F.R. Part 720.30(h)(7);

  • Doesn’t perform to offer a number of main properties that may decide using the product or product combination distributed in commerce; and

  • Just isn’t itself the one supposed for distribution in commerce as a chemical substance per se (though it might be a part of the product, product combination, or formulation, it has no business goal separate from the product, product combination, or formulation of which it’s a half).

The slides state that with respect to a modified CAM, “dopants are deliberately added to a base CAM to change into a part of the bottom CAM, ensuing within the modified CAM.” The modified CAM “subsequently is just not fashioned by the way and is the chemical substance that’s manufactured for distribution in commerce in its personal proper, as a chemical substance per se.”

EPA decided that MMOs/CAMs are amenable to a standardized method, permitting a number of submissions to be processed constantly. For a brand new chemical, EPA should make one among 5 determinations relying on its evaluate of the discover. In line with EPA, the dedication that has traditionally been made for brand new chemical MMOs has typically been that there’s “[i‌]nsufficient data to allow a reasoned analysis & might current an unreasonable threat.” Upon a “might current” discovering, EPA will take motion beneath TSCA Part 5(e). Actions might embrace:

  • A TSCA Part 5(e) order — usually a consent order;

  • Commercialization allowed with restrictions; and

  • Testing. If required, testing is mostly due at a specified level after commercialization of the chemical substance. If dangers can’t be mitigated, then testing is required earlier than commercialization of the chemical substance.

The slides checklist the next potential consent order phrases for MMOs beneath the standardized course of:

The webinar included a evaluate of the significance of the TSCA Stock for MMOs. If an MMO is listed on the TSCA Stock, then a premanufacture discover (PMN) is just not essential. As a result of roughly a fifth of all chemical compounds on the TSCA Stock are claimed as confidential enterprise data (CBI), corporations might have to submit a bona fide discover to find out if their MMOs are new chemical compounds.

Through the query and reply portion of the webinar, EPA was requested what data an organization ought to ask its provider to be sure that the provider understands the TSCA necessities. Jim Alwood, EPA, responded that an organization ought to ask the provider what the chemical is, what’s its identification, and whether or not it’s on the TSCA Stock. If the provider responds that it’s a combination of metals, then it’s as much as the corporate learn how to reply. Alwood instructed that if an organization has questions, it ought to contact EPA. A participant requested for particulars relating to issues that may result in water restrictions in a consent order. Alwood acknowledged that the restrictions rely upon what knowledge can be found. One other participant requested if EPA will construct particular databases. Keith Salazar, EPA, acknowledged that EPA doesn’t intend to construct particular databases. Numerous data is already accessible on these metals, it’s only a matter of gathering the info into one place so that there’s a standardized method. Particulars on this would be the focus of the following webinar. Salazar famous that the brand new choice tree won’t apply to nano-sized MMOs, and details about why will likely be supplied within the second webinar.

Commentary

On this webinar, the primary in a collection about EPA’s method to CAMs and different MMOs, EPA focuses on its interpretation of its combination steerage (Merchandise Containing Two or Extra Substances: Formulated and Statutory Mixtures), particularly, EPA’s interpretation of Part III.B., its Statutory Combination Steering (SMG). Producers and EPA have engaged for many years in discussions concerning the MMO part of EPA’s SMG. Through the years, EPA has taken motion (e.g., its notification about activated phosphors in 2010 (75 Fed. Reg. 8266)) and allowed producers to submit PMNs for phosphors that had been manufactured beneath the SMG with out looking for penalty, EPA has not accomplished so for different MMOs. EPA has issued quite a few statements, together with its assertion in October 2022 that it doesn’t view MMOs as statutory mixtures regardless of the actual fact that there’s a part of the SMG that particularly discusses MMOs as being a kind of product that could be thought-about a statutory combination (see Instance 10 of the SMG). EPA has repeatedly, and does so once more on this webinar, pointed to the truth that producers have submitted PMNs for MMOs through the years as conclusive proof that MMOs will not be mixtures. One producer’s business option to not avail itself of an exemption doesn’t get rid of one other producer’s capacity to rely on that very same exemption.

As is effectively established, suppliers and clients typically want to have exempt substances (e.g., exempt polymers) listed on the TSCA Stock for their very own business causes, fairly than counting on the relevant exemption and electing to submit PMNs. Simply because one producer lists an exempt polymer on the Stock doesn’t negate one other’s capacity to rely on the polymer exemption. In our view, the identical is true for substances that meet the statutory combination standards.

There isn’t a doubt {that a} response happens through the manufacture of MMOs, as acknowledged within the SMG. The purpose of the SMG is that there are specific instances through which a producer might think about the ensuing product a combination regardless of the actual fact {that a} response happens and never due to it. EPA has by no means rescinded that steerage, it has solely narrowed it with its notification about activated phosphors. EPA might want to rescind completely its SMG and might formally elect to take action, but it surely should accomplish that in an orderly manner and permit for producers which have relied on that steerage in good religion for many years time to organize and submit PMNs, as EPA did for activated phosphors.

EPA additionally notes that the “h7 exemption” doesn’t apply to MMOs, together with CAMs. We agree with this interpretation. The response that happens to type the MMO is just not a results of the product “performing as supposed” throughout its use.

The rest of the webinar pertains to establishing the chemical identification of CAMs, looking out the Stock, and the brand new chemical compounds course of — all of which is necessary data, however doesn’t apply solely to MMOs generally or CAMs particularly.

Later webinars reportedly will give attention to EPA’s categorical method to MMOs and CAMs. We applaud EPA taking class approaches every time it’s acceptable. EPA has used chemical classes for many years to make its evaluate of recent chemical compounds extra environment friendly. That method appeared to stall after the TSCA amendments had been applied in 2016 however has made a comeback with EPA’s implementation of its classes for surfactants, cationic polymers, polymers of low solubility and low toxicity, and, extra not too long ago, biofuels, and now CAMs. We hope that EPA will proceed to make use of its present classes and develop further classes in its evaluate of recent chemical compounds.

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