EPA Holds Webinar on New Chemical Risk Management Actions for Biofuels

On April 6, 2022, the U.S. Environmental Safety Company (EPA) held a webinar on “New Chemical Risk Management Actions under TSCA.” As reported in our January 24, 2022, weblog merchandise, in January 2022, EPA announced an effort to streamline the assessment of latest biobased or waste-derived chemical substances that might displace present, greater greenhouse fuel (GHG)-emitting transportation fuels. EPA states that to assist this effort, it’s providing outreach and coaching to stakeholders fascinated by biofuels. In accordance with EPA, the webinar sequence consists of reviewing necessities underneath the Poisonous Substances Management Act (TSCA), outlining the streamlined approaches for danger assessments and danger administration actions, and offering info on methods to navigate the brand new chemical substances premanufacture discover (PMN) course of.

Jim Alwood, EPA, reviewed the 5 determinations that EPA makes and the chance administration choices for every:

  • Presents an unreasonable danger of damage to well being or the surroundings: EPA should concern an order underneath TSCA Part 5(f) or a rule underneath TSCA Part 6(a) to limit or prohibit the chemical substance;

  • Inadequate info to allow a reasoned analysis and should current an unreasonable danger: As soon as EPA makes this dedication, it’s required to take motion to stop recognized dangers. EPA will concern a TSCA Part 5(e) order, usually a consent order. In accordance with Alwood, EPA often permits commercialization with restrictions. If testing is required, it’s typically due at a specified level after commercialization, but when the dangers can’t be managed, then testing may be required earlier than commercialization. Alwood acknowledged that he doesn’t suppose EPA can be requiring testing for biofuels as a result of these are properly characterised.

  • Produced in substantial portions and should moderately be anticipated to enter the surroundings in substantial portions or there could also be important or substantial human publicity: EPA has the identical kind of danger administration choices (issuing a TSCA Part 5(e) order, usually a consent order; permitting commercialization with restrictions; and testing, if required, typically due at a specified level after commercialization).

  • Data is inadequate to allow a reasoned analysis of the chance: Alwood famous that this can be a new dedication underneath the Frank R. Lautenberg Chemical Security for the twenty first Century Act (Lautenberg Act). Alwood acknowledged that he doesn’t anticipate EPA to make this dedication for many biofuels. EPA is required to take motion pending the event of data and usually does so via a TSCA Part 5(e) consent order. In accordance with Alwood, testing is usually required earlier than commercialization.

  • Not more likely to current an unreasonable danger: In accordance with Alwood, EPA will most likely not make this dedication typically for biofuels as a result of most biofuels have recognized dangers. Commercialization can start instantly after the dedication is made.

Alwood reviewed important new use guidelines (SNUR), which establish a possible new use of a chemical as a “significant new use.” If a chemical is the topic of a SNUR, anybody meaning to manufacture, import, and/or course of the chemical for a major new use should notify EPA no less than 90 days earlier than commencing that new use by submitting a major new use discover (SNUN). EPA should assessment the SNUN and make one of many 5 determinations described above. Alwood careworn {that a} SNUR is a not a ban or restriction on using a chemical, however acknowledged that it might not really feel that manner and should seem to be a restriction. EPA makes use of SNURs to look at new makes use of the place the makes use of could create issues by altering the publicity of individuals or the surroundings to these chemical substances.

Alwood acknowledged that EPA doesn’t have to make a danger dedication to concern a SNUR; it simply has to find out that the use within the PMN can change. TSCA requires EPA to think about:

  • The projected quantity of producing and processing of a chemical substance;

  • The extent to which a use adjustments the sort and/or type of publicity of people and/or the surroundings to a chemical substance;

  • The extent to which a use adjustments the magnitude and period of publicity of people and/or the surroundings to a chemical substance; and

  • The moderately anticipated method and strategies of producing, processing, distribution in commerce, and disposal of a chemical substance.

Alwood acknowledged that TSCA consent orders apply solely to the PMN submitter, and a SNUR extends the restrictions within the consent order to different producers, importers, and processors to make sure a stage enjoying area. Underneath the Lautenberg Act, EPA should contemplate promulgating a SNUR after it points a TSCA Part 5(e) consent order. If EPA doesn’t concern a SNUR, it should clarify why it has not. EPA will embrace the consent order exemptions and exclusions within the SNUR. In accordance with Alwood, EPA receives solely ten to fifteen SNURs a yr, not many.

Alwood famous that since his February 23, 2022, presentation, EPA has issued just a few consent orders for biofuels. EPA made a “may present an unreasonable risk” dedication and can concern a SNUR. Examples of typical consent order situations embrace:

  • Use solely as a gas or different use recognized within the PMN;

  • If there’s potential publicity to BTEX chemical substances (benzene, toluene, ethylbenzene, and xylene), then the consent order will reference following the Occupational Security and Well being Administration (OSHA) necessities for monitoring and assembly these publicity limits;

  • The consent order may also reference complying with different relevant EPA and OSHA laws for dealing with, storing, and disposal of gasoline and/or petroleum merchandise; and

  • If the biofuel is imported, the consent order will restrict use to import as a gas.

Alwood famous that for most biofuel consent orders, EPA can have dermal safety necessities.

Throughout the query and reply session, Alwood acknowledged that EPA has completed the assessment course of for two biofuel PMNs, and there are extra within the pipeline. If the TSCA hotline can not reply a query regarding a PMN, it is going to refer the caller to the New Chemical compounds Program. When requested how somebody beside the PMN submitter will know what makes use of EPA has evaluated, Alwood responded that if the PMN submitter has not claimed the use as confidential, it is going to embrace it within the Federal Register discover. In accordance with Alwood, EPA tries to do its finest to ensure the necessities that everybody has to comply with are usually not confidential. Alwood acquired a query asking how processors know what necessities apply to them when utilizing the chemical as supposed. Alwood acknowledged that there’s language in consent orders requiring the PMN submitter to tell clients in regards to the necessities within the consent order. SNUR laws require firms to inform clients in regards to the existence of a SNUR. Alwood famous that whereas there’s a biofuels assessment staff, stakeholders could have heard that EPA is having hassle assembly the 90-day assessment interval for PMNs for any chemical substance. EPA determines which makes use of of a chemical are foreseeable via literature searches, patent searches, and looking its PMN database for related PMNs that it has reviewed. Though there is no such thing as a timeframe through which EPA should concern a SNUR after signing a TSCA Part 5(e) consent order, Alwood commented that it’s in EPA’s curiosity to concern the SNUR as rapidly as attainable. Underneath the Lautenberg Act, EPA doesn’t contemplate the substitute advantages of a PMN substance, and as a substitute evaluates a brand new chemical substance, together with a biofuel, solely on its situations of use. In accordance with Alwood, EPA can contemplate substitute advantages on the danger administration stage.


EPA is to be recommended for presenting a well-organized and helpful webinar. EPA can also be to be recommended for creating an progressive program designed to streamline the assessment of latest biobased or waste-derived chemical substances that might displace present, greater GHG-emitting transportation fuels. Stakeholders within the biofuels house are urged to avail themselves of EPA’s outreach and coaching efforts.

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