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First 40 Candidate chemical substances for Prioritization under TSCA introduced

Friday, March 29, 2019

EPA has taken an extra step in enforcing the poisonous materials handle Act (TSCA). It has introduced the first set of 20 candidate chemical compounds for possible designation as excessive-priority resources and the first (perhaps simplest) set of 20 candidate chemicals for possible designation as low-precedence elements. eighty four Fed. Reg. 10491 (March 21, 2019). 

This indicators the beginning of EPA’s prioritization process to examine no matter if the 20 candidates for designation as excessive-priority components may additionally current an unreasonable possibility of damage to fitness or the atmosphere beneath the circumstances of use. If EPA makes that choice on the conclusion of this prioritization manner, EPA will designate those elements as high priorities for possibility evaluations and will start those chance evaluations. even so, where EPA has ample counsel, it'll designate a chemical substance that does not meet this regular as a low-precedence substance and take no extra motion. 

EPA is accepting initial comments on these forty candidate chemical compounds unless June 19, 2019. beneath area 6(b)(2)(B), EPA must post closing excessive- and low-priority designations with the aid of December 22, 2019. 

First 20 Candidate chemical substances for Designation as excessive-precedence elements

EPA recognized 7 chlorinated solvents:

  • p-Dichlorobenzene, CAS No. 106-forty six-7

  • 1,2-Dichloroethane, CAS No. 107-06-2

  • trans-1,2- Dichloroethylene, CAS No. 156-60-5

  • o-Dichlorobenzene, CAS No. 95-50-1

  • 1,1,2-Trichloroethane, CAS No. 79-00-5

  • 1,2-Dichloropropane, CAS No. 78-87-5

  • 1,1-Dichloroethane, CAS No. seventy five-34-three

  • It identified 5 phthalates:

  • Dibutyl phthalate (DBP) (1,2-Benzene- dicarboxylic acid, 1,2- dibutyl ester), CAS No. 84-74-2

  • Butyl benzyl phthalate (BBP) - 1,2-Benzene- dicarboxylic acid, 1- butyl 2(phenylmethyl) ester, CAS No. 85-sixty eight-7

  • Di-ethylhexyl phthalate (DEHP) - (1,2-Benzene- dicarboxylic acid, 1,2- bis(2-ethylhexyl) ester), CAS No. 117-81-7

  • Di-isobutyl phthalate (DIBP) - (1,2-Benzene- dicarboxylic acid, 1,2- bis-(2methylpropyl) ester), CAS No. 84-69-5

  • Dicyclohexyl phthalate, CAS No. eighty four-sixty one-7

  • It identified three halogenated flame retardants:

  • four,4’-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA), CAS No. 79-ninety four-7

  • Tris(2-chloroethyl) phosphate (TCEP), CAS No. a hundred and fifteen-96-8

  • Phosphoric acid, triphenyl ester (TPP), CAS No. 115-86-6

  • finally, it identified 5 other elements:

  • Ethylene dibromide, CAS No. 106-ninety three-4 (a chemical intermediate)

  • 1,three-Butadiene, CAS No. 106-99-0 (a monomer, regulated with the aid of OSHA as a carcinogen, 29 C.F.R. § 1910.1051)

  • 1,three,four,6,7,8-Hexahydro-four,6,6,7,8,eight-hexamethylcyclopenta [g]-2-benzopyran (HHCB), CAS No. 1222-05-2 (a fragrance chemical)

  • Formaldehyde, CAS No. 50-00-0 (a chemical intermediate, the discipline of a controversial IRIS evaluation, and controlled through OSHA as a carcinogen, 29 C.F.R. § 1910.1048)

  • Phthalic anhydride, CAS No. eighty five-forty four-9 (a phthalate precursor)

  • In deciding upon candidate chemical compounds for designation as excessive-precedence materials, EPA regarded to its 2014 TSCA Work Plan for Chemical Assessments. area 6(b)(2)(D) requires EPA to give choice to chemical components that are listed on the 2014 TSCA Work Plan that both: (a) have a persistence and bioaccumulation score of 3; or (b) that are customary human cancer causing agents and have high acute and persistent toxicity. EPA included the hazard, exposure, and persistence/bioaccumulation scores from the 2014 TSCA Work Plan for every candidate chemical in the Federal Register note as a groundwork for their choice. EPA also regarded no matter if chemical elements have been similar and even if there's latest EPA work or different publically-available risk assessments on these chemical elements. 

    among the many chemical compounds on the 2014 TSCA Work Plan that meet those alternative criteria however have been no longer blanketed among the many 20 candidates for designation as excessive precedence are:

  • Arsenic and arsenic compounds (acute and chronic toxicity from inhalation exposures)

  • Cadmium and cadmium compounds (acute and persistent toxicity from inhalation exposures)

  • Chromium and chromium compounds (acute and continual toxicity from inhalation exposures)

  • Cobalt and cobalt compounds (Persistence & Bioaccumulation rating of 3)

  • Lead and lead compounds (Persistence & Bioaccumulation ranking of 3)

  • long-chain chlorinated paraffins (C18-20) (Persistence & Bioaccumulation score of three)

  • Medium-chain chlorinated paraffins (C14-17) (Persistence & Bioaccumulation score of three)

  • Molybdenum and molybdenum compounds (acute and continual toxicity from inhalation exposures)

  • Nickel and nickel compounds (acute and chronic toxicity from inhalation exposures)

  • Octamethylcyclotetrasiloxane (D4), CAS No. 556-sixty seven-2 (Persistence & Bioaccumulation ranking of 3)

  • Pigment Yellow eighty three (Butanamide, 2,2’-[(3,3’-dichloro[1,1’-biphenyl]-four,4’-diyl)biz(azo)bis[N-(4-chloro-2, 5- dimethoxyphenyl)-3-oxo-), CAS No. 5565-15-7 (Persistence & Bioaccumulation ranking of 3)

  • As a part of the prioritization manner, EPA is required to agree with, with out consideration of prices or nonrisk components, even if a candidate chemical may also present an unreasonable possibility of harm to fitness or the ambiance because of a potential hazard and a possible route of publicity under the situations of use. EPA must designate a candidate chemical as a excessive-precedence substance if it concludes that it will probably current an unreasonable possibility. as soon as EPA designates a chemical substance as a high-priority substance, it have to provoke a chance assessment for such chemical substance. See TSCA section 6(b)(1)(B)(i); 40 C.F.R. half 702, Subpart A.

    EPA’s prioritization designation isn't a possibility finding. Designating a chemical substance as a excessive-priority substance does not suggest that the substance presents an unreasonable possibility, however quite that the chemical substance may current an unreasonable risk and for this reason warrants a possibility contrast. forty C.F.R. § 702.17.

    First 20 Candidate chemical substances for Designation as Low-precedence components

    EPA recognized the following listing of candidate chemicals for designation as low-precedence elements:

  • 1-Butanol, three-methoxy-, 1-acetate, CAS No. 4435-fifty three-4

  • D-gluco-Heptonic acid, sodium salt (1:1), (2.xi.)-, CAS No. 3113-65-5

  • D-Gluconic acid, CAS No. 526-95-four

  • D-Gluconic acid, calcium salt (2:1), CAS No. 299-28-5

  • D-Gluconic acid, .delta.-lactone, CAS No. ninety-eighty-2

  • D-Gluconic acid, potassium salt (1:1), CAS No. 299-27-4

  • D-Gluconic acid, sodium salt (1:1), CAS No. 527-07-1

  • Decanedioic acid, 1,10-dibutyl ester, CAS No. 109-forty three-3

  • 1-Docosanol, CAS No. 661-19-8

  • 1-Eicosanol, CAS No. 629-ninety six-9

  • 1,2-Hexanediol, CAS No. 6920-22-5

  • 1-Octadecanol, CAS No. 112-92-5

  • Propanol, [2-(2-butoxymethylethoxy)methylethoxy]-, CAS No. 55934-93-5

  • Propanedioic acid, 1,3-diethyl ester, CAS No. a hundred and five-53-3

  • Propanedioic acid, 1,3-dimethyl ester, CAS No. 108-fifty nine-8

  • Propanol, 1(or 2)-(2-methoxymethylethoxy)-, acetate, CAS No. 88917-22-0

  • Propanol, [(1-methyl-1,2-ethanediyl)bis(oxy)]bis-, CAS No. 24800-forty four-0

  • 2-Propanol, 1,1’-oxybis-, CAS No. a hundred and ten-98-5

  • Propanol, oxybis-, CAS No. 25265-seventy one-eight

  • Tetracosane, 2,6,10,15,19,23-hexamethyl-, CAS No. 111-10-three
  • EPA defined that the option of candidate chemical compounds for designation as low-precedence supplies changed into in response to low hazard, because the initial criterion. EPA additionally checked out no matter if these chemical elements have been evaluated by way of EPA or different governmental their bodies from OECD member states. EPA relied on its Safer chemical substances elements checklist and Chemical assessment administration application (ChAMP) as sources of chemical resources that have already been evaluated to a few degree.

    below section 6(b)(1)(B)(ii), EPA will designate a chemical substance as a low-priority substance if EPA concludes, without consideration of costs or other nonrisk components, that the substance doesn't meet the ordinary for designating a chemical substance as a excessive-priority substance (i.e., that the chemical substance may current an unreasonable risk of injury to fitness or the ambiance on account of a possible hazard and a potential route of exposure below the conditions of use). principally, EPA should have enough assistance upon which to make this resolution.

    If EPA designates a chemical substance as a low-precedence substance, EPA’s assessment of the chemical substance ends. although, EPA can reevaluate a low-precedence substance if new information concerning the chemical substance comes to gentle that calls into question its designation. section 6(b)(three)(B); 40 C.F.R. § 702.13.

    If EPA finds that the chemical substance may additionally latest an unreasonable risk or the agency does not have ample tips to make this choice, EPA have to designate the candidate chemical as a excessive-precedence substance and conduct a possibility comparison on the chemical substance. hence, it's vital that manufacturers and processors of those candidate chemical substances deliver information to EPA to make sure that EPA has ample counsel upon which to base its resolution.

    The Prioritization procedure and next Steps

    section 6(b)(2)(B) requires EPA to ensure that risk critiques are being performed on the first 20 high-precedence resources no later than December 22, 2019 (i.e., three and a half years after enactment of the Frank R. Lautenberg Chemical security for the twenty first Century Act). EPA need to additionally designate at the least 20 low-precedence resources by means of December 22, 2019.

    EPA is proposing a ninety-day comment duration for stakeholders to post information regarding these forty candidate chemical compounds. corporations with an pastime in any of the candidate chemical substances should believe submitting comments and tips to EPA. 

    all over the prioritization method, EPA must behavior a risk-based mostly screening of the candidate chemical compounds that considers their hazard and publicity advantage, situations of use or tremendous changes in conditions of use, and manufacturing or processing volumes or huge alterations in such extent. EPA will then put up a proposed designation for each and every candidate chemical as both a high- or low-priority substance. This must set forth the advice, evaluation, and foundation for EPA’s proposed designation. EPA should deliver 90 days for interested stakeholders to comment on proposed designations. as soon as EPA has considered comments on proposed designations, EPA will designate each chemical substance as a excessive- or low- priority, and start risk critiques for all high-precedence supplies.

    EPA must difficulty proposed priority designations no later than September 22, 2019, so as to meet its December 22, 2019, statutory cut-off date to designate 20 excessive- and low-precedence materials, but will seemingly need to do so neatly before this deadline to accept as true with feedback obtained on the proposed designations. 


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