Federal Register - June 29, 2021
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Source: Federal Register
Federal Register / Vol. 86, No. 122 / Tuesday, June 29, 2021 / Rules and Regulations reproductive and developmental effects, genotoxicity, neurotoxicity, immunotoxicity, endocrine effects, and other systemic toxicity; toxicokinetics absorption, distribution, metabolism, or elimination, including modelling studies, in humans or animals;
environmental effects; environmental fate; physical-chemical properties if performed as described in 40 CFR
716.50; and occupational both users and non-users, general population, consumer, bystander, and environmental exposure must be submitted. Studies showing any measurable content of the High-Priority Substance in the tested substance single substances or mixture must be reported. The composition and purity of test substances must be reported if included as part of the study. Studies previously submitted to EPA pursuant to a requirement under TSCA or of the submitters own accord and studies conducted or to be conducted pursuant to a TSCA section 4 action are exempt from the submission of lists of health and safety studies required under 40
CFR 716.35 and the submission of studies required under this rule.
10 For purposes of this paragraph, the term organohalogen flame retardant includes any substances listed in paragraphd of this section under the category Organohalogen flame retardants. For any organohalogen flame retardant, all unpublished studies on health effects including toxicity studies in vivo and in vitro on carcinogenicity, reproductive and developmental effects, genotoxicity, neurotoxicity, immunotoxicity, endocrine effects, and other systemic toxicity; toxicokinetics absorption, distribution, metabolism, or elimination, including modelling studies, in humans or animals;
environmental fate; physical-chemical properties if performed as described in 40 CFR 716.50; and occupational both users and non-users, general
population, consumer, bystander, and environmental exposure must be submitted. Studies showing any measurable content of the organohalogen flame retardant in the tested substance single substances or mixture must be reported. The composition and purity of test substances must be reported if included as part of the study. Studies previously submitted to EPA pursuant to a requirement under TSCA or of the submitters own accord and studies conducted or to be conducted pursuant to a TSCA section 4 action are exempt from the submission of lists of health and safety studies requirements under 40 CFR 716.35 and the submission of studies requirements under this rule.
3. In 716.120, amend the table in paragraph d by:
a. Adding in alphabetical order the category High-Priority Substances and entries 1,3-Butadiene, Butyl benzyl phthalate BBP1,2-Benzenedicarboxylic acid, 1-butyl 2phenylmethyl ester, Dibutyl phthalate DBP 1,2-Benzenedicarboxylic acid, 1,2-dibutyl ester, o-Dichlorobenzene, p-Dichlorobenzene, 1,1Dichloroethane, 1,2-Dichloroethane, Trans-1,2- Dichloroethylene, 1,2Dichloropropane, Dicyclohexyl phthalate, Di-ethylhexyl phthalate DEHP1,2-Benzene-dicarboxylic acid, 1,2- bis2-ethylhexyl ester, Diisobutyl phthalate DIBP1,2Benzenedicarboxylic acid, 1,2- bis2methylpropyl ester, Ethylene dibromide, Formaldehyde, 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8hexamethylcyclopenta g-2-benzopyran HHCB, 4,4-1Methylethylidenebis2, 6dibromophenol TBBPA, Phosphoric acid, triphenyl ester TPP, Phthalic anhydride, 1,1,2-Trichloroethane, and Tris2-chloroethyl phosphate TCEP; and
lotter on DSK11XQN23PROD with RULES1
Category
CAS No.
High-Priority Substances:
1,3-Butadiene
Butyl benzyl phthalate BBP1,2-Benzene-dicarboxylic acid, 1butyl 2phenylmethyl ester
Dibutyl phthalate DBP 1,2-Benzene-dicarboxylic acid, 1,2-dibutyl ester
o-Dichlorobenzene
p-Dichlorobenzene
1,1-Dichloroethane
1,2-Dichloroethane
Trans-1,2-Dichloroethylene
1,2-Dichloropropane
Dicyclohexyl phthalate
Di-ethylhexyl phthalate DEHP1,2-Benzene-dicarboxylic acid, 1,2bis2-ethylhexyl ester
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b. Adding in alphabetical order the category Organohalogen flame retardants and entries Bis2ethylhexyl tetrabromophthalate, Bishexachlorocyclopentadieno cyclooctane, 1,2-Bis2,4,6tribromophenoxyethane, 1,1-Ethane1,2-diylbispentabromobenzene, 2Ethylhexyl-2,3,4,5-tetrabromobenzoate, 2-2-Hydroxyethoxyethyl 2hydroxypropyl 3,4,5,6tetrabromophthalate, 2,2-1Methylethylidenebis2,6-dibromo-4,1phenyleneoxymethylenebisoxirane, Mixture of chlorinated linear alkanes C1417 with 4552% chlorine, N,NEthylene-bistetrabromophthalimide, Pentabromochlorocyclohexane, Pentabromophenylmethyl acrylate, Pentabromotoluene, Perbromo-1,4diphenoxybenzene, Phosphonic acid, 2-chloroethyl-, bis2-chloroethyl ester, Phosphoric acid, 2,2bischloromethyl-1,3-propanediyl tetrakis2-chloroethyl ester, Propanoic acid, 2-bromo-, methyl ester, Tetrabromobisphenol A-bis2,3dibromopropyl ether, Tetrabromobisphenol A bis2hydroxyethyl ether, Tetrabromobisphenol A diallyl ether, Tetrabromobisphenol A dimethyl ether, 2,4,6-Tribromoaniline, 1,3,5Tribromo-2-prop-2-en-1yloxybenzene, Tris2-chloroethyl phosphite, Tris1-chloro-2propylphosphate, Tris2-chloro-1propylphosphate, Tris2,3dibromopropyl phosphate, 1,3,5Tris2,3-dibromopropyl-1,3,5-triazine2,4,61H,3H,5H-trione, Tris1,3dichloro-2-propylphosphate, Tristribromoneopentylphosphate, and 2,4,6-Tris-2,4,6tribromophenoxy-1,3,5-triazine.
The additions read as follows:
716.120 Substances and listed mixtures to which this subpart applies.
d
Special exemptions
Effective date
Sunset date
106990
716.21a9
7/29/21
9/27/21
85687
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9/27/21
84742
95501
106467
75343
107062
156605
78875
84617
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