Quiero saber acerca de...

lotter on DSK11XQN23PROD with RULES1

34150

Federal Register / Vol. 86, No. 122 / Tuesday, June 29, 2021 / Rules and Regulations
All unpublished studies on occupational both users and non-users, general population, consumer, and environmental exposure, such as:
Unpublished studies on inhalation and dermal exposure, human biomonitoring, environmental monitoring of indoor and outdoor air, soil, water, and household dust, chamber emission rates from products or polymeric matrices, and unpublished modelling studies that estimate environmental concentrations or human exposures.
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.
Under this rule, manufacturers including importers of organohalogen flame retardants are required to submit the following:
Lists and copies of unpublished health and safety studies for all organohalogen flame retardants specified in this rule on health effects, such as toxicity studies in vivo and in vitro on carcinogenicity, reproductive and developmental effects, genotoxicity, neurotoxicity, immunotoxicity, endocrine effects, and other systemic toxicity and toxicokinetics absorption, distribution, metabolism, or elimination, including modelling studies, in humans or animals.
All unpublished studies on environmental effects, environmental fate, and physical-chemical properties if performed as described in 40 CFR
716.50 are also required under this rule.
All unpublished studies on occupational both users and non-users, general population, consumer, and environmental exposure, such as unpublished studies on inhalation and dermal exposure, human biomonitoring, environmental monitoring of indoor and outdoor air, soil, water, and household dust, chamber emission rates from products or polymeric matrices, and unpublished modelling studies that estimate environmental concentrations or human exposures, must be submitted.
Studies showing any measurable content of the organohalogen flame retardant in the tested substance single substances or mixture must be
VerDate Sep<11>2014

16:11 Jun 28, 2021

Jkt 253001

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.
D. Rationales and Background for Chemical Additions and Reporting Requirements 1. High-Priority Substances The 20 High-Priority Substances identified in this rule have been designated High-Priority under TSCA
section 6b because EPA has found that each of these chemical substances may present an unreasonable risk of injury to health or the environment Ref. 3. EPA
is seeking unpublished health and safety studies to ensure that such studies are available to EPA to inform its risk evaluation findings of whether any of these High-Priority Substances present an unreasonable risk of injury to health or the environment. Further, this information will be considered, as appropriate, when reviewing potential analogue data for read across and/or category development in assessing new chemicals.
2. Organohalogen Flame Retardants EPA requests this information to help support prioritization and evaluation activities under TSCA see TSCA
section 6b, and as discussed above.
Further, this information will be considered, as appropriate, when reviewing potential analogue data for read across and/or category development in assessing new chemicals. Additionally, CPSC, a representative member of the ITC, needs information on a group of organohalogen flame retardants because the Commission voted to grant a petition to begin rulemaking for this class of chemicals under the Federal Hazardous Substances Act FHSA, Ref.
5. Organohalogen flame retardants may be added to consumer products to prevent or slow combustion, but are additive, i.e., not covalently bound to the substrate, which can be textiles, polymers, or foam. Most organohalogen flame retardants are semi-volatile compounds SVOCs, that can migrate into air, where they bind to airborne particles and surfaces in the home. In addition to direct contact with organohalogen flame retardant-

PO 00000

Frm 00026

Fmt 4700

Sfmt 4700

containing products, a substantial portion of exposure is believed to occur from exposure to household dust, especially in children. Biomonitoring studies and measurements of household dust and indoor air demonstrate that exposure to organohalogen flame retardants is nearly ubiquitous.
Many organohalogen flame retardants have been shown to cause health effects.
Health effects associated with organohalogen flame retardants include carcinogenicity e.g., halogenated alkyl phosphates, developmental effects e.g., polybrominated diphenyl ethers PBDEs, and developmental neurotoxicity e.g., Decabromodiphenyl ether decaBDE.
In 2015, CPSC was petitioned by a number of organizations and individuals, such as consumer groups, medical associations, workers, and firefighter organizations, to ban the use of all additive, non-polymeric organohalogen flame retardants under the authority of the FHSA in the following consumer products: 1
Durable infant or toddler products, childrens toys, child care articles, or other childrens products other than car seats, which are under Department of Transportations jurisdiction; 2
Residential upholstered furniture; 3
Mattresses and mattress pads; and 4
The plastic casings of electronic devices Ref. 5.
CPSC granted the petition in 2017 and directed staff to complete a scoping and feasibility study in cooperation with the National Academy of Sciences, Engineering, and Medicine NASEM.
The task for this project was to develop a scientifically based scoping plan to identify the potential health hazards associated with additive, nonpolymeric organohalogen flame retardants as a class. The NASEM Committee published the report, A Class Approach to Hazard Assessment of Organohalogen Flame Retardants in May 2019 Ref. 6. A key conclusion of the NASEM Committee is that organohalogen flame retardants cannot be treated as a single class. Rather, the NASEM Committee identified 14
subclasses of organohalogen flame retardants, based on chemical structure, physicochemical properties of the chemicals, and predicted biologic activity. The NASEM Committee identified 161 organohalogen flame retardants and more than 1,000 analog chemicals. CPSC staff is undertaking the risk assessment of 14 classes of organohalogen flame retardants following the recommendations of the NASEM Committee.
Because preliminary searches show that little or no health and safety
E:FRFM29JNR1.SGM

29JNR1