Sec. 6. Prioritization screening
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The Toxic Substances Control Act is amended by inserting after section 4 ( 15 U.S.C. 2603 ) the following: Not later than 1 year after the date of enactment of this section, the Administrator shall establish, by rule, a risk-based screening process and explicit criteria for identifying existing chemical substances that are— a high priority for a safety assessment and safety determination under section 6 (referred to in this Act as high-priority substances ); and a low priority for a safety assessment and safety determination (referred to in this Act as low-priority substances ). Before the date of promulgation of the rule under paragraph
(1)and not later than 180 days after the date of enactment of this section, the Administrator— shall take into consideration and publish an initial list of high-priority substances and low-priority substances; and pursuant to section 6(b), may initiate or continue safety assessments and safety determinations for those high-priority substances. The initial list of chemical substances shall contain at least 10 high-priority substances, at least 5 of which are drawn from the list of chemical substances identified by the Administrator in the October, 2014 TSCA Work Plan and subsequent updates, and at least 10 low-priority substances. Insofar as possible, at least 50 percent of all substances subsequently identified by the Administrator as high-priority substances shall be drawn from the list of chemical substances identified by the Administrator in the October, 2014 TSCA Work Plan and subsequent updates, until all Work Plan chemicals have been designated under this subsection. The Administrator shall— 3 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , add additional high-priority substances sufficient to ensure that at least a total of 20 high-priority substances have undergone or are undergoing the process established in section 6(a), and additional low-priority substances sufficient to ensure that at least a total of 20 low-priority substances have been designated; and as soon as practicable and not later than 5 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , add additional high-priority substances sufficient to ensure that at least a total of 25 high-priority substances have undergone or are undergoing the process established in section 6(a), and additional low-priority substances sufficient to ensure that at least a total of 25 low-priority substances have been designated. In carrying out paragraph (1), the Administrator shall take into consideration active substances, as determined under section 8, which may include chemical substances on the interim list of active substances established under that section. In carrying out paragraph (1), the Administrator may take into consideration inactive substances, as determined under section 8, that the Administrator determines— have not been subject to a regulatory or other enforceable action by the Administrator to ban or phase out the substances; and have the potential for high hazard and widespread exposure; or have been subject to a regulatory or other enforceable action by the Administrator to ban or phase out the substances; and with respect to which there exists the potential for residual high hazards or widespread exposures not otherwise addressed by the regulatory or other action. On the completion of a safety determination under section 6 for a chemical substance, the Administrator shall remove the chemical substance from the list of high-priority substances established under this subsection. The Administrator shall add at least 1 chemical substance to the list of high-priority substances for each chemical substance removed from the list of high-priority substances established under this subsection, until a safety assessment and safety determination is completed for all high-priority substances. If a low-priority substance is subsequently designated as a high-priority substance, the Administrator shall remove that substance from the list of low-priority substances. The Administrator shall— not later than 180 days after the effective date of the final rule under paragraph (1), begin the prioritization screening process; and make every effort to complete the designation of all active substances as high-priority substances or low-priority substances in a timely manner. Not later than 90 days after the date of receipt of information regarding a chemical substance complying with a rule, testing consent agreement, or order issued under section 4(a)(2), the Administrator shall designate the chemical substance as a high-priority substance or low-priority substance. The Administrator shall screen substances and designate high-priority substances taking into consideration the ability of the Administrator to schedule and complete safety assessments and safety determinations under section 6 in a timely manner. The Administrator shall publish an annual goal for the number of chemical substances to be subject to the prioritization screening process. The Administrator may screen categories of chemical substances to ensure an efficient prioritization screening process to allow for timely and adequate designations of high-priority substances and low-priority substances and safety assessments and safety determinations for high-priority substances. Not less frequently than once each year, the Administrator shall publish a list of chemical substances that— are being considered in the prioritization screening process and the status of the chemical substances in the prioritization process, including those chemical substances for which prioritization decisions have been deferred; and are designated as high-priority substances or low-priority substances, including the bases for such designations. The criteria described in paragraph
(1)shall account for— the recommendation of the Governor of a State or a State agency with responsibility for protecting health or the environment from chemical substances appropriate for prioritization screening; the hazard and exposure potential of the chemical substance (or category of substances), including specific scientific classifications and designations by authoritative governmental entities; the conditions of use or significant changes in the conditions of use of the chemical substance; evidence and indicators of exposure potential to humans or the environment from the chemical substance, including potentially exposed or susceptible populations; the volume of a chemical substance manufactured or processed; whether the volume of a chemical substance as reported under a rule promulgated pursuant to section 8(a) has significantly increased or decreased during the period beginning on the date of a previous report or the date on which a notice has been submitted under section 5(b) for that chemical substance; the availability of information regarding potential hazards and exposures required for conducting a safety assessment or safety determination, with limited availability of relevant information to be a sufficient basis for designating a chemical substance as a high-priority substance, subject to the condition that limited availability shall not require designation as a high-priority substance; and the extent of Federal or State regulation of the chemical substance or the extent of the impact of State regulation of the chemical substance on the United States, with existing Federal or State regulation of any uses evaluated in the prioritization screening process as a factor in designating a chemical substance to be a low-priority substance. The prioritization screening process developed under subsection
(a)shall include a requirement that the Administrator shall— identify the chemical substances being considered for prioritization; request interested persons to supply information regarding the chemical substances being considered; apply the criteria identified in subsection (a)(4); and subject to paragraph
(5)and using the information available to the Administrator at the time of the decision, identify a chemical substance as a high-priority substance or a low-priority substance. The prioritization screening decision regarding a chemical substance shall integrate any hazard and exposure information relating to the chemical substance that is available to the Administrator. The Administrator— shall identify as a high-priority substance a chemical substance that, relative to other chemical substances, the Administrator determines has the potential for high hazard and widespread exposure; may identify as a high-priority substance a chemical substance that, relative to other chemical substances, the Administrator determines has the potential for high hazard or widespread exposure; and may identify as a high-priority substance an inactive substance, as determined under subsection (a)(3)(A)(ii) and section 8(b), that the Administrator determines warrants a safety assessment and safety determination under section 6. The Administrator shall identify as a low-priority substance a chemical substance that the Administrator concludes has information sufficient to establish that the chemical substance is likely to meet the applicable safety standard. If the Administrator determines that additional information is required to establish the priority of a chemical substance under this section, the Administrator may defer the prioritization screening decision for a reasonable period— to allow for the submission of additional information by an interested person and for the Administrator to evaluate the additional information; or to require the development of information pursuant to a rule, testing consent agreement, or order issued under section 4(a)(2). If the Administrator requests the development or submission of information under this section, the Administrator shall establish a deadline for submission of the information. The Administrator shall— publish the proposed decisions made under paragraphs (3), (4), and
(5)and the basis for the decisions; and provide an opportunity for public comment. At any time, and at the discretion of the Administrator, the Administrator may revise the designation of a chemical substance as a high-priority substance or a low-priority substance based on information available to the Administrator after the date of the determination under paragraph
(3)or (4). If limited availability of relevant information was a basis in the designation of a chemical substance as a high-priority substance, the Administrator shall reevaluate the prioritization screening of the chemical substance on receiving the relevant information. If, after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , a State proposes an administrative action or enacts a statute or takes an administrative action to prohibit or otherwise restrict the manufacturing, processing, distribution in commerce, or use of a chemical substance that the Administrator has not as designated a high-priority substance, the Governor or State agency with responsibility for implementing the statute or administrative action shall notify the Administrator. Following receipt of a notification provided under subparagraph (A), the Administrator may request any available information from the Governor or the State agency with respect to— scientific evidence related to the hazards, exposures and risks of the chemical substance under the conditions of use which the statute or administrative action is intended to address; any State or local conditions which warranted the statute or administrative action; the statutory or administrative authority on which the action is based; and any other available information relevant to the prohibition or other restriction, including information on any alternatives considered and their hazards, exposures, and risks. The Administrator shall conduct a prioritization screening under this subsection for all substances that— are the subject of notifications received under subparagraph (A); and the Administrator determines— are likely to have significant health or environmental impacts; are likely to have significant impact on interstate commerce; or have been subject to a prohibition or other restriction under a statute or administrative action in 2 or more States. Subject to section 14 and any applicable State law regarding the protection of confidential information provided to the State or to the Administrator, the Administrator shall make information received from a Governor or State agency under subparagraph
(A)publicly available. Nothing in this paragraph shall preempt a State statute or administrative action, require approval of a State statute or administrative action, or apply section 15 to a State. Not less frequently than once every 5 years after the date on which the process under this subsection is established, the Administrator shall— review the process on the basis of experience and taking into consideration resources available to efficiently and effectively screen and prioritize chemical substances; and if necessary, modify the prioritization screening process. Subject to section 18, a designation by the Administrator under this section with respect to a chemical substance shall not affect— the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance; or the regulation of those activities. The prioritization screening process developed under subsection
(a)shall— include a process by which a manufacturer or processor of an active chemical substance that has not been designated a high-priority substance, or that has not been subject to or is not in the process of a prioritization screening by the Administrator, may request that the Administrator designate the substance for a safety assessment and safety determination, subject to the payment of fees pursuant to section 26(b)(3)(E); and provide guidance to submitters on the information to be provided in such requests, and specify the criteria the Administrator shall use to determine whether or not to grant such a request, which shall include whether the substance is subject to restrictions imposed by statutes enacted or administrative actions taken by 1 or more States on the manufacture, processing, distribution in commerce, or use of the substance. Subject to paragraph (3), in deciding whether to grant requests under this subsection the Administrator shall give a preference to requests concerning substances for which the Administrator determines that restrictions imposed by 1 or more States have the potential to have a significant impact on interstate commerce or health or the environment. In considering whether to grant a request submitted under paragraph (1), the Administrator shall ensure that— not more than 15 percent of the total number of substances designated to undergo safety assessments and safety determinations under this section are substances designated under the process and criteria pursuant to paragraph (1); and the resources allocated to conducting safety assessments and safety determinations for additional priorities designated under this subsection are proportionate to the number of such substances relative to the total number of substances designated to undergo safety assessments and safety determinations under this section. The public shall be provided notice and an opportunity to comment on requests submitted under this subsection. Not later than 180 days after the date on which the Administrator receives a request under this subsection, the Administrator shall decide whether or not to grant the request. If the Administrator grants a request under this subsection, the safety assessment and safety determination— shall be conducted in accordance with the deadlines and other requirements of sections 3A(i) and 6; and shall not be expedited or otherwise subject to special treatment relative to high-priority substances designated pursuant to subsection (b)(3) that are undergoing safety assessments and safety determinations. Requests granted under this subsection shall not be subject to subsection (a)(3)(A)(iii) or section 18(b). .
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Sec. 6
Prioritization screening
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