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15 U.S. Code § 2604. Manufacturing and processing notices
(a) In general
(1)
(A) Except as provided in subparagraph (B) of this paragraph and subsection (h), no person may—
(i)
manufacture a new chemical substance on or after the 30th day after the date on which the Administrator first publishes the list required by section 2607(b) of this title, or
(ii)
manufacture or process any chemical substance for a use which the Administrator has determined, in accordance with paragraph (2), is a significant new use.
(B) A person may take the actions described in subparagraph (A) if—
(i)
such person submits to the Administrator, at least 90 days before such manufacture or processing, a notice, in accordance with subsection (d), of such person’s intention to manufacture or process such substance and such person complies with any applicable requirement of, or imposed pursuant to, subsection (b), (e), or (f); and
(ii) the Administrator—
(I)
conducts a review of the notice; and
(II)
makes a determination under subparagraph (A), (B), or (C) of paragraph (3) and takes the actions required in association with that determination under such subparagraph within the applicable review period.
(2) A determination by the Administrator that a use of a chemical substance is a significant new use with respect to which notification is required under paragraph (1) shall be made by a rule promulgated after a consideration of all relevant factors, including—
(A)
the projected volume of manufacturing and processing of a chemical substance,
(B)
the extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance,
(C)
the extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance, and
(D)
the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.
(3)Review and determination.—Within the applicable review period, subject to section 2617 of this title, the Administrator shall review such notice and determine—
(A)
that the relevant chemical substance or significant new use presents an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, in which case the Administrator shall take the actions required under subsection (f);
(B) that—
(i)
the information available to the Administrator is insufficient to permit a reasoned evaluation of the health and environmental effects of the relevant chemical substance or significant new use; or
(ii)
(I)
in the absence of sufficient information to permit the Administrator to make such an evaluation, the manufacture, processing, distribution in commerce, use, or disposal of such substance, or any combination of such activities, may present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator; or
(II)
such substance is or will be produced in substantial quantities, and such substance either enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to the substance,
in which case the Administrator shall take the actions required under subsection (e); or
(C)
that the relevant chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, in which case the submitter of the notice may commence manufacture of the chemical substance or manufacture or processing for a significant new use.
(4)Failure to render determination.—
(A)Failure to render determination.—
If the Administrator fails to make a determination on a notice under paragraph (3) by the end of the applicable review period and the notice has not been withdrawn by the submitter, the Administrator shall refund to the submitter all applicable fees charged to the submitter for review of the notice pursuant to section 2625(b) of this title, and the Administrator shall not be relieved of any requirement to make such determination.
(B)Limitations.—
(i)
A refund of applicable fees under subparagraph (A) shall not be made if the Administrator certifies that the submitter has not provided information required under subsection (b) or has otherwise unduly delayed the process such that the Administrator is unable to render a determination within the applicable review period.
(ii)
A failure of the Administrator to render a decision shall not be deemed to constitute a withdrawal of the notice.
(iii)
Nothing in this paragraph shall be construed as relieving the Administrator or the submitter of the notice from any requirement of this section.