(a) Cooperation of Federal agenciesUpon request by the Administrator, each Federal department and agency is authorized—
(1)
to make its services, personnel, and facilities available (with or without reimbursement) to the
Administrator to assist the
Administrator in the administration of this chapter; and
(2)
to furnish to the
Administrator such information, data, estimates, and statistics, and to allow the
Administrator access to all information in its possession as the
Administrator may reasonably determine to be necessary for the administration of this chapter.
(b) Fees
(1)
The
Administrator may, by rule, require the payment from any person required to submit information under
section 2603 of this title or a notice or other information to be reviewed by the
Administrator under
section 2604 of this title, or who
manufactures or
processes a
chemical substance that is the subject of a risk evaluation under
section 2605(b) of this title, of a fee that is sufficient and not more than reasonably necessary to defray the cost related to such
chemical substance of administering sections 2603, 2604, and 2605 of this title, and collecting, processing, reviewing, and providing access to and protecting from disclosure as appropriate under
section 2613 of this title information on
chemical substances under this subchapter, including contractor costs incurred by the
Administrator. In setting a fee under this paragraph, the
Administrator shall take into account the ability to pay of the person required to pay such fee and the cost to the
Administrator of carrying out the activities described in this paragraph. Such rules may provide for sharing such a fee in any case in which the expenses of testing are shared under section 2603 or 2604 of this title.
(2)
The
Administrator, after consultation with the
Administrator of the
Small Business Administration, shall by rule prescribe standards for determining the persons which qualify as small business concerns for purposes of paragraph (4).
(3) Fund.—
(A) Establishment.—
There is established in the Treasury of the
United States a fund, to be known as the TSCA Service Fee Fund (in this paragraph referred to as the “Fund”), consisting of such amounts as are deposited in the Fund under this paragraph.
(B) Collection and deposit of fees.—
Subject to the conditions of subparagraph (C), the
Administrator shall collect the fees described in this subsection and deposit those fees in the Fund.
(C) Use of funds by administrator.—
Fees authorized under this section shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts, and shall be available without fiscal year limitation for use in defraying the costs of the activities described in paragraph (1).
(D) Accounting and auditing.—
(i) Accounting.—
The
Administrator shall biennially prepare and submit to the Committee on
Environment and Public Works of the
Senate and the Committee on Energy and
Commerce of the
House of Representatives a report that includes an accounting of the fees paid to the
Administrator under this paragraph and amounts disbursed from the Fund for the period covered by the report, as reflected by financial statements provided in accordance with sections 3515 and 3521 of title 31.
(ii) Auditing.—
(I) In general.—
For the purpose of
section 3515(c) of title 31, the Fund shall be considered a component of a covered executive agency.
(II) Components of audit.—The annual audit required in accordance with sections 3515 and 3521 of title 31 of the financial statements of activities carried out using amounts from the Fund shall include an analysis of—
(aa)
the fees collected and amounts disbursed under this subsection;
(bb)
the reasonableness of the fees in place as of the date of the audit to meet current and projected costs of administering the provisions of this subchapter for which the fees may be used; and
(III) Federal responsibility.—
The Inspector General of the
Environmental Protection Agency shall conduct the annual audit described in subclause (II) and submit to the
Administrator a report that describes the findings and any recommendations of the Inspector General resulting from the audit.
(4) Amount and Adjustment of Fees; Refunds.—In setting fees under this section, the Administrator shall—
(A)
prescribe lower fees for small business concerns, after consultation with the
Administrator of the
Small Business Administration;
(B) set the fees established under paragraph (1) at levels such that the fees will, in aggregate, provide a sustainable source of funds to annually defray—
(i) the lower of—
(II)
$25,000,000 (subject to adjustment pursuant to subparagraph (F)); and
(ii)
the costs of risk evaluations specified in subparagraph (D);
(C)
reflect an appropriate balance in the assessment of fees between manufacturers and
processors, and allow the payment of fees by consortia of manufacturers or
processors;
(D) notwithstanding subparagraph (B)—
(iii)
apply fees collected pursuant to clauses (i) and (ii) only to defray the costs described in those clauses;
(E)
prior to the establishment or amendment of any fees under paragraph (1), consult and meet with parties potentially subject to the fees or their representatives, subject to the condition that no obligation under the
Federal Advisory Committee Act (
5 U.S.C. App.) or subchapter II of chapter 5 of title 5 is applicable with respect to such meetings;
(F) beginning with the fiscal year that is 3 years after June 22, 2016, and every 3 years thereafter, after consultation with parties potentially subject to the fees and their representatives pursuant to subparagraph (E), increase or decrease the fees established under paragraph (1) as necessary to adjust for inflation and to ensure that funds deposited in the Fund are sufficient to defray—
(ii)
the costs of risk evaluations specified in subparagraph (D); and
(G)
if a notice submitted under
section 2604 of this title is not reviewed or such a notice is withdrawn, refund the fee or a portion of the fee if no substantial work was performed on the notice.
(5) Minimum Amount of Appropriations.—
Fees may not be assessed for a fiscal year under this section unless the amount of appropriations for the Chemical Risk Review and Reduction program project of the Environmental Protection Agency for the fiscal year (excluding the amount of any fees appropriated for the fiscal year) are equal to or greater than the amount of appropriations for that program project for fiscal year 2014.
(6) Termination.—
The authority provided by this subsection shall terminate at the conclusion of the fiscal year that is 10 years after June 22, 2016, unless otherwise reauthorized or modified by Congress.
(c) Action with respect to categories
(2) For purposes of paragraph (1):
(A)
The term “
category of chemical substances” means a group of
chemical substances the members of which are similar in molecular structure, in physical, chemical, or biological properties, in use, or in mode of entrance into the human body or into the
environment, or the members of which are in some other way suitable for classification as such for purposes of this chapter, except that such term does not mean a group of
chemical substances which are grouped together solely on the basis of their being
new chemical substances.
(B)
The term “
category of mixtures” means a group of
mixtures the members of which are similar in molecular structure, in physical, chemical, or biological properties, in use, or in the mode of entrance into the human body or into the
environment, or the members of which are in some other way suitable for classification as such for purposes of this chapter.
(d) Assistance office
The Administrator shall establish in the Environmental Protection Agency an identifiable office to provide technical and other nonfinancial assistance to manufacturers and processors of chemical substances and mixtures respecting the requirements of this chapter applicable to such manufacturers and processors, the policy of the Agency respecting the application of such requirements to such manufacturers and processors, and the means and methods by which such manufacturers and processors may comply with such requirements.
(e) Financial disclosures
(1) Except as provided under paragraph (3), each officer or employee of the Environmental Protection Agency and the Department of Health and Human Services who—
(A)
performs any function or duty under this chapter, and
(B)
has any known financial interest (i) in any person subject to this chapter or any rule or order in effect under this chapter, or (ii) in any person who applies for or receives any grant or contract under this chapter,
shall, on
February 1, 1978, and on February 1 of each year thereafter, file with the
Administrator or the Secretary of Health and Human Services (hereinafter in this subsection referred to as the “Secretary”), as appropriate, a written statement concerning all such interests held by such officer or employee during the preceding calendar year. Such statement shall be made available to the public.
(2) The Administrator and the Secretary shall—
(A) act within 90 days of January 1, 1977—
(i)
to define the term “known financial interests” for purposes of paragraph (1), and
(ii)
to establish the methods by which the requirement to file written statements specified in paragraph (1) will be monitored and enforced, including appropriate provisions for review by the
Administrator and the Secretary of such statements; and
(B)
report to the Congress on June 1, 1978, and on June 1 of each year thereafter with respect to such statements and the actions taken in regard thereto during the preceding calendar year.
(3)
The
Administrator may by rule identify specific positions with the
Environmental Protection Agency, and the Secretary may by rule identify specific positions with the
Department of Health and Human Services, which are of a nonregulatory or nonpolicymaking nature, and the
Administrator and the Secretary may by rule provide that officers or employees occupying such positions shall be exempt from the requirements of paragraph (1).
(4)
This subsection does not supersede any requirement of chapter 11 of title 18.
(5)
Any officer or employee who is subject to, and knowingly violates, this subsection or any rule issued thereunder, shall be fined not more than $2,500 or imprisoned not more than one year, or both.
(f) Statement of basis and purpose
Any final order issued under this chapter shall be accompanied by a statement of its basis and purpose. The contents and adequacy of any such statement shall not be subject to judicial review in any respect.
(g) Assistant Administrator
(1)
The President, by and with the advice and consent of the
Senate, shall appoint an Assistant
Administrator for Toxic Substances of the
Environmental Protection Agency. Such Assistant
Administrator shall be a qualified individual who is, by reason of background and experience, especially qualified to direct a program concerning the effects of chemicals on human health and the
environment. Such Assistant
Administrator shall be responsible for (A) the collection of information, (B) the preparation of studies, (C) the making of recommendations to the
Administrator for regulatory and other actions to carry out the purposes and to facilitate the administration of this chapter, and (D) such other functions as the
Administrator may assign or delegate.
(2)
The Assistant
Administrator to be appointed under paragraph (1) shall be in addition to the Assistant
Administrators of the
Environmental Protection Agency authorized by section 1(d) of Reorganization Plan No. 3 of 1970.
(h) Scientific standardsIn carrying out sections 2603, 2604, and 2605 of this title, to the extent that the Administrator makes a decision based on science, the Administrator shall use scientific information, technical procedures, measures, methods, protocols, methodologies, or models, employed in a manner consistent with the best available science, and shall consider as applicable—
(1)
the extent to which the scientific information, technical procedures, measures, methods, protocols, methodologies, or models employed to generate the information are reasonable for and consistent with the intended use of the information;
(3)
the degree of clarity and completeness with which the data, assumptions, methods, quality assurance, and analyses employed to generate the information are documented;
(4)
the extent to which the variability and uncertainty in the information, or in the procedures, measures, methods, protocols, methodologies, or models, are evaluated and characterized; and
(5)
the extent of independent verification or peer review of the information or of the procedures, measures, methods, protocols, methodologies, or models.
(i) Weight of scientific evidence
The Administrator shall make decisions under sections 2603, 2604, and 2605 of this title based on the weight of the scientific evidence.
(j) Availability of informationSubject to section 2613 of this title, the Administrator shall make available to the public—
(1)
all notices, determinations, findings, rules, consent agreements, and orders of the
Administrator under this subchapter;
(4)
a list of the studies considered by the
Administrator in carrying out each such risk evaluation, along with the results of those studies; and
(l) Policies, procedures, and guidance
(1) Development
Not later than 2 years after June 22, 2016, the Administrator shall develop any policies, procedures, and guidance the Administrator determines are necessary to carry out the amendments to this chapter made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.
(2) ReviewNot later than 5 years after June 22, 2016, and not less frequently than once every 5 years thereafter, the Administrator shall—
(A)
review the adequacy of the policies, procedures, and
guidance developed under paragraph (1), including with respect to animal, nonanimal, and epidemiological test methods and procedures for assessing and determining risk under this subchapter; and
(B)
revise such policies, procedures, and
guidance as the
Administrator determines necessary to reflect new scientific developments or understandings.
(3) Testing of chemical substances and mixturesThe policies, procedures, and guidance developed under paragraph (1) applicable to testing chemical substances and mixtures shall—
(A)
address how and when the exposure level or exposure potential of a
chemical substance or
mixture would factor into decisions to require new testing, subject to the condition that the
Administrator shall not interpret the lack of exposure information as a lack of exposure or exposure potential; and
(B)
describe the manner in which the
Administrator will determine that additional information is necessary to carry out this subchapter, including information relating to potentially exposed or susceptible populations.
(5) Guidance
Not later than 1 year after June 22, 2016, the Administrator shall develop guidance to assist interested persons in developing and submitting draft risk evaluations which shall be considered by the Administrator. The guidance shall, at a minimum, address the quality of the information submitted and the process to be followed in developing draft risk evaluations for consideration by the Administrator.
(m) Report to Congress
(1) Initial reportNot later than 6 months after June 22, 2016, the Administrator shall submit to the Committees on Energy and Commerce and Appropriations of the House of Representatives and the Committees on Environment and Public Works and Appropriations of the Senate a report containing an estimation of—
(B)
the capacity of the
Environmental Protection Agency to conduct and publish risk evaluations under
section 2605(b)(4)(C)(ii) of this title, the likely demand for such risk evaluations, and the anticipated schedule for accommodating that demand;
(D)
the actual and anticipated efforts of the
Environmental Protection Agency to increase the Agency’s capacity to conduct and publish risk evaluations under
section 2605(b) of this title.
(2) Subsequent reports
The Administrator shall update and resubmit the report described in paragraph (1) not less frequently than once every 5 years.
(n) Annual plan
(1) In general
The Administrator shall inform the public regarding the schedule and the resources necessary for the completion of each risk evaluation as soon as practicable after initiating the risk evaluation.
(2) Publication of planAt the beginning of each calendar year, the Administrator shall publish an annual plan that—
(A)
identifies the
chemical substances for which risk evaluations are expected to be initiated or completed that year and the resources necessary for their completion;
(B)
describes the status of each risk evaluation that has been initiated but not yet completed; and
(C)
if the schedule for completion of a risk evaluation has changed, includes an updated schedule for that risk evaluation.
(o) Consultation with Science Advisory Committee on Chemicals
(1) Establishment
Not later than 1 year after June 22, 2016, the Administrator shall establish an advisory committee, to be known as the Science Advisory Committee on Chemicals (referred to in this subsection as the “Committee”).
(2) Purpose
The purpose of the Committee shall be to provide independent advice and expert consultation, at the request of the Administrator, with respect to the scientific and technical aspects of issues relating to the implementation of this subchapter.
(3) Composition
The Committee shall be composed of representatives of such science, government, labor, public health, public interest, animal protection, industry, and other groups as the Administrator determines to be advisable, including representatives that have specific scientific expertise in the relationship of chemical exposures to women, children, and other potentially exposed or susceptible subpopulations.
(4) Schedule
The Administrator shall convene the Committee in accordance with such schedule as the Administrator determines to be appropriate, but not less frequently than once every 2 years.
(p) Prior actions
(1) Rules, orders, and exemptions
Nothing in the Frank R. Lautenberg Chemical Safety for the 21st Century Act eliminates, modifies, or withdraws any rule promulgated, order issued, or exemption established pursuant to this chapter before June 22, 2016.
(2) Prior-initiated evaluations
Nothing in this chapter prevents the Administrator from initiating a risk evaluation regarding a chemical substance, or from continuing or completing such risk evaluation, prior to the effective date of the policies, procedures, and guidance required to be developed by the Administrator pursuant to the amendments made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.
(3) Actions completed prior to completion of policies, procedures, and guidance
Nothing in this chapter requires the Administrator to revise or withdraw a completed risk evaluation, determination, or rule under this chapter solely because the action was completed prior to the development of a policy, procedure, or guidance pursuant to the amendments made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.
(
Pub. L. 94–469, title I, § 26,
Oct. 11, 1976,
90 Stat. 2046;
Pub. L. 98–80, § 2(c)(2)(A),
Aug. 23, 1983,
97 Stat. 485; renumbered title I,
Pub. L. 99–519, § 3(c)(1),
Oct. 22, 1986,
100 Stat. 2989; amended
Pub. L. 114–182, title I, §§ 17, 19(q),
June 22, 2016,
130 Stat. 499, 510.)
References in Text
The Federal Advisory Committee Act, referred to in subsec. (b)(4)(E), is Pub. L. 92–463, Oct. 6, 1972, 86 Stat. 770, which is set out in the Appendix to Title 5, Government Organization and Employees.
Reorganization Plan No. 3 of 1970, referred to in subsec. (g)(2), is set out in the Appendix to Title 5, Government Organization and Employees.
The Frank R. Lautenberg Chemical Safety for the 21st Century Act, referred to in subsecs. (l)(1) and (p), is Pub. L. 114–182, June 22, 2016, 130 Stat. 492. For complete classification of this Act to the Code, see Short Title of 2016 Amendment note set out under section 2601 of this title and Tables.
Amendments
Subsec. (b)(1). Pub. L. 114–182, § 17(1), struck out “of a reasonable fee” before “from any person”, substituted “information under section 2603 of this title or a notice or other information to be reviewed by the Administrator under section 2604 of this title, or who manufactures or processes a chemical substance that is the subject of a risk evaluation under section 2605(b) of this title, of a fee that is sufficient and not more than reasonably necessary to defray the cost related to such chemical substance of administering sections 2603, 2604, and 2605 of this title, and collecting, processing, reviewing, and providing access to and protecting from disclosure as appropriate under section 2613 of this title information on chemical substances under this subchapter, including contractor costs incurred by the Administrator” for “data under section 2603 or 2604 of this title to defray the cost of administering this chapter”, struck out “Such rules shall not provide for any fee in excess of $2,500 or, in the case of a small business concern, any fee in excess of $100.” before “In setting a fee”, and substituted “pay such fee and the cost to the Administrator of carrying out the activities described in this paragraph” for “submit the data and the cost to the Administrator of reviewing such data”.
Subsec. (b)(2). Pub. L. 114–182, § 17(2)(A), substituted “paragraph (4)” for “paragraph (1)”.
Subsec. (b)(3) to (6). Pub. L. 114–182, § 17(2)(B), added pars. (3) to (6).
Subsec. (e). Pub. L. 114–182, § 19(q)(1), substituted “Health and Human Services” for “Health, Education, and Welfare” wherever appearing.
Subsec. (g)(1)(A). Pub. L. 114–182, § 19(q)(2), substituted “information” for “data”.
Subsecs. (h) to (p). Pub. L. 114–182, § 17(3), added subsecs. (h) to (p).
1983—Subsec. (g)(2). Pub. L. 98–80 struck out “(A)” before “be in addition” and “, and (B) be compensated at the rate of pay authorized for such Assistant Administrators” after “No. 3 of 1970”.
Termination of Reporting Requirements
For termination, effective May 15, 2000, of provisions in subsec. (e)(2)(B) of this section relating to annual reports to Congress, see section 3003 of Pub. L. 104–66, as amended, set out as a note under section 1113 of Title 31, Money and Finance, and pages 93 and 164 of House Document No. 103–7.
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