15 U.S.C. § 2625 — Administration

Page 1901 TITLE 15—COMMERCE AND TRADE § 2625 Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1984 AMENDMENT Amendment by Pub. L. 98–620 not applicable to cases pending on Nov. 8, 1984, see section 403 of Pub. L. 98–620, set out as an Effective Date note under section 1657 of Title 28, Judiciary and Judicial Procedure. EFFECTIVE DATE Section effective Jan. 1, 1977, see section 31 of Pub. L. 94–469, set out as a note under section 2601 of this title. § 2623. Employment effects (a) In general The Administrator shall evaluate on a con- tinuing basis the potential effects on employ- ment (including reductions in employment or loss of employment from threatened plant clo- sures) of— (1) the issuance of a rule or order under sec- tion 2603, 2604, or 2605 of this title, or (2) a requirement of section 2604 or 2605 of this title. (b) Investigations (1) Any employee (or any representative of an employee) may request the Administrator to make an investigation of— (A) a discharge or layoff or threatened dis- charge or layoff of the employee, or (B) adverse or threatened adverse effects on the employee’s employment, allegedly resulting from a rule or order under section 2603, 2604, or 2605 of this title or a re- quirement of section 2604 or 2605 of this title. Any such request shall be made in writing, shall set forth with reasonable particularity the grounds for the request, and shall be signed by the employee, or representative of such em- ployee, making the request. (2)(A) Upon receipt of a request made in ac- cordance with paragraph (1) the Administrator shall (i) conduct the investigation requested, and (ii) if requested by any interested person, hold public hearings on any matter involved in the investigation unless the Administrator, by order issued within 45 days of the date such hearings are requested, denies the request for the hearings because the Administrator deter- mines there are no reasonable grounds for hold- ing such hearings. If the Administrator makes such a determination, the Administrator shall notify in writing the person requesting the hear- ing of the determination and the reasons there- for and shall publish the determination and the reasons therefor in the Federal Register. (B) If public hearings are to be held on any matter involved in an investigation conducted under this subsection— (i) at least five days’ notice shall be provided the person making the request for the inves- tigation and any person identified in such re- quest, and (ii) each employee who made or for whom was made a request for such hearings and the employer of such employee shall be required to present information respecting the applica- ble matter referred to in paragraph (1)(A) or (1)(B) together with the basis for such infor- mation. (3) Upon completion of an investigation under paragraph (2), the Administrator shall make findings of fact, shall make such recommenda- tions as the Administrator deems appropriate, and shall make available to the public such find- ings and recommendations. (4) This section shall not be construed to re- quire the Administrator to amend or repeal any rule or order in effect under this chapter. (Pub. L. 94–469, title I, § 24, Oct. 11, 1976, 90 Stat. 2045; renumbered title I, Pub. L. 99–519, § 3(c)(1), Oct. 22, 1986, 100 Stat. 2989; amended Pub. L. 114–182, title I, § 19(p), June 22, 2016, 130 Stat. 510.) Editorial Notes AMENDMENTS 2016—Subsec. (b)(2)(B)(ii), (iii). Pub. L. 114–182 redes- ignated cl. (iii) as (ii) and struck out former cl. (ii) which read as follows: ‘‘such hearings shall be held in accordance with section 2605(c)(3) of this title, and’’. Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective Jan. 1, 1977, see section 31 of Pub. L. 94–469, set out as a note under section 2601 of this title. § 2624. Repealed. Pub. L. 114–182, title I, § 16, June 22, 2016, 130 Stat. 499 Section, Pub. L. 94–469, title I, § 25, Oct. 11, 1976, 90 Stat. 2046; Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93 Stat. 695; renumbered title I, Pub. L. 99–519, § 3(c)(1), Oct. 22, 1986, 100 Stat. 2989, required a study on indem- nification for actions taken by the Administrator under Federal law. § 2625. Administration (a) Cooperation of Federal agencies Upon request by the Administrator, each Fed- eral department and agency is authorized— (1) to make its services, personnel, and fa- cilities available (with or without reimburse- ment) to the Administrator to assist the Ad- ministrator in the administration of this chapter; and (2) to furnish to the Administrator such in- formation, data, estimates, and statistics, and to allow the Administrator access to all infor- mation 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 chem- ical substance that is the subject of a risk eval- uation 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, in- cluding contractor costs incurred by the Admin- istrator. In setting a fee under this paragraph, Page 1902 TITLE 15—COMMERCE AND TRADE § 2625 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 car- rying out the activities described in this para- graph. Such rules may provide for sharing such a fee in any case in which the expenses of test- ing are shared under section 2603 or 2604 of this title. (2) The Administrator, after consultation with the Administrator of the Small Business Admin- istration, 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’’), con- sisting of such amounts as are deposited in the Fund under this paragraph. (B) COLLECTION AND DEPOSIT OF FEES.—Sub- ject 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 col- lected 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 de- fraying the costs of the activities described in paragraph (1). (D) ACCOUNTING AND AUDITING.— (i) ACCOUNTING.—The Administrator shall biennially prepare and submit to the Com- mittee on Environment and Public Works of the Senate and the Committee on Energy and Commerce of the House of Representa- tives 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 sec- tion 3515(c) of title 31, the Fund shall be considered a component of a covered exec- utive 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 admin- istering the provisions of this subchapter for which the fees may be used; and (cc) the number of requests for a risk evaluation made by manufacturers under section 2605(b)(4)(C)(ii) of this title. (III) FEDERAL RESPONSIBILITY.—The In- spector General of the Environmental Pro- tection Agency shall conduct the annual audit described in subclause (II) and sub- mit to the Administrator a report that de- scribes the findings and any recommenda- tions of the Inspector General resulting from the audit. (4) AMOUNT AND ADJUSTMENT OF FEES; RE- FUNDS.—In setting fees under this section, the Administrator shall— (A) prescribe lower fees for small business concerns, after consultation with the Adminis- trator of the Small Business Administration; (B) set the fees established under paragraph (1) at levels such that the fees will, in aggre- gate, provide a sustainable source of funds to annually defray— (i) the lower of— (I) 25 percent of the costs to the Admin- istrator of carrying out sections 2603, 2604, and 2605 of this title, and of collecting, processing, reviewing, and providing ac- cess to and protecting from disclosure as appropriate under section 2613 of this title information on chemical substances under this subchapter, other than the costs to conduct and complete risk evaluations under section 2605(b) of this title; or (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 as- sessment of fees between manufacturers and processors, and allow the payment of fees by consortia of manufacturers or processors; (D) notwithstanding subparagraph (B)— (i) except as provided in clause (ii), for chemical substances for which the Adminis- trator has granted a request from a manu- facturer pursuant to section 2605(b)(4)(C)(ii) of this title, establish the fee at a level suffi- cient to defray the full costs to the Adminis- trator of conducting the risk evaluation under section 2605(b) of this title; (ii) for chemical substances for which the Administrator has granted a request from a manufacturer pursuant to section 2605(b)(4)(C)(ii) of this title, and which are included in the 2014 update of the TSCA Work Plan for Chemical Assessments, estab- lish the fee at a level sufficient to defray 50 percent of the costs to the Administrator of conducting the risk evaluation under section 2605(b) of this title; and (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 chapter 10 of title 5 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 po- tentially subject to the fees and their rep- resentatives pursuant to subparagraph (E), in- crease or decrease the fees established under paragraph (1) as necessary to adjust for infla- Page 1903 TITLE 15—COMMERCE AND TRADE § 2625 tion and to ensure that funds deposited in the Fund are sufficient to defray— (i) approximately but not more than 25 percent of the costs to the Administrator of carrying out sections 2603, 2604, and 2605 of this title, and of collecting, processing, re- viewing, and providing access to and pro- tecting from disclosure as appropriate under section 2613 of this title information on chemical substances under this subchapter, other than the costs to conduct and com- plete risk evaluations requested under sec- tion 2605(b)(4)(C)(ii) of this title; and (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 Protec- tion 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 fis- cal year 2014. (6) TERMINATION.—The authority provided by this subsection shall terminate at the conclu- sion of the fiscal year that is 10 years after June 22, 2016, unless otherwise reauthorized or modi- fied by Congress. (c) Action with respect to categories (1) Any action authorized or required to be taken by the Administrator under any provision of this chapter with respect to a chemical sub- stance or mixture may be taken by the Adminis- trator in accordance with that provision with respect to a category of chemical substances or mixtures. Whenever the Administrator takes ac- tion under a provision of this chapter with re- spect to a category of chemical substances or mixtures, any reference in this chapter to a chemical substance or mixture (insofar as it re- lates to such action) shall be deemed to be a ref- erence to each chemical substance or mixture in such category. (2) For purposes of paragraph (1): (A) The term ‘‘category of chemical sub- stances’’ means a group of chemical sub- stances the members of which are similar in molecular structure, in physical, chemical, or biological properties, in use, or in mode of en- trance into the human body or into the envi- ronment, 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 sub- stances which are grouped together solely on the basis of their being new chemical sub- stances. (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 clas- sification as such for purposes of this chapter. (d) Assistance office The Administrator shall establish in the Envi- ronmental Protection Agency an identifiable of- fice 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 proc- essors, 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 Adminis- trator 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 in- terests’’ for purposes of paragraph (1), and (ii) to establish the methods by which the requirement to file written statements spec- ified in paragraph (1) will be monitored and enforced, including appropriate provisions for review by the Administrator and the Sec- retary of such statements; and (B) report to the Congress on June 1, 1978, and on June 1 of each year thereafter with re- spect 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 Pro- tection 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 occu- pying such positions shall be exempt from the requirements of paragraph (1). (4) This subsection does not supersede any re- quirement 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 Page 1904 TITLE 15—COMMERCE AND TRADE § 2625 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 Assist- ant Administrator for Toxic Substances of the Environmental Protection Agency. Such Assist- ant Administrator shall be a qualified individual who is, by reason of background and experience, especially qualified to direct a program con- cerning the effects of chemicals on human health and the environment. Such Assistant Ad- ministrator shall be responsible for (A) the col- lection of information, (B) the preparation of studies, (C) the making of recommendations to the Administrator for regulatory and other ac- tions 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 ap- pointed under paragraph (1) shall be in addition to the Assistant Administrators of the Environ- mental Protection Agency authorized by section 1(d) of Reorganization Plan No. 3 of 1970. (h) Scientific standards In carrying out sections 2603, 2604, and 2605 of this title, to the extent that the Administrator makes a decision based on science, the Adminis- trator shall use scientific information, technical procedures, measures, methods, protocols, meth- odologies, or models, employed in a manner con- sistent with the best available science, and shall consider as applicable— (1) the extent to which the scientific infor- mation, technical procedures, measures, meth- ods, protocols, methodologies, or models em- ployed to generate the information are reason- able for and consistent with the intended use of the information; (2) the extent to which the information is relevant for the Administrator’s use in mak- ing a decision about a chemical substance or mixture; (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 pro- cedures, measures, methods, protocols, meth- odologies, or models, are evaluated and char- acterized; and (5) the extent of independent verification or peer review of the information or of the proce- dures, measures, methods, protocols, meth- odologies, 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 information Subject to section 2613 of this title, the Ad- ministrator shall make available to the public— (1) all notices, determinations, findings, rules, consent agreements, and orders of the Administrator under this subchapter; (2) any information required to be provided to the Administrator under section 2603 of this title; (3) a nontechnical summary of each risk evaluation conducted under section 2605(b) of this title; (4) a list of the studies considered by the Ad- ministrator in carrying out each such risk evaluation, along with the results of those studies; and (5) each designation of a chemical substance under section 2605(b) of this title, along with an identification of the information, analysis, and basis used to make the designations. (k) Reasonably available information In carrying out sections 2603, 2604, and 2605 of this title, the Administrator shall take into con- sideration information relating to a chemical substance or mixture, including hazard and ex- posure information, under the conditions of use, that is reasonably available to the Adminis- trator. (l) Policies, procedures, and guidance (1) Development Not later than 2 years after June 22, 2016, the Administrator shall develop any policies, pro- cedures, and guidance the Administrator de- termines are necessary to carry out the amendments to this chapter made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. (2) Review Not 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 ani- mal, 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 develop- ments or understandings. (3) Testing of chemical substances and mix- tures The policies, procedures, and guidance devel- oped 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 deci- sions 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 Ad- ministrator will determine that additional information is necessary to carry out this subchapter, including information relating to potentially exposed or susceptible popu- lations. Page 1905 TITLE 15—COMMERCE AND TRADE § 2625 (4) Chemical substances with completed risk assessments With respect to a chemical substance listed in the 2014 update to the TSCA Work Plan for Chemical Assessments for which the Adminis- trator has published a completed risk assess- ment prior to June 22, 2016, the Administrator may publish proposed and final rules under section 2605(a) of this title that are consistent with the scope of the completed risk assess- ment for the chemical substance and con- sistent with other applicable requirements of section 2605 of this title. (5) Guidance Not later than 1 year after June 22, 2016, the Administrator shall develop guidance to assist interested persons in developing and submit- ting draft risk evaluations which shall be con- sidered 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 evalua- tions for consideration by the Administrator. (m) Report to Congress (1) Initial report Not later than 6 months after June 22, 2016, the Administrator shall submit to the Com- mittees on Energy and Commerce and Appro- priations of the House of Representatives and the Committees on Environment and Public Works and Appropriations of the Senate a re- port containing an estimation of— (A) the capacity of the Environmental Protection Agency to conduct and publish risk evaluations under section 2605(b)(4)(C)(i) of this title, and the resources necessary to conduct the minimum number of risk eval- uations required under section 2605(b)(2) of this title; (B) the capacity of the Environmental Pro- tection 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; (C) the capacity of the Environmental Pro- tection Agency to promulgate rules under section 2605(a) of this title as required based on risk evaluations conducted and published under section 2605(b) of this title; and (D) the actual and anticipated efforts of the Environmental Protection Agency to in- crease 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 resub- mit 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 nec- essary for the completion of each risk evalua- tion as soon as practicable after initiating the risk evaluation. (2) Publication of plan At 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 re- sources necessary for their completion; (B) describes the status of each risk eval- uation 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 Com- mittee 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 Advi- sory 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 con- sultation, at the request of the Administrator, with respect to the scientific and technical as- pects of issues relating to the implementation of this subchapter. (3) Composition The Committee shall be composed of rep- resentatives of such science, government, labor, public health, public interest, animal protection, industry, and other groups as the Administrator determines to be advisable, in- cluding representatives that have specific sci- entific expertise in the relationship of chem- ical exposures to women, children, and other potentially exposed or susceptible subpopula- tions. (4) Schedule The Administrator shall convene the Com- mittee in accordance with such schedule as the Administrator determines to be appro- priate, but not less frequently than once every 2 years. (p) Prior actions (1) Rules, orders, and exemptions Nothing in the Frank R. Lautenberg Chem- ical Safety for the 21st Century Act elimi- nates, modifies, or withdraws any rule promul- gated, order issued, or exemption established pursuant to this chapter before June 22, 2016. (2) Prior-initiated evaluations Nothing in this chapter prevents the Admin- istrator from initiating a risk evaluation re- garding a chemical substance, or from con- tinuing or completing such risk evaluation, prior to the effective date of the policies, pro- cedures, and guidance required to be developed by the Administrator pursuant to the amend- ments 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 Admin- istrator to revise or withdraw a completed Page 1906 TITLE 15—COMMERCE AND TRADE § 2626 risk evaluation, determination, or rule under this chapter solely because the action was completed prior to the development of a pol- icy, procedure, or guidance pursuant to the amendments made by the Frank R. Lauten- berg 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; Pub. L. 117–286, § 4(a)(69), Dec. 27, 2022, 136 Stat. 4313.) Editorial Notes REFERENCES IN TEXT Reorganization Plan No. 3 of 1970, referred to in sub- sec. (g)(2), is set out in the Appendix to Title 5, Govern- ment 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 com- plete 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 2022—Subsec. (b)(4)(E). Pub. L. 117–286 substituted ‘‘chapter 10 of title 5’’ for ‘‘the Federal Advisory Com- mittee Act (5 U.S.C. App.)’’. 2016—Subsec. (b)(1). Pub. L. 114–182, § 17(1), struck out ‘‘of a reasonable fee’’ before ‘‘from any person’’, sub- stituted ‘‘information under section 2603 of this title or a notice or other information to be reviewed by the Ad- ministrator 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, review- ing, and providing access to and protecting from disclo- sure as appropriate under section 2613 of this title in- formation on chemical substances under this sub- chapter, including contractor costs incurred by the Ad- ministrator’’ 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 con- cern, 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), sub- stituted ‘‘information’’ for ‘‘data’’. Subsecs. (h) to (p). Pub. L. 114–182, § 17(3), added sub- secs. (h) to (p). 1983—Subsec. (g)(2). Pub. L. 98–80 struck out ‘‘(A)’’ be- fore ‘‘be in addition’’ and ‘‘, and (B) be compensated at the rate of pay authorized for such Assistant Adminis- trators’’ after ‘‘No. 3 of 1970’’. Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective Jan. 1, 1977, see section 31 of Pub. L. 94–469, set out as a note under section 2601 of this title. TERMINATION OF REPORTING REQUIREMENTS For termination, effective May 15, 2000, of provisions in subsec. (e)(2)(B) of this section relating to annual re- ports 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. § 2626. Development and evaluation of test meth- ods (a) In general The Secretary of Health and Human Services, in consultation with the Administrator and act- ing through the Assistant Secretary for Health, may conduct, and make grants to public and nonprofit private entities and enter into con- tracts with public and private entities for, projects for the development and evaluation of inexpensive and efficient methods (1) for deter- mining and evaluating the health and environ- mental effects of chemical substances and mix- tures, and their toxicity, persistence, and other characteristics which affect health and the envi- ronment, and (2) which may be used for the de- velopment of information to meet the require- ments of rules, orders, or consent agreements under section 2603 of this title. The Adminis- trator shall consider such methods in pre- scribing under section 2603 of this title protocols and methodologies for the development of infor- mation. (b) Approval by Secretary No grant may be made or contract entered into under subsection (a) unless an application therefor has been submitted to and approved by the Secretary. Such an application shall be sub- mitted in such form and manner and contain such information as the Secretary may require. The Secretary may apply such conditions to grants and contracts under subsection (a) as the Secretary determines are necessary to carry out the purposes of such subsection. Contracts may be entered into under such subsection without regard to section 3324(a) and (b) of title 31 and section 6101 of title 41. (Pub. L. 94–469, title I, § 27, Oct. 11, 1976, 90 Stat. 2049; renumbered title I, Pub. L. 99–519, § 3(c)(1), Oct. 22, 1986, 100 Stat. 2989; amended Pub. L. 104–66, title I, § 1061(a), Dec. 21, 1995, 109 Stat. 719; Pub. L. 114–182, title I, § 19(r), June 22, 2016, 130 Stat. 510.) Editorial Notes CODIFICATION In subsec. (b), ‘‘section 3324(a) and (b) of title 31 and section 6101 of title 41’’ substituted for ‘‘sections 3648 and 3709 of the Revised Statutes (31 U.S.C. 529; 41 U.S.C. 5)’’ on authority of Pub. L. 97–258, § 4(b), Sept. 13, 1982, 96 Stat. 1067, which Act enacted Title 31, Money and Fi- nance, and Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts. AMENDMENTS 2016—Subsec. (a). Pub. L. 114–182 substituted ‘‘Health and Human Services’’ for ‘‘Health, Education, and Wel- fare’’, ‘‘information’’ for ‘‘test data’’ in two places, ‘‘rules, orders, or consent agreements’’ for ‘‘rules pro- mulgated’’, and ‘‘protocols and methodologies’’ for ‘‘standards’’. 1995—Subsec. (c). Pub. L. 104–66 struck out heading and text of subsec. (c). Text read as follows: