42 U.S.C. § 300hh (2024) — Title 42: THE PUBLIC HEALTH AND WELFARE / Chapter 6A: PUBLIC HEALTH SERVICE / Subchapter XXVI: NATIONAL ALL-HAZARDS PREPAREDNESS FOR PUBLIC HEALTH EMERGENCIES / Section 300hh: Public health and medical preparedness and response functions
Public health and medical preparedness and response functions
Status: in_force

(a) In general

The Secretary of Health and Human Services shall lead all Federal public health and medical response to public health emergencies and incidents covered by the National Response Plan developed pursuant to section 314(6) 1 of title 6, or any successor plan.

(b) Interagency agreement

The Secretary, in collaboration with the Secretary of Veterans Affairs, the Secretary of Transportation, the Secretary of Defense, the Secretary of Homeland Security, and the head of any other relevant Federal agency, shall establish an interagency agreement, consistent with the National Response Plan or any successor plan, under which agreement the Secretary of Health and Human Services shall assume operational control of emergency public health and medical response assets, as necessary, in the event of a public health emergency, except that members of the armed forces under the authority of the Secretary of Defense shall remain under the command and control of the Secretary of Defense, as shall any associated assets of the Department of Defense.

(c) Coordination with Federal agencies

In leading the Federal public health and medical response to a declared or potential public health emergency, consistent with this section, the Secretary shall coordinate with, and may request support from, other Federal departments and agencies, as appropriate in order to carry out necessary activities and leverage the expertise of such departments and agencies, which may include the provision of assistance at the direction of the Secretary related to supporting the public health and medical response for States, localities, and Tribes.

(d) Annual report on emergency response and preparedness

The Secretary shall submit a written report each fiscal year to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, containing—

(1) updated information related to an assessment of the response to any public health emergency declared, or otherwise in effect, during the previous fiscal year;

(2) findings related to drills and operational exercises completed in the previous fiscal year pursuant to section 300hh–10(b)(4)(G) of this title;

(3) the state of public health preparedness and response capabilities for chemical, biological, radiological, and nuclear threats, including emerging infectious diseases; and

(4) any challenges in preparing for or responding to such threats, as appropriate.

(July 1, 1944, ch. 373, title XXVIII, §2801, as added Pub. L. 107–188, title I, §101(a), June 12, 2002, 116 Stat. 596; amended Pub. L. 109–417, title I, §101(2), Dec. 19, 2006, 120 Stat. 2832; Pub. L. 117–328, div. FF, title II, §2103(b)(1), (d), Dec. 29, 2022, 136 Stat. 5711, 5714.)

Editorial Notes

References in Text

Section 314(6) of title 6, referred to in subsec. (a), was in the original "section 502(6) of the Homeland Security Act of 2002", and was translated as meaning section 504(6) of Pub. L. 107–296, to reflect the probable intent of Congress and the renumbering of section 502 as 504 by Pub. L. 109–295, title VI, §611(8), Oct. 4, 2006, 120 Stat. 1395.

Amendments

2022—Subsec. (c). Pub. L. 117–328, §2103(b)(1), added subsec. (c).

Subsec. (d). Pub. L. 117–328, §2103(d), added subsec. (d).

2006—Pub. L. 109–417 amended section generally. Prior to amendment, section consisted of subsecs. (a) to (d) relating to a national preparedness plan for carrying out health-related activities to prepare for and respond effectively to bioterrorism and other public health emergencies.

Statutory Notes and Related Subsidiaries

Data Use Agreements

Pub. L. 117–328, div. FF, title II, §2213(c), Dec. 29, 2022, 136 Stat. 5735, provided that:

"(1) Interagency data use agreements within the department of health and human services for public health emergencies.—

"(A) In general.—The Secretary of Health and Human Services (referred to in this subsection as the 'Secretary') shall, as appropriate, facilitate the development of, or updates to, memoranda of understanding, data use agreements, or other applicable interagency agreements regarding appropriate access, exchange, and use of public health data between the Centers for Disease Control and Prevention, the Office of the Assistant Secretary for Preparedness and Response, other relevant agencies or offices within the Department of Health and Human Services, and other relevant Federal agencies, in order to prepare for, identify, monitor, and respond to declared or potential public health emergencies.

"(B) Requirements.—In carrying out activities pursuant to subparagraph (A), the Secretary shall—

"(i) ensure that the agreements and memoranda of understanding described in such subparagraph—

"(I) address the methods of granting access to data held by one agency or office with another to support the respective missions of such agencies or offices;

"(II) consider minimum necessary principles of data sharing for appropriate use;

"(III) include appropriate privacy and cybersecurity protections; and

"(IV) are subject to regular updates, as appropriate;

"(ii) collaborate with the Centers for Disease Control and Prevention, the Office of the Assistant Secretary for Preparedness and Response, the Office of the Chief Information Officer, and, as appropriate, the Office of the National Coordinator for Health Information Technology, and other entities within the Department of Health and Human Services; and

"(iii) consider the terms and conditions of any existing data use agreements with other public or private entities and any need for updates to such existing agreements, consistent with paragraph (2).

"(2) Data use agreements with external entities.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention and the Assistant Secretary for Preparedness and Response, may update memoranda of understanding, data use agreements, or other applicable agreements and contracts to improve appropriate access, exchange, and use of public health data between the Centers for Disease Control and Prevention and the Office of the Assistant Secretary for Preparedness and Response and external entities, including State, Tribal, and territorial health departments, laboratories, hospitals and other health care providers, electronic health records vendors, and other entities, as applicable and appropriate, in order to prepare for, identify, monitor, and respond to declared or potential public health emergencies.

"(3) Report.—Not later than 90 days after the date of enactment of this Act [Dec. 29, 2022], the Secretary shall report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on the status of the agreements under this subsection."

Guidance for Participation in Exercises and Drills

Pub. L. 116–22, title III, §306, June 24, 2019, 133 Stat. 941, provided that: "Not later than 2 years after the date of enactment of this Act [June 24, 2019], the Secretary of Health and Human Services shall issue final guidance regarding the ability of personnel funded by programs authorized under this Act [see Tables for classification] (including the amendments made by this Act) to participate in drills and operational exercises related to all-hazards medical and public health preparedness and response. Such drills and operational exercises may include activities that incorporate medical surge capacity planning, medical countermeasure distribution and administration, and preparing for and responding to identified threats for that region. Such personnel may include State, local, Tribal, and territorial public health department or agency personnel funded under this Act (including the amendments made by this Act). The Secretary shall consult with the Department of Homeland Security, the Department of Defense, the Department of Veterans Affairs, and other applicable Federal departments and agencies as necessary and appropriate in the development of such guidance. The Secretary shall make the guidance available on the internet website of the Department of Health and Human Services."

Government Accountability Office Report

Pub. L. 107–188, title I, §157, June 12, 2002, 116 Stat. 633, provided that:

"(a) In General [sic].—The Comptroller General shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate, and to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, a report that describes—

"(1) Federal activities primarily related to research on, preparedness for, and the management of the public health and medical consequences of a bioterrorist attack against the civilian population;

"(2) the coordination of the activities described in paragraph (1);

"(3) the effectiveness of such efforts in preparing national, State, and local authorities to address the public health and medical consequences of a potential bioterrorist attack against the civilian population;

"(4) the activities and costs of the Civil Support Teams of the National Guard in responding to biological threats or attacks against the civilian population;

"(5) the activities of the working group under subsection (a) and the efforts made by such group to carry out the activities described in such subsection; and

"(6) the ability of private sector contractors to enhance governmental responses to biological threats or attacks."

1 See References in Text note below.
42 U.S.C. § 1439 (2024) — Title 42: THE PUBLIC HEALTH AND WELFARE / Chapter 8: LOW-INCOME HOUSING / Subchapter III: MISCELLANEOUS PROVISIONS / Section 1439: Local housing assistance plan
Local housing assistance plan
Status: in_force

(a) Applicability of approved plan to housing assistance application; procedure upon receipt of application by Secretary of Housing and Urban Development; definitions

(1) The Secretary of Housing and Urban Development, upon receiving an application for housing assistance under the United States Housing Act of 1937 [42 U.S.C. 1437 et seq.],1 section 101 of the Housing and Urban Development Act of 1965 [12 U.S.C. 1701s], or,2 if the unit of general local government in which the proposed assistance is to be provided has an approved housing assistance plan, shall—

(A) not later than ten days after receipt of the application, notify the chief executive officer of such unit of general local government that such application is under consideration; and

(B) afford such unit of general local government the opportunity, during the thirty-day period beginning on the date of such notification, to object to the approval of the application on the grounds that the application is inconsistent with its housing assistance plan.

Upon receiving an application for such housing assistance, the Secretary shall assure that funds made available under this section shall be utilized to the maximum extent practicable to meet the needs and goals identified in the unit of local government's housing assistance plan.

(2) If the unit of general local government objects to the application on the grounds that it is inconsistent with its housing assistance plan, the Secretary may not approve the application unless he determines that the application is consistent with such housing assistance plan. If the Secretary determines, that such application is consistent with the housing assistance plan, he shall notify the chief executive officer of the unit of general local government of his determination and the reasons therefor in writing. If the Secretary concurs with the objection of the unit of local government, he shall notify the applicant stating the reasons therefor in writing.

(3) If the Secretary does not receive an objection by the close of the period referred to in paragraph (1)(B), he may approve the application unless he finds it inconsistent with the housing assistance plan. If the Secretary determines that an application is inconsistent with a housing assistance plan, he shall notify the applicant stating the reasons therefor in writing.

(4) The Secretary shall make the determinations referred to in paragraphs (2) and (3) within thirty days after he receives an objection pursuant to paragraph (1)(B) or within thirty days after the close of the period referred to in paragraph (1)(B), whichever is earlier.

(5) As used in this section, the term "housing assistance plan" means a housing assistance plan submitted and approved under section 5304 of this title or, in the case of a unit of general local government not participating under title I of this Act [42 U.S.C. 5301 et seq.], a housing plan approved by the Secretary as meeting the requirements of this section. In developing a housing assistance plan under this paragraph a unit of general local government shall consult with local public agencies involved in providing for the welfare of children to determine the housing needs of (A) families identified by the agencies as having a lack of adequate housing that is a primary factor in the imminent placement of a child in foster care or in preventing the discharge of a child from foster care and reunification with his or her family; and (B) children who, upon discharge of the child from foster care, cannot return to their family or extended family and for which adoption is not available. The unit of general local government shall include in the housing assistance plan needs and goals with respect to such families and children.

(b) Housing assistance applications subject to procedures

The provisions of subsection (a) shall not apply to—

(1) applications for assistance involving 12 or fewer units in a single project or development;

(2) applications for assistance with respect to housing in new community developments approved under title IV of the Housing and Urban Development Act of 1968 [42 U.S.C. 3901 et seq.] or title VII of the Housing and Urban Development Act of 1970 [42 U.S.C. 4501 et seq.] which the Secretary determines are necessary to meet the housing requirements under such title; or

(3) applications for assistance with respect to housing financed by loans or loan guarantees from a State or agency thereof, except that the provisions of subsection (a) shall apply where the unit of general local government in which the assistance is to be provided objects in its housing assistance plan to the exemption provided by this paragraph.

(c) Repealed. Pub. L. 105–276, title V, §551(1), Oct. 21, 1998, 112 Stat. 2610

(d) Allocation and reservation of housing assistance funds; purposes; prohibited reallocation of unutilized funds; enumerated uses for retained funds; competition for reservation and obligation of funds

(1)(A)(i) Except as provided by subparagraph (B), the Secretary shall allocate assistance referred to in subsection (a)(1) the first time it is available for reservation on the basis of a formula that is contained in a regulation prescribed by the Secretary, and that is based on the relative needs of different States, areas, and communities, as reflected in data as to population, poverty, housing overcrowding, housing vacancies, amount of substandard housing, and other objectively measurable conditions specified in the regulation. The Secretary may allocate assistance under the preceding sentence in such a manner that each State shall receive not less than one-half of one percent of the amount of funds available for each program referred to in subsection (a)(1) in each fiscal year. In allocating assistance under this paragraph for each program of housing assistance under subsection (a)(1), the Secretary shall apply the formula, to the extent practicable, in a manner so that the assistance under the program is allocated according to the particular relative needs under the preceding sentence that are characteristic of and related to the particular type of assistance provided under the program. Assistance under section 202 of the Housing Act of 1959 [12 U.S.C. 1701q] shall be allocated in a manner that ensures that awards of the assistance under such section are made for projects of sufficient size to accommodate facilities for supportive services appropriate to the needs of frail elderly residents. The preceding sentence shall not apply to projects acquired from the Resolution Trust Corporation under section 1441a(c) 3 of title 12. Amounts for tenant-based assistance under section 8(o) of the United States Housing Act of 1937 [42 U.S.C. 1437f(o)] may not be provided to any public housing agency that has been disqualified from providing such assistance.

(ii) Assistance under section 8(o) of the United States Housing Act of 1937 [42 U.S.C. 1437f(o)] shall be allocated in a manner that enables participating jurisdictions to carry out, to the maximum extent practicable, comprehensive housing affordability strategies approved in accordance with section 105 of the Cranston-Gonzalez National Affordable Housing Act [42 U.S.C. 12705]. Such jurisdictions shall submit recommendations for allocating assistance under such section 8(o) to the Secretary in accordance with procedures that the Secretary determines to be appropriate to permit allocations of such assistance to be made on the basis of timely and complete information. This clause may not be construed to prevent, alter, or otherwise affect the application of the formula established pursuant to clause (i) for purposes of allocating such assistance. For purposes of this clause, the term "participating jurisdiction" means a State or unit of general local government designated by the Secretary to be a participating jurisdiction under title II of the Cranston-Gonzalez National Affordable Housing Act [42 U.S.C. 12721 et seq.].

(B) The formula allocation requirements of subparagraph (A) shall not apply to—

(i) assistance that is approved in appropriation Acts for use under sections 4 9 [42 U.S.C. 1437g], or the rental rehabilitation grant program under section 17,3 of the United States Housing Act of 1937, except that the Secretary shall comply with section 102 of the Department of Housing and Urban Development Reform Act of 1989 [42 U.S.C. 3545] with respect to such assistance; or

(ii) other assistance referred to in subsection (a) that is approved in appropriation Acts for uses that the Secretary determines are incapable of geographic allocation, including amendments of existing contracts, renewal of assistance contracts, assistance to families that would otherwise lose assistance due to the decision of the project owner to prepay the project mortgage or not to renew the assistance contract, assistance to prevent displacement or to provide replacement housing in connection with the demolition or disposition of public housing, and assistance in support of the property disposition and loan management functions of the Secretary.

(C) Any allocation of assistance under subparagraph (A) shall, as determined by the Secretary, be made to the smallest practicable area, consistent with the delivery of assistance through a meaningful competitive process designed to serve areas with greater needs.

(D) Any amounts allocated to a State or areas or communities within a State that are not likely to be used within a fiscal year shall not be reallocated for use in another State, unless the Secretary determines that other areas or communities (that are eligible for assistance under the program) within the same State cannot use the amounts within that same fiscal year.

(2) The Secretary may reserve such housing assistance funds as he deems appropriate for use by a State or agency thereof.

(3)(A) Notwithstanding any other provision of law, with respect to fiscal years beginning after September 30, 1990, the Secretary may retain not more than 5 percent of the financial assistance that becomes available under programs described in subsection (a)(1) during any fiscal year. Any such financial assistance that is retained shall be available for subsequent allocation to specific areas and communities, and may only be used for—

(i) unforeseen housing needs resulting from natural and other disasters;

(ii) housing needs resulting from emergencies, as certified by the Secretary, other than such disasters;

(iii) housing needs resulting from the settlement of litigation; and

(iv) housing in support of desegregation efforts.

(B) Any amounts retained in any fiscal year under subparagraph (A) that are unexpended at the end of such fiscal year shall remain available for the following fiscal year under the program under subsection (a)(1) from which the amount was retained. Such amounts shall be allocated on the basis of the formula under subsection (d)(1).

(4)(A) The Secretary shall not reserve or obligate assistance subject to allocation under paragraph (1)(A) to specific recipients, unless the assistance is first allocated on the basis of the formula contained in that paragraph and then is reserved and obligated pursuant to a competition.

(B) Any competition referred to in subparagraph (A) shall be conducted pursuant to specific criteria for the selection of recipients of assistance. The criteria shall be contained in—

(i) a regulation promulgated by the Secretary after notice and public comment; or

(ii) to the extent authorized by law, a notice published in the Federal Register.

(C) Subject to the times at which appropriations for assistance subject to paragraph (1)(A) may become available for reservation in any fiscal year, the Secretary shall take such steps as the Secretary deems appropriate to ensure that, to the maximum extent practicable, the process referred to in subparagraph (A) is carried out with similar frequency and at similar times for each fiscal year.

(D) This paragraph shall not apply to assistance referred to in paragraph (4).3

(e) Assistance payments for properties in Jefferson County, Texas

From budget authority made available in appropriation Acts for fiscal year 1988, the Secretary shall enter into an annual contributions contract for a term of 180 months to obligate sufficient funds to provide assistance payments pursuant to section 8(b)(1) of the United States Housing Act of 1937 [42 U.S.C. 1437f(b)(1)] on behalf of 500 lower income families from budget authority made available for fiscal year 1988, so long as such families occupy properties in Jefferson County, Texas. If a lower income family receiving assistance payments pursuant to this subsection ceases to qualify for assistance payments pursuant to the provisions of section 8 of such Act [42 U.S.C. 1437f] or of this subsection during the 180-month term of the annual contributions contract, assistance payments shall be made on behalf of another lower income family who occupies a unit identified in the previous sentence.

(Pub. L. 93–383, title II, §213, Aug. 22, 1974, 88 Stat. 674; Pub. L. 95–128, title II, §207, Oct. 12, 1977, 91 Stat. 1130; Pub. L. 96–153, title II, §204, Dec. 21, 1979, 93 Stat. 1108; Pub. L. 96–399, title II, §202(d), Oct. 8, 1980, 94 Stat. 1629; Pub. L. 97–35, title III, §321(e), Aug. 13, 1981, 95 Stat. 399; Pub. L. 98–181, title I [title II, §201(a)(1), (2)], Nov. 30, 1983, 97 Stat. 1175; Pub. L. 98–479, title I, §102(e), Oct. 17, 1984, 98 Stat. 2222; Pub. L. 100–242, title V, §522(a), Feb. 5, 1988, 101 Stat. 1938; Pub. L. 101–235, title I, §§101(a)–(c), (e), 104(a), Dec. 15, 1989, 103 Stat. 1988–1990, 1998; Pub. L. 101–494, §5, Oct. 31, 1990, 104 Stat. 1186; Pub. L. 101–625, title V, §§556, 576, title VIII, §§801(b), 804(e), Nov. 28, 1990, 104 Stat. 4233, 4238, 4303, 4323; Pub. L. 102–389, title II, Oct. 6, 1992, 106 Stat. 1591; Pub. L. 102–550, title I, §154, Oct. 28, 1992, 106 Stat. 3718; Pub. L. 104–330, title V, §501(d)(3), Oct. 26, 1996, 110 Stat. 4043; Pub. L. 105–276, title V, §§522(b)(2), 551, Oct. 21, 1998, 112 Stat. 2564, 2610.)

Editorial Notes

References in Text

The United States Housing Act of 1937, referred to in subsec. (a)(1), is act Sept. 1, 1937, ch. 896, as revised generally by Pub. L. 93–383, title II, §201(a), Aug. 22, 1974, 88 Stat. 653, which is classified generally to this chapter (§1437 et seq.). Section 17 of the United States Housing Act of 1937, referred to in subsec. (d)(1)(B)(i), which was classified to section 1437o of this title, was repealed by Pub. L. 101–625, title II, §289(b), Nov. 28, 1990, 104 Stat. 4128. For complete classification of this Act to the Code, see Short Title note under section 1437 of this title and Tables.

Section 101 of the Housing and Urban Development Act of 1965, referred to in subsec. (a)(1), is section 101 of Pub. L. 89–117, Aug. 10, 1965, 79 Stat. 451, which enacted section 1701s of Title 12, Banks and Banking, and amended sections 1451 and 1465 of this title.

This Act, referred to in subsec. (a)(5), is Pub. L. 93–383, Aug. 22, 1974, 88 Stat. 633, known as the Housing and Community Development Act of 1974. Title I of the Housing and Community Development Act of 1974 is classified principally to chapter 69 (§5301 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 5301 of this title and Tables.

The Housing and Urban Development Act of 1968, referred to in subsec. (b)(2), is Pub. L. 90–448, Aug. 1, 1968, 82 Stat. 476. Title IV of the Housing and Urban Development Act of 1968 which was classified principally to chapter 48 (§3901 et seq.) of this title, was omitted from the Code pursuant to section 4528 of this title, which terminated the authority to guarantee bonds, debentures, notes, or other obligations under such title IV, after Dec. 31, 1970. For complete classification of this Act to the Code, see Short Title note set out under section 1701 of Title 12, Banks and Banking, and Tables.

The Housing and Urban Development Act of 1970, referred to in subsec. (b)(2), is Pub. L. 91–609, Dec. 31, 1970, 84 Stat. 1770. Title VII of the Housing and Urban Development Act of 1970, known as the Urban Growth and New Community Development Act of 1970, is classified principally to chapter 59 (§4501 et seq.) of this title. For complete classification of this Act to the Code, see Short Title of 1970 Amendment note set out under section 1701 of Title 12.

Section 1441a(c) of title 12, referred to in subsec. (d)(1)(A)(i), was repealed by Pub. L. 111–203, title III, §364(b), July 21, 2010, 124 Stat. 1555.

The Cranston-Gonzalez National Affordable Housing Act, referred to in subsec. (d)(1)(A)(ii), is Pub. L. 101–625, Nov. 28, 1990, 104 Stat. 4079. Title II of the Act, known as the "HOME Investments Partnership Act", is classified principally to subchapter II (§12721 et seq.) of chapter 130 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 12701 of this title and Tables.

Paragraph (4), referred to in subsec. (d)(4)(D), was redesignated paragraph (3) of subsec. (d) by Pub. L. 105–276, title V, §551(2)(C), Oct. 21, 1998, 112 Stat. 2610.

Codification

Section was enacted as part of the Housing and Community Development Act of 1974, and not as part of the United States Housing Act of 1937 which comprises this chapter.

Amendments

1998—Subsec. (c). Pub. L. 105–276, §551(1), struck out subsec. (c) which read as follows: "For areas in which an approved local housing assistance plan is not applicable the Secretary shall not approve an application for housing assistance unless he determines that there is a need for such assistance, taking into consideration any applicable State housing plans, and that there is or will be available in the area public facilities and services adequate to serve the housing proposed to be assisted. The Secretary shall afford the unit of general local government in which the assistance is to be provided an opportunity, during a 30-day period following receipt of an application by him, to provide comments or information relevant to the determination required to be made by the Secretary under this subsection."

Subsec. (d)(1)(A)(i). Pub. L. 105–276, §551(2)(A)(i), inserted at end "Amounts for tenant-based assistance under section 8(o) of the United States Housing Act of 1937 may not be provided to any public housing agency that has been disqualified from providing such assistance."

Subsec. (d)(1)(A)(ii). Pub. L. 105–276, §551(2)(A)(ii), substituted "8(o)" for "8(b)(1)" in two places.

Subsec. (d)(1)(B)(i). Pub. L. 105–276, §522(b)(2), which directed the amendment of subsec. (d)(1)(B)(ii), by striking out "or 14", was executed by striking out "or 14" after "9" in subsec. (d)(1)(B)(i) to reflect the probable intent of Congress.

Subsec. (d)(2) to (5). Pub. L. 105–276, §551(2)(B), (C), redesignated pars. (3) to (5) as (2) to (4), respectively, and struck out former par. (2) which read as follows: "Not later than sixty days after approval in an appropriation Act, the Secretary shall allocate from the amounts available for use in nonmetropolitan areas an amount of authority for assistance under section 8(d) of the United States Housing Act of 1937 determined in consultation with the Secretary of Agriculture for use in connection with section 1490m of this title during the fiscal year for which such authority is approved. The amount of assistance allocated to nonmetropolitan areas pursuant to this section in any fiscal year shall not be less than 20 nor more than 25 per centum of the total amount of the assistance that is subject to allocation under paragraph (1)(A)."

1996—Subsec. (d)(1)(B)(ii). Pub. L. 104–330 substituted "public housing" for "public and Indian housing".

1992—Subsec. (e). Pub. L. 102–389 and Pub. L. 102–550 amended subsec. (e) identically, substituting "Jefferson County, Texas" for "the Park Central New Community Project or in adjacent areas that are recognized by the unit of general local government in which such Project is located as being included within the Park Central New Town In Town Project".

1990—Subsec. (a)(1). Pub. L. 101–625, §801(b), struck out "section 202 of the Housing Act of 1959" before ", if the unit".

Subsec. (a)(5). Pub. L. 101–625, §576, inserted at end "In developing a housing assistance plan under this paragraph a unit of general local government shall consult with local public agencies involved in providing for the welfare of children to determine the housing needs of (A) families identified by the agencies as having a lack of adequate housing that is a primary factor in the imminent placement of a child in foster care or in preventing the discharge of a child from foster care and reunification with his or her family; and (B) children who, upon discharge of the child from foster care, cannot return to their family or extended family and for which adoption is not available. The unit of general local government shall include in the housing assistance plan needs and goals with respect to such families and children."

Subsec. (d)(1)(A). Pub. L. 101–625, §556, designated existing provisions as cl. (i) and added cl. (ii).

Pub. L. 101–494 inserted after first sentence "The Secretary may allocate assistance under the preceding sentence in such a manner that each State shall receive not less than one-half of one percent of the amount of funds available for each program referred to in subsection (a)(1) in each fiscal year."

Subsec. (d)(1)(A)(i). Pub. L. 101–625, §804(e), which directed amendment of subpar. (A) by inserting after the period at end "The preceding sentence shall not apply to projects acquired from the Resolution Trust Corporation under section 1441a(c) of title 12.", was executed by making the insertion after the period at end of cl. (i), to reflect the probable intent of Congress and the intervening amendment by Pub. L. 101–625, §556. See above.

1989—Subsec. (a)(1). Pub. L. 101–235, §101(e), struck out "section 235 or 236 of the National Housing Act," before "section 101 of the Housing and Urban Development Act of 1965".

Subsec. (d)(1). Pub. L. 101–235, §101(a), amended par. (1) generally. Prior to amendment, par. (1) read as follows: "The Secretary shall allocate assistance referred to in subsection (a) of this section (other than assistance approved in appropriation Acts for use under sections 9, 14, and 17 of the United States Housing Act of 1937) the first time it is available for reservation on the basis of a formula which is contained in a regulation prescribed by the Secretary, and which is based on the relative needs of different States, areas, and communities as reflected in data as to population, poverty, housing overcrowding, housing vacancies, amount of substandard housing, and other objectively measurable conditions specified in such regulation. Any amounts allocated to a State or areas or communities within a State which are not likely to be utilized within a fiscal year shall not be reallocated for use in another State unless the Secretary determines that other areas or communities within the same State cannot utilize the amounts within that same fiscal year."

Subsec. (d)(2). Pub. L. 101–235, §101(b), substituted "of the assistance that is subject to allocation under paragraph (1)(A)" for "of such assistance".

Subsec. (d)(4). Pub. L. 101–235, §104(a), amended par. (4) generally. Prior to amendment, par. (4) read as follows: "Notwithstanding any other provision of law, with respect to fiscal years beginning after September 30, 1981, the Secretary of Housing and Urban Development may not retain more than 15 per centum of the financial assistance which becomes available under programs described in subsection (a)(1) of this section during any fiscal year. Any such financial assistance which is retained shall be available for subsequent allocation to specific areas and communities, and may only be used for—

"(A) unforeseeable housing needs, especially those brought on by natural disasters or special relocation requirements;

"(B) support for the needs of the handicapped or for minority enterprise;

"(C) providing for assisted housing as a result of the settlement of litigation;

"(D) small research and demonstration projects;

"(E) lower-income housing needs described in housing assistance plans, including activities carried out under areawide housing opportunity plans; and

"(F) innovative housing programs or alternative methods for meeting lower-income housing needs approved by the Secretary, including assistance for infrastructure in connection with the Indian Housing Program."

Subsec. (d)(5). Pub. L. 101–235, §101(c), added par. (5).

1988—Subsec. (e). Pub. L. 100–242 added subsec. (e).

1984—Subsec. (d)(2). Pub. L. 98–479 substituted "section 1490m of this title" for "section 1490l of this title".

1983—Subsec. (a)(1). Pub. L. 98–181, §201(a)(1), inserted provision following subpar. (B) requiring that funds be utilized to meet the needs and goals identified in the unit of local government's housing assistance plan.

Subsec. (d)(1). Pub. L. 98–181, §201(a)(2), amended par. (1) generally, inserting provision respecting assistance approved in appropriation Acts for sections 9 and 17 of the United States Housing Act of 1937 uses, requiring allocation of assistance to be based on a formula contained in a regulation, making the relative needs provision applicable to different States, striking out requirement that Secretary assure, in carrying out national housing and community development objectives, that funds available for housing assistance programs be allocated or reserved in accordance with goals described in approved housing assistance plans, and striking out provision respecting allocation of funds for nonmetropolitan areas, which was reenacted as last sentence of par. (2).

Subsec. (d)(2). Pub. L. 98–181, §201(a)(2), amended par. (2) generally, inserting provision respecting allocation of nonmetropolitan area funds for use in connection with section 1490l of this title; reenacting as second sentence provision respecting amount of funds allocated for nonmetropolitan areas, which formerly constituted last sentence of par. (1); and striking out former provision respecting reservation of housing assistance funds for new community developments approved under title IV of the Housing and Urban Development Act of 1968 and title VII of the Housing and Urban Development Act of 1970 for persons of low- and moderate-income.

1981—Subsec. (d)(4). Pub. L. 97–35 added par. (4).

1980—Subsec. (d)(1). Pub. L. 96–399 substituted "carrying out section 14 of such Act" for "modernization of low-income housing projects".

1979—Subsec. (d)(1). Pub. L. 96–153 inserted provisions limiting allocation of assistance other than that approved in appropriation acts for use on and after Oct. 1, 1979 for modernization of low-income housing projects and inserted provision that any amounts allocated to a State or to areas or communities within a State which are not likely to be utilized within a fiscal year shall not be reallocated for use in another State unless the Secretary determines that other areas or communities within the same State cannot utilize the amounts in accordance with the appropriate housing assistance plans within that fiscal year.

1977—Subsec. (d)(1). Pub. L. 95–128 inserted provision requiring the Secretary to assure that funds available for subsec. (a) housing assistance programs shall be allocated or reserved in accordance with goals described in local, State, or other housing assistance plans approved by the Secretary pursuant to section 5304 of this title and shall be utilized to meet needs reflected in data referred to in the preceding sentence.

Statutory Notes and Related Subsidiaries

Effective Date of 1998 Amendment

Amendment by title V of Pub. L. 105–276 effective and applicable beginning upon Oct. 1, 1999, except as otherwise provided, with provision that Secretary may implement amendment before such date, except to extent that such amendment provides otherwise, and with savings provision, see section 503 of Pub. L. 105–276, set out as a note under section 1437 of this title.

Effective Date of 1996 Amendment

Amendment by Pub. L. 104–330 effective Oct. 1, 1997, except as otherwise expressly provided, see section 107 of Pub. L. 104–330, set out as an Effective Date note under section 4101 of Title 25, Indians.

Effective Date of 1990 Amendment

Amendment by section 801(b) of Pub. L. 101–625 effective Oct. 1, 1991, with respect to projects approved on or after such date, and subject to issuance of regulations, see section 801(c) of Pub. L. 101–625, set out as a note under section 1701q of Title 12, Banks and Banking.

Amendment by section 801(b) of Pub. L. 101–625 deemed enacted Nov. 5, 1990, see title II of Pub. L. 101–507, set out as a note under section 1701q of Title 12.

Effective Date of 1989 Amendment

Pub. L. 101–235, title I, §104(b), Dec. 15, 1989, 103 Stat. 1998, provided that: "Any assistance made available under section 213(d)(4) of the Housing and Community Development Act of 1974 [42 U.S.C. 1439(d)(4)] before October 1, 1990, or pursuant to a commitment for such assistance entered into before such date, shall be governed by the provisions of section 213(d)(4) as such section existed before the date of the enactment of this Act [Dec. 15, 1989]."

Effective Date of 1981 Amendment

Amendment by Pub. L. 97–35 effective Oct. 1, 1981, see section 371 of Pub. L. 97–35, set out as an Effective Date note under section 3701 of Title 12, Banks and Banking.

1 So in original. The comma probably should be "or".

2 So in original. The word "or" and the comma probably should not appear.

3 See References in Text note below.

4 So in original. Probably should be "section".
42 U.S.C. § 262a (2024) — Title 42: THE PUBLIC HEALTH AND WELFARE / Chapter 6A: PUBLIC HEALTH SERVICE / Subchapter II: GENERAL POWERS AND DUTIES / Section 262a: Enhanced control of dangerous biological agents and toxins
Enhanced control of dangerous biological agents and toxins
Status: in_force

(a) Regulatory control of certain biological agents and toxins

(1) List of biological agents and toxins

(A) In general

The Secretary shall by regulation establish and maintain a list of each biological agent and each toxin that has the potential to pose a severe threat to public health and safety.

(B) Criteria

In determining whether to include an agent or toxin on the list under subparagraph (A), the Secretary shall—

(i) consider—

(I) the effect on human health of exposure to the agent or toxin;

(II) the degree of contagiousness of the agent or toxin and the methods by which the agent or toxin is transferred to humans;

(III) the availability and effectiveness of pharmacotherapies and immunizations to treat and prevent any illness resulting from infection by the agent or toxin; and

(IV) any other criteria, including the needs of children and other vulnerable populations, that the Secretary considers appropriate; and

(ii) consult with appropriate Federal departments and agencies and with scientific experts representing appropriate professional groups, including groups with pediatric expertise.

(2) Biennial review

The Secretary shall review and republish the list under paragraph (1) biennially, or more often as needed, and shall by regulation revise the list as necessary in accordance with such paragraph.

(b) Regulation of transfers of listed agents and toxins

The Secretary shall by regulation provide for—

(1) the establishment and enforcement of safety procedures for the transfer of listed agents and toxins, including measures to ensure—

(A) proper training, including with respect to notification requirements under this section, of—

(i) individuals who are involved in the handling and use of such agents and toxins, including appropriate skills to handle such agents and toxins;

(ii) individuals whose responsibilities routinely place them in close proximity to laboratory facilities in which such agents and toxins are being transferred, possessed, or used; and

(iii) individuals who perform administrative or oversight functions of the facility related to the transfer, possession, or use of such agents and toxins on behalf of registered persons;

(B) proper laboratory facilities to contain and dispose of such agents and toxins;

(2) the establishment and enforcement of safeguard and security measures to prevent access to such agents and toxins for use in domestic or international terrorism or for any other criminal purpose;

(3) the establishment of procedures to protect the public safety in the event of a transfer or potential transfer of such an agent or toxin in violation of the safety procedures established under paragraph (1) or the safeguard and security measures established under paragraph (2); and

(4) appropriate availability of biological agents and toxins for research, education, and other legitimate purposes.

(c) Possession and use of listed agents and toxins

The Secretary shall by regulation provide for the establishment and enforcement of standards and procedures governing the possession and use of listed agents and toxins, including the provisions described in paragraphs (1) through (4) of subsection (b), in order to protect the public health and safety.

(d) Registration; identification; database

(1) Registration

Regulations under subsections (b) and (c) shall require registration with the Secretary of the possession, use, and transfer of listed agents and toxins, and shall include provisions to ensure that persons seeking to register under such regulations have a lawful purpose to possess, use, or transfer such agents and toxins, including provisions in accordance with subsection (e)(6).

(2) Identification; database

Regulations under subsections (b) and (c) shall require that registration include (if available to the person registering) information regarding the characterization of listed agents and toxins to facilitate their identification, including their source. The Secretary shall maintain a national database that includes the names and locations of registered persons, the listed agents and toxins such persons are possessing, using, or transferring, and information regarding the characterization of such agents and toxins.

(e) Safeguard and security requirements for registered persons

(1) In general

Regulations under subsections (b) and (c) shall include appropriate safeguard and security requirements for persons possessing, using, or transferring a listed agent or toxin commensurate with the risk such agent or toxin poses to public health and safety (including risks posed by the release, theft, or loss of such agent or toxin, or use in domestic or international terrorism). The Secretary shall establish such requirements in collaboration with the Secretary of Homeland Security and the Attorney General, and shall ensure compliance with such requirements as part of the registration system under such regulations.

(2) Limiting access to listed agents and toxins

Requirements under paragraph (1) shall include provisions to ensure that registered persons—

(A) provide access to listed agents and toxins to only those individuals whom the registered person involved determines have a legitimate need to handle or use such agents and toxins;

(B) submit the names and other identifying information for such individuals to the Secretary and the Attorney General, promptly after first determining that the individuals need access under subparagraph (A), and periodically thereafter while the individuals have such access, not less frequently than once every five years;

(C) deny access to such agents and toxins by individuals whom the Attorney General has identified as restricted persons; and

(D) limit or deny access to such agents and toxins by individuals whom the Attorney General has identified as within any category under paragraph (3)(B)(ii), if limiting or denying such access by the individuals involved is determined appropriate by the Secretary, in consultation with the Attorney General.

(3) Submitted names; use of databases by attorney general

(A) In general

Upon the receipt of names and other identifying information under paragraph (2)(B), the Attorney General shall, for the sole purpose of identifying whether the individuals involved are within any of the categories specified in subparagraph (B), promptly use criminal, immigration, national security, and other electronic databases that are available to the Federal Government and are appropriate for such purpose.

(B) Certain individuals

For purposes of subparagraph (A), the categories specified in this subparagraph regarding an individual are that—

(i) the individual is a restricted person; or

(ii) the individual is reasonably suspected by any Federal law enforcement or intelligence agency of—

(I) committing a crime set forth in section 2332b(g)(5) of title 18;

(II) knowing involvement with an organization that engages in domestic or international terrorism (as defined in section 2331 of such title 18) or with any other organization that engages in intentional crimes of violence; or

(III) being an agent of a foreign power (as defined in section 1801 of title 50).

(C) Notification by Attorney General regarding submitted names

After the receipt of a name and other identifying information under paragraph (2)(B), the Attorney General shall promptly notify the Secretary whether the individual is within any of the categories specified in subparagraph (B).

(4) Notifications by Secretary

The Secretary, after receiving notice under paragraph (3) regarding an individual, shall promptly notify the registered person involved of whether the individual is granted or denied access under paragraph (2). If the individual is denied such access, the Secretary shall promptly notify the individual of the denial.

(5) Expedited review

Regulations under subsections (b) and (c) shall provide for a procedure through which, upon request to the Secretary by a registered person who submits names and other identifying information under paragraph (2)(B) and who demonstrates good cause, the Secretary may, as determined appropriate by the Secretary—

(A) request the Attorney General to expedite the process of identification under paragraph (3)(A) and notification of the Secretary under paragraph (3)(C); and

(B) expedite the notification of the registered person by the Secretary under paragraph (4).

(6) Process regarding persons seeking to register

(A) Individuals

Regulations under subsections (b) and (c) shall provide that an individual who seeks to register under either of such subsections is subject to the same processes described in paragraphs (2) through (4) as apply to names and other identifying information submitted to the Attorney General under paragraph (2)(B). Paragraph (5) does not apply for purposes of this subparagraph.

(B) Other persons

Regulations under subsections (b) and (c) shall provide that, in determining whether to deny or revoke registration by a person other than an individual, the Secretary shall submit the name of such person to the Attorney General, who shall use criminal, immigration, national security, and other electronic databases available to the Federal Government, as appropriate for the purpose of promptly notifying the Secretary whether the person, or, where relevant, the individual who owns or controls such person, is a restricted person or is reasonably suspected by any Federal law enforcement or intelligence agency of being within any category specified in paragraph (3)(B)(ii) (as applied to persons, including individuals). Such regulations shall provide that a person who seeks to register under either of such subsections is subject to the same processes described in paragraphs (2) and (4) as apply to names and other identifying information submitted to the Attorney General under paragraph (2)(B). Paragraph (5) does not apply for purposes of this subparagraph. The Secretary may exempt Federal, State, or local governmental agencies from the requirements of this subparagraph.

(7) Review

(A) Administrative review

(i) In general

Regulations under subsections (b) and (c) shall provide for an opportunity for a review by the Secretary—

(I) when requested by the individual involved, of a determination under paragraph (2) to deny the individual access to listed agents and toxins; and

(II) when requested by the person involved, of a determination under paragraph (6) to deny or revoke registration for such person.

(ii) Ex parte review

During a review under clause (i), the Secretary may consider information relevant to the review ex parte to the extent that disclosure of the information could compromise national security or an investigation by any law enforcement agency.

(iii) Final agency action

The decision of the Secretary in a review under clause (i) constitutes final agency action for purposes of section 702 of title 5.

(B) Certain procedures

(i) Submission of ex parte materials in judicial proceedings

When reviewing a decision of the Secretary under subparagraph (A), and upon request made ex parte and in writing by the United States, a court, upon a sufficient showing, may review and consider ex parte documents containing information the disclosure of which could compromise national security or an investigation by any law enforcement agency. If the court determines that portions of the documents considered ex parte should be disclosed to the person involved to allow a response, the court shall authorize the United States to delete from such documents specified items of information the disclosure of which could compromise national security or an investigation by any law enforcement agency, or to substitute a summary of the information to which the person may respond. Any order by the court authorizing the disclosure of information that the United States believes could compromise national security or an investigation by any law enforcement agency shall be subject to the processes set forth in subparagraphs (A) and (B)(i) of section 2339B(f)(5) of title 18 (relating to interlocutory appeal and expedited consideration).

(ii) Disclosure of information

In a review under subparagraph (A), and in any judical 1 proceeding conducted pursuant to such review, neither the Secretary nor the Attorney General may be required to disclose to the public any information that under subsection (h) shall not be disclosed under section 552 of title 5.

(8) Notifications regarding theft or loss of agents

Requirements under paragraph (1) shall include the prompt notification of the Secretary, and appropriate Federal, State, and local law enforcement agencies, of the theft or loss of listed agents and toxins.

(9) Technical assistance for registered persons

The Secretary, in consultation with the Attorney General, may provide technical assistance to registered persons to improve security of the facilities of such persons.

(f) Inspections

The Secretary shall have the authority to inspect persons subject to regulations under subsection (b) or (c) to ensure their compliance with such regulations, including prohibitions on restricted persons and other provisions of subsection (e).

(g) Exemptions

(1) Clinical or diagnostic laboratories

Regulations under subsections (b) and (c) shall exempt clinical or diagnostic laboratories and other persons who possess, use, or transfer listed agents or toxins that are contained in specimens presented for diagnosis, verification, or proficiency testing, provided that—

(A) the identification of such agents or toxins is reported to the Secretary, and when required under Federal, State, or local law, to other appropriate authorities; and

(B) such agents or toxins are transferred or destroyed in a manner set forth by the Secretary by regulation.

(2) Products

(A) In general

Regulations under subsections (b) and (c) shall exempt products that are, bear, or contain listed agents or toxins and are cleared, approved, licensed, or registered under any of the Acts specified in subparagraph (B), unless the Secretary by order determines that applying additional regulation under subsection (b) or (c) to a specific product is necessary to protect public health and safety.

(B) Relevant laws

For purposes of subparagraph (A), the Acts specified in this subparagraph are the following:

(i) The Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.].

(ii) Section 262 of this title.

(iii) The Act commonly known as the Virus-Serum-Toxin Act (the eighth paragraph under the heading "Bureau of Animal Industry" in the Act of March 4, 1913; 21 U.S.C. 151–159).

(iv) The Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.].

(C) Investigational use

(i) In general

The Secretary may exempt an investigational product that is, bears, or contains a listed agent or toxin from the applicability of provisions of regulations under subsection (b) or (c) when such product is being used in an investigation authorized under any Federal Act and the Secretary determines that applying additional regulation under subsection (b) or (c) to such product is not necessary to protect public health and safety.

(ii) Certain processes

Regulations under subsections (b) and (c) shall set forth the procedures for applying for an exemption under clause (i). In the case of investigational products authorized under any of the Acts specified in subparagraph (B), the Secretary shall make a determination regarding a request for an exemption not later than 14 days after the first date on which both of the following conditions have been met by the person requesting the exemption:

(I) The person has submitted to the Secretary an application for the exemption meeting the requirements established by the Secretary.

(II) The person has notified the Secretary that the investigation has been authorized under such an Act.

(3) Public health emergencies

The Secretary may temporarily exempt a person from the applicability of the requirements of this section, in whole or in part, if the Secretary determines that such exemption is necessary to provide for the timely participation of the person in a response to a domestic or foreign public health emergency (whether determined under section 247d(a) of this title or otherwise) that involves a listed agent or toxin. With respect to the emergency involved, such exemption for a person may not exceed 30 days, except that the Secretary, after review of whether such exemption remains necessary, may provide one extension of an additional 30 days.

(4) Agricultural emergencies

Upon request of the Secretary of Agriculture, after the granting by such Secretary of an exemption under section 8401(g)(1)(D) of title 7 pursuant to a finding that there is an agricultural emergency, the Secretary of Health and Human Services may temporarily exempt a person from the applicability of the requirements of this section, in whole or in part, to provide for the timely participation of the person in a response to the agricultural emergency. With respect to the emergency involved, the exemption under this paragraph for a person may not exceed 30 days, except that upon request of the Secretary of Agriculture, the Secretary of Health and Human Services may, after review of whether such exemption remains necessary, provide one extension of an additional 30 days.

(h) Disclosure of information

(1) Nondisclosure of certain information

No Federal agency specified in paragraph (2) shall disclose under section 552 of title 5 any of the following:

(A) Any registration or transfer documentation submitted under subsections (b) and (c) for the possession, use, or transfer of a listed agent or toxin; or information derived therefrom to the extent that it identifies the listed agent or toxin possessed, used, or transferred by a specific registered person or discloses the identity or location of a specific registered person.

(B) The national database developed pursuant to subsection (d), or any other compilation of the registration or transfer information submitted under subsections (b) and (c) to the extent that such compilation discloses site-specific registration or transfer information.

(C) Any portion of a record that discloses the site-specific or transfer-specific safeguard and security measures used by a registered person to prevent unauthorized access to listed agents and toxins.

(D) Any notification of a release of a listed agent or toxin submitted under subsections (b) and (c), or any notification of theft or loss submitted under such subsections.

(E) Any portion of an evaluation or report of an inspection of a specific registered person conducted under subsection (f) that identifies the listed agent or toxin possessed by a specific registered person or that discloses the identity or location of a specific registered person if the agency determines that public disclosure of the information would endanger public health or safety.

(2) Covered agencies

For purposes of paragraph (1) only, the Federal agencies specified in this paragraph are the following:

(A) The Department of Health and Human Services, the Department of Justice, the Department of Agriculture, and the Department of Transportation.

(B) Any Federal agency to which information specified in paragraph (1) is transferred by any agency specified in subparagraph (A) of this paragraph.

(C) Any Federal agency that is a registered person, or has a sub-agency component that is a registered person.

(D) Any Federal agency that awards grants or enters into contracts or cooperative agreements involving listed agents and toxins to or with a registered person, and to which information specified in paragraph (1) is transferred by any such registered person.

(3) Other exemptions

This subsection may not be construed as altering the application of any exemptions to public disclosure under section 552 of title 5, except as to subsection 2 552(b)(3) of such title, to any of the information specified in paragraph (1).

(4) Rule of construction

Except as specifically provided in paragraph (1), this subsection may not be construed as altering the authority of any Federal agency to withhold under section 552 of title 5, or the obligation of any Federal agency to disclose under section 552 of title 5, any information, including information relating to—

(A) listed agents and toxins, or individuals seeking access to such agents and toxins;

(B) registered persons, or persons seeking to register their possession, use, or transfer of such agents and toxins;

(C) general safeguard and security policies and requirements under regulations under subsections (b) and (c); or

(D) summary or statistical information concerning registrations, registrants, denials or revocations of registrations, listed agents and toxins, inspection evaluations and reports, or individuals seeking access to such agents and toxins.

(5) Disclosures to Congress; other disclosures

This subsection may not be construed as providing any authority—

(A) to withhold information from the Congress or any committee or subcommittee thereof; or

(B) to withhold information from any person under any other Federal law or treaty.

(i) Civil money penalty

(1) In general

In addition to any other penalties that may apply under law, any person who violates any provision of regulations under subsection (b) or (c) shall be subject to the United States for a civil money penalty in an amount not exceeding $250,000 in the case of an individual and $500,000 in the case of any other person.

(2) Applicability of certain provisions

The provisions of section 1320a–7a of this title (other than subsections (a), (b), (h), and (i), the first sentence of subsection (c), and paragraphs (1) and (2) of subsection (f)) shall apply to a civil money penalty under paragraph (1) in the same manner as such provisions apply to a penalty or proceeding under section 1320a–7a(a) of this title. The Secretary may delegate authority under this subsection in the same manner as provided in section 1320a–7a(j)(2) of this title, and such authority shall include all powers as contained in section 406 of title 5.

(j) Notification in event of release

Regulations under subsections (b) and (c) shall require the prompt notification of the Secretary by a registered person whenever a release, meeting criteria established by the Secretary, of a listed agent or toxin has occurred outside of the biocontainment area of a facility of the registered person. Upon receipt of such notification and a finding by the Secretary that the release poses a threat to public health or safety, the Secretary shall take appropriate action to notify relevant State and local public health authorities, other relevant Federal authorities, and, if necessary, other appropriate persons (including the public). If the released listed agent or toxin is an overlap agent or toxin (as defined in subsection (l)), the Secretary shall promptly notify the Secretary of Agriculture upon notification by the registered person.

(k) Reports

(1) Notification with respect to Federal facilities

In the event of the release, loss, or theft of an agent or toxin listed by the Secretary pursuant to subsection (a)(1), or by the Secretary of Agriculture pursuant to section 8401(a)(1) of title 7, from or within a laboratory facility owned or operated by the Department of Health and Human Services, or other Federal laboratory facility subject to the requirements of this section, the Secretary, in a manner that does not compromise national security, shall—

(A) not later than 72 hours after such event is reported to the Secretary, notify the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives of such event, including—

(i) the Federal laboratory facility in which such release, loss, or theft occurred; and

(ii) the circumstances of such release, loss, or theft; and

(B) not later than 14 days after such notification, update such Committees on—

(i) any actions taken or planned by the Secretary to mitigate any potential threat such release, loss, or theft may pose to public health and safety; and

(ii) any actions taken or planned by the Secretary to review the circumstances of such release, loss, or theft, and prevent similar events.

(2) Annual report

The Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on an annual basis a report—

(A) summarizing the number and nature of notifications received under subsection (e)(8) (relating to theft or loss) and subsection (j) (relating to releases), during the preceding fiscal year;

(B) describing actions taken by the Secretary to address such incidents, such as any corrective action plans required and steps taken to promote adherence to, and compliance with, safety and security best practices, standards, and regulations; and

(C) describing any gaps, challenges, or limitations with respect to ensuring that such safety and security practices are consistently applied and adhered to, and actions taken to address such gaps, challenges, or limitations.

(3) Implementation of recommendations of the Federal Experts Security Advisory Panel and the fast track action committee on select agent regulations

(A) In general

Not later than 1 year after June 24, 2019, the Secretary shall report to the congressional committees of jurisdiction on the implementation of recommendations of the Federal Experts Security Advisory Panel concerning the select agent program.

(B) Continued updates

The Secretary shall report to the congressional committees of jurisdiction annually following the submission of the report under subparagraph (A) until the recommendations described in such subparagraph are fully implemented, or a justification is provided for the delay in, or lack of, implementation.

(l) Definitions

For purposes of this section:

(1) The terms "biological agent" and "toxin" have the meanings given such terms in section 178 of title 18.

(2) The term "listed agents and toxins" means biological agents and toxins listed pursuant to subsection (a)(1).

(3) The term "listed agents or toxins" means biological agents or toxins listed pursuant to subsection (a)(1).

(4) The term "overlap agents and toxins" means biological agents and toxins that—

(A) are listed pursuant to subsection (a)(1); and

(B) are listed pursuant to section 8401(a)(1) of title 7.

(5) The term "overlap agent or toxin" means a biological agent or toxin that—

(A) is listed pursuant to subsection (a)(1); and

(B) is listed pursuant to section 8401(a)(1) of title 7.

(6) The term "person" includes Federal, State, and local governmental entities.

(7) The term "registered person" means a person registered under regulations under subsection (b) or (c).

(8) The term "restricted person" has the meaning given such term in section 175b of title 18.

(m) Authorization of appropriations

For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2023 through 2027.

(July 1, 1944, ch. 373, title III, §351A, as added Pub. L. 107–188, title II, §201(a), June 12, 2002, 116 Stat. 637; amended Pub. L. 107–296, title XVII, §1709(a), Nov. 25, 2002, 116 Stat. 2318; Pub. L. 116–22, title IV, §405, June 24, 2019, 133 Stat. 949; Pub. L. 117–286, §4(b)(75), Dec. 27, 2022, 136 Stat. 4351; Pub. L. 117–328, div. FF, title II, §2311, Dec. 29, 2022, 136 Stat. 5759.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in subsec.(g)(2)(B)(i), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see section 301 of Title 21 and Tables.

The Act commonly known as the Virus-Serum-Toxin Act, referred to in subsec. (g)(2)(B)(iii), is the eighth paragraph under the heading "Bureau of Animal Industry" of act Mar. 4, 1913, ch. 145, 37 Stat. 832, which is classified generally to chapter 5 (§151 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see Short Title note set out under section 151 of Title 21 and Tables.

The Federal Insecticide, Fungicide, and Rodenticide Act, referred to in subsec. (g)(2)(B)(iv), is act June 25, 1947, ch. 125, as amended generally by Pub. L. 92–516, Oct. 21, 1972, 86 Stat. 973, which is classified generally to subchapter II (§136 et seq.) of chapter 6 of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title note set out under section 136 of Title 7 and Tables.

Amendments

2022—Subsec. (b)(1)(A). Pub. L. 117–328, §2311(1), amended subpar. (A) generally. Prior to amendment, text read as follows: "proper training and appropriate skills to handle such agents and toxins; and".

Subsec. (e)(1). Pub. L. 117–328, §2311(2), substituted "(including risks posed by the release, theft, or loss of such agent or toxin, or use in domestic or international terrorism)" for "(including the risk of use in domestic or international terrorism)".

Subsec. (i)(2). Pub. L. 117–286 substituted "section 406 of title 5." for "section 6 of the Inspector General Act of 1978 (5 U.S.C. App.)."

Subsec. (k)(1). Pub. L. 117–328, §2311(3)(B), added par. (1). Former par. (1) redesignated (2).

Subsec. (k)(2). Pub. L. 117–328, §2311(3)(A), (C), redesignated par. (1) as (2) and amended it generally. Prior to amendment, text read as follows: "The Secretary shall report to the Congress annually on the number and nature of notifications received under subsection (e)(8) (relating to theft or loss) and subsection (j) (relating to releases)." Former par. (2) redesignated (3).

Subsec. (k)(3). Pub. L. 117–328, §2311(3)(A), redesignated par. (2) as (3).

Subsec. (m). Pub. L. 117–328, §2311(4), substituted "fiscal years 2023 through 2027" for "fiscal years 2002 through 2007".

2019—Subsec. (k). Pub. L. 116–22 designated existing provisions as par. (1), inserted heading, and added par. (2).

2002—Subsec. (e)(1). Pub. L. 107–296 substituted "collaboration with the Secretary of Homeland Security and" for "consultation with".

Statutory Notes and Related Subsidiaries

Effective Date of 2002 Amendment

Amendment by Pub. L. 107–296 effective 60 days after Nov. 25, 2002, see section 4 of Pub. L. 107–296, set out as an Effective Date note under section 101 of Title 6, Domestic Security.

Effective Date

Pub. L. 107–188, title II, §203(b), June 12, 2002, 116 Stat. 647, provided that: "Subsection (h) of section 351A of the Public Health Service Act [42 U.S.C. 262a(h)], as added by section 201 of this Act, is deemed to have taken effect on the effective date of the Antiterrorism and Effective Death Penalty Act of 1996 [Pub. L. 104–132, Apr. 24, 1996, 110 Stat. 1214]."

Regulations

Pub. L. 107–188, title II, §203(a), June 12, 2002, 116 Stat. 647, provided that: "Regulations promulgated by the Secretary of Health and Human Services under section 511 of the Antiterrorism and Effective Death Penalty Act of 1996 [Pub. L. 104–132, 42 U.S.C. 262 note] are deemed to have been promulgated under section 351A of the Public Health Service Act [42 U.S.C. 262a], as added by section 201 of this Act. Such regulations, including the list under [former] subsection (d)(1) of such section 511, that were in effect on the day before the date of the enactment of this Act [June 12, 2002] remain in effect until modified by the Secretary in accordance with such section 351A and with section 202 of this Act [set out as a note below]."

Improving Research and Development of Medical Countermeasures for Novel Pathogens

Pub. L. 117–328, div. FF, title II, §2303(a), Dec. 29, 2022, 136 Stat. 5758, provided that:

"(1) Sample access.—Not later than 1 year after the date of enactment of this Act [Dec. 29, 2022], the Secretary of Health and Human Services (referred to in this subsection as the 'Secretary') shall make publicly available policies and procedures related to public and private entities accessing specimens of, or specimens containing, pathogens or suitable surrogates for, or alternatives to, such pathogens as the Secretary determines appropriate to support public health preparedness and response activities or biomedical research for purposes of the development and validation, as applicable, of medical products to address emerging infectious diseases and for use to otherwise respond to emerging infectious diseases. Such policies and procedures shall take into account, as appropriate, any applicable existing Federal resources.

"(2) Guidance.—The Secretary shall issue guidance regarding the procedures for carrying out paragraph (1), including—

"(A) the method for requesting such samples;

"(B) considerations for sample availability and use of suitable surrogates or alternatives to such pathogens, as appropriate, including applicable safeguard and security measures; and

"(C) information required to be provided in order to receive such samples or suitable surrogates or alternatives."

Strategy for Federal High-Containment Laboratories

Pub. L. 117–328, div. FF, title II, §2312, Dec. 29, 2022, 136 Stat. 5761, provided that:

"(a) Strategy for Federal High-containment Laboratories.—Not later than 1 year after the date of enactment of this Act [Dec. 29, 2022], the Director of the Office of Science and Technology Policy, in consultation with relevant Federal departments and agencies, shall establish a strategy for the management, maintenance, and oversight of federally-owned laboratory facilities operating at Biosafety Level 3 or 4, including equivalent classification levels and facilities with Biosafety Level 4 capabilities. Such strategy shall include—

"(1) a description of the roles and responsibilities of relevant Federal departments and agencies with respect to the management, maintenance, and oversight of Biosafety Level 3 or 4 laboratory facilities;

"(2) an assessment of the needs of the Federal Government with respect to Biosafety Level 3 or 4 laboratory facilities;

"(3) a summary of existing federally-owned Biosafety Level 3 or 4 laboratory facility capacity;

"(4) a summary of other Biosafety Level 3 or 4 laboratory facility capacity established through Federal funds;

"(5) a description of how the capacity described in paragraphs (3) and (4) addresses the needs of the Federal Government, including—

"(A) how relevant Federal departments and agencies coordinate to provide access to appropriate laboratory facilities to reduce unnecessary duplication; and

"(B) any gaps in such capacity related to such needs;

"(6) a summary of plans that are in place for the maintenance of such capacity within each relevant Federal department or agency, as applicable and appropriate, including processes for determining whether to maintain or expand such capacity, and a description of how the Federal Government will address rapid changes in the need for such capacity within each relevant Federal department or agency during a public health emergency; and

"(7) a description of how the heads of relevant Federal departments and agencies will coordinate to ensure appropriate oversight of federally-owned laboratory facility capacity and leverage such capacity within each relevant Federal department, as appropriate, to fulfill the needs of each Federal department and agency in order to reduce unnecessary duplication and improve collaboration within the Federal Government.

"(b) Clarification.—The strategy under subsection (a) shall not be construed to supersede the authorities of each relevant Federal department or agency with respect to the management, maintenance, and oversight of the Federally-owned laboratory facilities operated by any such Federal department or agency."

Research To Improve Biosafety

Pub. L. 117–328, div. FF, title II, §2314, Dec. 29, 2022, 136 Stat. 5763, provided that:

"(a) In General.—The Secretary of Health and Human Services (referred to in this section as the 'Secretary') shall, as appropriate, conduct or support research to improve the safe conduct of biomedical research activities involving pathogens of pandemic potential or biological agents or toxins listed pursuant to section 351A(a)(1) of the Public Health Service Act (42 U.S.C. 262a(a)(1)).

"(b) Report.—Not later than 5 years after the date of enactment of this Act [Dec. 29, 2022], the Secretary shall prepare and submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives regarding an overview of any research conducted or supported under this section, any relevant findings, and steps the Secretary is taking to disseminate any such findings to support the reduction of risks associated with biomedical research involving pathogens of pandemic potential or biological agents or toxins listed pursuant to section 351A(a)(1) of the Public Health Service Act (42 U.S.C. 262a(a)(1))."

National Science Advisory Board for Biosecurity

Pub. L. 109–417, title II, §205, Dec. 19, 2006, 120 Stat. 2851, formerly set out as a note under this section, was transferred and is set out as a National Science Advisory Board for Biosecurity: Provision of Advice, Guidance, or Recommendations note under section 283r of this title.

Report to Congress

Pub. L. 107–188, title II, §201(b), June 12, 2002, 116 Stat. 646, required the Secretary of Health and Human Services to report to Congress not later than one year after June 12, 2002, on the implementation, compliance, and future plans under this section.

Implementation by Department of Health and Human Services

Pub. L. 107–188, title II, §202, June 12, 2002, 116 Stat. 646, provided that:

"(a) Date Certain for Notice of Possession.—Not later than 90 days after the date of the enactment of this Act [June 12, 2002], all persons (unless exempt under subsection (g) of section 351A of the Public Health Service Act [42 U.S.C. 262a(g)], as added by section 201 of this Act) in possession of biological agents or toxins listed under such section 351A of the Public Health Service Act [42 U.S.C. 262a] shall notify the Secretary of Health and Human Services of such possession. Not later than 30 days after such date of enactment, the Secretary shall provide written guidance on how such notice is to be provided to the Secretary.

"(b) Date Certain for Promulgation; Effective Date Regarding Criminal and Civil Penalties.—Not later than 180 days after the date of the enactment of this Act [June 12, 2002], the Secretary of Health and Human Services shall promulgate an interim final rule for carrying out section 351A of the Public Health Service Act [42 U.S.C. 262a], subject to subsection (c). Such interim final rule shall take effect 60 days after the date on which such rule is promulgated, including for purposes of—

"(1) section 175b(c) of title 18, United States Code (relating to criminal penalties), as added by section 231(a)(5) of this Act; and

"(2) section 351A(i) of the Public Health Service Act [42 U.S.C. 262a(i)] (relating to civil penalties).

"(c) Transitional Provision Regarding Current Research and Education.—The interim final rule under subsection (b) shall include time frames for the applicability of the rule that minimize disruption of research or educational projects that involve biological agents and toxins listed pursuant to section 351A(a)(1) of the Public Health Service Act [42 U.S.C. 262a(a)(1)] and that were underway as of the effective date of such rule."

Executive Documents

Ex. Ord. No. 13546. Optimizing the Security of Biological Select Agents and Toxins in the United States

Ex. Ord. No. 13546, July 2, 2010, 75 F.R. 39439, provided:

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:

Section 1. Policy. It is the policy of the United States that:

(a) A robust and productive scientific enterprise that utilizes biological select agents and toxins (BSAT) is essential to national security;

(b) BSAT shall be secured in a manner appropriate to their risk of misuse, theft, loss, and accidental release; and

(c) Security measures shall be taken in a coordinated manner that balances their efficacy with the need to minimize the adverse impact on the legitimate use of BSAT.

Sec. 2. Definitions. (a) "Select Agent Program" (SAP) means the regulatory oversight and administrative activities conducted by the Secretaries of Health and Human Services and Agriculture and the Attorney General to implement the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Agricultural Bioterrorism Protection Act of 2002.

(b) "Select Agent Regulations" (SAR) means the Federal regulations found in Part 73 of Title 42 of the Code of Federal Regulations, Part 331 of Title 7 of the Code of Federal Regulations, and Part 121 of Title 9 of the Code of Federal Regulations.

(c) "Biological Select Agents and Toxins" means biological agents and toxins with the potential to pose a severe threat to public health and safety, animal and plant health, or animal and plant products and whose possession, use, and transfer are regulated by the Department of Health and Human Services and the Department of Agriculture under the SAR.

Sec. 3. Findings. (a) The use of BSAT presents the risk that BSAT might be lost, stolen, or diverted for malicious purpose. The SAP exists to provide effective regulatory oversight of the possession, use, and transfer of BSAT that reduces the risk of their misuse or mishandling. The absence of clearly defined, risk-based security measures in the SAR/SAP has raised concern about the need for optimized security and for risk management.

(b) In addition, variations in, and limited coordination of, individual executive departments' and agencies' oversight, security practices, and inspections have raised concerns that the cost and complexity of compliance for those who are registered to work with BSAT could discourage research or other legitimate activities.

(c) Understanding that research and laboratory work on BSAT is essential to both public health and national security, it is in the interest of the United States to address these issues.

Sec. 4. Risk-based Tiering of the Select Agent List. To help ensure that BSAT are secured according to level of risk, the Secretaries of Health and Human Services and Agriculture shall, through their ongoing review of the biological Select Agents and Toxins List ("Select Agent List") contained in regulations, and no later than 18 months from the date of this order:

(a) designate a subset of the Select Agent List (Tier 1) that presents the greatest risk of deliberate misuse with most significant potential for mass casualties or devastating effects to the economy, critical infrastructure, or public confidence;

(b) explore options for graded protection of Tier 1 agents and toxins as described in subsection (a) of this section to permit tailored risk management practices based upon relevant contextual factors; and

(c) consider reducing the overall number of agents and toxins on the Select Agent List.

Sec. 5. Revision of Regulations, Rules, and Guidance to Accommodate a Tiered Select Agent List. Consistent with section 4 of this order, I request that:

(a) The Secretaries of Health and Human Services and Agriculture, no later than 15 months from the date of this order, propose amendments to their respective parts of the SAR that would establish security standards specific to Tier 1 agents and toxins.

(b) The Secretaries of Health and Human Services and Agriculture each, no later than 27 months from the date of this order, promulgate final rules and guidance that clearly articulate security actions for registrants who possess, use, or transfer Tier 1 agents and toxins.

Sec. 6. Coordination of Federal Oversight for BSAT Security. To ensure that the policies and practices used to secure BSAT are harmonized and that the related oversight activities of the Federal Government are coordinated, the heads of executive departments and agencies identified in section 7(a)(ii) of this order shall:

(a) no later than 6 months from the date of this order, develop and implement a plan for the coordination of BSAT security oversight that:

(i) articulates a mechanism for coordinated and reciprocal inspection of and harmonized administrative practices for facilities registered with the SAP;

(ii) ensures consistent and timely identification and resolution of BSAT security and compliance issues;

(iii) facilitates information sharing among departments and agencies regarding ongoing oversight and inspection activities; and

(iv) provides for comprehensive and effective Federal oversight of BSAT security; and

(b) no later than 6 months from the issuance of final rules and guidance as described in section 5 of this order, and annually thereafter, review for inconsistent requirements and revise or rescind, as appropriate, any regulations, directives, guidance, or policies regarding BSAT security within their department or agency that exceed those in the updated SAR and guidance as described in section 5 of this order.

Sec. 7. Implementation. (a) Establishment, Operation, and Functions of the Federal Experts Security Advisory Panel.

(i) There is hereby established, within the Department of Health and Human Services for administrative purposes only, the Federal Experts Security Advisory Panel (Panel), which shall make technical and substantive recommendations on BSAT security concerning the SAP.

(ii) The Panel shall consist of representatives from the following, who may consult with additional experts from their department or agency as required:

1. the Department of State;

2. the Department of Defense;

3. the Department of Justice;

4. the Department of Agriculture (Co-Chair);

5. the Department of Commerce;

6. the Department of Health and Human Services (Co-Chair);

7. the Department of Transportation;

8. the Department of Labor;

9. the Department of Energy;

10. the Department of Veterans Affairs;

11. the Department of Homeland Security;

12. the Environmental Protection Agency;

13. the Office of the Director of National Intelligence;

14. the Office of Science and Technology Policy;

15. the Joint Chiefs of Staff; and

16. any other department or agency designated by the Co-Chairs.

(iii) To assist the Secretaries of Health and Human Services and Agriculture and the Attorney General in implementing the policies set forth in sections 1, 4, 5, and 6 of this order, the Panel shall, no later than 4 months from the date of this order, provide consensus recommendations concerning the SAP on:

1. the designation of Tier 1 agents and toxins;

2. reduction in the number of agents on the Select Agent List;

3. the establishment of appropriate practices to ensure reliability of personnel with access to Tier 1 agents and toxins at registered facilities;

4. the establishment of appropriate practices for physical security and cyber security for facilities that possess Tier 1 agents. The Department of Homeland Security shall Chair a Working Group of the Panel that develops recommended laboratory critical infrastructure security standards in these areas; and

5. other emerging policy issues relevant to the security of BSAT.

Thereafter, the Panel shall continue to provide technical advice concerning the SAP on request.

(iv) If the Panel is unable to reach consensus on recommendations for an issue within its charge, the matter shall be resolved through the interagency policy committee process led by the National Security Staff.

(v) The Secretaries of Health and Human Services and Agriculture and the Attorney General shall report to the Assistant to the President for Homeland Security and Counterterrorism on the consideration and implementation of Panel recommendations concerning the SAP, including a rationale for failure to implement any recommendations.

(vi) The Panel shall be chartered for a period of 4 years subject to renewal through the interagency policy committee process led by the National Security Staff.

(b) To further assist the Secretaries of Health and Human Services and Agriculture and the Attorney General in implementing the policy set forth in sections 1, 4, 5, and 6 of this order, the National Science Advisory Board for Biosecurity shall provide technical advice and serve as a conduit for public consultation, as needed, on topics of relevance to the SAP.

Sec. 8. Sharing of Select Agent Program Information. (a) Consistent with applicable laws and regulations, the Secretaries of Health and Human Services and Agriculture and the Attorney General shall, no later than 6 months from the date of this order, develop a process and the criteria for making SAP information available to executive departments and agencies when such information is necessary for furthering a public health, safety, security, law enforcement, or national security mission.

(b) SAP information shall continue to be safeguarded properly and handled securely to minimize the risk of disclosing sensitive, personal, and other information protected by the Privacy Act, 5 U.S.C. 552a.

Sec. 9. General Provisions. (a) The National Security Staff shall, on a biennial basis, review the implementation and effectiveness of this order and refer to the interagency policy committee process any issues that require further deliberation or adjudication.

(b) Nothing in this order shall be construed to impair or otherwise affect the authority granted by law to a department or agency, or the head thereof, or functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(c) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.

(d) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

Barack Obama.      

[Reference to the National Security Staff deemed to be a reference to the National Security Council Staff, see Ex. Ord. No. 13657, set out as a note under section 3021 of Title 50, War and National Defense.]

1 So in original. Probably should be "judicial".

2 So in original. Probably should be "section".
42 U.S.C. § 421 (2024) — Title 42: THE PUBLIC HEALTH AND WELFARE / Chapter 7: SOCIAL SECURITY / Subchapter II: FEDERAL OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE BENEFITS / Section 421: Disability determinations
Disability determinations
Status: in_force

(a) State agencies

(1) In the case of any individual, the determination of whether or not he is under a disability (as defined in section 416(i) or 423(d) of this title) and of the day such disability began, and the determination of the day on which such disability ceases, shall be made by a State agency, notwithstanding any other provision of law, in any State that notifies the Commissioner of Social Security in writing that it wishes to make such disability determinations commencing with such month as the Commissioner of Social Security and the State agree upon, but only if (A) the Commissioner of Social Security has not found, under subsection (b)(1), that the State agency has substantially failed to make disability determinations in accordance with the applicable provisions of this section or rules issued thereunder, and (B) the State has not notified the Commissioner of Social Security, under subsection (b)(2), that it does not wish to make such determinations. If the Commissioner of Social Security once makes the finding described in clause (A) of the preceding sentence, or the State gives the notice referred to in clause (B) of such sentence, the Commissioner of Social Security may thereafter determine whether (and, if so, beginning with which month and under what conditions) the State may again make disability determinations under this paragraph.

(2) The disability determinations described in paragraph (1) made by a State agency shall be made in accordance with the pertinent provisions of this subchapter and the standards and criteria contained in regulations or other written guidelines of the Commissioner of Social Security pertaining to matters such as disability determinations, the class or classes of individuals with respect to which a State may make disability determinations (if it does not wish to do so with respect to all individuals in the State), and the conditions under which it may choose not to make all such determinations. In addition, the Commissioner of Social Security shall promulgate regulations specifying, in such detail as the Commissioner deems appropriate, performance standards and administrative requirements and procedures to be followed in performing the disability determination function in order to assure effective and uniform administration of the disability insurance program throughout the United States. The regulations may, for example, specify matters such as—

(A) the administrative structure and the relationship between various units of the State agency responsible for disability determinations,

(B) the physical location of and relationship among agency staff units, and other individuals or organizations performing tasks for the State agency, and standards for the availability to applicants and beneficiaries of facilities for making disability determinations,

(C) State agency performance criteria, including the rate of accuracy of decisions, the time periods within which determinations must be made, the procedures for and the scope of review by the Commissioner of Social Security, and, as the Commissioner finds appropriate, by the State, of its performance in individual cases and in classes of cases, and rules governing access of appropriate Federal officials to State offices and to State records relating to its administration of the disability determination function,

(D) fiscal control procedures that the State agency may be required to adopt, and

(E) the submission of reports and other data, in such form and at such time as the Commissioner of Social Security may require, concerning the State agency's activities relating to the disability determination.

Nothing in this section shall be construed to authorize the Commissioner of Social Security to take any action except pursuant to law or to regulations promulgated pursuant to law.

(b) Determinations by Commissioner

(1) If the Commissioner of Social Security finds, after notice and opportunity for a hearing, that a State agency is substantially failing to make disability determinations in a manner consistent with the Commissioner's regulations and other written guidelines, the Commissioner of Social Security shall, not earlier than 180 days following the Commissioner's finding, and after the Commissioner has complied with the requirements of paragraph (3), make the disability determinations referred to in subsection (a)(1).

(2) If a State, having notified the Commissioner of Social Security of its intent to make disability determinations under subsection (a)(1), no longer wishes to make such determinations, it shall notify the Commissioner of Social Security in writing of that fact, and, if an agency of the State is making disability determinations at the time such notice is given, it shall continue to do so for not less than 180 days, or (if later) until the Commissioner of Social Security has complied with the requirements of paragraph (3). Thereafter, the Commissioner of Social Security shall make the disability determinations referred to in subsection (a)(1).

(3)(A) The Commissioner of Social Security shall develop and initiate all appropriate procedures to implement a plan with respect to any partial or complete assumption by the Commissioner of Social Security of the disability determination function from a State agency, as provided in this section, under which employees of the affected State agency who are capable of performing duties in the disability determination process for the Commissioner of Social Security shall, notwithstanding any other provision of law, have a preference over any other individual in filling an appropriate employment position with the Commissioner of Social Security (subject to any system established by the Commissioner of Social Security for determining hiring priority among such employees of the State agency) unless any such employee is the administrator, the deputy administrator, or assistant administrator (or his equivalent) of the State agency, in which case the Commissioner of Social Security may accord such priority to such employee.

(B) The Commissioner of Social Security shall not make such assumption of the disability determination function until such time as the Secretary of Labor determines that, with respect to employees of such State agency who will be displaced from their employment on account of such assumption by the Commissioner of Social Security and who will not be hired by the Commissioner of Social Security to perform duties in the disability determination process, the State has made fair and equitable arrangements to protect the interests of employees so displaced. Such protective arrangements shall include only those provisions which are provided under all applicable Federal, State and local statutes including, but not limited to, (i) the preservation of rights, privileges, and benefits (including continuation of pension rights and benefits) under existing collective-bargaining agreements; (ii) the continuation of collective-bargaining rights; (iii) the assignment of affected employees to other jobs or to retraining programs; (iv) the protection of individual employees against a worsening of their positions with respect to their employment; (v) the protection of health benefits and other fringe benefits; and (vi) the provision of severance pay, as may be necessary.

(c) Review of determination by Commissioner

(1) The Commissioner of Social Security may on the Commissioner's own motion or as required under paragraphs (2) and (3) review a determination, made by a State agency under this section, that an individual is or is not under a disability (as defined in section 416(i) or 423(d) of this title) and, as a result of such review, may modify such agency's determination and determine that such individual either is or is not under a disability (as so defined) or that such individual's disability began on a day earlier or later than that determined by such agency, or that such disability ceased on a day earlier or later than that determined by such agency. A review by the Commissioner of Social Security on the Commissioner's own motion of a State agency determination under this paragraph may be made before or after any action is taken to implement such determination.

(2) The Commissioner of Social Security (in accordance with paragraph (3)) shall review determinations, made by State agencies pursuant to this section, that individuals are under disabilities (as defined in section 416(i) or 423(d) of this title). Any review by the Commissioner of Social Security of a State agency determination under this paragraph shall be made before any action is taken to implement such determination.

(3)(A) In carrying out the provisions of paragraph (2) with respect to the review of determinations made by State agencies pursuant to this section that individuals are under disabilities (as defined in section 416(i) or 423(d) of this title), the Commissioner of Social Security shall review—

(i) at least 50 percent of all such determinations made by State agencies on applications for benefits under this subchapter, and

(ii) other determinations made by State agencies pursuant to this section to the extent necessary to assure a high level of accuracy in such other determinations.

(B) In conducting reviews pursuant to subparagraph (A), the Commissioner of Social Security shall, to the extent feasible, select for review those determinations which the Commissioner of Social Security identifies as being the most likely to be incorrect.

(C) Not later than April 1, 1992, and annually thereafter, the Commissioner of Social Security shall submit to the Committee on Ways and Means of the House of Representatives and the Committee on Finance of the Senate a written report setting forth the number of reviews conducted under subparagraph (A)(ii) during the preceding fiscal year and the findings of the Commissioner of Social Security based on such reviews of the accuracy of the determinations made by State agencies pursuant to this section.

(d) Hearings and judicial review

Any individual dissatisfied with any determination under subsection (a), (b), (c), or (g) shall be entitled to a hearing thereon by the Commissioner of Social Security to the same extent as is provided in section 405(b) of this title with respect to decisions of the Commissioner of Social Security, and to judicial review of the Commissioner's final decision after such hearing as is provided in section 405(g) of this title.

(e) State's right to cost from Trust Funds

Each State which is making disability determinations under subsection (a)(1) shall be entitled to receive from the Trust Funds, in advance or by way of reimbursement, as determined by the Commissioner of Social Security, the cost to the State of making disability determinations under subsection (a)(1). The Commissioner of Social Security shall from time to time certify such amount as is necessary for this purpose to the Managing Trustee, reduced or increased, as the case may be, by any sum (for which adjustment hereunder has not previously been made) by which the amount certified for any prior period was greater or less than the amount which should have been paid to the State under this subsection for such period; and the Managing Trustee, prior to audit or settlement by the Government Accountability Office, shall make payment from the Trust Funds at the time or times fixed by the Commissioner of Social Security, in accordance with such certification. Appropriate adjustments between the Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund with respect to the payments made under this subsection shall be made in accordance with paragraph (1) of subsection (g) of section 401 of this title (but taking into account any refunds under subsection (f) of this section) to insure that the Federal Disability Insurance Trust Fund is charged with all expenses incurred which are attributable to the administration of section 423 of this title and the Federal Old-Age and Survivors Insurance Trust Fund is charged with all other expenses.

(f) Use of funds

All money paid to a State under this section shall be used solely for the purposes for which it is paid; and any money so paid which is not used for such purposes shall be returned to the Treasury of the United States for deposit in the Trust Funds.

(g) Regulations governing determinations in certain cases

In the case of individuals in a State which does not undertake to perform disability determinations under subsection (a)(1), or which has been found by the Commissioner of Social Security to have substantially failed to make disability determinations in a manner consistent with the Commissioner's regulations and guidelines, in the case of individuals outside the United States, and in the case of any class or classes of individuals for whom no State undertakes to make disability determinations, the determinations referred to in subsection (a) shall be made by the Commissioner of Social Security in accordance with regulations prescribed by the Commissioner.

(h) Evaluation of impairments by qualified medical professionals

An initial determination under subsection (a), (c), (g), or (i) shall not be made until the Commissioner of Social Security has made every reasonable effort to ensure—

(1) in any case where there is evidence which indicates the existence of a mental impairment, that a qualified psychiatrist or psychologist has completed the medical portion of the case review and any applicable residual functional capacity assessment; and

(2) in any case where there is evidence which indicates the existence of a physical impairment, that a qualified physician has completed the medical portion of the case review and any applicable residual functional capacity assessment.

(i) Review of disability cases to determine continuing eligibility; permanent disability cases; appropriate number of cases reviewed; reporting requirements

(1) In any case where an individual is or has been determined to be under a disability, the case shall be reviewed by the applicable State agency or the Commissioner of Social Security (as may be appropriate), for purposes of continuing eligibility, at least once every 3 years, subject to paragraph (2); except that where a finding has been made that such disability is permanent, such reviews shall be made at such times as the Commissioner of Social Security determines to be appropriate. Reviews of cases under the preceding sentence shall be in addition to, and shall not be considered as a substitute for, any other reviews which are required or provided for under or in the administration of this subchapter.

(2) The requirement of paragraph (1) that cases be reviewed at least every 3 years shall not apply to the extent that the Commissioner of Social Security determines, on a State-by-State basis, that such requirement should be waived to insure that only the appropriate number of such cases are reviewed. The Commissioner of Social Security shall determine the appropriate number of cases to be reviewed in each State after consultation with the State agency performing such reviews, based upon the backlog of pending reviews, the projected number of new applications for disability insurance benefits, and the current and projected staffing levels of the State agency, but the Commissioner of Social Security shall provide for a waiver of such requirement only in the case of a State which makes a good faith effort to meet proper staffing requirements for the State agency and to process case reviews in a timely fashion. The Commissioner of Social Security shall report annually to the Committee on Finance of the Senate and the Committee on Ways and Means of the House of Representatives with respect to the determinations made by the Commissioner of Social Security under the preceding sentence.

(3) The Commissioner of Social Security shall report annually to the Committee on Finance of the Senate and the Committee on Ways and Means of the House of Representatives with respect to the number of reviews of continuing disability carried out under paragraph (1), the number of such reviews which result in an initial termination of benefits, the number of requests for reconsideration of such initial termination or for a hearing with respect to such termination under subsection (d), or both, and the number of such initial terminations which are overturned as the result of a reconsideration or hearing.

(4) In any case in which the Commissioner of Social Security initiates a review under this subsection of the case of an individual who has been determined to be under a disability, the Commissioner of Social Security shall notify such individual of the nature of the review to be carried out, the possibility that such review could result in the termination of benefits, and the right of the individual to provide medical evidence with respect to such review.

(5) For suspension of reviews under this subsection in the case of an individual using a ticket to work and self-sufficiency, see section 1320b–19(i) of this title.

(j) Rules and regulations; consultative examinations

The Commissioner of Social Security shall prescribe regulations which set forth, in detail—

(1) the standards to be utilized by State disability determination services and Federal personnel in determining when a consultative examination should be obtained in connection with disability determinations;

(2) standards for the type of referral to be made; and

(3) procedures by which the Commissioner of Social Security will monitor both the referral processes used and the product of professionals to whom cases are referred.

Nothing in this subsection shall be construed to preclude the issuance, in accordance with section 553(b)(A) of title 5, of interpretive rules, general statements of policy, and rules of agency organization relating to consultative examinations if such rules and statements are consistent with such regulations.

(k) Establishment of uniform standards for determination of disability

(1) The Commissioner of Social Security shall establish by regulation uniform standards which shall be applied at all levels of determination, review, and adjudication in determining whether individuals are under disabilities as defined in section 416(i) or 423(d) of this title.

(2) Regulations promulgated under paragraph (1) shall be subject to the rulemaking procedures established under section 553 of title 5.

(l) Special notice to blind individuals with respect to hearings and other official actions

(1) In any case where an individual who is applying for or receiving benefits under this subchapter on the basis of disability by reason of blindness is entitled to receive notice from the Commissioner of Social Security of any decision or determination made or other action taken or proposed to be taken with respect to his or her rights under this subchapter, such individual shall at his or her election be entitled either (A) to receive a supplementary notice of such decision, determination, or action, by telephone, within 5 working days after the initial notice is mailed, (B) to receive the initial notice in the form of a certified letter, or (C) to receive notification by some alternative procedure established by the Commissioner of Social Security and agreed to by the individual.

(2) The election under paragraph (1) may be made at any time, but an opportunity to make such an election shall in any event be given, to every individual who is an applicant for benefits under this subchapter on the basis of disability by reason of blindness, at the time of his or her application. Such an election, once made by an individual, shall apply with respect to all notices of decisions, determinations, and actions which such individual may thereafter be entitled to receive under this subchapter until such time as it is revoked or changed.

(m) Work activity as basis for review

(1) In any case where an individual entitled to disability insurance benefits under section 423 of this title or to monthly insurance benefits under section 402 of this title based on such individual's disability (as defined in section 423(d) of this title) has received such benefits for at least 24 months—

(A) no continuing disability review conducted by the Commissioner may be scheduled for the individual solely as a result of the individual's work activity;

(B) no work activity engaged in by the individual may be used as evidence that the individual is no longer disabled; and

(C) no cessation of work activity by the individual may give rise to a presumption that the individual is unable to engage in work.

(2) An individual to which paragraph (1) applies shall continue to be subject to—

(A) continuing disability reviews on a regularly scheduled basis that is not triggered by work; and

(B) termination of benefits under this subchapter in the event that the individual has earnings that exceed the level of earnings established by the Commissioner to represent substantial gainful activity.

(Aug. 14, 1935, ch. 531, title II, §221, as added Sept. 1, 1954, ch. 1206, title I, §106(g), 68 Stat. 1081; amended Aug. 1, 1956, ch. 836, title I, §103(c)(7), (8), (h), 70 Stat. 818, 823; Pub. L. 90–248, title I, §158(c)(3), (4), Jan. 2, 1968, 81 Stat. 869; Pub. L. 96–265, title III, §§304(a)–(f), 311(a), June 9, 1980, 94 Stat. 453–456, 460; Pub. L. 97–455, §§3(a), 6, Jan. 12, 1983, 96 Stat. 2499, 2500; Pub. L. 98–369, div. B, title VI, §2663(a)(14), July 18, 1984, 98 Stat. 1164; Pub. L. 98–460, §§6(a), 8(a), 9(a)(1), 10(a), 17(a), Oct. 9, 1984, 98 Stat. 1802, 1804, 1805, 1811; Pub. L. 99–514, title XVIII, §1883(a)(9), Oct. 22, 1986, 100 Stat. 2916; Pub. L. 100–647, title VIII, §8012(a), Nov. 10, 1988, 102 Stat. 3789; Pub. L. 101–239, title X, §10306(a)(1), Dec. 19, 1989, 103 Stat. 2484; Pub. L. 101–508, title V, §5128(a), Nov. 5, 1990, 104 Stat. 1388–286; Pub. L. 103–296, title I, §107(a)(4), Aug. 15, 1994, 108 Stat. 1478; Pub. L. 106–170, title I, §§101(b)(1)(A), 111(a), Dec. 17, 1999, 113 Stat. 1873, 1881; Pub. L. 108–271, §8(b), July 7, 2004, 118 Stat. 814; Pub. L. 114–74, title VIII, §832(a), Nov. 2, 2015, 129 Stat. 613.)

Editorial Notes

Prior Provisions

A prior section 421, act Aug. 14, 1935, ch. 531, title II, §221, as added July 18, 1952, ch. 945, §3(e), 66 Stat. 772; amended by 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631, relating to disability determinations, ceased to be in effect at the close of June 30, 1953. See section 3(g) of act July 18, 1952, set out as an Effective and Termination Date of 1952 Amendment note under section 413 of this title.

Amendments

2015—Subsec. (h). Pub. L. 114–74 amended subsec. (h) generally. Prior to amendment, text read as follows: "An initial determination under subsection (a), (c), (g), or (i) that an individual is not under a disability, in any case where there is evidence which indicates the existence of a mental impairment, shall be made only if the Commissioner of Social Security has made every reasonable effort to ensure that a qualified psychiatrist or psychologist has completed the medical portion of the case review and any applicable residual functional capacity assessment."

2004—Subsec. (e). Pub. L. 108–271 substituted "Government Accountability Office" for "General Accounting Office".

1999—Subsec. (i)(5). Pub. L. 106–170, §101(b)(1)(A), added par. (5).

Subsec. (m). Pub. L. 106–170, §111(a), added subsec. (m).

1994—Pub. L. 103–296 substituted "Commissioner of Social Security" for "Secretary" wherever appearing except where appearing before "of Labor" in subsec. (b)(3)(B) and substituted "the Commissioner deems" for "he deems" and "the Commissioner finds" for "he finds" in subsec. (a)(2), "the Commissioner's" for "his" wherever appearing in subsecs. (b)(1), (c)(1), and (g), "the Commissioner has complied" for "he has complied" in subsec. (b)(1), "Commissioner's" for "Secretary's" in subsec. (d), and "prescribed by the Commissioner" for "prescribed by him" in subsec. (g).

1990—Subsec. (c)(3). Pub. L. 101–508 amended par. (3) generally. Prior to amendment, par. (3) read as follows: "In carrying out the provisions of paragraph (2) with respect to the review of determinations, made by State agencies pursuant to this section, that individuals are under disabilities (as defined in section 416(i) or 423(d) of this title), the Secretary shall review—

"(A) at least 15 percent of all such determinations made by State agencies in the fiscal year 1981,

"(B) at least 35 percent of all such determinations made by State agencies in the fiscal year 1982, and

"(C) at least 65 percent of all such determinations made by State agencies in any fiscal year after the fiscal year 1982."

1989—Subsec. (l). Pub. L. 101–239 added subsec. (l).

1988—Subsec. (i)(3). Pub. L. 100–647 substituted "semiannually" for "annually".

1986—Subsec. (e). Pub. L. 99–514 struck out "under this section" before "shall be entitled".

1984—Subsec. (a)(1)(A). Pub. L. 98–460, §17(a)(2), (b), temporarily substituted "subsection (b)(1)(C)" for "subsection (b)(1)". See Effective and Termination Dates of 1984 Amendments note below.

Subsec. (b)(1). Pub. L. 98–460, §17(a)(1), (b), temporarily amended par. (1) generally. Prior to amendment, par. (1) read as follows: "If the Secretary finds, after notice and opportunity for a hearing, that a State agency is substantially failing to make disability determinations in a manner consistent with his regulations and other written guidelines, the Secretary shall, not earlier than 180 days following his finding, and after he has complied with the requirements of paragraph (3), make the disability determinations referred to in subsection (a)(1)." See Effective and Termination Dates of 1984 Amendments note below.

Subsec. (b)(3). Pub. L. 98–460, §17(a)(3), (b), temporarily substituted "Except as provided in subparagraph (D)(i) of paragraph (1), the Secretary" for "The Secretary" in subpars. (A) and (B). See Effective and Termination Dates of 1984 Amendments note below.

Subsec. (d). Pub. L. 98–460, §17(a)(4), (b), temporarily substituted "Except as provided in subsection (b)(1)(D), any individual" for "Any individual". See Effective and Termination Dates of 1984 Amendments note below.

Subsec. (e). Pub. L. 98–369 substituted "Federal Disability Insurance Trust Fund is charged" for "Federal Disability Trust Fund is charged".

Subsec. (h). Pub. L. 98–460, §8(a), added subsec. (h).

Subsec. (i)(4). Pub. L. 98–460, §6(a), added par. (4).

Subsec. (j). Pub. L. 98–460, §9(a)(1), added subsec. (j).

Subsec. (k). Pub. L. 98–460, §10(a), added subsec. (k).

1983—Subsec. (i). Pub. L. 97–455 designated existing provisions as par. (1), inserted ", subject to paragraph (2)" after "at least once every 3 years", and added pars. (2) and (3).

1980—Subsec. (a). Pub. L. 96–265, §304(a), completely revised provisions under which determinations are to be made by State agencies.

Subsec. (b). Pub. L. 96–265, §304(b), substituted provisions covering the making of disability determinations by the Secretary rather than by the State for provisions relating to agreements between the Secretary and the State under which the State would make disability determinations.

Subsec. (c). Pub. L. 96–265, §304(c), designated existing provisions as par. (1), inserted provision that a review by the Secretary on his own motion of a State agency determination may be made before or after any action is taken to implement that determination, and added pars. (2) and (3).

Subsec. (d). Pub. L. 96–265, §304(d), substituted "subsection (a), (b), (c), or (g)" for "subsection (a), (c), or (g)".

Subsec. (e). Pub. L. 96–265, §304(e), substituted "which is making disability determinations under subsection (a)(1)" for "which has an agreement with the Secretary", substituted "as determined by the Secretary" for "as may be mutually agreed upon", and substituted "making disability determinations under subsection (a)(1)" for "carrying out the agreement under this section".

Subsec. (g). Pub. L. 96–265, §304(f), substituted "does not undertake to perform disability determinations under subsection (a)(1), or which has been found by the Secretary to have substantially failed to make disability determinations in a manner consistent with his regulations and guidelines" for "has no agreement under subsection (b)" and "for whom no State undertakes to make disability determinations" for "not included in an agreement under subsection (b)".

Subsec. (i). Pub. L. 96–265, §311(a), added subsec. (i).

1968—Subsec. (a). Pub. L. 90–248, §158(c)(3), substituted in first sentence reference to "423(d)" for "423(c)".

Subsec. (c). Pub. L. 90–248, §158(c)(4), substituted reference to "423(d)" for "423(c)".

1956—Subsec. (a). Act Aug. 1, 1956, §103(c)(7), inserted reference to section 423(c) of this title.

Subsec. (c). Act Aug. 1, 1956, §103(c)(8), restricted disability to definition of such term contained in section 416(i) or 423(c) of this title.

Subsec. (e). Act Aug. 1, 1956, §103(h), substituted "Trust Funds" for "Trust Fund", and provided for adjustments between the Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund with respect to payments made under this subsection.

Subsec. (f). Act Aug. 1, 1956, §103(h), substituted "Trust Funds" for "Trust Fund".

Statutory Notes and Related Subsidiaries

Effective Date of 2015 Amendment

Pub. L. 114–74, title VIII, §832(b), Nov. 2, 2015, 129 Stat. 613, provided that: "The amendment made by subsection (a) [amending this section] shall apply with respect to determinations of disability made on or after the date that is 1 year after the date of the enactment of this Act [Nov. 2, 2015]."

Effective Date of 1999 Amendment

Amendment by section 101(b)(1)(A) of Pub. L. 106–170 effective with the first month following one year after Dec. 17, 1999, subject to section 101(d) of Pub. L. 106–170, see section 101(c) of Pub. L. 106–170, set out as an Effective Date note under section 1320b–19 of this title.

Pub. L. 106–170, title I, §111(b), Dec. 17, 1999, 113 Stat. 1881, provided that: "The amendment made by subsection (a) [amending this section] shall take effect on January 1, 2002."

Effective Date of 1994 Amendment

Amendment by Pub. L. 103–296 effective Mar. 31, 1995, see section 110(a) of Pub. L. 103–296, set out as a note under section 401 of this title.

Effective Date of 1990 Amendment

Pub. L. 101–508, title V, §5128(b), Nov. 5, 1990, 104 Stat. 1388–287, provided that: "The amendment made by subsection (a) [amending this section] shall apply with respect to determinations made by State agencies in fiscal years after fiscal year 1990."

Effective Date of 1989 Amendment

Pub. L. 101–239, title X, §10306(a)(3), Dec. 19, 1989, 103 Stat. 2484, provided that: "The amendment made by this section [amending this section] shall apply with respect to notices issued on or after July 1, 1990."

Effective Date of 1988 Amendment

Pub. L. 100–647, title VIII, §8012(b), Nov. 10, 1988, 102 Stat. 3789, provided that: "The amendment made by this section [amending this section] shall apply to reports required to be submitted after the date of the enactment of this Act [Nov. 10, 1988]."

Effective and Termination Dates of 1984 Amendment

Pub. L. 98–460, §8(c), Oct. 9, 1984, 98 Stat. 1804, provided that: "The amendments made by this section [amending this section and section 1382c of this title] shall apply to determinations made after 60 days after the date of the enactment of this Act [Oct. 9, 1984]."

Pub. L. 98–460, §17(b), Oct. 9, 1984, 98 Stat. 1812, provided that: "The amendments made by subsection (a) of this section [amending this section] shall become effective on the date of the enactment of this Act [Oct. 9, 1984] and shall expire on December 31, 1987. The provisions of the Social Security Act amended by subsection (a) of this section (as such provisions were in effect immediately before the date of the enactment of this Act) shall be effective after December 31, 1987."

Amendment by Pub. L. 98–369 effective July 18, 1984, but not to be construed as changing or affecting any right, liability, status, or interpretation which existed (under the provisions of law involved) before that date, see section 2664(b) of Pub. L. 98–369, set out as a note under section 401 of this title.

Effective Date of 1983 Amendment

Pub. L. 97–455, §3(b), Jan. 12, 1983, 96 Stat. 2499, provided that: "The amendments made by subsection (a) [amending this section] shall become effective on the date of the enactment of this Act [Jan. 12, 1983]."

Effective Date of 1980 Amendment

Pub. L. 96–265, title III, §304(h), June 9, 1980, 94 Stat. 456, provided that: "The amendments made by subsections (a), (b), (d), (e), and (f) [amending this section] shall be effective beginning with the twelfth month following the month in which this Act is enacted [June 1980]. Any State that, on the effective date of the amendments made by this section, has in effect an agreement with the Secretary of Health and Human Services under section 221(a) of the Social Security Act [42 U.S.C. 421(a)] (as in effect prior to such amendments) will be deemed to have given to the Secretary the notice specified in section 221(a)(1) of such Act as amended by this section, in lieu of continuing such agreement in effect after the effective date of such amendments. Thereafter, a State may notify the Secretary in writing that it no longer wishes to make disability determinations, effective not less than 180 days after the notification is given."

Pub. L. 96–265, title III, §311(b), June 9, 1980, 94 Stat. 460, provided that: "The amendment made by subsection (a) [amending this section] shall become effective on January 1, 1982."

Effective Date of 1968 Amendment

Amendment by Pub. L. 90–248 applicable with respect to application for disability insurance benefits under section 423 of this title and to disability determinations under section 416(i) of this title, see section 158(e) of Pub. L. 90–248, set out as a note under section 423 of this title.

Expansion of Cooperative Disability Investigations Units

Pub. L. 114–74, title VIII, §811, Nov. 2, 2015, 129 Stat. 601, provided that:

"(a) In General.—Not later than October 1, 2022, the Commissioner of Social Security shall take any necessary actions, subject to the availability of appropriations, to ensure that cooperative disability investigations units have been established, in areas where there is cooperation with local law enforcement agencies, that would cover each of the 50 States, the District of Columbia, Puerto Rico, Guam, the Northern Mariana Islands, the Virgin Islands, and American Samoa.

"(b) Report.—Not later than 90 days after the date of the enactment of this Act [Nov. 2, 2015] and annually thereafter until the earlier of 2022 or the date on which nationwide coverage is achieved, the Commissioner of Social Security shall submit to the Committee on Ways and Means of the House of Representatives and the Committee on Finance of the Senate a report describing a plan to implement the nationwide coverage described in subsection (a) and outlining areas where the Social Security Administration did not receive the cooperation of local law enforcement agencies."

Report on Work-Related Continuing Disability Reviews

Pub. L. 114–74, title VIII, §845(b), Nov. 2, 2015, 129 Stat. 618, provided that:

"The Commissioner of Social Security shall annually submit to the Committee on Ways and Means of the House of Representatives and the Committee on Finance of the Senate a report on the number of work-related continuing disability reviews conducted each year to determine whether earnings derived from services demonstrate an individual's ability to engage in substantial gainful activity. Such report shall include—

"(1) the number of individuals receiving benefits based on disability under title II of such Act [probably means title II of act Aug. 14, 1935, ch. 531, which is classified to 42 U.S.C. 401 et seq.] for whom reports of earnings were received from any source by the Commissioner in the previous calendar year, reported as a total number and separately by the source of the report;

"(2) the number of individuals for whom such reports resulted in a determination to conduct a work-related continuing disability review, and the basis on which such determinations were made;

"(3) in the case of a beneficiary selected for a work-related continuing disability review on the basis of a report of earnings from any source—

"(A) the average number of days—

"(i) between the receipt of the report and the initiation of the review;

"(ii) between the initiation and the completion of the review; and

"(iii) the average amount of overpayment, if any;

"(B) the number of such reviews completed during such calendar year, and the number of such reviews that resulted in a suspension or termination of benefits;

"(C) the number of such reviews initiated in the current year that had not been completed as of the end of such calendar year;

"(D) the number of such reviews initiated in a prior year that had not been completed as of the end of such calendar year;

"(4) the total savings to the Trust Funds and the Treasury generated from benefits suspended or terminated as a result of such reviews; and

"(5) with respect to individuals for whom a work-related continuing disability review was completed during such calendar year—

"(A) the number who participated in the Ticket to Work program under section 1148 [probably means section 1148 of act Aug. 14, 1935, ch. 531, which is classified to 42 U.S.C. 1319b–19] during such calendar year;

"(B) the number who used any program work incentives during such calendar year; and

"(C) the number who received vocational rehabilitation services during such calendar year with respect to which the Commissioner of Social Security reimbursed a State agency under section 222(d) [probably means section 222(d) of act Aug. 14, 1935, ch. 531, which is classified to 42 U.S.C. 422(d)]."

Election Under Subsection (l)(1) by Current Recipients

Pub. L. 101–239, title X, §10306(a)(2), Dec. 19, 1989, 103 Stat. 2484, provided that: "Not later than July 1, 1990, the Secretary of Health and Human Services shall provide every individual receiving benefits under title II of the Social Security Act [42 U.S.C. 401 et seq.] on the basis of disability by reason of blindness an opportunity to make an election under section 221(l)(1) of such Act [42 U.S.C. 421(l)(1)] (as added by paragraph (1))."

Moratorium on Mental Impairment Reviews

Pub. L. 98–460, §5, Oct. 9, 1984, 98 Stat. 1801, provided that:

"(a) The Secretary of Health and Human Services (hereafter in this section referred to as the 'Secretary') shall revise the criteria embodied under the category 'Mental Disorders' in the 'Listing of Impairments' in effect on the date of the enactment of this Act [Oct. 9, 1984] under appendix 1 to subpart P of part 404 of title 20 of the Code of Federal Regulations. The revised criteria and listings, alone and in combination with assessments of the residual functional capacity of the individuals involved, shall be designed to realistically evaluate the ability of a mentally impaired individual to engage in substantial gainful activity in a competitive workplace environment. Regulations establishing such revised criteria and listings shall be published no later than 120 days after the date of the enactment of this Act.

"(b)(1) Until such time as revised criteria have been established by regulation in accordance with subsection (a), no continuing eligibility review shall be carried out under section 221(i) of the Social Security Act [42 U.S.C. 421(i)], or under the corresponding requirements established for disability determinations and reviews under title XVI of such Act [42 U.S.C. 1381 et seq.], with respect to any individual previously determined to be under a disability by reason of a mental impairment, if—

"(A) no initial decision on such review has been rendered with respect to such individual prior to the date of the enactment of this Act, or

"(B) an initial decision on such review was rendered with respect to such individual prior to the date of the enactment of this Act but a timely appeal from such decision was filed or was pending on or after June 7, 1983.

For purposes of this paragraph and subsection (c)(1) the term 'continuing eligibility review', when used to refer to a review of a previous determination of disability, includes any reconsideration of or hearing on the initial decision rendered in such review as well as such initial decision itself, and any review by the Appeals Council of the hearing decision.

"(2) Paragraph (1) shall not apply in any case where the Secretary determines that fraud was involved in the prior determination, or where an individual (other than an individual eligible to receive benefits under section 1619 of the Social Security Act [42 U.S.C. 1382h]) is determined by the Secretary to be engaged in substantial gainful activity (or gainful activity, in the case of a widow, surviving divorced wife, widower, or surviving divorced husband for purposes of section 202(e) and (f) of such Act [42 U.S.C. 402(e), (f)]).

"(c)(1) Any initial determination that an individual is not under a disability by reason of a mental impairment and any determination that an individual is not under a disability by reason of a mental impairment in a reconsideration of or hearing on an initial disability determination, made or held under title II or XVI of the Social Security Act [42 U.S.C. 401 et seq., 1381 et seq.] after the date of the enactment of this Act [Oct. 9, 1984] and prior to the date on which revised criteria are established by regulation in accordance with subsection (a), and any determination that an individual is not under a disability by reason of a mental impairment made under or in accordance with title II or XVI of such Act in a reconsideration of, hearing on, review by the Appeals Council of, or judicial review of a decision rendered in any continuing eligibility review to which subsection (b)(1) applies, shall be redetermined by the Secretary as soon as feasible after the date on which such criteria are so established, applying such revised criteria.

"(2) In the case of a redetermination under paragraph (1) of a prior action which found that an individual was not under a disability, if such individual is found on redetermination to be under a disability, such redetermination shall be applied as though it had been made at the time of such prior action.

"(3) Any individual with a mental impairment who was found to be not disabled pursuant to an initial disability determination or a continuing eligibility review between March 1, 1981, and the date of the enactment of this Act [Oct. 9, 1984], and who reapplies for benefits under title II or XVI of the Social Security Act, may be determined to be under a disability during the period considered in the most recent prior determination. Any reapplication under this paragraph must be filed within one year after the date of the enactment of this Act, and benefits payable as a result of the preceding sentence shall be paid only on the basis of the reapplication."

Institution of Notification System

Pub. L. 98–460, §6(c), Oct. 9, 1984, 98 Stat. 1802, provided that: "The Secretary shall institute a system of notification required by the amendments made by subsections (a) and (b) [amending this section and section 1383b of this title] as soon as is practicable after the date of the enactment of this Act [Oct. 9, 1984]."

Demonstration Projects; Opportunity for Personal Appearance Prior to Disability Determinations; Report to Congressional Committees

Pub. L. 98–460, §6(d), (e), Oct. 9, 1984, 98 Stat. 1802, 1803, required the Secretary of Health and Human Services, as soon as practicable after Oct. 9, 1984, to implement demonstration projects in at least five States in which the opportunity for a personal appearance prior to a determination of ineligibility for disability benefits under 42 U.S.C. 421(i) or prior to initial disability determinations under 42 U.S.C. 421(a), (c), (g) and title XVI of the Social Security Act (42 U.S.C. 1381 et seq.) was substituted for the face to face evidentiary hearing required by 42 U.S.C. 405(b)(2), and to report to the appropriate committees of Congress by Dec. 31, 1986.

Promulgation of Regulations

Pub. L. 98–460, §9(a)(2), Oct. 9, 1984, 98 Stat. 1805, provided that: "The Secretary of Health and Human Services shall prescribe regulations required under section 221(j) of the Social Security Act [42 U.S.C. 421(j)] not later than 180 days after the date of the enactment of this Act [Oct. 9, 1984]."

Frequency of Continuing Eligibility Reviews

Pub. L. 98–460, §15, Oct. 9, 1984, 98 Stat. 1808, provided that: "The Secretary of Health and Human Services shall promulgate final regulations, within 180 days after the date of the enactment of this Act [Oct. 9, 1984], which establish the standards to be used by the Secretary in determining the frequency of reviews under section 221(i) of the Social Security Act [42 U.S.C. 421(j)]. Until such regulations have been issued as final regulations, no individual may be reviewed more than once under section 221(i) of the Social Security Act."

Travel Expenses for Medical Examinations, Reconsideration Interviews, and Proceedings Before Administrative Law Judges

Provisions authorizing payment of travel expenses either on an actual cost or commuted basis, to an individual for travel incident to medical examinations, and to parties, their representatives and all reasonably necessary witnesses for travel within the United States, Puerto Rico, and the Virgin Islands, to reconsider interviews and to proceedings before administrative law judges under subchapters II, XVI, and XVIII of this chapter were contained in the following appropriation acts:

Oct. 18, 1978, Pub. L. 95–480, title II, 92 Stat. 1582.

Sept. 30, 1976, Pub. L. 94–439, title II, 90 Stat. 1432.

Jan. 28, 1976, Pub. L. 94–206, title II, 90 Stat. 17.

Dec. 7, 1974, Pub. L. 93–517, title II, 88 Stat. 1645.

Dec. 18, 1973, Pub. L. 93–192, title II, 87 Stat. 759.

Aug. 10, 1971, Pub. L. 92–80, title II, 85 Stat. 296.

Jan. 11, 1971, Pub. L. 91–667, title II, 84 Stat. 2013.

Mar. 5, 1970, Pub. L. 91–204, title II, 84 Stat. 41.

Oct. 11, 1968, Pub. L. 90–557, title II, 82 Stat. 988.

Nov. 8, 1967, Pub. L. 90–132, title II, 81 Stat. 402.

Nov. 7, 1966, Pub. L. 89–787, title II, 80 Stat. 1395.

Aug. 31, 1965, Pub. L. 89–156, title II, 79 Stat. 604.

Sept. 19, 1964, Pub. L. 88–605, title II, 78 Stat. 974.

Oct. 11, 1963, Pub. L. 88–136, title II, 77 Stat. 239.

Aug. 14, 1962, Pub. L. 87–582, title II, 76 Stat. 375.

Sept. 22, 1961, Pub. L. 87–290, title II, 75 Stat. 604.

Sept. 2, 1960, Pub. L. 86–703, title II, 74 Stat. 769.

Aug. 14, 1959, Pub. L. 86–158, title II, 73 Stat. 352.

Aug. 1, 1958, Pub. L. 85–580, title II, 72 Stat. 471.

June 29, 1957, Pub. L. 85–67, title II, 71 Stat. 221.

June 29, 1956, ch. 477, title II, 70 Stat. 434.

Aug. 1, 1955, ch. 437, title II, 69 Stat. 408.

Review of Decisions Rendered by Administrative Law Judges as Result of Disability Hearings; Report to Congress

Pub. L. 96–265, title III, §304(g), June 9, 1980, 94 Stat. 456, required the Secretary of Health and Human Services to implement a program of reviewing decisions rendered by administrative law judges based on hearings under subsec. (d) of this section and to report to Congress by Jan. 1, 1982, on its progress.

Assumption by Secretary of Functions and Operations of State Disability Determination Units

Pub. L. 96–265, title III, §304(i), June 9, 1980, 94 Stat. 457, directed Secretary of Health and Human Services to submit to Congress by July 1, 1980, a detailed plan on how he intended to assume functions and operations of a State disability determination unit when this became necessary under amendments made by this section [amending this section], and how he intended to meet requirements of section 221(b)(3) of Social Security Act [42 U.S.C. 421(b)(3)]. Such plan was to assume the uninterrupted operation of disability determination function and utilization of best qualified personnel to carry out such function, and was to include recommendations for any amendment of Federal law or regulation required to carry out such plan.
42 U.S.C. § 16281 (2024) — Title 42: THE PUBLIC HEALTH AND WELFARE / Chapter 149: NATIONAL ENERGY POLICY AND PROGRAMS / Subchapter IX: RESEARCH AND DEVELOPMENT / Section 16281: Advanced nuclear fuel availability
Advanced nuclear fuel availability
Status: in_force

(a) Program

(1) Establishment

The Secretary shall establish and carry out, through the Office of Nuclear Energy, a program to support the availability of HA–LEU for civilian domestic research, development, demonstration, and commercial use.

(2) Program elements

In carrying out the program under paragraph (1), the Secretary—

(A) shall develop, in consultation with the Commission, criticality benchmark data to assist the Commission in—

(i) the licensing and regulation of special nuclear material fuel fabrication and enrichment facilities under part 70 of title 10, Code of Federal Regulations; and

(ii) certification of transportation packages under part 71 of title 10, Code of Federal Regulations;

(B) shall conduct research and development, and provide financial assistance to assist commercial entities, to design and license transportation packages for HA–LEU, including canisters for metal, gas, and other HA–LEU compositions;

(C) shall, to the extent practicable—

(i) by January 1, 2024, support commercial entity submission of such transportation package designs to the Commission for certification by the Commission under part 71 of title 10, Code of Federal Regulations; and

(ii) encourage the Commission to have such transportation package designs so certified by the Commission within 24 months after receipt of an application;

(D) shall consider options for acquiring or providing HA–LEU from a stockpile of uranium owned by the Department, or using enrichment technology, to make available to members of the consortium established pursuant to subparagraph (F) for commercial use or demonstration projects, taking into account cost and amount of time required, and prioritizing methods that would produce usable HA–LEU the quickest, including options for acquiring or providing HA–LEU—

(i) that—

(I) directly meets the needs of an end user; and

(II) has been previously used or fabricated for another purpose;

(ii) that meets the needs of an end user after having radioactive or other contaminants that resulted from a previous use or fabrication of the fuel for research, development, demonstration, or deployment activities of the Department removed;

(iii) that is produced from high-enriched uranium that is blended with lower assay uranium to become HA–LEU to meet the needs of an end user;

(iv) that is produced by Department research, development, and demonstration activities;

(v) that is produced in the United States by—

(I) a United States-owned commercial entity operating United States-origin technology;

(II) a United States-owned commercial entity operating a foreign-origin technology; or

(III) a foreign-owned entity operating a foreign-origin technology;

(vi) that does not require extraction of uranium or development of uranium from lands managed by the Federal Government, cause harm to the natural or cultural resources of Tribal communities or sovereign Native Nations, or result in degraded ground or surface water quality on publicly managed or privately owned lands; or

(vii) that does not negatively impact the availability of HA–LEU by the Department to support the production of medical isotopes, including the medical isotopes defined under the American Medical Isotopes Production Act of 2012 (Public Law 112–239; 126 Stat. 2211);

(E) not later than 1 year after December 27, 2020, and biennially thereafter, shall conduct a survey of stakeholders to estimate the quantity of HA–LEU necessary for domestic commercial use for each of the 5 subsequent years;

(F) shall establish, and from time to time update, a consortium, which may include entities involved in any stage of the nuclear fuel cycle, to partner with the Department to support the availability of HA–LEU for civilian domestic demonstration and commercial use, including by—

(i) providing information to the Secretary for purposes of surveys conducted under subparagraph (E);

(ii) purchasing HA–LEU made available by the Secretary to members of the consortium for commercial use under the program; and

(iii) carrying out demonstration projects using HA–LEU provided by the Secretary under the program;

(G) if applicable, shall, prior to acquiring or providing HA–LEU under subparagraph (H), in coordination with the consortium established pursuant to subparagraph (F), develop a schedule for cost recovery of HA–LEU made available to members of the consortium using HA–LEU for commercial use pursuant to subparagraph (H);

(H) shall, beginning not later than 3 years after the establishment of a consortium under subparagraph (F), have the capability to acquire or provide HA–LEU, in order to make such HA–LEU available to members of the consortium beginning not later than January 1, 2026, in amounts that are consistent, to the extent practicable, with—

(i) the quantities estimated under the surveys conducted under subparagraph (E); plus

(ii) the quantities necessary for demonstration projects carried out under the program, as determined by the Secretary;

(I) shall, for advanced reactor demonstration projects, prioritize the provision of HA–LEU made available under this section through a merit-based, competitive selection process; and

(J) shall seek to ensure that the activities carried out under this section do not cause any delay in the progress of any HA–LEU project between private industry and the Department that is underway as of December 27, 2020.

(3) Applicability of USEC Privatization Act

(A) Sale or transfer to consortium

The requirements of section 3112 of the USEC Privatization Act (42 U.S.C. 2297h–10), except for the requirements of subparagraph (A) of section 3112(d)(2), shall not apply to the provision of enrichment services, or the sale or transfer of HA–LEU for commercial use by the Secretary to a member of the consortium under this subsection.

(B) Demonstration

HA–LEU made available to members of the consortium established pursuant to paragraph (2)(F) for demonstration projects shall remain the property of and title will remain with the Department, which shall be responsible for the storage, use, and disposition of all radioactive waste and spent nuclear fuel created by the irradiation, processing, or purification of such uranium, and shall not be subject to the requirements of a sale or transfer of uranium under sections 3112, except for the requirements of subparagraph (A) of section 3112, and 3113 of the USEC Privatization Act (42 U.S.C. 2297h–10; 42 U.S.C. 2297h–11).

(4) National security needs

The Secretary shall only make available to a member of the consortium under this section for commercial or demonstration project use material that the President has determined is not necessary for national security needs, provided that this available material shall not include any material that the Secretary may determine to be necessary for the National Nuclear Security Administration or other critical Departmental missions.

(5) DOE acquisition of HA–LEU

The Secretary may not make commitments under this section (including cooperative agreements (used in accordance with section 6305 of title 31), purchase agreements, guarantees, leases, service contracts, or any other type of commitment) for the purchase or other acquisition of HA–LEU unless—

(A) funds are specifically provided for such purposes in advance in subsequent appropriations Acts, and only to the extent that the full extent of anticipated costs stemming from such commitments is recorded as an obligation up front and in full at the time it is made; or

(B) such committing agreement includes a clause conditioning the Federal Government's obligation on the availability of future year appropriations.

(6) Sunset

The authority of the Secretary to carry out the program under this subsection shall expire on the earlier of—

(A) September 30, 2034; or

(B) 90 days after the date on which HA–LEU is available to provide a reliable and adequate supply for civilian domestic advanced nuclear reactors in the commercial market.

(7) Limitation

The Secretary shall not barter or otherwise sell or transfer uranium in any form in exchange for services relating to the final disposition of radioactive waste from uranium that is made available under this subsection.

(b) Reports to Congress

(1) Commission report on necessary regulatory updates

Not later than 12 months after December 27, 2020, the Commission shall submit to Congress a report that includes—

(A) identification of updates to regulations, certifications, and other regulatory policies that the Commission determines are necessary in order for HA–LEU to be commercially available, including—

(i) guidance for material control and accountability of special nuclear material;

(ii) certifications relating to transportation packaging for HA–LEU; and

(iii) licensing of enrichment, conversion, and fuel fabrication facilities for HA–LEU, and associated physical security plans for such facilities;

(B) a description of such updates; and

(C) a timeline to complete such updates.

(2) DOE report on program to support the availability of HA–LEU for civilian domestic demonstration and commercial use

(A) In general

Not later than 180 days after December 27, 2020, the Secretary shall submit to Congress a report that describes actions proposed to be carried out by the Secretary under the program described in subsection (a)(1).

(B) Coordination and stakeholder input

In developing the report under this paragraph, the Secretary shall consult with—

(i) the Commission;

(ii) suppliers of medical isotopes that have converted their operations to use HA–LEU;

(iii) the National Laboratories;

(iv) institutions of higher education;

(v) a diverse group of entities from the nuclear energy industry;

(vi) a diverse group of technology developers;

(vii) experts in nuclear nonproliferation, environmental safety, safeguards and security, and public health and safety; and

(viii) members of the consortium created under subsection (a)(2)(F).

(C) Cost and schedule estimates

The report under this paragraph shall include estimated costs, budgets, and timeframes for all activities carried out under this section.

(D) Required evaluations

The report under this paragraph shall evaluate—

(i) the actions required to establish and carry out the program under subsection (a)(1) and the cost of such actions, including with respect to—

(I) proposed preliminary terms for contracting between the Department and recipients of HA–LEU under the program (including guidelines defining the roles and responsibilities between the Department and the recipient); and

(II) the potential to coordinate with recipients of HA–LEU under the program regarding—

(aa) fuel fabrication; and

(bb) fuel transport;

(ii) the potential sources and fuel forms available to provide uranium for the program under subsection (a)(1);

(iii) options to coordinate the program under subsection (a)(1) with the operation of the versatile, reactor-based fast neutron source under section 16279a of this title (as added by section 2003);

(iv) the ability of uranium producers to provide materials for advanced nuclear reactor fuel;

(v) any associated legal, regulatory, and policy issues that should be addressed to enable—

(I) implementation of the program under subsection (a)(1); and

(II) the establishment of an industry capable of providing HA–LEU; and

(vi) any research and development plans to develop criticality benchmark data under subsection (a)(2)(A), if needed.

(3) Alternate fuels report

Not later than 180 days after December 27, 2020, the Secretary shall, after consulting with relevant entities, including National Laboratories, institutions of higher education, and technology developers, submit to Congress a report identifying any and all options for providing nuclear material, containing isotopes other than the uranium-235 isotope, such as uranium-233 and thorium-232 to be used as fuel for advanced nuclear reactor research, development, demonstration, or commercial application purposes.

(c) Authorization of appropriations

There are authorized to be appropriated to carry out research, development, demonstration, and transportation activities in this section—

(1) $31,500,000 for fiscal year 2021;

(2) $33,075,000 for fiscal year 2022;

(3) $34,728,750 for fiscal year 2023;

(4) $36,465,188 for fiscal year 2024; and

(5) $38,288,447 for fiscal year 2025.

(d) Definitions

In this section:

(1) Commission

The term "Commission" means the Nuclear Regulatory Commission.

(2) Demonstration project

The term "demonstration project" has the meaning given such term in section 16279a of this title.

(3) HA–LEU

The term "HA–LEU" means high-assay low-enriched uranium.

(4) High-assay low-enriched uranium

The term "high-assay low-enriched uranium" means uranium having an assay greater than 5.0 weight percent and less than 20.0 weight percent of the uranium-235 isotope.

(5) High-enriched uranium

The term "high-enriched uranium" means uranium with an assay of 20.0 weight percent or more of the uranium-235 isotope.

(6) Secretary

The term "Secretary" means the Secretary of Energy.

(Pub. L. 116–260, div. Z, title II, §2001, Dec. 27, 2020, 134 Stat. 2453.)

Editorial Notes

References in Text

The American Medical Isotopes Production Act of 2012, referred to in subsec. (a)(2)(D)(vii), is subtitle F (§3171 et seq.) of title XXXI of div. C of Pub. L. 112–239, Jan. 2, 2013, 126 Stat. 2211. For complete classification of this Act to the Code, see Short Title of 2013 Amendment note set out under section 2011 of this title and Tables.

Section 16279a of this title (as added by section 2003), referred to in subsec. (b)(2)(D)(iii), is section 16279a of this title as added by section 2003 of div. Z of Pub. L. 116–260.

Codification

Section was enacted as part of the Energy Act of 2020, and not as part of the Energy Policy Act of 2005 which comprises this chapter.

Statutory Notes and Related Subsidiaries

Development, Qualification, and Licensing of Advanced Nuclear Fuel Concepts

Pub. L. 118–67, div. B, title IV, §404, July 9, 2024, 138 Stat. 1469, provided that:

"(a) In General.—The [Nuclear Regulatory] Commission shall establish an initiative to enhance preparedness and coordination with respect to the qualification and licensing of advanced nuclear fuel.

"(b) Agency Coordination.—Not later than 180 days after the date of enactment of this Act [July 9, 2024], the Commission and the Secretary of Energy shall enter into a memorandum of understanding—

"(1) to share technical expertise and knowledge through—

"(A) enabling the testing and demonstration of accident tolerant fuels for existing commercial nuclear reactors and advanced nuclear reactor fuel concepts to be proposed and funded, in whole or in part, by the private sector;

"(B) operating a database to store and share data and knowledge relevant to nuclear science and engineering between Federal agencies and the private sector;

"(C) leveraging expertise with respect to safety analysis and research relating to advanced nuclear fuel; and

"(D) enabling technical staff to actively observe and learn about technologies, with an emphasis on identification of additional information needed with respect to advanced nuclear fuel; and

"(2) to ensure that—

"(A) the Department of Energy has sufficient technical expertise to support the timely research, development, demonstration, and commercial application of advanced nuclear fuel;

"(B) the Commission has sufficient technical expertise to support the evaluation of applications for licenses, permits, and design certifications and other requests for regulatory approval for advanced nuclear fuel;

"(C)(i) the Department of Energy maintains and develops the facilities necessary to enable the timely research, development, demonstration, and commercial application by the civilian nuclear industry of advanced nuclear fuel; and

"(ii) the Commission has access to the facilities described in clause (i), as needed; and

"(D) the Commission consults, as appropriate, with the modeling and simulation experts at the Office of Nuclear Energy of the Department of Energy, at the National Laboratories, and within industry fuel vendor teams in cooperative agreements with the Department of Energy to leverage physics-based computer modeling and simulation capabilities.

"(c) Report.—

"(1) In general.—Not later than 2 years after the date of enactment of this Act, the Commission shall submit to the appropriate committees of Congress [Committee on Energy and Commerce of the House of Representatives and Committee on Environment and Public Works of the Senate] a report describing the efforts of the Commission under subsection (a), including—

"(A) an assessment of the preparedness of the Commission to review and qualify for use—

"(i) accident tolerant fuel;

"(ii) ceramic cladding materials;

"(iii) fuels containing silicon carbide;

"(iv) high-assay, low-enriched uranium fuels;

"(v) molten-salt based liquid fuels;

"(vi) fuels derived from spent nuclear fuel or depleted uranium; and

"(vii) other related fuel concepts, as determined by the Commission;

"(B) activities planned or undertaken under the memorandum of understanding described in subsection (b);

"(C) an accounting of the areas of research needed with respect to advanced nuclear fuel; and

"(D) any other challenges or considerations identified by the Commission.

"(2) Consultation.—In developing the report under paragraph (1), the Commission shall seek input from—

"(A) the Secretary of Energy;

"(B) National Laboratories;

"(C) the nuclear energy industry;

"(D) technology developers;

"(E) nongovernmental organizations; and

"(F) other public stakeholders."

[For definitions of terms used in section 404 of Pub. L. 118–67, set out above, see section 2 of Pub. L. 118–67, set out as a note under section 2011 of this title.]

Receipts To Be Credited to American Energy Independence Fund

Pub. L. 118–42, div. D, title III, §312(a), Mar. 9, 2024, 138 Stat. 210, provided in part: "That notwithstanding 31 U.S.C. 3302, receipts from the sale or transfer of LEU and HALEU or from any other transaction in connection with the amounts repurposed, transferred, or otherwise made available pursuant to this section shall hereafter be credited to the 'American Energy Independence Fund' as discretionary offsetting collections and shall be available, for the same purposes as funds repurposed or transferred pursuant to this section, to the extent and in the amounts provided in advance in appropriations Acts: Provided further, That receipts may hereafter be collected from transactions entered into pursuant to section 2001(a)(2)(F)(iii) of the Energy Act of 2020 (42 U.S.C. 16281(a)(2)(F)(iii)) and, notwithstanding 31 U.S.C. 3302, receipts from any transaction entered into pursuant to section 2001(a)(2)(F)(ii) and (iii) of such Act (42 U.S.C. 16281(a)(2)(F)(ii) and (iii)) shall hereafter be credited to the 'American Energy Independence Fund' as discretionary offsetting collections and shall be available, for the same purposes as funds repurposed or transferred pursuant to this section, to the extent and in the amounts provided in advance in appropriations Acts".