§8308a — Title 7 Agriculture | U.S. Code

Summary

The law creates programs to strengthen U.S. veterinary labs, prepare for animal disease outbreaks, and keep a national stockpile of animal vaccines and medicines. The Secretary of Agriculture must make agreements with qualified diagnostic labs to boost response to animal bioterrorism and outbreaks, and to standardize tests, biosafety, quality systems, data reporting, and emergency readiness. Eligible laboratory: a diagnostic lab that meets rules the Secretary sets with state and university lab input. The Secretary should give priority to existing Federal, State, and university labs. The law also starts the National Animal Disease Preparedness and Response Program to protect livestock, trade, and the economy. Activities include surveillance, outreach and education, targeted inspections, better threat detection technology, improved biosecurity, emergency response training, electronic data sharing, and development of vaccines, diagnostics, drugs for minor uses/species, medical devices, and other countermeasures. The Secretary can make cooperative agreements with eligible entities (for example, State agriculture offices, State chief animal health offices, vet colleges, livestock producer groups, State emergency agencies, tribal governments, Federal agencies, and recognized veterinary organizations). Priority goes to State applicants and to work in States or regions with Federal concern or higher risk. Applicants must apply, follow audit and reporting rules, and may use funds only as agreed; sub-awards are allowed and recipients must report results within 90 days after an activity. The law creates a National Animal Vaccine and Veterinary Countermeasures Bank and directs the Secretary to keep enough stock to respond quickly, with special focus on foot-and-mouth disease vaccine and related diagnostics and to use existing stockpile systems when useful. Funding from the Commodity Credit Corporation is: $120,000,000 for fiscal years 2019–2022 (at least $5,000,000 per year for the Program); $30,000,000 per year for fiscal years 2023–2025 (at least $18,000,000 per year for the Program); $233,000,000 per year for fiscal years 2026–2030 (each year at least $10,000,000 for lab network, $70,000,000 for the Program, and $153,000,000 for the Vaccine Bank); and $75,000,000 for fiscal year 2031 and each year after (at least $45,000,000 per year for the Program). In addition, up to $30,000,000 per year was authorized to be appropriated for fiscal years 2019–2023 for the lab network, and other sums as needed were authorized for 2019–2023 for the Program and the Vaccine Bank. The Secretary may keep up to 4% of funds for administrative costs, and eligible recipients may keep up to 10% for administration under the Program. Funds stay available until spent, proceeds from Vaccine Bank sales go to the U.S. Treasury and are credited back to the Vaccine Bank account, and funds cannot be used to build or expand facilities. The Secretary must offer agreements under these programs each fiscal year 2019–2023, and existing agreements remain in force.

Title 7, §8308a

Agriculture — Source: USLM XML via OLRC

(a)(1)In this subsection, the term “eligible laboratory” means a diagnostic laboratory that meets specific criteria developed by the Secretary, in consultation with State animal health officials, State veterinary diagnostic laboratories, and veterinary diagnostic laboratories at institutions of higher education (as defined in section 1001 of title 20).

(2)The Secretary, in consultation with State veterinarians, shall offer to enter into contracts, grants, cooperative agreements, or other legal instruments with eligible laboratories for any of the following purposes:

(A)To enhance the capability of the Secretary to respond in a timely manner to emerging or existing bioterrorist threats to animal health.

(B)To provide the capacity and capability for standardized—

(i)test procedures, reference materials, and equipment;

(ii)laboratory biosafety and biosecurity levels;

(iii)quality management system requirements;

(iv)interconnected electronic reporting and transmission of data; and

(v)evaluation for emergency preparedness.

(C)To coordinate the development, implementation, and enhancement of national veterinary diagnostic laboratory capabilities, with special emphasis on surveillance planning and vulnerability analysis, technology development and validation, training, and outreach.

(3)To the extent practicable and to the extent capacity and specialized expertise may be necessary, the Secretary shall give priority to existing Federal facilities, State facilities, and facilities at institutions of higher education.

(b)(1)The Secretary shall establish a program, to be known as the National Animal Disease Preparedness and Response Program (referred to in this section as “the Program”), to address the increasing risk of the introduction and spread within the United States of animal pests and diseases affecting the economic interests of the livestock and related industries of the United States, including the maintenance and expansion of export markets.

(2)Activities under the Program shall include, to the extent practicable, the following:

(A)Enhancing animal pest and disease analysis and surveillance.

(B)Expanding outreach and education.

(C)Targeting domestic inspection activities at vulnerable points in the safeguarding continuum.

(D)Enhancing and strengthening threat identification technology.

(E)Improving biosecurity.

(F)Enhancing emergency preparedness and response capabilities, including training additional emergency response personnel.

(G)Conducting technology development to enhance electronic sharing of animal health data for risk analysis between State and Federal animal health officials.

(H)Enhancing the development and effectiveness of animal health technologies to treat and prevent animal disease, including—

(i)veterinary biologics and diagnostics;

(ii)animal drugs for minor uses and minor species;

(iii)animal medical devices; and

(iv)emerging veterinary countermeasures.

(I)Such other activities as determined appropriate by the Secretary, in consultation with eligible entities specified in paragraph (3).

(3)To carry out the Program, the Secretary shall offer to enter into cooperative agreements or other legal instruments, as authorized under section 8312 of this title (referred to in this section as “agreements”) with eligible entities, to be selected by the Secretary, which may include any of the following entities, either individually or in combination:

(A)A State department of agriculture.

(B)The office of the chief animal health official of a State.

(C)An entity eligible to receive funds under a capacity and infrastructure program (as defined in section 6971(f)(1)(C) of this title).

(D)A college of veterinary medicine, including a veterinary emergency team at such college.

(E)A State or national livestock producer organization with direct and significant economic interest in livestock production.

(F)A State emergency agency.

(G)A State, national, allied, or regional veterinary organization or specialty board recognized by the American Veterinary Medical Association.

(H)An Indian Tribe.

(I)A Federal agency.

(4)In entering into agreements under this subsection, the Secretary shall give priority to applications submitted by—

(A)a State department of agriculture or an office of the chief animal health official of a State; or

(B)an eligible entity that will carry out program activities in a State or region in which—

(i)an animal pest or disease is a Federal concern; or

(ii)the Secretary determines a potential exists for the spread of an animal pest or disease after taking into consideration—

(I)the agricultural industries in the State or region;

(II)factors contributing to animal pest or disease in the State or region, such as the climate, natural resources, and geography of, and native and exotic wildlife species and other disease vectors in, the State or region; and

(III)the movement of animals in the State or region.

(5)For purposes of setting priorities under this subsection, the Secretary shall consult with eligible entities specified in paragraph (3). The Federal Advisory Committee Act (5 U.S.C. App.) 11 See References in Text note below. shall not apply to consultation carried out under this paragraph.

(6)(A)An eligible entity specified in paragraph (3) seeking to enter into an agreement under the Program shall submit to the Secretary an application containing such information as the Secretary may require.

(B)The Secretary shall notify each applicant of—

(i)the requirements to be imposed on the eligible entity that is the recipient of funds under the Program for auditing of, and reporting on, the use of such funds; and

(ii)the criteria to be used to ensure activities supported using such funds are based on sound scientific data or thorough risk assessments.

(C)When deciding whether to enter into an agreement under the Program with an eligible entity described in paragraph (3), the Secretary—

(i)may take into consideration an eligible entity’s ability to contribute non-Federal funds to carry out such an agreement; and

(ii)shall not require such an eligible entity to make such a contribution as a condition to enter into an agreement.

(7)(A)The recipient of funds under the Program shall use the funds for the purposes and in the manner provided in the agreement under which the funds are provided.

(B)Nothing in this section prevents an eligible entity from using funds received under the Program to enter into sub-agreements with another eligible entity or with a political subdivision of a State that has legal responsibilities relating to animal disease prevention, surveillance, or rapid response.

(8)Not later than 90 days after the date of completion of an activity conducted using funds provided under the Program, the recipient of such funds shall submit to the Secretary a report that describes the purposes and results of the activities.

(c)(1)The Secretary shall establish a national animal vaccine and veterinary countermeasures bank (to be known as the National Animal Vaccine and Veterinary Countermeasures Bank and referred to in this subsection as the “Vaccine Bank”) to benefit the domestic interests of the United States.

(2)Through the Vaccine Bank, the Secretary shall—

(A)maintain sufficient quantities of veterinary countermeasures to appropriately and rapidly respond to the most damaging animal diseases affecting or with potential to affect human health or the economy of the United States; and

(B)leverage, when appropriate, the mechanisms and infrastructure that have been developed for the management, storage, and distribution of the National Veterinary Stockpile.

(3)The Secretary shall prioritize the acquisition and maintenance of sufficient quantities of foot and mouth disease vaccine and accompanying diagnostic products for the Vaccine Bank. As part of such prioritization, the Secretary may offer to enter into one or more contracts with one or more entities that are capable of producing foot and mouth disease vaccine and that have surge production capacity of the vaccine.

(d)(1)(A)Of the funds of the Commodity Credit Corporation, the Secretary shall make available to carry out this section $120,000,000 for the period of fiscal years 2019 through 2022, of which not less than $5,000,000 shall be made available for each of those fiscal years to carry out subsection (b).

(B)Of the funds of the Commodity Credit Corporation, the Secretary shall make available to carry out this section $30,000,000 for each of fiscal years 2023 through 2025, of which not less than $18,000,000 shall be made available for each of those fiscal years to carry out subsection (b).

(C)Of the funds of the Commodity Credit Corporation, the Secretary shall make available to carry out this section $233,000,000 for each of fiscal years 2026 through 2030, of which—

(i)not less than $10,000,000 shall be made available for each such fiscal year to carry out subsection (a);

(ii)not less than $70,000,000 shall be made available for each such fiscal year to carry out subsection (b); and

(iii)not less than $153,000,000 shall be made available for each such fiscal year to carry out subsection (c).

(D)Of the funds of the Commodity Credit Corporation, the Secretary shall make available to carry out this section $75,000,000 for fiscal year 2031 and each fiscal year thereafter, of which not less than $45,000,000 shall be made available for each of those fiscal years to carry out subsection (b).

(2)(A)In addition to the funds made available under paragraph (1), there is authorized to be appropriated $30,000,000 for each of fiscal years 2019 through 2023 to carry out subsection (a).

(B)In addition to the funds made available under paragraph (1), there is authorized to be appropriated such sums as are necessary for each of fiscal years 2019 through 2023 to carry out subsections (b) and (c).

(C)The funds authorized for appropriation under this paragraph are in addition to any funds authorized or otherwise made available under this section or section 8316 of this title.

(3)(A)Of the funds made available under this section or section 8316 of this title to carry out the National Animal Health Laboratory Network under subsection (a) and the National Animal Disease Preparedness and Response Program under subsection (b), not more than 4 percent may be retained by the Secretary to pay administrative costs incurred by the Secretary.

(B)Of the funds made available under this section or section 8316 of this title to carry out the National Animal Disease Preparedness and Response Program under subsection (b), not more than 10 percent may be retained by an eligible entity that receives funds under any agreement entered into under such subsection, including any sub-agreement under paragraph (7)(B) of such subsection to pay administrative costs incurred by the eligible entity to carry out activities under the Program.

(4)Funds made available under this subsection, including any proceeds credited under paragraph (5), shall remain available until expended.

(5)Any proceeds of a sale of veterinary countermeasures from the Vaccine Bank shall be—

(A)deposited into the Treasury of the United States; and

(B)credited to the account for the operation of the Vaccine Bank to be made available for expenditure without further appropriation.

(6)Funds made available under the National Animal Health Laboratory Network, the National Animal Disease Preparedness and Response Program, and the Vaccine Bank shall not be used for the construction of a new building or facility or the acquisition or expansion of an existing building or facility, including site grading and improvement and architect fees.

(e)(1)Using the funds made available under subsection (d), the Secretary of Agriculture shall offer to enter into contracts, grants, cooperative agreements, or other legal instruments under subsections (a) through (c) during each of the fiscal years 2019 through 2023.

(2)Nothing in paragraph (1) shall be construed to terminate a contract, grant, cooperative agreement, or other legal instrument entered into during the period specified in such paragraph.

Notes & Related Subsidiaries

Editorial Notes

References in Text

The Federal Advisory Committee Act, referred to in subsec. (b)(5), is Pub. L. 92–463, Oct. 6, 1972, 86 Stat. 770, which was set out in the Appendix to Title 5, Government Organization and Employees, and was substantially repealed and restated in chapter 10 (§ 1001 et seq.) of Title 5 by Pub. L. 117–286, §§ 3(a), 7, Dec. 27, 2022, 136 Stat. 4197, 4361. For disposition of sections of the Act into chapter 10 of Title 5, see Disposition Table preceding section 101 of Title 5.

Amendments

2025—Subsec. (d)(1)(B). Pub. L. 119–21, § 10607(a)(1), substituted “Fiscal years 2023 through 2025” for “Subsequent fiscal years” in heading and “each of fiscal years 2023 through 2025” for “fiscal year 2023 and each fiscal year thereafter” in text. Subsec. (d)(1)(C), (D). Pub. L. 119–21, § 10607(a)(2), added subpars. (C) and (D). 2018—Pub. L. 115–334, § 12101(b)(1), substituted “Animal disease prevention and management” for “National animal health laboratory network” in section catchline. Subsec. (a). Pub. L. 115–334, § 12101(b)(2), (4), substituted “National Animal Health Laboratory Network” for “Definition of eligible laboratory” in heading, inserted par. (1) designation and heading and substituted “In this subsection,” for “In this section,”, redesignated subsecs. (b) and (c) as pars. (2) and (3), respectively, and realigned margins. Subsec. (a)(2). Pub. L. 115–334, § 12101(b)(3)(B), redesignated pars. (1) to (3) of former subsec. (b) as subpars. (A) to (C), respectively, and realigned margins. Subsec. (a)(2)(B). Pub. L. 115–334, § 12101(b)(3)(A), redesignated subpars. (A) to (E) of former subsec. (b)(2) as cls. (i) to (v), respectively, and realigned margins. Subsec. (b). Pub. L. 115–334, § 12101(b)(5), added subsec. (b). Former subsec. (b) redesignated (a)(2). Subsec. (c). Pub. L. 115–334, § 12101(c), added subsec. (c). Former subsec. (c) redesignated (a)(3). Subsecs. (d), (e). Pub. L. 115–334, § 12101(d), added subsecs. (d) and (e) and struck out former subsec. (d) which authorized to be appropriated to carry out this section $15,000,000 for each of fiscal years 2014 through 2018.

§8308a Animal disease prevention and management