| 1 | 1 | | By: Harrison H.B. No. 1023 |
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| 2 | 2 | | |
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| 3 | 3 | | |
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| 4 | 4 | | A BILL TO BE ENTITLED |
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| 5 | 5 | | AN ACT |
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| 6 | 6 | | relating to the regulation of laboratory developed tests during a |
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| 7 | 7 | | federally declared public health emergency. |
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| 8 | 8 | | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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| 9 | 9 | | SECTION 1. Subtitle D, Title 2, Health and Safety Code, is |
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| 10 | 10 | | amended by adding Chapter 100B to read as follows: |
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| 11 | 11 | | CHAPTER 100B. REGULATION OF LABORATORY DEVELOPED TESTS DURING |
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| 12 | 12 | | FEDERALLY DECLARED PUBLIC HEALTH EMERGENCY |
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| 13 | 13 | | Sec. 100B.001. DEFINITIONS. In this chapter: |
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| 14 | 14 | | (1) "Federally declared public health emergency" |
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| 15 | 15 | | means: |
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| 16 | 16 | | (A) a public health emergency declared by the |
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| 17 | 17 | | United States secretary of health and human services under 42 |
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| 18 | 18 | | U.S.C. Section 247d; or |
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| 19 | 19 | | (B) an emergency or disaster declared, including |
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| 20 | 20 | | under a renewal of the declaration, by the president of the United |
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| 21 | 21 | | States in relation to a public health emergency described by |
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| 22 | 22 | | Paragraph (A) under: |
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| 23 | 23 | | (i) the National Emergencies Act (50 U.S.C. |
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| 24 | 24 | | Section 1601 et seq.); or |
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| 25 | 25 | | (ii) the Robert T. Stafford Disaster Relief |
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| 26 | 26 | | and Emergency Assistant Act (42 U.S.C. Section 5121 et seq.). |
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| 27 | 27 | | (2) "Laboratory developed test" means a test used in |
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| 28 | 28 | | the same clinical laboratory in Texas that designed and |
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| 29 | 29 | | manufactured the test to detect a pathogen or agent or to diagnose |
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| 30 | 30 | | a health condition caused by a pathogen or agent, and as result, |
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| 31 | 31 | | such test is deemed to be a test used and manufactured solely |
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| 32 | 32 | | intrastate. |
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| 33 | 33 | | Sec. 100B.002. PROHIBITED REGULATION BY UNITED STATES FOOD |
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| 34 | 34 | | AND DRUG ADMINISTRATION. (a) Notwithstanding any other law, |
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| 35 | 35 | | during a federally declared public health emergency, a clinical |
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| 36 | 36 | | laboratory is considered a state agency for purposes of regulation |
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| 37 | 37 | | by the United States Food and Drug Administration when the |
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| 38 | 38 | | laboratory is performing a laboratory developed test on a pathogen |
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| 39 | 39 | | or agent that is the basis for the emergency declaration or to |
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| 40 | 40 | | diagnose the health condition that is the basis for the emergency |
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| 41 | 41 | | declaration. |
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| 42 | 42 | | (b) Subsection (a) does not affect a clinical laboratory's |
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| 43 | 43 | | liability under any applicable state or federal law, except to the |
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| 44 | 44 | | extent the laboratory's liability is limited under the Public |
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| 45 | 45 | | Readiness and Emergency Preparedness Act (42 U.S.C. Section 247d) |
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| 46 | 46 | | and further does not authorize any state agency to exercise any |
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| 47 | 47 | | authority over laboratories that it did not possess prior the |
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| 48 | 48 | | issuance of the public health emergency. |
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| 49 | 49 | | SECTION 2. This Act takes effect immediately if it receives |
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| 50 | 50 | | a vote of two-thirds of all the members elected to each house, as |
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| 51 | 51 | | provided by Section 39, Article III, Texas Constitution. If this |
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| 52 | 52 | | Act does not receive the vote necessary for immediate effect, this |
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| 53 | 53 | | Act takes effect September 1, 2023. |
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