bill treating Texas labs as state agencies during emergencies

The text as introduced · 416 words

By: Harrison
H.B. No. 964

A BILL TO BE ENTITLED

AN ACT

relating to the regulation of laboratory developed tests during a

federally declared public health emergency.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:

SECTION 1. Subtitle D, Title 2, Health and Safety Code, is

amended by adding Chapter 100B to read as follows:

CHAPTER 100B. REGULATION OF LABORATORY DEVELOPED TESTS DURING

FEDERALLY DECLARED PUBLIC HEALTH EMERGENCY

Sec. 100B.001. DEFINITIONS. In this chapter:

(1) "Federally declared public health emergency"

means:

(A) a public health emergency declared by the

United States secretary of health and human services under 42

U.S.C. Section 247d; or

(B) an emergency or disaster declared, including

under a renewal of the declaration, by the president of the United

States in relation to a public health emergency described by

Paragraph (A) under:

(i) the National Emergencies Act (50 U.S.C.

Section 1601 et seq.); or

(ii) the Robert T. Stafford Disaster Relief

and Emergency Assistance Act (42 U.S.C. Section 5121 et seq.).

(2) "Laboratory developed test" means a test used in

the same clinical laboratory in Texas that designed and

manufactured the test to detect a pathogen or agent or to diagnose

a health condition caused by a pathogen or agent, and as result,

such test is deemed to be a test used and manufactured solely

intrastate.

Sec. 100B.002. PROHIBITED REGULATION BY UNITED STATES FOOD

AND DRUG ADMINISTRATION. (a) Notwithstanding any other law,

during a federally declared public health emergency, a clinical

laboratory is considered a state agency for purposes of regulation

by the United States Food and Drug Administration when the

laboratory is performing a laboratory developed test on a pathogen

or agent that is the basis for the emergency declaration or to

diagnose the health condition that is the basis for the emergency

declaration.

(b) Subsection (a) does not affect a clinical laboratory's

liability under any applicable state or federal law, except to the

extent the laboratory's liability is limited under the Public

Readiness and Emergency Preparedness Act (42 U.S.C. Section 247d)

and further does not authorize any state agency to exercise any

authority over laboratories that it did not possess prior the

issuance of the public health emergency.

SECTION 2. This Act takes effect immediately if it receives

a vote of two-thirds of all the members elected to each house, as

provided by Section 39, Article III, Texas Constitution. If this

Act does not receive the vote necessary for immediate effect, this

Act takes effect September 1, 2025.