SecondHB1201_H_BUS.001 RegularNOT SessionAMENDED Seventy-thirdHOUSE GeneralCOMMITTEE AssemblyOF STATEREFERENCE OFREPORT COLORADO_______________________________ INTRODUCEDMarch LLS3, NO.2022 Chair of Committee Date Committee on Business Affairs & Labor .

22-0049.01After Kristenconsideration Forrestalon x4217the HOUSEmerits, BILLthe 22-1201Committee HOUSErecommends SPONSORSHIPthe Vanfollowing: Beber, Holtorf, Lynch, Pelton, Pico, Ransom, Rich, Van Winkle, Will SENATE SPONSORSHIP (None), House Committees Senate Committees Business Affairs & Labor A BILL FOR AN ACT C ONCERNING STANDARDS FOR IMMUNIZATION REQUIREMENTS .

BillHB22-1201 Summarybe (Note:postponed indefinitely.

This** summary*** applies** to*** this** bill as introduced and does notreflectanyamendmentsthatmaybesubsequentlyadopted.Ifthisbill passes third reading in the house of introduction, a bill summary that applies to the reengrossed version of this bill will be available at http://leg.colorado.gov.) The bill allows individuals who are required to receive an immunization for any purpose to claim an exemption from the requirement if the:

! Immunization has not been approved by the federal food and drug administration (FDA);

! Immunization has only received emergency use authorization;

! Immunizationmanufacturerisnotliableforinjuryordeath Shading denotes HOUSE amendment.

Double underlining denotes SENATE amendment.

Capital letters or bold & italic numbers indicate new material to be added to existing statute.

Dashes through the words indicate deletions from existing statute.

caused by the immunization;

or ! Pivotal clinical trial the FDA relied on to approve the immunization did not evaluate the immunization's safety, for at least one year after the immunization was first administered, against a control group.

Thebillrequiresthedepartmentof publichealthandenvironment to post on its website:

! The criteria that must be met for an individual to claim an exemption from an immunization requirement;

and ! For each immunization required:

! Theinjuriesordiseasescausedbytheimmunization and the rate at which each injury or disease occurs;

and ! Whether the risk of permanent disability or death from the required immunization has been proven to belessthantheriskofpermanentdisabilityordeath from the infection or disease the immunization is intended to prevent.

Be it enacted by the General Assembly of the State of Colorado:

SECTION1.

InColoradoRevisedStatutes,addpart26toarticle 4 of title 25 as follows:

PART 26 STANDARDS FOR IMMUNIZATION REQUIREMENTS 25-4-2601.

Legislativedeclaration.(1) TGENERALASSEMBLY FINDS AND DECLARES THAT :

(a) IN ORDER TO INCREASE PUBLIC CONFIDENCE IN IMMUNIZATIONS , THE DEPARTMENT SHALL PUBLICIZE THAT EACH IMMUNIZATION MUST MEET SPECIFIC STANDARDS IN ORDER FOR ANY ENTITY TO REQUIRE THE IMMUNIZATION FOR ANY PURPOSE ;AND (b) AN INDIVIDUAL MAY CLAIM AN EXEMPTION FROM AN IMMUNIZATION ON BEHALF OF THE INDIVIDUAL OR THE INDIVIDUAL 'S DEPENDENTS IF THE STANDARDS ARE NOT MET .

(2) IT IS THE INTENT OF THE GENERAL ASSEMBLY TO SET FORTH -2- HB22-1201 MINIMUM STANDARDS THAT ALL REQUIRED IMMUNIZATIONS MUST MEET .

25-4-2602.

Definitions.

A USED IN THIS PART26,UNLESS THE CONTEXT OTHERWISE REQUIRES :

(1) "DEPARTMENT "MEANS THE DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT .

(2) "FDA" MEANS THE FOOD AND DRUG ADMINISTRATION IN THE U NITEDS TATESDEPARTMENTOFHEALTHANDHUMANSERVICES ,ORANY SUCCESSOR ENTITY .

(3) "PIVOTAL CLINICAL TRIA" MEANS A HUMAN CLINICAL TRIAL OF AN IMMUNIZATION THAT IS INTENDED TO:

(a) PROVIDE EVIDENCE FOR OBTAINING REGULATORY APPROVAL FROM THE FDA AFTER THE END OF PHASEIIOF THE TRIAL;AND (b) ESTABLISH THE SAFETYANDEFFICACY OFTHE IMMUNIZATION IN PATIENTS.

25-4-2603.

Standards for immunization requirements - exemption - department to post information.

(1) NWITHSTANDING ANYOTHERLAWTOTHECONTRARY ,ANINDIVIDUALWHOISREQUIREDBY A PERSON TO RECEIVE AN IMMUNIZATION FOR ANY PURPOSE ,INCLUDING AS A CONDITION OF EMPLOYMENT ,SCHOOL ATTENDANCE ,OR OBTAINING A LICENSE,CERTIFICATION,REGISTRATION ,OR DEGREE ,MAY CLAIM AN EXEMPTION FROM THE IMMUNIZATION REQUIREMENT IF :

(a) THE IMMUNIZATION HAS NOT BEEN APPROVED BY THE FDA;

(b) T HE IMMUNIZATION HAS ONLY RECEIVED EMERGENCY USE AUTHORIZATION FROM THE FDA;

(c) THEMANUFACTUREROFTHEIMMUNIZATIONISNOTSUBJECTTO LIABILITY FOR DEATH OR INJURY CAUSED BY THE IMMUNIZATION;OR (d) THEPIVOTALCLINICALTRIALTHE FDA RELIEDONTOAPPROVE -3- HB22-1201 THEIMMUNIZATIONDIDNOTEVALUATETHEIMMUNIZATION 'SSAFETY,FOR ATLEASTONEYEARAFTERTHEIMMUNIZATIONWASFIRSTADMINISTERED , AGAINST A CONTROL GROUP THAT RECEIVED:

(I) APLACEBO ;OR (II) AIFFERENTIMMUNIZATIONAUTHORIZEDBYTHE FDA, BASED ON A PIVOTAL CLINICAL TRIAL THAT EVALUATED THE SAFETY OF THE IMMUNIZATION AGAINST A CONTROL GROUP THAT RECEIVED A PLACEBO.

(2) THE DEPARTMENT SHALL POST ON ITS WEBSI:E (a) THAT AN INDIVIDUAL MAY CLAIM AN EXEMPTION FROM AN IMMUNIZATION REQUIREMENT PURSUANT TO SUBSECTION (1) OF THIS SECTION;

(b) FOR EACH IMMUNIZATION REQUIRED BY THE STATE , AN AGENCY OR DEPARTMENT OF THE STATE ,EXECUTIVE ORDER OF THE GOVERNOR , OR ANY OTHER ENTITY WITH AUTHORITY TO REQUIRE AN IMMUNIZATION :