What’s Happening
The Florida Department of Health (DOH) has begun rulemaking to amend Rule 64D-3.046, Florida Administrative Code, which governs immunization and documentation requirements for children entering schools and childcare programs.
Although proposed text has not yet been released, reports indicate that the Department may remove several vaccine requirements that exist only by rule, which includes hepatitis B, varicella, Haemophilus influenzae type b (Hib), and pneumococcal conjugate (PCV) immunizations, while vaccines expressly mandated by statute (such as measles, mumps, rubella, diphtheria, tetanus, pertussis, and polio) would remain unchanged.
If adopted, these changes would also require revisions to related Department of Health forms and guidance documents that implement the rule, including:
- DH 680 Florida Certification of Immunization official form completed by healthcare providers to document a child’s required vaccines or medical exemption;
- DH 681 Religious Exemption from Immunization official form issued by county health departments to parents or guardians claiming a religious exemption; and
- The Immunization Guidelines for Florida Schools, Childcare Facilities, and Family Daycare Homes.
The Department also plans to update the opt-out language for the Florida SHOTS registry, the statewide immunization database.
Why This Matters
Any revisions to Rule 64D-3.046 and its implementing forms would directly affect:
- Parents and guardians, who must submit proper immunization documentation at enrollment;
- Schools and childcare facilities, which are required to maintain or verify compliance through Florida SHOTS; and
- Healthcare providers and county health departments, which issue and complete the required forms.
Changes to the rule could alter both the list of required vaccines and the process by which immunization records are verified, and exemptions are granted.
It is advisable for interested stakeholders to monitor this rulemaking.
Steps in the Rulemaking Process
A Notice of Rule Development has been filed, which provides for any member of the public to request a workshop during this early stage. When requested, DOH typically schedules a workshop with at least two weeks’ public notice, allowing stakeholders to comment and advocate for the rule’s direction before a draft is finalized.
Stakeholder participation in a rule development workshop is often an effective way to shape an agency’s proposal and resolve concerns without administrative litigation. Once a proposed rule is published, the process will move to the Statement of Estimated Regulatory Costs (SERC) stage.
The SERC is required if the proposed rule is expected to increase regulatory costs by more than $200,000 within one year. It also evaluates whether the total economic impact is likely to exceed $1 million in the aggregate over five years. If the SERC meets that threshold, the rule cannot take effect without legislative ratification. If a SERC exceeds the $1 million threshold, it is important because then legislative ratification is required, which brings the issue before the Legislature for a broader policy discussion that may address considerations that the agency did not fully explore during rule development.
While the Department of Health generally has independent authority to set school-entry immunization requirements by rule, a rule with an estimated economic impact of over $1 million must be reviewed and approved by the Legislature before taking effect. This process provides an additional level of oversight and another opportunity for stakeholder involvement. Stakeholders may also challenge the SERC if they believe the Department underestimated the rule’s financial or operational effects.
After the SERC and proposed rule are published, substantially affected parties may file formal administrative challenges under section 120.56, Florida Statutes, to address whether the rule exceeds DOH’s authority or conflicts with existing law.
