Senate Bill 1716
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Florida Senate - 1998 SB 1716
By Senator Brown-Waite
10-1474B-98
1 A bill to be entitled
2 An act relating to the rulemaking authority of
3 the Department of Health with respect to laws
4 that protect the public health, safety, and
5 welfare (RAB); amending s. 232.032, F.S.;
6 authorizing the department to adopt rules
7 governing the immunization of children;
8 amending s. 381.0011, F.S.; authorizing the
9 department to adopt rules specifying conditions
10 and procedures for imposing quarantines;
11 amending s. 381.003, F.S.; providing
12 requirements for the department in adopting
13 rules governing the prevention and control
14 program for communicable diseases; amending s.
15 381.0031, F.S.; requiring that certain
16 hospitals and laboratories report to the
17 department the occurrence of diseases that are
18 a threat to public health; authorizing the
19 department to adopt rules governing the
20 reporting of such diseases; amending s.
21 381.006, F.S.; providing that the department's
22 public health mission includes the regulation
23 of sanitary facilities; amending s. 381.0062,
24 F.S.; providing additional requirements for the
25 department in regulating suppliers of water;
26 authorizing fees to cover inspection costs;
27 amending s. 381.0065, F.S.; requiring that the
28 department inspect and regulate certain
29 commercial sewage systems and temporary
30 facilities; providing inspection requirements
31 for establishments that use an aerobic
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1 treatment unit or that generate commercial
2 waste; requiring approval by the department
3 before a municipality or political subdivision
4 issues certain building or plumbing permits or
5 authorizes occupancy; amending s. 381.0072,
6 F.S.; redefining the term "food service
7 establishment"; requiring that the department
8 adopt rules governing sanitation standards;
9 amending s. 381.008, F.S.; clarifying the
10 definition of terms with respect to the
11 department's regulation of migrant labor camps;
12 amending s. 381.0083, F.S.; requiring that a
13 person notify the department before
14 constructing or renovating a migrant labor
15 camp; requiring that a new owner of any such
16 camp apply to the department for a permit;
17 amending s. 381.0086, F.S.; authorizing the
18 department to issue rules for maintaining the
19 roads of a migrant labor camp; amending s.
20 381.0087, F.S.; specifying a time period for
21 correcting a violation of a department rule;
22 amending s. 381.0098, F.S.; providing for a
23 funeral home that performs embalming procedures
24 to be regulated as a biomedical waste
25 generator; requiring that the department adopt
26 rules for operating plans for managing
27 biomedical waste; exempting certain generators
28 of biomedical waste from permit requirements;
29 authorizing the department to prorate fees;
30 providing for enforcement; amending s.
31 381.0101, F.S.; revising terms with respect to
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1 the regulation of environmental health
2 professionals; providing additional duties of
3 the Environmental Health Professionals Advisory
4 Board; providing requirements for the
5 department in adopting rules; amending s.
6 381.89, F.S., relating to the regulation of
7 tanning facilities; providing requirements for
8 inspection reports and the training of
9 operators; amending s. 383.011, F.S.; revising
10 duties of the department with respect to
11 administering the federal Child and Adult Care
12 Food Program; authorizing the department to
13 adopt rules for administering certain other
14 federal programs; amending s. 384.33, F.S.;
15 authorizing the department to adopt rules with
16 respect to procedures for notifying a physician
17 or person's partner of a sexually transmissible
18 disease; amending s. 384.34, F.S.; authorizing
19 the department to adopt rules for administering
20 penalty provisions; amending s. 401.26, F.S.;
21 requiring a vehicle permit for an aircraft used
22 to provide life-support services; providing
23 certain exceptions; requiring the department to
24 adopt certain criteria and rules; amending ss.
25 401.265, 401.30, F.S.; authorizing the
26 department to adopt rules governing the
27 provision of life-support services; creating s.
28 401.465, F.S.; requiring the licensure of
29 programs in emergency medical technician and
30 paramedic education; providing qualification
31 requirements for licensing such a program;
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1 providing for the department to collect fees;
2 authorizing the department to conduct site
3 visits; specifying prohibited activities;
4 authorizing the department to suspend or revoke
5 a license; providing for fees and fines to be
6 deposited into the Emergency Medical Services
7 Trust Fund; creating s. 401.475, F.S.;
8 providing penalties for operating an unlicensed
9 emergency medical technician program or
10 paramedic program; amending ss. 403.0625,
11 403.863, F.S.; authorizing the department to
12 adopt rules governing the certification of
13 environmental laboratories and public water
14 supply laboratories; specifying acts for which
15 the department may impose disciplinary
16 sanctions; amending s. 404.056, F.S.;
17 authorizing the department to establish
18 criteria for certifying persons and businesses
19 that conduct radon gas or radon progeny
20 measurements; providing additional requirements
21 for reporting the results of such measurements;
22 amending s. 404.22, F.S.; providing
23 requirements for the department in inspecting
24 radiation machines and components; requiring
25 persons who install such machines to register
26 with the department; amending s. 468.306, F.S.;
27 providing requirements for examinations;
28 amending s. 489.553, F.S.; providing for
29 out-of-state work experience and examinations
30 to fulfill certain requirements for
31 registration as a septic tank contractor;
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1 amending s. 489.555, F.S.; providing additional
2 requirements for the certification of
3 partnerships and corporations that offer septic
4 tank contracting services; amending s. 499.005,
5 F.S.; prohibiting misrepresentation or fraud in
6 obtaining or distributing a prescription drug
7 or device; amending s. 499.01, F.S.;
8 authorizing the department to issue a permit
9 for the distribution of drugs to a health care
10 entity; providing for changing the type of
11 permit issued; amending s. 499.012, F.S.;
12 redefining the term "wholesale distribution"
13 for purposes of the regulation of the sale of
14 prescription drugs; authorizing the department
15 to adopt rules for issuing permits and handling
16 prescription drugs; amending s. 499.0121, F.S.;
17 providing for the exemption of certain
18 establishments from requirements governing the
19 storage and handling of prescription drugs;
20 amending s. 499.0122, F.S.; authorizing the
21 department to adopt rules governing the sale of
22 veterinary legend drugs; amending s. 499.013,
23 F.S.; authorizing the department to adopt rules
24 governing manufacturers of drugs or devices;
25 amending s. 499.014, F.S.; requiring persons
26 who process returned drugs to obtain a permit
27 from the department; amending s. 499.015, F.S.;
28 providing requirements for registering product
29 names with the department; amending ss. 499.03,
30 499.65, F.S.; authorizing the department to
31 adopt rules to allow researchers to possess
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1 prescription drugs or ether; amending s.
2 499.05, F.S.; requiring the department to adopt
3 rules governing the storage and handling of
4 medical devices and over-the-counter drugs;
5 amending s. 499.66, F.S.; revising the
6 recordkeeping requirements for sales of ether;
7 amending s. 499.67, F.S.; specifying unlawful
8 acts with respect to the purchase, storage, or
9 use of ether; amending s. 501.122, F.S.;
10 authorizing the department to establish
11 additional standards for the use of lasers;
12 amending s. 513.045, F.S.; revising the permit
13 fees charged to operators of mobile home parks
14 and recreational camps; amending s. 513.05,
15 F.S.; providing additional rulemaking authority
16 for the department with respect to such parks
17 and camps; amending s. 514.011, F.S.; defining
18 the term "portable pool"; amending s. 514.0115,
19 F.S.; authorizing the department to grant
20 variances with respect to regulations governing
21 the operation of swimming pools; amending s.
22 514.03, F.S.; revising requirements for
23 construction plans for a public swimming pool
24 or bathing place; amending s. 514.031, F.S.;
25 requiring the posting of an operating permit
26 for a pool; prohibiting the use of a portable
27 pool as a public pool; amending s. 514.033,
28 F.S.; providing for the department to prorate
29 certain fees for an operating permit; amending
30 s. 514.05, F.S.; authorizing the department to
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1 adopt rules specifying conditions for closing a
2 pool; providing an effective date.
3
4 Be It Enacted by the Legislature of the State of Florida:
5
6 Section 1. Subsection (1) of section 232.032, Florida
7 Statutes, is amended to read:
8 232.032 Immunization against communicable diseases;
9 school attendance requirements; exemptions.--
10 (1) The Department of Health may adopt rules necessary
11 to administer and enforce this section. The Department of
12 Health, after consultation with the Department of Education,
13 shall adopt promulgate rules governing the immunization of
14 children against, the testing for, and the control of
15 preventable communicable diseases. The rules must include
16 procedures for exempting a child from immunization
17 requirements. Immunizations shall be required for
18 poliomyelitis, diphtheria, rubeola, rubella, pertussis, mumps,
19 tetanus, and other communicable diseases as determined by
20 rules of the Department of Health. The manner and frequency
21 of administration of the immunization or testing shall conform
22 to recognized standards of medical practice. The Department
23 of Health shall supervise and secure the enforcement of the
24 required immunization. Immunizations required by this section
25 act shall be available at no cost from the county health
26 departments.
27 Section 2. Subsection (6) of section 381.0011, Florida
28 Statutes, is amended to read:
29 381.0011 Duties and powers of the Department of
30 Health.--It is the duty of the Department of Health to:
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1 (6) Declare, enforce, modify, and abolish quarantine
2 of persons, animals, and premises as the circumstances
3 indicate for controlling communicable diseases or providing
4 protection from unsafe conditions that pose a threat to public
5 health, except as provided in s. 384.28 and ss.
6 392.545-392.60.
7 (a) The department shall adopt rules to specify the
8 conditions and procedures for imposing and releasing a
9 quarantine. The rules must include provisions related to:
10 1. The closure of premises.
11 2. The movement of persons or animals exposed to or
12 infected with a communicable disease.
13 3. The tests or prophylactic treatment for
14 communicable disease required prior to employment or admission
15 to the premises.
16 4. Testing or destruction of animals with or suspected
17 of having a disease transmissible to humans.
18 5. Access by the department to quarantined premises.
19 6. The disinfection of quarantined animals, persons,
20 or premises.
21 (b) Any health regulation that restricts travel or
22 trade within the state may not be adopted or enforced in this
23 state except by authority of the department.
24 Section 3. Section 381.003, Florida Statutes, is
25 amended to read:
26 381.003 Communicable disease and acquired immune
27 deficiency syndrome prevention and control.--
28 (1) The department shall conduct a communicable
29 disease prevention and control program as part of fulfilling
30 its public health mission. A communicable disease is any
31 disease caused by transmission of a specific infectious agent,
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1 or its toxic products, from an infected person, an infected
2 animal, or the environment to a susceptible host, either
3 directly or indirectly. The communicable disease This program
4 must shall include, but need is not be limited to:
5 (a) Programs for the prevention and control of
6 tuberculosis in accordance with chapter 392.
7 (b) Programs for the prevention and control of human
8 immunodeficiency virus infection and acquired immune
9 deficiency syndrome in accordance with chapter 384 and this
10 chapter.
11 (c) Programs for the prevention and control of
12 sexually transmissible diseases in accordance with chapter
13 384.
14 (d) Programs for the prevention, control, and
15 reporting of diseases of public health significance as
16 provided for in this chapter.
17 (e) Programs for the prevention and control of
18 vaccine-preventable diseases, including programs to immunize
19 school children as required by s. 232.032.
20 (2) The department may adopt, repeal, and amend rules
21 related to the prevention and control of communicable
22 diseases, including procedures for investigating disease,
23 timeframes for reporting disease, requirements for followup
24 reports of known or suspected exposure to disease, and
25 procedures for providing access to confidential information
26 necessary for disease investigations the programs discussed in
27 this section.
28 Section 4. Section 381.0031, Florida Statutes, is
29 amended to read:
30 381.0031 Report of diseases of public health
31 significance to department.--
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1 (1) Any practitioner, licensed in this state Florida
2 to practice medicine, osteopathic medicine, chiropractic,
3 naturopathy, or veterinary medicine; any hospital licensed
4 under part I of chapter 395; or any laboratory licensed under
5 chapter 483 that, who diagnoses or suspects the existence of a
6 disease of public health significance shall immediately report
7 the fact to the Department of Health.
8 (2) Periodically the department shall issue a list of
9 infections or noninfections diseases determined by it to be a
10 threat to public health and therefore of public health
11 significance to public health within the meaning of this
12 chapter and shall furnish a copy of the list to the
13 practitioners listed in subsection (1).
14 (3) Reports required by this section must be in
15 accordance with methods made on forms furnished, or by
16 electronic means specified, by rule of the department.
17 (4) Information submitted in reports required by this
18 section is confidential, exempt from the provisions of s.
19 119.07(1), and is to be made public only when necessary to
20 public health. A report so submitted is not a violation of the
21 confidential relationship between practitioner and patient.
22 (5) The department may adopt rules related to
23 reporting diseases of significance to public health, which
24 must specify the information to be included in the report, who
25 is required to report, the method and time period for
26 reporting, requirements for enforcement, and required followup
27 activities by the department which are necessary to protect
28 public health.
29
30 This section does not affect s. 384.25.
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1 Section 5. Subsection (15) is added to section
2 381.006, Florida Statutes, to read:
3 381.006 Environmental health.--The department shall
4 conduct an environmental health program as part of fulfilling
5 the state's public health mission. The purpose of this program
6 is to detect and prevent disease caused by natural and manmade
7 factors in the environment. The environmental health program
8 shall include, but not be limited to:
9 (15) A sanitary facilities function, which shall
10 include minimum standards for the maintenance and sanitation
11 of sanitary facilities; public access to sanitary facilities;
12 the number, operation, design, and maintenance of plumbing
13 fixtures in places serving the public and places of
14 employment; and fixture ratios for special or temporary events
15 and for homeless shelters.
16
17 The department may adopt rules to carry out the provisions of
18 this section.
19 Section 6. Paragraphs (j) and (k) are added to
20 subsection (3) of section 381.0062, Florida Statutes, to read:
21 381.0062 Supervision; private and certain public water
22 systems.--
23 (3) SUPERVISION.--The department and its agents shall
24 have general supervision and control over all private water
25 systems, and public water systems not covered or included in
26 the Florida Safe Drinking Water Act (part VI of chapter 403),
27 and over those aspects of the public water supply program for
28 which it has the duties and responsibilities provided for in
29 part VI of chapter 403. The department shall:
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1 (j) Require suppliers of water to give public notice
2 of water problems and corrective measures under the conditions
3 specified by rule of the department.
4 (k) Require a fee to cover the cost of reinspection of
5 any system regulated under this section, which may not be less
6 than $25 or more than $40.
7 Section 7. Paragraphs (b) and (m) of subsection (3)
8 and subsection (4) of section 381.0065, Florida Statutes, are
9 amended to read:
10 381.0065 Onsite sewage treatment and disposal systems;
11 regulation.--
12 (3) DUTIES AND POWERS OF THE DEPARTMENT OF
13 HEALTH.--The department shall:
14 (b) Perform application reviews and site evaluations,
15 issue permits, and conduct inspections and complaint
16 investigations associated with the construction, installation,
17 maintenance, modification, abandonment, or repair of an onsite
18 sewage treatment and disposal system for a residence or
19 establishment with an estimated domestic sewage flow of 10,000
20 gallons or less per day, or an estimated commercial sewage
21 flow of 5,000 gallons or less per day, which is not currently
22 regulated under chapter 403.
23 (m) Permit and inspect portable or temporary toilet
24 services and holding tanks. The department shall review
25 applications, perform site evaluations, and issue permits for
26 the temporary use of holding tanks, privies, portable toilets,
27 or any other toilet facility that is intended for use on a
28 permanent or nonpermanent basis, including facilities placed
29 on construction sites when workers are present. The department
30 may specify standards for the construction, maintenance, use,
31 and operation of any such facility for temporary use.
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1 (4) PERMITS; INSTALLATION; AND CONDITIONS.--A person
2 may not construct, repair, modify, abandon, or operate an
3 onsite sewage treatment and disposal system without first
4 obtaining a permit approved by the department. The department
5 may issue permits to carry out this section. A construction
6 permit is valid for 18 months from the issuance date and may
7 be extended by the department for one 90-day period under
8 rules adopted by the department. A repair permit is valid for
9 90 days from the date of issuance. An operating permit must be
10 obtained prior to the use of any aerobic treatment unit or if
11 the establishment generates commercial waste. Buildings or
12 establishments that use an aerobic treatment unit or generate
13 commercial waste shall be inspected by the department at least
14 annually to assure compliance with the terms of the operating
15 permit. The An operating permit is valid for 1 year from the
16 date of issuance and must be renewed annually. If all
17 information pertaining to the siting, location, and
18 installation conditions or repair of an onsite sewage
19 treatment and disposal system remains the same, a construction
20 or repair permit for the onsite sewage treatment and disposal
21 system may be transferred to another person, if the transferee
22 files, within 60 days after the transfer of ownership, an
23 amended application providing all corrected information and
24 proof of ownership of the property. There is no fee
25 associated with the processing of this supplemental
26 information. A person may not contract to construct, modify,
27 alter, repair, service, abandon, or maintain any portion of an
28 onsite sewage treatment and disposal system without being
29 registered under part III of chapter 489. A property owner
30 who personally performs construction, maintenance, or repairs
31 to a system serving his or her own owner-occupied
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1 single-family residence is exempt from registration
2 requirements for performing such construction, maintenance, or
3 repairs on that residence, but is subject to all permitting
4 requirements. A municipality or political subdivision of the
5 state may not issue a building or plumbing permit for any
6 building that requires the use of an onsite sewage treatment
7 and disposal system unless the owner or builder has received a
8 construction permit for such system from the department. A
9 building or structure may not be occupied and a municipality,
10 political subdivision, or any state or federal agency may not
11 authorize occupancy until the department approves the final
12 installation of the onsite sewage treatment and disposal
13 system. A municipality or political subdivision of the state
14 may not approve any change in occupancy or tenancy of a
15 building that uses an onsite sewage treatment and disposal
16 system until the department has reviewed the use of the system
17 with the proposed change, approved the change, and amended the
18 operating permit.
19 (a) Subdivisions and lots in which each lot has a
20 minimum area of at least one-half acre and either a minimum
21 dimension of 100 feet or a mean of at least 100 feet of the
22 side bordering the street and the distance formed by a line
23 parallel to the side bordering the street drawn between the
24 two most distant points of the remainder of the lot may be
25 developed with a water system regulated under s. 381.0062 and
26 onsite sewage treatment and disposal systems, provided the
27 projected daily domestic sewage flow does not exceed an
28 average of 1,500 gallons per acre per day, and provided
29 satisfactory drinking water can be obtained and all distance
30 and setback, soil condition, water table elevation, and other
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1 related requirements of this section and rules adopted under
2 this section can be met.
3 (b) Subdivisions and lots using a public water system
4 as defined in s. 403.852 may use onsite sewage treatment and
5 disposal systems, provided there are no more than four lots
6 per acre, provided the projected daily domestic sewage flow
7 does not exceed an average of 2,500 gallons per acre per day,
8 and provided that all distance and setback, soil condition,
9 water table elevation, and other related requirements that are
10 generally applicable to the use of onsite sewage treatment and
11 disposal systems are met.
12 (c) Notwithstanding the provisions of paragraphs (a)
13 and (b), for subdivisions platted of record on or before
14 October 1, 1991, when a developer or other appropriate entity
15 has previously made or makes provisions, including financial
16 assurances or other commitments, acceptable to the Department
17 of Health, that a central water system will be installed by a
18 regulated public utility based on a density formula, private
19 potable wells may be used with onsite sewage treatment and
20 disposal systems until the agreed upon densities are reached.
21 The department may consider assurances filed with the
22 Department of Business and Professional Regulation under
23 chapter 498 in determining the adequacy of the financial
24 assurance required by this paragraph. In a subdivision
25 regulated by this paragraph, the average daily domestic sewage
26 flow may not exceed 2,500 gallons per acre per day. This
27 section does not affect the validity of existing prior
28 agreements. After October 1, 1991, the exception provided
29 under this paragraph is not available to a developer or other
30 appropriate entity.
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1 (d) Paragraphs (a) and (b) do not apply to any
2 proposed residential subdivision with more than 50 lots or to
3 any proposed commercial subdivision with more than 5 lots
4 where a publicly owned or investor-owned sewerage system is
5 available. It is the intent of this paragraph not to allow
6 development of additional proposed subdivisions in order to
7 evade the requirements of this paragraph. The department
8 shall report to the Legislature by February 1 of each
9 odd-numbered year concerning the success in meeting this
10 intent.
11 (e) Onsite sewage treatment and disposal systems must
12 not be placed closer than:
13 1. Seventy-five feet from a private potable well.
14 2. Two hundred feet from a public potable well serving
15 a residential or nonresidential establishment having a total
16 sewage flow of greater than 2,000 gallons per day.
17 3. One hundred feet from a public potable well serving
18 a residential or nonresidential establishment having a total
19 sewage flow of less than or equal to 2,000 gallons per day.
20 4. Seventy-five feet from surface waters.
21 5. Fifty feet from any nonpotable well.
22 6. Ten feet from any storm sewer pipe, to the maximum
23 extent possible, but in no instance shall the setback be less
24 than 5 feet.
25 7. Fifteen feet from the design high-water line of
26 retention areas, detention areas, or swales designed to
27 contain standing or flowing water for less than 72 hours after
28 a rainfall or the design high-water level of normally dry
29 drainage ditches or normally dry individual-lot
30 stormwater-retention areas.
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1 (f) All provisions of this section and rules adopted
2 under this section relating to soil condition, water table
3 elevation, distance, and other setback requirements must be
4 equally applied to all lots, with the following exceptions:
5 1. Any residential lot that was platted and recorded
6 on or after January 1, 1972, or that is part of a residential
7 subdivision that was approved by the appropriate permitting
8 agency on or after January 1, 1972, and that was eligible for
9 an onsite sewage treatment and disposal system construction
10 permit on the date of such platting and recording or approval
11 shall be eligible for an onsite sewage treatment and disposal
12 system construction permit, regardless of when the application
13 for a permit is made. If rules in effect at the time the
14 permit application is filed cannot be met, residential lots
15 platted and recorded or approved on or after January 1, 1972,
16 shall, to the maximum extent possible, comply with the rules
17 in effect at the time the permit application is filed. At a
18 minimum, however, those residential lots platted and recorded
19 or approved on or after January 1, 1972, but before January 1,
20 1983, shall comply with those rules in effect on January 1,
21 1983, and those residential lots platted and recorded or
22 approved on or after January 1, 1983, shall comply with those
23 rules in effect at the time of such platting and recording or
24 approval. In determining the maximum extent of compliance
25 with current rules that is possible, the department shall
26 allow structures and appurtenances thereto which were
27 authorized at the time such lots were platted and recorded or
28 approved.
29 2. Lots platted before 1972 are subject to a 50-foot
30 minimum surface water setback and are not subject to lot size
31 requirements. The projected daily flow for domestic onsite
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1 sewage treatment and disposal systems for lots platted before
2 1972 may not exceed:
3 a. Two thousand five hundred gallons per acre per day
4 for lots served by public water systems as defined in s.
5 403.852.
6 b. One thousand five hundred gallons per acre per day
7 for lots served by water systems regulated under s. 381.0062.
8 (g)1. The department may grant variances in hardship
9 cases which may be less restrictive than the provisions
10 specified in this section. If a variance is granted and the
11 onsite sewage treatment and disposal system construction
12 permit has been issued, the variance may be transferred with
13 the system construction permit, if the transferee files,
14 within 60 days after the transfer of ownership, an amended
15 construction permit application providing all corrected
16 information and proof of ownership of the property and if the
17 same variance would have been required for the new owner of
18 the property as was originally granted to the original
19 applicant for the variance. There is no fee associated with
20 the processing of this supplemental information. A variance
21 may not be granted under this section until the department is
22 satisfied that:
23 a. The hardship was not caused intentionally by the
24 action of the applicant;
25 b. No reasonable alternative exists for the treatment
26 of the sewage; and
27 c. The discharge from the onsite sewage treatment and
28 disposal system will not adversely affect the health of the
29 applicant or the public or significantly degrade the
30 groundwater or surface waters.
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1 Where soil conditions, water table elevation, and setback
2 provisions are determined by the department to be
3 satisfactory, special consideration must be given to those
4 lots platted before 1972.
5 2. The department shall appoint a variance review and
6 advisory committee, which shall meet monthly to recommend
7 agency action on variance requests. The board consists of the
8 following:
9 a. The Division Director for Environmental Health of
10 the department or his or her designee.
11 b. A representative from the county health
12 departments.
13 c. A representative from the home building industry.
14 d. A representative from the septic tank industry.
15 e. A representative from the Department of
16 Environmental Protection.
17
18 Members shall be appointed for a term of 3 years, with such
19 appointments being staggered so that the terms of no more than
20 two members expire in any one year. Members shall serve
21 without remuneration, but are entitled to reimbursement may be
22 reimbursed for per diem and travel expenses as provided in s.
23 112.061.
24 (h) A construction permit may not be issued for an
25 onsite sewage treatment and disposal system in any area zoned
26 or used for industrial or manufacturing purposes, or its
27 equivalent, where a publicly owned or investor-owned sewage
28 treatment system is available, or where a likelihood exists
29 that the system will receive toxic, hazardous, or industrial
30 waste. An existing onsite sewage treatment and disposal
31 system may be repaired if a publicly owned or investor-owned
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1 sewerage system is not available within 500 feet of the
2 building sewer stub-out and if system construction and
3 operation standards can be met. This paragraph does not
4 require publicly owned or investor-owned sewerage treatment
5 systems to accept anything other than domestic wastewater.
6 1. A building located in an area zoned or used for
7 industrial or manufacturing purposes, or its equivalent, when
8 such building is served by an onsite sewage treatment and
9 disposal system, must not be occupied until the owner or
10 tenant has obtained written approval from the department. The
11 department shall not grant approval when the proposed use of
12 the system is to dispose of toxic, hazardous, or industrial
13 wastewater or toxic or hazardous chemicals.
14 2. Each person who owns or operates a business or
15 facility in an area zoned or used for industrial or
16 manufacturing purposes, or its equivalent, or who owns or
17 operates a business that has the potential to generate toxic,
18 hazardous, or industrial wastewater or toxic or hazardous
19 chemicals, and uses an onsite sewage treatment and disposal
20 system that is installed on or after July 5, 1989, must obtain
21 an annual system operating permit from the department. A
22 person who owns or operates a business that uses an onsite
23 sewage treatment and disposal system that was installed and
24 approved before July 5, 1989, need not obtain a system
25 operating permit. However, upon change of ownership or
26 tenancy, the new owner or operator must notify the department
27 of the change, and the new owner or operator must obtain an
28 annual system operating permit, regardless of the date that
29 the system was installed or approved.
30 3. The department shall periodically review and
31 evaluate the continued use of onsite sewage treatment and
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1 disposal systems in areas zoned or used for industrial or
2 manufacturing purposes, or its equivalent, and may require the
3 collection and analyses of samples from within and around such
4 systems. If the department finds that toxic or hazardous
5 chemicals or toxic, hazardous, or industrial wastewater have
6 been or are being disposed of through an onsite sewage
7 treatment and disposal system, the department shall initiate
8 enforcement actions against the owner or tenant to ensure
9 adequate cleanup, treatment, and disposal.
10 (i) An onsite sewage treatment and disposal system for
11 a single-family residence that is designed by a professional
12 engineer registered in the state and certified by such
13 engineer as complying with performance criteria adopted by the
14 department must be approved by the department subject to the
15 following:
16 1. The performance criteria applicable to
17 engineer-designed systems must be limited to those necessary
18 to ensure that such systems do not adversely affect the public
19 health or significantly degrade the groundwater or surface
20 water. Such performance criteria shall include consideration
21 of the quality of system effluent, the proposed total sewage
22 flow per acre, wastewater treatment capabilities of the
23 natural or replaced soil, water quality classification of the
24 potential surface-water-receiving body, and the structural and
25 maintenance viability of the system for the treatment of
26 domestic wastewater. However, performance criteria shall
27 address only the performance of a system and not a system's
28 design.
29 2. The technical review and advisory panel shall
30 assist the department in the development of performance
31 criteria applicable to engineer-designed systems. Workshops
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1 on the development of the rules delineating such criteria
2 shall commence not later than September 1, 1996, and the
3 department shall advertise such rules for public hearing no
4 later than October 1, 1997.
5 3. A person electing to utilize an engineer-designed
6 system shall, upon completion of the system design, submit
7 such design, certified by a registered professional engineer,
8 to the county health department. The county health department
9 may utilize an outside consultant to review the
10 engineer-designed system, with the actual cost of such review
11 to be borne by the applicant. Within 5 working days after
12 receiving an engineer-designed system permit application, the
13 county health department shall request additional information
14 if the application is not complete. Within 15 working days
15 after receiving a complete application for an
16 engineer-designed system, the county health department either
17 shall issue the permit or, if it determines that the system
18 does not comply with the performance criteria, shall notify
19 the applicant of that determination and refer the application
20 to the department for a determination as to whether the system
21 should be approved, disapproved, or approved with
22 modification. The department engineer's determination shall
23 prevail over the action of the county health department. The
24 applicant shall be notified in writing of the department's
25 determination and of the applicant's rights to pursue a
26 variance or seek review under the provisions of chapter 120.
27 4. The owner of an engineer-designed performance-based
28 system must obtain an annual system operating permit from the
29 department. The department shall inspect the system at least
30 annually and may collect system-effluent samples if
31 appropriate to determine compliance with the performance
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1 criteria. The fee for the annual operating permit shall be
2 collected beginning with the second year of system operation.
3 5. If an engineer-designed system fails to properly
4 function or fails to meet performance standards, the system
5 shall be re-engineered, if necessary, to bring the system into
6 compliance with the provisions of this section.
7 (j) An innovative system may be approved in
8 conjunction with an engineer-designed site-specific system
9 which is certified by the engineer to meet the
10 performance-based criteria adopted by the department.
11 (k) For the Florida Keys, the department shall adopt a
12 special rule for the construction, installation, modification,
13 operation, repair, maintenance, and performance of onsite
14 sewage treatment and disposal systems which considers the
15 unique soil conditions and which considers water table
16 elevations, densities, and setback requirements. On lots
17 where a setback distance of 75 feet from surface waters,
18 saltmarsh, and buttonwood association habitat areas cannot be
19 met, an injection well, approved and permitted by the
20 department, may be used for disposal of effluent from onsite
21 sewage treatment and disposal systems. The department shall
22 require effluent from onsite sewage treatment and disposal
23 systems to meet advanced waste treatment concentrations, as
24 defined in s. 403.086.
25 (l) No product sold in the state for use in onsite
26 sewage treatment and disposal systems may contain any
27 substance in concentrations or amounts that would interfere
28 with or prevent the successful operation of such system, or
29 that would cause discharges from such systems to violate
30 applicable water quality standards. The department shall
31 publish criteria for products known or expected to meet the
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1 conditions of this paragraph. In the event a product does not
2 meet such criteria, such product may be sold if the
3 manufacturer satisfactorily demonstrates to the department
4 that the conditions of this paragraph are met.
5 (m) Evaluations for determining the seasonal
6 high-water table elevations or the suitability of soils for
7 the use of a new onsite sewage treatment and disposal system
8 shall be performed by department personnel, professional
9 engineers registered in the state, or such other persons with
10 expertise, as defined by rule, in making such evaluations.
11 The department shall accept evaluations submitted by
12 professional engineers and such other persons as meet the
13 expertise established by rule unless the department has a
14 reasonable scientific basis for questioning the accuracy or
15 completeness of the evaluation.
16 (n) The department shall appoint a research review and
17 advisory committee, which shall meet at least semiannually.
18 The committee shall advise the department on directions for
19 new research, review and rank proposals for research
20 contracts, and review draft research reports and make
21 comments. The committee is comprised of:
22 1. A representative of the Division of Environmental
23 Health of the Department of Health.
24 2. A representative from the septic tank industry.
25 3. A representative from the home building industry.
26 4. A representative from an environmental interest
27 group.
28 5. A representative from the State University System,
29 from a department knowledgeable about onsite sewage treatment
30 and disposal systems.
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1 6. A professional engineer registered in this state
2 who has work experience in onsite sewage treatment and
3 disposal systems.
4 7. A representative from the real estate profession.
5 8. A representative from the restaurant industry.
6 9. A consumer.
7
8 Members shall be appointed for a term of 3 years, with the
9 appointments being staggered so that the terms of no more than
10 four members expire in any one year. Members shall serve
11 without remuneration, but are entitled to reimbursement may be
12 reimbursed for per diem and travel expenses as provided in s.
13 112.061.
14 (o) An application for an onsite sewage treatment and
15 disposal system permit shall be completed in full, signed by
16 the owner or the owner's authorized representative, or by a
17 contractor licensed under chapter 489, and shall be
18 accompanied by all required exhibits and fees. No specific
19 documentation of property ownership shall be required as a
20 prerequisite to the review of an application or the issuance
21 of a permit. The issuance of a permit does not constitute
22 determination by the department of property ownership.
23 (p) The department may not require any form of
24 subdivision analysis of property by an owner, developer, or
25 subdivider prior to submission of an application for an onsite
26 sewage treatment and disposal system.
27 (q) Nothing in this section limits the power of a
28 municipality or county to enforce other laws for the
29 protection of the public health and safety.
30
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1 Section 8. Paragraph (b) of subsection (1) and
2 paragraph (a) of subsection (2) of section 381.0072, Florida
3 Statutes, are amended to read:
4 381.0072 Food service protection.--It shall be the
5 duty of the Department of Health to adopt and enforce
6 sanitation rules consistent with law to ensure the protection
7 of the public from food-borne illness. These rules shall
8 provide the standards and requirements for the storage,
9 preparation, serving, or display of food in food service
10 establishments as defined in this section and which are not
11 permitted or licensed under chapter 500 or chapter 509.
12 (1) DEFINITIONS.--As used in this section, the term:
13 (b) "Food service establishment" means any facility,
14 as described in this paragraph, where food is prepared and
15 intended for individual portion service, and includes the site
16 at which individual portions are provided. The term includes
17 any such facility regardless of whether consumption is on or
18 off the premises and regardless of whether there is a charge
19 for the food. The term includes detention facilities, child
20 care facilities, schools, institutions, civic or fraternal
21 organizations, and bars and lounges and facilities used at
22 temporary food events, mobile food units, and vending machines
23 at any facility regulated under this section. The term does
24 not include private homes where food is prepared or served for
25 individual family consumption; nor does the term include
26 churches, synagogues, or other not-for-profit religious
27 organizations as long as these organizations serve only their
28 members and guests and do not advertise food or drink for
29 public consumption, or any facility or establishment permitted
30 or licensed under chapter 500 or chapter 509; nor does the
31 term include any theater, if the primary use is as a theater
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1 and if patron service is limited to food items customarily
2 served to the admittees of theaters; nor does the term include
3 a research and development test kitchen limited to the use of
4 employees and which is not open to the general public.
5 (2) DUTIES.--
6 (a) The department shall adopt rules consistent with
7 law prescribing minimum sanitation standards and manager
8 certification requirements as prescribed in s. 509.039, which
9 shall be enforced in food service establishments as defined in
10 this section. The sanitation standards must address the
11 construction, operation, and maintenance of the establishment;
12 plan review; design, construction, installation, maintenance,
13 sanitation, and storage of food equipment; employee training,
14 health, hygiene, and work practices; food supplies,
15 preparation, storage, transportation, and service; and
16 sanitary facilities and controls, including water supply and
17 sewage disposal; plumbing and toilet facilities; garbage and
18 refuse collection, storage, and disposal; and vermin control.
19 Public and private schools, hospitals licensed under chapter
20 395, nursing homes licensed under part II of chapter 400,
21 child care facilities as defined in s. 402.301, and
22 residential facilities colocated with a nursing home or
23 hospital if all food is prepared in a central kitchen that
24 complies with nursing or hospital regulations shall be exempt
25 from the rules developed for manager certification. The
26 department shall administer a comprehensive inspection,
27 monitoring, and sampling program to ensure such standards are
28 maintained. With respect to food service establishments
29 permitted or licensed under chapter 500 or chapter 509, the
30 department shall assist the Division of Hotels and Restaurants
31 of the Department of Business and Professional Regulation and
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1 the Department of Agriculture and Consumer Services with
2 rulemaking by providing technical information.
3 Section 9. Subsections (5) and (8) of section 381.008,
4 Florida Statutes, are amended to read:
5 381.008 Definitions of terms used in ss.
6 381.008-381.00897.--As used in ss. 381.008-381.00897, the
7 following words and phrases mean:
8 (5) "Migrant labor camp"--One or more buildings,
9 structures, barracks, or dormitories, and the land
10 appertaining thereto, constructed, established, operated, or
11 furnished as an incident of employment as living quarters for
12 seasonal or migrant farmworkers whether or not rent is paid or
13 reserved in connection with the use or occupancy of such
14 premises. The term does not include a single family residence
15 that is occupied by a single family.
16 (8) "Residential migrant housing"--A building,
17 structure, mobile home, barracks, or dormitory, and any
18 combination thereof on adjacent property which is under the
19 same ownership, management, or control, and the land
20 appertaining thereto, that is rented or reserved for occupancy
21 by five or more migrant farmworkers, except:
22 (a) Housing furnished as an incident of employment.;
23 (b) A single-family residence or mobile home dwelling
24 unit that is not under the same ownership, management, or
25 control as other farmworker housing to which it is adjacent or
26 contiguous.;
27 (c) A hotel, motel, or resort condominium, as defined
28 in chapter 509, that is furnished for transient occupancy.
29 (d) Any housing owned or operated by a public housing
30 authority except for housing which is specifically provided
31
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1 for persons whose principal income is derived from
2 agriculture.
3 Section 10. Section 381.0083, Florida Statutes, is
4 amended to read:
5 381.0083 Issuance of permit to operate migrant labor
6 camp or residential migrant housing.--Any person who is
7 planning to construct, enlarge, remodel, use, or occupy a
8 migrant labor camp or residential migrant housing or convert
9 property for use as a migrant labor camp or residential
10 migrant housing must give written notice to the department of
11 the intent to do so at least 45 days before beginning such
12 construction, enlargement, or renovation. If the department is
13 satisfied, after causing an inspection to be made, that the
14 camp or the residential migrant housing meets the minimum
15 standards of construction, sanitation, equipment, and
16 operation required by rules issued under s. 381.0086 and that
17 the applicant has paid the application fees required by s.
18 381.0084, it shall issue in the name of the department the
19 necessary permit in writing on a form to be prescribed by the
20 department. The permit, unless sooner revoked, shall expire
21 on September 30 next after the date of issuance, and it shall
22 not be transferable. An application for a permit shall be
23 filed with the department 30 days prior to operation. When
24 there is a change in ownership of a currently permitted
25 migrant labor camp or residential migrant housing, the new
26 owner must file an application with the department at least 15
27 days before the change. In the case of a facility owned or
28 operated by a public housing authority, an annual satisfactory
29 sanitation inspection of the living units by the Farmers Home
30 Administration or the Department of Housing and Urban
31
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1 Development shall substitute for the pre-permitting inspection
2 required by the department.
3 Section 11. Subsection (1) of section 381.0086,
4 Florida Statutes, is amended to read:
5 381.0086 Rules; variances; penalties.--
6 (1) The department shall adopt rules necessary to
7 protect the health and safety of migrant farm workers and
8 other migrant labor camp or residential migrant housing
9 occupants. These rules must include provisions relating to
10 plan review of the construction of new, expanded, or remodeled
11 camps, personal hygiene facilities, lighting, sewage disposal,
12 safety, minimum living space per occupant, bedding, food
13 storage and preparation, insect and rodent control, garbage,
14 heating equipment, water supply, maintenance and operation of
15 the camp, or housing, or roads, and such other matters as the
16 department finds to be appropriate or necessary to protect the
17 life and health of the occupants. Housing operated by a
18 public housing authority is exempt from the provisions of any
19 administrative rule that conflicts with or is more stringent
20 than the federal standards applicable to the housing.
21 Section 12. Subsections (1) and (2) of section
22 381.0087, Florida Statutes, are amended to read:
23 381.0087 Enforcement; citations.--
24 (1) Department personnel or crew chief compliance
25 officers employed by the Bureau of Compliance of the Florida
26 Department of Labor and Employment Security may issue
27 citations that contain an order of correction or an order to
28 pay a fine, or both, for violations of ss. 381.008-381.00895
29 or the field sanitation facility rules adopted by the
30 department when a violation of those sections or rules is
31 enforceable by an administrative or civil remedy, or when a
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1 violation of those sections or rules is a misdemeanor of the
2 second degree. A citation issued under this section
3 constitutes a notice of proposed agency action. The recipient
4 of a citation for a major deficiency, as defined by rule of
5 the department, will be given a maximum of 48 hours to make
6 satisfactory correction or demonstrate that provisions for
7 correction are satisfactory.
8 (2) Citations must be in writing and must describe the
9 particular nature of the violation, including specific
10 reference to the provision of statute or rule allegedly
11 violated. Continual or repeat violations of the same
12 requirement will result in the issuance of a citation.
13 Section 13. Paragraph (b) of subsection (2),
14 subsection (3), paragraphs (a), (d), and (f) of subsection
15 (4), and subsection (7) of section 381.0098, Florida Statutes,
16 are amended to read:
17 381.0098 Biomedical waste.--
18 (2) DEFINITIONS.--As used in this section, the term:
19 (b) "Biomedical waste generator" means a facility or
20 person that produces or generates biomedical waste. The term
21 includes, but is not limited to, hospitals, skilled nursing or
22 convalescent hospitals, intermediate care facilities, clinics,
23 dialysis clinics, dental offices, health maintenance
24 organizations, surgical clinics, medical buildings,
25 physicians' offices, laboratories, veterinary clinics, and
26 funeral homes where embalming procedures are performed.
27 (3) OPERATING STANDARDS.--The department shall adopt
28 rules necessary to protect the health, safety, and welfare of
29 the public and to carry out the purpose of this section. Such
30 rules shall address, but need not be limited to, the packaging
31 of biomedical waste, including specific requirements for the
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1 segregation of the waste at the point of generation; the safe
2 packaging of sharps; the placement of the waste in containers
3 that will protect waste handlers and the public from exposure;
4 the appropriate labeling of containers of waste; written
5 operating plans for managing biomedical waste; and the
6 transport, storage, and treatment of biomedical wastes.
7 (4) PERMITS AND FEES.--
8 (a) All persons who generate, store, or treat
9 biomedical waste shall obtain a permit from the department
10 prior to commencing operation, except that a biomedical waste
11 generator generating less than 25 pounds of biomedical waste
12 in each 30-day period shall be exempt from the registration
13 and fee requirements of this subsection. A biomedical waste
14 generator need not obtain a separate permit if such generator
15 works less than 6 hours in a 7-day period at a location
16 different than the location specified on the permit. The
17 department may issue combined permits for generation, storage,
18 and treatment as appropriate to streamline permitting
19 procedures. Application for such permit shall be made on an
20 application form provided by the department.
21 (d) The permit for a biomedical waste generator shall
22 not be transferred from one owner to another. When the
23 ownership or name of a biomedical waste generator is changed
24 and continues to operate, the new owner shall apply to the
25 department, upon forms provided by the department, for
26 issuance of a permit in the timeframe and manner prescribed by
27 rule of the department.
28 (f) The department shall establish a schedule of fees
29 for such permits. Fees assessed under this section shall be in
30 an amount sufficient to meet the costs of carrying out the
31 provisions of this section and rules adopted under this
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1 section. The fee schedule shall not be less than $50 or more
2 than $400 for each year the permit is valid. Fees may be
3 prorated on a quarterly basis when a facility will be in
4 operation for 6 months or less before the annual renewal date.
5 The department shall assess the minimum fees provided in this
6 subsection until a fee schedule is promulgated by rule of the
7 department. Facilities owned and operated by the state shall
8 be exempt from the payment of any fees.
9 (7) ENFORCEMENT AND PENALTIES.--Any person or public
10 body in violation of this section or rules adopted under this
11 section is subject to penalties provided in ss. 381.0012,
12 381.0025, and 381.0061. However, an administrative fine not to
13 exceed $2,500 may be imposed for each day such person or
14 public body is in violation of this section. The department
15 may deny, suspend, or revoke any biomedical waste permit or
16 registration if the permittee violates this section, any rule
17 adopted under this section, or any lawful order of the
18 department.
19 Section 14. Paragraphs (d), (f), and (g) of subsection
20 (2), paragraph (b) of subsection (4), and subsections (5) and
21 (7) of section 381.0101, Florida Statutes, are amended to
22 read:
23 381.0101 Environmental health professionals.--
24 (2) DEFINITIONS.--As used in this section:
25 (d) "Environmental health professional" means a person
26 who is employed or assigned the responsibility for assessing
27 the environmental health or sanitary conditions, as defined by
28 the department, within a building, on an individual's
29 property, or within the community at large, and who has the
30 knowledge, skills, and abilities to carry out these tasks.
31
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1 Environmental health professionals may be either field,
2 supervisory, or administrative staff members.
3 (f) "Registered sanitarian," or "R.S.," "Registered
4 Environmental Health Specialist," or "R.E.H.S." means a person
5 who has been certified by either the National Environmental
6 Health Association or the Florida Environmental Health
7 Association as knowledgeable in the environmental health
8 profession.
9 (g) "Primary environmental health program" means those
10 programs determined by the department to be essential for
11 providing basic environmental and sanitary protection to the
12 public. At a minimum, these programs shall include food
13 protection program work hygiene evaluations, and onsite sewage
14 treatment and disposal system evaluations.
15 (4) ENVIRONMENTAL HEALTH PROFESSIONALS ADVISORY
16 BOARD.--The State Health Officer shall appoint an advisory
17 board to assist the department in the promulgation of rules
18 for certification, testing, establishing standards, and
19 seeking enforcement actions against certified professionals.
20 (b) The board shall advise the department as to the
21 minimum disciplinary guidelines and standards of competency
22 and proficiency necessary to obtain certification in a primary
23 area of environmental health practice.
24 1. The board shall recommend primary areas of
25 environmental health practice in which environmental health
26 professionals should be required to obtain certification.
27 2. The board shall recommend minimum standards of
28 practice which the department shall incorporate into rule.
29 3. The board shall evaluate and recommend to the
30 department existing registrations and certifications which
31 meet or exceed minimum department standards and should,
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1 therefore, exempt holders of such certificates or
2 registrations from compliance with this section.
3 4. The board shall hear appeals of certificate
4 denials, revocation, or suspension and shall advise the
5 department as to the disposition of such an appeal.
6 5. The board shall meet as often as necessary, but no
7 less than semiannually, handle appeals to the department, and
8 conduct other duties of the board.
9 6. Members of the board shall receive no compensation
10 but are entitled to reimbursement shall be reimbursed for per
11 diem and travel expenses in accordance with s. 112.061.
12 (5) STANDARDS FOR CERTIFICATION.--The department shall
13 adopt rules that establish minimum standards of education,
14 training, or experience for those persons subject to this
15 section. The rules shall also address the process for
16 application, examination, issuance, expiration, and renewal of
17 certification and ethical standards of practice for the
18 profession.
19 (a) Persons employed as environmental health
20 professionals shall exhibit a knowledge of rules and
21 principles of environmental and public health law in Florida
22 through examination. A No person may not shall conduct
23 environmental health evaluations in a primary program area
24 unless he or she is currently certified in that program area
25 or works under the direct supervision of a certified
26 environmental health professional.
27 1. All persons who begin employment in a primary
28 environmental health program on or after September 21, 1994,
29 must be certified in that program within 6 months after
30 employment.
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1 2. Persons employed in a primary environmental health
2 program prior to September 21, 1994, shall be considered
3 certified while employed in that position and shall be
4 required to adhere to any professional standards established
5 by the department pursuant to paragraph (b), complete any
6 continuing education requirements imposed under paragraph (d),
7 and pay the certificate renewal fee imposed under subsection
8 (7).
9 3. Persons employed in a primary environmental health
10 program prior to September 21, 1994, who change positions or
11 program areas and transfer into another primary environmental
12 health program area on or after September 21, 1994, must be
13 certified in that program within 6 months after such transfer,
14 except that they will not be required to possess the college
15 degree required under paragraph (e).
16 4. Registered sanitarians shall be considered
17 certified and shall be required to adhere to any professional
18 standards established by the department pursuant to paragraph
19 (b).
20 (b) At a minimum, the department shall establish
21 standards for professionals in the areas of food hygiene and
22 onsite sewage treatment and disposal.
23 (c) Those persons conducting primary environmental
24 health evaluations shall be certified by examination to be
25 knowledgeable in any primary area of environmental health in
26 which they are routinely assigned duties.
27 (d) Persons who are certified shall renew their
28 certification biennially by completing not less than 24
29 contact hours of continuing education for each program area in
30 which they maintain certification.
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1 (e) Applicants for certification shall have graduated
2 from an accredited 4-year college or university with a degree
3 or major coursework in public health, environmental health,
4 environmental science, or a physical or biological science.
5 (f) A certificateholder shall notify the department
6 within 60 days after any change of name or address from that
7 which appears on the current certificate.
8 (7) FEES.--The department shall charge fees in amounts
9 necessary to meet the cost of providing certification. Fees
10 for certification shall be not no less than $10 or $25 nor
11 more than $300 and shall be set by rule. Application,
12 examination, and certification costs shall be included in this
13 fee. Fees for renewal of a certificate shall be no less than
14 $25 nor more than $150 per biennium.
15 Section 15. Paragraph (b) of subsection (4), paragraph
16 (a) of subsection (6), and subsection (13) of section 381.89,
17 Florida Statutes, are amended to read:
18 381.89 Regulation of tanning facilities.--
19 (4)
20 (b) A tanning facility must have a copy of the
21 facility's most recent inspection report available to the
22 public and must post a warning sign in any area where a
23 tanning device is used. Posting this sign does not absolve the
24 facility of any liability. The sign must state:
25
26 DANGER, ULTRAVIOLET RADIATION
27 Follow these instructions:
28 1. Avoid frequent or lengthy exposure. As with
29 natural sunlight, exposure can cause eye and skin injury or
30 allergic reactions. Repeated exposure can cause chronic sun
31
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1 damage characterized by wrinkling, dryness, fragility and
2 bruising of the skin or skin cancer.
3 2. Wear protective eyewear. FAILURE TO USE PROTECTIVE
4 EYEWEAR CAN RESULT IN SEVERE BURNS OR LONG-TERM INJURY TO THE
5 EYES.
6 3. Ultraviolet radiation from sunlamps will aggravate
7 the effects of the sun. Therefore, do not sunbathe before or
8 after exposure to ultraviolet radiation.
9 4. Using medications or cosmetics can increase your
10 sensitivity to ultraviolet radiation. Consult a physician
11 before using a sunlamp if you are using medications, have a
12 history of skin problems, or believe you are especially
13 sensitive to sunlight. Women who are pregnant or on birth
14 control who use this product can develop discolored skin. IF
15 YOU DO NOT TAN IN THE SUN YOU WILL NOT TAN BY USING THIS
16 DEVICE.
17
18 (6) A tanning facility must:
19 (a) During operating hours, have an operator present
20 who is sufficiently knowledgeable and trained in accordance
21 with rules of the department in the correct operation of the
22 tanning devices to inform and assist each customer in the
23 proper use of the devices.
24 (13) The department shall adopt rules to implement
25 this section act. The rules may include, but need not be
26 limited to, requirements for training tanning facility
27 operators and employees; the approval of training courses;
28 safety; plan review; and the design, construction, operation,
29 maintenance, and cleanliness of tanning facilities and tanning
30 devices.
31
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1 Section 16. Paragraph (g) of subsection (1) and
2 subsection (2) of section 383.011, Florida Statutes, are
3 amended, and paragraph (i) is added to subsection (1) of that
4 section, to read:
5 383.011 Administration of maternal and child health
6 programs.--
7 (1) The Department of Health is designated as the
8 state agency for:
9 (g) Receiving the federal funds for the "Special
10 Supplemental Nutrition Food Program for Women, Infants, and
11 Children," or WIC, authorized by the Child Nutrition Act of
12 1966, as amended, and for administering the statewide WIC
13 program. (The WIC program provides nutrition education and
14 supplemental foods, by means of food instruments called checks
15 that are redeemed by authorized food vendors, to participants
16 certified by the department as pregnant, breastfeeding, or
17 postpartum women; infants; or children.)
18 (h) Designating facilities that provide maternity
19 services or newborn infant care as "baby-friendly" when the
20 facility has established a breastfeeding policy under s.
21 383.016.
22 (i) Receiving federal funds for children eligible for
23 assistance through the portion of the federal Child and Adult
24 Care Food Program for children, which is referred to as the
25 Child Care Food Program, and for administering the program.
26 (2) The Department of Health shall follow federal
27 requirements and may adopt any rules necessary for the
28 implementation of the maternal and child health care program,
29 or the WIC program, and the Child Care Food Program.
30 (a) The department may adopt rules that are necessary
31 to administer the maternal and child health care program. The
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1 rules may include, but need not be limited to, requirements
2 for client eligibility, program standards, service delivery,
3 quality assurance, and provider selection.
4 (b) The department may adopt rules that are necessary
5 to administer the statewide WIC program. The rules may
6 include, but need not be limited to, criteria for grocers'
7 participation, client eligibility, contracts with local
8 agencies for service delivery, and food purchases and
9 penalties for program abuse.
10 Section 17. Section 384.33, Florida Statutes, is
11 amended to read:
12 384.33 Rules.--The department may adopt rules to carry
13 out the provisions of this chapter. The rules may include
14 requirements for methods of notifying a physician or a
15 person's partner of the presence of a sexually transmissible
16 disease and for maintaining the security of confidential
17 information.
18 Section 18. Subsection (4) of section 384.34, Florida
19 Statutes, is amended to read:
20 384.34 Penalties.--
21 (4) Any person who violates the provisions of the
22 department's rules pertaining to sexually transmissible
23 diseases may be punished by a fine not to exceed $500 for each
24 violation. Any penalties enforced under this subsection shall
25 be in addition to other penalties provided by this chapter
26 act. The department may enforce this section and adopt rules
27 necessary to administer this section.
28 Section 19. Section 401.26, Florida Statutes, is
29 amended to read:
30 401.26 Vehicle permits for basic life support and
31 advanced life support services.--
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1 (1) Every licensee shall possess a valid permit for
2 each transport vehicle, and advanced life support nontransport
3 vehicle, and aircraft in use. Applications for such permits
4 shall be made upon forms prescribed by the department. The
5 licensee shall provide documentation that each vehicle for
6 which a permit is sought meets the appropriate requirements
7 for a basic life support or advanced life support service
8 vehicle, whichever is applicable, as specified by rule of the
9 department. A permit is not required for an advanced life
10 support nontransport vehicle that is intended to be used for
11 scene supervision, incident command, or the augmentation of
12 supplies.
13 (2) To receive a valid vehicle permit, the applicant
14 must submit a completed application form for each vehicle or
15 aircraft for which a permit is desired, pay the appropriate
16 fees established as provided in s. 401.34, and provide
17 documentation that each vehicle or aircraft meets the
18 following requirements as established by rule of the
19 department; the vehicle or aircraft must:
20 (a) Be furnished with essential medical supplies and
21 equipment which is in good working order.
22 (b) Meet appropriate standards for design and
23 construction.
24 (c) Be equipped with an appropriate communication
25 system.
26 (d) Meet appropriate safety standards.
27 (e) Meet sanitation and maintenance standards.
28 (f) Be insured for an appropriate sum against injuries
29 to or the death of any person arising out of an accident.
30 (3) The department may deny, suspend, or revoke a
31 permit if it determines that the vehicle, aircraft, or its
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1 equipment fails to meet the requirements specified in this
2 part or in the rules of the department.
3 (4) A permit issued in accordance with this section
4 will expire automatically concurrent with the service license.
5 (5) In order to renew a vehicle or aircraft permit
6 issued pursuant to this part, the applicant must:
7 (a) Submit a renewal application. Such application
8 must be received by the department not more than 90 days or
9 less than 30 days prior to the expiration of the permit.
10 (b) Submit the appropriate fee or fees, established as
11 provided in s. 401.34.
12 (c) Provide documentation that current standards for
13 issuance of a permit are met.
14 (6) The department shall establish criteria and time
15 limits for substitution of permitted vehicles that are out of
16 services for maintenance purposes.
17 (7) The department shall adopt and enforce rules
18 necessary to administer this section.
19 Section 20. Subsection (4) is added to section
20 401.265, Florida Statutes, to read:
21 401.265 Medical directors.--
22 (4) The department shall adopt and enforce all rules
23 necessary to administer this section.
24 Section 21. Subsection (4) is added to section 401.30,
25 Florida Statutes, to read:
26 401.30 Records.--
27 (4) The department shall adopt and enforce all rules
28 necessary to administer this section.
29 Section 22. Section 401.465, Florida Statutes, is
30 created to read:
31
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1 401.465 Licensure of emergency medical technician and
2 paramedic educational programs; fees; records; site visits;
3 exemptions; continuing education or refresher program
4 approval; transfer of program license; disciplinary action and
5 penalties.--
6 (1) As used in this section, the term "training
7 program licensee" means any individual, institution, school,
8 corporation, or government entity licensed under this section.
9 (2) Each individual, institution, school, corporation,
10 or governmental entity that operates, conducts, maintains,
11 advertises, or engages in the business of providing emergency
12 medical technician or paramedic education must be licensed as
13 an emergency medical technician or paramedic education
14 program, whichever is applicable, before offering such
15 service. The application for such license must be submitted to
16 the department on forms developed and provided for this
17 purpose. The application must include documentation that the
18 applicant meets the requirements for an emergency medical
19 technician or paramedic education program, whichever is
20 applicable, as specified by rule of the department.
21 (3)(a) The department shall issue a program license to
22 any applicant who complies with the following requirements:
23 1. Is recognized by the Department of Education as an
24 institution that may grant college credit or has an agreement
25 with the Department of Education to articulate college
26 credits.
27 2. Has paid the fees required in this section.
28 3. Has complied with all of the applicable laws and
29 rules of the Department of Education.
30 4. Has the resources specified by rule of the
31 department to conduct training, including financial and
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1 administrative support, equipment and supplies, a qualified
2 faculty, a medical director, a physical facility, a library
3 and other learning resources, clinical and field internship
4 contracts, and meets all other requirements of this section
5 and s. 401.475 and rules for providing an emergency medical
6 technician or paramedic educational program.
7 5. Uses the most current United States Department of
8 Transportation National Standard Emergency Medical Technician
9 Basic Curriculum as the basis for a 250-hour program, which
10 must include training in human immunodeficiency virus (HIV)
11 and acquired immunodeficiency syndrome (AIDS), other
12 blood-borne pathogens, and hazardous materials. The program
13 must include components of didactic, laboratory, clinical, and
14 field internship experience. The department may reduce the
15 number of hours required on a case-by-case basis if the
16 training program licensee documents that each student meets
17 all of the requirements.
18 6. Uses the most current United States Department of
19 Transportation National Standard Paramedic Curriculum as the
20 basis for an 1100-hour program, which must include training in
21 human immunodeficiency virus (HIV) and acquired
22 immunodeficiency syndrome (AIDS), other blood-borne pathogens,
23 and hazardous materials. The program must include components
24 of didactic, laboratory, clinical, and field internship
25 experience. The department may reduce the number of hours
26 required on a case-by-case basis if the training program
27 licensee documents that each student meets all of the
28 requirements.
29 (b) In addition, for a paramedic program to be granted
30 an initial program license, the training program licensee must
31 agree to meet the following requirements:
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1 1. Within 1 year after the date the license is issued
2 by the department, apply for accreditation from an accrediting
3 association recognized by the United States Department of
4 Education, or one recognized by the Council on Higher
5 Education Accreditation, as specified by rule of the
6 department.
7 2. Within 18 months after the date the license is
8 issued by the department, submit the program self-study
9 document, along with the required fee, to the accrediting
10 association.
11 3. Notify the department within 14 days after the
12 training program licensee meets the requirements in
13 subparagraphs 1. and 2.
14 (4) The license of an initial paramedic program that
15 is in compliance with paragraph (3)(b) and is accredited by an
16 accrediting association recognized by the United States
17 Department of Education or the Council on Higher Education
18 Accreditation shall remain in effect concurrent with the
19 period of accreditation. The department shall establish by
20 rule the timeframes, procedures, and fees for renewal of the
21 paramedic program license. The license of a paramedic program
22 denied accreditation shall expire at the time of denial.
23 (5) Each initial emergency medical technician program
24 license issued in accordance with this section shall expire 1
25 year after the date of issuance and may be renewed for a
26 period of 2 years by meeting the requirements that are in
27 effect at the time of renewal.
28 (6) Each entity or person subject to this section must
29 pay to the department a nonrefundable fee, not to exceed
30 $2,000, sufficient to cover the actual cost of the program.
31
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1 (7) Fees collected under this section must be
2 deposited to the credit of the Emergency Medical Services
3 Trust Fund and must be applied solely for salaries and
4 expenses of the department incurred in administering and
5 enforcing this part.
6 (8) An entity that provides training for
7 recertification as an emergency medical technician or
8 paramedic is not required to be licensed under this section
9 but is subject to the disciplinary actions and penalties
10 outlined in this section.
11 (9) Each training program licensee must maintain
12 accurate records and reports, including student applications;
13 records of attendance; records of participation in clinical
14 and field training; medical records; course objectives and
15 course outlines; class schedules; learning objectives; lesson
16 plans, number of applicants; number of students accepted;
17 admission requirements; description of the qualifications,
18 duties, and responsibilities of faculty members, including the
19 medical director; and any correspondence received from the
20 department. These records must be available for inspection by
21 the department at any reasonable time, and copies thereof must
22 be furnished to the department upon request. Any record
23 furnished by a training program licensee at the request of the
24 department must be the original record and must not be altered
25 or have information deleted.
26 (10) Each license is valid only for the training
27 program licensee to whom it is issued and is not subject to
28 sale or other transfer. A license is valid only for the
29 program-facility location for which it was originally issued.
30 (11) Not later than 60 days before changing the
31 facility location or name registered with the department, the
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1 training program licensee shall notify the department in
2 writing. The department shall establish by rule the
3 application procedure for such changes.
4 (12) Any emergency medical technician or paramedic
5 education program owned, operated, or contracted by the United
6 States Government for the sole purpose of training its own
7 personnel is exempt from this section.
8 (13) In order to carry out the requirements of this
9 section, the department shall conduct site visits to training
10 program licensees to determine compliance with the
11 requirements of this section and departmental rules. The
12 department shall conduct site visits without impeding the
13 student-learning process.
14 (14) Upon completion of a site visit, the department
15 may request corrective action of any violations found during
16 the site visit. The department shall adopt, by rule,
17 procedures that provide for categories of violations, the type
18 of violations in each category, the time for correcting
19 violations in each category, and the time for notifying the
20 department that corrective action has been completed.
21 (15) The department may deny, suspend, or revoke a
22 license or may reprimand or fine any training program licensee
23 operating under this section for any of the following:
24 (a) The violation of any rule of the department or any
25 provision of this section.
26 (b) Knowingly making false or fraudulent claims to
27 procure, or attempting to procure, a license.
28 (c) Unprofessional conduct, including, but not limited
29 to, any departure from or failure to conform to the minimal
30 prevailing standards of acceptable practice for an emergency
31 medical technician or paramedic educational program.
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1 (d) The failure to give to the department, or its
2 authorized representative, true information upon request
3 regarding an alleged or confirmed violation of this section or
4 rule of the department.
5 (e) The refusal of a training program licensee to
6 allow a site visit is grounds for revocation of the license.
7 (f) Failure of a training program licensee to submit
8 the corretive-action statement within the required time is a
9 ground for discipline as provided in this section.
10 (g) Fraudulent or misleading advertising.
11 (h) Fraudulent or misleading financial conduct.
12 (i) Loss of national accreditation or revocation or
13 suspension of a license issued by the Department of Education.
14 (j) Any disciplinary action by the Department of
15 Education which results in a fine or penalty.
16 (16) A suspension or revocation of a license shall
17 apply to both the emergency medical technician and paramedic
18 program if the training program licensee holds a license for
19 both programs, unless the department, in its sole discretion,
20 suspends or revokes only one license.
21 (17) In addition to any other administrative action
22 authorized by law, the department may impose an administrative
23 fine, not to exceed $1,000 per violation of this section or
24 rule of the department. Each day of a violation constitutes a
25 separate violation and is subject to a separate fine.
26 (18) Fines collected under this section must be
27 deposited to the credit of the Emergency Medical Services
28 Trust Fund and must be applied solely for salaries and
29 expenses of the department incurred in administering and
30 enforcing this part.
31
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1 (19) The department shall adopt and enforce all rules
2 necessary to administer this section.
3 Section 23. Section 401.475, Florida Statutes, is
4 created to read:
5 401.475 Penalties for operating an unlicensed
6 emergency medical technician or paramedic program.--
7 (1) When the department has probable cause to believe
8 that any person not licensed by the department to provide
9 emergency medical technician or paramedic education has
10 conducted programs in emergency medical technician or
11 paramedic education, or has violated any provision of this
12 chapter or any other law or rule that relates to the licensure
13 of emergency medical technician or paramedic education
14 programs, the department may issue and deliver to such person
15 a notice to cease and desist from such violation. The issuance
16 of a notice to cease and desist does not constitute agency
17 action for which a hearing may be sought under s. 120.57. For
18 the purpose of enforcing a cease and desist order, the
19 department may file a proceeding in the name of the state
20 seeking issuance of an injunction or a writ of mandamus
21 against any person who violates any provision of such order.
22 In addition to the foregoing remedies, the department may
23 impose an administrative penalty not to exceed $5,000 per
24 incident pursuant to chapter 120. If the department seeks
25 enforcement of the agency order for a penalty pursuant to s.
26 120.569, it may collect attorney's fees and costs, together
27 with any cost of collection.
28 (2) In addition to or in lieu of any remedy provided
29 in subsection (1), the department may seek the imposition of a
30 civil penalty through the circuit court for any violation for
31 which the department may issue a notice to cease and desist
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1 under subsection (1). The civil penalty may not be less than
2 $500 or more than $5,000 for each offense. The court may also
3 award to the prevailing party court costs and reasonable
4 attorney's fees and, if the department prevails, the court may
5 also award reasonable costs of investigation.
6 Section 24. Section 403.0625, Florida Statutes, is
7 amended to read:
8 403.0625 Environmental laboratory certification; water
9 quality tests conducted by a certified laboratory.--
10 (1) To assure the acceptable quality, reliability, and
11 validity of testing results, the department and the Department
12 of Health and Rehabilitative Services shall jointly establish
13 criteria for certification of laboratories that perform
14 analyses of environmental water quality samples that which are
15 not covered by the provisions in s. 403.863 and that wish to
16 be certified. The Department of Health and Rehabilitative
17 Services shall have the responsibility for the operation and
18 implementation of such laboratory certification. The
19 Department of Health and Rehabilitative Services may charge
20 and collect fees for the certification of such laboratories.
21 The fee schedule shall be based on the number of analytical
22 functions for which certification is sought. Such fees shall
23 be sufficient to meet the costs incurred by the Department of
24 Health and Rehabilitative Services in administering this
25 program in coordination with the department. All fees
26 collected pursuant to this section shall be deposited in a
27 trust fund to be administered by the Department of Health and
28 Rehabilitative Services and shall be used only for the
29 purposes of this section.
30 (2) An environmental water quality test to determine
31 the quality of the effluent of a domestic wastewater facility
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1 must be conducted by a laboratory certified under this section
2 if such test results are to be submitted to the department or
3 a local pollution control program pursuant to s. 403.182.
4 (3) The Department of Health may adopt and enforce
5 rules to administer this section, including, but not limited
6 to, definitions of terms, certified laboratory personnel
7 requirements, sample collection methodology and proficiency
8 testing, the format and frequency of reports, onsite
9 inspections of laboratories, and quality assurance.
10 (4) The following acts constitute grounds for which
11 the disciplinary actions specified in subsection (5) may be
12 taken:
13 (a) Making false statements on an application or on
14 any document associated with certification.
15 (b) Making consistent errors in analyses or erroneous
16 reporting.
17 (c) Permitting personnel who are not qualified, as
18 required by rules of the Department of Health, to perform
19 analyses.
20 (d) Falsifying the results of analyses.
21 (e) Failing to employ approved laboratory methods in
22 performing analyses as outlined in rules of the Department of
23 Health.
24 (f) Failing to properly maintain facilities and
25 equipment according to the laboratory's quality assurance
26 plan.
27 (g) Failing to report analytical test results or
28 maintain required records of test results as outlined in rules
29 of the Department of Health.
30
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1 (h) Failing to participate successfully in a
2 performance-evaluation program approved by the Department of
3 Health.
4 (i) Violating any provision of this section or of the
5 rules adopted under this section.
6 (j) Falsely advertising services or credentials.
7 (k) Failing to pay fees for initial certification or
8 renewal certification or to pay inspection expenses incurred
9 by the Department of Health.
10 (l) Failing to report any change of an item included
11 in the initial or renewal certification application.
12 (m) Refusing to allow representatives of the
13 department or the Department of Health to inspect a laboratory
14 and its records during normal business hours.
15 (5) When the Department of Health finds any applicant
16 or certificateholder guilty of any of the grounds set forth in
17 subsection (4), it may enter an order imposing one or more of
18 the following penalties:
19 (a) Denial of an application for certification.
20 (b) Revocation or suspension of certification.
21 (c) Imposition of an administrative fine not to exceed
22 $1,000 for each count or separate offense.
23 (d) Issuance of a reprimand.
24 (e) Placement of the certification on probation for a
25 period of time and subject to such conditions as the
26 Department of Health specifies.
27 (f) Restricting the authorized scope of the
28 certification.
29 (6) The certification program shall be governed by
30 chapter 120.
31
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1 Section 25. Section 403.863, Florida Statutes, is
2 amended to read:
3 403.863 State public water supply laboratory
4 certification program.--
5 (1) Within 120 days of the effective date of this act,
6 The department and the Department of Health and Rehabilitative
7 Services shall jointly develop a state program, and the
8 Department of Health and Rehabilitative Services shall adopt
9 rules for the evaluation and certification of all laboratories
10 in the state, other than the principal state laboratory, which
11 perform or make application to perform analyses pursuant to
12 the Florida Safe Drinking Water Act or which conduct a
13 water-analysis business. Such joint development shall be
14 funded in part through the use of a portion of the State
15 Public Water Systems Supervision Program grants received by
16 the department from the Federal Government in order to
17 implement the federal act.
18 (2) The Department of Health may adopt and enforce
19 rules to administer this section, including, but not limited
20 to, definitions of terms, certified laboratory personnel
21 requirements, methodologies for the collection of samples, the
22 handling and analysis of samples, methodology and proficiency
23 testing, the format and frequency of reports, onsite
24 inspections of laboratories, and quality assurance.
25 (3)(2) The Department of Health and Rehabilitative
26 Services shall have the responsibility for the operation and
27 implementation of the state laboratory certification program,
28 except that, upon completion of the evaluation and review of
29 the laboratory certification application, the evaluation shall
30 be forwarded, along with recommendations, to the department
31
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1 for review and comment, prior to final approval or
2 disapproval.
3 (4) The following acts constitute grounds for which
4 the disciplinary actions specified in subsection (5) may be
5 taken:
6 (a) Making false statements on an application or on
7 any document associated with certification.
8 (b) Making consistent errors in analyses or erroneous
9 reporting.
10 (c) Permitting personnel who are not qualified, as
11 required by rules of the Department of Health, to perform
12 analyses.
13 (d) Falsifying the results of analyses.
14 (e) Failing to employ approved laboratory methods in
15 performing analyses as outlined in rules of the Department of
16 Health.
17 (f) Failing to properly maintain facilities and
18 equipment according to the laboratory's quality assurance
19 plan.
20 (g) Failing to report analytical test results or
21 maintain required records of test results as outlined in rules
22 of the Department of Health.
23 (h) Failing to participate successfully in a
24 performance-evaluation program approved by the Department of
25 Health.
26 (i) Violating any provision of this section or of the
27 rules adopted under this section.
28 (j) Falsely advertising services or credentials.
29 (k) Failing to pay fees for initial certification or
30 renewal certification or to pay inspection expenses incurred
31 by the Department of Health.
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1 (l) Failing to report any change of an item included
2 in the initial or renewal certification application.
3 (m) Refusing to allow representatives of the
4 department or the Department of Health to inspect a laboratory
5 and its records during normal business hours.
6 (5) When the Department of Health finds any applicant
7 or certificateholder guilty of any of the grounds set forth in
8 subsection (4), it may enter an order imposing one or more of
9 the following penalties:
10 (a) Denial of an application for certification.
11 (b) Revocation or suspension of certification.
12 (c) Imposition of an administrative fine not to exceed
13 $1,000 for each count or separate offense.
14 (d) Issuance of a reprimand.
15 (e) Placement of the certification on probation for a
16 period of time and subject to such conditions as the
17 Department of Health specifies.
18 (f) Restricting the authorized scope of the
19 certification.
20 (6)(3) Any federal grant funds received by the
21 department for the operation and implementation of the state
22 laboratory certification program shall be transferred to the
23 Department of Health and Rehabilitative Services by
24 interagency agreement between the two departments. Such
25 agreement shall require the Department of Health and
26 Rehabilitative Services to provide the department with a
27 quarterly accounting of the funds transferred.
28 (7)(4) A Within 60 days of the effective date of the
29 rules adopted pursuant to this section, no laboratory in the
30 state which conducts a water-analysis business, except the
31 principal state laboratory, may not shall perform analyses
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1 pursuant to the Florida Safe Drinking Water Act without having
2 applied for and received certification under the state
3 certification program to perform such analyses.
4 (8)(5) For the purposes of this section, the term
5 "principal state laboratory" means the central laboratory of
6 the Department of Health and Rehabilitative Services.
7 (9)(6) For the purposes of this section, the term
8 "certification" means regulatory recognition given to a
9 laboratory that performs analyses pursuant to the Florida Safe
10 Drinking Water Act, that it meets minimum analytical
11 performance standards.
12 (10) The certification program shall be governed by
13 chapter 120.
14 Section 26. Subsection (3) of section 404.056, Florida
15 Statutes, is amended to read:
16 404.056 Environmental radiation standards and
17 programs; radon protection.--
18 (3) CERTIFICATION.--
19 (a) The department is authorized to certify persons
20 who perform radon gas or radon progeny measurements, including
21 sample collection, analysis, or interpretation of such
22 measurements, and who perform mitigation of buildings for
23 radon gas or radon progeny, and shall collect a fee for such
24 certification. Before performing radon measurement or radon
25 mitigation services, including collecting samples, performing
26 analysis, or interpreting measurement results, a certified
27 individual must own, be employed by, or be retained as a
28 consultant to a certified radon measurement or certified radon
29 mitigation business. The department may establish criteria for
30 the application, certification, and annual renewal of
31 individuals, which may include requirements for education and
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1 experience, approved training, examinations, and reporting.
2 The department may approve training courses for certification
3 and establish criteria for training courses and instructors.
4 The department may observe and evaluate training sessions,
5 instructors, and course material without charge.
6 (b) A After January 1, 1989, no person may not shall
7 participate in performing radon gas or radon progeny
8 measurements, including sample collection, analysis, or
9 interpretation of such measurements, or perform mitigation of
10 buildings for radon gas or radon progeny, and charge a fee or
11 obtain other remuneration as benefit for such services or
12 devices, unless that person is certified by the department. A
13 certification issued in accordance with this section
14 automatically expires at the end of the certification period
15 stated on the certificate. An uncertified commercial business
16 may subcontract radon measurements to a certified radon
17 business. The uncertified commercial business must provide the
18 complete radon report from the certified radon business to the
19 client and direct all the client's questions about the
20 measurements or radon report to the certified radon business.
21 (c) The results of measurements of radon gas or radon
22 progeny performed by persons certified under the provisions of
23 this subsection shall be reported to the department and
24 persons contracting for the service. Upon request, the
25 results of measurements of radon gas or radon progeny which
26 are performed to evaluate the effectiveness of a radon
27 mitigation system shall be reported to the certified business
28 that installed the mitigation system. The report must shall
29 include the radon levels detected; and the location, age, and
30 description of the building; the name and certification
31 numbers of the certified radon measurement business and
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1 individual who performed the measurements; and other
2 information determined by the department to meet the
3 requirements of the protocols and procedures for the type of
4 measurement performed. Each installation of a radon mitigation
5 system performed by a person certified under this section must
6 be reported to the department according to the schedule set by
7 the department. The report must include the premitigation and
8 postmitigation radon levels; the type or types of systems
9 installed; the location, age, and description of the building;
10 and the name and certification number of the certified
11 mitigation business that performed the mitigation.
12 (d) Authorized representatives of the department have
13 the authority to inspect the business and records of any
14 person certified under the provisions of this subsection, at
15 all reasonable times, to examine records and test procedures
16 to determine compliance with or violation of the provisions of
17 this section.
18 (e) Any person who practices fraud, deception, or
19 misrepresentation in performing radon gas or radon progeny
20 measurements or in performing mitigation of buildings for
21 radon gas or radon progeny is subject to the penalties
22 provided in s. 404.161.
23 (f) The department is authorized to charge and collect
24 nonrefundable fees for the certification and annual
25 recertification of persons who perform radon gas or radon
26 progeny measurements or who perform mitigation of buildings
27 for radon gas or radon progeny. The amount of the initial
28 application fee and certification shall be not less than $200
29 or more than $900. The amount of the annual recertification
30 fee shall be not less than $200 or more than $900. Effective
31 July 1, 1988, the fee amounts shall be the minimum fee
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1 prescribed in this paragraph, and such fee amounts shall
2 remain in effect until the effective date of a fee schedule
3 promulgated by rule by the department. The fees collected
4 shall be deposited in the Radiation Protection Trust Fund and
5 shall be used only to implement the provisions of this
6 section. The surcharge established pursuant to subsection (3)
7 may be used to supplement the fees established in this
8 paragraph in carrying out the provisions of this subsection.
9 (g) The department may deny, suspend, or revoke a
10 certification, or impose an administrative fine not to exceed
11 $1,000 per violation per day, for the violation of any
12 provision of this section or rule promulgated pursuant
13 thereto.
14 (h) A certificateholder in good standing remains in
15 good standing when he or she becomes a member of the Armed
16 Forces of the United States on active duty without payment of
17 renewal fees as long as he or she is a member of the Armed
18 Forces on active duty and for a period of 6 months after his
19 or her discharge from active duty, if he or she is not engaged
20 in practicing radon measurement or radon mitigation in the
21 private sector for profit. The certificateholder must pay a
22 renewal fee to renew the certificate.
23 (i) A certificateholder who is in good standing
24 remains in good standing if he or she is absent from the state
25 because of his or her spouse's active duty with the Armed
26 Forces of the United States. The certificateholder remains in
27 good standing without payment of renewal fees as long as his
28 or her spouse is a member of the Armed Forces on active duty
29 and for a period of 6 months after the spouse's discharge from
30 active duty, if the certificateholder is not engaged in
31 practicing radon measurement or radon mitigation in the
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1 private sector for profit. The certificateholder must pay a
2 renewal fee to renew the certificate.
3 (j) The department may set criteria and requirements
4 for the application, certification, and annual renewal of
5 certification for radon measurement and mitigation businesses,
6 which may include:
7 1. Requirements for measurement devices and
8 measurement procedures, including the disclosure of mitigation
9 materials, systems, and other mitigation services offered.
10 2. The identification of certified specialists and
11 technicians employed by the business and requirements for
12 specialist staffing and duties.
13 3. The analysis of measurement devices by proficient
14 analytical service providers.
15 4. Requirements for a quality assurance and quality
16 control program.
17 5. The disclosure of client measurement reporting
18 forms and warranties and operating instructions for mitigation
19 systems.
20 6. Requirements for radon services publications and
21 the identification of the radon business certification number
22 in advertisements.
23 7. Requirements for a worker health and safety
24 program.
25 8. Requirements for maintaining radon records.
26 9. The operation of branch office locations.
27 10. Requirements for supervising subcontractors who
28 install mitigation systems.
29 11. Requirements for building inspections and
30 evaluation and standards for the design and installation of
31 mitigation systems.
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1 12. Prescribing conditions of mitigation measurements.
2 (k) Any change in the information provided to the
3 department in the original business application to be reported
4 within 10 days after the change.
5 Section 27. Subsections (1) and (2) of section 404.22,
6 Florida Statutes, are amended to read:
7 404.22 Radiation machines and components;
8 inspection.--
9 (1) The department and its duly authorized agents may
10 have the power to inspect in a lawful manner at all reasonable
11 hours any hospital or other health care facility or other
12 place in the state in which a radiation machine is installed
13 for the purpose of determining whether the facility, the
14 radiation machine and its components, the film and film
15 processing equipment, the techniques and procedures, any
16 mechanical holding devices, the warning labels and signs, the
17 written safety procedures, and the resultant image produced
18 meet the standards of the department as set forth in this
19 chapter and rules adopted pursuant thereto. If, in the
20 opinion of the department, a radiation machine which fails to
21 meet such standards can be made to meet the standards through
22 an adjustment or limitation upon the stations or range of the
23 radiation machine or through the purchase of a component
24 meeting the standards, the department shall order the owner of
25 the radiation machine to make the necessary adjustment or to
26 purchase the necessary component within 90 days of the date or
27 receipt of the order. However, if the radiation machine cannot
28 be made to meet the standards, the department shall order the
29 owner to cease the utilization of the radiation machine.
30 (2) Any person who enters the state with a radiation
31 machine or component owned by him or her for the purpose of
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1 installing and utilizing the radiation machine shall register
2 the radiation machine with the department. The department
3 shall inspect the radiation machine to determine its
4 compliance with the standards and shall approve or disapprove
5 the radiation machine or shall order adjustments to the
6 radiation machine in accordance with the provisions of
7 subsection (1). Each person who installs or offers to install
8 or service radiation machines must register with the
9 department and must apply to the department, on forms
10 furnished by the department, before furnishing or offering to
11 furnish any such service.
12 Section 28. Subsection (2) of section 468.306, Florida
13 Statutes, is amended to read:
14 468.306 Examinations.--All applicants, except those
15 certified pursuant to s. 468.3065, shall be required to pass
16 an examination. The department is authorized to develop or
17 use examinations for each type of certificate.
18 (2) Examinations shall be given for each type of
19 certificate at least twice a year at such times and places as
20 the department may determine to be advantageous for
21 applicants. If an applicant applies less than 75 days before
22 an examination, the department may schedule the applicant for
23 a later examination.
24 Section 29. Paragraph (d) of subsection (4) of section
25 489.553, Florida Statutes, is amended to read:
26 489.553 Administration of part; registration
27 qualifications; examination.--
28 (4) To be eligible for registration by the department
29 as a septic tank contractor, the applicant must:
30 (d) Have a total of at least 3 years of active
31 experience serving an apprenticeship as a skilled workman
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1 under the supervision and control of a registered septic tank
2 contractor or a plumbing contractor as defined in s. 489.105
3 who has provided septic tank contracting services. Related
4 work experience or educational experience may be substituted
5 for no more than 2 years of active contracting experience.
6 Each 30 hours of coursework approved by the department will
7 substitute for 6 months of work experience. Out-of-state work
8 experience shall be accepted on a year-for-year basis for any
9 applicant who demonstrates that he or she holds a current
10 license issued by another state for septic tank contracting
11 which was issued upon satisfactory completion of an
12 examination and continuing education courses that are
13 equivalent to the requirements in this state. For purposes of
14 this section, an equivalent examination must include the
15 topics of system location and installation, site evaluation,
16 system size determinations, disposal of septage, construction
17 standards for drainfield systems, and the soil-texture
18 classification system of the United States Department of
19 Agriculture. A person employed by and under the supervision of
20 a licensed contractor shall be granted up to 2 years of
21 related work experience.
22 Section 30. Subsection (1) of section 489.555, Florida
23 Statutes, is amended to read:
24 489.555 Certification of partnerships and
25 corporations.--
26 (1) The practice of or the offer to practice septic
27 tank contracting services by registrants through a parent
28 corporation, corporation, subsidiary of a corporation, or
29 partnership offering septic tank contracting services to the
30 public through registrants under this chapter as agents,
31 employers, officers, or partners is permitted, provided that
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1 one or more of the principal officers of the corporation or
2 one or more partners of the partnership and all personnel of
3 the corporation or partnership who act in its behalf as septic
4 tank contractors or master septic tank contractors in this
5 state are registered as provided by this part, and further
6 provided that the corporation or partnership has been issued a
7 certificate of authorization by the department as provided in
8 this section. A registered contractor may not be the sole
9 qualifying contractor for more than one business that requests
10 a certificate of authorization. A business organization that
11 loses its qualifying contractor has 60 days following the date
12 the qualifier terminates his or her affiliation within which
13 to obtain another qualifying contractor. During this period,
14 the business organization may complete any existing contract
15 or continuing contract, but may not undertake any new
16 contract. This period may be extended once by the department
17 for an additional 60 days upon a showing of good cause.
18 Nothing in this section shall be construed to mean that a
19 certificate of registration to practice septic tank
20 contracting shall be held by a corporation. No corporation or
21 partnership shall be relieved of responsibility for the
22 conduct or acts of its agents, employees, or officers by
23 reason of its compliance with this section, nor shall any
24 individual practicing septic tank contracting be relieved of
25 responsibility for professional services performed by reason
26 of his or her employment or relationship with a corporation or
27 partnership.
28 Section 31. Subsection (6) of section 499.005, Florida
29 Statutes, is amended, and subsection (23) is added to that
30 section, to read:
31
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1 499.005 Prohibited acts.--It is unlawful to perform or
2 cause the performance of any of the following acts in this
3 state:
4 (6) The refusal or constructive refusal:
5 (a) To allow the department to enter or inspect an
6 establishment in which drugs, devices, or cosmetics are
7 manufactured, processed, repackaged, sold, brokered, or held;
8 (b) To allow inspection of any record of that
9 establishment;
10 (c) To allow the department to enter and inspect any
11 vehicle that is being used to transport drugs, devices, or
12 cosmetics; or
13 (d) To allow the department to take samples of any
14 drug, device, or cosmetic.
15 (23) Obtaining or attempting to obtain a prescription
16 drug or device by fraud, deceit, misrepresentation or
17 subterfuge, or engaging in misrepresentation or fraud in the
18 distribution of a drug or device.
19 Section 32. Subsection (1) of section 499.01, Florida
20 Statutes, is amended to read:
21 499.01 Permits; applications; renewal; general
22 requirements.--
23 (1) Any person that is required under ss.
24 499.001-499.081 to have a permit must apply to the department
25 on forms furnished by the department.
26 (a) A permit issued pursuant to ss. 499.001-499.081
27 may be issued only to an individual who is at least 18 years
28 of age or to a corporation that is registered pursuant to
29 chapter 607 or chapter 617 and each officer of which is at
30 least 18 years of age.
31
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1 (b) An establishment that is a place of residence may
2 not receive a permit and may not operate under ss.
3 499.001-499.081.
4 (c) A person that applies for or renews a permit to
5 manufacture or distribute legend drugs may not use a name
6 identical to the name used by any other establishment or
7 licensed person authorized to purchase prescription drugs in
8 this state, except that a restricted drug-distributor permit
9 issued to a health care entity will be issued in the name in
10 which the institutional pharmacy permit is issued and a retail
11 pharmacy drug wholesaler will be issued a permit in the name
12 of its retail pharmacy permit.
13 (d) A permit is required for each establishment that
14 operates as a:
15 1. Prescription drug manufacturer;
16 2. Over-the-counter drug manufacturer;
17 3. Compressed medical gas manufacturer;
18 4. Device manufacturer;
19 5. Cosmetic manufacturer;
20 6. Prescription drug wholesaler;
21 7. Compressed medical gas wholesaler;
22 8. Out-of-state prescription drug wholesaler;
23 9. Retail pharmacy drug wholesaler;
24 10. Veterinary legend drug retail establishment;
25 11. Medical oxygen retail establishment; or
26 12. Complimentary drug distributor; or.
27 13. Restricted prescription drug distributor.
28 (e) A permit for a prescription drug manufacturer,
29 prescription drug wholesaler, or retail pharmacy wholesaler
30 may not be issued to the address of a health care entity.
31
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1 (f) Notwithstanding subsection (4), a permitted person
2 in good standing may change the type of permit issued to that
3 person by completing a new application for the requested
4 permit, paying the amount of the difference in the permit fees
5 if the fee for the new permit is more than the fee for the
6 original permit, and meeting the applicable permitting
7 conditions for the new permit type. The new permit expires on
8 the expiration date of the original permit being changed. A
9 refund may not be issued if the biennial fee for the new
10 permit is less than the original permit for which a fee was
11 paid.
12 Section 33. Paragraph (a) of subsection (1) and
13 paragraph (a) of subsection (2) of section 499.012, Florida
14 Statutes, are amended, and subsection (5) is added to that
15 section, to read:
16 499.012 Wholesale distribution; definitions; permits;
17 general requirements.--
18 (1) As used in this section, the term:
19 (a) "Wholesale distribution" means distribution of
20 prescription drugs to persons other than a consumer or
21 patient, but does not include:
22 1. Any of the following activities, which is not a
23 violation of s. 499.005(21) if such activity is conducted in
24 accordance with s. 499.014:
25 a.1. The purchase or other acquisition by a hospital
26 or other health care entity that is a member of a group
27 purchasing organization of a prescription drug for its own use
28 from the group purchasing organization or from other hospitals
29 or health care entities that are members of that
30 organization.;
31
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1 b.2. The sale, purchase, or trade of a prescription
2 drug or an offer to sell, purchase, or trade a prescription
3 drug by a charitable organization described in s. 501(c)(3) of
4 the Internal Revenue Code of 1986, as amended and revised, to
5 a nonprofit affiliate of the organization to the extent
6 otherwise permitted by law.;
7 c.3. The sale, purchase, or trade of a prescription
8 drug or an offer to sell, purchase, or trade a prescription
9 drug among hospitals or other health care entities that are
10 under common control. For purposes of this section, "common
11 control" means the power to direct or cause the direction of
12 the management and policies of a person or an organization,
13 whether by ownership of stock, by voting rights, by contract,
14 or otherwise.
15 2. Any of the following activities, which is not a
16 violation of s. 499.005(21) if such activity is conducted in
17 accordance with rules established by the department:
18 a.4. The sale, purchase, or trade of a prescription
19 drug among federal, state, or local government health care
20 entities that are under common control and are authorized to
21 purchase such prescription drug.
22 b.5. The sale, purchase, or trade of a prescription
23 drug or an offer to sell, purchase, or trade a prescription
24 drug for emergency medical reasons; for purposes of this
25 subparagraph, the term "emergency medical reasons" includes
26 transfers of prescription drugs by a retail pharmacy to
27 another retail pharmacy to alleviate a temporary shortage.;
28 c.6. The purchase or acquisition of a prescription
29 drug by an emergency medical services medical director for use
30 by emergency medical services providers acting within the
31 scope of their professional practice pursuant to chapter 401.
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1 d. The revocation of a sale or the return of a
2 prescription drug to the person's prescription drug wholesale
3 supplier.
4 e. The donation of a prescription drug by a health
5 care entity to a charitable organization that has been granted
6 an exemption under s. 501(c)(3) of the Internal Revenue Code
7 of 1986, as amended, and that is authorized to possess
8 prescription drugs.
9 f. The transfer of a prescription drug by a person
10 authorized to purchase or receive prescription drugs to a
11 person licensed or permitted to handle reverse distributions
12 or destruction under the laws of the jurisdiction in which the
13 person handling the reverse distribution or destruction
14 receives the drug.
15 3.7. The dispensing of a prescription drug pursuant to
16 a prescription;
17 4.8. The distribution of prescription drug samples by
18 manufacturers' representatives or distributors'
19 representatives; or
20 5.9. The sale, purchase, or trade of blood and blood
21 components intended for transfusion. As used in this section,
22 the term "blood" means whole blood collected from a single
23 donor and processed either for transfusion or further
24 manufacturing, and the term "blood components" means that part
25 of the blood separated by physical or mechanical means.
26 (2) The following types of wholesaler permits are
27 established:
28 (a) A prescription drug wholesaler's permit. A
29 prescription drug wholesaler is a wholesale distributor that
30 may engage in the wholesale distribution of prescription
31 drugs. A prescription drug wholesaler that applies to the
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1 department after January 1, 1993, must submit a bond of $200,
2 payable to the Florida Drug, Device, and Cosmetic Trust Fund.
3 This bond will be refunded to the permittee when the permit is
4 returned to the department and the permittee ceases to
5 function as a business. A permittee that fails to notify the
6 department before changing the address of the business, fails
7 to notify the department before closing the business, or fails
8 to notify the department before a change of ownership forfeits
9 its bond. The department may adopt rules for issuing a
10 prescription drug wholesaler-broker permit to a person who
11 engages in the wholesale distribution of prescription drugs
12 and does not take physical possession of any prescription
13 drugs.
14 (5) The department may adopt rules governing the
15 recordkeeping, storage, and handling with respect to each of
16 the distributions of prescription drugs specified in paragraph
17 (1)(a), and any other rules related to such distributions
18 which are necessary to protect public health, safety, and
19 welfare.
20 Section 34. Section 499.0121, Florida Statutes, is
21 amended to read:
22 499.0121 Storage and handling of prescription
23 drugs.--The department shall adopt such rules to administer
24 this section relating to wholesale drug distribution as are
25 necessary to protect the public health, safety, and welfare.
26 Such rules shall include, but not be limited to, requirements
27 for the storage and handling of prescription drugs and for the
28 establishment and maintenance of prescription drug
29 distribution records.
30
31
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1 (1) ESTABLISHMENTS.--An establishment at which
2 prescription drugs are stored, warehoused, handled, held,
3 offered, marketed, or displayed must:
4 (a) Be of suitable size and construction to facilitate
5 cleaning, maintenance, and proper operations;
6 (b) Have storage areas designed to provide adequate
7 lighting, ventilation, temperature, sanitation, humidity,
8 space, equipment, and security conditions;
9 (c) Have a quarantine area for storage of prescription
10 drugs that are outdated, damaged, deteriorated, misbranded, or
11 adulterated, or that are in immediate or sealed, secondary
12 containers that have been opened;
13 (d) Be maintained in a clean and orderly condition;
14 and
15 (e) Be free from infestation by insects, rodents,
16 birds, or vermin of any kind.
17 (2) SECURITY.--
18 (a) An establishment that is used for wholesale drug
19 distribution must be secure from unauthorized entry.
20 1. Access from outside the premises must be kept to a
21 minimum and be well-controlled.
22 2. The outside perimeter of the premises must be
23 well-lighted.
24 3. Entry into areas where prescription drugs are held
25 must be limited to authorized personnel.
26 (b) An establishment that is used for wholesale drug
27 distribution must be equipped with:
28 1. An alarm system to detect entry after hours;
29 however, the department may exempt by rule establishments that
30 only hold a permit as prescription drug wholesaler-brokers and
31 establishments that only handle medical oxygen; and
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1 2. A security system that will provide suitable
2 protection against theft and diversion. When appropriate, the
3 security system must provide protection against theft or
4 diversion that is facilitated or hidden by tampering with
5 computers or electronic records.
6 (3) STORAGE.--All prescription drugs shall be stored
7 at appropriate temperatures and under appropriate conditions
8 in accordance with requirements, if any, in the labeling of
9 such drugs, or with requirements in the official compendium.
10 (a) If no storage requirements are established for a
11 prescription drug, the drug may be held at "controlled" room
12 temperature, as defined in the official compendium, to help
13 ensure that its identity, strength, quality, and purity are
14 not adversely affected.
15 (b) Appropriate manual, electromechanical, or
16 electronic temperature and humidity recording equipment,
17 devices, or logs must be used to document proper storage of
18 prescription drugs.
19 (c) The recordkeeping requirements in subsection (6)
20 must be followed for all stored prescription drugs.
21 (4) EXAMINATION OF MATERIALS.--
22 (a) Upon receipt, each outside shipping container must
23 be visually examined for identity and to prevent the
24 acceptance of contaminated prescription drugs that are
25 otherwise unfit for distribution. This examination must be
26 adequate to reveal container damage that would suggest
27 possible contamination or other damage to the contents.
28 (b) Each outgoing shipment must be carefully inspected
29 for identity of the prescription drug products and to ensure
30 that there is no delivery of prescription drugs that have
31
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1 expired or been damaged in storage or held under improper
2 conditions.
3 (c) The recordkeeping requirements in subsection (6)
4 must be followed for all incoming and outgoing prescription
5 drugs.
6 (5) RETURNED, DAMAGED, OR OUTDATED PRESCRIPTION
7 DRUGS.--
8 (a)1. Prescription drugs that are outdated, damaged,
9 deteriorated, misbranded, or adulterated must be quarantined
10 and physically separated from other prescription drugs until
11 they are destroyed or returned to their supplier. A
12 quarantine section must be separate and apart from other
13 sections where prescription drugs are stored so that
14 prescription drugs in this section are not confused with
15 usable prescription drugs.
16 2. Prescription drugs must be examined at least every
17 12 months, and drugs for which the expiration date has passed
18 must be removed and quarantined.
19 (b) Any prescription drugs of which the immediate or
20 sealed outer containers or sealed secondary containers have
21 been opened or used must be identified as such and must be
22 quarantined and physically separated from other prescription
23 drugs until they are either destroyed or returned to the
24 supplier.
25 (c) If the conditions under which a prescription drug
26 has been returned cast doubt on the drug's safety, identity,
27 strength, quality, or purity, the drug must be destroyed or
28 returned to the supplier, unless examination, testing, or
29 other investigation proves that the drug meets appropriate
30 standards of safety, identity, strength, quality, and purity.
31 In determining whether the conditions under which a drug has
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1 been returned cast doubt on the drug's safety, identity,
2 strength, quality, or purity, the wholesale drug distributor
3 must consider, among other things, the conditions under which
4 the drug has been held, stored, or shipped before or during
5 its return and the conditions of the drug and its container,
6 carton, or labeling, as a result of storage or shipping.
7 (d) The recordkeeping requirements in subsection (6)
8 must be followed for all outdated, damaged, deteriorated,
9 misbranded, or adulterated prescription drugs.
10 (6) RECORDKEEPING.--The department shall adopt rules
11 that require keeping such records of prescription drugs as are
12 necessary for the protection of the public health.
13 (a) Wholesale drug distributors must establish and
14 maintain inventories and records of all transactions regarding
15 the receipt and distribution or other disposition of
16 prescription drugs. These records must provide a complete
17 audit trail from receipt to sale or other disposition, be
18 readily retrievable for inspection, and include, at a minimum,
19 the following information:
20 1. The source of the drugs, including the name and
21 principal address of the seller or transferor, and the address
22 of the location from which the drugs were shipped;
23 2. The name, principal address, and state license
24 permit or registration number of the person authorized to
25 purchase prescription drugs;
26 3. The name, strength, dosage form, and quantity of
27 the drugs received and distributed or disposed of; and
28 4. The dates of receipt and distribution or other
29 disposition of the drugs.
30 (b) Inventories and records must be made available for
31 inspection and photocopying by authorized federal, state, or
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1 local officials for a period of 2 years following disposition
2 of the drugs.
3 (c) Records described in this section that are kept at
4 the inspection site or that can be immediately retrieved by
5 computer or other electronic means must be readily available
6 for authorized inspection during the retention period.
7 Records that are kept at a central location outside of this
8 state and that are not electronically retrievable must be made
9 available for inspection within 2 working days after a request
10 by an authorized official of a federal, state, or local law
11 enforcement agency. Records that are maintained at a central
12 location within this state must be maintained at an
13 establishment that is permitted pursuant to ss.
14 499.001-499.081 and must be readily available.
15 (d)1. Each person who is engaged in the wholesale
16 distribution of a prescription drug, and who is not an
17 authorized distributor of record of such drug, must provide to
18 each wholesale distributor of such drug, before the sale is
19 made to such wholesale distributor, a written statement
20 identifying each previous sale of the drug. The written
21 statement identifying all sales of such drug must accompany
22 the drug for each subsequent wholesale distribution of the
23 drug to a wholesale distributor. The department shall adopt
24 rules relating to the requirements of this written statement.
25 2. Each wholesale distributor of prescription drugs
26 must maintain separate and distinct from other required
27 records all statements that are required under subparagraph 1.
28 3. Each manufacturer of a prescription drug sold in
29 this state must maintain at its corporate offices a current
30 list of authorized distributors and must make such list
31 available to the department upon request.
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1
2 For the purposes of this subsection, the term "authorized
3 distributors of record" means those distributors with whom a
4 manufacturer has established an ongoing relationship to
5 distribute the manufacturer's products.
6 (7) WRITTEN POLICIES AND PROCEDURES.--Wholesale drug
7 distributors must establish, maintain, and adhere to written
8 policies and procedures, which must be followed for the
9 receipt, security, storage, inventory, and distribution of
10 prescription drugs, including policies and procedures for
11 identifying, recording, and reporting losses or thefts, and
12 for correcting all errors and inaccuracies in inventories.
13 Wholesale drug distributors must include in their written
14 policies and procedures:
15 (a) A procedure whereby the oldest approved stock of a
16 prescription drug product is distributed first. The procedure
17 may permit deviation from this requirement, if the deviation
18 is temporary and appropriate.
19 (b) A procedure to be followed for handling recalls
20 and withdrawals of prescription drugs. Such procedure must be
21 adequate to deal with recalls and withdrawals due to:
22 1. Any action initiated at the request of the Food and
23 Drug Administration or any other federal, state, or local law
24 enforcement or other government agency, including the
25 department.
26 2. Any voluntary action by the manufacturer to remove
27 defective or potentially defective drugs from the market; or
28 3. Any action undertaken to promote public health and
29 safety by replacing existing merchandise with an improved
30 product or new package design.
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1 (c) A procedure to ensure that wholesale drug
2 distributors prepare for, protect against, and handle any
3 crisis that affects security or operation of any facility if a
4 strike, fire, flood, or other natural disaster, or a local,
5 state, or national emergency, occurs.
6 (d) A procedure to ensure that any outdated
7 prescription drugs are segregated from other drugs and either
8 returned to the manufacturer or destroyed. This procedure
9 must provide for written documentation of the disposition of
10 outdated prescription drugs. This documentation must be
11 maintained for 2 years after disposition of the outdated
12 drugs.
13 (8) RESPONSIBLE PERSONS.--Wholesale drug distributors
14 must establish and maintain lists of officers, directors,
15 managers, and other persons in charge of wholesale drug
16 distribution, storage, and handling, including a description
17 of their duties and a summary of their qualifications.
18 (9) COMPLIANCE WITH FEDERAL, STATE, AND LOCAL LAW.--A
19 wholesale drug distributor must operate in compliance with
20 applicable federal, state, and local laws and regulations.
21 (a) A wholesale drug distributor must allow the
22 department and authorized federal, state, and local officials
23 to enter and inspect its premises and delivery vehicles, and
24 to audit its records and written operating procedures, at
25 reasonable times and in a reasonable manner, to the extent
26 authorized by law.
27 (b) A wholesale drug distributor that deals in
28 controlled substances must register with the Drug Enforcement
29 Administration and must comply with all applicable state,
30 local, and federal laws. A wholesale drug distributor that
31 distributes any substance controlled under chapter 893 must
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1 notify the department when registering with the Drug
2 Enforcement Administration pursuant to that chapter and must
3 provide the department with its DEA number.
4 (10) SALVAGING AND REPROCESSING.--A wholesale drug
5 distributor is subject to any applicable federal, state, or
6 local laws or regulations that relate to prescription drug
7 product salvaging or reprocessing.
8 Section 35. Paragraphs (a) and (d) of subsection (1)
9 of section 499.0122, Florida Statutes, are amended to read:
10 499.0122 Medical oxygen and veterinary legend drug
11 retail establishments; definitions, permits, general
12 requirements.--
13 (1) As used in this section, the term:
14 (a) "Medical oxygen retail establishment" means a
15 person licensed to sell medical oxygen to patients only. The
16 sale must be based on an order from a practitioner authorized
17 by law to prescribe. The term does not include a pharmacy
18 licensed under chapter 465.
19 1. A medical oxygen retail establishment may not
20 possess, purchase, sell, or trade any legend drug other than
21 medical oxygen.
22 2. A medical oxygen retail establishment may refill
23 medical oxygen for an individual patient based on an order
24 from a practitioner authorized by law to prescribe. A medical
25 oxygen retail establishment that refills medical oxygen must
26 comply with all appropriate state and federal good
27 manufacturing practices.
28 (d) "Veterinary legend drug retail establishment"
29 means a person permitted to sell veterinary legend drugs to
30 the public or to veterinarians, but does not include a
31 pharmacy licensed under chapter 465.
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1 1. The sale to the public must be based on a valid
2 written order from a veterinarian licensed in this state who
3 has a valid client-veterinarian relationship with the
4 purchaser's animal.
5 2. Veterinary legend drugs may not be sold in excess
6 of the amount clearly indicated on the order or beyond the
7 date indicated on the order.
8 3. An order may not be valid for more than 1 year.
9 4. A veterinary legend drug retail establishment may
10 not purchase, sell, trade, or possess human prescription drugs
11 or any controlled substance as defined in chapter 893.
12 5. A veterinary legend drug retail establishment must
13 sell a veterinary legend drug drugs in the original, sealed
14 manufacturer's container containers with all labeling intact
15 and legible. The department may adopt by rule additional
16 labeling requirements for the sale of a veterinary legend
17 drug.
18 Section 36. Paragraph (e) of subsection (2) of section
19 499.013, Florida Statutes, is amended to read:
20 499.013 Manufacturers of drugs, devices, and
21 cosmetics; definitions, permits, and general requirements.--
22 (2) Any person that engages in the manufacture of
23 drugs, devices, or cosmetics in this state must first obtain
24 one of the following permits and may engage only in the
25 activity allowed under that permit:
26 (e) A cosmetic manufacturer's permit is required for
27 any person that manufactures cosmetics in this state.
28 1. A person that only labels or changes the labeling
29 of a cosmetic but does not open the container sealed by the
30 manufacturer of the product is exempt from obtaining a permit
31 under this paragraph.
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1 (3)2. The department may adopt such rules as are
2 necessary for the protection of the public health, safety, and
3 welfare regarding good manufacturing practices that cosmetic
4 manufacturers must follow to ensure the safety of the
5 products.
6 Section 37. Section 499.014, Florida Statutes, is
7 amended to read:
8 499.014 Distribution of legend drugs by hospitals,
9 health care entities, and charitable organizations and return
10 or destruction companies; permits, general requirements.--
11 (1) A restricted prescription drug distributor permit
12 is required for any person that engages in the distribution of
13 a legend drug, which distribution is made in accordance with
14 and is not considered "wholesale distribution" under
15 subparagraph (1)(a)1., subparagraph (1)(a)2., or subparagraph
16 (1)(a)3. of s. 499.012.
17 (2) A person who engages in the receipt or
18 distribution of a legend drug in this state for the purpose of
19 processing its return or its destruction must obtain a permit
20 as a restricted prescription drug distributor if such person
21 is not the person initiating the return, the prescription drug
22 wholesale supplier of the person initiating the return, or the
23 manufacturer of the drug.
24 (3)(2) Storage and handling, and recordkeeping of
25 these distributions must comply with the requirements for
26 wholesale distributors under s. 499.0121.
27 (4) A person who applies for a permit as a restricted
28 prescription drug distributor, or for the renewal of such a
29 permit, must provide to the department the information
30 required under s. 499.01.
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1 (5)(3) The department may issue permits to restricted
2 prescription drug distributors and may adopt rules regarding
3 the distribution of prescription drugs by hospitals, health
4 care entities, charitable organizations, or other persons not
5 involved in wholesale distribution, which rules are necessary
6 for the protection of the public health, safety, and welfare.
7 Section 38. Subsection (7) is added to section
8 499.015, Florida Statutes, to read:
9 499.015 Registration of drugs, devices, and cosmetics;
10 issuance of certificates of free sale.--
11 (7) A product registration is valid only for the
12 company named on the registration and located at the address
13 on the registration. A person whose product is registered by
14 the department under this section must notify the department
15 before any change in the name or address of the establishment
16 to which the product is registered. If a person whose product
17 is registered ceases conducting business, the person must
18 notify the department before closing the business.
19 Section 39. Subsection (4) is added to section 499.03,
20 Florida Statutes, to read:
21 499.03 Possession of new drugs or legend drugs without
22 prescriptions unlawful; exemptions and exceptions.--
23 (4) The department may by rule authorize persons
24 engaged in lawful research or testing to possess prescription
25 drugs and may issue letters of exemption to facilitate the
26 lawful possession of prescription drugs under this section.
27 Section 40. Subsection (3) is added to section 499.05,
28 Florida Statutes, to read:
29 499.05 Rules.--
30 (3) The department shall adopt rules regulating the
31 storage and handling of medical devices and over-the-counter
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1 drugs and the maintenance of distribution records to protect
2 the public health, safety, and welfare from adulterated
3 products.
4 Section 41. Subsection (5) is added to section 499.65,
5 Florida Statutes, to read:
6 499.65 Possession of ether without license or permit
7 prohibited; confiscation and disposal; exceptions.--
8 (5) The department may by rule authorize persons
9 engaged in lawful research or testing to possess ether and may
10 issue letters of exemption to facilitate the lawful possession
11 of ether under this section.
12 Section 42. Subsection (2) of section 499.66, Florida
13 Statutes, is amended to read:
14 499.66 Maintenance of records and sales of ether by
15 manufacturers, distributors, and dealers; inspections.--
16 (2) Each sale or transfer of 2.5 gallons, or
17 equivalent by weight, or more of ether shall be evidenced by
18 an invoice, receipt, sales ticket, or sales slip which shall
19 bear the name, address, and license or permit number of the
20 manufacturer, distributor, or dealer and the purchaser or
21 transferee, the date of sale or transfer, and the quantity
22 sold or transferred. All original invoices, receipts, sales
23 tickets, and sales slips shall be retained by the
24 manufacturer, distributor, or dealer, and a copy thereof
25 provided to the purchaser or transferee.
26 Section 43. Subsection (1) of section 499.67, Florida
27 Statutes, is amended to read:
28 499.67 Maintenance of records by purchasers;
29 inspections.--
30 (1) It is unlawful for any person permittee to
31 purchase, receive, store, or use ether without maintaining an
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1 accurate and current written inventory of all ether purchased,
2 received, stored, and used.
3 Section 44. Paragraph (e) of subsection (1) and
4 subsection (2) of section 501.122, Florida Statutes, are
5 amended to read:
6 501.122 Control of nonionizing radiations; laser;
7 penalties.--
8 (1) DEFINITIONS.--For the purposes of this section:
9 (e) "Department" means the Department of Health and
10 Rehabilitative Services.
11 (2) AUTHORITY TO ISSUE REGULATIONS.--Except for
12 electrical transmission and distribution lines and substation
13 facilities subject to regulation by the Department of
14 Environmental Protection pursuant to chapter 403, the
15 Department of Health and Rehabilitative Services shall adopt
16 promulgate such rules and regulations as it may determine to
17 be necessary to protect the health and safety of persons
18 exposed to laser devices and other nonionizing radiation,
19 including the user or any others who might come in contact
20 with such radiation. The Department of Health may and
21 Rehabilitative Services is further authorized:
22 (a) To develop a program for registration of laser
23 devices and uses and of identifying and controlling sources
24 and uses of other nonionizing radiations.
25 (b) To maintain liaison with, and receive information
26 from, industry, industry associations, and other organizations
27 or individuals relating to present or future
28 radiation-producing products or devices.
29 (c) To study and evaluate the degree of hazard
30 associated with the use of laser devices or other sources of
31 radiation.
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1 (d) To establish and prescribe performance standards
2 for lasers laser and other radiation control, including
3 requirements for the qualifications, duties, and training of
4 users; the posting of warning signs and labels for facilities
5 and devices; recordkeeping; and reports to the department, if
6 it determines that such standards are necessary for the
7 protection of the public health.
8 (e) To amend or revoke any performance standard
9 established under the provisions of this section.
10 Section 45. Paragraph (b) of subsection (1) of section
11 513.045, Florida Statutes, is amended to read:
12 513.045 Permit fees.--
13 (1)
14 (b) Fees established pursuant to this subsection must
15 be based on the actual costs incurred by the department in
16 carrying out its responsibilities under this chapter. The fee
17 for a permit may not be set at a rate that is more than $6.50
18 per space or less than $3.50 per space. Until rules setting
19 these fees are adopted by the department, the permit fee per
20 space is $3.50. The permit fee for a nonexempt recreational
21 camp shall be based on an equivalency rate for which two camp
22 occupants equal one space. However, in no case may The total
23 fee assessed to an applicant may not be more than $600 or less
24 than $50, except that a fee may be prorated on a quarterly
25 basis.
26 Section 46. Section 513.05, Florida Statutes, is
27 amended to read:
28 513.05 Rules.--The department may adopt such rules
29 pertaining to the location, construction, modification,
30 equipment, and operation of mobile home parks, lodging parks,
31 recreational vehicle parks, and recreational camps except as
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1 provided in s. 633.022, as may be necessary to implement this
2 chapter. Such rules may include requirements for plan reviews
3 of proposed and existing parks and camps; plan reviews of
4 parks that consolidate space or change space size; water
5 supply; sewage collection and disposal; plumbing and backflow
6 prevention; garbage and refuse storage, collection, and
7 disposal; insect and rodent control; space requirements;
8 heating facilities; food service; lighting; sanitary
9 facilities; bedding; an occupancy equivalency to spaces for
10 permits for recreational camps; sanitary facilities in
11 recreational vehicle parks; and the owners' responsibilities
12 at recreational vehicle parks and recreational camps.
13 Section 47. Subsection (5) is added to section
14 514.011, Florida Statutes, to read:
15 514.011 Definitions.--As used in this chapter:
16 (5) "Portable pool" means a pool or spa, and related
17 equipment systems of any kind, which is designed or intended
18 to be movable from location to location.
19 Section 48. Section 514.0115, Florida Statutes, is
20 amended to read:
21 514.0115 Exemptions from supervision or regulation;
22 variances.--
23 (1) Private pools and water therapy facilities
24 connected with facilities connected with hospitals, medical
25 doctors' offices, and licensed physical therapy establishments
26 shall be exempt from supervision under this chapter.
27 (2)(a) Pools serving no more than 32 condominium or
28 cooperative units which are not operated as a public lodging
29 establishment shall be exempt from supervision under this
30 chapter, except for water quality.
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1 (b) Pools serving condominium or cooperative
2 associations of more than 32 units and whose recorded
3 documents prohibit the rental or sublease of the units for
4 periods of less than 60 days are exempt from supervision under
5 this chapter, except that the condominium or cooperative owner
6 or association must file applications with the department and
7 obtain construction plans approval and receive an initial
8 operating permit. The department shall inspect the swimming
9 pools at such places annually, at the fee set forth in s.
10 514.033(3), or upon request by a unit owner, to determine
11 compliance with department rules relating to water quality and
12 lifesaving equipment. The department may not require
13 compliance with rules relating to swimming pool lifeguard
14 standards.
15 (3) A private pool used for instructional purposes in
16 swimming shall not be regulated as a public pool.
17 (4) The department may grant variances from any rule
18 adopted under this chapter pursuant to procedures adopted by
19 department rule.
20 Section 49. Subsection (4) is added to section 514.03,
21 Florida Statutes, to read:
22 514.03 Construction plans approval necessary to
23 construct, develop, or modify public swimming pools or bathing
24 places.--It is unlawful for any person or public body to
25 construct, develop, or modify any public swimming pool or
26 bathing place without a valid construction plans approval from
27 the department.
28 (4) An approval of construction plans issued by the
29 department under this section becomes void 1 year after the
30 date the approval was issued if the construction is not
31 commenced within 1 year after the date of issuance.
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1 Section 50. Subsections (5) and (6) of section
2 514.031, Florida Statutes, are amended to read:
3 514.031 Permit necessary to operate public swimming
4 pool or bathing place.--It is unlawful for any person or
5 public body to operate or continue to operate any public
6 swimming pool or bathing place without a valid permit from the
7 department, such permit to be obtained in the following
8 manner:
9 (5) Each such operating permit shall be renewed
10 annually and the permit must be posted in a conspicuous place.
11 (6) An owner or operator of a public swimming pool,
12 including, but not limited to, a spa, wading, or special
13 purpose pool, to which admittance is obtained by membership
14 for a fee shall post in a prominent location within the
15 facility the most recent pool inspection report issued by the
16 department pertaining to the health and safety conditions of
17 such facility. The report shall be legible and readily
18 accessible to members or potential members. The department
19 shall adopt promulgate rules to enforce this subsection
20 provision. A portable pool may not be used as a public pool.
21 Section 51. Subsections (4) and (5) of section
22 514.033, Florida Statutes, are amended to read:
23 514.033 Creation of fee schedules authorized.--
24 (4) Fees collected by the department in accordance
25 with the provisions of this chapter shall be deposited into
26 the Public Swimming Pool and Bathing Place Trust Fund for the
27 payment of costs incurred in the administration of this
28 chapter. Fees collected by county health departments
29 performing functions pursuant to s. 514.025 shall be deposited
30 into the County Health Department Trust Fund. Any fee
31 collected under this chapter is nonrefundable.
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1 (5) The department may not charge No other fees shall
2 be charged for services provided under the provisions of this
3 chapter. However, the department shall prorate the initial
4 annual fee for an operating permit on a half-year basis.
5 Section 52. Subsection (5) is added to section 514.05,
6 Florida Statutes, to read:
7 514.05 Denial, suspension, or revocation of permit;
8 administrative fines.--
9 (5) Under conditions specified by rule, the department
10 may close a public pool that is not in compliance with this
11 chapter or the rules adopted under this chapter.
12 Section 53. This act shall take effect July 1, 1998.
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1 *****************************************
2 SENATE SUMMARY
3 Provides additional rulemaking authority to the
Department of Health. Authorizes the department to adopt
4 rules governing programs for immunizing children,
imposing quarantines, and controlling communicable
5 diseases. Provides additional requirements for the
department in regulating sanitary facilities, suppliers
6 of water, and sewage systems. Requires that the
department adopt rules governing sanitation standards.
7 Revises requirements for operating migrant labor camps.
Provides for a funeral home that performs embalming
8 procedures to be subject to regulation as a biomedical
waste generator. Provides additional rulemaking authority
9 to the department with respect to the management of
biomedical waste. Provides requirements for operators of
10 tanning facilities. Specifies duties of the department
with respect to administering the federal Child and Adult
11 Care Food Program and certain other federal programs.
Authorizes the department to adopt rules governing the
12 provision of life-support services. Requires that the
department approve and license emergency medical
13 technician and paramedic education programs. Authorizes
the department to adopt rules governing the certification
14 of environmental laboratories and public water supply
laboratories. Provides criteria for certifying persons
15 and businesses that conduct radon gas or radon progeny
measurements. Requires that the department inspect
16 radiation machines and components. Revises registration
requirements for septic tank contractors. Revises
17 requirements for the department in issuing permits for
the distribution of drugs. Authorizes the department to
18 adopt rules governing the sale of veterinary legend drugs
and regulating manufacturers of drugs or devices.
19 Requires persons who process returned drugs to obtain a
permit from the department. Specifies unlawful acts with
20 respect to the purchase, storage, or use of ether.
Authorizes the department to establish additional
21 standards for the use of lasers. Provides additional
rulemaking authority for the department with respect to
22 regulating mobile home parks and recreational camps.
Authorizes the department to grant variances with respect
23 to regulations governing the operation of swimming pools.
Prohibits using a portable pool as a public pool.
24 Authorizes the department to adopt rules specifying
conditions for closing a pool. (See bill for details.)
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