Senate Bill 1716er

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  1

  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; amending

28         ss. 403.0625, 403.863, F.S.; authorizing the

29         department to adopt rules governing the

30         certification of environmental laboratories and

31         public water supply laboratories; specifying


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  1         acts for which the department may impose

  2         disciplinary sanctions; amending s. 404.056,

  3         F.S.; authorizing the department to establish

  4         criteria for certifying persons and businesses

  5         that conduct radon gas or radon progeny

  6         measurements; providing additional requirements

  7         for reporting the results of such measurements;

  8         amending s. 404.22, F.S.; providing

  9         requirements for the department in inspecting

10         radiation machines and components; requiring

11         persons who install such machines to register

12         with the department; amending s. 468.306, F.S.;

13         providing requirements for examinations;

14         amending s. 489.553, F.S.; providing for

15         out-of-state work experience and examinations

16         to fulfill certain requirements for

17         registration as a septic tank contractor;

18         amending s. 489.555, F.S.; providing additional

19         requirements for the certification of

20         partnerships and corporations that offer septic

21         tank contracting services; amending s. 499.005,

22         F.S.; prohibiting misrepresentation or fraud in

23         obtaining or distributing a prescription drug

24         or device; amending s. 499.01, F.S.;

25         authorizing the department to issue a permit

26         for the distribution of drugs to a health care

27         entity; providing for changing the type of

28         permit issued; amending s. 499.012, F.S.;

29         redefining the term "wholesale distribution"

30         for purposes of the regulation of the sale of

31         prescription drugs; authorizing the department


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  1         to adopt rules for issuing permits and handling

  2         prescription drugs; amending s. 499.0121, F.S.;

  3         providing for the exemption of certain

  4         establishments from requirements governing the

  5         storage and handling of prescription drugs;

  6         amending s. 499.0122, F.S.; authorizing the

  7         department to adopt rules governing the sale of

  8         veterinary legend drugs; amending s. 499.013,

  9         F.S.; authorizing the department to adopt rules

10         governing manufacturers of drugs or devices;

11         amending s. 499.014, F.S.; requiring persons

12         who process returned drugs to obtain a permit

13         from the department; amending s. 499.015, F.S.;

14         providing requirements for registering product

15         names with the department; amending ss. 499.03,

16         499.65, F.S.; authorizing the department to

17         adopt rules to allow researchers to possess

18         prescription drugs or ether; amending s.

19         499.05, F.S.; requiring the department to adopt

20         rules governing recordkeeping and the storage,

21         handling, and distribution of medical devices

22         and over-the-counter drugs; amending s. 499.66,

23         F.S.; revising the recordkeeping requirements

24         for sales of ether; amending s. 499.67, F.S.;

25         specifying unlawful acts with respect to the

26         purchase, storage, or use of ether; amending s.

27         501.122, F.S.; authorizing the department to

28         establish additional standards for the use of

29         lasers; amending s. 513.045, F.S.; revising the

30         permit fees charged to operators of mobile home

31         parks and recreational camps; amending s.


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  1         513.05, F.S.; providing additional rulemaking

  2         authority for the department with respect to

  3         such parks and camps; amending s. 514.011,

  4         F.S.; defining the term "portable pool";

  5         amending s. 514.0115, F.S.; authorizing the

  6         department to grant variances with respect to

  7         regulations governing the operation of swimming

  8         pools; amending s. 514.03, F.S.; revising

  9         requirements for construction plans for a

10         public swimming pool or bathing place; amending

11         s. 514.031, F.S.; requiring the posting of an

12         operating permit for a pool; prohibiting the

13         use of a portable pool as a public pool;

14         amending s. 514.033, F.S.; providing for the

15         department to prorate certain fees for an

16         operating permit; amending s. 514.05, F.S.;

17         authorizing the department to adopt rules

18         specifying conditions for closing a pool;

19         providing an effective date.

20

21  Be It Enacted by the Legislature of the State of Florida:

22

23         Section 1.  Subsection (1) of section 232.032, Florida

24  Statutes, is amended to read:

25         232.032  Immunization against communicable diseases;

26  school attendance requirements; exemptions.--

27         (1)  The Department of Health may adopt rules necessary

28  to administer and enforce this section. The Department of

29  Health, after consultation with the Department of Education,

30  shall adopt promulgate rules governing the immunization of

31  children against, the testing for, and the control of


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  1  preventable communicable diseases. The rules must include

  2  procedures for exempting a child from immunization

  3  requirements. Immunizations shall be required for

  4  poliomyelitis, diphtheria, rubeola, rubella, pertussis, mumps,

  5  tetanus, and other communicable diseases as determined by

  6  rules of the Department of Health.  The manner and frequency

  7  of administration of the immunization or testing shall conform

  8  to recognized standards of medical practice.  The Department

  9  of Health shall supervise and secure the enforcement of the

10  required immunization. Immunizations required by this section

11  act shall be available at no cost from the county health

12  departments.

13         Section 2.  Subsection (6) of section 381.0011, Florida

14  Statutes, is amended to read:

15         381.0011  Duties and powers of the Department of

16  Health.--It is the duty of the Department of Health to:

17         (6)  Declare, enforce, modify, and abolish quarantine

18  of persons, animals, and premises as the circumstances

19  indicate for controlling communicable diseases or providing

20  protection from unsafe conditions that pose a threat to public

21  health, except as provided in s. 384.28 and ss.

22  392.545-392.60.

23         (a)  The department shall adopt rules to specify the

24  conditions and procedures for imposing and releasing a

25  quarantine. The rules must include provisions related to:

26         1.  The closure of premises.

27         2.  The movement of persons or animals exposed to or

28  infected with a communicable disease.

29         3.  The tests or prophylactic treatment for

30  communicable disease required prior to employment or admission

31  to the premises.


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  1         4.  Testing or destruction of animals with or suspected

  2  of having a disease transmissible to humans.

  3         5.  Access by the department to quarantined premises.

  4         6.  The disinfection of quarantined animals, persons,

  5  or premises.

  6         (b)  Any health regulation that restricts travel or

  7  trade within the state may not be adopted or enforced in this

  8  state except by authority of the department.

  9         Section 3.  Section 381.003, Florida Statutes, is

10  amended to read:

11         381.003  Communicable disease and acquired immune

12  deficiency syndrome prevention and control.--

13         (1)  The department shall conduct a communicable

14  disease prevention and control program as part of fulfilling

15  its public health mission. A communicable disease is any

16  disease caused by transmission of a specific infectious agent,

17  or its toxic products, from an infected person, an infected

18  animal, or the environment to a susceptible host, either

19  directly or indirectly. The communicable disease This program

20  must shall include, but need is not be limited to:

21         (a)  Programs for the prevention and control of

22  tuberculosis in accordance with chapter 392.

23         (b)  Programs for the prevention and control of human

24  immunodeficiency virus infection and acquired immune

25  deficiency syndrome in accordance with chapter 384 and this

26  chapter.

27         (c)  Programs for the prevention and control of

28  sexually transmissible diseases in accordance with chapter

29  384.

30

31


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  1         (d)  Programs for the prevention, control, and

  2  reporting of diseases of public health significance as

  3  provided for in this chapter.

  4         (e)  Programs for the prevention and control of

  5  vaccine-preventable diseases, including programs to immunize

  6  school children as required by s. 232.032.

  7         (2)  The department may adopt, repeal, and amend rules

  8  related to the prevention and control of communicable

  9  diseases, including procedures for investigating disease,

10  timeframes for reporting disease, requirements for followup

11  reports of known or suspected exposure to disease, and

12  procedures for providing access to confidential information

13  necessary for disease investigations the programs discussed in

14  this section.

15         Section 4.  Section 381.0031, Florida Statutes, is

16  amended to read:

17         381.0031  Report of diseases of public health

18  significance to department.--

19         (1)  Any practitioner, licensed in this state Florida

20  to practice medicine, osteopathic medicine, chiropractic,

21  naturopathy, or veterinary medicine; any hospital licensed

22  under part I of chapter 395; or any laboratory licensed under

23  chapter 483 that, who diagnoses or suspects the existence of a

24  disease of public health significance shall immediately report

25  the fact to the Department of Health.

26         (2)  Periodically the department shall issue a list of

27  infectious or noninfectious diseases determined by it to be a

28  threat to public health and therefore of public health

29  significance to public health within the meaning of this

30  chapter and shall furnish a copy of the list to the

31  practitioners listed in subsection (1).


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  1         (3)  Reports required by this section must be in

  2  accordance with methods made on forms furnished, or by

  3  electronic means specified, by rule of the department.

  4         (4)  Information submitted in reports required by this

  5  section is confidential, exempt from the provisions of s.

  6  119.07(1), and is to be made public only when necessary to

  7  public health. A report so submitted is not a violation of the

  8  confidential relationship between practitioner and patient.

  9         (5)  The department may adopt rules related to

10  reporting diseases of significance to public health, which

11  must specify the information to be included in the report, who

12  is required to report, the method and time period for

13  reporting, requirements for enforcement, and required followup

14  activities by the department which are necessary to protect

15  public health.

16

17  This section does not affect s. 384.25.

18         Section 5.  Subsection (15) is added to section

19  381.006, Florida Statutes, to read:

20         381.006  Environmental health.--The department shall

21  conduct an environmental health program as part of fulfilling

22  the state's public health mission. The purpose of this program

23  is to detect and prevent disease caused by natural and manmade

24  factors in the environment.  The environmental health program

25  shall include, but not be limited to:

26         (15)  A sanitary facilities function, which shall

27  include minimum standards for the maintenance and sanitation

28  of sanitary facilities; public access to sanitary facilities;

29  the number, operation, design, and maintenance of plumbing

30  fixtures in places serving the public and places of

31


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  1  employment; and fixture ratios for special or temporary events

  2  and for homeless shelters.

  3

  4  The department may adopt rules to carry out the provisions of

  5  this section.

  6         Section 6.  Paragraphs (j) and (k) are added to

  7  subsection (3) of section 381.0062, Florida Statutes, to read:

  8         381.0062  Supervision; private and certain public water

  9  systems.--

10         (3)  SUPERVISION.--The department and its agents shall

11  have general supervision and control over all private water

12  systems, and public water systems not covered or included in

13  the Florida Safe Drinking Water Act (part VI of chapter 403),

14  and over those aspects of the public water supply program for

15  which it has the duties and responsibilities provided for in

16  part VI of chapter 403.  The department shall:

17         (j)  Require suppliers of water to give public notice

18  of water problems and corrective measures under the conditions

19  specified by rule of the department.

20         (k)  Require a fee to cover the cost of reinspection of

21  any system regulated under this section, which may not be less

22  than $25 or more than $40.

23         Section 7.  Paragraphs (b) and (m) of subsection (3)

24  and subsection (4) of section 381.0065, Florida Statutes, are

25  amended to read:

26         381.0065  Onsite sewage treatment and disposal systems;

27  regulation.--

28         (3)  DUTIES AND POWERS OF THE DEPARTMENT OF

29  HEALTH.--The department shall:

30         (b)  Perform application reviews and site evaluations,

31  issue permits, and conduct inspections and complaint


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  1  investigations associated with the construction, installation,

  2  maintenance, modification, abandonment, or repair of an onsite

  3  sewage treatment and disposal system for a residence or

  4  establishment with an estimated domestic sewage flow of 10,000

  5  gallons or less per day, or an estimated commercial sewage

  6  flow of 5,000 gallons or less per day, which is not currently

  7  regulated under chapter 403.

  8         (m)  Permit and inspect portable or temporary toilet

  9  services and holding tanks. The department shall review

10  applications, perform site evaluations, and issue permits for

11  the temporary use of holding tanks, privies, portable toilet

12  services, or any other toilet facility that is intended for

13  use on a permanent or nonpermanent basis, including facilities

14  placed on construction sites when workers are present. The

15  department may specify standards for the construction,

16  maintenance, use, and operation of any such facility for

17  temporary use.

18         (4)  PERMITS; INSTALLATION; AND CONDITIONS.--A person

19  may not construct, repair, modify, abandon, or operate an

20  onsite sewage treatment and disposal system without first

21  obtaining a permit approved by the department. The department

22  may issue permits to carry out this section.  A construction

23  permit is valid for 18 months from the issuance date and may

24  be extended by the department for one 90-day period under

25  rules adopted by the department.  A repair permit is valid for

26  90 days from the date of issuance. An operating permit must be

27  obtained prior to the use of any aerobic treatment unit or if

28  the establishment generates commercial waste. Buildings or

29  establishments that use an aerobic treatment unit or generate

30  commercial waste shall be inspected by the department at least

31  annually to assure compliance with the terms of the operating


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  1  permit. The An operating permit is valid for 1 year from the

  2  date of issuance and must be renewed annually.  If all

  3  information pertaining to the siting, location, and

  4  installation conditions or repair of an onsite sewage

  5  treatment and disposal system remains the same, a construction

  6  or repair permit for the onsite sewage treatment and disposal

  7  system may be transferred to another person, if the transferee

  8  files, within 60 days after the transfer of ownership, an

  9  amended application providing all corrected information and

10  proof of ownership of the property.  There is no fee

11  associated with the processing of this supplemental

12  information.  A person may not contract to construct, modify,

13  alter, repair, service, abandon, or maintain any portion of an

14  onsite sewage treatment and disposal system without being

15  registered under part III of chapter 489.  A property owner

16  who personally performs construction, maintenance, or repairs

17  to a system serving his or her own owner-occupied

18  single-family residence is exempt from registration

19  requirements for performing such construction, maintenance, or

20  repairs on that residence, but is subject to all permitting

21  requirements. A municipality or political subdivision of the

22  state may not issue a building or plumbing permit for any

23  building that requires the use of an onsite sewage treatment

24  and disposal system unless the owner or builder has received a

25  construction permit for such system from the department. A

26  building or structure may not be occupied and a municipality,

27  political subdivision, or any state or federal agency may not

28  authorize occupancy until the department approves the final

29  installation of the onsite sewage treatment and disposal

30  system. A municipality or political subdivision of the state

31  may not approve any change in occupancy or tenancy of a


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  1  building that uses an onsite sewage treatment and disposal

  2  system until the department has reviewed the use of the system

  3  with the proposed change, approved the change, and amended the

  4  operating permit.

  5         (a)  Subdivisions and lots in which each lot has a

  6  minimum area of at least one-half acre and either a minimum

  7  dimension of 100 feet or a mean of at least 100 feet of the

  8  side bordering the street and the distance formed by a line

  9  parallel to the side bordering the street drawn between the

10  two most distant points of the remainder of the lot may be

11  developed with a water system regulated under s. 381.0062 and

12  onsite sewage treatment and disposal systems, provided the

13  projected daily domestic sewage flow does not exceed an

14  average of 1,500 gallons per acre per day, and provided

15  satisfactory drinking water can be obtained and all distance

16  and setback, soil condition, water table elevation, and other

17  related requirements of this section and rules adopted under

18  this section can be met.

19         (b)  Subdivisions and lots using a public water system

20  as defined in s. 403.852 may use onsite sewage treatment and

21  disposal systems, provided there are no more than four lots

22  per acre, provided the projected daily domestic sewage flow

23  does not exceed an average of 2,500 gallons per acre per day,

24  and provided that all distance and setback, soil condition,

25  water table elevation, and other related requirements that are

26  generally applicable to the use of onsite sewage treatment and

27  disposal systems are met.

28         (c)  Notwithstanding the provisions of paragraphs (a)

29  and (b), for subdivisions platted of record on or before

30  October 1, 1991, when a developer or other appropriate entity

31  has previously made or makes provisions, including financial


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  1  assurances or other commitments, acceptable to the Department

  2  of Health, that a central water system will be installed by a

  3  regulated public utility based on a density formula, private

  4  potable wells may be used with onsite sewage treatment and

  5  disposal systems until the agreed upon densities are reached.

  6  The department may consider assurances filed with the

  7  Department of Business and Professional Regulation under

  8  chapter 498 in determining the adequacy of the financial

  9  assurance required by this paragraph.  In a subdivision

10  regulated by this paragraph, the average daily domestic sewage

11  flow may not exceed 2,500 gallons per acre per day.  This

12  section does not affect the validity of existing prior

13  agreements. After October 1, 1991, the exception provided

14  under this paragraph is not available to a developer or other

15  appropriate entity.

16         (d)  Paragraphs (a) and (b) do not apply to any

17  proposed residential subdivision with more than 50 lots or to

18  any proposed commercial subdivision with more than 5 lots

19  where a publicly owned or investor-owned sewerage system is

20  available.  It is the intent of this paragraph not to allow

21  development of additional proposed subdivisions in order to

22  evade the requirements of this paragraph.  The department

23  shall report to the Legislature by February 1 of each

24  odd-numbered year concerning the success in meeting this

25  intent.

26         (e)  Onsite sewage treatment and disposal systems must

27  not be placed closer than:

28         1.  Seventy-five feet from a private potable well.

29         2.  Two hundred feet from a public potable well serving

30  a residential or nonresidential establishment having a total

31  sewage flow of greater than 2,000 gallons per day.


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  1         3.  One hundred feet from a public potable well serving

  2  a residential or nonresidential establishment having a total

  3  sewage flow of less than or equal to 2,000 gallons per day.

  4         4.  Seventy-five feet from surface waters.

  5         5.  Fifty feet from any nonpotable well.

  6         6.  Ten feet from any storm sewer pipe, to the maximum

  7  extent possible, but in no instance shall the setback be less

  8  than 5 feet.

  9         7.  Fifteen feet from the design high-water line of

10  retention areas, detention areas, or swales designed to

11  contain standing or flowing water for less than 72 hours after

12  a rainfall or the design high-water level of normally dry

13  drainage ditches or normally dry individual-lot

14  stormwater-retention areas.

15         (f)  All provisions of this section and rules adopted

16  under this section relating to soil condition, water table

17  elevation, distance, and other setback requirements must be

18  equally applied to all lots, with the following exceptions:

19         1.  Any residential lot that was platted and recorded

20  on or after January 1, 1972, or that is part of a residential

21  subdivision that was approved by the appropriate permitting

22  agency on or after January 1, 1972, and that was eligible for

23  an onsite sewage treatment and disposal system construction

24  permit on the date of such platting and recording or approval

25  shall be eligible for an onsite sewage treatment and disposal

26  system construction permit, regardless of when the application

27  for a permit is made. If rules in effect at the time the

28  permit application is filed cannot be met, residential lots

29  platted and recorded or approved on or after January 1, 1972,

30  shall, to the maximum extent possible, comply with the rules

31  in effect at the time the permit application is filed.  At a


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  1  minimum, however, those residential lots platted and recorded

  2  or approved on or after January 1, 1972, but before January 1,

  3  1983, shall comply with those rules in effect on January 1,

  4  1983, and those residential lots platted and recorded or

  5  approved on or after January 1, 1983, shall comply with those

  6  rules in effect at the time of such platting and recording or

  7  approval.  In determining the maximum extent of compliance

  8  with current rules that is possible, the department shall

  9  allow structures and appurtenances thereto which were

10  authorized at the time such lots were platted and recorded or

11  approved.

12         2.  Lots platted before 1972 are subject to a 50-foot

13  minimum surface water setback and are not subject to lot size

14  requirements.  The projected daily flow for domestic onsite

15  sewage treatment and disposal systems for lots platted before

16  1972 may not exceed:

17         a.  Two thousand five hundred gallons per acre per day

18  for lots served by public water systems as defined in s.

19  403.852.

20         b.  One thousand five hundred gallons per acre per day

21  for lots served by water systems regulated under s. 381.0062.

22         (g)1.  The department may grant variances in hardship

23  cases which may be less restrictive than the provisions

24  specified in this section.  If a variance is granted and the

25  onsite sewage treatment and disposal system construction

26  permit has been issued, the variance may be transferred with

27  the system construction permit, if the transferee files,

28  within 60 days after the transfer of ownership, an amended

29  construction permit application providing all corrected

30  information and proof of ownership of the property and if the

31  same variance would have been required for the new owner of


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  1  the property as was originally granted to the original

  2  applicant for the variance.  There is no fee associated with

  3  the processing of this supplemental information.  A variance

  4  may not be granted under this section until the department is

  5  satisfied that:

  6         a.  The hardship was not caused intentionally by the

  7  action of the applicant;

  8         b.  No reasonable alternative exists for the treatment

  9  of the sewage; and

10         c.  The discharge from the onsite sewage treatment and

11  disposal system will not adversely affect the health of the

12  applicant or the public or significantly degrade the

13  groundwater or surface waters.

14

15  Where soil conditions, water table elevation, and setback

16  provisions are determined by the department to be

17  satisfactory, special consideration must be given to those

18  lots platted before 1972.

19         2.  The department shall appoint a variance review and

20  advisory committee, which shall meet monthly to recommend

21  agency action on variance requests.  The board consists of the

22  following:

23         a.  The Division Director for Environmental Health of

24  the department or his or her designee.

25         b.  A representative from the county health

26  departments.

27         c.  A representative from the home building industry.

28         d.  A representative from the septic tank industry.

29         e.  A representative from the Department of

30  Environmental Protection.

31


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  1  Members shall be appointed for a term of 3 years, with such

  2  appointments being staggered so that the terms of no more than

  3  two members expire in any one year.  Members shall serve

  4  without remuneration, but are entitled to reimbursement may be

  5  reimbursed for per diem and travel expenses as provided in s.

  6  112.061.

  7         (h)  A construction permit may not be issued for an

  8  onsite sewage treatment and disposal system in any area zoned

  9  or used for industrial or manufacturing purposes, or its

10  equivalent, where a publicly owned or investor-owned sewage

11  treatment system is available, or where a likelihood exists

12  that the system will receive toxic, hazardous, or industrial

13  waste.  An existing onsite sewage treatment and disposal

14  system may be repaired if a publicly owned or investor-owned

15  sewerage system is not available within 500 feet of the

16  building sewer stub-out and if system construction and

17  operation standards can be met.  This paragraph does not

18  require publicly owned or investor-owned sewerage treatment

19  systems to accept anything other than domestic wastewater.

20         1.  A building located in an area zoned or used for

21  industrial or manufacturing purposes, or its equivalent, when

22  such building is served by an onsite sewage treatment and

23  disposal system, must not be occupied until the owner or

24  tenant has obtained written approval from the department.  The

25  department shall not grant approval when the proposed use of

26  the system is to dispose of toxic, hazardous, or industrial

27  wastewater or toxic or hazardous chemicals.

28         2.  Each person who owns or operates a business or

29  facility in an area zoned or used for industrial or

30  manufacturing purposes, or its equivalent, or who owns or

31  operates a business that has the potential to generate toxic,


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  1  hazardous, or industrial wastewater or toxic or hazardous

  2  chemicals, and uses an onsite sewage treatment and disposal

  3  system that is installed on or after July 5, 1989, must obtain

  4  an annual system operating permit from the department.  A

  5  person who owns or operates a business that uses an onsite

  6  sewage treatment and disposal system that was installed and

  7  approved before July 5, 1989, need not obtain a system

  8  operating permit. However, upon change of ownership or

  9  tenancy, the new owner or operator must notify the department

10  of the change, and the new owner or operator must obtain an

11  annual system operating permit, regardless of the date that

12  the system was installed or approved.

13         3.  The department shall periodically review and

14  evaluate the continued use of onsite sewage treatment and

15  disposal systems in areas zoned or used for industrial or

16  manufacturing purposes, or its equivalent, and may require the

17  collection and analyses of samples from within and around such

18  systems.  If the department finds that toxic or hazardous

19  chemicals or toxic, hazardous, or industrial wastewater have

20  been or are being disposed of through an onsite sewage

21  treatment and disposal system, the department shall initiate

22  enforcement actions against the owner or tenant to ensure

23  adequate cleanup, treatment, and disposal.

24         (i)  An onsite sewage treatment and disposal system for

25  a single-family residence that is designed by a professional

26  engineer registered in the state and certified by such

27  engineer as complying with performance criteria adopted by the

28  department must be approved by the department subject to the

29  following:

30         1.  The performance criteria applicable to

31  engineer-designed systems must be limited to those necessary


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  1  to ensure that such systems do not adversely affect the public

  2  health or significantly degrade the groundwater or surface

  3  water.  Such performance criteria shall include consideration

  4  of the quality of system effluent, the proposed total sewage

  5  flow per acre, wastewater treatment capabilities of the

  6  natural or replaced soil, water quality classification of the

  7  potential surface-water-receiving body, and the structural and

  8  maintenance viability of the system for the treatment of

  9  domestic wastewater.  However, performance criteria shall

10  address only the performance of a system and not a system's

11  design.

12         2.  The technical review and advisory panel shall

13  assist the department in the development of performance

14  criteria applicable to engineer-designed systems.  Workshops

15  on the development of the rules delineating such criteria

16  shall commence not later than September 1, 1996, and the

17  department shall advertise such rules for public hearing no

18  later than October 1, 1997.

19         3.  A person electing to utilize an engineer-designed

20  system shall, upon completion of the system design, submit

21  such design, certified by a registered professional engineer,

22  to the county health department.  The county health department

23  may utilize an outside consultant to review the

24  engineer-designed system, with the actual cost of such review

25  to be borne by the applicant.  Within 5 working days after

26  receiving an engineer-designed system permit application, the

27  county health department shall request additional information

28  if the application is not complete.  Within 15 working days

29  after receiving a complete application for an

30  engineer-designed system, the county health department either

31  shall issue the permit or, if it determines that the system


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  1  does not comply with the performance criteria, shall notify

  2  the applicant of that determination and refer the application

  3  to the department for a determination as to whether the system

  4  should be approved, disapproved, or approved with

  5  modification. The department engineer's determination shall

  6  prevail over the action of the county health department.  The

  7  applicant shall be notified in writing of the department's

  8  determination and of the applicant's rights to pursue a

  9  variance or seek review under the provisions of chapter 120.

10         4.  The owner of an engineer-designed performance-based

11  system must obtain an annual system operating permit from the

12  department.  The department shall inspect the system at least

13  annually and may collect system-effluent samples if

14  appropriate to determine compliance with the performance

15  criteria. The fee for the annual operating permit shall be

16  collected beginning with the second year of system operation.

17         5.  If an engineer-designed system fails to properly

18  function or fails to meet performance standards, the system

19  shall be re-engineered, if necessary, to bring the system into

20  compliance with the provisions of this section.

21         (j)  An innovative system may be approved in

22  conjunction with an engineer-designed site-specific system

23  which is certified by the engineer to meet the

24  performance-based criteria adopted by the department.

25         (k)  For the Florida Keys, the department shall adopt a

26  special rule for the construction, installation, modification,

27  operation, repair, maintenance, and performance of onsite

28  sewage treatment and disposal systems which considers the

29  unique soil conditions and which considers water table

30  elevations, densities, and setback requirements.  On lots

31  where a setback distance of 75 feet from surface waters,


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  1  saltmarsh, and buttonwood association habitat areas cannot be

  2  met, an injection well, approved and permitted by the

  3  department, may be used for disposal of effluent from onsite

  4  sewage treatment and disposal systems.  The department shall

  5  require effluent from onsite sewage treatment and disposal

  6  systems to meet advanced waste treatment concentrations, as

  7  defined in s. 403.086.

  8         (l)  No product sold in the state for use in onsite

  9  sewage treatment and disposal systems may contain any

10  substance in concentrations or amounts that would interfere

11  with or prevent the successful operation of such system, or

12  that would cause discharges from such systems to violate

13  applicable water quality standards. The department shall

14  publish criteria for products known or expected to meet the

15  conditions of this paragraph. In the event a product does not

16  meet such criteria, such product may be sold if the

17  manufacturer satisfactorily demonstrates to the department

18  that the conditions of this paragraph are met.

19         (m)  Evaluations for determining the seasonal

20  high-water table elevations or the suitability of soils for

21  the use of a new onsite sewage treatment and disposal system

22  shall be performed by department personnel, professional

23  engineers registered in the state, or such other persons with

24  expertise, as defined by rule, in making such evaluations.

25  The department shall accept evaluations submitted by

26  professional engineers and such other persons as meet the

27  expertise established by rule unless the department has a

28  reasonable scientific basis for questioning the accuracy or

29  completeness of the evaluation.

30         (n)  The department shall appoint a research review and

31  advisory committee, which shall meet at least semiannually.


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  1  The committee shall advise the department on directions for

  2  new research, review and rank proposals for research

  3  contracts, and review draft research reports and make

  4  comments.  The committee is comprised of:

  5         1.  A representative of the Division of Environmental

  6  Health of the Department of Health.

  7         2.  A representative from the septic tank industry.

  8         3.  A representative from the home building industry.

  9         4.  A representative from an environmental interest

10  group.

11         5.  A representative from the State University System,

12  from a department knowledgeable about onsite sewage treatment

13  and disposal systems.

14         6.  A professional engineer registered in this state

15  who has work experience in onsite sewage treatment and

16  disposal systems.

17         7.  A representative from the real estate profession.

18         8.  A representative from the restaurant industry.

19         9.  A consumer.

20

21  Members shall be appointed for a term of 3 years, with the

22  appointments being staggered so that the terms of no more than

23  four members expire in any one year.  Members shall serve

24  without remuneration, but are entitled to reimbursement may be

25  reimbursed for per diem and travel expenses as provided in s.

26  112.061.

27         (o)  An application for an onsite sewage treatment and

28  disposal system permit shall be completed in full, signed by

29  the owner or the owner's authorized representative, or by a

30  contractor licensed under chapter 489, and shall be

31  accompanied by all required exhibits and fees.  No specific


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  1  documentation of property ownership shall be required as a

  2  prerequisite to the review of an application or the issuance

  3  of a permit.  The issuance of a permit does not constitute

  4  determination by the department of property ownership.

  5         (p)  The department may not require any form of

  6  subdivision analysis of property by an owner, developer, or

  7  subdivider prior to submission of an application for an onsite

  8  sewage treatment and disposal system.

  9         (q)  Nothing in this section limits the power of a

10  municipality or county to enforce other laws for the

11  protection of the public health and safety.

12         Section 8.  Paragraph (b) of subsection (1) and

13  paragraph (a) of subsection (2) of section 381.0072, Florida

14  Statutes, are amended to read:

15         381.0072  Food service protection.--It shall be the

16  duty of the Department of Health to adopt and enforce

17  sanitation rules consistent with law to ensure the protection

18  of the public from food-borne illness. These rules shall

19  provide the standards and requirements for the storage,

20  preparation, serving, or display of food in food service

21  establishments as defined in this section and which are not

22  permitted or licensed under chapter 500 or chapter 509.

23         (1)  DEFINITIONS.--As used in this section, the term:

24         (b)  "Food service establishment" means any facility,

25  as described in this paragraph, where food is prepared and

26  intended for individual portion service, and includes the site

27  at which individual portions are provided.  The term includes

28  any such facility regardless of whether consumption is on or

29  off the premises and regardless of whether there is a charge

30  for the food. The term includes detention facilities, child

31  care facilities, schools, institutions, civic or fraternal


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  1  organizations, and bars and lounges and facilities used at

  2  temporary food events, mobile food units, and vending machines

  3  at any facility regulated under this section.  The term does

  4  not include private homes where food is prepared or served for

  5  individual family consumption; nor does the term include

  6  churches, synagogues, or other not-for-profit religious

  7  organizations as long as these organizations serve only their

  8  members and guests and do not advertise food or drink for

  9  public consumption, or any facility or establishment permitted

10  or licensed under chapter 500 or chapter 509; nor does the

11  term include any theater, if the primary use is as a theater

12  and if patron service is limited to food items customarily

13  served to the admittees of theaters; nor does the term include

14  a research and development test kitchen limited to the use of

15  employees and which is not open to the general public.

16         (2)  DUTIES.--

17         (a)  The department shall adopt rules consistent with

18  law prescribing minimum sanitation standards and manager

19  certification requirements as prescribed in s. 509.039, which

20  shall be enforced in food service establishments as defined in

21  this section. The sanitation standards must address the

22  construction, operation, and maintenance of the establishment;

23  plan review; design, construction, installation, maintenance,

24  sanitation, and storage of food equipment; employee training,

25  health, hygiene, and work practices; food supplies,

26  preparation, storage, transportation, and service; and

27  sanitary facilities and controls, including water supply and

28  sewage disposal; plumbing and toilet facilities; garbage and

29  refuse collection, storage, and disposal; and vermin control.

30  Public and private schools, hospitals licensed under chapter

31  395, nursing homes licensed under part II of chapter 400,


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  1  child care facilities as defined in s. 402.301, and

  2  residential facilities colocated with a nursing home or

  3  hospital if all food is prepared in a central kitchen that

  4  complies with nursing or hospital regulations shall be exempt

  5  from the rules developed for manager certification. The

  6  department shall administer a comprehensive inspection,

  7  monitoring, and sampling program to ensure such standards are

  8  maintained. With respect to food service establishments

  9  permitted or licensed under chapter 500 or chapter 509, the

10  department shall assist the Division of Hotels and Restaurants

11  of the Department of Business and Professional Regulation and

12  the Department of Agriculture and Consumer Services with

13  rulemaking by providing technical information.

14         Section 9.  Subsections (5) and (8) of section 381.008,

15  Florida Statutes, are amended to read:

16         381.008  Definitions of terms used in ss.

17  381.008-381.00897.--As used in ss. 381.008-381.00897, the

18  following words and phrases mean:

19         (5)  "Migrant labor camp"--One or more buildings,

20  structures, barracks, or dormitories, and the land

21  appertaining thereto, constructed, established, operated, or

22  furnished as an incident of employment as living quarters for

23  seasonal or migrant farmworkers whether or not rent is paid or

24  reserved in connection with the use or occupancy of such

25  premises. The term does not include a single family residence

26  that is occupied by a single family.

27         (8)  "Residential migrant housing"--A building,

28  structure, mobile home, barracks, or dormitory, and any

29  combination thereof on adjacent property which is under the

30  same ownership, management, or control, and the land

31


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  1  appertaining thereto, that is rented or reserved for occupancy

  2  by five or more migrant farmworkers, except:

  3         (a)  Housing furnished as an incident of employment.;

  4         (b)  A single-family residence or mobile home dwelling

  5  unit that is not under the same ownership, management, or

  6  control as other farmworker housing to which it is adjacent or

  7  contiguous.;

  8         (c)  A hotel, motel, or resort condominium, as defined

  9  in chapter 509, that is furnished for transient occupancy.

10         (d)  Any housing owned or operated by a public housing

11  authority except for housing which is specifically provided

12  for persons whose principal income is derived from

13  agriculture.

14         Section 10.  Section 381.0083, Florida Statutes, is

15  amended to read:

16         381.0083  Issuance of permit to operate migrant labor

17  camp or residential migrant housing.--Any person who is

18  planning to construct, enlarge, remodel, use, or occupy a

19  migrant labor camp or residential migrant housing or convert

20  property for use as a migrant labor camp or residential

21  migrant housing must give written notice to the department of

22  the intent to do so at least 45 days before beginning such

23  construction, enlargement, or renovation. If the department is

24  satisfied, after causing an inspection to be made, that the

25  camp or the residential migrant housing meets the minimum

26  standards of construction, sanitation, equipment, and

27  operation required by rules issued under s. 381.0086 and that

28  the applicant has paid the application fees required by s.

29  381.0084, it shall issue in the name of the department the

30  necessary permit in writing on a form to be prescribed by the

31  department.  The permit, unless sooner revoked, shall expire


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  1  on September 30 next after the date of issuance, and it shall

  2  not be transferable.  An application for a permit shall be

  3  filed with the department 30 days prior to operation. When

  4  there is a change in ownership of a currently permitted

  5  migrant labor camp or residential migrant housing, the new

  6  owner must file an application with the department at least 15

  7  days before the change. In the case of a facility owned or

  8  operated by a public housing authority, an annual satisfactory

  9  sanitation inspection of the living units by the Farmers Home

10  Administration or the Department of Housing and Urban

11  Development shall substitute for the pre-permitting inspection

12  required by the department.

13         Section 11.  Subsection (1) of section 381.0086,

14  Florida Statutes, is amended to read:

15         381.0086  Rules; variances; penalties.--

16         (1)  The department shall adopt rules necessary to

17  protect the health and safety of migrant farm workers and

18  other migrant labor camp or residential migrant housing

19  occupants.  These rules must include provisions relating to

20  plan review of the construction of new, expanded, or remodeled

21  camps, personal hygiene facilities, lighting, sewage disposal,

22  safety, minimum living space per occupant, bedding, food

23  storage and preparation, insect and rodent control, garbage,

24  heating equipment, water supply, maintenance and operation of

25  the camp, or housing, or roads, and such other matters as the

26  department finds to be appropriate or necessary to protect the

27  life and health of the occupants.  Housing operated by a

28  public housing authority is exempt from the provisions of any

29  administrative rule that conflicts with or is more stringent

30  than the federal standards applicable to the housing.

31


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  1         Section 12.  Subsections (1) and (2) of section

  2  381.0087, Florida Statutes, are amended to read:

  3         381.0087  Enforcement; citations.--

  4         (1)  Department personnel or crew chief compliance

  5  officers employed by the Bureau of Compliance of the Florida

  6  Department of Labor and Employment Security may issue

  7  citations that contain an order of correction or an order to

  8  pay a fine, or both, for violations of ss. 381.008-381.00895

  9  or the field sanitation facility rules adopted by the

10  department when a violation of those sections or rules is

11  enforceable by an administrative or civil remedy, or when a

12  violation of those sections or rules is a misdemeanor of the

13  second degree.  A citation issued under this section

14  constitutes a notice of proposed agency action. The recipient

15  of a citation for a major deficiency, as defined by rule of

16  the department, will be given a maximum of 48 hours to make

17  satisfactory correction or demonstrate that provisions for

18  correction are satisfactory.

19         (2)  Citations must be in writing and must describe the

20  particular nature of the violation, including specific

21  reference to the provision of statute or rule allegedly

22  violated. Continual or repeat violations of the same

23  requirement will result in the issuance of a citation.

24         Section 13.  Paragraph (b) of subsection (2),

25  subsection (3), paragraphs (a), (d), and (f) of subsection

26  (4), and subsection (7) of section 381.0098, Florida Statutes,

27  are amended to read:

28         381.0098  Biomedical waste.--

29         (2)  DEFINITIONS.--As used in this section, the term:

30         (b)  "Biomedical waste generator" means a facility or

31  person that produces or generates biomedical waste.  The term


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  1  includes, but is not limited to, hospitals, skilled nursing or

  2  convalescent hospitals, intermediate care facilities, clinics,

  3  dialysis clinics, dental offices, health maintenance

  4  organizations, surgical clinics, medical buildings,

  5  physicians' offices, laboratories, veterinary clinics, and

  6  funeral homes where embalming procedures are performed.

  7         (3)  OPERATING STANDARDS.--The department shall adopt

  8  rules necessary to protect the health, safety, and welfare of

  9  the public and to carry out the purpose of this section.  Such

10  rules shall address, but need not be limited to, the packaging

11  of biomedical waste, including specific requirements for the

12  segregation of the waste at the point of generation; the safe

13  packaging of sharps; the placement of the waste in containers

14  that will protect waste handlers and the public from exposure;

15  the appropriate labeling of containers of waste; written

16  operating plans for managing biomedical waste; and the

17  transport, storage, and treatment of biomedical wastes.

18         (4)  PERMITS AND FEES.--

19         (a)  All persons who generate, store, or treat

20  biomedical waste shall obtain a permit from the department

21  prior to commencing operation, except that a biomedical waste

22  generator generating less than 25 pounds of biomedical waste

23  in each 30-day period shall be exempt from the registration

24  and fee requirements of this subsection. A biomedical waste

25  generator need not obtain a separate permit if such generator

26  works less than 6 hours in a 7-day period at a location

27  different than the location specified on the permit. The

28  department may issue combined permits for generation, storage,

29  and treatment as appropriate to streamline permitting

30  procedures.  Application for such permit shall be made on an

31  application form provided by the department.


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  1         (d)  The permit for a biomedical waste generator shall

  2  not be transferred from one owner to another.  When the

  3  ownership or name of a biomedical waste generator is changed

  4  and continues to operate, the new owner shall apply to the

  5  department, upon forms provided by the department, for

  6  issuance of a permit in the timeframe and manner prescribed by

  7  rule of the department.

  8         (f)  The department shall establish a schedule of fees

  9  for such permits. Fees assessed under this section shall be in

10  an amount sufficient to meet the costs of carrying out the

11  provisions of this section and rules adopted under this

12  section.  The fee schedule shall not be less than $50 or more

13  than $400 for each year the permit is valid.  Fees may be

14  prorated on a quarterly basis when a facility will be in

15  operation for 6 months or less before the annual renewal date.

16  The department shall assess the minimum fees provided in this

17  subsection until a fee schedule is promulgated by rule of the

18  department.  Facilities owned and operated by the state shall

19  be exempt from the payment of any fees.

20         (7)  ENFORCEMENT AND PENALTIES.--Any person or public

21  body in violation of this section or rules adopted under this

22  section is subject to penalties provided in ss. 381.0012,

23  381.0025, and 381.0061. However, an administrative fine not to

24  exceed $2,500 may be imposed for each day such person or

25  public body is in violation of this section. The department

26  may deny, suspend, or revoke any biomedical waste permit or

27  registration if the permittee violates this section, any rule

28  adopted under this section, or any lawful order of the

29  department.

30         Section 14.  Paragraphs (d), (f), and (g) of subsection

31  (2), paragraph (b) of subsection (4), and subsections (5) and


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  1  (7) of section 381.0101, Florida Statutes, are amended to

  2  read:

  3         381.0101  Environmental health professionals.--

  4         (2)  DEFINITIONS.--As used in this section:

  5         (d)  "Environmental health professional" means a person

  6  who is employed or assigned the responsibility for assessing

  7  the environmental health or sanitary conditions, as defined by

  8  the department, within a building, on an individual's

  9  property, or within the community at large, and who has the

10  knowledge, skills, and abilities to carry out these tasks.

11  Environmental health professionals may be either field,

12  supervisory, or administrative staff members.

13         (f)  "Registered sanitarian," or "R.S.," "Registered

14  Environmental Health Specialist," or "R.E.H.S." means a person

15  who has been certified by either the National Environmental

16  Health Association or the Florida Environmental Health

17  Association as knowledgeable in the environmental health

18  profession.

19         (g)  "Primary environmental health program" means those

20  programs determined by the department to be essential for

21  providing basic environmental and sanitary protection to the

22  public.  At a minimum, these programs shall include food

23  protection program work hygiene evaluations, and onsite sewage

24  treatment and disposal system evaluations.

25         (4)  ENVIRONMENTAL HEALTH PROFESSIONALS ADVISORY

26  BOARD.--The State Health Officer shall appoint an advisory

27  board to assist the department in the promulgation of rules

28  for certification, testing, establishing standards, and

29  seeking enforcement actions against certified professionals.

30         (b)  The board shall advise the department as to the

31  minimum disciplinary guidelines and standards of competency


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  1  and proficiency necessary to obtain certification in a primary

  2  area of environmental health practice.

  3         1.  The board shall recommend primary areas of

  4  environmental health practice in which environmental health

  5  professionals should be required to obtain certification.

  6         2.  The board shall recommend minimum standards of

  7  practice which the department shall incorporate into rule.

  8         3.  The board shall evaluate and recommend to the

  9  department existing registrations and certifications which

10  meet or exceed minimum department standards and should,

11  therefore, exempt holders of such certificates or

12  registrations from compliance with this section.

13         4.  The board shall hear appeals of certificate

14  denials, revocation, or suspension and shall advise the

15  department as to the disposition of such an appeal.

16         5.  The board shall meet as often as necessary, but no

17  less than semiannually, handle appeals to the department, and

18  conduct other duties of the board.

19         6.  Members of the board shall receive no compensation

20  but are entitled to reimbursement shall be reimbursed for per

21  diem and travel expenses in accordance with s. 112.061.

22         (5)  STANDARDS FOR CERTIFICATION.--The department shall

23  adopt rules that establish minimum standards of education,

24  training, or experience for those persons subject to this

25  section. The rules shall also address the process for

26  application, examination, issuance, expiration, and renewal of

27  certification and ethical standards of practice for the

28  profession.

29         (a)  Persons employed as environmental health

30  professionals shall exhibit a knowledge of rules and

31  principles of environmental and public health law in Florida


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  1  through examination.  A No person may not shall conduct

  2  environmental health evaluations in a primary program area

  3  unless he or she is currently certified in that program area

  4  or works under the direct supervision of a certified

  5  environmental health professional.

  6         1.  All persons who begin employment in a primary

  7  environmental health program on or after September 21, 1994,

  8  must be certified in that program within 6 months after

  9  employment.

10         2.  Persons employed in a primary environmental health

11  program prior to September 21, 1994, shall be considered

12  certified while employed in that position and shall be

13  required to adhere to any professional standards established

14  by the department pursuant to paragraph (b), complete any

15  continuing education requirements imposed under paragraph (d),

16  and pay the certificate renewal fee imposed under subsection

17  (7).

18         3.  Persons employed in a primary environmental health

19  program prior to September 21, 1994, who change positions or

20  program areas and transfer into another primary environmental

21  health program area on or after September 21, 1994, must be

22  certified in that program within 6 months after such transfer,

23  except that they will not be required to possess the college

24  degree required under paragraph (e).

25         4.  Registered sanitarians shall be considered

26  certified and shall be required to adhere to any professional

27  standards established by the department pursuant to paragraph

28  (b).

29         (b)  At a minimum, the department shall establish

30  standards for professionals in the areas of food hygiene and

31  onsite sewage treatment and disposal.


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  1         (c)  Those persons conducting primary environmental

  2  health evaluations shall be certified by examination to be

  3  knowledgeable in any primary area of environmental health in

  4  which they are routinely assigned duties.

  5         (d)  Persons who are certified shall renew their

  6  certification biennially by completing not less than 24

  7  contact hours of continuing education for each program area in

  8  which they maintain certification.

  9         (e)  Applicants for certification shall have graduated

10  from an accredited 4-year college or university with a degree

11  or major coursework in public health, environmental health,

12  environmental science, or a physical or biological science.

13         (f)  A certificateholder shall notify the department

14  within 60 days after any change of name or address from that

15  which appears on the current certificate.

16         (7)  FEES.--The department shall charge fees in amounts

17  necessary to meet the cost of providing certification. Fees

18  for certification shall be not no less than $10 or $25 nor

19  more than $300 and shall be set by rule. Application,

20  examination, and certification costs shall be included in this

21  fee.  Fees for renewal of a certificate shall be no less than

22  $25 nor more than $150 per biennium.

23         Section 15.  Paragraph (b) of subsection (4), paragraph

24  (a) of subsection (6), and subsection (13) of section 381.89,

25  Florida Statutes, are amended to read:

26         381.89  Regulation of tanning facilities.--

27         (4)

28         (b)  A tanning facility must have a copy of the

29  facility's most recent inspection report available to the

30  public and must post a warning sign in any area where a

31


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  1  tanning device is used. Posting this sign does not absolve the

  2  facility of any liability. The sign must state:

  3

  4                  DANGER, ULTRAVIOLET RADIATION

  5                    Follow these instructions:

  6         1.  Avoid frequent or lengthy exposure.  As with

  7  natural sunlight, exposure can cause eye and skin injury or

  8  allergic reactions.  Repeated exposure can cause chronic sun

  9  damage characterized by wrinkling, dryness, fragility and

10  bruising of the skin or skin cancer.

11         2.  Wear protective eyewear.  FAILURE TO USE PROTECTIVE

12  EYEWEAR CAN RESULT IN SEVERE BURNS OR LONG-TERM INJURY TO THE

13  EYES.

14         3.  Ultraviolet radiation from sunlamps will aggravate

15  the effects of the sun.  Therefore, do not sunbathe before or

16  after exposure to ultraviolet radiation.

17         4.  Using medications or cosmetics can increase your

18  sensitivity to ultraviolet radiation.  Consult a physician

19  before using a sunlamp if you are using medications, have a

20  history of skin problems, or believe you are especially

21  sensitive to sunlight. Women who are pregnant or on birth

22  control who use this product can develop discolored skin.  IF

23  YOU DO NOT TAN IN THE SUN YOU WILL NOT TAN BY USING THIS

24  DEVICE.

25

26         (6)  A tanning facility must:

27         (a)  During operating hours, have an operator present

28  who is sufficiently knowledgeable and trained in accordance

29  with rules of the department in the correct operation of the

30  tanning devices to inform and assist each customer in the

31  proper use of the devices.


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  1         (13)  The department shall adopt rules to implement

  2  this section act. The rules may include, but need not be

  3  limited to, requirements for training tanning facility

  4  operators and employees; the approval of training courses;

  5  safety; plan review; and the design, construction, operation,

  6  maintenance, and cleanliness of tanning facilities and tanning

  7  devices.

  8         Section 16.  Paragraph (g) of subsection (1) and

  9  subsection (2) of section 383.011, Florida Statutes, are

10  amended, and paragraph (i) is added to subsection (1) of that

11  section, to read:

12         383.011  Administration of maternal and child health

13  programs.--

14         (1)  The Department of Health is designated as the

15  state agency for:

16         (g)  Receiving the federal funds for the "Special

17  Supplemental Nutrition Food Program for Women, Infants, and

18  Children," or WIC, authorized by the Child Nutrition Act of

19  1966, as amended, and for administering the statewide WIC

20  program. (The WIC program provides nutrition education and

21  supplemental foods, by means of food instruments called checks

22  that are redeemed by authorized food vendors, to participants

23  certified by the department as pregnant, breastfeeding, or

24  postpartum women; infants; or children.)

25         (h)  Designating facilities that provide maternity

26  services or newborn infant care as "baby-friendly" when the

27  facility has established a breastfeeding policy under s.

28  383.016.

29         (i)  Receiving federal funds for children eligible for

30  assistance through the portion of the federal Child and Adult

31


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  1  Care Food Program for children, which is referred to as the

  2  Child Care Food Program, and for administering the program.

  3         (2)  The Department of Health shall follow federal

  4  requirements and may adopt any rules necessary for the

  5  implementation of the maternal and child health care program,

  6  or the WIC program, and the Child Care Food Program.

  7         (a)  The department may adopt rules that are necessary

  8  to administer the maternal and child health care program. The

  9  rules may include, but need not be limited to, requirements

10  for client eligibility, program standards, service delivery,

11  quality assurance, and provider selection.

12         (b)  The department may adopt rules that are necessary

13  to administer the statewide WIC program. The rules may

14  include, but need not be limited to, criteria for grocers'

15  participation, client eligibility, contracts with local

16  agencies for service delivery, and food purchases and

17  penalties for program abuse.

18         Section 17.  Section 384.33, Florida Statutes, is

19  amended to read:

20         384.33  Rules.--The department may adopt rules to carry

21  out the provisions of this chapter. The rules may include

22  requirements for methods of contacting a physician to

23  determine the need for follow-up services related to sexually

24  transmissible diseases and for maintaining the security of

25  confidential information.

26         Section 18.  Subsection (4) of section 384.34, Florida

27  Statutes, is amended to read:

28         384.34  Penalties.--

29         (4)  Any person who violates the provisions of the

30  department's rules pertaining to sexually transmissible

31  diseases may be punished by a fine not to exceed $500 for each


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  1  violation. Any penalties enforced under this subsection shall

  2  be in addition to other penalties provided by this chapter

  3  act. The department may enforce this section and adopt rules

  4  necessary to administer this section.

  5         Section 19.  Section 401.26, Florida Statutes, is

  6  amended to read:

  7         401.26  Vehicle permits for basic life support and

  8  advanced life support services.--

  9         (1)  Every licensee shall possess a valid permit for

10  each transport vehicle, and advanced life support nontransport

11  vehicle, and aircraft in use. Applications for such permits

12  shall be made upon forms prescribed by the department.  The

13  licensee shall provide documentation that each vehicle for

14  which a permit is sought meets the appropriate requirements

15  for a basic life support or advanced life support service

16  vehicle, whichever is applicable, as specified by rule of the

17  department. A permit is not required for an advanced life

18  support nontransport vehicle that is intended to be used for

19  scene supervision, incident command, or the augmentation of

20  supplies.

21         (2)  To receive a valid vehicle permit, the applicant

22  must submit a completed application form for each vehicle or

23  aircraft for which a permit is desired, pay the appropriate

24  fees established as provided in s. 401.34, and provide

25  documentation that each vehicle or aircraft meets the

26  following requirements as established by rule of the

27  department; the vehicle or aircraft must:

28         (a)  Be furnished with essential medical supplies and

29  equipment which is in good working order.

30         (b)  Meet appropriate standards for design and

31  construction.


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  1         (c)  Be equipped with an appropriate communication

  2  system.

  3         (d)  Meet appropriate safety standards.

  4         (e)  Meet sanitation and maintenance standards.

  5         (f)  Be insured for an appropriate sum against injuries

  6  to or the death of any person arising out of an accident.

  7         (3)  The department may deny, suspend, or revoke a

  8  permit if it determines that the vehicle, aircraft, or its

  9  equipment fails to meet the requirements specified in this

10  part or in the rules of the department.

11         (4)  A permit issued in accordance with this section

12  will expire automatically concurrent with the service license.

13         (5)  In order to renew a vehicle or aircraft permit

14  issued pursuant to this part, the applicant must:

15         (a)  Submit a renewal application.  Such application

16  must be received by the department not more than 90 days or

17  less than 30 days prior to the expiration of the permit.

18         (b)  Submit the appropriate fee or fees, established as

19  provided in s. 401.34.

20         (c)  Provide documentation that current standards for

21  issuance of a permit are met.

22         (6)  The department shall establish criteria and time

23  limits for substitution of permitted vehicles that are out of

24  service for maintenance purposes.

25         (7)  The department shall adopt and enforce rules

26  necessary to administer this section.

27         Section 20.  Subsection (4) is added to section

28  401.265, Florida Statutes, to read:

29         401.265  Medical directors.--

30         (4)  The department shall adopt and enforce all rules

31  necessary to administer this section.


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  1         Section 21.  Subsection (4) is added to section 401.30,

  2  Florida Statutes, to read:

  3         401.30  Records.--

  4         (4)  The department shall adopt and enforce all rules

  5  necessary to administer this section.

  6         Section 22.  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

31


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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 23.  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 that

30  conducts a water-analysis business in the state, 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 24.  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 25.  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 26.  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 27.  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 28.  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 29.  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 30.  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 31.  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

17  subparagraphs (1)(a)1., 2., 4., and 5.

18         Section 32.  Section 499.0121, Florida Statutes, is

19  amended to read:

20         499.0121  Storage and handling of prescription

21  drugs.--The department shall adopt such rules to implement

22  this section relating to wholesale drug distribution as are

23  necessary to protect the public health, safety, and welfare.

24  Such rules shall include, but not be limited to, requirements

25  for the storage and handling of prescription drugs and for the

26  establishment and maintenance of prescription drug

27  distribution records.

28         (1)  ESTABLISHMENTS.--An establishment at which

29  prescription drugs are stored, warehoused, handled, held,

30  offered, marketed, or displayed must:

31


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  1         (a)  Be of suitable size and construction to facilitate

  2  cleaning, maintenance, and proper operations;

  3         (b)  Have storage areas designed to provide adequate

  4  lighting, ventilation, temperature, sanitation, humidity,

  5  space, equipment, and security conditions;

  6         (c)  Have a quarantine area for storage of prescription

  7  drugs that are outdated, damaged, deteriorated, misbranded, or

  8  adulterated, or that are in immediate or sealed, secondary

  9  containers that have been opened;

10         (d)  Be maintained in a clean and orderly condition;

11  and

12         (e)  Be free from infestation by insects, rodents,

13  birds, or vermin of any kind.

14         (2)  SECURITY.--

15         (a)  An establishment that is used for wholesale drug

16  distribution must be secure from unauthorized entry.

17         1.  Access from outside the premises must be kept to a

18  minimum and be well-controlled.

19         2.  The outside perimeter of the premises must be

20  well-lighted.

21         3.  Entry into areas where prescription drugs are held

22  must be limited to authorized personnel.

23         (b)  An establishment that is used for wholesale drug

24  distribution must be equipped with:

25         1.  An alarm system to detect entry after hours;

26  however, the department may exempt by rule establishments that

27  only hold a permit as prescription drug wholesaler-brokers and

28  establishments that only handle medical oxygen; and

29         2.  A security system that will provide suitable

30  protection against theft and diversion. When appropriate, the

31  security system must provide protection against theft or


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  1  diversion that is facilitated or hidden by tampering with

  2  computers or electronic records.

  3         (3)  STORAGE.--All prescription drugs shall be stored

  4  at appropriate temperatures and under appropriate conditions

  5  in accordance with requirements, if any, in the labeling of

  6  such drugs, or with requirements in the official compendium.

  7         (a)  If no storage requirements are established for a

  8  prescription drug, the drug may be held at "controlled" room

  9  temperature, as defined in the official compendium, to help

10  ensure that its identity, strength, quality, and purity are

11  not adversely affected.

12         (b)  Appropriate manual, electromechanical, or

13  electronic temperature and humidity recording equipment,

14  devices, or logs must be used to document proper storage of

15  prescription drugs.

16         (c)  The recordkeeping requirements in subsection (6)

17  must be followed for all stored prescription drugs.

18         (4)  EXAMINATION OF MATERIALS.--

19         (a)  Upon receipt, each outside shipping container must

20  be visually examined for identity and to prevent the

21  acceptance of contaminated prescription drugs that are

22  otherwise unfit for distribution. This examination must be

23  adequate to reveal container damage that would suggest

24  possible contamination or other damage to the contents.

25         (b)  Each outgoing shipment must be carefully inspected

26  for identity of the prescription drug products and to ensure

27  that there is no delivery of prescription drugs that have

28  expired or been damaged in storage or held under improper

29  conditions.

30

31


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  1         (c)  The recordkeeping requirements in subsection (6)

  2  must be followed for all incoming and outgoing prescription

  3  drugs.

  4         (5)  RETURNED, DAMAGED, OR OUTDATED PRESCRIPTION

  5  DRUGS.--

  6         (a)1.  Prescription drugs that are outdated, damaged,

  7  deteriorated, misbranded, or adulterated must be quarantined

  8  and physically separated from other prescription drugs until

  9  they are destroyed or returned to their supplier.  A

10  quarantine section must be separate and apart from other

11  sections where prescription drugs are stored so that

12  prescription drugs in this section are not confused with

13  usable prescription drugs.

14         2.  Prescription drugs must be examined at least every

15  12 months, and drugs for which the expiration date has passed

16  must be removed and quarantined.

17         (b)  Any prescription drugs of which the immediate or

18  sealed outer containers or sealed secondary containers have

19  been opened or used must be identified as such and must be

20  quarantined and physically separated from other prescription

21  drugs until they are either destroyed or returned to the

22  supplier.

23         (c)  If the conditions under which a prescription drug

24  has been returned cast doubt on the drug's safety, identity,

25  strength, quality, or purity, the drug must be destroyed or

26  returned to the supplier, unless examination, testing, or

27  other investigation proves that the drug meets appropriate

28  standards of safety, identity, strength, quality, and purity.

29  In determining whether the conditions under which a drug has

30  been returned cast doubt on the drug's safety, identity,

31  strength, quality, or purity, the wholesale drug distributor


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  1  must consider, among other things, the conditions under which

  2  the drug has been held, stored, or shipped before or during

  3  its return and the conditions of the drug and its container,

  4  carton, or labeling, as a result of storage or shipping.

  5         (d)  The recordkeeping requirements in subsection (6)

  6  must be followed for all outdated, damaged, deteriorated,

  7  misbranded, or adulterated prescription drugs.

  8         (6)  RECORDKEEPING.--The department shall adopt rules

  9  that require keeping such records of prescription drugs as are

10  necessary for the protection of the public health.

11         (a)  Wholesale drug distributors must establish and

12  maintain inventories and records of all transactions regarding

13  the receipt and distribution or other disposition of

14  prescription drugs.  These records must provide a complete

15  audit trail from receipt to sale or other disposition, be

16  readily retrievable for inspection, and include, at a minimum,

17  the following information:

18         1.  The source of the drugs, including the name and

19  principal address of the seller or transferor, and the address

20  of the location from which the drugs were shipped;

21         2.  The name, principal address, and state license

22  permit or registration number of the person authorized to

23  purchase prescription drugs;

24         3.  The name, strength, dosage form, and quantity of

25  the drugs received and distributed or disposed of; and

26         4.  The dates of receipt and distribution or other

27  disposition of the drugs.

28         (b)  Inventories and records must be made available for

29  inspection and photocopying by authorized federal, state, or

30  local officials for a period of 2 years following disposition

31  of the drugs.


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  1         (c)  Records described in this section that are kept at

  2  the inspection site or that can be immediately retrieved by

  3  computer or other electronic means must be readily available

  4  for authorized inspection during the retention period.

  5  Records that are kept at a central location outside of this

  6  state and that are not electronically retrievable must be made

  7  available for inspection within 2 working days after a request

  8  by an authorized official of a federal, state, or local law

  9  enforcement agency.  Records that are maintained at a central

10  location within this state must be maintained at an

11  establishment that is permitted pursuant to ss.

12  499.001-499.081 and must be readily available.

13         (d)1.  Each person who is engaged in the wholesale

14  distribution of a prescription drug, and who is not an

15  authorized distributor of record of such drug, must provide to

16  each wholesale distributor of such drug, before the sale is

17  made to such wholesale distributor, a written statement

18  identifying each previous sale of the drug.  The written

19  statement identifying all sales of such drug must accompany

20  the drug for each subsequent wholesale distribution of the

21  drug to a wholesale distributor. The department shall adopt

22  rules relating to the requirements of this written statement.

23         2.  Each wholesale distributor of prescription drugs

24  must maintain separate and distinct from other required

25  records all statements that are required under subparagraph 1.

26         3.  Each manufacturer of a prescription drug sold in

27  this state must maintain at its corporate offices a current

28  list of authorized distributors and must make such list

29  available to the department upon request.

30

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  1  For the purposes of this subsection, the term "authorized

  2  distributors of record" means those distributors with whom a

  3  manufacturer has established an ongoing relationship to

  4  distribute the manufacturer's products.

  5         (7)  WRITTEN POLICIES AND PROCEDURES.--Wholesale drug

  6  distributors must establish, maintain, and adhere to written

  7  policies and procedures, which must be followed for the

  8  receipt, security, storage, inventory, and distribution of

  9  prescription drugs, including policies and procedures for

10  identifying, recording, and reporting losses or thefts, and

11  for correcting all errors and inaccuracies in inventories.

12  Wholesale drug distributors must include in their written

13  policies and procedures:

14         (a)  A procedure whereby the oldest approved stock of a

15  prescription drug product is distributed first.  The procedure

16  may permit deviation from this requirement, if the deviation

17  is temporary and appropriate.

18         (b)  A procedure to be followed for handling recalls

19  and withdrawals of prescription drugs.  Such procedure must be

20  adequate to deal with recalls and withdrawals due to:

21         1.  Any action initiated at the request of the Food and

22  Drug Administration or any other federal, state, or local law

23  enforcement or other government agency, including the

24  department.

25         2.  Any voluntary action by the manufacturer to remove

26  defective or potentially defective drugs from the market; or

27         3.  Any action undertaken to promote public health and

28  safety by replacing existing merchandise with an improved

29  product or new package design.

30         (c)  A procedure to ensure that wholesale drug

31  distributors prepare for, protect against, and handle any


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  1  crisis that affects security or operation of any facility if a

  2  strike, fire, flood, or other natural disaster, or a local,

  3  state, or national emergency, occurs.

  4         (d)  A procedure to ensure that any outdated

  5  prescription drugs are segregated from other drugs and either

  6  returned to the manufacturer or destroyed.  This procedure

  7  must provide for written documentation of the disposition of

  8  outdated prescription drugs. This documentation must be

  9  maintained for 2 years after disposition of the outdated

10  drugs.

11         (8)  RESPONSIBLE PERSONS.--Wholesale drug distributors

12  must establish and maintain lists of officers, directors,

13  managers, and other persons in charge of wholesale drug

14  distribution, storage, and handling, including a description

15  of their duties and a summary of their qualifications.

16         (9)  COMPLIANCE WITH FEDERAL, STATE, AND LOCAL LAW.--A

17  wholesale drug distributor must operate in compliance with

18  applicable federal, state, and local laws and regulations.

19         (a)  A wholesale drug distributor must allow the

20  department and authorized federal, state, and local officials

21  to enter and inspect its premises and delivery vehicles, and

22  to audit its records and written operating procedures, at

23  reasonable times and in a reasonable manner, to the extent

24  authorized by law.

25         (b)  A wholesale drug distributor that deals in

26  controlled substances must register with the Drug Enforcement

27  Administration and must comply with all applicable state,

28  local, and federal laws. A wholesale drug distributor that

29  distributes any substance controlled under chapter 893 must

30  notify the department when registering with the Drug

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  1  Enforcement Administration pursuant to that chapter and must

  2  provide the department with its DEA number.

  3         (10)  SALVAGING AND REPROCESSING.--A wholesale drug

  4  distributor is subject to any applicable federal, state, or

  5  local laws or regulations that relate to prescription drug

  6  product salvaging or reprocessing.

  7         Section 33.  Paragraphs (a) and (d) of subsection (1)

  8  of section 499.0122, Florida Statutes, are amended to read:

  9         499.0122  Medical oxygen and veterinary legend drug

10  retail establishments; definitions, permits, general

11  requirements.--

12         (1)  As used in this section, the term:

13         (a)  "Medical oxygen retail establishment" means a

14  person licensed to sell medical oxygen to patients only.  The

15  sale must be based on an order from a practitioner authorized

16  by law to prescribe.  The term does not include a pharmacy

17  licensed under chapter 465.

18         1.  A medical oxygen retail establishment may not

19  possess, purchase, sell, or trade any legend drug other than

20  medical oxygen.

21         2.  A medical oxygen retail establishment may refill

22  medical oxygen for an individual patient based on an order

23  from a practitioner authorized by law to prescribe. A medical

24  oxygen retail establishment that refills medical oxygen must

25  comply with all appropriate state and federal good

26  manufacturing practices.

27         (d)  "Veterinary legend drug retail establishment"

28  means a person permitted to sell veterinary legend drugs to

29  the public or to veterinarians, but does not include a

30  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 34.  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 35.  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 36.  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 37.  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 adopt rules regarding persons

24  engaged in lawful teaching, research, or testing who possess

25  prescription drugs and may issue letters of exemption to

26  facilitate the lawful possession of prescription drugs under

27  this section.

28         Section 38.  Subsection (3) is added to section 499.05,

29  Florida Statutes, to read:

30         499.05  Rules.--

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  1         (3)  The department shall adopt rules regulating

  2  recordkeeping for and the storage, handling, and distribution

  3  of medical devices and over-the-counter drugs to protect the

  4  public from adulterated products.

  5         Section 39.  Subsection (5) is added to section 499.65,

  6  Florida Statutes, to read:

  7         499.65  Possession of ether without license or permit

  8  prohibited; confiscation and disposal; exceptions.--

  9         (5)  The department may adopt rules regarding persons

10  engaged in lawful teaching, research, or testing who possess

11  ether and may issue letters of exemption to facilitate the

12  lawful possession of ether under this section.

13         Section 40.  Subsection (2) of section 499.66, Florida

14  Statutes, is amended to read:

15         499.66  Maintenance of records and sales of ether by

16  manufacturers, distributors, and dealers; inspections.--

17         (2)  Each sale or transfer of 2.5 gallons, or

18  equivalent by weight, or more of ether shall be evidenced by

19  an invoice, receipt, sales ticket, or sales slip which shall

20  bear the name, address, and license or permit number of the

21  manufacturer, distributor, or dealer and the purchaser or

22  transferee, the date of sale or transfer, and the quantity

23  sold or transferred.  All original invoices, receipts, sales

24  tickets, and sales slips shall be retained by the

25  manufacturer, distributor, or dealer, and a copy thereof

26  provided to the purchaser or transferee.

27         Section 41.  Subsection (1) of section 499.67, Florida

28  Statutes, is amended to read:

29         499.67  Maintenance of records by purchasers;

30  inspections.--

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  1         (1)  It is unlawful for any person permittee to

  2  purchase, receive, store, or use ether without maintaining an

  3  accurate and current written inventory of all ether purchased,

  4  received, stored, and used.

  5         Section 42.  Paragraph (e) of subsection (1) and

  6  subsection (2) of section 501.122, Florida Statutes, are

  7  amended to read:

  8         501.122  Control of nonionizing radiations; laser;

  9  penalties.--

10         (1)  DEFINITIONS.--For the purposes of this section:

11         (e)  "Department" means the Department of Health and

12  Rehabilitative Services.

13         (2)  AUTHORITY TO ISSUE REGULATIONS.--Except for

14  electrical transmission and distribution lines and substation

15  facilities subject to regulation by the Department of

16  Environmental Protection pursuant to chapter 403, the

17  Department of Health and Rehabilitative Services shall adopt

18  promulgate such rules and regulations as it may determine to

19  be necessary to protect the health and safety of persons

20  exposed to laser devices and other nonionizing radiation,

21  including the user or any others who might come in contact

22  with such radiation. The Department of Health may and

23  Rehabilitative Services is further authorized:

24         (a)  To Develop a program for registration of laser

25  devices and uses and of identifying and controlling sources

26  and uses of other nonionizing radiations.

27         (b)  To Maintain liaison with, and receive information

28  from, industry, industry associations, and other organizations

29  or individuals relating to present or future

30  radiation-producing products or devices.

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  1         (c)  To Study and evaluate the degree of hazard

  2  associated with the use of laser devices or other sources of

  3  radiation.

  4         (d)  To Establish and prescribe performance standards

  5  for lasers laser and other radiation control, including

  6  requirements for the qualifications, duties, and training of

  7  users; the posting of warning signs and labels for facilities

  8  and devices; recordkeeping; and reports to the department, if

  9  it determines that such standards are necessary for the

10  protection of the public health.

11         (e)  To Amend or revoke any performance standard

12  established under the provisions of this section.

13         Section 43.  Paragraph (b) of subsection (1) of section

14  513.045, Florida Statutes, is amended to read:

15         513.045  Permit fees.--

16         (1)

17         (b)  Fees established pursuant to this subsection must

18  be based on the actual costs incurred by the department in

19  carrying out its responsibilities under this chapter.  The fee

20  for a permit may not be set at a rate that is more than $6.50

21  per space or less than $3.50 per space.  Until rules setting

22  these fees are adopted by the department, the permit fee per

23  space is $3.50. The permit fee for a nonexempt recreational

24  camp shall be based on an equivalency rate for which two camp

25  occupants equal one space. However, in no case may The total

26  fee assessed to an applicant may not be more than $600 or less

27  than $50, except that a fee may be prorated on a quarterly

28  basis.

29         Section 44.  Section 513.05, Florida Statutes, is

30  amended to read:

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  1         513.05  Rules.--The department may adopt such rules

  2  pertaining to the location, construction, modification,

  3  equipment, and operation of mobile home parks, lodging parks,

  4  recreational vehicle parks, and recreational camps except as

  5  provided in s. 633.022, as may be necessary to implement this

  6  chapter. Such rules may include requirements for plan reviews

  7  of proposed and existing parks and camps; plan reviews of

  8  parks that consolidate space or change space size; water

  9  supply; sewage collection and disposal; plumbing and backflow

10  prevention; garbage and refuse storage, collection, and

11  disposal; insect and rodent control; space requirements;

12  heating facilities; food service; lighting; sanitary

13  facilities; bedding; an occupancy equivalency to spaces for

14  permits for recreational camps; sanitary facilities in

15  recreational vehicle parks; and the owners' responsibilities

16  at recreational vehicle parks and recreational camps.

17         Section 45.  Subsection (5) is added to section

18  514.011, Florida Statutes, to read:

19         514.011  Definitions.--As used in this chapter:

20         (5)  "Portable pool" means a pool or spa, and related

21  equipment systems of any kind, which is designed or intended

22  to be movable from location to location.

23         Section 46.  Section 514.0115, Florida Statutes, is

24  amended to read:

25         514.0115  Exemptions from supervision or regulation;

26  variances.--

27         (1)  Private pools and water therapy facilities

28  connected with facilities connected with hospitals, medical

29  doctors' offices, and licensed physical therapy establishments

30  shall be exempt from supervision under this chapter.

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  1         (2)(a)  Pools serving no more than 32 condominium or

  2  cooperative units which are not operated as a public lodging

  3  establishment shall be exempt from supervision under this

  4  chapter, except for water quality.

  5         (b)  Pools serving condominium or cooperative

  6  associations of more than 32 units and whose recorded

  7  documents prohibit the rental or sublease of the units for

  8  periods of less than 60 days are exempt from supervision under

  9  this chapter, except that the condominium or cooperative owner

10  or association must file applications with the department and

11  obtain construction plans approval and receive an initial

12  operating permit.  The department shall inspect the swimming

13  pools at such places annually, at the fee set forth in s.

14  514.033(3), or upon request by a unit owner, to determine

15  compliance with department rules relating to water quality and

16  lifesaving equipment.  The department may not require

17  compliance with rules relating to swimming pool lifeguard

18  standards.

19         (3)  A private pool used for instructional purposes in

20  swimming shall not be regulated as a public pool.

21         (4)  The department may grant variances from any rule

22  adopted under this chapter pursuant to procedures adopted by

23  department rule.

24         Section 47.  Subsection (4) is added to section 514.03,

25  Florida Statutes, to read:

26         514.03  Construction plans approval necessary to

27  construct, develop, or modify public swimming pools or bathing

28  places.--It is unlawful for any person or public body to

29  construct, develop, or modify any public swimming pool or

30  bathing place without a valid construction plans approval from

31  the department.


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  1         (4)  An approval of construction plans issued by the

  2  department under this section becomes void 1 year after the

  3  date the approval was issued if the construction is not

  4  commenced within 1 year after the date of issuance.

  5         Section 48.  Subsections (5) and (6) of section

  6  514.031, Florida Statutes, are amended to read:

  7         514.031  Permit necessary to operate public swimming

  8  pool or bathing place.--It is unlawful for any person or

  9  public body to operate or continue to operate any public

10  swimming pool or bathing place without a valid permit from the

11  department, such permit to be obtained in the following

12  manner:

13         (5)  Each such operating permit shall be renewed

14  annually and the permit must be posted in a conspicuous place.

15         (6)  An owner or operator of a public swimming pool,

16  including, but not limited to, a spa, wading, or special

17  purpose pool, to which admittance is obtained by membership

18  for a fee shall post in a prominent location within the

19  facility the most recent pool inspection report issued by the

20  department pertaining to the health and safety conditions of

21  such facility. The report shall be legible and readily

22  accessible to members or potential members. The department

23  shall adopt promulgate rules to enforce this subsection

24  provision. A portable pool may not be used as a public pool.

25         Section 49.  Subsections (4) and (5) of section

26  514.033, Florida Statutes, are amended to read:

27         514.033  Creation of fee schedules authorized.--

28         (4)  Fees collected by the department in accordance

29  with the provisions of this chapter shall be deposited into

30  the Public Swimming Pool and Bathing Place Trust Fund for the

31  payment of costs incurred in the administration of this


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  1  chapter.  Fees collected by county health departments

  2  performing functions pursuant to s. 514.025 shall be deposited

  3  into the County Health Department Trust Fund. Any fee

  4  collected under this chapter is nonrefundable.

  5         (5)  The department may not charge any No other fees

  6  shall be charged for services provided under the provisions of

  7  this chapter other than those fees authorized in this section.

  8  However, the department shall prorate the initial annual fee

  9  for an operating permit on a half-year basis.

10         Section 50.  Subsection (5) is added to section 514.05,

11  Florida Statutes, to read:

12         514.05  Denial, suspension, or revocation of permit;

13  administrative fines.--

14         (5)  Under conditions specified by rule, the department

15  may close a public pool that is not in compliance with this

16  chapter or the rules adopted under this chapter.

17         Section 51.  This act shall take effect July 1, 1998.

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