99-000005RX Discovery Experimental And Development, Inc. vs. Department Of Health Status: Closed DOAH Final Order on Monday, February 22, 1999.

Summary: Rule 64F-12.006 was not invalid. Sweeping use of terms "building," "property," "spaces," and "records" makes invalid the Department of Health Inspector`s rule applicable to drug manufacturing establishments.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DISCOVERY EXPERIMENTAL AND )

DEVELOPMENT, INC., )

)

Petitioner, )

)

vs. ) Case No. 99-0005RX

)

DEPARTMENT OF HEALTH, )

)

Respondent. )

___________________________________)

JAMES T. KIMBALL, )

)

Petitioner, )

)

vs. ) Case No. 99-0006RX

)

DEPARTMENT OF HEALTH, )

)

Respondent. )

___________________________________)

FINAL ORDER

These consolidated cases were heard by David M. Maloney,

Administrative Law Judge of the Division of Administrative

Hearings, on January 26, 1999, in Tallahassee, Florida.

APPEARANCES

For Petitioner Discovery: R. Elliott Dunn, Jr., Attorney

29949 State Road 54, West

Wesley Chapel, Florida 33543

For Petitioner Kimball: James T. K imball, pro se

29949 State Road 54, West

Wesley Chapel, Florida 33543

For Respondent: Robert P. Daniti, Attorney

Angela Hall, Attorney

Steve Foxwell, Attorney

Department of Hea lth

Bin A02

2020 Capital Circle, Southeast

Tallahassee, Florida 32399-1703

STATEMENT OF THE ISSUE

Whether Rules 64F-12.006 and 64F-12.019, Florida

Administrative Code, in whole or in part, constitute invalid

exercises of delegated legislative authority?

PRELIMINARY STATEMENT

On January 5, 1999, Discovery Experimental and Development,

Inc., (Discovery) filed with the Division of Administrative

Hearings a petition denominated, "Petition for Rule Challenge."

The petition requested that three rules of the Department of

Health be declared invalid exercises of legislative authority.

The rules listed in the petition were Rules 10D-45.0545,

64F-12.006, and 64F-12.019, Florida Administrative Code.

On the same da te, January 5, James T. Kimball filed a

petition by the same denomination. Just as Discovery's

petition, Mr. Kimball's petition requested that several rules of

the Department of Health be declared invalid. Unlike the

Discovery petition, however, Mr. Kimball's petition did not seek

a declaration with regard to Rule 64F-12.006. The petition was

limited to Rules 10D-45.0545 and 64F-12.019.

On January 6, 1999, a letter advising that two petitions

had been filed was sent by the Division of Administrative

Hearings to the Bureau of Administrative Code in the Department

of State. On the same date, the Division assigned the two cases

(DOAH Case Nos. 99-0005RX and 99-0006RX) to David M. Maloney,

Administrative Law Judge.

Orders establishing prehearing procedures and notices of

hearing setting separately the final hearings in the two cases

were issued January 7, 1999. Following orders to show cause why

the cases should not be consolidated, the cases were

consolidated without objection. The cases proceeded to hearing

on January 26, 1997.

In the interim, the Department filed in each case motions

to dismiss. The motions were denied. Together, the parties

filed a joint prehearing stipulation four days before final

hearing. In the stipulation, the parties "agreed that, since

Rule 10D-45.0545 is no longer in effect, the challenges to that

rule are moot." 1 Joint Exhibit No. 1.

At final hearing, no witnesses were called. The joint

exhibit was offered and admitted into evidence as well as three

exhibits of Discovery's, Discovery Exhibits No. 1 - 3, and four

of the Department's, Department's Exhibits No. 1 - 4. An

exhibit offered by Petitioner Kimball was marked as Kimball

Exhibit No. 1. The Department objected to the exhibit's

admission into evidence. Before a ruling was entered on the

objection, Mr. Kimball withdrew the offer.

The transcript of the proceeding was filed on January 29,

1999. Petitioners Discovery and Kimball filed their proposed

final orders on February 9, 1999; the Department filed its

proposed final order on February 10, 1999. All proposed final

orders were timely filed.

FINDINGS OF FACT

a. The Challenged Rules

1. Following the parties' stipulation that the challenges

by Petitioners to Rule 10D-45.0545 are moot, two rules remain in

this proceeding subject to challenge: Rules 64F-12.006 and 64F-

12.019, Florida Administrative Code. The parties further

stipulated that "[P]etitioners do not contest the rulemaking

procedures or requirements, used or followed by the Department

in the adoption of the rules which are the subject of these rule

challenges." Joint Exhibit No. 1, (c)(5), page 3.

i. Rule 64F-12.006; the Labeling Requirements Rule

2. Formerly numbered Rule 10D-45.39 and later 10D-45.039,

Rule 64F-12.006, (the "Labeling Requirements Rule") was amended

by a substantial rewording on June 11, 1996. The amendment took

effect July 1, 1996 (when it was numbered 10D-45.039). It has

not been amended since although it has been renumbered as Rule

64F-12.006. The part of Rule 64F-12.006, Florida Administrative

Code, challenged by Discovery, provides:

(1) The department hereby adopts and

incorporates by reference the labeling

requirements for prescription drugs and

over-the-counter drugs as set forth in the

federal act at 21 U.S.C. ss. 301 et seq. and

in Title 21 Code of Federal Regulations

Parts 1-1299.

* * *

Specific Authority 499.05 FS.

Law Implemented 499.007,499.0122,499.013 FS

History--New 1-1-77, Amended 12-12-82,

7-8-84, Formerly 10D-45.39, Amended 11-26-

86, 7-1-96, Formerly 10D-45.039.

ii. Rule 64F-12.019; the "Inspection Rule"

3. Formerly numbered Rule 10D-45.545 and later as Rule

10D-45.0545, Rule 64F-12.019, Florida Administrative Code, (the

"Inspection Rule") was last amended when still numbered 10D-

45.0545. The amendment was by a substantial rewording on

June 11, 1996; it became effective twenty days later, July 1,

1996. It has not been amended since, but it has been renumbered

with its present number. It provides:

Inspections, Investigations, Monitoring.

(1) Inspections and investigations are

conducted to determine compliance with the

provisions of Chapter 499, Chapter 893,

F.S.,

and this rule chapter and may include:

(a) entry at reasonable times or during

normal business hours to any property,

building, establishment, or vehicle;

(b) inspection of furniture and equipment,

finished or unfinished materials,

containers,

labels, labeling, products, supplies,

spaces,

records, files, papers, processes, controls,

and facilities;

(c) review and copying of all records

including receiving documents, shipping

documents, purchase orders, purchase

requisitions, invoices, paid receipts,

contracts, checks, deposits, and credits or

debits in any form whatsoever;

(d) surveillance of procedures;

(e) collection of facts and information;

(f) questioning of persons who may have

information relating to the inspection or

investigation and taking sworn statements

from these persons;

(g) sampling of products, materials,

documents, literature, labels, or other

evidence;

(h) photographing materials, physical plant,

articles or products;

(i) observations and identification of:

1. drugs, devices or cosmetics consisting

wholly or in part of filthy, putrid or

decomposed substances;

2. undesirable conditions or practices

bearing on filth, contamination, or

decomposition which may result in the drug,

device or cosmetic becoming adulterated or

misbranded;

3. unsanitary conditions or practices which

may render a drug, device or cosmetic

injurious to health;

4. faulty manufacturing, processing,

packaging, or holding of drugs, devices or

cosmetics as related to current good

manufacturing practices including inadequate

or inaccurate recordkeeping;

5. deviations from recommended processing,

storage or temperature requirements;

6. deviations of label and labeling

requirements;

7. any other action to determine compliance

with Chapters 499 and 893, F.S., and this

rule chapter.

(j) taking of evidence; and

(k) removing potentially misbranded or

adulterated drugs, devices, or cosmetics

from

commerce or public access.

(2) Inspections and investigations may be

announced or unannounced at the discretion

of

the department.

(3) The department shall take reasonable

steps to assure that a sampled product is

not

reintroduced into commerce if it is or has

become adulterated or misbranded.

Specific Authority 499.05 FS. Law

Implemented Ch. 499, Parts I, II, and III

FS.

History--New 7-8-84, Formerly 10D-45.545,

Amended 11-26-86, 7-1-96, Formerly

10D-45.0545.

b. The Parties

4. Discovery (Petitioner in Case No. 99-0005RX) is a drug

manufacturer. Its business establishment is located in Pasco

County at 29949 State Road 54 West, Wesley Chapel, Florida. As

a drug manufacturer, Discovery is regulated by Chapter 499,

Florida Statutes.

5. James T. Kimball (Petition er in Case NO. 99-0006RX) is

a private citizen of the State of Florida and the President of

Discovery. He resides at 6036 Country Club Road, Wesley Chapel,

Florida 33544.

6. The Department of Health is the agency of the State of

Florida responsible, inter alia , to "administer and enforce

[Part I of Chapter 499]," Section 499.004, Florida Statutes, the

"Florida Drug and Cosmetic Act." These duties are prescribed

for the Department in order "to prevent fraud, adulteration,

misbranding, or false advertising in the preparation,

manufacture, repackaging, or distribution of drugs . . ." Id.

Pursuant to power conferred on the Department's predecessor, the

Department of Health and Rehabilitative Services (power to which

the Department succeeded), the challenged rules were adopted

originally as part of Rule Chapter 10D-45.

c. Warrantless Searches

7. On May 12, 1993, agents of the Department of Health

conducted inspections without warrants at both Discovery's

business establishment and the residence of Mr. Kimball.

8. On July 13, 1994, agents of the Department of Health

conducted an inspection without a warrant at Discovery's

business establishment.

9. A number of items were seized by the agents during the

second search of Discovery's business establishment.

d. Filings with the Department of State

10. On June 11, 1996, the Department of Health and

Rehabilitative Services filed with the Department of State a

document denominated, "CERTIFICATION OF MATERIALS INCORPORATED

BY REFERENCE IN RULES FILED WITH THE DEPARTMENT OF STATE."

Department Exhibit No. 3. Included within an attachment of "a

true and complete copy of materials incorporated by reference

into Rule Chapter 10D-45, Florida Administrative Code . . ."

id. , were "21 U.S.C. ss. 301 et. seq. and federal regulations

promulgated thereunder in Title 21 Code of Federal Regulations

(CFR) referenced in Rule[] . . . 10D-45.039(1) . . ." Id.

11. The filing was confirmed on January 21, 1999, when the

Secretary of State certified "that the Food and Drug and

European Union Pharmaceutical Libraries (96-02) compact disc,

containing 21 U.S.C. ss. 301 et. seq. and federal regulations

promulgated thereunder in Title 21 Code of Federal Regulations,

was incorporated by reference in rule Chapter 10D-45, Florida

Administrative Code, rules and regulations of the Department of

Health and Rehabilitative Services, which was filed on June 11,

1996, as shown by the records of this office." Department

Exhibit No. 4.

CONCLUSIONS OF LAW

e. Jurisdiction

12. The Division of Adm inistrative Hearings has

jurisdiction over the parties and the subject matter of these

consolidated cases (challenges to existing rules). Section

120.56, Florida Statutes.

f. Standing

13. The parties stipulated to the standing of Discovery.

14. As to Mr. Kimball, the Department contends that he has

failed to prove standing and therefore, that his petition should

be dismissed.

15. Mr. Kimball, in turn, relies on both the inspection of

his residence in 1993 and his status as corporate president of

Discovery, a drug manufacturer, to support standing.

16. The record is not favored with a copy of the rule (the

"prior inspection rule") under which the Department conducted

inspections authorized by Chapter 499 at the time of the

inspection of Mr. Kimball's residence in 1993. No proof was

offered by Mr. Kimball of the nexus between either the prior

inspection rule or the existing rule and the inspection of his

residence in 1993. The department's inspection more than five

years ago of his residence, moreover, when another, however

similar, rule was in existence does not demonstrate that he is

affected today, or in the future, by the challenged rule.

17. Furthermore, Mr. Kimball neither alleged nor proved

that he is a drug manufacturer or that he comes within the ambit

of interests regulated either by the Florida Drug and Cosmetic

Act, Part I of Chapter 499, Florida Statutes, or the inspection

rule adopted by the Department under the Act.

18. Any reliance on his status as a corporate officer to

establish standing is subsumed under the standing of the

corporation to seek administrative relief in the form of a

declaration of the invalidity of the challenged rules.

19. In short, Mr. Kimball did not provide proof at hearing

to establish that he is substantially affected by the rules he

challenges. The petition in Case No. 99-0006RX should be

dismissed.

h. The Labeling Requirements Rule

20. The issues raised by Discovery with regard to the

Labeling Requirements Rule are set out in the Joint Prehearing

Stipulation:

Whether the documents filed with the

Department of State, in connection with Rule

64F-12.006, are sufficient to comply with

[s.] 120.54(1)(i) and (6)(e), Fla. Stat.

Joint Exhibit No. 1, p. 4.

21. The portions of Section 120.54, Florida Statues, th e

application of which are at issue, state:

(1) GENERAL PROVISIONS APPLICABLE TO ALL

RULES OTHER THAN EMERGENCY RULES.--

* * *

(i) A rule may incorporate material by

reference but only as the material exists on

the date the rule is adopted. For purposes

of the rule, changes in the material are not

effective unless the rule is amended to

incorporate the changes. No rule may be

amended by reference only. Amendments must

set out the amended rule in full in the same

manner as required by the State Constitution

for laws.

* * *

(6) ADOPTION OF FEDERAL STANDARDS.--

* * *

(e) Whenever all or part of any rule

proposed for adoption by the agency is

substantively identical to a regulation

adopted pursuant to federal law, such rule

shall be written in a manner so that the

rule specifically references the regulation

whenever possible.

22. Discovery's argument with regard to application of

Section 120.54(1)(i), Florida Statutes, is that the Labeling

Requirements Rule does not by its term specify the date the rule

was adopted or whether the material incorporated therein by

reference existed on the date the rule was adopted. Further,

Discovery argues, the rule does not by its terms identify with

specificity the Federal regulations that are intended to be

incorporated by reference therein.

23. With regard to the latter argument, the rule quite

clearly identifies the material to be incorporated by reference:

"the labeling requirements for prescription drugs and over-the-

counter drugs as set forth in the federal act at 21 U.S.C. ss.

301 et seq. and in Title 21 Code of Federal Regulations Part 1-

1299." It is true that the rule does not cull out from the

portions of the federal act and the code of federal regulations

identified the specific parts that relate to labeling

requirements. Without doubt, there are provisions of the

portions of the federal act and federal regulatory code cited in

the rule that do not relate to labeling. But there is no

requirement in Section 120.54(6)(e) for the specificity

Discovery demands. The statute requires only that the rule be

written in a manner so that it "specifically references the

[adopted federal] regulation whenever possible ." (emphasis

supplied) The reference in the rule to "22 U.S.C. ss. 301 et.

seq. and in Title 21 Code of Federal Regulations Part 1-1299" is

adequate for any reader of the rule in need of finding the

labeling requirements in federal regulatory law. These

references, moreover, meet the requirement of the statute that

the federal regulation be specifically referenced "whenever

possible." In short, while the references to federal

regulations in the rule could be more specific, they are

specific enough.

24. Subsection (6) of Section 120.54, Florida Statutes,

applies only to rules adopted "in pursuance of state

implementation, operation, or enforcement of federal programs."

Therefore, the Department argues, paragraph (e) of Subsection

(6), has no applicability here since, on its face, it implements

provisions of state law found in Chapter 499 of the Florida

Statutes, not any federal program. Indeed, Discovery did not

prove that the rule was adopted "in the pursuance of state

implementation, operation, or enforcement of federal programs."

As the Department asserts, the rule, on its face, appears to

implement provisions of state law, namely, the Florida Drug and

Cosmetic Act. In the implementation of that Act, the Department

has adopted certain federal standards as the Department's

standards. But there has been no showing that the Department is

attempting to enforce those standards as part of a federal

program.

25. As for the first argument made by Discovery, the

history portion of the rule shows that it was amended July 1,

1996. This date is the effective date of the amendments filed

on June 11, 1996. On the latter date, the Secretary of State

received a certification of materials incorporated by reference

in rules filed with the department of state. Among the material

so incorporated were "21 U.S.C. ss. 301 et. seq. and federal

regulations promulgated thereunder in Title 21 Code of Federal

Regulations (CFR) referenced in Rule[] . . . 10D-45.039(1) and

(2) [the predecessor to Rule 64F-12.006]." The materials filed

with the Department of State have not been shown by Discovery to

be anything other than material as it existed on the date the

rule was adopted.

26. There has been no proof offered by Discovery that the

rule violates in any way the requirements of Section

120.54(1)(i), Florida Statutes.

27. In sum, the labeling requirements rule has not been

shown to violate either paragraphs (1)(i) or (6)(e) of Section

120.54, Florida Statutes.

i. The Inspection Rule

28. Rule 64F-12.019, Florida Administrative Code, provides

for inspections and investigations by the department to

determine compliance with both Chapter 499, Florida Statutes,

(and the rules which implement Chapter 499) and Chapter 893,

Florida Statutes, the "Florida Comprehensive Drug Abuse

Prevention and Control Act." The rule implements all provisions

of Chapter 499, Florida Statutes.

29. Inspections conducted under the rule may be "announced

or unannounced at the discretion of the department." Rule 64F-

12.019(2), Florida Administrative Code. Significantly, the rule

does not require a warrant or probable cause that meets Fourth

Amendment "probable cause" standards for an inspection to be

conducted. In fact, the rule does not contain any language that

hints at the implication of Fourth Amendment rights.

30. Discussion of the Fourth Amendment's relationship to

administrative rules authorizing warrantless regulatory

inspections or searches occurred recently in appellate review of

a final order declaring such a rule of the Division of Pari-

Mutuel Wagering to be an invalid exercise of delegated

legislative authority. In Department of Professional Regulation

v. Calder Race Course, Inc., et al. , 23 Fla. L. Weekly D1795,

1st DCA, Op. filed July 29, 1998, the First District Court of

Appeal observed that the United State Supreme Court,

has recognized exceptions to the general

rule that warrantless inspections are

unconstitutional as violative of the Fourth

Amendment in cases such as Colonnade

Catering Corp. v. United States [citations

ommitted] (liquor dealer); United States v.

Biswell [citations ommitted] (gun dealer),

and Donovan v. Dewey [citations ommitted]

(stone quarry). The reason these exceptions

have been allowed involves the nature of the

business regulated. As the Court pointed

out in Marshall v. Barlow's, Inc. ,

[citations ommitted]:

Certain industries have such a history of

government oversight that no reasonable

expectation of privacy could exist for a

proprietor over the stock of such an

enterprise. Liquor (Colonnade) and firearms

(Biswell) are industries of this type; when

an entrepreneur embarks upon such a

business, he has voluntarily chosen to

subject himself to a full arsenal of

governmental regulation.

Industries such as these fall within the

"certain carefully defined classes of case,"

referenced in Camara [387 U.S.] at 528, 87

S.Ct. at 1731. The element that

distinguishes these enterprises from

ordinary business is along tradition of

close government supervision, of which any

person who chooses to enter such a business

must already be aware.

Calder Race Course , above, at D1796. The pharmaceutical

industry is such an industry. It has a long history of

pervasive supervision and inspection. United States v.

Jamieson-McKames Pharmaceuticals, Inc. , 651 F. 2d 532, 537-38

(8th Cir. 1981); cert. den. , 455 U.S. 1016 (1982).

31. The rule authorizing warrantless inspectio n in the

pari-mutuel industry had withstood a rule challenge prior to the

Calder decision because the rule was determined to be reasonably

related to its enabling legislation and found to be not

arbitrary or capricious. But the rule was declared invalid in

the wake of the 1996 amendments to the Administrative Procedure

Act because it was not supported by "a specific law to be

implemented." Section 120.52(8), Florida Statutes. This is not

the ground advanced by Discovery in making its case against the

Inspection Rule.

32. Instead, Discovery argues, in essence, that the rule

is "vague, fails to establish adequate standards for agency

decisions, or vests unbridled discretion in the agency," one of

the definitions for "invalid exercise of delegated legislative

authority," found in Section 120.52(8), Florida Statutes.

33. In making its argument, Discovery draws comparison

between the language of the current inspection rule and its

predecessor Rule 10D-45.0545, Florida Administrative Code. The

predecessor rule had been found to place reasonable limits upon

the discretion of the Department's inspectors in Arthritis

Medical Center v. State of Florida, Department of Health and

Rehabilitative Services , an unreported opinion, Case No. 87-

6078-CIV (US District Court, So. Dist. Fla., August 22, 1988),

rev. den. 473 F.2d 209 (11th Cir. 1989).

34. Discovery points out that the language of 10D-45.0545

in effect at the time of Arthritis Medical Center was definitive

so as to give guidance to the meaning of certain terms used in

the Rule. By way of example, Discovery points to language in

the rule as it existed at the time of the federal district court

decision which modifies the word "records" so as to define with

precision the records subject to inspection: "'all records and

other information required by Chapter 499 and the rules

promulgated thereunder available to the inspecting officer."

(Emphasis supplied.) Discovery's Proposed Final Order, p. 8.

35. The precision with which the term "records" was

described in the former rule underscores, for Discovery, the

vagueness of a number of terms used in the current Inspection

Rule. These terms are "records," "property," "building,"

"space" and "document."

36. As Discovery points out, none of the terms used in the

Inspection Rule and listed in paragraph 35, above, are defined

in the Inspection Rule, itself, in provisions of Chapter 499,

Florida Statutes, or in any of the rules promulgated for the

purpose of implementing Chapter 499.

37. Discovery offered into eviden ce definitions of these

same trms from Webster's New World Dictionary, Third College

Edition. Among the definitions for the noun, "record," are the

following:

2/a) anything that is written down and

preserved as evidence; account of events; b)

anything that serves as evidence of an

event, etc.; c) an official written report

of public proceedings, as in a legislature

or court of law, preserved for future

reference; 3/ anything that written evidence

is put on or in, as a register or monument;

4/a) the known or recorded facts about

anyone or anything, as about one's career;

Discovery Exhibit No. 2., p. 1122. As Discovery points out,

this definition, " anything that is written down and preserved as

evidence; account of events; . . . anything that serves as

evidence of an event, etc. " (emphasis supplied) is sweepingly

broad. Commonly understood definitions of the other terms of

which Discovery complains are likewise vast in scope and

indiscriminately broad:

building . . . n. 1. anything that is built

with walls and a roof, as in a house,

factory, etc.; structure.

id. , at 183 (emphasis supplied);

space . . . n. . . . 2 a) the distance,

expanse, or area between, over, within, etc.

things b) area or room sufficient for or

allotted to something [a parking space] . .

.

id., at 1284.

38. The Department counters Discovery's argument of

vagueness and overbreadth with the assertion that in the

argument, "the challenged terms are taken completely out of

context." Department's Proposed Final Order , p. 11.

39. The De partment points to the language of section (1)

of the Inspection Rule which declares the subject of what

follows to concern inspections and investigations which the

Department conducts for ". . . determining compliance with

Chapter 499 and 893, Florida Statutes." Since those statutes

relate only to the regulation of drug, devices, cosmetics, ether

and controlled substances, the Department concludes, "it is

patently absurd to argue that the challenged terms exceed what

these statutes require to document compliance." Id.

40. As the Department argues, the terms "records" and

"documents" necessarily, of course, include:

that which is required under good

manufacturing practice regulations. Section

499.013, F.S. requires such compliance, and

Rule 64F-12.001(2)(r), F.A.C. defines "State

Current Good Manufacturing Practises" to

incorporate federal regulations on this

subject. The records required of a

prescription drug wholesale distributor are

set forth in section 499.0121(6), F.S., and

Rule 64F-12.012, F.A.C., as to sales by the

manufacturer of its prescription drugs.

Id.

41. The terms "buildings" and "property" and "spaces" used

in the rule do not exceed delegated legislative authority, the

Department's argument goes, because Section 499.003, Florida

Statutes, and Section 499.051, Florida Statutes, only reference

the inspection of an "establishment," so that these terms as

used in the rule are limited by the statute to buildings and

property that constitute an establishment and spaces within an

establishment.

42. Indeed, Section 499.003(12) defines "establishment,"

as "a place of business at one general physical location."

Section 499.005 declares among those acts it is unlawful to

perform:

The refusal:

(a) To allow the department to enter or

inspect an establishment in which drugs,

devices, or cosmetics are manufactured,

processed, repackaged, sold, brokered, or

held;

(b) To allow inspection of any record of

that establishment ;

Section 499.005(6), Florida Statutes (emphasis supplied) And

Section 499.051, Florida Statues, containing the provisions

which authorize warrantless inspections within the drug

manufacturing industry provides, in pertinent part:

(1) The agents of the Department of Health

. . . and of the Department of Law

Enforcement, after they present proper

identification, may inspect, monitor, and

investigate any establishment permitted

pursuant to [Chapter 499] during business

hours for the purpose of enforcing . . .

chapter [499], 465, 501 and 893, and the

rules of the department that protect public

health, safety and welfare.

(2) In addition to the authority set forth

in subsection (1), the department and any

duly designated officer or employee of the

department may enter and inspect any other

establishment for the purpose of determining

compliance with the [law].

(emphasis supplied)

43. The Department's argument overlooks that not only does

the rule not define the terms Discovery sees as objectionable

but it lists some of those terms in a group of terms that

includes "establishment" as if "property" and "building" were

physical areas that go beyond the term "establishment."

Accentuating that point is the rule's use of the term "any" as a

modifier:

(1) Inspections and investigations . . . may

include:

(a) entry at reasonable time or during

normal business hours to any property,

building, establishment , or vehicle;

Rule 64F-12.019, Florida Administrative Code.

44. Were the Department's argument correct, so long as a

rule cited to the statutes it implements (which all rules must

do), it would never be invalid on one of the very bases for

invalidity found in the definition of "invalid exercise of

delegated legislative authority," in Section 120.52(8), Florida

Statutes:

[t]he rule enlarges, modifies, or

contravenes the specific provisions of law

implemented, citation to which is required

by s. 120.54(3)(a)1.;

Section 120.52(8)(c), Florida Statutes.

45. Comparison of the rule and the statute is decisive.

The rule does not circumscribe the terms at all. In contrast,

the statute makes clear that inspections are limited to

"establishments" as defined in Chapter 499. The rule would

allow inspection of homes, that is, the rule authorizes

warrantless inspections of places not historically subject to

pervasive governmental oversight. In other words, the rule

authorizes warrantless searches of places where reasonable

expectations of privacy do exist, places guaranteed protection

from unreasonable searches by the Fourth Amendment. There is no

reading of Chapter 499, Florida Statutes, by which one could

determine that this is what the legislature intended.

46. Discovery's challenge to the Inspection Rule fails in

one way. The terms complained of are not vague. Quite to the

contrary, Discovery has offered into evidence common dictionary

definitions of the terms that are strikingly clear.

47. But Discovery has otherwise soundly based its

challenge on one of the bases for determining a rule to be

"invalid exercise," paragraph (d) of Section 120.52(8), Florida

Statutes. The problem with the terms is that within the rule

they are not confined in the way the statute demands. The

difficulty with the terms is shown under the example of contrast

drawn by Discovery between "records required by Chapter 499 and

the rules promulgated thereunder," and simply "records" with no

delineation as to what "records" under the current rule are

meant. What must be meant, then, under the plain wording of the

rule is "all" records, whether they relate to or are required by

Chapter 499 and its rules or not. The same is true for the

other terms, "any building" and "any property." Thus, in acting

under the rule, agents of the Department do not have "adequate

standards for agency decisions [that is, the decision of where

and what to subject to an unannounced warrantless search]."

Under the plain wording of the Inspection Rule, they are free to

search any building, any property and all records, no matter

whether or not inside an establishment permitted under Chapter

499 or inside a place of business in one general location as

authorized by Section 499.051(2) and as defined in Section

499.003(12), Florida Statutes. At the same time, the breadth to

which these terms are plainly used in the rule, in contravention

of the statute implemented, and therefore, the rule, itself,

"vests unbridled discretion in the agency." Section

120.52(8)(d), Florida Statutes.

48. At bottom, the statute not only circumscribes when

such searches may take place but also the "where and of what"

the searches may take place pursuant to Chapter 499. The rule

by using the undefined and unrestrained terms of "property,"

"building," "spaces," and "records" does not.

49. The Inspection Rule is an invalid exercise of

delegated legislative authority.

ORDER

Based on the foregoing, it is, hereby, ORDERE D that:

1. Rule 64F-12.006, Florida Administrative Code, is not

determined to be invalid.

2. Rule 64F-12.019, Florida Administrative Code, is

determined to be an invalid exercise of legislative authority

because it fails to establish adequate standards for decisions

with regard to inspections by the Department and vests unbridled

discretion in the Department.

3. Jurisdiction is reserved to determine any appropriate

award of reasonable costs and attorney's fees pursuant to

Section 120.595(3), Florida Statutes.

DONE AND ORDERED this 22nd day of February, 1999, in

Tallahassee, Leon County, Florida.

___________________________________

DAVID M. MALONEY

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Par kway

Tallahassee, Florida 32399-3060

[phone] SUNCOM 278-9675

Fax Filing [phone]

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 22nd day of February, 1999.

ENDNOTE

1 The challenge is not merely moot. That the rule is no longer

in existence deprives the division of jurisdiction under Section

120.56, Florida Statutes:

CHALLENGING EXISTING RULES' SPECIAL

PROVISIONS.--

(a) A substantially affected person may

seek an administrative determination of the

invalidity of an existing rule at any time

during the existence of the rule .

COPIES FURNISHED:

James T. Kimball, pro se

29949 State Road 54, West

Wesley Chapel, Florida 33543

R. Elliott Dunn, Jr., Attorney

29949 State Road 54, West

Wesley Chapel, Florida 33543

Robert P. Daniti, Attorney

Angela Hall, Attorney

Steve Foxwell, Attorney

Department of Health

Bin A02

2020 Capital Circle, Southeast

Tallahassee, Florida 32399-1703

Carroll Webb, Executive Director

Joint Administrative Procedures Committee

Holland Building, Room 120

Tallahassee, Florida 32399-1300

Liz Cloud, Chief

Bureau of Administrative Code

The Elliott Building

Tallahassee, Florida 32399-0250

Angela T. Hall, Agency Clerk

Department of Health

Bin A02

2020 Capital Circle, Southeast

Tallahassee, Florida 32399-1703

Pete Peterson, General Counsel

Department of Health

Bin A02

2020 Capital Circle, Southeast

Tallahassee, Florida 32399-1703

Dr. James Howell, Secretary

Department of Health

Bin A00

2020 Capital Circle, Southeast

Tallahassee, Florida 32399-0703

NOTICE OF RIGHT TO JUDICIAL REVIEW

A party who is adversely affected by this Final Order is

entitled to judicial review pursuant to Section 120.68, Florida

Statutes. Review proceedings are governed by the Florida rules

of Appellate Procedure. Such proceedings are commenced by

filing one copy of a notice of appeal with the Clerk of the

Division of Administrative Hearings and a second copy,

accompanied by filing fees prescribed by law, with the District

Court of Appeal, First District, or with the District Court of

Appeal in the Appellate District where the party resides. The

notice of appeal must be filed within 30 days of rendition of

the order to be reviewed.