93-000244RP Florida Nutrition Counselors Association vs. Board Of Medicine, Dietetics And Nutrition Practice Council Status: Closed DOAH Final Order on Friday, May 6, 1994.

Summary: All proposed rules under challenge held valid except that which states counselors "should" report apparent rule violations which was invalid as vague.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

FLORIDA NUTRITION COUNSELORS )

ASSOCIATION, )

)

Petitioner, )

)

vs. ) CASE NO. 93-0244RP

)

DEPARTMENT OF BUSINESS AND )

PROFESSIONAL REGULATION, BOARD OF )

MEDICINE, DIETETICS AND NUTRITION )

PRACTICE COUNSEL, )

)

Respondent. )

__________________________________)

FINAL ORDER

A hearing was held in this case in Tallahassee, Florida on January 24 - 26,

1994, before Arnold H. Pollock, a Hearing Officer with the Division of

Administrative Hearings.

APPEARANCES

For the Petitioner: Frank R. Rainer, Esquire

Gerald B. Sternstein, Esquire

Ruden, Barnett, McClosky, Smith,

Schuster and Russell, P.A.

215 South Monroe Street, Suite 815

Tallahassee, Florida 32301

For the Respondent: Ann Cocheu, Esquire

M. Catherine Lannon, Esquire

Office of the Attorney General

Suite PL-01, The Capitol

Tallahassee, Florida 32399

STATEMENT OF THE ISSUES

The issue for consideration in this hearing is whether the Board of

Medicine's proposed amendments to Rules 21M-49.002(6), 21M-50.002(3)(f) and (j),

21M-50.003(1), 21M-50.007(3) and (18), and 21M-50.009(1), F.A.C., are invalid

because of being vague and an invalid exercise of delegated legislative

authority.

PRELIMINARY MATTERS

Notice of the propose rule amendments in issue here, as identified above,

was published on December 31, 1992 in the Florida Administrative Weekly.

Shortly thereafter, on January 21, 1993, the Florida Nutrition Counselors

Association, (Association), filed a Petition to determine the validity of the

proposed rule amendments.

This matter was originally assigned to the undersigned to hold the required

formal hearing, and by Notice of hearing dated January 27, 1993, the matter was

set for hearing in Tallahassee on February 16, 1993.

Respondent, on February 3, 1993, filed a Motion to Dismiss which was denied

by the undersigned on February 12, 1993, by Order in which he also granted the

parties' Joint Motion For Continuance and reset the hearing for April 26, 1993.

On April 16, 1993, the undersigned granted Respondent's unopposed Motion For

Continuance and required the parties to respond by May 15, 1993 with preferred

hearing dates.

This case was thereafter reassigned to Hearing Officer William F.

Quattlebaum who, on July 2, 1993, entered an order establishing prehearing

procedures. On July 20, 1993, Hearing Officer Quattlebaum set the case for

hearing on August 18 - 20, 1993. Petitioner's subsequent Motion For Continuance

was denied by Order dated July 30, 1993, but by Order dated August 12, 1993,

Hearing Officer Quattlebaum cancelled the hearing because the parties had not

properly complied with his earlier Order establishing prehearing procedures.

The matter was subsequently again transferred to the undersigned who, by Order

dated September 10, 1993, set hearing for January 24, 1994 at which time it was

held as scheduled.

At the hearing, Petitioner presented the testimony of seven witnesses, six

of whom were present at the hearing and one of whom testified by telephone.

Petitioner also introduced Petitioner's Exhibits 1 - 8. Respondent presented

the testimony of seven witnesses and introduced Respondent's Exhibits D and E.

Together the parties introduced Joint Exhibits 1 - 12.

FINDINGS OF FACT

1. At all times pertinent to the issues herein, the Florida Board of

Medicine, (Board), was the state agency responsible for the licensing of medical

professionals and the regulation of the medical profession in Florida. A sub-

agency of the Board is the Dietetics and Nutrition Practice Council, (Council).

The Council is the agency which drafted and initially promulgated the proposed

rule amendments herein concerned, though the Board is ultimately responsible for

the final promulgation of the rules and amendments thereto.

2. The Florida Nutrition Counselors Association is an organization of

approximately 150 Florida-licensed health care practitioners. No evidence was

produced by either party to indicate how many individuals are licensed as

nutrition counselors in this state or how many practitioners of that profession

may be substantially affected by the proposed rule amendments.

3. The Council was established in 1989, and since that time has been

concerned with licensure issues regarding dietitians, nutritionists and

nutrition counselors. Over the intervening years the Council became concerned

that some nutrition counselors might be practicing outside the permissible

parameters of their specialty and as a result, the Board directed the Council to

draft proposed rules designed to insure the proper practice of that profession.

4. Thereafter, workshops were held to solicit public input and collect

documents to be used in the drafting of the proposed rules and amendments to

existing rules. There is no allegation that the rule-making methodology

followed by the Council was either inappropriate or unlawful and it is found

that the process followed was lawful. As the drafting process continued, though

no members of the Association were represented on the Council, Association

members were afforded the opportunity to and did participate and/or observe.

Much of the preliminary activity of the Council consisted of surveying the

scientific community to identify the prevailing standards for the practice of

nutrition.

5. Encompassed within the framework of the National Nutritional Foods

Association is a trade association for health food and supplement retailers and

nutrition counselors. This organization, known as SoHo, has been involved in

the legislative process relating to the practice of nutrition and dietetics in

Florida for several years. Representatives of this organization were present

during a portion of the rule-making process and were afforded the opportunity to

discuss the possible economic impact the proposed rules and amendments would

have on its membership. It was determined this effect would be minimal and this

determination was made known to Petitioner by letter from counsel for the Board

to counsel for Petitioner. In addition, Petitioner was invited to submit input

on this issue before a joint session of the Board and Council but failed to do

so. Therefore, the aforementioned letter from counsel was adopted as the

economic impact statement.

6. Whereas the legislature has recognized that the practice of dietetics

and nutrition by unskilled and incompetent practitioners presents a danger to

the public health and safety it has not, itself, set any standards for that

practice. Instead, it has authorized the Board of Medicine and the Council to

adopt rules to implement such standards in furtherance of the legislative

purpose to protect the public. In some instances, the proposed rule amendments

would prohibit or interfere with the currently existing practices of some

nutrition counselors. In that regard, it should be noted that many nutrition

counselors were licensed under a grandfather provision without examination or

other means of establishing qualification to practice.

7. Nutrition counseling is an emerging profession. Its orientation is to

promote the health of people though nutrition. There are, currently, no

national organizations for nutrition counselors and only twelve states require

them to be licensed.

8. Nutrition counselors, generally, perform an assessment of a client's

nutritional condition and, thereafter, suggest foods or food supplements to

provide for or rectify any deficiencies identified. Nutrition counselling can

also be an educational tool, but the bona fide nutrition counselor does not

prescribe items designed to cure conditions.

9. Dietitians make up a much more established profession whose orientation

is the delivery of foods, planning menus, institutional food service, recipe

development and the quantitative analyses of foods. Having developed out of the

home economics programs at university level, they are well organized nationally

through the American Dietetic Association, and in Florida through the Florida

Dietetics Association. As opposed to nutrition counselors, who perform in a

community setting, dieticians work in a more clinical setting. Both are

ancillary health professionals who work both with a physician and independently.

10. There are many methods used to perform a nutrition assessment, but for

the most part, all include the taking of simple measurements of the client's

height, weight, mid-arm circumference, blood serum, albumin and serum

transferrin, and a history of the client's diet and life-style. It is common

for the nutrition counselor to have the client obtain a blood and urine test

through a physician.

11. Some practitioners utilize such procedures as hair analysis,

biological ionization, herbology or iridology. All are non-invasive. These

latter procedures are not well recognized in the mainstream of nutrition and

dietetics, however, and are considered, by the mainstream medical and dietetics

professionals, not to be standard tests for nutrition assessments.

12. The major thrust of nutrition counseling is the improvement of

nutritional intake and it is entirely appropriate for the nutrition counselor to

confer with the client's physician to obtain information about medical

conditions and medications being taken, and to seek the physician's assistance

by ordering laboratory testing.

13. The term, "nutrition counselor" is but a title. The practice of

nutrition counseling is a technique utilized within the parameters of the

broader field of nutrition. Both nutritionists and nutrition counselors provide

counsel and are bound by appropriate standards for counseling.

14. The proposed amendment to Rule 21M-49.002(6), which outlines those

activities prohibited to nutrition counselors refers to such proscribed

activities as diagnosis, treatment, operation, prescription for disease, pain,

injury, deformity other physical or mental condition. The proposed amendment

adopts the practice of medicine definition as outlined in Florida Statutes.

15. Diagnosis is the identification of or the ruling out of specific

disease states. Nutrition counselors do not diagnose disease, pain or injury.

Identification of nutritional deficiencies and the recommendation of specific

foods of food supplements to correct those nutritional deficiencies do not

constitute the diagnosis, or treatment prohibited by the proposal. Assessment

of physical and mental conditions, however, closely approaches diagnosis which

is the sole purview of the physician. If a physician diagnoses a physical

condition and identifies the cause thereof, and thereafter refers the patient to

a nutrition counselor for development of a dietary plan, the counselor may,

within those parameters, work with the client to develop a diet and supplement

plan consistent with the physician's diagnosis and recommended treatment.

16. Proposed amendment to Rule 21M-50.002(3), relating to fraudulent,

false, deceptive or misleading advertising, prohibits reference to questionable

methods of assessment or treatment or treatment which is experimental or without

generally accepted scientific validation.

17. As with any other science, experimentation is an acceptable part of

research but it must always be conducted only under strictly regulated

conditions, and only physicians may carry on patient experimentation. Patient

experimentation is not a part of the scope and practice of nutrition counseling

as defined by the Dietetics and Nutrition Practice Act.

18. As mentioned previously, some nutrition counselors utilize certain

procedures which are not accepted as valid by the more established medical and

nutrition communities. These may include hair analysis, iridology, blood

ionization and herbology, and have been characterized by some in the scientific

community as "questionable methods."

19. "Questionable methods" and "generally accepted scientific validation"

are phrases which have a generally accepted meaning within the scientific

community. In general, the latter refers to those principles and that pertinent

information which has been effectively tested by qualified evaluators against

known standards and validated by results found to be routinely consistent and

reliable. This is neither difficult to understand or to follow.

20. Proposed Rule amendment 21M-50.007(3) restricts the practice of

nutrition counseling to generally accepted scientific principles and current

information.

21. To be sure, there is a plethora of information and procedures which

exists on the periphery of established science and for which there is a fund of

supporting information and a host of advocates. When tested in scientific

evaluation against known standards and analyzed statistically for acceptance

within the scientific community, this information and these procedures are

usually found to be insufficiently supported and generally unaccepted in the

better practice of nutrition and dietetics.

22. Proposed Rule 21M-50.007(18) suggests, by the use of the operative

word, "should", that nutrition counselors police themselves by upholding their

standards for professional practice and by reporting violations to the Council,

the Board, and the Department. While this provision is not mandatory, it is

expected to be followed. Petitioners object to it as unnecessary and as having

the potential for subjecting one practitioner to discipline because of the

misconduct of another. As proposed, it is inartful, vague, and, conceivably,

unenforceable.

23. Petitioners also object to the provisions of Proposed Rule 21M-

50.009(1) which prohibits the use of instruments, devices or treatments not

regularly taught in a recognized college or university. In that regard, most

colleges do not treat extensively upon the subject of nutrition counseling which

is, to a large extent, ignored by the mainstream medical profession. Most

nutrition counseling techniques are taught at workshops and seminars and in

apprenticeships. For this reason and because of their belief that the proposed

rule does not accurately reflect the current standard of practice in the

profession, Petitioners object to it. Little, if any, evidence in support of

this position was set forth, however.

24. Proposed Rule 21M-50.009(1) also lists those procedures which are

prohibited to the practice of nutrition counseling and which include biological

ionization, biomagnetic devices, cytoloxic testing, hair analysis, herbology,

homeopathy, iridology, nutropathy, and oxidation/ionization devices or

psychotronics-radiation devices. Those in issue here are herbology, iridology,

hair analysis and biological ionization. Petitioners have abandoned their

challenge to the remainder.

25. Herbology is not an assessment tool but a modality. It comes closest

to being classified as current information within the definition of the proposed

rules.

26. Iridology, which is an analysis of the human condition through

examination of the iris, is considered by the Board to be within the parameters

of the practice of medicine. It is non-invasive and has not been shown to cause

physical harm. It is an assessment technique but not a diagnostic tool, a cure

or treatment. It is designed to show cholesterol and body acid levels, but it

is, however, felt to be unproven and bordering on quackery by the mainstream

medical profession whether accomplished by a medical doctor or a nutrition

counselor.

27. Hair analysis, a procedure utilized by an unknown number of

Association members, including its President, involves the analysis of hair

samples taken from the client to determine the presence of trace minerals, and

as a toxic metal screen. Though used in criminology and by the Environmental

Protection Agency to detect toxic metal exposure in environmental enforcement,

hair analysis is not mainstream practice and it can be influenced by numerous

outside factors, including hair dye and other preparations, the age of the

sample, and the like. Hair is considered a tissue sample which, under Florida

law, can be submitted to a properly licensed clinical laboratory only by

appropriately licensed persons. Nutrition counselors do not fall within this

category. Hair analysis is not invasive nor is the gathering of hair for

analysis.

28. Most clinical laboratories recognize approximately 2,000 laboratory

tests. Hair analysis in not one of them. While there are many licensed

clinical laboratories in this state, only eight laboratories, nationwide, do

hair analysis. None are in Florida except for laboratories which perform

analysis of hair samples for forensic purposes.

29. In biological ionization, used in conjunction with iridology, urine

and saliva samples are provided by the client and are measured for ph factor.

While this procedure is done by an unknown number of Association members, it is

not considered by the medical profession to be an acceptable assessment.

CONCLUSIONS OF LAW

30. The Division of Administrative Hearings has jurisdiction over the

parties and the subject matter in this case. Section 120.57(1), Florida

Statutes.

31. Petitioners allege that, when considering the entire applicable

statutory scheme applicable to the proposed rules herein, the Board and Council

have unlawfully enlarged, modified and contravened the applicable underlying

enabling statutory authority for their promulgation. To succeed in this

challenge, Petitioners have the burden of establishing the correctness of their

position by a preponderance of the evidence. Dravo Basic Materials Company, Inc.

v. Department of Transportation, 602 So.2d 632, 635 (Fla. 2DCA 1992); Agrico

Chemical Company v. Department of Environmental Regulation, 365 So.2d 759, 763

(Fla. 1DCA 1978).

32. Agency rules are presumed to be correct. The court, in Agrico, supra,

noted that when, as here, a rule is challenged as being arbitrary and

capricious, those terms are defined as follows:

A capricious action is one which is taken

without thought or reason or irrationally.

An arbitrary decision is one not supported by

facts or logic, or despotic. Administrative

discretion must be reasoned and based upon

competent substantial evidence. Competent

substantial evidence has been described as

such evidence as a reasonable person would

accept as adequate to support a conclusion.

33. The court has also stated, in Adam Smith Enterprises v. State,

Department of Environmental Regulation, 553 So.2d 1260, 1273 (Fla. 1DCA 1989),

that an agency's rule-making activity is to be subjected to only the most

rudimentary requirement of rationality by a reviewing court which must consider

whether the agency: (1) has considered all relevant factors; (2) has given

actual, good faith consideration to those factors; and (3) has used reason

rather than whim to progress from consideration of these factors to its final

decision.

34. As early as 1974, the First District Court of Appeals clearly

elucidated the proposition that when the legislature has delegated broad

discretionary rule-making authority to an agency, the validity of regulations

promulgated thereunder will be sustained so long as "they are reasonably related

to the purposes of the enabling legislation and are not arbitrary or

capricious." Florida Beverage Corporation v. Wynne, 306 So.2d 200, 202 (Fla.

1DCA 1974).

35. That same court, in Department of Professional Regulation, Board of

Medical Examiners v. Durrani, 455 So.2d 515 (Fla. 1DCA 1984), affirmed earlier

decisions when it held:

The well recognized general rule is that

agencies are to be accorded wide discretion

in the exercise of their lawful rule-making,

clearly conferred or fairly implied and

consistent with the agencies' general

statutory duties. An agency's construction

of the statute it administers is entitled to

great weight and is not to be overturned

unless clearly erroneous.

* * *

Moreover, the agency's interpretation of a

statute need not be the sole possible

interpretation or even the most desirable

one; it need only be within the range of

possible interpretations.

36. Petitioner also challenges these proposed rules for vagueness. The

test for that is, (1) whether persons of common intelligence are required to

guess at the rule's meaning, and (2) whether persons affected by the rule were

properly apprised of the rule's effect on them. In this assessment, the

language of the rule must be given its plain meaning. City of St. Petersburg v.

Pinellas County Police Benevolent Association, 414 So.2d 293 (Fla. 2DCA 1982);

Boca Raton Artificial Kidney Center v. Department of Health and Rehabilitative

Services, 493 So.2d 1055 (Fla. 1DCA 1986).

37. When the empowering provision of a statute does no more than provide

an agency may "make such rules and regulations as may be necessary to carry out

the provision of this act," the rules will be sustained so long as they are

reasonably related to the purposes of the enabling legislation and are not

arbitrary or capricious. General Telephone Co. of Florida v. Florida Public

Service Commission, 446 So.2d 1063, 1067 (Fla. 1984). In this case, Section

468.507, Florida Statutes, provides:

(1) The board may adopt such rules not

inconsistent with law as may be necessary to

carry out the duties and authority conferred

upon the board by ss. 468.501 - 468.518 and

chapter 455. The powers and duties as set

forth [herein] shall in no way limit or

interfere with its powers and duties set

forth in chapter 458. All powers and duties

of the board set forth [herein] shall be

supplemental and additional powers and duties

to those conferred upon the board by chapter 458.

It is clear from this section that the Board is given broad authority to

promulgate rules designed to govern the practice of nutrition counseling in

addition to the practice of medicine, both within the framework of its charter

to protect the health, safety and welfare of the public.

38. This provision is not, however, immune from application in conjunction

with and consideration in comparison to the provisions of Section 455.201,

Florida Statutes. This provision sets reasonable limits on the operations,

including rule-making, of the various regulatory boards within the Department of

Professional Regulation. It provides:

(1) It is the intent of the Legislature that

persons desiring to engage in any lawful

profession regulated by the Department of

Professional Regulation shall be entitled to

do so as a matter of right if otherwise

qualified.

(2) The Legislature further believes that

such professions shall be regulated only for

the preservation of the health, safety and

welfare of the public under the police powers

of the state. Such professions shall be

regulated when:

(a) Their unregulated practice can harm

or endanger the health, safety and welfare of

the public, and when the potential for such

harm is recognizable and clearly outweighs

any competitive impact which may result from

licensing.

(b) The public is not effectively

protected by other means, including but not

limited to, other states' statutes, local

ordinances, or federal legislation.

(c) Less restrictive means of regulation

are not available.

(3). No board within the Department of

Professional Regulation shall create

unreasonably restrictive and extraordinary

standards that deter qualified persons from

entering the various professions.

39. Both Petitioner and Respondent agree that the language contained in

Proposed Rule 21M-49.002, including the terms "diagnosis, treatment, operation

or prescription for any human disease, pain, injury, deformity, or other

physical or mental condition" whether phrased as the definition of the practice

of medicine in Section 458.305(3), Florida Statutes, or as the "anti-definition"

of nutrition counseling as set out in the proposed rule, is, in fact, a form of

the definition of the practice of medicine.

40. Petitioner claims that by promulgating that definition, the Board has

imposed the definition for the practice of medicine on nutrition counselors, an

action which enlarges the application of Section 458.305, Florida Statutes,

which provides, at subsection (1)(a):

The provisions of ...[this section] shall

have no application to:

Other duly licensed health care practitioners

acting within their scope of practice

authorized by statute.

41. Petitioner's argument is not well taken. In Section 468.503(4),

Florida Statutes, the legislature has defined dietetics and nutrition practices

as including:

... assessing nutrition needs and status

using appropriate data; recommending

appropriate dietary regimens, nutrition

support, and nutrition intake; improving

health status through nutrition research,

counseling, and education; and developing,

implementing, and managing nutrition care

systems, which includes, but is not limited

to, evaluating, modifying, and maintaining

appropriate standards of high quality in food

and nutrition care services.

In addition, at Section 468.503(9), nutrition counseling is defined as:

... advising and assisting individuals or

groups on appropriate nutrition intake by

integrating information from the nutrition

assessment.

42. In furtherance of the legislature's obvious intention to limit the

scope of nutrition and nutrition counseling practice, by Section 468.518(1)(j)

and (k) it established as bases for disciplinary action to be taken against

offending nutritionists or nutrition counselors:

Treating or undertaking to treat human

ailments by means other than by dietetics and

nutrition practice as defined in ss 468.501 -

468.518.

and

Failing to maintain acceptable standards of

practice as set forth by the board and the

council in rules adopted pursuant to ss

468.501 - 568.518.

43. It is obvious, therefore, that the Board intended for there to be no

misunderstanding as to what was permissible practice for nutrition counselors.

Not only did it define what nutrition counseling encompassed, it also made it

clear that doing those things which constitute the practice of medicine is not

nutrition counseling and might well subject the offender to discipline. Such

action, while perhaps evidencing an overabundance of consideration for the

Board's regulatees, can certainly not be considered vague or an arbitrary or

capricious act. Therefore, it is not an invalid exercise of delegated

legislative authority.

44. Petitioner has objected to the promulgation of proposed rule 21M-

50.002(3)((f) because of the board's use of the terms, "questionable method of

assessment or treatment", "experimental", or "without generally accepted

scientific validation" as the standard by which a determination will be made if

advertising by nutrition counselors is false, fraudulent, deceptive or

misleading; and of proposed rule 21M-50.007(3), because of the use of the terms

"generally accepted scientific principles" and "current information" to

determine the standard of practice for nutrition counselors. The Association

also contests the banning of practices or procedures which are not contained in

textbooks or taught in accredited colleges, and challenge is also laid to the

banning of the use of hair analysis, biological ionization, iridology and

herbology by nutrition counselors, all of which is provided for in proposed rule

21M-50.009(1).

45. Bases for disciplinary action against nutrition counselors are found

in Sections 468.518(1)(g), (h), (j) and (k), which, respectively, authorize

discipline for:

advertising goods or services in a manner

which is fraudulent, false, deceptive, or

misleading in form or content;

committing an act of fraud or deceit, or

negligence, incompetence, or misconduct in

the practice of dietetics or nutrition;

treating or undertaking to treat human

ailments by means other than by dietetics and

nutrition practice as defined in ss. 468.501

- 468.518; or

failing to maintain acceptable standards of

practice as set forth by the board and the

council in rules adopted pursuant to ss. 468-

501 - 468.518.

46. Petitioner claims the board was not granted the "right" to adopt

regulations utilizing the contested terms as standards. The legislature does

not define or direct the language to be contained in rules and guidelines

promulgated by agencies pursuant to a legislative grant of rule-making

authority. The term used by the legislature in this case was "such rules not

inconsistent with law as may be necessary."

47. The legislature also defined as the purpose for the regulation of the

practice of dietetics and nutrition as the reduction or removal of the danger to

the public by such practice by unskilled and incompetent practitioners.

(Section 468.502). It is but fitting and proper that the legislature left to

those most qualified to define the standard of practice what should be

encompassed within the scope of such practice, and how such practice should be

carried out. A reasonable exercise of that authority, as here, is neither

arbitrary nor capricious.

48. The terms complained of by Petitioner here are, as used in these

proposed rules, words of art which have a meaning particular to the profession

to be regulated. When the public health, welfare and safety are involved, the

legislature has the responsibility to demand, and the Board has the duty to

insure, that those who deal with the public's health, safety and welfare are the

best qualified to do so, and who utilize the most appropriate, proven, and

reliable procedures in doing so. To claim that the Board does not have the

authority to define and impose standards for practice and procedure is patently

incorrect. The evidence of record here clearly indicates the Board's

interpretation of the enabling statute is both permissible and reasonable.

49. Petitioner argues that the Board's implementation of the proposed

rules fails to recognize the inherent right of professionals to practice their

profession free from "value decisions being made about practice methodologies

which are not shown to be harmful or fraudulently proposed to the public." It

also contends that the proposals do not impose the least restrictive means of

regulation, citing the evidence of federal regulatory bans against medical

devices. To accept Petitioner's arguments here would be to concede that the

Board has no right to regulate where the federal government is also regulating.

Clearly, this position is unsupportable.

50. Petitioner claims the Board's proposed rules create evidentiary

presumptions which are the exclusive province of the legislature. Specifically,

it cites the proscription against the use of assessments or counseling

modalities, treatments, or procedures which have been deemed "unproven,

questionable, experimental, without generally accepted scientific validation"

and the like. To be sure, those criteria require the making of value

judgements, but the enforcement process provides an appropriate means for making

those value judgements, and a process for their review. Again, this is neither

arbitrary nor capricious.

51. The framers of the proposed rules, acting in open session at workshops

at which members of the Petitioner organization were welcome and received,

drafted them in such a manner as to insure the public could understand them and

practitioners comply with them. Petitioner, with one exception, has not

satisfied its burden to show, by a preponderance of the evidence, that the rules

are vague or vest the agency with unbridled authority to selectively enforce

them. That selected individuals might consider them vague and meaningless is

not binding on this tribunal, and a characterization that they are subject to

Board and Council discretion is not fatal so long as that discretion is properly

exercised.

52. In only one case does it appear that the Board's proposed rule is

defective for vagueness. In proposed rule 21M-50.007(18), the Board asserts the

licensee:

... should accept the obligation to protect

society and the profession by upholding the

standards for professional practice and

conduct and by reporting alleged

misrepresentations and violations of the

rules and Statutes to the Council, Board, or

Department.

The use of the term "should" as the operative word of a subparagraph in a

proposed rule which purports to set the standards of practice for the

profession, leaves too much to subsequent interpretation and would be difficult

to enforce. As was stated previously herein, the language of this provisions is

inartful and too vague to permit the provision to stand.

53. Petitioner has submitted a lengthy yet scholarly discussion and

argument in support of its position that the proposed rules in issue here were

enacted without authority to do so and are, as enacted, not only vague but also

arbitrary and capricious. It is, however, for the most part, not persuasive.

Taken as a whole, the evidence and argument by the Petitioner does not support a

conclusion that the proposed rules, with one exception, must be rejected. It

is, therefore:

ORDERED THAT

Petitioner, Florida Nutrition Counselors Association's, Petition to

Challenge Proposed Rule 21M-49.002, 21M-50.002, 21M-50.003, 21M-50.007(3), and

21M-50.009, is rejected and the dismissed, but the challenge to proposed rule

21M-50.007(18) is sustained and that proposed rule is deemed invalid as fatally

vague.

DONE AND ORDERED this 6th day of May, 1994, in Tallahassee, Florida.

__________________________________

ARNOLD H. POLLOCK, Hearing Officer

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-1550

[phone]

Filed with the Clerk of the

Division of Administrative Hearings

this 6th day of May, 1994.

APPENDIX TO FINAL ORDER

IN CASE NO. 93-0244RP

The following constitutes my specific rulings pursuant to Section

120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted

by the parties to this case.

FOR THE PETITIONER:

1. Accepted except for the term Committee in line 4 which

should be Council.

2. - 8. Accepted and incorporated herein.

9. Accepted.

10. Not a Finding of Fact but a listing of witnesses

qualified as experts.

11. & 12. Accepted and incorporated herein.

13. Accepted.

14. - 23. Accepted and incorporated herein.

24. Rejected as a Finding of Fact. A restatement of the

proposed rule.

25. Accepted and incorporated herein.

26. Accepted.

27. & 28. Accepted and incorporated herein.

29. & 30. Accepted.

31. Accepted but not probative of any contested issue of

fact.

32. Rejected.

33. Not a Finding of Fact but a Conclusion of Law.

34. Rejected as speculation.

35. Not a Finding of Fact but a Conclusion of Law.

36. Not a Finding of Fact. A restatement of the proposed

rule.

37. Accepted and incorporated herein.

38. & 39. Accepted but not probative of any contested issue of

fact.

40. Rejected.

41. & 42. Accepted.

43. Rejected as not supported by evidence of record.

44. Accepted.

45. Rejected as argument and not Finding of Fact.

46. Accepted.

47. & 48. Rejected as argument and not Finding of Fact.

49. Accepted.

50. Accepted as statement of position but not probative

of any one issue since several subjects are treated.

51. Rejected.

52. & 53. Rejected as argument and irrelevant to any issue

involved.

54. Not a Finding of Fact. A restatement of the proposed

rule.

55. Argument, not fact.

56. Accepted.

57. & 58. Rejected as argument and not proper Finding of Fact.

59. Not a Finding of Fact. A restatement of the proposed

rule.

60. Accepted.

61. Accepted as a position statement.

62. Not a Finding of Fact. A restatement of the proposed

rule.

63. Accepted as explanatory of rule.

64. & 65. Accepted and incorporated herein.

66. Accepted.

67. Accepted and incorporated herein.

68. - 70. Accepted.

71. Rejected as irrelevant to any issue of fact herein.

72. Not a Finding of Fact. A restatement of the proposed

rule.

73. & 74. Accepted.

75. Accepted and incorporated herein.

76. - 78. Accepted.

79. & 80. Accepted and incorporated herein.

81. - 83. Accepted.

84. - 90. Accepted and incorporated herein.

91. Rejected.

92. Accepted and incorporated herein.

93. Accepted and incorporated herein.

94. & 95. Accepted.

96. Accepted but irrelevant to any issue of fact herein.

FOR THE RESPONDENT:

1. & 2. Accepted and incorporated herein.

3. - 6. Accepted and incorporated herein.

7. - 11. Accepted.

12. Accepted and incorporated herein.

13. Not a Finding of Fact but a statement of position.

14. - 18. Accepted and incorporated herein.

19. & 20. Accepted and incorporated herein.

21. Irrelevant to any issue of fact or law herein.

22. First Sentence accepted and incorporated herein.

Balance is only a restatement of testimony.

23. Accepted and incorporated herein.

24. & 25. Accepted and incorporated herein.

26. Accepted.

27. Not a Finding of Fact but a comment on the evidence.

28. & 29. Not Findings of Fact but statements of opposing

party's position.

30. Accepted.

31. Not a proper Finding of Fact. More a comment on the

evidence.

32. & 33. Not Findings of Fact but comments on the weight of the

evidence.

34. First and second sentences accepted. Third sentence,

along with Proposed FOF 35 no more than a recitation

of party position.

35. See above.

36. & 37. Accepted.

38. & 39. Accepted.

40. & 41. Accepted.

42. - 44. Accepted and incorporated herein.

45. Accepted.

COPIES FURNISHED:

Frank R. Rainer, Esquire

Gerald B. Sternstein, Esquire

Ruden, Barnett, McClosky, Smith,

Schuster and Russell, P.A.

215 South Monroe Street

Suite 815

Tallahassee, Florida 32301

Ann Cocheu, Esquire

M. Catherine Lannon, Esquire

Assistant Attorneys General

Suite PL-01, The Capitol

Tallahassee, Florida 32399

George Stuart

Secretary

Department of Business and

Professional Regulation

1940 North Monroe Street

Tallahassee, Florida 32399-0792

Jack McRay

General Counsel

Department of Business and

Professional Regulation

1940 North Monroe Street

Tallahassee, Florida 32399-0792

Dr. Marm Harris

Executive Director

Board of Medicine

1940 North Monroe Street

Tallahassee, Florida 32399-0792

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions to this Recommended

Order. All agencies allow each party at least 10 days in which to submit

written exceptions. Some agencies allow a larger period within which to submit

written exceptions. You should consult with the agency which will issue the

Final Order in this case concerning its rules on the deadline for filing

exceptions to this Recommended Order. Any exceptions to this Recommended Order

should be filed with the agency which will issue the Final Order in this case.

=================================================================

DISTRICT COURT OPINION

=================================================================

IN THE DISTRICT COURT OF APPEAL

FIRST DISTRICT, STATE OF FLORIDA

FLORIDA NUTRITION COUNSELORS NOT FINAL UNTIL TIME EXPIRES TO

ASSOCIATION, FILE MOTION FOR REHEARING AND

DISPOSITION THEREOF IF FILED.

Appellant,

CASE NO. 94-1764

v. DOAH CASE NO. 93-244RP

DEPARTMENT OF BUSINESS AND

PROFESSIONAL REGULATION, BOARD

OF MEDICINE, DIETETICS AND

NUTRITION PRACTICE COUNCIL,

Appellee.

_______________________________/

Opinion filed August 10, 1995.

An appeal from an order of the Division of Administrative Hearings. Arnold H.

Pollock, Hearing Officer.

Gerald B. Sternstein and Frank P. Rainer of Ruden, Barnett, McClosky, Smith,

Schuster & Russell, P.A., Tallahassee, for Appellant.

Robert A. Butterworth, Attorney General, and Ann Cocheu, Assistant Attorney

General, Tallahassee, for Appellee.

WENTWORTH, Senior Judge.

This is an appeal by Florida Nutrition Counselors Association (FNCA) from a

final order of a hearing officer entered after evidentiary hearing on a rule

challenge under section 120.56, Florida Statutes. The order invalidated one

rule for vagueness but upheld four of the rule amendments proposed by the Board

of Medicine (Board) and the Dietetics and Nutrition Council (Council), a sub-

agency within the Florida Department of Business and Professional Regulation

(DBPR). We affirm as to Rules 21M-49.002 (6) 1/ and 21M-50.002(3)(j), but

reverse as to Rules 21M-50.002(3)(f), 21M-50.007(3), and 21M-50.009(1), Fla.

Admin. Code. We find no lawful basis stated in the order or record for those

rules, which effectively forbid and penalize all nutrition counseling assessment

methods or treatments except those taught in regular college curricula or that

have received generally accepted scientific validation.

FNCA contends that all of the controverted rule amendments unlawfully

enlarge, modify and contravene 2/ the controlling statutory authority,

including the Dietetics and Nutrition Practice Act (Ch. 88-236, Laws of

Florida), Ch. 468, Part X, Florida Statutes, and related provisions. 3/

Section 468.502 declares the "sole legislative purpose . . is to ensure . . .

minimum requirements for safe practice. It is the legislative intent that any

person . . . who falls below minimum competency or who otherwise presents a

danger to the public be prohibited from practicing in this state." (Emphasis

supplied.)

The challenged rules read in material part as follows:

(1) 21M-49.002.... (6) Nutrition counseling does not

include diagnosis, treatment, operation, or prescription

for any human disease, pain, injury, deformity, or other

physical or mental condition.

(2) 21M-50.007 Standards of Practice ....(3) The

licensee shall practice dietetics and nutrition

counseling based on generally accepted scientific

principles and current information. (Emphasis supplied.)

(3) 21M-50.002.... (3) Any advertisement ....shall

be deemed by the Board to be fraudulent, false,

deceptive, or misleading if it ...

(4) "Dietetics and nutrition practice" shall include

assessing nutrition needs and status using appropriate

data; recommending appropriate dietary regimens,

nutrition support, and nutrient intake; improving

health status through nutrition research, counseling,

and education. ...

(8) "Nutrition assessment" means the evaluation of the

nutrition needs ...using appropriate data to

determine nutrient needs or status and make appropriate

nutrition recommendations.

(9) "Nutrition counseling" means advising ....on

appropriate nutrition intake by integrating information

from the nutrition assessment.

Sec. 468.507, Florida Statutes:

The board may adopt such rules not inconsistent with

law as may be necessary to carry out the duties and

authority conferred upon the board by ss. 468.501-

468.518 and chapter 455....

(f) represents the licensee uses questionable

methods of assessment or treatment when such treatment is

experimental or without generally accepted scientific

validation: or ...

(j) makes false, unproven or misleading claims about

the validity safety, or effectiveness of any dietetic or

nutrition related service, product or test....

(Emphasis supplied.)

(4) 21M-50.009 Unauthorized Devices, Testing, or

Treatments. (1) In the course of dietetic/nutrition or

nutrition counseling practice, licensees shall not use

diagnostic and treatment instruments, devices, testing,

or treatments, the use of which are not taught in the

regular course of instruction in a college recognized by

the U.S. Department of Education or Council on Post

Secondary Education. Instruments, treatments, or testing

modalities which are unauthorized include: biological

ionization, biomagnetic devices, cytotoxic testing, hair

analysis, herbology, homeopthy iridology, nutropathy

and oxidation/ionization devices or psychotronics -

radionics devices. (Emphasis supplied.)

The first of the challenged amendments, proposed Rule 21M- 49.002(6),

above, simply states that nutrition counseling shall not include "diagnosis,

treatment, operation, or prescription" for human "disease, pain, injury,

deformity, or other physical or mental condition." Because the quoted

terminology is identical to the definition of "Practice of medicine" in section

458.305(3), Florida Statutes, the order on appeal found the rule "made it clear

that doing those things which constitute the practice of medicine is not

nutrition counseling and might well subject the offender to discipline." FNCA

urges conflict with the statutory limitation in section 468.518(1)(j) 4/ That

provision would in terms permit "treating ....human ailments by ...nutrition

practice" as statutorily defined, as a necessary inference from its provision

for discipline for such treatment "by means other than nutrition practice as

defined...." (Emphasis supplied.)

Because this proposed definitional rule amendment is construed by the order

as simply restricting nutrition counselors from the practice of medicine

regulated by Ch. 458, Florida Statutes, and the general terms of the rule must

in all events be applied consistent with section 468.518(1)(j), there would

appear to be not compelling argument for facial invalidity. FNCA makes an

alternative conclusory argument as to deprivation of constitutional equal

protection, asserting that no reasonable relation to the enabling statute can

justify restricting nutrition counselors, but not dietitians, to the practice of

medicine definition. Neither the face of the statute nor the record before us

establishes error on this point. We therefore affirm the order on this issue,

and also affirm with respect to subparagraph (3)(j) of proposed Rule 21M-50.002,

supra, which we find properly proscribes advertising claims which are "unproven"

and therefore misleading.

The second proposed rule quoted above, 21M-50.007(3), amends standards of

practice for nutrition counselors to permit only "counseling based on generally

accepted scientific principles and current information." FNCA frames issues

taking that language in conjunction with the third quoted rule, 21M-

50.002(3)(f), which penalizes as fraudulent all advertisements representing that

the licensee uses any treatment or assessment which is "questionable" when it is

"without generally accepted scientific validation" or "experimental." The gist

of the argument as to these proposed rule amendments is that they do not

encompass, and the record does not show, the necessary reasonable relationship

to the protection of public health and safety, which is the sole permissible

purpose for those regulations under section 455.201, 5/ Florida Statutes, and

section 468.507, supra.

The order on appeal, with reference to the terminology above questioned,

recites the Council's survey of the general scientific community to identify

prevailing standards for the practice of nutrition. The order finds in part as

to Rule 21M-50.002(3)(f):

"Questionable methods" and "generally accepted

scientific validation" are phrases which have a

generally accepted meaning within the scientific

community. In general, the latter refers to those

principles and that pertinent information which

has been effectively tested by qualified

evaluators against known standards and

validated by results found to be routinely

consistent and reliable. This is neither difficult to

understand or to follow.

As to Rule 21M-50.007(3):

To be sure, there is a plethora of information

and procedures which exists on the periphery

of established science and for which there is

a fund of supporting information and a host

of advocates. When tested in scientific

evaluation against known standards and

analyzed statistically for acceptance within

the scientific community, this information

and these procedures are usually found to be

insufficiently supported and generally

unaccepted in the better practice

of nutrition and dietetics.

The order concludes that the Board has the duty to insure that licensees

"utilize the most appropriate, proven, and reliable procedures." The order

reflects a recognition that the terms in question "require the making of value

judgments, but the enforcement process provides an appropriate means for making

those value judgments, and a process for their review."

Even assuming (without deciding) that these portions of the order respond

adequately to assertions of vagueness and subjectivity in the prescribed

standards for practice and advertising, the enforcement process under the

proposed language would clearly require only proof of use or advertisement of

"unproven" methods, or those without general scientific acceptance and

validation. That was precisely the fault found as a basis for reversing

sanctions imposed against a doctor for failure to conform to "prevailing medical

practice" in State Bd. of Medical Examiners v. Rogers, 387 So.2d 937 (Fla.

1980):

Sanctions were imposed ....because he utilized a

modality not accepted by the Board as having been proven

effective, not because the Board found that the treatment

was harmful or that Dr. Rogers had defrauded his patients

into believing that ...treatment was a cure.... [T]he

state imposed limitation ...has not been shown by the

evidence to have a reasonable relationship to the

protection of the health and welfare of the public. ...

The Board's action is an unreasonable exercise of the

police power, and we affirm ....quashing the order of

the Board." 387 So.2d 939, 940. (emphasis supplied).

Appellees would distinguish the Rogers rationale on such grounds as the vast

difference in professional functions (such as patient experimentation) between

practitioners in medicine and those in nutrition and the proven significant

minority opinion favoring the treatment involved in Rogers. But for the

purposes of state regulation here in question, we find no material distinction.

6/ We therefore reverse as to, this rule.

The fourth proposed rule above quoted, 21M-50.009(1), forbids use of

"instruments, devices, testing, or treatments, the use of which are not taught

in the regular course of instruction" in specified colleges. The order makes

the following factual finding:

In that regard, most colleges do not treat extensively

upon the subject of nutrition counseling which is, to a

large extent, ignored by the mainstream medical

profession. Most nutrition counseling techniques are

taught at workshops and seminars and in apprenticeships.

For this reason and because of their belief that the

proposed rule does not accurately reflect the current

standard of practice in the profession, Petitioners

object to it. Little, if any, evidence in support of

this position was set forth, however. (emphasis

supplied).

The factual determinations (1) that most colleges do not teach nutrition

counseling "extensively," and (2) that most techniques are taught in other

educational formats, lend support to FNCA's argument. A primary contention here

is that this proposed rule would effectively do indirectly what the Board cannot

do directly, i.e., eliminate practice by those counselors explicitly

"grandfathered" into licensure by section 468.51, Florida Statutes (1993). 7/

Certainly the rule would impose on those licensees, like all others, the ongoing

burden of determining what specific subjects are taught In the referenced

colleges from time to time. The rule effectively vests in such colleges the

absolute discretion, by choice of curricula, to determine permissible

"instruments, devices, testing, or treatments." Even if we disregard potential

constitutional issues, and recognize considerable latitude as to formal

educational requirements for licensure (subject to the legislative "grandfather"

clause), such a delegation of authority to colleges to control practice

standards for licensees, absent any stated guidelines, appears to be clearly

arbitrary and beyond the Board's delegated authority. Cf. Staten v. Couch, 507

So.2d 702 (Fla. 1st DCA 1987). The rule should accordingly be stricken.

The second sentence of this rule does specify certain treatments or testing

modalities which are "unauthorized," among which there remain in issue:

herbology, iridology, hair analysis "and biological ionization. 8/ Because

this delineation of proscribed activities is made in apparent illustration of

what would not be taught in the specified curricula, we find it to be an

integral part of the initial standard invalidated above. It cannot, then, stand

independently. We therefore do not evaluate the sufficiency of the evidence

supporting the conclusions in the order on each of these activities. We note,

however, as in findings on the other rules, an absence of identification of harm

from the acts which are restrlcted. 9/

For reasons above stated as to each rule, we reverse with directions for

entry of an order striking proposed rules 21M-50.002(3)(f), 21M-50.007(3), and

21M-50.009(1), Fla. Admin. Code, and otherwise sustaining the challenged rules.

ALLEN and DAVIS, JJ., CONCUR.

ENDNOTES

1/ Appellees reference the new numbers of the rules in question as of July 1,

1994, to be 59R-43.002(6), 59R- 44.002(3)(f) and (j), 59R-44.007(3), and 59R-

44.009(1), F.A.C.

2/ See Arico Chem. Co. v. Dept. Env. Reg., 365 So.2d 759 (Fla. 1st DCA 1979).

Among grounds listed for challenge of a rule as an invalid exercise of delegated

legislative authority in Sec. 120.52(8), F.S., are:

(c) [t]he rule enlarges, modifies, or contravenes the

law implemented . . .

(d) [t]he rule is vague, fails to establish adequate

standards for agency decisions, or vests unbridled

discretion in the agency; or

(e) [t]he rule is arbitrary or capricious.

3/ Sec. 468.503 Definitions.--- ....

4/ Subparagraph (j) lists as a ground for disciplinary action against nutrition

counselors:

(j) Treating or undertaking to treat human ailments by

means other than by... nutrition practice, as defined in ss. 468.501-

468.518.

5/ Sec. 455.201(2), Florida Statutes, provides "professions shall be regulated

only for the preservation of the health, safety, and welfare of the public under

the police powers of the state. ...

6/ See Sec. 455.201(3), Florida Statutes (Supp. 1994): "It is further

legislative intent that the use of the term "profession" with respect to those

activities licensed and regulated by the department shall not be deemed to mean

that such activities are not occupations for other purposes in state or federal

law."

7/ Section 468.51(3) provides "[t]he board shall certify as qualified any

applicant who documents that the applicant was employed as a practitioner of

nutrition counseling previous to and on April 1, 1988.

8/ The order reads in material part:

25. Herbology is not an assessment tool but a

modality. It come's closest to being classified as

current information within the definition of the

proposed rules.

26. Iridology, which is an analysis of the human

condition through examination of the iris, is

considered by the Board to be within the parameters of

the practice of medicine. It is noninvasive and has

not been shown to cause physical harm. It is an

assessment technique but not a diagnostic tool, a cure

or treatment. It is designed to show cholesterol and

body acid levels, but it is, however, felt to be

unproven and bordering on quackery by the mainstream

medical profession whether accomplished by a medical

doctor or a nutrition counselor.

27. Hair analysis, a procedure utilized by an

unknown number of Association members, including its

President, involves the analysis of hair, samples taken

from the client to determine the presence of trace

minerals, and as a toxic metal screen. Though used in

criminology and by the Environmental Protection Agency

to detect toxic metal exposure in environmental

enforcement, hair analysis is not mainstream practice

and it can be influenced by numerous outside factors,

including hair dye and other preparations, the age of

the sample, and the like. Hair is considered a tissue

sample which, under Florida law, can be submitted to a

properly licensed clinical laboratory only by

appropriately licensed persons. Nutrition counselors

do not fall within this category. Hair analysis is not

invasive nor is the gathering of hair for analysis.

28. Most clinical laboratories recognize

approximately 2,000 laboratory tests. Hair analysis in

[sic] not one of them. While there are many licensed

clinical laboratories in this state, only eight

laboratories, nationwide, do hair analysis. None are

in Florida except for laboratories which perform

analysis of hair samples for forensic purposes.

29. In biological ionization, used in conjunction

with iridology, urine and saliva samples are provided

by the client and are measured for ph factor. While

this procedure is done by an unknown number of

Association members, it is not considered by the

medical profession to be an acceptable assessment.

9/ Argument is directed to the potential for financial harm from use of

"unproven" treatment, but we find no evidence substantiating such an impact.

Section 455.201 (2)(a) provides:

(2) The Legislature further believes that such

professions shall be regulated only for the

preservation of the health, safety, and welfare of the

public under the police powers of the state. Such

professions shall be regulated when:

(a) Their unregulated practice can harm or

endanger the health, safety, and welfare of the public,

and when the potential for such harm is recognizable

and clearly outweighs any anticompetitive impact which

may result from regulation.