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:

       1. 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.

       2. The public is not effectively protected by other means, including but not limited to, other states' statutes, local ordinances, or federal legislation.

       3. 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

(904) 488-9675

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.

   1. Accepted.

   2. Not a Finding of Fact but a listing of witnesses qualified as experts.

   3. & 12. Accepted and incorporated herein.

      1. Accepted.

      2. - 23. Accepted and incorporated herein.

         		24. 25.	Rejected as a Finding of Fact. A restatement of the proposed rule. 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.

         1. Accepted and incorporated herein.

         2. & 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.

1. - 11. Accepted.

   1. Accepted and incorporated herein.

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

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.

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DISTRICT COURT OPINION

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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

1. 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. ...

1. "Nutrition assessment" means the evaluation of the nutrition needs ...using appropriate data to

   determine nutrient needs or status and make appropriate nutrition recommendations.

   
   

2. "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:

1. [t]he rule enlarges, modifies, or contravenes the law implemented . . .

2. [t]he rule is vague, fails to establish adequate standards for agency decisions, or vests unbridled discretion in the agency; or

3. [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:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

Docket for Case No: 93-000244RP

Orders for Case No: 93-000244RP