Part 1.
DEPARTMENT OF STATE HEALTH SERVICES
Chapter 129.
OPTICIANS' REGISTRY
25 TAC §§129.1, 129.2, 129.4, 129.5, 129.7 - 129.13
The Executive Commissioner of the Health and Human Services
Commission, on behalf of the Department of State Health Services (department),
proposes amendments to §§129.1, 129.2, 129.4, 129.5 and 129.7 -
129.13, concerning the voluntary registration and regulation of opticians.
BACKGROUND AND PURPOSE
The proposed amendments implement requirements adopted by the 79th Texas
Legislature, Regular Session (2005), House Bill (HB) 2680, located in Occupations
Code, Chapter 112, relating to reduced fees and continuing education requirements
for retired health professionals, including voluntarily registered opticians
engaged in the provision of voluntary charity care. The amendments also implement
Health and Safety Code, §12.0111, which requires the department to charge
fees for issuing or renewing a license.
Government Code, §2001.039, requires that each state agency review
and consider for readoption each rule adopted by that agency pursuant to the
Government Code, Chapter 2001 (Administrative Procedure Act). Sections 129.1,
129.2, 129.4, 129.5 and 129.7 - 129.13 have been reviewed and the department
has determined that reasons for adopting the sections continue to exist because
rules on this subject are needed.
SECTION-BY-SECTION SUMMARY
An amendment to §129.1 reflects a clarification to add the word "registered".
Amendments to §129.2 reflect changes to the department's name, the abolishment
of the "Board of Health"; and the addition of "Executive Commissioner". The
section has also been renumbered to reflect deletions and insertions. Amendments
to §129.4 reflect the new reduced fee for renewal for a retired optician
providing voluntary charity care required by HB 2680 of $50 (for a retired
optician holding one registration) and $80 (for a retired optician holding
a dual registration) for each two-year renewal. Amendments to §§129.4,
129.5, 129.7, and 129.10 - 129.12 reflect changes to the department's name.
Amendments to §129.8 reflect the renewal requirements for a retired optician
providing voluntary charity care required by HB 2680. Amendments to §129.9
reflect the reduced continuing education requirements for a retired optician
providing voluntary charity care required by HB 2680. Amendments to §129.13
reflect changes to the department's name and wording changes related to prescription
verification.
FISCAL NOTE
Kathy Perkins, Manager, Health Care Quality Section, has determined that
for each year of the first five-year period that the sections are in effect,
there will be minimal fiscal implications to state or local government as
a result of enforcing or administering the sections as proposed. The impact
of the possible decrease in renewal fees collected due to the implementation
of reduced renewal fees for retired opticians over the age of 55 providing
voluntary charity care is insignificant due to the small population of retired
registered opticians anticipated to provide charity care services.
SMALL AND MICRO-BUSINESS IMPACT ANALYSIS
Ms. Perkins has also determined that there will be no effect on small businesses
or micro-businesses required to comply with the sections as proposed. This
determination was made because the amendments implement Federal laws which
are already in effect. There is no anticipated economic cost to persons who
are required to comply with the sections as proposed. There is no anticipated
negative impact on local employment.
PUBLIC BENEFIT
In addition, Ms. Perkins has also determined that for each year of the
first five years the sections are in effect, the public will benefit from
the adoption of the sections. The public benefit anticipated as a result of
enforcing or administering the sections is to continue to ensure public health
and safety through the voluntary registration and regulation of opticians.
REGULATORY ANALYSIS
The department has determined that this proposal is not a "major environmental
rule" as defined by Government Code, §2001.0225. "Major environmental
rule" is defined to mean a rule the specific intent of which is to protect
the environment or reduce risk to human health from environmental exposure
and that may adversely affect, in a material way, the economy, a sector of
the economy, productivity, competition, jobs, the environment or the pubic
health and safety of a state or a sector of the state. This proposal is not
specifically intended to protect the environment or reduce risks to human
health from environmental exposure.
TAKINGS IMPACT ASSESSMENT
The department has determined that the proposal does not restrict or limit
an owner's right to his or her property that would otherwise exist in the
absence of government action and, therefore, does not constitute a taking
under Government Code, §2007.043.
PUBLIC COMMENT
Comments on the proposal may be submitted to Yvonne Feinleib, Program Director,
Opticians' Registry, Professional Licensing and Certification Unit, Division
for Regulatory Services, Department of State Health Services, 1100 West 49th
Street, Austin, Texas 78756, (512) 834-4521 or by email to Yvonne.Feinleib@dshs.state.tx.us.
Comments will be accepted for 30 days following publication of the proposal
in the
Texas Register.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Cathy Campbell,
certifies that the proposed rules have been reviewed by legal counsel and
found to be within the state agencies' authority to adopt.
STATUTORY AUTHORITY
The proposed amendments are authorized by Occupations Code, Chapter 352;
and Health and Safety Code, §12.0111, which requires the department to
charge fees for issuing or renewing a license; and Government Code, §531.0055,
and Health and Safety Code, §1001.075, which authorize the Executive
Commissioner of the Health and Human Services Commission to adopt rules and
policies necessary for the operation and provision of health and human services
by the department and for the administration of Health and Safety Code, Chapter
1001.
The proposed amendments affect the Occupations Code, Chapter 352, and Health
and Safety Code, Chapters 12 and 1001; and Government Code, Chapter 531. Review
of the rules implements Government Code, §2001.039.
§129.1.Purpose and Construction.
(a)
Purpose. This chapter implements the provisions of the
Opticians' Registry Act, Texas Occupations Code, Chapter 352, concerning the
voluntary registration and regulation of dispensing opticians by providing
a means by which the public can identify
registered
providers of
ophthalmic dispensing services and products that meet minimum standards of
competence.
(b)
(No change.)
§129.2.Definitions.
The following words and terms, when used in this chapter, shall have
the following meanings, unless the context clearly indicates otherwise.
(1) - (3)
(No change.)
[(4)
Board--The Texas Board of Health.]
(4)
[
(5)
[
(6)
[
(7)
[
(A)
the physician or the Texas [
(B)
the optometrist or the Texas Optometry Board.
(8)
[
(9)
[
(10)
[
(11)
[
(12)
Executive Commissioner--The Executive
Commissioner of the Health and Human Services Commission.
(13) - (17)
(No change.)
§129.4.Fees.
(a)
Schedule of fees. The fees are as follows:
(1) - (2)
(No change.)
(3)
registration renewal fee;
(A) - (B)
(No change.)
(C)
for a retired optician registration issued
for two years--$50;
(4)
dual registration renewal fee;
(A) - (B)
(No change.)
(C)
for a retired optician registration issued
for two years--$80;
(5) - (6)
(No change.)
(7)
examination fee--the then current fee assessed by the [
(b)
Payment of fees. If paid by mail, all fees shall be submitted
in the form of a personal check, certified check for guaranteed funds or a
money order made payable to the [
(c) - (e)
(No change.)
§129.5.Application Procedures and Requirements for Registration.
(a)
(No change.)
(b)
General.
(1)
Unless otherwise indicated, an applicant must submit all
required information and documentation of credentials on official [
(2) - (4)
(No change.)
(c) - (f)
(No change.)
§129.7.Issuance of Certificate of Registration.
(a)
Issuance of certificate. The [
(b) - (h)
(No change.)
§129.8.Renewal of Registration.
(a)
(No change.)
(b)
General.
(1) - (2)
(No change.)
(3)
Each registrant is responsible for renewing the registration
certificate before the expiration date indicated on the face of the certificate
and shall not be excused from paying the late registration fee. Failure to
receive notification from the [
(4) - (7)
(No change.)
(c) - (e)
(No change.)
(f)
A retired registrant who wishes to use
the titles authorized by §129.7(g) of this title (relating to Issuance
of Certificate of Registration), only in the provision of voluntary charity
care, may renew the registration every two years by submitting the renewal
form and the retired optician registration renewal fee in accordance with
the renewal procedures described in this section. Voluntary charity care means
engaging in the practice of contact lens dispensing and/or spectacle dispensing
at no cost to the consumer.
§129.9.Requirements for Continuing Education.
(a)
Purpose. The purpose of this section is to establish the
continuing education requirements a registrant shall meet to maintain registration.
The requirements are intended to maintain and improve the quality of services
provided to the public by registered spectacle dispensing opticians and registered
contact lens dispensers. Continuing education credit includes programs beyond
the basic preparation which are designed to promote and enrich knowledge,
improve skills, and develop attitudes for the enhancement of dispensing opticians,
thus improving health care to the public. The [
(b) - (e)
(No change.)
(f)
Reduced hours required for retired opticians
providing voluntary charity care. A retired registered optician renewing under §129.8(f)
of this title (relating to Renewal of Registration) is required to complete
one-half of the hours regularly required for registration renewal.
§129.10.Change of Name or Address.
(a)
(No change.)
(b)
The registrant shall notify the [
(c) - (d)
(No change.)
§129.11.Violations, Complaints, Investigation of Complaints, and Disciplinary Actions.
(a)
Purpose. The purpose of this section is to set out:
(1)
(No change.)
(2)
[
(b)
(No change.)
(c)
Filing of complaints.
(1)
(No change.)
(2)
A person wishing to file a complaint against a registered
dispensing optician or another person shall notify the department. The initial
notification of a complaint may be in writing, by telephone, or by personal
visit to the administrator's office. The mailing address is Opticians' Registry,
[
(3) - (4)
(No change.)
(d) - (g)
(No change.)
§129.12.Registration of Applicants with Criminal Backgrounds.
(a)
(No change.)
(b)
Criminal convictions which directly relate to the occupation
of dispensing opticians shall be considered by the [
(1) - (2)
(No change.)
(c)
(No change.)
§129.13.Professional and Ethical Standards.
(a) - (b)
(No change.)
(c)
A registrant shall not provide any information that is
false, deceptive, or misleading to the [
(d) - (k)
(No change.)
(l)
A registrant may not sell, deliver, or dispense contact
lenses to a patient or other consumer in this state unless the registrant
receives
or verifies
a prescription that conforms to the requirements
of the Texas Contact Lens Prescription Act, Texas Occupations Code, Chapter
353. The registrant must fill the prescription accurately without modification.
(m)
(No change.)
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of
the Secretary of State on August 3, 2006.
TRD-200604026
Cathy Campbell
General Counsel
Department of State Health Services
Earliest possible date of adoption: September 17, 2006
For further information, please call: (512) 458-7111 x6972
The Executive Commissioner of the Health and Human Services Commission
(commission), on behalf of the Department of State Health Services (department),
proposes amendments to §229.182, concerning licensure of food manufacturers,
food wholesalers, and warehouse operators, and §§229.435, 229.439,
229.441, 229.443, and 229.444, concerning licensing of device distributors
and manufacturers.
BACKGROUND AND PURPOSE
The Texas Legislature passed the General Appropriations Act, Senate Bill
1, 79th Legislature, Regular Session (2005). Article II, Rider 85, makes a
portion of the appropriation contingent upon collection of fees above the
Comptroller of Public Accounts' Biennial Revenue estimate. To meet these requirements,
a cost recovery fee is included in these amendments.
Programs with regulatory authority over food manufacturers, food wholesalers,
and warehouse operators; and device distributors and manufacturers, were evaluated
to determine the level of increase in fees based on the following criteria:
the date of the last fee increase for the specific program area; the licensee's
ability to pay in comparison to average salary of professionals; the percentage
of revenue above costs for the specific program; the cost of licenses compared
to other similar licenses; and the value added analysis of the license. Additional
costs of administration and enforcement of the program, due to a recent legislative
increase in pay, longevity pay, and travel reimbursement, were also factored
in to determine the direct and indirect costs of each program.
Finally, the sections require updating to be consistent with changes resulting
from House Bill 2292, 78th Legislative Session, 2003. The amendments update
and clarify the sections to reflect current licensing procedures and license
term durations as well as identification of the state agencies responsible
for certain licensing, enforcement and advisory committee functions.
SECTION-BY-SECTION SUMMARY
Amendments to §229.182 contain increases in licensing fees for food
wholesalers with combination products for initial and renewal applications
per location, based upon gross annual sales. Specifically, new §229.182(b)(3)(A)
increases the license fee for wholesalers of combination products with gross
annual sales of $0.00 - $199,999.99 by $120 for a two-year term; new §229.182(b)(3)(B)
increases the license fee for wholesalers of combination products with gross
annual sales of $200,000.00 - $499,999.99 by $180 for a two-year term; new §229.182(b)(3)(C)
increases the license fee for wholesalers of combination products with gross
annual sales of $500,000.00 - $999,999.99 by $240 for a two-year term; new §229.182(b)(3)(D)
increases the license fee for wholesalers of combination products with gross
annual sales of $1 million - $9,999,999.99 by $300 for a two-year term; and
new §229.182(b)(3)(E) increases the license fee for wholesalers of combination
products with gross annual sales of greater than or equal to $10 million by
$450 for a two-year term.
Amendments to §229.435 remove the reference to one-year license fees
changing the reference to two years, and correctly identify the responsible
licensing agency as the Department of State Health Services.
Amendments to §229.439 contain increases in fees for device distributor
licenses and renewal licenses for distributors with combination products.
Amendments to §229.439(a)(1)(A) - (C) remove references to two-year fees
related to minor changes within the licensure period. Specifically, §229.439(a)(2)(A)
increases the license fee for distributors with gross annual sales of $0 -
$199,999.99 by $120 for a two-year term; §229.439(a)(2)(B) increases
the license fee for distributors with gross annual sales of $200,000 - $499,999.99
by $180 for a two-year term; §229.439(a)(2)(C) increases the license
fee for distributors with gross annual sales of $500,000 - $999,999.99 by
$240 for a two-year term; §229.439(a)(2)(D) increases the license fee
for distributors of combination productions with gross annual sales of $1
million - $9,999,999.99 by $300 for a two-year term; §229.439(a)(2)(E)
increases the license fee for distributors of combination products with gross
annual sales of greater than or equal to $10 million by $450 for a two-year
term. Amendments to §229.439(a)(3) add a statement about late fees and
remove references to two-year fees related to minor changes within the licensure
period.
Amendments to §229.441 correctly reflect that the device-related policies
of the U.S. Food and Drug Administration are also the policies of the Department
of State Health Services. In addition, the amendments recognize that the Executive
Commissioner of the Health and Human Services Commission is responsible for
any modification or rejection of rules relating to device labeling exemptions
adopted under the Federal Food, Drug and Cosmetic Act. References to the "Board
of Health" were removed and replaced with "Executive Commissioner of the Health
and Human Services Commission" due to the abolishment of the board.
Amendments to §229.443 and §229.444 correctly reflect that the
agency responsible for certain enforcement actions with respect to adulterated
and misbranded devices is the Department of State Health Services and that
the Executive Commissioner of the Health and Human Services Commission is
responsible for oversight of the functions and duties of the Device Distributors
and Manufacturers Advisory Committee. Changes were made due to agency name
changes and the abolishment of the Board of Health.
FISCAL NOTE
Susan E. Tennyson, Section Director, Environmental and Consumer Safety
Section, has determined that for each fiscal year of the first five years
the sections are in effect, there will be fiscal implications to the state
as a result of enforcing or administering the sections as proposed. Section
229.182 will provide an increase in revenue to the state of $29,100 for Fiscal
Years 2007 through 2011. The affect of §229.439 on state government will
be an increase in revenue to the state of $71,910 for Fiscal Years 2007 through
2011. Sections 229.435, 229.431, 229.433 and 229.444 do not contain any fiscal
implications.
These additional revenues will offset the increased costs associated with
the legislative increase in pay, longevity pay, and travel reimbursement.
Implementation of the proposed sections will not result in any fiscal implications
for local governments.
SMALL AND MICRO-BUSINESS IMPACT ANALYSIS
Ms. Tennyson has also determined that there are anticipated economic costs
to small businesses or micro-businesses required to comply with the sections
as proposed.
There will be an increase of 30% in the §229.182 and §229.439
licensing fees for businesses or persons operating as food wholesalers with
combination products or as device distributors with combination products.
The probable economic cost to persons required to comply with the sections
as proposed will be an increase in license fees from $120 - $450 for the two-year
term of the license. Sections 229.435, 229.441, 229.443 and 229.444 will not
affect costs to small businesses, micro-businesses, or persons required to
comply with these sections as proposed.
There is no anticipated negative impact on local employment.
PUBLIC BENEFIT
In addition, Ms. Tennyson has also determined that for each year of the
first five years the sections are in effect, the public will benefit from
adoption of the sections.
The public benefit anticipated as a result of enforcing or administering §229.182
is to generate funding to operate the program to ensure the safety of foods
manufactured, stored and distributed to the public.
The public benefit anticipated as a result of enforcing or administering §229.439
is to generate funding to operate the program to continue enforcement of the
minimum standards for device distributors and manufacturers, ensuring these
medical products are safe and effective for use by the public and consumers.
The public benefits for §§229.435, 229.441, 229.443 and 229.444
are continued enforcement of the minimum standards for device distributors
and manufacturers, ensuring these medical products are safe and effective
for use by the public and consumers.
REGULATORY ANALYSIS
The department has determined that this proposal is not a "major environmental
rule" as defined by Government Code, §2001.0225. "Major environmental
rule" is defined to mean a rule the specific intent of which is to protect
the environment or reduce risk to human health from environmental exposure
and that may adversely affect, in a material way, the economy, a sector of
the economy, productivity, competition, jobs, the environment or the pubic
health and safety of a state or a sector of the state. This proposal is not
specially intended to protect the environment or reduce risks to human health
from environmental exposure.
TAKINGS IMPACT ASSESSMENT
The department has determined that the proposed amendments do not restrict
or limit an owner's right to his or her property that would otherwise exist
in the absence of government action and, therefore, do not constitute a taking
under Government Code, §2007.043.
PUBLIC COMMENT
Comments on the proposal regarding §229.182 may be submitted to Julie
Loera, Policy/Standards/Quality Assurance Unit, Environmental and Consumer
Safety Section, Division for Regulatory Services, Department of State Health
Services, 1100 West 49th Street, Austin, Texas 78756, (512) 834-6670, extension
2145, or by e-mail to Julie.Loera@dshs.state.tx.us. Comments will be accepted
for 30 days following publication of the proposal in the
Texas Register.
Comments on the proposal concerning §§229.435, 229.439, 229.441,
229.443, and 229.444 may be submitted to Tom Brinck, Policy/Standards/Quality
Assurance Unit, Environmental and Consumer Safety Section, Division for Regulatory
Services, Department of State Health Services, 1100 West 49th Street, Austin,
Texas 78756, (512) 834-6755, extension 2388, or by e-mail to Tom.Brinck@dshs.state.tx.us.
Comments will be accepted for 30 days following publication of the proposal
in the
Texas Register.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Cathy Campbell,
certifies that the proposed rules have been reviewed by legal counsel and
found to be within the state agencies' authority to adopt.
Subchapter L. LICENSURE OF FOOD MANUFACTURERS, FOOD WHOLESALERS, AND WAREHOUSE OPERATORS
(5)
] Commissioner--The commissioner
of the [
Texas
] Department of
State
Health
Services
.
(6)
] Consumer--An individual receiving
services or obtaining a product from a registered dispensing optician.
(7)
] Contact lens dispensing--The
fabrication, ordering, mechanical adjustment, dispensing, sale, and delivery
to the consumer of contact lenses prescribed by and dispensed in accordance
with a prescription from a licensed physician or optometrist, together with
appropriate instructions for the care and handling of the lenses. The term
does not include the taking of any measurements of the eye or the cornea or
evaluating the physical fit of the contact lenses, unless that action is directed
or approved by a licensed physician.
(8)
] Contact lens prescription--A
written specification by a licensed physician or optometrist for therapeutic,
corrective, or cosmetic contact lenses that states the refractive power of
the product and other information as required by:
State Board of
]
Medical
Board
[
Examiners
]; or
(9)
] Department--The [
Texas
] Department of
State
Health
Services
.
(10)
] Dispensing optician--A person
who provides or offers to provide spectacle or contact lens dispensing services
or products to the public.
(11)
] Dual application--An application
by one person as both a registered spectacle dispensing optician and a registered
contact lens dispenser.
(12)
] Examination--A qualifying
test administered to eligible applicants by the department or its designee.
Texas
] Department of
State Health Services'
[
Health's
] (department's) designee for the examination.
Texas
] Department of
State
Health
Services
. If submitted in person, cash may be accepted
by the department's cashier.
Texas
] Department of
State
Health
Services
(department)
forms.
Texas
] Department
of
State
Health
Services
(department) shall issue a
certificate of registration and a registration identification card containing
a registration number and expiration date to each qualified applicant.
Texas
] Department of
State
Health
Services
(department) prior to the expiration date
of the registration certificate will not excuse failure to apply for renewal
or late renewal.
Texas
] Department
of
State
Health
Services
(department) assumes dispensing
opticians will maintain the high standards of the profession in selecting
quality educational programs to fulfill the continuing education requirements.
Texas
] Department
of
State
Health
Services
(department) of changes in
name, preferred mailing address, or place of business or employment within
30 days of such change.
Texas
] Department of
State
Health
Services
(department) actions against a person when violations have
occurred.
Texas
] Department of
State
Health
Services
,
1100 West 49th Street, Austin, Texas 78756-3183.
Texas
] Department
of
State
Health
Services
(department) as follows.
Texas
] Department of
State
Health
Services
(department).
Chapter 229.
FOOD AND DRUG