Part I.
Texas Department of Health
Chapter 37.
Maternal and Child Health Services
Subchapter M. Texas Perinatal Care System
25 TAC §§37.251-37.259
The Texas Department of Health (department) proposes new
§§37.251-37.259, concerning the establishment of a voluntary perinatal
health care system. These rules are proposed to implement Senate Bill 1229,
74th Legislature, 1995, which amended Health and Safety Code, Chapter 32,
the Maternal and Infant Health Improvement Act (MIHIA). Specifically, the
new sections cover the purpose of the rules; definitions; professional standards/guidelines;
statewide oversight of the perinatal care system and interstate cooperation;
perinatal planning areas; perinatal resource coordinating groups; perinatal
networks; perinatal plans; data analysis and progress report; and designation
of perinatal care facilities.
The intent of the legislation and these sections is the promotion of safe,
quality care for women and for their infants; continuity and comprehensiveness
of care; optimal and cost-effective utilization of perinatal personnel and
facilities; and the provision of health promotion and health education for
women from preconception through the postpartum period, and parenting information
through the first year of their infants' lives.
Lesa Ross Brown, Director, Financial Management Division, Community Health
and Resources Development Associateship, has determined that, for the first
five years the new sections are in effect, there will be fiscal implications
as a result of administering the sections as proposed. The effect on state
government will be increased expenditures of approximately $240,000 per year
paid from currently budgeted funds for staff, marketing, automation, and data
management to establish the statewide perinatal care system. There will be
no impact on local government.
Ms. Ross Brown has also determined that for the first five years these
sections are in effect, the public benefit anticipated as a result of enforcing
these sections will be improved safety and quality of care for women and their
infants, as well as improved access for women to health promotion and health
education from preconception through the postpartum period and parenting information
through the first year of their infants' lives. There will be no effect on
small businesses. There are no anticipated economic costs to persons who are
required to comply with the sections as proposed. There is no anticipated
impact on local employment.
Comments on the proposed rules may be sent to Kathleen Hamilton, Acting
Chief, Bureau of Children's Health, Texas Department of Health, 1100 West
49th Street, Austin, Texas 78756, (512) 457-7700. Comments will be accepted
for 30 days following publication of this proposal in the
Texas Register
.
The new sections are proposed under Health and Safety Code, §32.042,
which authorizes the Texas Board of Health (board) to adopt rules to implement
a perinatal health care system; and Health and Safety Code, §12.001,
which authorizes the board to adopt rules to implement every duty imposed
by law on the board, the department, and the commissioner of health.
The new sections affect Health and Safety Code, Chapter 32.
§37.251.Purpose.
The purpose of these sections is to establish the procedures and standards
for the implementation of a statewide system for perinatal health care that
fosters:
(1)
safe, quality care for women and for their infants;
(2)
continuity and comprehensiveness of care;
(3)
optimal and cost-effective utilization of perinatal
personnel and facilities; and
(4)
access for women to health promotion and health education
from preconception through the postpartum period, and parenting information
through the first year of their infants' lives.
§37.252.Definitions.
The following words and terms pertain explicitly to this subchapter
and shall have the following meanings, unless the context clearly indicates
otherwise.
(1)
Basic perinatal facility - An inpatient facility providing
care during the prenatal period for women and infants whose care is or is
expected to be uncomplicated.
(2)
Department - Texas Department of Health, 1100 West
49th Street, Austin, Texas 78756.
(3)
Health education - Provision of health information
and anticipatory guidance concerning nutrition, fitness, and the prevention
and early recognition of perinatal risk conditions and/or illnesses.
(4)
Health promotion - Provision of information or activities
which motivate individuals to adopt healthy behaviors, including the appropriate
use of health resources.
(5)
Infant - An individual from birth through the first
year of life.
(6)
Intrapartum - The period beginning at the onset of
labor or childbirth and ending with delivery.
(7)
Neonate - An infant from birth through the completion
of the 27th day of life.
(8)
Parenting information - Information provided to any
person responsible for the care of a child about practices which promote the
child's mental and physical health and quality of life.
(9)
Perinatal - The period which begins before conception
in a woman of child-bearing age and ends on the infant's first birthday.
(10)
Postpartum - The six-week period following delivery.
(11)
Prenatal - The period beginning on the date of conception
and ending with the commencement of labor or childbirth.
(12)
Provider - A person, facility, and/or organized entity
that delivers or affects the delivery of perinatal care.
(13)
Specialty perinatal facility - An inpatient facility
providing care during the prenatal period for women and infants whose care
is or is expected to be uncomplicated as well as for the majority of those
women and infants who are at high risk for or who require complicated care.
(14)
State - The State of Texas.
(15)
Subspecialty perinatal facility - An inpatient facility
providing care during the prenatal period for all pregnant women and infants,
including those with serious illnesses and abnormal health conditions, which
is supervised by a full-time board certified/eligible maternal-fetal specialist
and/or a board certified/eligible neonatal-perinatal medicine specialist.
§37.253.Professional Standards/Guidelines.
(a)
Activities of the department and providers pursuant to
this subchapter will be conducted in accordance with guidelines and standards
for perinatal care found in the following obstetric and pediatric professional
publications:
(1)
Guidelines for Perinatal Care,
Fourth Edition
(American Academy of Pediatrics, American College of
Obstetricians and Gynecologists, 1997).
(A)
Table 1-1: Ambulatory Prenatal Care Provider Capabilities
and Expertise, page 3;
(B)
Table 1-2: Health Screening for Women of Reproductive Age,
page 10;
(C)
Table 2-1: Recommended Nurse/Patient Ratios for Perinatal
Care Services, page 19;
(D)
Table 4-2: Risk Factors Associated with Spontaneous Preterm
Labor and Birth, page 89;
(E)
Appendix B: Early Pregnancy Risk Identification for Consultation,
page 299;
(F)
Appendix C: Ongoing Pregnancy Risk Identification for Consultation,
page 301;
(G)
Appendix D: Federal Requirements for Patient Screening
and Transfer, page 303;
(H)
In-Hospital Perinatal Care, pages 4-7;
(I)
Inpatient Perinatal Care Services, pages 14-50;
(J)
Interhospital Care of the Perinatal Patient, pages 52-61;
(K)
Patient Education, pages 68-69;
(L)
Intrapartum Care, pages 94-96; and
(2)
Toward Improving The
Outcomes of Pregnancy, The 90s and Beyond
(March of Dimes, American
Academy of Pediatrics, and American College of Obstetricians and Gynecologists,
1993); Appendix 6: Levels of Inpatient Perinatal Care, pages 102-115.
(b)
Copies of these publications may be viewed during normal
business hours at the Texas Department of Health, 1100 West 49th Street, Austin,
Texas 78756-3199 or they may be obtained from the American Academy of Pediatrics,
the American College of Obstetricians and Gynecologists, or the March of Dimes
publications office. Contact numbers for these organizations are available
from the department at the address in this subsection.
§37.254.Statewide Oversight of the Perinatal Care System and Interstate Cooperation.
(a)
The department shall develop and maintain a reporting and
analysis system to monitor outcomes of the statewide perinatal care system.
(b)
The department shall request information as specific issues
arise from persons with expertise in the provision of perinatal care, data
analysis, and community networking/systems development, including, but not
limited to, individuals from academic institutions, professional groups, advocacy
groups, and other state agencies. The department shall also seek ongoing input
from consumers or recipients of perinatal care and from representatives of
their identified community-based social support systems (e.g. extended families,
churches).
(c)
The department shall facilitate the organization and operations
of the perinatal resource coordinating groups described in §37.256 of
this title (relating to Perinatal Resource Coordinating Groups).
(d)
The department shall facilitate cooperation and coordination
with perinatal care providers and systems in adjoining states.
§37.255.Perinatal Planning Areas.
(a)
Eight perinatal planning areas (PPAs), encompassing every
county in the state, shall be established for descriptive, planning, and continuous
quality improvement purposes. The PPA boundaries shall be based upon the regional
organization of the Texas Health and Human Services Commission (HHSC).
(b)
PPA boundaries are not intended to restrict decisions concerning
client referral or transfer to other facilities or providers.
(c)
The perinatal planning areas shall include the following
counties:
(1)
Area One (HHSC Region 1): Armstrong, Bailey, Briscoe, Carson,
Castro, Childress, Cochran, Collingsworth, Crosby, Dallam, Deaf Smith, Dickens,
Donley, Floyd, Garza, Gray, Hale, Hall, Hansford, Hartley, Hemphill, Hockley,
Hutchinson, King, Lamb, Lipscomb, Lubbock, Lynn, Moore, Motley, Ochiltree,
Oldham, Parmer, Potter, Randall, Roberts, Sherman, Swisher, Terry, Wheeler,
and Yoakum;
(2)
Area Two (HHSC Region 2/3): Archer, Baylor, Brown,
Callahan, Clay, Coleman, Collin, Comanche, Cooke, Cottle, Dallas, Denton,
Eastland, Ellis, Erath, Fannin, Fisher, Foard, Grayson, Hardeman, Haskell,
Hood, Hunt, Jack, Johnson, Jones, Kaufman, Kent, Knox, Mitchell, Montague,
Navarro, Nolan, Palo Pinto, Parker, Rockwall, Runnels, Scurry, Shackelford,
Somervell, Stephens, Stonewall, Tarrant, Taylor, Throckmorton, Wichita, Wilbarger,
Wise, and Young;
(3)
Area Three (HHSC Region 4/5): Anderson, Angelina,
Bowie, Camp, Cass, Cherokee, Delta, Franklin, Gregg, Harrison, Henderson,
Hopkins, Houston, Jasper, Lamar, Marion, Morris, Nacogdoches, Newton, Panola,
Polk, Rains, Red River, Rusk, Sabine, San Augustine, San Jacinto, Shelby,
Smith, Titus, Trinity, Tyler, Upshur, Van Zandt, and Wood;
(4)
Area Four (HHSC Region 6/5): Austin, Brazoria, Chambers,
Colorado, Fort Bend, Galveston, Hardin, Harris, Jefferson, Liberty, Matagorda,
Montgomery, Orange, Walker, Waller, and Wharton;
(5)
Area Five (HHSC Region 7): Blanco, Bosque, Brazos,
Burleson, Burnet, Caldwell, Coryell, Falls, Fayette, Freestone, Grimes, Hamilton,
Hays, Hill, Lampasas, Lee, Leon, Limestone, Llano, McLennan, Madison, Milam,
Mills, Robertson, San Saba, Travis, Washington, and Williamson;
(6)
Area Six (HHSC Region 8): Atascosa, Bandera, Bexar,
Calhoun, Comal, De Witt, Dimmit, Edwards, Frio, Gillespie, Goliad, Gonzales,
Guadalupe, Jackson, Karnes, Kendall, Kerr, Kinney, La Salle, Lavaca, Maverick,
Medina, Real, Uvalde, Val Verde, Victoria, Wilson, and Zavala;
(7)
Area Seven (HHSC Region 9/10): Andrews, Borden, Brewster,
Coke, Concho, Crane, Crockett, Culberson, Dawson, Ector, El Paso, Gaines,
Glasscock, Howard, Hudspeth, Irion, Jeff Davis, Kimble, Loving, McCulloch,
Martin, Mason, Menard, Midland, Pecos, Presidio, Reagan, Reeves, Schleicher,
Sterling, Sutton, Terrell, Tom Green, Upton, Ward, and Winkler; and
(8)
Area Eight (HHSC Region 11): Aransas, Bee, Brooks,
Cameron, Duval, Hidalgo, Jim Hogg, Jim Wells, Kenedy, Kleberg, Live Oak, McMullen,
Nueces, Refugio, San Patricio, Starr, Webb, Willacy, and Zapata.
§37.256.Perinatal Resource Coordinating Groups.
(a)
A perinatal resource coordinating group (PRCG) shall be
established within each perinatal planning area (PPA) to examine outcomes,
to develop community-based plans for continuous improvement of perinatal care
services, to work with communities in order to establish perinatal networks,
and to develop at-risk and emergency transfer/transport protocols, considering
the standards/guidelines listed in §37.253 of this title (relating to
Professional Standards/Guidelines).
(b)
A PRCG shall be established in each PPA within five years
from the date this subchapter becomes effective.
(c)
PRCG members shall be initially recruited by the following
department staff:
(1)
the Regional Medical Director or designee from the region
in which most of the counties in the PPA are located;
(2)
a representative of the Emergency Medical Services
Division; and
(3)
representatives from the Medicaid and maternal and
child health programs.
(d)
PRCG membership shall include broad-based community representation
from the counties in the PPA; providers from basic, specialty, and subspecialty
perinatal care facilities; advocacy groups; consumers; social support systems;
and primary care residency programs. PRCG membership shall reflect the demographics
of the population.
(e)
Each PRCG shall adopt bylaws describing the purpose; membership
and member terms; officers and their terms of office; and periodicity of meetings.
(f)
The department shall provide data and technical assistance
to the PRCGs.
(g)
Each PRCG shall be charged with:
(1)
analyzing perinatal data, including, but not limited to
the following:
(A)
reports provided by the department concerning the perinatal
vital statistics in the PPA; and
(B)
aggregated reports of problems identified by the maternal,
neonatal, and infant mortality review committees of each participating facility
and by communities in the PPA;
(2)
responding to consumer and/or provider complaints
that pertain to perinatal care and that have been directed to the PRCG;
(3)
responding to complaints that pertain to perinatal
care originally received by the Texas Department of Insurance and/or the department;
(4)
identifying and supporting health care delivery systems
and social support infrastructures within the communities of the PPA that
enhance the quality of perinatal health care;
(5)
providing technical assistance to communities to establish
perinatal networks composed of providers (including perinatal transport providers),
consumers, and community-based support entities that coordinate planning and
delivery of perinatal services within the PPA;
(6)
identifying unmet community needs, such as gaps in
perinatal care or breakdowns in communications; and
(7)
developing a community-based perinatal plan to coordinate
existing services and address unmet needs that builds upon and bolsters community
strengths, health care delivery systems, and social support infrastructures.
The plan will address community-based, culturally competent health promotion
activities, both consumer and provider health education, the development and
support of perinatal networks, and referral/transport protocols for high-risk
pregnant women and newborn infants.
§37.257.Perinatal Plans.
(a)
The perinatal resource coordinating group (PRCG) in each
perinatal planning area (PPA) shall submit for approval to the department
an initial perinatal plan concerning the provision of perinatal care for women
of child-bearing age and infants within the PPA. The plan shall be submitted
in a format specified by the department.
(b)
Each PRCG shall submit an annual revised plan in a format
specified by the department.
(c)
The initial plan and any revisions shall be subject to
approval by the department, contingent upon documentation of the following:
(1)
individuals representing the geographic and demographic
diversity of all counties within the PPA have been involved in the development
and implementation of the plan;
(2)
individuals representing all perinatal care facilities
have been given an opportunity to participate in the planning and implementation
process, through participation in either the PRCG or the perinatal networks;
(3)
mechanisms are in place for communication and coordination
of services among the PPA perinatal networks;
(4)
the plan includes:
(A)
a list of participants in the PRCG and the perinatal networks;
(B)
a list of identified strengths and unmet needs of the PPA
based on analysis of the PPA data, registered complaints, and discussions
with consumers, community-based support entities, and providers;
(C)
a list of goals and objectives to improve the quality of
perinatal care based upon the identified strengths and unmet needs in the
PPA and the health outcomes measures referenced in §37.258 of this title
(relating to Data Analysis and Progress Report);
(D)
mechanisms for completing referrals and returning reports
of care provided among the perinatal care providers;
(E)
protocols for exchange of confidential patient records
among participating providers in the perinatal planning area;
(F)
descriptions of emergency transport capability requirements
and protocols;
(G)
protocols for at-risk and emergency maternal and neonatal
transfer from one hospital to another for the purpose of receiving more intensive
or specialized care;
(H)
protocols for return transfer of a pregnant woman and/or
her infant from a referral center to the original referring hospital or to
a local hospital for continuing care;
(I)
triage criteria for appropriate level referrals; and
(J)
mechanisms and protocols for:
(i)
conducting high-risk screening and counseling guidance;
(ii)
increasing community awareness of the existence of the
perinatal plan(s) and the importance of early and preventive care for women
of child-bearing age and infants;
(iii)
increasing consumer access to the perinatal network(s);
(iv)
continuing improvement of the quality of perinatal care;
and
(v)
community-based and area-wide perinatal health education,
health promotion, and dissemination of parenting information.
§37.258.Data Analysis and Progress Report.
(a)
Annually the department shall provide each perinatal resource
coordinating group (PRCG) with:
(1)
information pertaining to the population of women of child-bearing
age and infants within its perinatal planning area (PPA), including:
(A)
neonatal mortality rate, postneonatal (from 28 days up
to 12 months of age) mortality rate, infant mortality rate, and maternal mortality
rate;
(B)
information collated from birth and death certificates,
including but not limited to:
(i)
trimester of entry into prenatal care;
(ii)
number of prenatal visits related to time of entry into
prenatal care;
(iii)
maternal use of tobacco, drugs, and alcohol;
(iv)
number of low birth weight infants;
(v)
number of pre-term infants;
(vi)
numbers and rates of low birth weight and very low birth
weight infants by facility of birth;
(vii)
causes of infant deaths;
(viii)
maternal transports and infant transports; and
(C)
other information available from state reported data and
registries upon request of the PRCG; and
(2)
information recorded by the department pertaining
to the perinatal care facilities within the PPA, including licensure status
and level designation as perinatal center.
(b)
Each PRCG shall file an annual report in a format approved
by the department describing its activities and progress toward outcome objectives
projected in the plan or in the revised plan, as described in §37.257
of this title (relating to Perinatal Plans). The report shall include:
(1)
evidence that the members of the PRCG and perinatal networks
are involved in evaluation and management of the plan;
(2)
changes in the membership of the PRCG;
(3)
documentation of community-based consumer education,
including topics concerning prevention of health risks; the importance of
early and regular preventive health check-ups; and access to the perinatal
care systems;
(4)
documentation of provider education in the availability
of high risk screening tools, patient counseling, referral protocols, and
population-based health needs assessment; and
(5)
documentation of progress toward the goals and objectives
stated in their plan.
(c)
The department shall maintain the confidentiality of all
information in these reports to the extent authorized by the Texas Open Records
Act, Government Code, Chapter 552.
§37.259.Designation of Perinatal Care Facilities.
(a)
The department or its designee(s) shall request inpatient
facilities to report to the department their self-designations as basic, specialty,
or subspecialty perinatal care facilities. Designations shall be self-reported
by facilities based upon the standards and guidelines in the publications
listed in §37.253 of this title (relating to Professional Standards/Guidelines).
Facilities shall select the designation category that most accurately describes
their capacity to provide perinatal care.
(b)
Each facility providing inpatient perinatal care may voluntarily
report to the department its self-designated category.
(c)
The department shall publish the designation categories
of all participating perinatal facilities in each perinatal planning area
annually.
(d)
The department or its designees may evaluate a facility
to confirm the facility's self-declared designation category through a random
review process or upon request by a perinatal resource coordinating group
(PRCG), at the discretion of the department.
(e)
The review team for specialty and subspecialty perinatal
facilities may include board certified/eligible specialists in obstetrics,
maternal-fetal medicine, pediatrics, and/or neonatal-perinatal medicine, as
appropriate for the facility to be reviewed, and a department representative.
(f)
The review team for basic perinatal facilities may include
an active perinatal care provider and a department representative.
(g)
The department shall provide a copy of the review report
and recommendations to the reviewed facility, the review team, and the PRCG.
(h)
Whenever a facility review is conducted, the department
may confirm the self-declared designation or approve a different designation.
(i)
If a perinatal care facility disagrees with the department's
designation decision, the facility may request an administrative hearing which
shall be conducted according to §§1.51-1.55 of this title (relating
to Fair Hearing Procedures).
(j)
A participating perinatal care facility shall notify the
department and its PRCG within 30 days if it is unable or chooses not to continue
providing perinatal care commensurate with its designation category.
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
March 19, 1999.
TRD-9901664
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 2, 1999
For further information, please call: (512) 458-7236
The Texas Department of Health (department) proposes the repeal of
§205.11; amendments to §§205.1 - 205.6, §§205.8 -
205.10; and new §§205.11 - 205.17, concerning the regulation of
manufacturers, renovators, importers, wholesalers, distributors, processors
and business establishments that sanitize and rent or sell mattresses and
other sleep products. Specifically, the amendments, and the new sections are
proposed to implement Chapter 345, Health and Safety Code, as amended by Senate
Bill 1284, 75th Legislature, 1997, and to clarify and bring the rules into
conformity with the
Texas Register
format.
The General Appropriations Act, House Bill 1, Article IX, Rider 167, passed
by the 75th Legislature, requires each state agency to review and consider
for readoption each rule adopted by the agency pursuant to the Government
Code, Chapter 2001 (Administrative Procedure Act). Sections 205.1 - 205.11
have been reviewed and the department has determined that the reasons for
adopting the sections continue to exist in that the rules are being revised,
and §205.11 is being repealed and proposed as a new rule.
The amendment to §205.1 is for clarification. The amendment to §205.2
adds definitions from Chapter 345, Health and Safety Code, as amended by Senate
Bill 1284, 75th Legislature, 1997; and other definitions. The amendment to
§205.3 clarifies applicability of the regulations; exempts from labeling
requirements custom upholstery businesses that do not repair or renovate bedding
for resale; prohibits removal of required labels; deletes the obsolete 20%
variance in the contents stated on the label of feather and down products
consistent with the repeal of the variance by the Federal Trade Commission;
prohibits the co-mingling of new and secondhand bedding articles; and requires
that all mattresses and mattress pads sold in the state meet federal flammability
standards. The amendment to §205.4 imposes new labeling requirements
for secondhand bedding articles and authorizes the use of languages other
than English when used on separate labels. The amendment to §205.5 deletes
the obsolete 20% variance in the contents stated on the label of down products
consistent with the repeal of the variance by the Federal Trade Commission;
and adds three new filling material definitions. The amendments to §205.6
bring the regulations into conformity with the
Texas
Register
format.
The amendment to §205.8 clarifies current regulations concerning germicidal
treatment of secondhand and renovated bedding; requires the germicidal treatment
of sofa beds and studio couches; requires removal and prohibits the use or
reuse of contaminated filling materials; requires removal and prohibits reuse
of outer covers on renovated mattresses; requires that the chemical method
of germicidal treatment be applied prior to the installation of new covers;
increases the heating duration of bedding germicidally treated by the dry
heat method; authorizes the expanded use of the commercial laundry method
as an approved treatment method for certain bedding articles; and clarifies
current record keeping requirements. The amendment to §205.9 clarifies
current regulations concerning sanitary premises and requires that articles
of bedding and materials be securely housed and protected from the elements.
The amendment to §205.10 is for clarification.
New §205.11 replaces the repealed §205.11. Stamp Exemption and
Reporting, which was deleted by Senate Bill 1284, 75th Legislature, 1997,
and proposes general permit requirements for engaging in the business of selling
bedding or filling materials in the state; exempts custom upholstery businesses
who do not repair or renovate bedding for resale; describes specific types
of permits, permit fees and permit application procedures and requirements;
and conditions for permit issuance, denial, suspension or revocation. The
new permit requirements would be implemented as new permits are issued and
expiring permits are renewed. New §205.12 clarifies the department's
authority to impose administrative penalties for violations. New §205.13
clarifies the department's authority to detain or embargo bedding for violations.
New §205.14 clarifies the department's authority to issue a removal order
to secure detained or embargoed bedding for violations. New §205.15 clarifies
the department's authority to seek condemnation of bedding for violations.
New §205.16 clarifies the department's authority to order bedding to
be recalled from commerce for violations. New §205.17 clarifies the department's
authority to inspect business establishments and to take samples for inspection,
analysis or evidence.
The department published a Notice of Intention to Review §§205.1
- 205.11, as required by Rider 167 in the
Texas Register
on February 5, 1999, (24 Tex Reg 831).
Charles Branton, Director, Product Safety Division, has determined that
for each year of the first five years the proposed rules are in effect, there
will be fiscal implications as a result of administering and enforcing the
regulations as proposed. The effect on state government will be increased
fee revenue to the department estimated to be $68,000 for each of the years
FY99, FY2000, FY2001, FY2002, and FY2003. It is estimated that the costs to
the department to administer and enforce the new provisions will equal the
estimated revenue. There will be no impact on local government.
Mr. Branton has also determined that for each year of the first five years
the sections are in effect, that the public benefit anticipated as a result
of administering and enforcing the sections will be a reduction in the incidence
of consumer complaints, illnesses, and burn-related injuries and deaths associated
with bedding products. Approximately 440 presently permitted custom upholstery
businesses will be exempted from permitting and labeling requirements, whereas,
other permittees will incur increased annual fees averaging approximately
18%. Businesses purchasing a low volume permit will incur higher percentage
increases but the actual increase in dollar cost will range from $35 to $85
per year. Mattress manufacturers will also incur higher than average increases.
For example, fees for a manufacturer of 12,000 mattresses per year would increase
from $160 to $300 per year. There will be no effect on local employment. Comments
on the proposed regulations may be submitted to Mr. Charles Branton, Director,
Product Safety Division, Texas Department of Health, 1100 West 49th Street,
Austin , Texas 78756, (512) 834- 6773. Comments will be accepted for 30 days
following publication of this proposal in the
Texas
Register
.
Subchapter A. Bedding Rules
25 TAC §§205.1-205.6, 205.8-205.17
The amendments and new sections are proposed under Health
and Safety Code, Chapter 345, §345.082, which provides the department
with the authority to adopt necessary rules to implement and enforce Chapter
345; and Health and Safety Code, §12.001, which provides the Texas Board
of Health (board) with the authority to adopt rules for the performance of
every duty imposed by law on the board, the department, and the commissioner
of health.
The amendments and new sections affect Health and Safety Code, Chapter
345; Chapter 12; and the General Appropriations Act, House Bill 1, Article
IX, Rider 167, passed by the 75th Legislature.
§205.1.Purpose and Scope.
The purpose of these sections is to designate the
requirements
and the
terms, definitions, nomenclature, and conditions as commonly
used and recognized in the manufacture, sale, and distribution of bedding
and furniture products and filling materials. Classifications of materials
in these [
§205.2.Definitions.
(a)
The following words and terms [
(1)
Act -
Texas Bedding Act, Health and Safety Code, Chapter
345.
[
(2)
Authorized agent - An employee of
the department who is designated by the commissioner of health to enforce
the provisions of the Act.
(3)
Bedding - A mattress, mattress pad,
mattress protector, box spring, sofa bed studio couch, chair bed, convertible
bed, convertible lounge, pillow, bolster, quilt, quilted spread, comforter,
cot pad, sleeping bag, lounge chair pad, utility or all-purpose pad, crib
pad, playpen pad, crib bumper pad, car bed pad, infant carrier pad, convertible
stroller pad, bassinet pad, bed rest and lounge-type cushion, or a stuffed
or filled article that can be used by a human for sleeping or reclining.
(4)
Commissioner - The Commissioner of
Health.
(5)
[
(6)
Detained or embargoed bedding - Bedding
that has been detained or embargoed under the Act.
(7)
Distributor - A person located in
this state who on his own account sells or distributes in this state bedding,
or filling material to be used in bedding. The term does not include an affiliate
or subsidiary if the ownership and the name of the affiliate or subsidiary
are the same as the manufacturer, and the affiliate or subsidiary is the exclusive
sales outlet for the manufacturer.
(8)
[
(9)
Germicidal Treatment Operator - A
person who sanitizes used bedding articles or filling materials by a method
or process that has been approved by the department.
(10)
Importer - A person who on his own
account sells or distributes in this state bedding, or filling material to
be used in bedding that was manufactured or processed in a country other than
the United States. The term does not include an affiliate or subsidiary if
the ownership and name of the affiliate or subsidiary are the same as the
manufacturer, and the affiliate or subsidiary is the exclusive sales outlet
for the manufacturer.
(11)
[
(12)
Manufacturer - A person whose principal
business is the manufacture of bedding from new materials for the purpose
of resale in this state by a distributor, wholesaler, importer, or retail
outlet or subsidiary outlet if the ownership and name are the same as the
manufacturer, or if it is an exclusive sales outlet for the manufacturer,
or both.
(13)
Material - An article, substance,
or part of an article or substance, used in the manufacturer, repair, or renovation
of bedding.
(14)
New - Bedding or filling material
that has had no previous use for an purpose.
(15)
[
(16)
[
(17)
Processor - A person who manufacturers
or processes, and sells in this state or for delivery in this state any filling
materials, including felt, batting, pads, or foam, to be used or that could
be used in bedding, other than frames or metal springs.
(18)
Recycled material - Material
that:
(A)
is composed of recyclable material or that is
derived from post consumer waste; and
(B)
may be used in place of raw or virgin filling
material in manufacturing, repairing, or renovating bedding.
(19)
Renovate - To restore to a former
condition or to place in a good state of repair.
(20)
[
(21)
[
(22)
Wholesaler - A person located outside
this state who on his own account sells, distributes, or jobs into this state
to another for the purpose of resale bedding or filling material to be used
in bedding. This does not include an affiliate or subsidiary if the ownership
and the name of the affiliate or subsidiary are the same as the manufacturer,
and the affiliate or subsidiary is the exclusive sales outlet for the manufacturer.
(b)
(No change.)
§205.3.General Requirements.
(a)
The Act and these sections shall apply to all persons,
partnerships, corporations, and associations engaged in the business of manufacturing,
renovating, wholesaling,
distributing, importing,
processing, germicidally
treating, and selling items of bedding or processed filling materials. These
regulations do not apply to persons who make, renovate, or germicidally treat
bedding for their own use.
(b)
These regulations shall apply to each separate manufacturing
plant facility
or business location
regardless of name or ownership.
(c)
Each item of bedding and processed filling material shall
be labeled in conformity with the requirements of the Act and
these
regulations.
This requirement does not apply to a custom upholstery business
that does not repair or renovate bedding for resale.
(d)
No person shall
remove the label or
position,
arrange or display an
article
[
(e)
To allow for unintentional variations, a tolerance or variation
not in excess of 10% by weight from the amount stated on the label shall be
allowed
.
[
(f) - (g)
(No change.)
(h)
The presence of a metal spring unit in an
article
[
(i) - (j)
(No change.)
(k)
Identification and storage of
secondhand
[
(1)
Persons engaged in the manufacture,
distribution,
wholesaling, importation
, renovation, processing, and/or germicidal
treatment shall keep new and
secondhand
[
(2)
Persons engaged in the business of selling or storing
articles of bedding shall keep new and
secondhand
[
(3)
When new and
secondhand
[
(l)
Mattresses and mattress pads manufactured,
renovated or delivered into or within this state for purposes of sale in this
state shall meet the federal standard for flammability of mattresses set forth
in 16 Code of Federal Regulations, Part 1632.
§205.4.Labeling Requirements.
(a)
It shall be unlawful to make any false or misleading statement
on any label or tag required by the Act and
these
regulations;
it shall be unlawful for any person to remove, deface, alter, or position
any label or tag or statement thereon for the purpose of defeating the provisions
of the Act and
these
regulations, except that the label or tag
may be removed by the consumer.
(b)
All labels, tags, or markings required by
the
[
(c)
Labels and tags
shall
[
(d)
Information required on the label
shall
[
(e)
Required printed matter on the label shall not be concealed,
in whole or in part, by any other label, tag or printed matter not required
by
the
[
(f)
(No change.)
(g)
The terms used on the label to describe materials used
in filling shall be restricted to those defined in
these
[
(h)
Any chemical treatment applied to the filling
materials shall be described in the statement of contents section. e.g. "blended
cotton felt--boric acid treated".
(i)
[
(j)
The information presented on the label
shall be in English and the label shall be clearly visible at all times. Other
languages may be used in addition to English, but shall be presented on separate
labels.
(k)
[
(1)
Mattresses, box springs, pillows, pads, sleeping bags,
and most infant bedding articles shall have the label attached on the end/side
border or top panel and in proximity of any advertising labels, company logos,
streamers, or any other labels not required by the Act. In the absence of
any private labels, the law label
shall
[
(2)
Articles such as quilted bedspreads, mattress protectors,
quilts, etc., packaged in clear or see through packaging material
shall
[
(3)
Articles of bedding packaged in concealed packaging
shall
[
(4)
Processed filling material identification tag location
is optional except that it
shall
be securely attached where clearly
visible.
(5)
Reclining chairs shall have the label attached to
the underside of the foot rest in such a way as to allow the label to be unfolded
for easy access. Chairs with detachable cushions may have the label attached
to the front part of the platform under the cushion.
(6)
Upholstered furniture articles with detachable cushions
(e.g., sleeper sofas, sofa beds, chair beds) shall have the label attached
to the front part of the platform under the cushions. Upholstered furniture
articles without detachable cushions shall have the label attached to the
front part of the article in such a way as to make it accessible and visible.
(7)
Attaching
[
(8)
Attaching the label in a location or manner which,
while the article of bedding is on display for sale, conceals the label from
open view to the purchaser shall be considered as a willful act to intentionally
defeat the intent of the [
(l)
[
(1)
The label attached to bedding
wholly manufactured from new materials shall have a minimum size of six square
inches and state, plainly stamped or printed in black ink on all white material:
(A)
"ALL NEW MATERIAL" in capital letters at least
one-eighth inch high;
(B)
the kind and grade of each material used in
the filling and, if more than one kind or grade of material is used, the percentage,
in descending order, by weight of each material;
(C)
the manufacturer's permit identification number
assigned by the department; and
(D)
shall be in the following form:
Figure: 25 TAC §205.4(l)(1)(D)
[
[
(2)
The label attached to
bedding any part of which is manufactured or renovated from secondhand or
recycled material, other than bedding reworked, repaired, or renovated for
the owner for the owner's own use, shall be at least 12 square inches and
state, plainly stamped or printed in red ink on all white material:
(A)
"SECONDHAND MATERIAL" or "RECYCLED MATERIAL"
in capital letters at least one-fourth inch high;
(B)
the manufacturer's or renovator's permit identification
number assigned by the department; and
(C)
shall be in the following form:
Figure: 25 TAC §205.4(l)(2)(C)
[
[
(3)
The label attached to
material or bedding that has been germicidally treated shall be at least 12
square inches and state, plainly stamped or printed in black ink on all yellow
material:
(A)
"SECONDHAND (USED) ARTICLE - SANITIZED" in capital
letters at least one-fourth inch high;
(B)
that the article or material has been germicidally
treated by a method approved by the department;
(C)
the method of germicidal treatment applied;.
(D)
the date the article was germicidally treated;
(E)
the name and address of the person for whom
the article was germicidally treated;
(F)
the permit identification number of the person
applying the germicidal treatment assigned by the department; and
(G)
shall be in the following form:
Figure: 25 TAC §205.4(l)(3)(G)
[
The second hand
material label shall have a minimum size of 12 square inches, the tag shall
be printed in red ink on white background, and the label shall be in the following
form:]
[
[
[
(4)
[
Figure: 25 TAC §205.4(l)(4)
[
§205.5.Definitions and Designations of Filling Materials.
(a)
(No change.)
(b)
Down.
(1)- (4)
(No change.)
[
The tolerance levels
for the labeling of down are as follows:]
[
a minimum of 80% down, plumules, and down fiber;]
[
consisting of down and plumules-minimum of
70%;]
[
consisting of down fiber-minimum of 10%;]
[
the remaining 20% may consist of a combination
of the following:]
[
natural waterfowl feathers;]
[
down fiber;]
[
damaged feathers-maximum 3.0%;]
[
chicken feather and fiber-maximum 2.0%;]
[
residue-maximum 2.0%;]
[
waterfowl feather fiber.]
[
Species designation
tolerance. If the down product is labeled as to the waterfowl (goose or duck),
a minimum of 90% of the waterfowl plumage contained therein must be of that
species.]
(c)
Feathers.
(1) - (6)
(No change.)
(7)
Emu feathers are feathers of any kind
of emu, which are whole in physical structure.
(8)
[
(9)
[
(10)
[
(d)
Foam.
(1) - (3)
(No change.)
(4)
Urethane foam high resilience is a permissible term
for urethane foam with a minimum density of 2.5 pounds per cubic foot, a minimum
resilience of 60%, and a minimum support ratio of 2.4 pounds per cubic
foot
[
(5)
Polystyrene foam beads are a filling material which
has been processed into small round droplets
approximately 1/2 inch
[
(6)
When
[
(e)
Hair.
(1)
(No change.)
(2)
Hair mixtures - The hair of different animal origin
used in a blend or mixture. The kind and percentage, by weight of each, shall
be stated on the [
(f)
(No change.)
(g)
Miscellaneous fibers.
(1) - (2)
(No change.)
(3)
Excelsior - Generic term for shredded wood fibers
but does not include waste such as
shavings
[
(4) - (7)
(No change.)
(h) - (i)
(No change.)
(j)
Gel. Generic term for any filling material
of a semi-solid form, typically encased in a leak proof fabric cover and consisting
of a mixture of water or other liquid base, dissolved chemicals and/or a suspension
of other chemicals, which provides special ergonomic and resiliency properties.
(k)
Buckwheat hulls. Generic term for the hulls
removed from the seed of the buckwheat plant.
(l)
[
(1)
Card, strip or stripping - Tangled or matted mass of fibers
removed from the carding cloth during the carding process.
(2)
Comber or noils - Tangled fibers removed during the
combing process of textile fibers.
(3)
Fly - Fibers removed from the machines during carding,
drawing or similar textile operations.
(4)
Napper - Lint removed during the process of raising
the face of a cloth.
(5)
Picker, picker motes, or motes - Matted or tangled
masses of fiber resulting from the opening and cleaning of fibers in opener
room of the textile mill.
(6)
Sweepings - The fibrous sweepings from the floors
of the textile mill.
§205.6.Adjunctive Terms.
(a)
The terms in this section are required to be used with
definitions when applicable for descriptive terminology.
(b)
Batting, blended, felt
- Material
[
(c)
Boric acid treated
- Must
[
(d)
By-products
- Vegetable
[
(e)
Garnetted clippings
- Materials
[
(f)
Pad
- Material
[
(g)
Pieces
- Urethane
[
(h)
Resinated
- The term
must precede the generic
material which has received a resin application (e.g., resinated cotton fiber
pad).
(i)
Rubberized
-The term
must precede the generic
material which has received a latex application (e.g., rubberized hair pad).
(j)
Shredded
- Material
[
(k)
Shredded clippings
-Materials
[
(l)
Waste
- By-products
[
(1)
cotton waste [
(2)
material which contains bits of paper, cardboard,
string, etc.
(m)
(No change.)
§205.8.Germicidal Treatment Requirements; Methods.
(a)
General Requirements.
(1)
Secondhand bedding articles.
(A)
Secondhand bedding articles shall be cleaned
and germicidally treated by a method approved by the department in subsection
(b) of this section before they may be sold, leased or rented to consumers.
(B)
Bedding articles manufactured, repaired, or
renovated in whole or in part from secondhand or recycled materials shall
be germicidally treated by a method approved by the department in subsection
(b) of this section before they may be sold, leased or rented to consumers.
(C)
Upholstered sofa beds and studio couches are
subject to the requirements set forth in paragraph (1)(A) and (B) of this
subsection.
(2)
Renovated bedding articles.
(A)
Secondhand or recycled materials shall be germicidally
treated by a method approved by the department in subsection (b) of this section
before they may be used in the manufacture, repair or renovation of bedding
articles.
(B)
Materials that are filthy, stained, oily, have
obnoxious odors, harbor insects or pathogenic organisms, were obtained from
dumps or junkyards or have been exposed to the elements shall not be used
in the manufacture, repair or renovation of bedding articles.
(C)
The outer covers on secondhand mattresses and
box springs to be renovated or rebuilt for resale shall be removed to expose
the concealed filling materials. Materials described in paragraph (2)(B) of
this subsection shall be removed and discarded. When the chemical method of
germicidal treatment is used, the mattresses and box springs shall be treated
prior to the installation of new covers. Secondhand covers shall not be reused
regardless of the germicidal treatment method.
(b)
Treatment methods.
(1)
[
(A)
[
(B)
[
(C)
[
(D)
[
(E)
[
(F)
[
(G)
[
(2)
[
(A)
[
(B)
[
(C)
[
(D)
[
(3)
[
(A)
[
(B)
[
(4)
[
(5)
[
(6)
[
§205.9.Sanitary Premises.
Every person engaged in the business of manufacturing, renovating,
or processing bedding and/or bedding materials shall keep
each business
location
[
(1)
Adequate housing and floor space shall be provided to prevent
crowding of materials and equipment and to allow for the practice of cleanliness
and sanitation.
Articles of bedding and/or processed bedding materials
shall be securely housed at all times and may not be exposed to the elements.
(2) - (4)
(No change.)
(5)
Walls and ceilings of all rooms where materials are
stored, processed, or otherwise used in the manufacturing or renovating of
bedding, shall be of tight, smooth construction, shall be painted, and kept
clean and in good repair
.
[
(6) - (9)
(No change.)
(10)
A water supply and drinking fountain acceptable to
the department shall be provided. Paper cups with dispenser may be used instead
of a fountain. The
use of a
common drinking cup is prohibited.
§205.10.Adjustments to the Minimum Requirements.
The department shall, through its authorized representatives, have
the right to require adjustments
to
[
§205.11.Permit Requirements; Types; Application; Conditions; Suspension.
(a)
General requirements.
(1)
A person may not manufacture, import, wholesale, distribute,
or engage in the business of renovating or selling bedding in this state or
for delivery in this state unless the person first obtains a permit for that
specific purpose from the department. This requirement does not apply to a
custom upholstery business that does not repair or renovate bedding for resale.
(2)
A processor may not sell filling material in this
state or for delivery in this state unless the person first obtains a permit
for that purpose from the department.
(3)
A person may not apply a germicidal treatment method
to bedding unless the method has been registered with and approved in writing
by the department and the person has been issued a germicidal treatment permit
by the department.
(4)
These permit requirements apply to each separate business
location regardless of business name or ownership.
(5)
All permits expire 12 months from the date of issuance
by the department. The department may prorate permit fees as appropriate to
provide for a common expiration date for persons holding and/or applying for
more than one permit.
(b)
Types of permits and permit fees.
(1)
Mattress Manufacturer Permit. Required of all manufacturers
of mattresses or box springs prior to shipping mattresses and/or box springs
into or within this state for the purpose of resale. Permit fees are graduated
based on the number of articles the manufacturer is requesting authorization
to ship during the permit period. The fees are set out in Schedule A as follows:
Figure: 25 TAC 205.11(b)(1)
(2)
Mattress Renovator Permit. Required of all renovators
of mattresses or box springs prior to shipping mattresses and/or box springs
in or within this state for the purpose of resale. Permit fees are graduated
based on the number of mattresses or box springs the renovator is requesting
authorization to ship during the permit period. The fees are set out in subsection
(b)(1) of this section.
(3)
Bedding Product Manufacturer Permit. Required of all
manufacturers of bedding products, other than mattresses and box springs,
prior to shipping such articles in or within this state for the purpose of
resale. Permit fees are graduated based on the number of articles the manufacturer
is requesting authorization to ship during the permit period. The fees are
set out in Schedule B as follows:
Figure 25 TAC §205.11(b)(3)
(4)
Wholesaler/Distributor Permit. Required of all wholesalers
and distributors of bedding articles or filling materials prior to shipping
such articles or filling materials into this state for the purpose of resale.
Permit fees are graduated based on the number of articles or units of filling
materials the wholesaler/distributor is requesting authorization to ship during
the permit period. The fees are set out in Schedule B, subsection (b)(3) of
this section.
(5)
Importer Permit. Required of all importers of bedding
articles or filling materials prior to shipping such articles or filling materials
into this state for the purpose of resale. Permit fees are graduated based
on the number of imported articles or units of filling materials the importer
is requesting authorization to ship during the permit period. The fees are
set out in Schedule B in subsection (b)(3) of this section.
(6)
Processor Permit. Required of all manufacturers and/or
processors of bulk filling materials prior to selling and shipping such filling
materials into this state. The annual permit fee is $50.
(7)
Germicidal Treatment Permit. Required of all persons
prior to the application of a germicidal treatment process, approved by the
department, to articles of bedding and/or filling materials to be shipped
into or to be sold in this state. The annual permit fee is $50.
(8)
Arts and Crafts Permit. Required of all persons who
manufacture bedding articles other than mattresses (such as pillows, quilts,
comforters), have no paid employees, and manufacture less than 250 articles
per year for sale in this state. The annual permit fee is $25.
(c)
Permit application.
(1)
Application for an initial permit or to renew an expiring
permit must be made through the department on an approved application form
which may be obtained from the Product Safety Division, Texas Department of
Health, 1100 West 49th Street, Austin, Texas 78756.
(2)
A separate application must be completed and submitted
for each specific permit applied for at each specific business location or
plant location.
(3)
The appropriate permit fee, payable to the department,
must accompany each application.
(4)
Additional information that may be required by the
department includes the following:
(A)
copy of current permits or licenses issued by another state,
or state;
(B)
copy of most recent bedding inspection report if the business
or plant is located in a city, county, state or country that has bedding laws
and regulations and conducts inspections;
(C)
copies of bedding article labels proposed for use in this
state;
(D)
samples of products to be shipped into this state;
(E)
confirmation of compliance with applicable federal flammability
standards for mattresses and mattress pads or test results from an independent
testing facility acceptable to the department;
(F)
explanation of the germicidal treatment method to be applied
to second- hand articles of bedding; and
(G)
any other information that the department may determine
is necessary for the protection of the public health and safety.
(d)
Permit conditions.
(1)
Each person required to obtain a permit shall keep accurate
and up-to-date records of all articles of bedding shipped into or within this
state and such records shall be made available to authorized representatives
of the department when requested. The department may require, at the expense
of the person, that an independent audit of the records of the person be conducted
with the results of such audit provided to the department and the person.
(2)
Each person required to obtain a Germicidal Treatment
Permit shall:
(A)
conspicuously post the permit on the premises of the person's
business near the treatment device; and
(B)
keep accurate records in a bound log book describing all
bedding articles or materials treated, date of treatment, method of treatment,
and the name and address of the owner of each item.
(3)
Each person required to obtain a permit shall
provide product samples in sufficient numbers to determine compliance with
these regulations when requested by the department and shall reimburse retail
business establishments for samples of bedding or materials taken by authorized
representatives of the department.
(4)
Each person required to obtain a permit shall provide
test results acceptable to the department confirming compliance with federal
flammability standards for mattresses and mattress pads when requested by
the department.
(5)
Each person required to obtain a permit shall maintain
each business location in a sanitary condition that complies with §205.9
of this title.
(6)
Each person required to obtain a permit shall allow,
during normal business hours, an authorized representative or representatives
of the department to conduct an announced or unannounced inspection of their
place of business for purposes of determining compliance with the Act and
regulations and to take samples of bedding articles or materials for inspection
and analysis or to be held as evidence of a violation of these regulations.
(7)
Each person required to obtain a permit shall allow
an authorized representative or representatives of the department to copy
records and take photographs of articles of bedding or materials during inspections.
(e)
Permit denial, suspension, revocation
(1)
An application for permit issuance or renewal will be denied
by the department if the applicant fails or refuses to provide a complete
application, pay the appropriate permit fee, provide requested information
or product samples or test results, or if the business location or plant location
is not in a sanitary condition in violation of the Act and regulations.
(2)
An application for permit issuance or renewal may
be denied by the department if the applicant has failed to make acceptable
progress implementing corrective actions agreed upon by the applicant and
the department to remedy previous violations of the Act or these regulations.
(3)
A permit may be suspended or revoked by the department
if the permit holder fails to maintain the permitted business location or
plant location in a sanitary condition, manufactures or renovates and sells
mattresses or mattress pads that do not comply with federal flammability standards,
fails to germicidally treat articles of used bedding prior to resale, or commits
any other or repeated violations of the Act or these regulations.
§205.12.Administrative Penalty.
(a)
The department may assess an administrative penalty against
a person who violates the Act or a rule adopted by the department under the
Act as provided by this section.
(b)
The penalty may not exceed $25,000 for each violation.
Each day of a continuing violation constitutes a separate violation.
(c)
In determining the amount of the administrative penalty,
the department shall consider:
(1)
the seriousness of the violation;
(2)
the history of previous violations;
(3)
the amount necessary to deter future violations;
(4)
efforts made to correct the violation; and
(5)
any other matters that justice may require.
(d)
Individual violations may be reduced or increased based
on the considerations listed in subsection (c) of this section.
(e)
A person is subject to double the initial penalty on second
finding of violation of any provision of the Act or regulations. Third and
subsequent violations of a provision are subject to five times the initial
penalty, not to exceed $25,000 per day, per violation.
(f)
Violations shall be placed in one of the following severity
levels:
(1)
Critical violation. Severity Level III includes the types
of violations that are the most significant and present a threat to public
health and safety. The base penalty for a first violation will generally not
exceed $10,000 per day, per violation. The same violation continuing written
after notification by the department constitute separate violations. Examples
of Severity Level III violations include but are not limited to:
(A)
failure to germicidally treat, or properly treat, bedding
by a method approved by the department;
(B)
failure to maintain a business location in a sanitary condition;
(C)
failure to comply with federal flammability standards for
mattresses and mattress pads;
(D)
failure to remove old covers from renovated mattresses
and/or remove filling materials that are filthy, stained, have obnoxious odors,
harbor insects or pathogenic organisms, were obtained from alleys, dumps or
junkyards or other sources where the materials were exposed to the elements;
(E)
labeling secondhand (used) bedding and/or bedding that
was not properly germicidally treated as new or sanitized bedding;
(F)
failure to obtain or renew the appropriate permit, or permits,
prior to doing business in the state;
(G)
falsifying required records or submitting false test results
on bedding;
(H)
refusal to recall bedding from commerce when so directed
by the commissioner or the department;
(I)
operating under another person's permit or a permit issued
to another location; and
(J)
using filling materials in bedding that emit irritating
or toxic fumes or vapors.
(2)
Serious violation. Severity Level II includes
violations that are significant and which, if not corrected, could threaten
public health and safety. The base penalty for a first violation will generally
not exceed $2,500 per day, per violation. Examples of Level II violations
include, but are not limited to:
(A)
mixing germicidally treated bedding with untreated bedding;
(B)
failure to label or accurately label bedding;
(C)
failure to keep accurate and up-to-date records;
(D)
selling unlabeled or falsely labeled bedding;
(E)
selling used bedding that has not been germicidally treated;
and
(F)
concealing the label from the view of consumers.
(3)
Significant violation. Severity Level I includes
violations that are of more than minor significance and, if left uncorrected,
could lead to more serious circumstances. The base penalty for Level I violations
on first occurrence will generally not exceed $500 per day, per violation.
Examples of Level I violations include, but are not limited to:
(A)
attaching labels to bedding in unauthorized locations;
(B)
failure to identify multiple filling materials on the label
in terms of percentage, by weight, in descending order;
(C)
failure to notify the department of changes in business
location or ownership; and
(D)
exceeding the 10 percent variance limit when stating the
percentage, by weight, for bedding filling materials.
(g)
All proceedings for the assessment of an administrative
penalty are subject to Chapter 2001, Government Code.
(h)
If, after investigation of a possible violation and the
facts surrounding that possible violation the department determines that a
violation has occurred, the department shall give written notice of the violation
to the person alleged to have committed the violation. The notice must include:
(1)
a brief summary of the alleged violation; and
(2)
a statement of the amount of the proposed penalty
based on the factors set forth in subsection (c) of this section; and a statement
of the person's right to a hearing on the occurrence of the violation, the
amount of the penalty, or both.
(i)
Not later than the 20th day after the date on which the
notice is received, the person notified may accept the alleged violation and
penalty determined by the department under subsection (c) of this section,
or may make a written request for a hearing on that determination.
(j)
If the person notified of the violation accepts the determination
of the department or if the person fails to respond in a timely manner to
the notice, the commissioner or the commissioner's designee shall issue an
order approving the determination and ordering that the person pay the proposed
penalty.
(k)
If the person notified requests a hearing, the department
shall:
(1)
set a hearing date;
(2)
give written notice of the hearing to the person;
and
(3)
designate a hearings examiner to conduct the hearing.
(l)
The hearings examiner shall make findings of fact and conclusions
of law and shall promptly issue to the commissioner or the commissioner's
designee a proposal for decision as to the occurrence of the violation and
a recommendation of the amount of any proposed penalty.
(m)
Based on the findings of fact and conclusions of law and
the recommendations of the hearings examiner, the commissioner or the commissioner's
designee by order may find that a violation has occurred and may assess a
penalty or may find that no violation has occurred.
(n)
The department shall give notice of the order to the person
alleged to have committed the violation. The notice must include:
(1)
separate statements of the findings of fact and conclusions
of law;
(2)
the amount of any penalty assessed; and
(3)
a statement of the right of the person to judicial
review of the order under Chapter 2001, Government Code.
§205.13.Detained or Embargoed Bedding.
(a)
The commissioner or an authorized agent may detain or embargo
bedding if the commissioner or authorized agent finds or has probable cause
to believe that the bedding violates the Act or these regulations.
(b)
The commissioner or an authorized agent shall affix to
the detained or embargoed bedding a notice or other appropriate marking indicating
that:
(1)
the bedding violates or is suspected of violating the Act
or these regulations; and
(2)
the bedding has been detained or embargoed.
(c)
The notice or marking on detained or embargoed bedding
must warn all persons not to use the bedding, remove the bedding from the
premises, or dispose of the bedding by sale or otherwise until permission
for use, removal, or disposal is given by the commissioner, the authorized
agent, or a court.
(d)
A person may not use detained or embargoed bedding, remove
detained or embargoed bedding from the premises, or dispose of detained or
embargoed bedding by sale or otherwise without permission of the commissioner,
the authorized agent, or a court.
(e)
The commissioner or an authorized agent shall remove the
notice or other marking from detained or embargoed bedding if the commissioner
or authorized agent finds that the bedding does not violate the Act or these
regulations.
§205.14.Removal Order for Detained or Embargoed Bedding.
(a)
If the claimant of the detained or embargoed bedding or
the claimant's agent fails or refuses to transfer the bedding to a secure
place after the notice or other appropriate marking has been affixed as provided
by §205.12 of this title (relating to Administrative Penalty), the commissioner
or an authorized agent may order the transfer of the bedding to one or more
secure storage areas to prevent unauthorized use, removal, or disposal.
(b)
The commissioner or an authorized agent may provide for
the transfer of the bedding if the claimant of the bedding or the claimant's
agent does not carry out the transfer in a timely manner.
(c)
The claimant of the bedding or the claimant's agent shall
pay the costs of the transfer, and the costs of any transfer made under subsection
(a) or (b) of this section shall be assessed against the claimant of the bedding
or the claimant's agent.
(d)
The commissioner may request the attorney general to bring
an action in the district court in Travis County to recover the costs of the
transfer. In a judgement in favor of the state, the court may award costs,
attorney fees, court costs, and interest from the time the expense was incurred
through the time the department was reimbursed.
§205.15.Condemnation.
An action for the condemnation of bedding may be brought before a court
in whose jurisdiction the bedding is located, detained, or embargoed if the
bedding violates the Act or these regulations.
§205.16.Recall Orders.
(a)
In conjunction with the detention or embargo of bedding
under §205.13 of this title (relative to Detained or Embargoed Bedding),
the commissioner may order bedding to be recalled from commerce.
(b)
The commissioner's recall order may require the bedding
to be removed to one or more secure areas approved by the commissioner or
an authorized agent.
(c)
The recall order must be in writing and signed by the commissioner.
(d)
The recall order may be issued before or in conjunction
with the affixing of the notice under §205.13 of this title.
(e)
The recall is effective until the order:
(1)
expires on its own terms;
(2)
is withdrawn by the commissioner; or
(3)
is reversed by a court in an order denying condemnation.
(f)
The claimant of the bedding or the claimant's agent shall
pay the costs of the removal and storage of the bedding removed.
(g)
If the claimant or the claimant's agent fails or refuses
to carry out the recall order in a timely manner, the commissioner may provide
for the recall of the bedding. The costs of the recall shall be assessed against
the claimant of the bedding or the claimant's agent.
(h)
The commissioner may request the attorney general to bring
an action in the district court of Travis County to recover the costs of the
recall, attorney's fees, court costs, and interest from the time the expense
was incurred through the date the department was reimbursed.
§205.17.Inspection.
(a)
To determine compliance with the Act or regulations, an
authorized representative, or representatives, may enter a place at which:
(1)
bedding is manufactured, repaired, renovated, stored, or
sold;
(2)
materials are prepared for use in bedding; or
(3)
germicidal treatment of bedding is performed.
(b)
An authorized representative of the department may take
a sample of bedding or materials for inspection or analysis.
(c)
An authorized representative of the department may hold
for evidence bedding or materials manufactured, repaired, renovated, or sold
in violation, or suspected violation, of the Act or regulation.
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
March 19, 1999.
TRD-9901671
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 2, 1999
For further information, please call: (512) 458-7236
25 TAC §205.11
(Editor's note: The text of the following section proposed for
repeal will not be published. The section may be examined in the offices of
the Texas Department of Health or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeal is proposed under Health and Safety Code,
Chapter 345, §345.082, which provides the department with the authority
to adopt necessary rules to implement and enforce Chapter 345; and Health
and Safety Code, §12.001, which provides the Texas Board of Health (board)
with the authority to adopt rules for the performance of every duty imposed
by law on the board, the department, and the commissioner of health.
The repeal affects Health and Safety Code, Chapter 345; Chapter 12; and
the General Appropriations Act, House Bill 1, Article IX, Rider 167, passed
by the 75th Legislature.
§205.11.Stamp Exemption and Reporting.
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
March 19, 1999.
TRD-9901672
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 2, 1999
For further information, please call: (512) 458-7236
Subchapter L. Licensure of Food Manufacturers and Food Wholesalers - Including Good Manufacturing Practices and Good Warehousing Practices in Manufacturing, Packing, and Holding Human Food
25 TAC §§229.181-229.183
The Texas Department of Health (department) proposes amendments
to §§229.181 - 229.183, concerning licensure of food manufacturers
and food wholesalers - including good manufacturing practices. Specifically,
these sections are basic operating requirements for all manufacturers of food
and wholesale distributors of food and concern definitions; licensing fees
and procedures; and minimum standards for licensure. The amended regulations
will provide an update to existing regulations regarding food safety.
The General Appropriations Act, House Bill 1, Article IX, Rider 167, passed
by the 75th Legislature, 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). The sections have been
reviewed and the department has determined that reasons for adopting the sections
continue to exist.
Proposed amendments to §229.181 include updated clarification of terms
and bring definitions into
Texas Register
numerical format in compliance with 1 Texas Administrative Code §91.1
effective February 17, 1998. Section 229.182 is amended to improve licensing
procedures as to location, ownership information, and business status. Amended
§229.183 references new manufacturing and warehousing standards for licensure.
Other minor changes were made for the purpose of clarification of the sections.
The department published a Notice of Intention to Review §§229.181
- 229.184 as required by Rider 167 in the
Texas Register
(24 TexReg 831) on February 5, 1999.
Robert D. Sowards, Jr., Director, Manufactured Foods Division, has determined
that for each year of the first five-year period the sections are in effect
there will be no fiscal implications to state government or local government.
Mr. Sowards also has determined that for each year of the first five years
the sections are in effect, the public benefit anticipated as a result of
appending the sections will be additional assurance that foods manufactured,
packaged, and held by Texas food manufacturers are not adulterated or misbranded.
There will be no effect on small businesses. There are no anticipated economic
costs to persons who are required to comply with the sections as proposed.
There is no impact on local employment.
Comments on the proposal may be submitted to Robert D. Sowards, Jr., Director,
Manufactured Foods Division, Texas Department of Health, 1100 West 49th Street,
Austin, Texas 78756, (512) 719-0243. Comments will be accepted for 30 days
following publication of the proposal in the
Texas
Register
.
The amendments are proposed under the Health and Safety Code,
§431.241, which provides the department with the authority to adopt necessary
regulations pursuant to the enforcement of Chapter 431; and §12.001,
which provides the Texas Board of Health (board) with the authority to adopt
rules for the performance of every duty imposed by law on the board, the department,
and the commissioner of health.
The proposed amendments affect the Health and Safety Code, Chapter 431;
and the General Appropriations Act, House Bill 1, Article IX, Rider 167, passed
by the 75th Legislature is implemented by this proposal.
§229.181.Definitions.
The following words and terms, when used in these sections, shall have
the following meanings, unless the context clearly indicates otherwise.
(1)
Consumer - Any person, firm, corporation, or other public
or private legal entity which utilizes articles of food as supplied to that
person, firm, or corporation, or which further processes or packages such
articles of food.
(2)
Direct seller - An individual:
(A)
who is not affiliated with a permanent retail
establishment and who engages in the business of:
(i)
in-person sales of prepackaged nonperishable
foods, including dietary supplements, to a buyer on a buy-sell basis, a deposit-commission
basis, or a similar basis for resale in a home; or
(ii)
sales of prepackaged nonperishable foods, including
dietary supplements, in a home;
(B)
who receives substantially all remuneration
for a service, whether in cash or other form of payment, which is directly
related to sales or other output, including the performance of the service,
and not to the number of hours worked; or
(C)
who performs services under a written contract
between the individual and the person for whom the service is performed, and
the contract provides that the individual is not treated as an employee with
respect to federal tax purposes.
(3)
[
(4)
[
(5)
[
(6)
[
(7)
[
[
(8)
Package - Any container or wrapping
in which a consumer commodity is enclosed for use in the delivery or display
of that consumer commodity to retail purchasers. The term includes wrapped
meats enclosed in papers or other materials as prepared by the manufacturers
thereof for sale. The term does not include:
(A)
shipping containers or wrappings used solely
for the transportation of a consumer commodity in bulk or in quantity to manufacturers,
packers, or processors, or to wholesale or retail distributors; or
(B)
shipping containers or outer wrappings
used by retailers to ship or deliver a commodity to retail customers if the
containers and wrappings do not bear printed matter relating to any particular
commodity.
(9)
[
[
(10)
Sale - The manufacture, production,
processing, packaging, exposure, offer, possession, or holding of any such
article for sale; and the sale, dispensing, and giving of any such article,
and the supplying or applying of any such articles in the conduct of any food,
drug, or device place of business.
§229.182.Licensing Fee and Procedures.
(a)
Licensing fee and exemptions.
(1) - (2)
(No change.)
(3)
All food wholesalers in Texas shall obtain a license
annually with the Texas Department of Health. Except as provided for in paragraph
(4) of this subsection, food wholesalers shall pay a license fee as follows:
(A) - (C)
(No change.)
(D)
$400 for each place of business having gross annual food
sales of $1 million-$9,999,999.99;
and
(E)
$600 for each place of business having gross annual food
sales of greater than or equal to $10 million
.
[
[
(4)
(No change.)
(5)
For the purpose of collecting licensing fees under
this section, a person that distributes both its own manufactured food and
food it does not manufacture must obtain only a food manufacturer's license.
However, when calculating the amount of the licensing fee, the manufacturer
must include the total for all food
manufactured and wholesaled
[
[
(6)
[
(b)
(No change.)
(c)
License application. All food manufacturers and food wholesalers
shall file a license application on a form
authorized
[
(1)
(No change.)
(2)
the
physical
address of
the place
of
[
(3)
the mailing address of the place of
business in the state that is licensed;
(4)
[
(5)
[
(6)
[
(d) - (e)
(No change.)
(f)
Issuance of license. The department may license a manufacturer
or wholesaler of foods who meets the requirements of this section and §229.183
of this title (relating to Minimum Standards for Licensure).
(1) - (2)
(No change.)
(3)
A current license shall only be issued
when all past due fees and late fees are paid.
(g)
Renewal of license.
(1)
(No change.)
(2)
A person who holds a license issued by the department
under the Health and Safety Code shall renew the license by filing an application
for renewal on a form
authorized
[
(3)
(No change.)
(h)
Amendment of license.
(1)
(No change.)
(2)
Change in
name, ownership, status, or
location
[
(i)
This section does not apply
to:
(1)
a person, firm, or corporation that harvests,
packages, washes, or ships raw fruits or vegetables;
(2)
a direct seller who is not otherwise engaged
in manufacturing;
(3)
a person engaged solely in the distribution
of alcoholic beverages in sealed containers by holders of licenses or permits
issued under the Alcoholic Beverage Code, Chapters 19, 20, 21, 23, 64, or
65; or
(4)
a food service establishment or a commissary
which distributes food primarily intended for immediate consumption on the
premises of a retail outlet under common ownership unless the business regularly
engages in the labeling, combining, and purifying of food which is either
sold for resale or packaged for sale in other than individual portions.
[
§229.183.Minimum Standards for Licensure.
[
Food manufacturers and food wholesalers.
[
(1)
All
food manufacturers
[
(2)
All food wholesalers in Texas shall
comply with §§229.211 - 229.219 of this title in addition to the
existing standards contained in the following statutes: Health and Safety
Code, Chapters 431, 434, and 438.
[
(3)
Living areas. No manufacturing
or holding
of foods
for distribution
shall be conducted in any room used as
living or sleeping quarters. All
food
manufacturing
and storage
[
[
(4)
[
[
Food wholesalers.]
[
Food storage facilities shall be properly constructed
and maintained. All walls, ceilings, and floors shall be intact to preclude
entry of vermin and environmental contaminants.]
[
Doors and loading docks shall be tight-fitting
and kept closed at all times when not in use, or adequately screened during
normal operating hours to prevent entry of rodents, birds, or other pests.]
[
Outer premises, including trash receptacles,
shall be kept clean and free of odors, debris, high weeds, or standing water
which could harbor or attract vermin.]
[
Hand-washing and toilet facilities shall
be provided and maintained, including hot and cold running water, hand soap,
and single-service towels as deemed appropriate by the regulatory authority
for the types of food handled by the licensee.]
[
Adequate lighting shall be provided to
facilitate cleaning and inspection of stored goods.]
[
Wastewater shall be disposed of in a manner
approved by the regulatory authority.]
[
All foods, including refrigerated and
frozen foods, shall be stored off the floor and away from walls to help prevent
contamination by vermin (rodents and insects for example) and moisture, and
to facilitate cleaning and inspection.]
[
Food storage facilities and transportation
vehicles shall be kept free of rodents, insects, birds, and other pests which
may contaminate food.]
[
Damaged, distressed, and infested foods
shall be stored in a "morgue area," adequately separated from undamaged foods
and shall be disposed of in a timely manner to preclude further contamination.]
[
The internal temperature of potentially
hazardous foods shall be maintained at 45 degrees Fahrenheit (7 degrees Centigrade)
or below at all times to preclude temperature abuse during staging, loading,
and transporting. Frozen foods shall be kept frozen at all times.]
[
During warehousing and transporting,
all chemicals shall be properly stored and physically separated from foods
and to preclude contamination.]
[
Foods being warehoused shall be rotated
on a "first in, first out" basis.]
[
Packaged foods, including imported foods,
shall comply with all applicable food labeling regulations.]
[
Food storage facilities and transportation
vehicles operated under the control of the licensee shall be kept clean and
free of excessive dust, dirt, spillage, and other debris, including excess
moisture.]
[
Food transport vehicles shall be operated
in compliance with federal regulations pertaining to back-hauling.]
[
Each incoming lot shall be examined at
the time of receipt to preclude acceptance of contaminated or adulterated
foods.]
[
Swollen, leaking, and/or severely dented
containers of food shall be segregated and promptly placed in the "morgue
area" to preclude further contamination, attraction of vermin, or sale prior
to reconditioning.]
[
Distressed foods salvaged by the licensee
shall be salvaged in accordance with §§229.191-229.202 of this title
(relating to Regulation of Food, Drug, Device, and Cosmetic Salvage Establishments
and Brokers).]
[
Only pesticides approved by the Environmental
Protection Agency (EPA) for use in a food warehouse and/or food processing
facility may be used. Pesticides shall be used only according to label directions.
Rodenticides shall be placed inside enclosed bait boxes or other approved
receptacles. Only a licensed pesticide applicator may apply restricted use
pesticides.]
[
Food wholesalers engaged in the receipt
and distribution of over-the-counter or prescription drugs shall comply with
§229.253 of this title (relating to Minimum Standards for Licensure).]
[
The licensee shall keep accurate distribution
records to facilitate the recall of any foods found to be unfit for human
consumption.]
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
March 19, 1999.
TRD-9901667
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 2, 1999
For further information, please call: (512) 458-7236
The Texas Department of Health (department) proposes the repeal of
existing §§229.191 - 229.208, and new §§229.191 - 229.208,
concerning the regulation of food, drug, device, and cosmetic salvage establishments
and brokers. New §§229.191 - 229.208 cover purpose; applicable federal
laws and regulations; definitions; exemptions; licensure requirements; licensure
procedures; report of changes; licensure fees; denial, suspension, or revocation
of license; personnel; construction and maintenance of physical facilities;
sanitary facilities and controls; general provisions for handling distressed
merchandise; handling distressed food; handling distressed drugs; handling
distressed devices; records; and enforcement and penalties.
The new sections contain new language and incorporate language presently
located in existing §§229.191 - 229.208, which are being proposed
for repeal. Existing §§229.191 - 229.208 are being repealed for
the purpose of reorganization. The new sections establish new licensure fees
for salvagers to allow the department to recover the costs associated with
inspecting salvage establishments and brokers and administering the program.
The new sections contain new language to clarify existing requirements for
device salvagers and include language to standardize licensure requirements
to improve the timeliness and efficiency of the licensure process. The new
sections also clarify the department's inspection authority and enforcement
options available under Health and Safety Code, Chapter 432 (Texas Food, Drug,
Device, and Cosmetic Salvage Act).
The General Appropriations Act, House Bill 1, Article IX, Rider 167, passed
by the 75th Legislature, requires that each state agency review and consider
for readoption each rule adopted by the agency pursuant to the Government
Code, Chapter 2001 (Administrative Procedures Act). These sections have been
reviewed and the department has determined that the reason for readopting
the sections continues to exist; however, the rules need revisions as described
in this preamble.
The department published a Notice of Intention to Review for §§229.191
- 229.208 as required by Rider 167 in the
Texas Register
(23 TexReg 9078) on September 4, 1998. No comments were received by
the department on these sections.
Cynthia T. Culmo, R.Ph., Director, Drugs and Medical Devices Division,
Bureau of Food and Drug Safety, has determined that for the first five-year
period the sections are in effect there will be fiscal implications as a result
of enforcing or administering these sections as proposed. The effect on state
government will be an estimated annual gain of $46,550 in fee-generated revenue.
The proposed increase in revenue will recover the department's cost in conducting
inspections and processing licensure applications. There are no anticipated
fiscal implications for local government.
Ms. Culmo has determined that for each year of the first five years the
sections are in effect the public benefit anticipated as a result of enforcing
these sections will be the prevention of serious injury to consumers from
the use of adulterated and misbranded foods, drugs, devices and cosmetics.
The injury prevention will be achieved through the additional clarification
and understanding of the salvage requirements provided by this proposal. The
anticipated economic cost to persons or small businesses who are required
to comply with the sections as proposed will be an additional $100 annually
in licensure fees for food, drug, and cosmetic salvagers and an additional
$250 annually in licensure fees for device salvagers. There will be no effect
on local employment.
Comments on the proposed rule may be submitted to Thomas E. Brinck, Drugs
and Medical Devices Division, Texas Department of Health, 1100 West 49th Street,
Austin, Texas 78756, (512) 719-0237. Comments will be accepted for 30 days
from the date of publication of this proposal in the
Texas Register
.
Subchapter M. Regulation of Food, Drug, Device and Cosmetic Salvage Establishments and Brokers
25 TAC §§229.191-229.208
(Editor's note: The text of the following sections proposed for
repeal will not be published. The sections may be examined in the offices
of the Texas Department of Health or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeals are proposed under the Health and Safety
Code, §432.011, which provides the department with the authority to adopt
necessary regulations pursuant to the enforcement of Chapter 432; and §12.001,
which provides the Texas Board of Health (board) with the authority to adopt
rules for the performance of every duty imposed by law on the board, the department,
and the commissioner of health.
The proposed repeal affects Health and Safety Code, Chapter 432; and the
General Appropriations Act, House Bill 1, Article IX, Rider 167, passed by
the 75th Legislature is implemented by this proposal.
§229.191.Intent and Scope.
§229.192.Definitions.
§229.193.Personnel.
§229.194.Protection of Salvageable and Salvaged Merchandise.
§229.195.Equipment and Utensils Design and Fabrication.
§229.196.Cleaning, Sanitization, and Storage of Equipment and Utensils.
§229.197.Sanitary Facilities and Controls.
§229.198.Construction and Maintenance of Physical Facilities.
§229.199.Handling of Distressed Merchandise.
§229.200.Reconditioning and Labeling of Distressed Merchandise.
§229.201.Handling of Nonsalvageable Merchandise.
§229.202.Record Keeping.
§229.203.License.
§229.204.Denial, Suspension, and Revocation of Licenses.
§229.205.Inspections.
§229.206.Penalties.
§229.207.Salvage Establishments and Brokers Outside Jurisdiction of the Department.
§229.208.Temporary Permits.
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
March 19, 1999.
TRD-9901668
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 2, 1999
For further information, please call: (512) 458-7236
25 TAC §§229.191-229.208
The new sections are proposed under the Health and Safety
Code, §432.011, which provides the department with the authority to adopt
necessary regulations pursuant to the enforcement of Chapter 432; and §12.001,
which provides the Texas Board of Health (board) with the authority to adopt
rules for the performance of every duty imposed by law on the board, the department,
and the commissioner of health.
The proposed new sections affect Health and Safety Code, Chapter 432; and
the General Appropriations Act, House Bill 1, Article IX, Rider 167, passed
by the 75th Legislature is implemented by this proposal.
§229.191.Purpose.
These sections provide for the licensing and regulation of salvage
establishments and brokers to prevent the sale or distribution of adulterated
or misbranded food, drugs, devices, or cosmetics to consumers.
§229.192.Applicable Federal Laws and Regulations.
(a)
The Texas Department of Health (department) adopts by reference
the following federal laws and regulations:
(1)
Federal Food, Drug, and Cosmetic Act, 21 United States
Code, et seq. as amended;
(2)
Fair Packaging and Labeling Act, 15 United States
Code 1451 et seq. as amended;
(3)
§501(c)(3), Internal Revenue Code of 1986, as
amended;
(4)
21 Code of Federal Regulations (CFR), Part 110, Current
Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food,
as amended;
(5)
21 CFR, Part 210, Current Good Manufacturing Practice
in Manufacturing, Processing, Packing, or Holding of Drugs; General, as amended;
(6)
21 CFR, Part 211, Current Good Manufacturing Practice
for Finished Pharmaceuticals, as amended; and
(7)
21 CFR, Part 820, Quality System Regulation, as amended.
(b)
Copies of these laws and regulations are indexed and filed
in the office of the Bureau of Food and Drug Safety, Texas Department of Health,
1100 West 49th Street, Austin, Texas 78756, and are available for inspection
during normal working hours.
(c)
Nothing in these sections shall relieve any person of the
responsibility for compliance with other applicable federal laws and regulations.
§229.193.Definitions.
The following words and terms, when used in these sections, shall have
the following meanings, unless the context clearly indicates otherwise:
(1)
Act - The Texas Food, Drug, Device, and Cosmetic Salvage
Act, Health and Safety Code, Chapter 432.
(2)
Adulterated food - Has the meaning specified in the
Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431, §431.081.
(3)
Adulterated cosmetic - Has the meaning specified in
the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431,
§431.141.
(4)
Adulterated drug or device - Has the meaning specified
in the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter
431, §431.111.
(5)
Board - The Texas Board of Health.
(6)
Commissioner - The Commissioner of Health.
(7)
Cosmetic - Any article or substance intended to be
rubbed, poured, sprinkled, or sprayed on or introduced into, or otherwise
applied to the human body for cleansing, beautifying, promoting attractiveness,
or altering appearances; or an article or substance for use as a component
of such an article, except that the term does not include soap.
(8)
Department - The Texas Department of Health.
(9)
Device - An instrument, apparatus, or contrivance,
including any components, parts, and accessories, designed or intended for
use in diagnosis, cure, mitigation, treatment, or prevention of disease in
man or other animals; or to affect the structure or any function of the body
of man or other animals.
(10)
Device remanufacturer - A person who processes, conditions,
renovates, repackages, restores, or does any other act to a finished device
that significantly changes the finished device's performance or safety specifications,
or intended use.
(11)
Distressed merchandise - Any food, drug, device,
or cosmetic that has been subjected to prolonged or improper storage, loss
of label or identity, or abnormal environmental conditions such as extremes
in temperature, humidity, smoke, water, fumes, pressure, or radiation that
are due to natural disasters or otherwise or that may have been rendered unsafe
or unsuitable for human consumption or use for any other reason.
(12)
Drug -
(A)
an article or substance recognized in the official United
States Pharmacopoeia, the official Homeopathic Pharmacopoeia of the United
States, the official National Formulary, or any supplement of them;
(B)
an article or substance designed or intended for use in
the diagnosis, cure, mitigation, treatment, or prevention of disease in man
or other animals;
(C)
an article or substance, other than food, intended to affect
the structure or any function of the body of man or other animals; or
(D)
an article or substance intended for use as a component
of any article or substance specified in this definition.
(E)
The term does not include devices or their components,
parts, or accessories.
(13)
Drug manufacturer - A person who manufactures,
prepares, propagates, compounds, processes, packages, or changes the container,
wrapper, or labeling of any drug package.
(14)
Finished device - A device, or any accessory to a
device, which is suitable for use, whether or not packaged or labeled for
commercial distribution.
(15)
Food-
(A)
any article of food or drink for man;
(B)
chewing gum; or
(C)
an article used for components of any such article.
(16)
Food reclamation center - A facility or person
that engages in the reconditioning or inventorying, separating, and disposing
of distressed food on a fee for service basis. Distressed food may originate
from a wholesale distributor, manufacturer, or retail facility, and may be
handled within said facility by someone other than the distributor, manufacturer,
or retail facility. For the purpose of licensure under these sections, a food
reclamation center is a salvage establishment.
(17)
Manufacture - The combining, purifying, processing,
packing, or repacking of food, drugs, devices, or cosmetics for wholesale
or retail sale.
(18)
Manufacturer - Includes a person who represents himself
as responsible for the purity and proper labeling of a food, drug, device,
or cosmetic.
(19)
Misbranded food - Has the meaning specified in the
Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431, §431.082.
(20)
Misbranded cosmetic - Has the meaning specified in
the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431,
§431.142.
(21)
Misbranded drug or device - Has the meaning specified
in the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter
431, §431.112.
(22)
Nonprofit organization - An organization which has
received an exemption from federal taxation under 26 U. S. C. § 501(c)(3).
(23)
Nonsalvageable merchandise - Distressed merchandise,
as defined in this section, which cannot be safely or practically reconditioned.
(24)
Perishable - Capable of spoilage or deterioration
due to improper refrigeration or handling.
(25)
Person - An individual, corporation, business trust,
estate, trust, partnership, association, or any other public or private legal
entity.
(26)
Personnel - Any person employed by a salvage establishment
or salvage broker who does or may in any manner handle or come in contact
with the handling, storing, transporting, or selling and distributing of salvageable
or salvaged merchandise.
(27)
Place of business - Each location from which a salvage
establishment or salvage broker operates.
(28)
Potentially hazardous food - A food that is natural
or synthetic and that requires temperature control because it is in a form
capable of supporting the rapid and progressive growth of infectious or toxigenic
microorganisms; the growth and toxin production of
Clostridium botulinum
; or in raw shell eggs, the growth of
Salmonella enteritidis
.
(29)
Quality audit - An independent examination of a salvage
establishment, including the organizational structure and responsibilities,
procedures, and processes necessary to ensure that such resources and activities
comply with the requirements of these sections and result in the adequate
reconditioning of distressed merchandise.
(30)
Reconditioning - Any appropriate process or procedure
by which distressed merchandise can be brought into compliance with the standards
of the department for consumption or use by the public. In addition, all reconditioned
merchandise must be in compliance with the Texas Food, Drug, and Cosmetic
Act, Health and Safety Code, Chapter 431.
(31)
Sale or distribution - The act of selling or distributing,
whether for compensation or not, and includes delivery, holding, or offering
for sale, transfer, auction, storage, or other means of handling or trafficking.
(32)
Salvage broker - A person who engages in the business
of selling, distributing, or otherwise trafficking in any distressed or salvaged
merchandise who does not operate a salvage establishment.
(33)
Salvage establishment - Any place of business engaged
in reconditioning or by other means salvaging distressed merchandise or that
sells, buys, or distributes for human use any salvaged merchandise. For the
purpose of licensure under these sections, a food reclamation center is a
salvage establishment.
(34)
Salvage operator - A person who is engaged in the
business of operating a salvage establishment.
(35)
Salvage warehouse - A separate storage facility used
by a salvage broker or salvage establishment for the purpose of holding distressed
or salvaged merchandise.
(36)
Salvageable merchandise - Any distressed merchandise,
as defined in this section, which can be reconditioned to the satisfaction
of the department.
(37)
Salvaged merchandise - Any distressed merchandise
that has been reconditioned.
(38)
Sanitize - Adequate treatment of surfaces by a process
that is effective in destroying vegetative cells of microorganisms of public
health significance and in substantially reducing numbers of other microorganisms.
Such treatments shall not adversely affect the product and shall be safe to
the consumer.
(39)
Vehicles - Any truck, car, bus, or other means by
which distressed, salvageable, or salvaged merchandise is transported from
one location to another.
§229.194.Exemptions.
A person is exempt from licensing under these sections if the person
is:
(1)
a manufacturer, distributor, or processor of a food, drug,
device, or cosmetic who in the normal course of business engages in the activities
of reconditioning the items manufactured, distributed, or processed by or
for that person and not purchased by that person solely for the purpose of
reconditioning and sale;
(2)
a common carrier or the common carrier's agent who
disposes of or otherwise transfers undamaged or distressed foods, drugs, devices,
or cosmetics to a person who is exempt under this section or to a licensed
salvage broker or salvage operator;
(3)
a person who transfers distressed merchandise to a
licensed salvage broker or salvage operator; or
(4)
a nonprofit organization that distributes food to
the needy under the provisions of the Good Faith Donor Act, Civil Practice
and Remedies Code, Chapter 76, but does not recondition such food.
§229.195.Licensure Requirements.
(a)
General. Except as provided by §229.194 of this title
(relating to Exemptions), it shall be unlawful for any person to operate a
salvage establishment or operate as a salvage broker within the State of Texas,
who does not possess a current and valid license issued by the department.
(b)
Licensure of out of state salvage establishments and brokers.
A person who operates a salvage establishment or acts as a salvage broker
outside this state may not sell, distribute, or otherwise traffic in distressed
or salvaged merchandise within this state unless the person holds a license
from the department.
(c)
Display of license. The license shall be displayed in an
open public area at each place of business and each salvage operator shall
have a copy of a valid license in each vehicle used by the salvage operator
to transport distressed merchandise.
(d)
New place of business. Each person acquiring or establishing
a place of business for the purpose of operating a salvage establishment or
operating as a salvage broker shall apply for a license of such business prior
to beginning operation.
(e)
Two or more places of business. If the salvage establishment
or salvage broker operates more than one place of business, the salvage establishment
or salvage broker shall license each place of business separately.
(f)
Issuance of license. The department may license a salvage
establishment or salvage broker who meets the requirements of these sections.
(g)
Reports from other jurisdictions. The department may accept
reports from authorities in other jurisdictions to determine the extent of
compliance with these sections and with theprovisions of the Act.
(h)
Transfer of license. Licenses shall not be transferable
from one person to another or from one place of business to another.
(i)
License expiration. Unless the department revokes or suspends
a license as provided in §229.199 of this title (relating to Denial,
Suspension, or Revocation of License), the initial license shall be valid
for one year from the date of issuance which becomes the anniversary date.
(j)
Renewal of license.
(1)
Each year prior to the anniversary date, the salvage establishment
or salvage broker shall renew its license following the requirements of this
section and §229.196 of this title (relating to Licensure Procedures).
(2)
The renewal license shall be valid for one year from
the anniversary date.
(3)
The license renewal application and nonrefundable
renewal fee for each place of business shall be submitted to the department
30 days prior to the expiration date of the current license in accordance
with department procedures in §229.196 of this title (relating to Licensure
Procedures). A person who files a renewal application after the expiration
date must pay an additional $100 as a delinquency fee.
(4)
Failure to submit the renewal application prior to
the current licensure expiration date may subject the salvage establishment
or salvage broker to the enforcement provisions under the Act and also to
the provisions of §229.199 of this title (relating to Denial, Suspension,
or Revocation of License).
(5)
The department shall renew the license of a licensee
who submits a renewal application and pays the renewal fee after finding that
the licensee is in compliance with these sections as determined by an inspection
of the licensee's place of business or as outlined in subsection (g) of this
section.
(k)
Amendment of license. A license that is amended, including
a change of name, ownership, or a notification of a change in the location
of a licensed place of business will require submission of fees as outlined
in §229.198 of this title (relating to Licensure Fees).
§229.196.Licensure Procedures.
(a)
License application. Any person desiring to operate a salvage
establishment or act as a salvage broker shall make written application for
a license on forms provided by the department. A separate application is required
for each place of business to be licensed. License application forms may be
obtained from the Texas Department of Health, Bureau of Food and Drug Safety,
1100 West 49th Street, Austin, Texas, 78756.
(b)
Contents of license application. The salvage establishment
or salvage broker license application shall be signed and verified, shall
be made on a form furnished by the department, and shall contain the following
information:
(1)
the legal name under which the business is conducted;
(2)
the address of the place of business to be licensed
and the mailing address if different;
(3)
the address of any salvage warehouse used by a salvage
establishment or salvage broker;
(4)
if a sole proprietorship, the name of the proprietor;
if a partnership, the names of all partners; if a corporation, the names and
titles of all officers; in any other association, those in a managerial capacity;
and
(5)
a statement signed and verified by the sole proprietor,
managing partner, corporate officer, or person in a managerial capacity for
an association that acknowledges the applicant has read, understood, and agrees
to abide by the provisions of these sections and those of the Act.
§229.197.Report of Changes.
The license holder shall notify the department in writing within 10
days of any change which would render the information contained in the application
for the license, reported pursuant to §229.196 of this title (relating
to Licensure Procedures), no longer accurate. Failure to inform the department
no later than 10 days of a change in the information required in the application
for a license may result in a suspension or revocation of the license.
§229.198.Licensure Fees.
(a)
Licensure fee.
(1)
All salvage establishments and salvage brokers operating
in Texas shall obtain a license annually with the department. Except as provided
for in subsection (a)(2) of this section, salvage establishments and salvage
brokers shall pay a nonrefundable licensure fee of $400 for each place of
business operated.
(2)
A salvage establishment or salvage broker that engages
in the business of reconditioning, selling, distributing, or otherwise trafficking
in distressed or salvaged devices shall pay a nonrefundable licensure fee
of $550.
(3)
Reinspection fee. A salvage establishment or salvage
broker who requests reinstatement of a license that has been denied, suspended,
or revoked pursuant to §229.199(g) of this title (relating to Denial,
Suspension, or Revocation of License), shall pay a nonrefundable inspection
fee of $400.
(b)
Exemption from licensure fees. A person is exempt from
the licensure fees required by this section if the person is a nonprofit organization,
as described in the Internal Revenue Code of 1986, §501(c)(3), or a nonprofit
affiliate of the organization, to the extent otherwise permitted by law.
§229.199.Denial, Suspension, or Revocation of License.
(a)
General. The department may deny, suspend, or revoke the
license of an applicant who fails to comply with the Act or these sections.
(b)
Denials.
(1)
The department may deny an application for a license if
the applicant fails to meet the standards or requirements of the Act or these
sections.
(2)
The department shall give the applicant written notice
of the denial, the reasons for the denial, and opportunity for a hearing.
(c)
Emergency suspensions.
(1)
The department may suspend a license without notice when
there is an imminent threat to the health and safety of the public caused
by the licensee.
(2)
Within 10 days after the emergency suspension, the
licensee may request a hearing on the emergency suspension and the hearing
will be held within 20 days of the request.
(d)
Nonemergency suspensions.
(1)
The department may suspend a license on a nonemergency
basis when there is no imminent threat to public health and safety and when
the licensee violates any one of the following requirements:
(A)
failure to comply with the Act or these sections; or
(B)
falsification of the application for a license.
(2)
The department shall give the licensee written
notice of the proposed suspension, including the reasons and an opportunity
for a hearing.
(e)
Revocations.
(1)
The department may revoke a license when the licensee:
(A)
repeatedly violates the provisions of the Act or these
sections;
(B)
refuses to allow the department to conduct an inspection
or collect samples;
(C)
interferes with the department in the performance of its
duties;
(D)
removes or disposes of a detained food, drug, device, or
cosmetic in violation of the Texas Food, Drug, and Cosmetic Act, Health and
Safety Code, §431.021; or
(E)
fails to inform the department of any salvage warehouse(s)
at the time of an inspection or when requested by the department.
(2)
Prior to revoking the license, the department
shall give the licensee written notice of the proposed revocation, including
the reasons and an opportunity for a hearing.
(f)
Hearings.
(1)
Any hearings for the denial, suspension, emergency suspension,
or revocation of a license are governed by the department's formal hearing
procedures in Chapter 1 of this title (relating to the Texas Board of Health)
and the Administrative Procedure Act, Government Code, Chapter 2001.
(2)
Within 10 days after an emergency suspension or within
20 days after the postmark date of the department's written notice of proposed
denial, nonemergency suspension, or revocation, the applicant or licensee
may request in writing a hearing from the department's Bureau of Food and
Drug Safety. If the applicant or licensee does not request a hearing during
the required time period, then the applicant or licensee is deemed to have
waived their right to a hearing.
(g)
Reinstatement of license.
(1)
A person whose application for a license has been denied
or whose license has been placed under an emergency suspension may request
a reinspection for the purpose of granting or reinstating a license not later
than the 30th day after the denial or emergency suspension. Not later than
the 10th day after the receipt of a written request from the applicant or
licensee, the department shall make a reinspection.
(2)
As regards a nonemergency suspension or a revocation,
the licensee may request at any time, an inspection for reinstating the license
or for issuing a new license.
(3)
If, after inspection, the department determines that
the applicant or licensee meets the requirements of the Act or these sections,
the department shall reinstate the license or issue a new license, as appropriate.
(4)
Reinspection fee. Except as provided for in §229.198(b)
of this title (relating to Licensure Fees), a salvage establishment or salvage
broker who requests reinstatement of a license that has been denied, suspended,
or revoked pursuant to this section shall pay a nonrefundable inspection fee
of $400.
§229.200.Personnel.
(a)
Employee health requirements. No person known to be or
suspected of being affected with any disease in a communicable form, or while
a carrier of such disease, or while afflicted with boils, infected wounds,
sores, or respiratory infection, shall work in an area of a salvage establishment
or for a salvage broker in any capacity in which there is any possibility
of such person contaminating salvageable or salvaged merchandise with pathogenic
organisms, or transmitting disease to other individuals.
(b)
Personal cleanliness.
(1)
All personnel while working in direct contact with salvageable
merchandise or while engaged in reconditioning, repacking, or otherwise handling
any ingredients or components of salvagable merchandise shall wear clean outer
garments, maintain a high degree of personal cleanliness, and conform to hygienic
practices while on duty.
(2)
Personnel engaged in reconditioning salvageable merchandise
shall wash their hands thoroughly in a department approved hand-washing facility
before starting work, and as often as may be necessary to remove soil and
contamination.
(3)
No person shall resume work after visiting the toilet
room without first washing their hands.
§229.201.Construction and Maintenance of Physical Facilities.
(a)
Buildings. Buildings used by salvage establishments and
salvage brokers shall be of suitable design and contain sufficient space to
perform necessary operations, prevent mixups, and assure orderly handling.
(b)
Floor construction.
(1)
The floor surfaces in all rooms and areas in which salvageable
or salvaged merchandise is stored or processed and in which utensils are washed,
and walk-in refrigerators, dressing or locker rooms, and toilet rooms, shall
be of smooth, nonabsorbent materials, and so constructed as to be easily cleanable.
Floors of nonrefrigerated, dry storage areas need not be nonabsorbent.
(2)
All floors shall be kept clean and in good repair.
(3)
Floor drains shall be provided in all rooms where
floors are subjected to flooding-type cleaning or where normal operations
release or discharge water or other liquid waste on the floor.
(c)
Walls and ceilings. Walls and ceilings of all rooms shall
be clean, smooth, and in good repair.
(d)
Lighting.
(1)
Artificial light sources shall be installed to provide
at least 50 footcandles of light on all working surfaces and at least 30 footcandles
on all other surfaces and equipment, in reconditioning and storage areas,
utensil-washing and hand-washing areas, and toilet rooms. At least 20 footcandles
of light at a distance of 30 inches from the floor shall be required in all
other areas during cleaning operations.
(2)
Sources of artificial light shall be provided and
used to the extent necessary to provide the required amounts of light on all
surfaces when in use and when being cleaned.
(e)
Ventilation.
(1)
All rooms, in which salvageable or salvaged merchandise
is reconditioned or utensils are washed, dressing or locker rooms, toilet
rooms, and garbage and rubbish storage areas shall be well ventilated.
(2)
Ventilation hoods and related equipment when used
shall be designed to prevent condensation from dripping onto salvageable merchandise
or onto work surfaces.
(3)
Filters, when used, shall be readily removable for
cleaning or replacement.
(4)
Ventilation systems shall comply with applicable federal,
state, and local fire prevention and air pollution requirements.
(f)
Locker area. Adequate facilities shall be provided for
the orderly storage of personnel clothing and personal belongings.
(g)
Cleanliness of facilities.
(1)
All parts of the salvage establishment or salvage warehouse
and its premises shall be kept neat, clean, and free of litter and rubbish.
(2)
Cleaning operations shall be conducted in such a manner
as to prevent contamination of salvageable and salvaged merchandise.
(3)
None of the operations connected with a salvage establishment
or salvage warehouse shall be conducted in any room used as an employee lounge
or toilet facility, or living or sleeping quarters.
(4)
Soiled coats and aprons shall be kept in suitable
containers until removed for laundering.
(5)
No birds or animals shall be allowed in any areas
used for the conduct of salvage establishment operations or the storage of
salvageable and salvaged merchandise.
(h)
Vehicles. Vehicles used to transport distressed, salvageable,
or salvaged merchandise shall be maintained in a clean and sanitary condition
to protect the product from contamination.
§229.202.Sanitary Facilities and Controls.
(a)
Water supply. The water supply shall be adequate, of a
safe, sanitary quality, and from a source constructed and operated in accordance
with the Minimum Standards of Sanitation and Health Protection, Health and
Safety Code, Chapter 341, and rules promulgated under this chapter.
(b)
Sewage. All sewage, including liquid waste, shall be disposed
of in a public sewerage system or, in the absence thereof, in a manner applicable
with the Minimum Standards of Sanitation and Health Protection, Health and
Safety Code, Chapter 341, and rules promulgated under this chapter.
(c)
Plumbing. Plumbing shall be sized, installed, and maintained
in accordance with applicable state and local plumbing codes.
(d)
Toilet facilities.
(1)
Each salvage establishment shall provide its employees
with adequate and conveniently located toilet facilities.
(2)
Toilet facilities, including rooms and fixtures, shall
be kept in a clean condition and in good repair at all times.
(3)
The doors of all toilet rooms shall be self-closing.
(4)
Toilet tissue shall be provided.
(5)
Easily cleanable receptacles shall be provided for
waste materials, and such receptacles in toilet rooms for women shall be covered.
(6)
Where the use of non-water-carried sewage disposal
facilities are approved by the department they shall be located at least 100
linear feet from the salvage establishment and from any well or stream.
(e)
Handwashing facilities. Each salvage establishment shall
be provided with adequate, conveniently located hand-washing facilities for
its personnel, including a lavatory or lavatories equipped with hot and cold
or tempered running water, hand-cleansing soap or detergent, and approved
sanitary towels or other approved hand-drying devices. Such facilities shall
be kept clean and in good repair.
(f)
Garbage and refuse.
(1)
All refuse shall, prior to disposal, be kept in leakproof,
nonabsorbent containers which shall be kept covered with tight-fitting lids
when filled or stored, or not in continuous use; provided that such containers
need not be covered when stored in a special vermin-proofed room or enclosure,
or in a waste refrigerator. All other refuse shall be stored in containers,
rooms, or areas in an approved manner.
(2)
Adequate cleaning facilities shall be provided, and
each container, room, or area shall be thoroughly cleaned after the emptying
or removal of refuse.
(3)
All refuse shall be disposed of with sufficient frequency
and in such a manner as to prevent contamination.
(g)
Insect and rodent control. Effective measures shall be
taken to protect against the entrance into the salvage establishment or salvage
warehouse and the breeding or presence on the premises of rodents, insects,
and other vermin.
§229.203.General Provisions for Handling Distressed Merchandise.
(a)
Protection of Salvageable and Salvaged Merchandise.
(1)
All salvageable and salvaged merchandise stored by salvage
establishments or salvage brokers shall be held at appropriate temperatures
and under appropriate conditions in accordance with requirements, if any,
in the labeling of such merchandise.
(2)
All salvageable and salvaged merchandise, while being
stored or processed at a salvage establishment, salvage warehouse, or during
transportation, shall be protected from contamination.
(3)
Poisonous and toxic materials shall be identified
and handled under such conditions as will not contaminate other salvageable
or salvaged merchandise, or constitute a hazard to personnel.
(b)
Segregation of merchandise. All salvageable merchandise
shall be promptly sorted and segregated from nonsalvageable merchandise to
prevent further contamination of the distressed merchandise to be salvaged
or offered for sale or distribution.
(c)
Nonsalvageable merchandise.
(1)
Containers, including metal and glass containers with press
caps, screw caps, pull rings, or other types of openings which have been in
contact with nonpotable water, liquid foam, or other deleterious substances,
as a result of fire fighting efforts, flood, sewer backups, or similar mishaps,
shall be deemed unfit for sale or distribution, i.e., nonsalvageable merchandise
as defined in §229.193(23) of this title (relating to Definitions).
(2)
Distressed merchandise which is deemed to be nonsalvageable
by a duly authorized agent of the Texas Department of Health shall, at the
request of the agent, be destroyed under the supervision of that agent at
the expense of the owner.
(d)
Transporting of distressed merchandise.
(1)
Distressed merchandise shall be moved from the site of
a fire, flood, sewer backup, wreck, or other cause as expeditiously as possible
after compliance with subsection (a) of this section so as not to become putrid,
rodent or insect defiled, or otherwise hazardous to public health.
(2)
All distressed and salvageable merchandise of a perishable
nature shall, prior to reconditioning, be transported only in vehicles provided
with adequate refrigeration, if necessary, for product maintenance.
(3)
Distressed or salvageable merchandise shall not be
moved out of the State of Texas without the prior approval of the department
and the responsible state agency in the state to receive the merchandise.
Concurrence shall also be obtained from the U.S. Food and Drug Administration,
or U.S. Department of Agriculture, Food Safety and Inspection Service, prior
to interstate movement.
(e)
Handling of distressed articles other than foods, drugs,
devices, or cosmetics. If distressed articles other than foods, drugs, devices,
or cosmetics are also salvaged, they shall be handled separately so as to
prevent contamination from poisonous and toxic materials or other contaminants.
(f)
Cross-contamination protection. Sufficient precautions
shall be taken to prevent cross-contamination (animal feed to human food,
etc.) among the various types of merchandise which are salvageable or salvaged.
(g)
Salvageable merchandise. All salvageable merchandise shall
be reconditioned prior to sale or distribution except for such sale or distribution
to a person holding a valid license to engage in a salvage operation.
(h)
Reconditioned merchandise. All reconditioned merchandise
must be in compliance with the Texas Food, Drug, and Cosmetic Act, Health
and Safety Code, Chapter 431.
(i)
Labeling. All salvaged merchandise must be labeled in accordance
with the requirements of the Texas Food, Drug, and Cosmetic Act, Health and
Safety Code, Chapter 431; the Federal Food, Drug, and Cosmetic Act, 21 United
States Code, et seq. as amended; the Fair Packaging and Labeling Act, 15 United
States Code 1451 et seq. as amended; and the federal regulations promulgated
under those Acts.
(j)
Salvage warehouses. A person may not use a salvage warehouse
to recondition merchandise or sell to consumers.
§229.204.Handling Distressed Food.
(a)
Good manufacturing practices. The requirements of this
section are in addition to those described in 21 CFR, Part 110, Current Good
Manufacturing Practice in Manufacturing, Packing, or Holding Human Food, as
amended; except where this section is more restrictive.
(b)
Perishable foods. All perishable foods shall be kept at
a temperature that will provide protection against spoilage.
(c)
Potentially hazardous foods. All potentially hazardous
foods shall be maintained at a safe temperature, 41 degrees Fahrenheit (5
degrees Celsius) or below; 140 degrees Fahrenheit (60 degrees Celsius) or
above.
(d)
Distressed or nonsalvageable merchandise.
(1)
All metal cans of food offered for sale or distribution
shall be essentially free from rust (pitting) and dents (especially at rim,
end double seams, and/or side seams).
(2)
Leakers, springers, flippers, and swells shall be
deemed unfit for sale or distribution.
(e)
Metal containers of food. All metal containers of food,
other than those mentioned in subsection (d) of this section, whose integrity
has not been compromised and whose integrity would not be compromised by the
reconditioning, and which have been partially or totally submerged in water,
liquid foam, or other deleterious substance as the result of flood, sewer
backup, or other reasons shall, after thorough cleaning, be subjected to sanitizing
rinse of a concentration of 100 ppm available chlorine for a minimum period
of one minute, or shall be sanitized by another method approved by the department.
They shall subsequently be treated to inhibit rust formation.
(f)
Label removal.
(1)
Any cans or tins showing surface rust shall have labels
removed, the outer surface cleaned by buffing, a protective coating applied
where necessary, and shall be relabeled.
(2)
Relabeling of other salvageable nonmetal (glass, plastic,
etc.) containers shall be required when original labels are missing or illegible.
(g)
Relabeling. All salvaged food in containers shall be provided
with labels meeting the requirements in §229.203(i) of this title (relating
to General Provisions for Handling Distressed Merchandise). Where original
labels are removed from containers which are to be resold or redistributed,
the replacement labels must show the name and address of the salvage establishment.
§229.205.Handling Distressed Drugs.
(a)
Distressed drugs. Drug products that have been subjected
to improper storage conditions including extremes in temperature, humidity,
smoke, fumes, pressure, age, or radiation due to natural disasters, fires,
accidents, or equipment failures shall not be salvaged and returned to the
marketplace. Whenever there is a question whether drug products have been
subjected to such conditions, salvaging operations may be conducted only if
there is:
(1)
evidence from laboratory tests and assays (including animal
feeding studies where applicable) that the drug products meet all applicable
standards of identity, strength, quality, and purity; and
(2)
evidence from inspection of the premises that the
drug products and their associated packaging were not subjected to improper
storage conditions as a result of the disaster or accident. Organoleptic examinations
shall be acceptable only as supplemental evidence that the drug products meet
appropriate standards of identity, strength, quality, and purity.
(b)
Drug manufacturers. Those salvage establishments who are
also drug manufacturers shall comply with the wholesale drug distributor requirements
in the Texas Food, Drug, and Cosmetic Act, Health and Safety, Chapter 431,
Subchapter I; as well as the requirements in 21 CFR, Part 210, Current Good
Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of
Drugs - General; and 21 CFR, Part 211, Current Good Manufacturing Practice
for Finished Pharmaceuticals.
(c)
Department notification. It shall be the duty of any person
owning or having possession of distressed drugs to make personal contact with
the department within 24 hours after the drugs become distressed and prior
to their removal from the place at which they were located when they became
distressed. If emergency removal of such distressed drugs is required, such
notice to the department shall be made as soon thereafter as possible.
(d)
Legend drugs. A salvage broker or salvage operator may
not possess, sell or transfer any distressed drugs whose labels bear the legend
"CAUTION: Federal law prohibits dispensing without prescription" unless the
salvage broker or salvage operator is authorized to possess, sell, or transfer
such drugs in compliance with the Texas Food, Drug, and Cosmetic Act, Health
and Safety Code, Chapter 431, Subchapter I, and the Texas Dangerous Drug Act,
Health and Safety Code, Chapter 483.
(e)
Controlled substances. A salvage broker or salvage operator
may not take possession of distressed drugs which are controlled substances
without being licensed as a wholesale drug distributor under §229.252
of this title (relating to Licensing Fee and Procedures) and currently registered
with the United States Drug Enforcement Administration and the Texas Department
of Public Safety.
§229.206.Handling Distressed Devices.
(a)
Internal audits. Each salvage establishment that engages
in the reconditioning of devices shall establish written procedures for conducting
an internal quality audit and shall conduct such an audit at least annually.
The dates and results of the audit shall be documented, including any deficiencies
found and the corrective action taken to address the deficiencies.
(b)
Personnel. Each salvage establishment that engages in the
reconditioning of devices shall have sufficient personnel with the necessary
education, background, training, and experience to assure that all reconditioning
activities are correctly performed. Training of personnel engaged in reconditioning
activities shall be documented.
(c)
Identification. Each salvage establishment that engages
in the reconditioning of devices shall establish and maintain written procedures
for identifying devices during all stages of receipt, reconditioning, distribution,
and installation to prevent mixups.
(d)
Inspection, measuring, and test equipment.
(1)
Each salvage establishment that engages in the reconditioning
of devices shall ensure that all inspection, measuring, and test equipment
used in the reconditioning of devices is:
(A)
suitable for its intended purpose and capable of producing
valid results; and
(B)
routinely calibrated, inspected, checked, and maintained.
(2)
Each salvage establishment that engages in the
reconditioning of devices shall establish and maintain calibration records
for inspection, measuring, and test equipment to include:
(A)
the equipment identification;
(B)
dates of calibration;
(C)
the individual performing each calibration; and
(D)
the next scheduled calibration date.
(e)
Corrective and preventative action. Each salvage establishment
that engages in the reconditioning of devices shall document any action taken
by the salvage establishment to correct or prevent any nonconformities relating
to a salvaged device or to the reconditioning of a device.
(f)
Labeling. In addition to the general labeling requirements
found in §229.203(i) of this title (relating to General Provisions for
Handling Distressed Merchandise), all reconditioned devices shall be labeled
with the statement "Reconditioned by (name and business address of the salvage
establishment responsible for the reconditioning of the device)".
(g)
Device history record. Each salvage establishment that
engages in the reconditioning of devices shall maintain a device history record
for each batch, lot, or unit reconditioned to ensure that devices are reconditioned
in accordance with subsection (h) of this section. The device history record
shall include the following information:
(1)
the dates of reconditioning;
(2)
the quantity reconditioned;
(3)
the quantity released for distribution;
(4)
the acceptance records which demonstrate the device
is reconditioned in accordance with the device master record;
(5)
copies of any labeling required by these sections;
and
(6)
any device identification or control number used.
(h)
Device master record. Each salvage establishment that engages
in the reconditioning of devices shall maintain device master records for
each type of device reconditioned. The device master record shall include,
or refer to the location of, the following information:
(1)
device specifications, including appropriate drawings,
composition, formulation, component specifications, and software specifications;
(2)
reconditioning process specifications, including the
appropriate equipment specifications, reconditioning methods, reconditioning
procedures, and reconditioning environment specifications;
(3)
final acceptance procedures and specifications, including
acceptance criteria and the inspection, measuring, and test equipment to be
used;
(4)
packaging and labeling specifications, including methods
and processes used; and
(5)
installation, maintenance, and servicing procedures
and methods.
(i)
Complaint files. Each salvage establishment and salvage
broker that engages in the reconditioning or distribution of distressed or
salvaged devices shall maintain complaint files. Any complaint involving the
possible failure of a device, labeling, or packaging to meet any of its specifications
shall be reviewed, evaluated, and investigated. All records of investigation
shall include:
(1)
the name of the device;
(2)
the date the complaint was received;
(3)
any device identification(s) and control number(s)
used;
(4)
the name, address, and phone number of the complainant;
(5)
whether the complaint is associated with any illness
or injury involving the device;
(6)
the nature and details of the complaint;
(7)
the dates and results of the investigation;
(8)
any corrective action taken;
(9)
any reply to the complainant; and
(10)
the name and signature of the person formally designated
by the salvage establishment or salvage broker as responsible for investigating
all complaints.
(j)
A device salvage establishment or device salvage broker
must comply with the device distributor requirements of the Texas Food, Drug,
and Cosmetic Act, Health and Safety Code, Chapter 431, Subchapter L, prior
to taking possession of devices that are unsafe for self- medication (prescription
devices) as referenced in the Texas Dangerous Drug Act, Health and Safety
Code, Chapter 483.
(k)
Device remanufacturers. Those salvage establishments who
are also device remanufacturers shall comply with these sections and with
the device manufacturer requirements in the Texas Food, Drug, and Cosmetic
Act, Health and Safety, Chapter 431, Subchapter L, including the applicable
requirements in 21 CFR, Part 820, Quality System Regulation, as amended.
§229.207.Records.
(a)
Inventory Records. A written record or receipt of distressed,
salvageable, and salvaged merchandise shall be maintained by the salvage establishment
or salvage broker and shall include:
(1)
a general description of the distressed merchandise received;
(2)
the source of the distressed merchandise;
(3)
the date received;
(4)
the type of damage (fire, flood, etc.); and
(5)
the name of the individual or business that purchases
any such merchandise for the purpose of sale or distribution and the date
of any such transaction.
(b)
Retention of records. All records required in these sections
shall be kept at the place of business of the salvage establishment or salvage
broker for a period of two years following the completion of transactions
involving a lot of merchandise.
§229.208.Enforcement and Penalties.
(a)
Inspection. To enforce these sections or the Act, the commissioner,
an authorized agent, or a health authority may, on presenting appropriate
credentials to the owner, operator, or agent in charge of a place of business:
(1)
enter at reasonable times the place of business of a salvage
establishment or salvage broker;
(2)
enter a salvage warehouse used to store or hold distressed
or salvaged merchandise;
(3)
enter a vehicle being used to transport or hold distressed
or salvaged merchandise; or
(4)
inspect at reasonable times, any place of business
of a salvage establishment or salvage broker, salvage warehouse, or vehicle
and all equipment, finished and unfinished materials, containers, and labeling
of any item and obtain samples necessary for the enforcement of these sections
or the Act.
(b)
Access to records. A person who is required to maintain
records referenced in these sections or under the Act or a person who is in
charge or custody of those records shall, at the request of an authorized
agent or health authority, permit the authorized agent or health authority
at all reasonable times access to and to copy and verify the records.
(c)
Receipt for samples. An authorized agent or health authority
who makes an inspection of a place of business, including any vehicle or salvage
warehouse, and obtains a sample during or on completion of the inspection
and before leaving the place of business, shall give to the owner, operator,
or the owner's or operator's agent a receipt describing the sample.
(d)
Emergency order. The commissioner or the commissioner's
designee may issue an emergency order relating to the operation of a salvage
establishment or salvage broker in the department's jurisdiction if the commissioner
or the commissioner's designee determines:
(1)
operation of the salvage establishment or salvage broker
creates or poses an immediate and serious threat to human life or health;
and
(2)
other procedures available to the department to remedy
or prevent the threat will result in unreasonable delay.
(e)
Administrative penalties. Administrative penalties, as
provided in Health and Safety Code, §432.021, and in §229.261 of
this title (relating to Assessment of Administrative or Civil Penalties),
may be assessed for violation of these sections.
(f)
Criminal penalty.
(1)
A person commits an offense if the person violates the
Act or rules adopted under the Act.
(2)
An offense under the Act is a Class A misdemeanor.
(g)
Civil penalty; Injunction. If it appears that a person
has violated or is violating the Act, or an order issued or a rule adopted
under authority of the chapter, the commissioner may request the attorney
general or the district or county attorney or the municipal attorney of a
municipality in the jurisdiction where the violation is alleged to have occurred
or may occur to institute a civil suit for:
(1)
an order enjoining the violation;
(2)
a permanent or temporary injunction, a temporary restraining
order, or other appropriate remedy if the department shows that the person
has engaged in or is engaging in a violation;
(3)
the assessment and recovery of a civil penalty; or
(4)
both injunctive relief and a civil penalty.
(h)
Venue. Venue for a suit brought under the Act shall be
in the county in which the violation or the threat of violation is alleged
to have occurred or in Travis County.
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
March 19, 1999.
TRD-9901669
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 2, 1999
For further information, please call: (512) 458-7236
25 TAC §§229.211-229.222
The Texas Department of Health (department) proposes new
§§229.211 - 229.222 concerning current good manufacturing practice
and good warehousing practice in manufacturing, packing or holding human food.
Specifically, the criteria and definitions in these sections shall apply in
determining whether a food is adulterated within the meaning of Texas Health
and Safety Code, Chapter 431, the Texas Food, Drug, and Cosmetic Act.
The good manufacturing practices and good warehousing practices were previously
adopted as part of the minimum standards for licensure. The proposed new rules
ensure that the good manufacturing practices and good warehousing practices
are applicable to all food irrespective of licensure requirements.
Robert D. Sowards, Jr., Director, Manufactured Foods Division, has determined
that for each year of the first five-year period the sections are in effect
there will be no fiscal implications to state government or local government.
Mr. Sowards has also determined that for each year the sections are in
effect, the public benefit will be consistency with federal regulations and
assurance of safer foods by applying the sections to all food manufacturers
and wholesalers irrespective of licensure requirements. There will be no effect
on small businesses. There are no anticipated economic costs to persons who
are required to comply with the sections as adopted, since these requirements
were already applicable under other sections and by federal regulation. There
is no impact on local employment.
Comments on the proposal may be submitted to Robert D. Sowards, Jr., Director,
Manufactured Foods Division, Texas Department of Health, 1100 West 49th Street,
Austin, Texas 78756, (512) 719-0243. Comments will be accepted for 30 days
following publication of the proposal in the
Texas
Register
.
The new sections are proposed under the Health and Safety Code,
§431.241, which provides the department with the authority to adopt necessary
regulations pursuant to the enforcement of Chapter 431; and §12.001,
which provides the Texas Board of Health (board) with the authority to adopt
rules for the performance of every duty imposed by law on the board, the department,
and the commissioner of health.
The new sections affect the Health and Safety Code, Chapter 431.
§229.211.Definitions.
The following words and terms, when used in this subchapter, shall
have the following meanings, unless the context clearly indicates otherwise.
Those definitions and interpretations of terms of the Federal Food, Drug,
and Cosmetic Act (the Act), §201, are also applicable when used in this
subchapter.
(1)
Acid foods or acidified foods - Foods that have an equilibrium
pH of 4.6 or below.
(2)
Act - Federal Food, Drug, and Cosmetic Act.
(3)
Adequate - That which is needed to accomplish the
intended purpose in keeping with good public health practice.
(4)
Batter - A semifluid substance, usually composed of
flour and other ingredients, into which principal components of food are dipped
or with which they are coated, or which may be used directly to form bakery
foods.
(5)
Blanching (except for tree nuts and peanuts) - A prepackaging
heat treatment of foodstuffs for a sufficient time and at a sufficient temperature
to partially or completely inactivate the naturally occurring enzymes and
to effect other physical or biochemical changes in the food.
(6)
Control point - Any point, step, or procedure at which
biological, physical, or chemical factors can be controlled.
(7)
Food - Articles used for food or drink for human consumption;
chewing gum; and articles used for components of any such article.
(8)
Food-contact surfaces - Those surfaces that contact
human food and those surfaces from which drainage onto the food or onto surfaces
that contact the food ordinarily occurs during the normal course of operations.
"Food-contact surfaces'' includes utensils and food-contact surfaces of equipment.
(9)
Lot - Food produced during a period of time indicated
by a specific code.
(10)
Microorganisms - Yeasts, molds, bacteria, and viruses
which include, but are not limited to, species having public health significance.
The term "undesirable microorganisms'' includes those microorganisms that
are of public health significance; that subject food to decomposition; that
indicate that food is contaminated with filth; or that otherwise may cause
food to be adulterated within the meaning of the Act. Occasionally in these
regulations, the adjective "microbial'' is used instead of using an adjectival
phrase containing the word microorganism.
(11)
Pests - Any objectionable animal or insect including,
but not limited to, birds, rodents, flies, and larvae.
(12)
Plant - The building or facility, or parts thereof,
used for or in connection with the manufacturing, packaging, labeling, or
holding of human food.
(13)
Potentially hazardous food - A food that is natural
or synthetic and requires temperature control because it is in a form capable
of supporting the rapid and progressive growth of infectious or toxigenic
microorganisms; the growth and toxin production of
Clostridium botulinum
; or in raw shell eggs, the growth of
Salmonella enteritidis
.
(A)
The term includes a food of animal origin that is raw or
heat-treated; a food of plant origin that is heat-treated or consists of raw
seed sprouts; cut melons; and garlic and oil mixtures that are not acidified
or otherwise modified at a food processing plant in a way that results in
mixtures that do not support growth as specified in this definition.
(B)
The term does not include an air-cooled hard-boiled egg
with shell intact; a food with a water activity (a
w
) value of 0.85 or less; a food with a pH level of 4.6 or below when
measured at 24 degrees Celsius (75 degrees Fahrenheit); and a food, in an
unopened hermetically sealed container, that is commercially processed to
achieve and maintain commercial sterility under conditions of nonrefrigerated
storage and distribution. The term also does not include a food for which
laboratory evidence demonstrates that the rapid and progressive growth of
infectious or toxigenic microorganisms or the growth of
S. enteritidis
in eggs or
C. botulinum
cannot occur, such as a food that has an a
w
and
a pH that are above the levels specified above and that may contain a preservative,
other barrier to the growth of microorganisms, or a combination of barriers
that inhibit the growth of microorganisms. The term also does not include
a food that may contain an infectious or toxigenic microorganism or chemical
or physical contaminant at a level sufficient to cause illness, but that does
not support the growth of microorganisms as specified in the definition of
a potentially hazardous food.
(14)
Quality control operation - A planned and systematic
procedure for taking all actions necessary to prevent food from being adulterated
within the meaning of the Act.
(15)
Raw agricultural commodity - Any food in its raw
or natural state, including all fruits that are washed, colored, or otherwise
treated in their unpeeled natural form prior to marketing.
(16)
Rework - Clean, unadulterated food that has been
removed from processing for reasons other than insanitary conditions or that
has been successfully reconditioned by reprocessing and that is suitable for
use as food.
(17)
Safe-moisture level - A level of moisture low enough
to prevent the growth of undesirable microorganisms in the finished product
under the intended conditions of manufacturing, storage, and distribution.
The maximum safe moisture level for a food is based on its water activity
(a
w
). An (a
w
) will
be considered safe for a food if adequate data are available that demonstrate
that the food at or below the given (a
w
) will
not support the growth of undesirable microorganisms.
(18)
Sanitize - Adequately treating food-contact surfaces
by a process that is effective in destroying vegetative cells of microorganisms
of public health significance, and in substantially reducing numbers of other
undesirable microorganisms, but without adversely affecting the product or
its safety for the consumer.
(19)
Shall - Term to state mandatory requirements.
(20)
Should - Term to state recommended or advisory procedures
or identify recommended equipment.
(21)
Water activity (a
w
)
- A measure of the free moisture in a food. The quotient of the water vapor
pressure of the substance divided by the vapor pressure of pure water at the
same temperature.
§229.212.Current Good Manufacturing Practice.
(a)
The criteria and definitions in this part shall apply in
determining whether a food is adulterated within the meaning of Texas Health
and Safety Code, Chapter 431, Texas Food, Drug, and Cosmetic Act, §431.081(a)(3)
in that the food has been manufactured under such conditions that it is unfit
for food; or within the meaning of §431.081(a)(4) of the Act in that
the food has been prepared, packed, or held under insanitary conditions whereby
it may have become contaminated with filth, or whereby it may have been rendered
injurious to health.
(b)
Food subject to the requirements of these sections may
also be subject to specific current good manufacturing practice regulation
found in the Code of Federal Regulations or in other sections of this title
(25 Texas Administrative Code).
§229.213.Personnel.
The plant management shall take all reasonable measures and precautions
to ensure the following:
(1)
Disease control. Any person who, by medical examination
or supervisory observation, is shown to have, or appears to have, an illness;
open lesion, including boils, sores, or infected wounds; or any other abnormal
source of microbial contamination by which there is a reasonable possibility
of food, food-contact surfaces, or food-packaging materials becoming contaminated,
shall be excluded from any operations which may be expected to result in such
contamination until the condition is corrected. Personnel shall be instructed
to report such health conditions to their supervisors.
(2)
Cleanliness. All persons working in direct contact
with food, food-contact surfaces, and food-packaging materials shall conform
to hygienic practices while on duty to the extent necessary to protect against
contamination of food. The methods for maintaining cleanliness include, but
are not limited to:
(A)
wearing outer garments suitable to the operation in a manner
that protects against the contamination of food, food-contact surfaces, or
food-packaging materials;
(B)
maintaining adequate personal cleanliness;
(C)
washing hands thoroughly (and sanitizing if necessary to
protect against contamination with undesirable microorganisms) in a hand-washing
facility that meets the provisions of §229.217(e) of this title (relating
to Sanitary Facilities and Control), before starting work, after each absence
from the work station, and at any other time when the hands may have become
soiled or contaminated;
(D)
removing all unsecured jewelry and other objects that might
fall into food, equipment, or containers, and removing hand jewelry that cannot
be adequately sanitized during periods in which food is manipulated by hand.
If such hand jewelry cannot be removed, it may be covered by material which
can be maintained in an intact, clean, and sanitary condition and which effectively
protects against the contamination by these objects of the food, food-contact
surfaces, or food-packaging materials;
(E)
maintaining gloves, if they are used in food handling,
in an intact, clean, and sanitary condition. The gloves should be of an impermeable
material;
(F)
wearing, where appropriate and in an effective manner,
hair nets, headbands, caps, beard covers, or other effective hair restraints;
(G)
storing clothing or other personal belongings in areas
other than where food is exposed or where equipment or utensils are washed;
(H)
confining the following to areas other than where food
may be exposed or where equipment or utensils are washed: eating food, chewing
gum, drinking beverages, or using tobacco; and
(I)
taking any other necessary precautions to protect against
contamination of food, food-contact surfaces, or food-packaging materials
with microorganisms or foreign substances including, but not limited to, perspiration,
hair, cosmetics, tobacco, chemicals, and medicines applied to the skin.
(3)
Education and training. Personnel responsible
for identifying sanitation failures or food contamination should have a background
of education or experience, or a combination thereof, to provide a level of
competency necessary for production of clean and safe food. Food handlers
and supervisors should receive appropriate training in proper food handling
techniques and food-protection principles and should be informed of the danger
of poor personal hygiene and insanitary practices.
(4)
Supervision. Responsibility for assuring compliance
by all personnel with all requirements of this section shall be clearly assigned
to competent supervisory personnel.
§229.214.Exclusions.
The following operations are not subject to this section: Establishments
engaged solely in the harvesting, storage, or distribution of one or more
raw agricultural commodities which are ordinarily cleaned, prepared, treated,
or otherwise processed before being marketed to the consuming public.
§229.215.Plant and Grounds.
(a)
Grounds. The grounds around a food plant under the control
of the operator shall be kept in a condition that will protect against the
contamination of food. The methods for adequate maintenance of grounds include,
but are not limited to:
(1)
properly storing equipment, removing litter and waste,
and cutting weeds or grass within the immediate vicinity of the plant buildings
or structures that may constitute an attractant, breeding place, or harborage
for pests;
(2)
maintaining roads, yards, and parking lots so that
they do not constitute a source of contamination in areas where food is exposed;
(3)
draining areas that may contribute contamination to
food by seepage, foot-borne filth, or providing a breeding place for pests;
(4)
operating systems for waste treatment and disposal
in a manner so that they do not constitute a source of contamination in areas
where food is exposed; and
(5)
if the plant grounds are bordered by grounds not under
the operator's control and not maintained in the manner described in paragraphs
(1) through (4) of this subsection, care shall be exercised in the plant by
inspection, extermination, or other means to exclude pests, dirt, and filth
that may be a source of food contamination.
(b)
Plant construction and design. Plant buildings and structures
shall be suitable in size, construction, and design to facilitate maintenance
and sanitary operations for food-manufacturing purposes. The plant and facilities
shall:
(1)
provide sufficient space for such placement of equipment
and storage of materials as is necessary for the maintenance of sanitary operations
and the production of safe food;
(2)
permit the taking of proper precautions to reduce
the potential for contamination of food, food-contact surfaces, or food-packaging
materials with microorganisms, chemicals, filth, or other extraneous material.
The potential for contamination may be reduced by adequate food safety controls
and operating practices which may include the design, separation of operations,
location, time, partition, air flow, enclosed systems, or other effective
means;
(3)
permit the taking of proper precautions to protect
food in outdoor bulk fermentation vessels by any effective means, including:
(A)
using protective coverings;
(B)
controlling areas over and around the vessels to eliminate
harborages for pests;
(C)
checking on a regular basis for pests and pest infestation;
and
(D)
skimming the fermentation vessels, as necessary;
(4)
be constructed in such a manner that floors,
walls, and ceilings may be adequately cleaned and kept clean and kept in good
repair; that drip or condensate from fixtures, ducts and pipes does not contaminate
food, food-contact surfaces, or food-packaging materials; and that aisles
or working spaces are provided between equipment and walls and are adequately
unobstructed and of adequate width to permit employees to perform their duties
and to protect against contaminating food or food-contact surfaces with clothing
or personal contact;
(5)
provide sufficient lighting in hand-washing areas,
dressing and locker rooms, and toilet rooms and in all areas where food is
examined, processed, or stored and where equipment or utensils are cleaned;
and provide safety-type light bulbs, fixtures, skylights, or other glass suspended
over exposed food in any step of preparation or otherwise protect against
food contamination in case of glass breakage;
(6)
provide ventilation or control equipment to minimize
odors and vapors (including steam and noxious fumes) in areas where they may
contaminate food; and locate and operate fans and other air-blowing equipment
in a manner that minimizes the potential for contaminating food, food-packaging
materials, and food-contact surfaces; and
(7)
provide, where necessary, screening or other protection
against pests.
§229.216.Sanitary Operations.
(a)
General maintenance. Buildings, fixtures, and other physical
facilities of the plant shall be maintained in a sanitary condition and shall
be kept in repair so that food does not become adulterated within the meaning
of the act. Cleaning and sanitizing of utensils and equipment shall be conducted
in a manner that protects against contamination of food, food-contact surfaces,
or food-packaging materials.
(b)
Substances used in cleaning and sanitizing; storage of
toxic materials. Cleaning compounds and sanitizing agents used in cleaning
and sanitizing procedures shall be free from undesirable microorganisms and
shall be safe and adequate under the conditions of use. Compliance with this
requirement may be verified by any effective means including purchase of these
substances under a supplier's guarantee or certification, or examination of
these substances for contamination. Only the following toxic materials may
be used or stored in a plant where food is processed or exposed:
(1)
those required to maintain clean and sanitary conditions;
(2)
those necessary for use in laboratory testing procedures;
(3)
those necessary for plant and equipment maintenance
and operation; and
(4)
those necessary for use in the plant's operations.
(c)
Toxic cleaning compounds, sanitizing agents, and pesticide
chemicals shall be identified, held, and stored in a manner that protects
against contamination of food, food-contact surfaces, or food-packaging materials.
All relevant regulations promulgated by other federal, state, and local government
agencies for the application, use, or holding of these products should be
followed.
(d)
Pest control. No pests shall be allowed in any area of
a food plant. Guard or guide dogs may be allowed in some areas of a plant
if the presence of the dogs is unlikely to result in contamination of food,
food-contact surfaces, or food-packaging materials. Effective measures shall
be taken to exclude pests from the processing areas and to protect against
the contamination of food on the premises by pests. The use of insecticides
or rodenticides is permitted only under precautions and restrictions that
will protect against the contamination of food, food-contact surfaces, and
food-packaging materials.
(e)
Sanitation of food-contact surfaces. All food-contact surfaces,
including utensils and food-contact surfaces of equipment, shall be cleaned
as frequently as necessary to protect against contamination of food.
(1)
Food-contact surfaces used for manufacturing or holding
low-moisture food shall be in a dry, sanitary condition at the time of use.
When the surfaces are wet-cleaned, they shall, when necessary, be sanitized
and thoroughly dried before subsequent use.
(2)
In wet processing, when cleaning is necessary to protect
against the introduction of microorganisms into food, all food-contact surfaces
shall be cleaned and sanitized before use and after any interruption during
which the food-contact surfaces may have become contaminated. Where equipment
and utensils are used in a continuous production operation, the utensils and
food-contact surfaces of the equipment shall be cleaned and sanitized as necessary.
(3)
Non-food-contact surfaces of equipment used in the
operation of food plants should be cleaned as frequently as necessary to protect
against contamination of food.
(4)
Single-service articles (such as utensils intended
for one-time use, paper cups, and paper towels) should be stored in appropriate
containers and shall be handled, dispensed, used, and disposed of in a manner
that protects against contamination of food or food-contact surfaces.
(5)
Sanitizing agents shall be adequate for sanitization
and safe under conditions of use. Any facility, procedure, or machine is acceptable
for cleaning and sanitizing equipment and utensils if the facility, procedure,
or machine will routinely render equipment and utensils clean and provide
adequate cleaning and sanitizing treatment.
(f)
Storage and handling of cleaned portable equipment and
utensils. Cleaned and sanitized portable equipment with food-contact surfaces
and utensils should be stored in a location and manner that protects food-contact
surfaces from contamination.
§229.217.Sanitary Facilities and Controls.
Each plant shall be equipped with adequate sanitary facilities and
accommodations including, but not limited to:
(1)
Water supply. The water supply shall be sufficient for
the operations intended and shall be derived from an adequate source. Any
water that contacts food or food-contact surfaces shall be safe and of sanitary
quality for its intended use. Running water at a suitable temperature, and
under pressure as needed, shall be provided in all areas where required for
the processing of food, for the cleaning of equipment, utensils, and food-packaging
materials, or for employee sanitary facilities.
(2)
Plumbing. Plumbing shall be of adequate size and design
and adequately installed and maintained to:
(A)
carry sufficient quantities of water to required locations
throughout the plant;
(B)
properly convey sewage and liquid disposable waste from
the plant;
(C)
avoid constituting a source of contamination to food, water
supplies, equipment, or utensils or creating an unsanitary condition;
(D)
provide floor drainage in all areas where floors are subject
to flooding-type cleaning or where normal operations release or discharge
water or other liquid waste on the floor; and
(E)
provide that there is no backflow from, or cross-connection
between, piping systems that discharge waste water or sewage and piping systems
that carry water for food or food manufacturing.
(3)
Sewage disposal. Sewage disposal shall be made
into an approved sewerage system or disposed of through other adequate means.
(4)
Toilet facilities. Each plant shall provide its employees
with readily accessible toilet facilities adequate in number and location.
Compliance with this requirement may be accomplished by:
(A)
maintaining the toilet facilities in a sanitary condition;
(B)
keeping the toilet facilities in good repair at all times;
(C)
providing self-closing doors on toilet facilities; and
(D)
providing doors on toilet facilities that do not open into
areas where food is exposed to airborne contamination, except where alternate
means have been taken to protect against such contamination (such as double
doors or positive air-flow systems).
(5)
Hand-washing facilities. Hand-washing facilities
shall be adequate in number and location and be furnished with running water
at a suitable temperature. Compliance with this requirement may be accomplished
by providing:
(A)
hand-washing and, where appropriate, hand-sanitizing facilities
at each location in the plant where good sanitary practices require employees
to wash and/or sanitize their hands;
(B)
effective hand-cleaning and sanitizing preparations;
(C)
sanitary towel service or suitable drying devices;
(D)
devices or fixtures, such as water control valves, so designed
and constructed to protect against recontamination of clean, sanitized hands;
(E)
readily understandable signs directing employees handling
unprotected food, unprotected food-packaging materials, or food-contact surfaces
to wash and, where appropriate, sanitize their hands before they start work,
after each absence from post of duty, and when their hands may have become
soiled or contaminated. These signs may be posted in the processing room(s)
and in all other areas where employees may handle such food, materials, or
surfaces; and
(F)
refuse receptacles that are constructed and maintained
in a manner that protects against contamination of food.
(6)
Rubbish and offal disposal. Rubbish and any offal
shall be so conveyed, stored, and disposed of as to minimize the development
of odor; minimize the potential for the waste becoming an attractant and harborage
or breeding place for pests; and protect against contamination of food, food-contact
surfaces, water supplies, and ground surfaces.
§229.218.Equipment and Utensils.
(a)
All plant equipment and utensils shall be so designed and
of such material and workmanship as to be cleanable, and shall be properly
maintained. The design, construction, and use of equipment and utensils shall
preclude the adulteration of food with lubricants, fuel, metal fragments,
contaminated water, or any other contaminants. All equipment should be so
installed and maintained as to facilitate the cleaning of the equipment and
of all adjacent spaces. Food-contact surfaces shall be corrosion-resistant
when in contact with food. They shall be made of nontoxic materials and designed
to withstand the environment of their intended use and the action of food,
and, if applicable, cleaning compounds and sanitizing agents. Food-contact
surfaces shall be maintained to protect food from being contaminated by any
source, including unlawful indirect food additives.
(b)
Seams on food-contact surfaces shall be smoothly bonded
or maintained so as to minimize accumulation of food particles, dirt, and
organic matter and thus minimize the opportunity for growth of microorganisms.
(c)
Equipment that is in the manufacturing or food-handling
area and that does not come into contact with food shall be constructed so
that it can be kept in a clean condition.
(d)
Holding, conveying, and manufacturing systems, including
gravimetric, pneumatic, closed, and automated systems, shall be designed and
constructed so as to be maintained in an appropriate sanitary condition.
(e)
Each freezer and cold storage compartment used to store
and hold food capable of supporting growth of microorganisms shall be fitted
with an indicating thermometer, temperature- measuring device, or temperature-recording
device installed to accurately show the temperature within the compartment,
and should be fitted with an automatic control for regulating temperature
or with an automatic alarm system to indicate a significant temperature change
in a manual operation.
(f)
Instruments and controls used for measuring, regulating,
or recording temperatures, pH, acidity, water activity, or other conditions
that control or prevent the growth of undesirable microorganisms in food shall
be accurate and properly maintained, and in sufficient quantity for their
designated uses.
(g)
Compressed air or other gases mechanically introduced into
food or used to clean food-contact surfaces or equipment shall be treated
in such a way that food is not contaminated with unlawful food additives.
§229.219.Production and Process Controls.
All operations in the receiving, inspecting, transporting, segregating,
preparing, manufacturing, packaging, and storing of food shall be conducted
in accordance with good public health and sanitation principles. Appropriate
quality control operations shall be employed to ensure that food is suitable
for human consumption and that food-packaging materials are safe and suitable.
Overall sanitation of the plant shall be under the supervision of one or more
competent individuals assigned responsibility for this function. All reasonable
precautions shall be taken to ensure that production procedures do not contribute
contamination from any source. Testing procedures shall be used where necessary
to identify sanitation failures or possible food contamination by chemicals,
microbes, or extraneous materials. All food that has become contaminated to
the extent that it is adulterated within the meaning of the Act shall be rejected,
or if permissible, treated or processed to eliminate the contamination.
(1)
Raw materials and other ingredients.
(A)
Raw materials and other ingredients shall be inspected
and segregated or otherwise handled as necessary to ascertain that they are
clean and suitable for processing into food and shall be stored under conditions
that will protect against contamination and minimize deterioration. Raw materials
shall be washed or cleaned as necessary to remove soil or other contamination.
Water used for washing, rinsing, or conveying food shall be safe and of sanitary
quality for its intended use. Water may be reused for washing, rinsing, or
conveying food if it does not increase the level of contamination of the food.
Containers and carriers of raw materials should be inspected on receipt to
ensure that their condition has not contributed to contamination or deterioration
of food.
(B)
Raw materials and other ingredients shall either: not contain
levels of microorganisms that may produce food poisoning or other disease
in humans; or they shall be pasteurized or otherwise treated during manufacturing
operations so that they no longer contain levels that would cause the product
to be adulterated within the meaning of the Act. Compliance with this requirement
may be verified by any effective means, including purchasing raw materials
and other ingredients under a supplier's guarantee or certification.
(C)
Raw materials and other ingredients susceptible to contamination
with aflatoxin or other natural toxins shall comply with current Food and
Drug Administration regulations, guidelines, and action levels for poisonous
or deleterious substances before these materials or ingredients are incorporated
into finished food. Compliance with this requirement may be accomplished by
purchasing raw materials and other ingredients under a supplier's guarantee
or certification, or may be verified by analyzing these materials and ingredients
for aflatoxins and other natural toxins.
(D)
Raw materials, other ingredients, and rework susceptible
to contamination with pests, undesirable microorganisms, or material shall
comply with applicable Food and Drug Administration regulations, guidelines,
and defect action levels for natural or unavoidable defects if a manufacturer
wishes to use the materials in manufacturing food. Compliance with this requirement
may be verified by any effective means, including purchasing the materials
under a supplier's guarantee or certification, or examination of these materials
for contamination.
(E)
Raw materials, other ingredients, and rework shall be held
in bulk, or in containers designed and constructed so as to protect against
contamination and shall be held at a temperature and relative humidity and
in a manner to prevent the food from becoming adulterated within the meaning
of the Act. Material scheduled for rework shall be identified as such.
(F)
Frozen raw materials and other frozen ingredients shall
be kept frozen. If thawing is required prior to use, it shall be done in a
manner that prevents the raw materials and other ingredients from becoming
adulterated within the meaning of the Act.
(G)
Liquid or dry raw materials and other ingredients received
and stored in bulk form shall be held in a manner that protects against contamination.
(2)
Manufacturing operations.
(A)
Equipment and utensils and finished food containers shall
be maintained in an acceptable condition through appropriate cleaning and
sanitizing. As necessary, equipment shall be taken apart for thorough cleaning.
(B)
All food manufacturing, including packaging and storage,
shall be conducted under such conditions and controls as are necessary to
minimize the potential for the growth of microorganisms, or for the contamination
of food. Compliance with this requirement may be accomplished by careful monitoring
of physical factors such as time, temperature, humidity, a
w
, pH, pressure, flow rate, and manufacturing operations such as freezing,
dehydration, heat processing, acidification, and refrigeration to ensure that
mechanical breakdowns, time delays, temperature fluctuations, and other factors
do not contribute to the decomposition or contamination of food.
(C)
The internal temperature of potentially hazardous foods
during transport and storage shall be maintained at 45 degrees Fahrenheit
or lower as appropriate for the food.
(i)
After October 5, 2003, the internal temperature of potentially
hazardous foods shall be maintained at 41 degrees Fahrenheit or lower as appropriate
for the food.
(ii)
Frozen foods shall be kept frozen at all times.
(iii)
Shell eggs, after initial packing, must be transported
and stored at a temperature of 45 degrees Fahrenheit or less. If the United
States Department of Agriculture and the U.S. Food and Drug Administration
determine by law that a lower temperature must be maintained, the lower temperature
shall prevail.
(iv)
Molluscan shellstock shall:
(I)
be iced; or
(II)
be placed in a storage area or conveyance maintained at
45 degrees Fahrenheit or less unless the U.S. Food and Drug Administration
determines by law that a lower temperature must be maintained, in which case
the lower temperature shall prevail; and
(III)
not be permitted to remain without ice, mechanical refrigeration,
or other approved means of refrigeration for more than two hours at points
of transfer such as loading docks.
(v)
Hot foods shall be maintained at 140 degrees Fahrenheit
(60 degrees Celsius) or above.
(vi)
Acid or acidified foods shall be heat treated to destroy
mesophilic microorganisms when those foods are to be held in hermetically
sealed containers at ambient temperatures.
(D)
Measures such as sterilizing, irradiating, pasteurizing,
freezing, refrigerating, controlling pH or controlling a
w
that are taken to destroy or prevent the growth of undesirable microorganisms,
particularly those of public health significance, must be adequate under the
conditions of manufacture, handling, and distribution to prevent food from
being adulterated within the meaning of the Act.
(E)
Work-in-process shall be handled in a manner that protects
against contamination.
(F)
Effective measures shall be taken to protect finished food
from contamination by raw materials, other ingredients, or refuse. When raw
materials, other ingredients, or refuse are unprotected, they shall not be
handled simultaneously in a receiving, loading, or shipping area if that handling
could result in contaminated food. Food transported by conveyor shall be protected
against contamination as necessary.
(G)
Equipment, containers, and utensils used to convey, hold,
or store raw materials, work-in-process, rework, or food shall be constructed,
handled, and maintained during manufacturing or storage in a manner that protects
against contamination.
(H)
Effective measures shall be taken to protect against the
inclusion of metal or other extraneous material in food. Compliance with this
requirement may be accomplished by using sieves, traps, magnets, electronic
metal detectors, or other suitable effective means.
(I)
Food, raw materials, and other ingredients that are adulterated
within the meaning of the act shall be disposed of in a manner that protects
against the contamination of other food. If the adulterated food is capable
of being reconditioned, it shall be reconditioned using a method that has
been proven to be effective or it shall be reexamined and confirmed to be
safe within the meaning of the Act before being incorporated into other food.
(J)
Mechanical manufacturing steps such as washing, peeling,
trimming, cutting, sorting and inspecting, mashing, dewatering, cooling, shredding,
extruding, drying, whipping, defatting, and forming shall be performed so
as to protect food against contamination. Compliance with this requirement
may be accomplished by providing adequate physical protection of food from
contaminants that may drip, drain, or be drawn into the food. Protection may
be provided by cleaning and sanitizing all food-contact surfaces, and by using
time and temperature controls at and between each manufacturing step.
(K)
Heat blanching, when required in the preparation of food,
should be effected by heating the food to the required temperature, holding
it at this temperature for the required time, and then either rapidly cooling
the food or passing it to subsequent manufacturing without delay. Thermophilic
growth and contamination in blanchers should be minimized by the use of sufficient
operating temperatures and by periodic cleaning. Where the blanched food is
washed prior to filling, water used shall be safe and of sanitary quality
for its intended use.
(L)
Batters, breading, sauces, gravies, dressings, and other
similar preparations shall be treated or maintained in such a manner that
they are protected against contamination. Compliance with this requirement
may be accomplished by any effective means, including one or more of the following:
(i)
using ingredients free of contamination;
(ii)
employing adequate heat processes where applicable;
(iii)
using proper time and temperature controls;
(iv)
providing adequate physical protection of components from
contaminants that may drip, drain, or be drawn into them;
(v)
cooling to a sufficient temperature during manufacturing;
or
(vi)
disposing of batters at appropriate intervals to protect
against the growth of microorganisms.
(M)
Filling, assembling, packaging, and other operations shall
be performed in such a way that the food is protected against contamination.
Compliance with this requirement may be accomplished by any effective means,
including:
(i)
use of a quality control operation in which the control
points are identified and controlled during manufacturing;
(ii)
proper cleaning and sanitizing of all food-contact surfaces
and food containers;
(iii)
using materials for food containers and food- packaging
materials that are safe and suitable for their intended use;
(iv)
providing physical protection from contamination, particularly
airborne contamination; and
(v)
using sanitary handling procedures.
(N)
Food such as, but not limited to, dry mixes, nuts, intermediate
moisture food, and dehydrated food, that relies on the control of a
w
for preventing the growth of undesirable microorganisms shall be
processed to and maintained at a safe moisture level. Compliance with this
requirement may be accomplished by any effective means, including employment
of one or more of the following practices:
(i)
monitoring the a
w
of food;
(ii)
controlling the soluble solids-water ratio in finished
food; and
(iii)
protecting finished food from moisture pickup, by use
of a moisture barrier or by other means, so that the a
w
of the food does not increase to an unsafe level.
(O)
Acid food, acidified food, and similar food that relies
principally on the control of pH for preventing the growth of undesirable
microorganisms shall be monitored and maintained at a pH of 4.6 or below.
Compliance with this requirement may be accomplished by any effective means,
including employment of one or both of the following practices:
(i)
monitoring the pH of raw materials, food in process, and
finished food; and
(ii)
controlling the amount of acid or acidified food added
to low-acid food.
(P)
When ice is used in contact with food, it shall be made
from water that is safe and of adequate sanitary quality, and shall be used
only if it has been manufactured in accordance with current good manufacturing
practice as outlined in this part.
(Q)
Food-manufacturing areas and equipment used for manufacturing
human food should not be used to manufacture nonhuman food-grade animal feed
or inedible products, unless there is no reasonable possibility for the contamination
of the human food.
§229.220.Natural or Unavoidable Defects in Food for Human Use That Present No Health Hazard.
(a)
Some foods, even when produced under current good manufacturing
practice, contain natural or unavoidable defects that at low levels are not
hazardous to health. The United States Food and Drug Administration establishes
maximum levels for these defects in foods produced under current good manufacturing
practice and uses these levels in deciding whether to recommend regulatory
action.
(b)
Compliance with defect action levels does not excuse violation
of the requirement in the Health and Safety Code, Chapter 431, §431.081(a)(3)
that food not be prepared, packed, or held under unsanitary conditions or
the requirements in this section that food manufacturers, distributors, and
holders shall observe current good manufacturing practice. Evidence indicating
that such a violation exists causes the food to be adulterated within the
meaning of the act, even though the amounts of natural or unavoidable defects
are lower than the currently established defect action levels. The manufacturer,
distributor, and holder of food shall at all times utilize quality control
operations that reduce natural or unavoidable defects to the lowest level
currently feasible.
(c)
The mixing of a food containing defects above the current
defect action level with another lot of food is not permitted and renders
the final food adulterated within the meaning of the act, regardless of the
defect level of the final food.
(d)
A compilation of the current defect action levels for natural
or unavoidable defects in food for human use that present no health hazard
may be obtained upon request from the Texas Department of Health, Manufactured
Foods Division, 1100 West 49th Street, Austin, Texas, 78756.
§229.221.Good Warehousing Practice.
(a)
Plant and grounds.
(1)
Storage and transportation of food shall be under conditions
that will protect food against physical, chemical, and microbial contamination
as well as against deterioration of the food and the container.
(2)
Food storage facilities shall be properly constructed
and maintained. All walls, ceilings, and floors shall be intact to preclude
entry of vermin and environmental contaminants.
(3)
Doors and loading docks shall be tight-fitting and
kept closed at all times when not in use, or adequately screened during normal
operating hours to prevent entry of rodents, birds, or other pests.
(4)
Outer premises, including trash receptacles, shall
be kept clean and free of odors, debris, high weeds, or standing water which
could harbor or attract vermin.
(5)
Adequate lighting shall be provided to facilitate
cleaning and inspection of stored goods.
(b)
Sanitary facilities.
(1)
Hand-washing and toilet facilities shall be provided and
maintained, including hot and cold running water, hand soap, and single-service
towels as deemed appropriate by the regulatory authority for the types of
foods handled by the licensee.
(2)
Wastewater shall be disposed of in a manner approved
by the regulatory authority.
(c)
Sanitary operations.
(1)
All foods, including refrigerated and frozen foods, shall
be stored off the floor and away from walls to help prevent contamination
by vermin (rodents and insects for example) and moisture, and to facilitate
cleaning and inspection.
(2)
Food storage facilities and transportation vehicles
shall be kept free of rodents, insects, birds, and other pests which may contaminate
food.
(3)
Damaged, distressed, and infested foods shall be stored
in a "morgue area," adequately separated from undamaged foods and shall be
disposed of in a timely manner to preclude further contamination.
(4)
The internal temperature of potentially hazardous
foods during transport and storage shall be maintained at 45 degrees Fahrenheit
or lower as appropriate for the food.
(A)
After October 5, 2003, the internal temperature of potentially
hazardous foods shall be maintained at 41 degrees Fahrenheit or lower as appropriate
for the food.
(B)
Frozen foods shall be kept frozen at all times.
(C)
Shell eggs after initial packing, must be transported and
stored at a temperature of 45 degrees Fahrenheit or less. If the United States
Department of Agriculture and the U.S. Food and Drug Administration determine
by law that a lower temperature must be maintained, the lower temperature
shall prevail.
(D)
Molluscan shellstock shall:
(i)
be iced; or
(ii)
be placed in a storage area or conveyance maintained at
45 degrees Fahrenheit or less unless the U.S. Food and Drug Administration
determines by law that a lower temperature must be maintained, in which case
the lower temperature shall prevail; and
(iii)
not be permitted to remain without ice, mechanical refrigeration,
or other approved means of refrigeration for more than two hours at points
of transfer such as loading docks.
(5)
During warehousing and transporting, all
chemicals shall be properly stored and physically separated from foods to
preclude contamination.
(6)
Foods being warehoused shall be rotated on a "first
in, first out" basis or by oldest date of pack.
(7)
Food storage facilities and transportation vehicles
operated under the control of the licensee shall be kept clean and free of
excessive dust, dirt, spillage, and other debris, including excess moisture.
(8)
Food transport vehicles shall be operated in compliance
with federal regulations pertaining to back-hauling.
(9)
Each incoming lot shall be examined at the time of
receipt and contaminated or adulterated foods shall not be accepted.
(10)
Swollen, leaking, and/or severely dented containers
of food shall be segregated and promptly placed in the "morgue area" and further
contamination, attraction of vermin, or sale prior to reconditioning shall
be prevented.
(11)
Only pesticides approved by the Environmental Protection
Agency (EPA) for use in a food warehouse and/or food processing facility may
be used. Pesticides shall be used only according to label directions. Rodenticides
shall be placed inside enclosed bait boxes or other approved receptacles.
Only a licensed pesticide applicator may apply restricted use pesticides.
(d)
Other provisions.
(1)
Distressed foods salvaged by the licensee shall be salvaged
in accordance with §§229.191-229.202 of this title (relating to
Regulation of Food, Drug, Device, and Cosmetic Salvage Establishments and
Brokers).
(2)
Food wholesalers engaged in the receipt and distribution
of over-the-counter or prescription drugs shall comply with §229.253
of this title (relating to Minimum Standards for Licensure).
(3)
The licensee shall keep accurate distribution records
so that any foods found to be unfit for human consumption may be recalled
expeditiously.
§229.222.Penalties.
(a)
Criminal penalties as provided in Health and Safety Code
§431.059 may be assessed for violations of these sections.
(b)
Civil penalties as provided in Health and Safety Code §431.0585
may be assessed for violations of these sections.
(c)
Administrative penalties as provided in Health and Safety
Code §431.054 and in §229.261 of this title (relating to Assessment
of Administrative or Civil Penalties), may be assessed for violation of these
sections.
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
March 19, 1999.
TRD-9901666
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 2, 1999
For further information, please call: (512) 458-7236
25 TAC §229.221, §229.222
(Editor's note: The text of the following sections proposed for
repeal will not be published. The sections may be examined in the offices
of the Texas Department of Health or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The Texas Department of Health (department) proposes
repeal of §229.221 and §229.222, concerning chemical and pesticide
tolerance levels in food. Specifically, these sections establish tolerance
levels for ethylene dibromide in food and the effective date for tolerance
levels of ethylene dibromide in food. The repeal of these rules is necessary
because any tolerance for the pesticide in food was revoked in 1984 by federal
regulations.
The General Appropriations Act, House Bill 1, Article IX, Rider 167, enacted
by the 75th Texas Legislature, 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). The sections have been
reviewed and the department has determined that reasons for adopting the sections
no longer exist.
The department published a Notice of Intention to Review §229.221
and §229.222 as required by Rider 167 in the
Texas Register
(24 TexReg 831) on February 5, 1999.
Robert D. Sowards, Jr., Director, Manufactured Foods Division, has determined
that for each year of the first five-year period the sections are no longer
in effect there will be no fiscal implications to state government or local
government.
Mr. Sowards also has determined that for each year of the first five years
the sections are repealed, the public benefit anticipated as a result of repealing
the sections will be consistent with federal regulations. There will be no
effect on small businesses. There are no anticipated economic costs to persons
who are required to comply with the sections as repealed. There is no impact
on local employment.
Comments on the proposal may be submitted to Robert D. Sowards, Jr., Director,
Manufactured Foods Division, Texas Department of Health, 1100 West 49th Street,
Austin, Texas 78756, (512) 719-0243. Comments will be accepted for 30 days
following publication of the proposal in the
Texas
Register
.
The repeals are proposed under the Health and Safety Code, §431.241,
which provides the department with the authority to adopt necessary regulations
pursuant to the enforcement of Chapter 431; and §12.001, which provides
the Texas Board of Health (board) with the authority to adopt rules for the
performance of every duty imposed by law on the board, the department, and
the commissioner of health.
The proposed repeals affect the Health and Safety Code, Chapter 4; and
the General Appropriations Act, House Bill 1, Article IX, Rider 167, passed
by the 75th Legislature, is implemented by the proposal.
§229.221.Tolerance Levels for Ethylene Dibromide (EDB) in Food.
§229.222.Effective Date for the Tolerance Levels for Ethylene Dibromide (EDB) in Food Being Less Than One Part Per Billion.
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
March 19, 1999.
TRD-9901665
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 2, 1999
For further information, please call: (512) 458-7236
Subchapter C. Texas Asbestos Health Protection
Chapter 205.
Product Safety
rules and
] regulations are intended to have understandable
meaning to
regulated businesses and consumers
[
the ultimate
consumer
]. The definitions used are in conformity with those adopted
by the majority of [
the
] states [
in the union
], Canada,
the Federal Trade Commission and [
by
] the Association of Bedding
and Furniture Law Officials.
,
] when used
in this chapter [
,
] shall have the following meanings [
,
]
unless the context otherwise specifically requires.
Texas Civil Statutes, Article 4476a.
]
(2)
] Department - Texas Department
of Health
(3)
] Filling materials
-
[
--
] Materials used as filling in the manufacture, repair,
or renovation of bedding and shall include materials used as filling in quilted
borders and quilted ticking. Stiffening materials such as fiberboard, corrugated
fiberboard, paper, etc., shall be considered to be filling material.
(4)
] Label,
law label,
labeled, tag and tagged - May be used interchangeably and means any
label or tag required to be on or affixed to finished bedding products and
processed filling material and on which the information required is to appear.
(5)
] Pillows and cushions
- Any bag, case, or covering which has been stuffed or filled and which is
not an integral part of another item of bedding or furniture but which can
be used by human beings for sleeping, resting, or reclining purposes. The
terms do not apply to pillows or cushions which do not exceed 10 inches in
their greatest dimension or
have
[
to which is
] permanently
affixed figurines, statuettes, dolls, etc.
(6)
] Processed filling material
- Felt, batting, pad, foam product, quilted product, or any other filling
material which has been prepared, manufactured, or processed into a form in
which it can be used in articles of bedding.
(7)
]
Secondhand
[
Second-hand
] -
Bedding or filling material with previous
use in any manner.
[
Product which has had prior use but does not
apply to new materials subjected to manufacturing processes or to new materials
which are the by-product of manufacturing processes.
]
(8)
] Sell - [
Sell
]
Offer
[
offer
], or expose for sale, include in a sale, barter,
trade, deliver, consign, lease, possess with intent to sell or dispose of
in any [
other
] commercial manner. For purposes of these sections,
lease shall also include the term "rent" when used for commercial purposes.
Article
] of bedding in
such a manner as to obstruct the view of the [
law
] label from the
purchaser and/or department representatives.
A tolerance not to exceed 20% shall be allowed for
feather and down except when the species is stated, in which case the 10%
tolerance applies.
]
Article
] of bedding must be stated as the last item in
the statement of content section. Stating the number of coils is not required,
but if stated it must be true and correct.
second-hand
] bedding articles and filling materials shall be as follows
:
[
.
]
second-hand
]
articles and/or materials segregated
.
[
and shall tag or mark
all second-hand articles and materials to show name and address of owner and
reason for possession.
]
second-hand
] articles segregated prior to germicidal treatment of the
secondhand
[
second-hand
] articles.
Secondhand
[
Second-hand
] articles which have not been germicidally treated and properly labeled,
shall not be displayed on the sales floor
.
[
unless there has
been affixed thereto a tag, label or marking to indicate not for sale.
]
second-hand
] filling materials or new and untreated
secondhand
[
second-hand
] articles of bedding have been mixed, the entire mixture
shall be regarded as
secondhand
[
second-hand
]
and shall be germicidally treated and properly labeled prior to sale.
this
] Act
and these regulations
shall be attached by
the
permitted
[
registered
] manufacturer
or renovator
at the factory
or at the location where germicidal treatment is
performed
.
must
] be printed
on substantial [
white
] cloth or a material of equal quality. Material
shall
[
must
] be resistant to tear and have prior departmental
approval. [
Paper stock is not allowed except in the tagging of processed
materials.
]
must
] be printed, typed, or stamped in [
black
] ink
.
[
unless otherwise specified for an individual label.
] Printing
shall
[
must
] be legible and be resistant to smudging and
smearing.
Print size shall be of the height specified.
this
] Act.
the
] regulations
or specifically approved by the department
.
Only generic terms shall be used; trade names, trademarks or registered terms
shall not be used in describing filling material. No information or wording
other than descriptions of filling material shall appear in the statement
of content section.
(h)
] It is permitted, as the last
item on the label, to include
the name of the manufacturer, importer,
distributor and/or retailer, bar code,
size, weight, country of origin,
[
or
] any federal/state requirements relating to flammability or
fiber identification information
, and other information approved by the
department
.
(i)
] Labels shall be affixed to
the outer covering of bedding
articles
[
Articles
] and
shall
[
must
] be so located as to make the label and the information
thereon completely and clearly visible to the purchaser at all times. Germicidal
treatment label attachment methods
shall
[
must
] have
prior approval by the department. Specific locations for label attachments
shall be as follows
:
[
.
]
should
] be
attached at the location most likely to be prominently displayed to the purchaser.
must
] be folded in such a manner so that the label and
printed matter thereon is visible to the purchaser.
must
] have a label affixed to both the article and
an exact duplicate label attached to the outside of the package.
The practice of attaching
] the label to the dust cover or bottom of large articles, to the back
side of railings or support braces, to the outside back, or in any other location
which is not easily accessible to the purchaser, is
prohibited.
[
not allowed.
]
Texas Bedding
] Act
and these regulations
.
(j)
]The different types of required
labels and illustrations of each are as follows
:
[
.
]
(1)
The all new materials label
shall have a minimum size of six square inches and shall be in the following
form:
]
Figure: 25 TAC §205.4(j)(1)
]
(2)
The renovate label shall have
a minimum size of 12 square inches and shall be in the following form:
]
Figure: 25 TAC §205.4(j)(2)
]
(3)
Figure: 25 TAC §205.4(j)(3)
]
(4)
The germicidal treatment label shall
have a minimum size of 12 square inches and shall be in the following form:
]
Figure: 25 TAC §205.4(j)(4)
]
(5)
] The processed filling
material label is an identification label. The type and material of this label
is optional. However, the label shall be visible, the printed matter shall
be legible, [
and
] generic terms shall be used as the descriptive
terminology
and the processor's identification number assigned by the
department shall be stated.
Illustrations of
a form for
this
label [
are as
]
follow
[
follows
]:
Figure: 25 TAC §205.4(j)(5)
]
(5)
(A)
(i)
(ii)
(B)
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(6)
(7)
] Damaged feathers, in
conjunction with the name of the fowl from which the feathers come, shall
mean feathers which have been broken, injured by insects or depreciated from
the original value in any manner and which exceeds the 10% allowable tolerance.
(8)
] Crushed feathers, in
conjunction with the name of the fowl from which the feathers come, shall
mean feathers which have been processed by a curling, crushing, or chopping
machine.
(9)
] Feather mixtures when
from two or more species shall be designated by name, character, and percentage
by weight of each constituent in order of predominance, or mixtures may be
designated by lowest grade as to species of origin (grades in descending order:
goose, duck, turkey, chicken).
feet
].
usually from 0-1/2 inches
] in diameter
, or less
.
If
] generic terms are
used for foam products, they
shall
[
must
] be true and
correct.
law
] label. Where materials other than hair are
used with hair in a mixture, the kind and percentage by weight of each material
shall be stated on the [
law
] label.
shaving
],
sawdust, or similar wastes.
(j)
] Universal definitions. The
following terms are common industry definitions for fibers obtained as by-products
during the various machine operations necessary in the manufacture of cotton
yarn up to but not including the process of spinning. These terms must be
preceded by the name of the textile fiber from which it is produced.
are
materials
] which
has
[
have
] been carded in layers
or
sheets
[
sheet
] by a garnett or felting machine. Shall
not be used as an all inclusive term for material of different genera (e.g.,
blended cotton felt, polyester batting).
must
]
be used in connection with filling material that has been treated with a boric
acid solution as a flame retardant treatment (e.g., blended cotton felt-boric
acid treated).
are vegetable
] and synthetic fibers recovered from various machine operations up
to but not including the process of spinning. Term may be used in lieu of
generic terms for a mixture of like material (e.g., synthetic fiber by-product).
are materials
] which have been made into thread, yarn, or fabric and subsequently
reduced to a fibrous state (e.g., garnetted polyester clippings, garnetted
textile clippings).
is a material
] which
has been interwoven, punched, pressed, formed, shaped or otherwise fabricated
into a pad (e.g., sisal pad, coir fiber pad).
are urethane
]
foam and rubber products which have been cut or broken into pieces of indefinite
shape, size or form, but not shredded. The term applies to loose as well as
cemented or bonded filling material (e.g., urethane foam pieces, latex foam
rubber pieces).
is material
]
which has been subjected to a shredding process (e.g., shredded urethane foam).
are materials
] which have been made into thread, yarn, or fabric and subsequently
cut up, torn up, broken up or ground up (e.g., shredded polyester clippings,
shredded textile clippings).
is by-products
]
or reclaimed materials which have the following characteristics:
-Cotton origin
] containing more
than 10% of hull, leaf, stem, and pulp;
(a)
] Chemical spray.
(1)
] Only those products specifically
approved by the department may be used as a germicidal treatment method.
(2)
] Mechanical, compressed air,
hand pump, or electric sprayers must be used and they must be of the continuous
spray type. No intermittent spray devices are allowed.
(3)
] Chemicals must be in liquid
form. Aerosol sprays shall not be used.
(4)
] Fluid sprays must include a
simple but positive means of detection or verification by means of an ultra-violet
lamp unit.
(5)
] Liquid sprays requiring premixing
or dilution shall not be approved.
(6)
] Spray area must be in such
a location as to be protected from wind.
(7)
] Manufacturers specifications
such as amount of coverage, operator safety precautions, and other warning
labels must be followed.
(b)
] Dry heat.
(1)
] A minimum temperature of 230
degrees Fahrenheit for a period of one hour
and 15 minutes
, within
a closed
chamber
[
container
] is required for proper
germicidal treatment.
The minimum temperature may be reduced to 205 degrees
Fahrenheit for a period of one hour and 30 minutes for foam products which
may be damaged at 230 degrees Fahrenheit.
(2)
] The dry heat chamber shall
be equipped with a recording clock to accurately record the time and temperature.
The clock shall be attached on the outside of the chamber and the heat bulb
sending unit must be installed within the chamber at the furtherest point
practical from the entry of the heat.
(3)
] The chamber and automatic circulating
heat devices shall [
be construed to
] maintain equal and uniform
temperatures in all sections of the chamber.
(4)
] All articles of bedding shall
be spaced within the chamber to allow not less than four inches on all sides
of each article for full circulation of heat or air.
(c)
] Steam.
(1)
] Treatment by the steam method
shall consist of steam under pressure of 15 pounds
per square inch
maintained for 30 minutes or a pressure of 20 pounds
per square inch
maintained for 20 minutes.
(2)
] An alternate method may consist
of two applications of streaming steam, maintained for a period of one hour
each, to be applied at intervals of not less than six nor more than 24 hours.
(d)
]
Commercial laundry
method. Pillows, quilts, quilted spreads, comforters, pads, sleeping bags,
and other similar items will be considered as having been germicidally treated
when the filling materials and covering material or ticking are kept intact
without opening, and cleaned by a commercial laundry method
.[
Washing
and drying. Down and feather pillows will be considered as having been germicidally
treated when the feathers and ticking are kept intact without opening, and
washed by a commercial laundry method and subsequent drying to remove moisture.
]
(e)
] Other methods. Any other
method of germicidal treatment may be used provided it has first been approved
in writing
by the department.
(f)
] Records. All records [
as may be
] required by the Act and [
the department
]
regulations
shall be kept as part of the operator's records for a period
of not less than two years. The records shall be available to the department
on request
. [
The lot numbers and tag numbers as set forth under
the Act, §4c, shall apply only to approved germicidal treatment methods
which utilize a permanent recording device.
]
his place of business
] in a sanitary condition
by complying with the following
minimum
requirements
:
[
.
]
;
]
Cracks
[
cracks
] or recesses which would tend to harbor vermin and
pathogens
[
bacteria
] shall not be allowed.
in
] the minimum
requirements [
as
] set forth in
these
[
the
]
sections when such adjustments are deemed necessary for the protection of
the public health and public welfare.
Chapter 229.
Food and Drug
(2)
] Food - Any article
of food or drink for man; chewing gum; or an article used for components of
any such article.
(3)
] Food manufacturer - A
person who combines, purifies, processes, or packages food for sale through
a wholesale outlet. The term also includes a retail outlet that packages or
labels food before sale and a person that represents itself as responsible
for the purity and proper labeling of an article of food by labeling the food
with the person's name and address.
(4)
] Food service establishment
- Any place where food is prepared and intended for individual portion service,
and includes the site at which individual portions are provided. The term
includes any such place regardless of whether consumption is on or off the
premises and regardless of whether there is a charge for the food. The term
also includes delicatessen-type operations that prepare sandwiches intended
for individual portion service. The term does not include private homes where
food is prepared or served for individual family consumption, retail food
stores, the location of food vending machines, and supply vehicles.
(5)
] Food wholesaler - A person
who distributes food for resale, either through a retail outlet owned by that
person or through sales to another person. The term "food wholesaler" shall
not include a commissary which distributes food primarily intended for immediate
consumption on the premises of a retail outlet under common ownership
or an establishment engaged solely in the distribution of nonalcoholic beverages
in sealed containers
.
(6)
] Manufacture - The process
of combining or purifying food
or
[
and
] packaging food
for sale to a
person
[
consumer
] at wholesale or retail
, and includes repackaging or labeling of any food
.
(7)
Packaging - Any covering, wrapper,
or container in which a product is placed for retail or wholesale distribution,
either before or after sale, to a consumer.
]
(8)
] Place of business
- Each location where a person manufactures food or where
food for wholesale
is distributed
[
a person holds food for wholesale distribution.
The term "place of business" shall not include the location of a food service
establishment or a commissary supplying food service establishments unless
the business regularly engages in the labeling, combining, and purifying of
food which is either sold for resale or packaged for sale in other than individual
portions
].
(9)
Public food warehouse (terminal)--A
food storage facility from which foods owned by others are stored and distributed,
and for which services the operator of the facility is paid for the storage
and/or distribution of the foods.
]
; and
]
(F)
$100 for each drop ship location, operated
by a food manufacturer for temporary storage of foods for the purpose of further
distribution.
]
distributed
] from the place of business. In addition, food warehousing
locations operated by a food manufacturer, including locations from which
foods are held for limited periods of time for distribution, and which are
totally separate from any manufacturing location, must be individually licensed
as food wholesalers.
(6)
For the purpose of collecting licensing
fees under this section, a food broker which engages in the storage of food,
even for limited periods of time, must obtain a license as a food wholesaler.
]
(7)
] A firm that has more
than one business location may request a one-time proration of fees when applying
for a license for each new location. Upon approval by the department, the
expiration date of the license for the new location will be established the
same as the firm's previously licensed locations.
furnished
] by the department. The application form shall be signed and verified,
and shall contain the following information:
each place of
] business in the state that is licensed;
(3)
] if a sole proprietorship,
the name of the proprietor; if a partnership, the names of all partners; if
a corporation,
the name of the corporation,
the date and place
of incorporation and name and address of its registered agent in the state;
or if any other type of association, the names of the principals of such association;
(4)
] the names [
and residences
] of those individuals in an actual administrative capacity which, in
the case of a sole proprietorship shall be the managing proprietor; in a partnership,
the managing partner; in a corporation, the officers and directors; in any
other association, those in a managerial capacity; [
and the residence
address of a person in charge of each place of business;
] and
(5)
] a list of categories
of gross annual sales which must be marked and adhered to by the licensee
in the determination and paying of the license fee.
prescribed
] by the
department accompanied by the appropriate licensing fee. A licensee must file
for renewal before the expiration date of the current license. A person who
files a renewal application after the expiration date must pay an additional
$100 as a delinquency fee.
of place
] of business. Not later than the 31st day before the
date of the change
in the name, status, or location of a licensed place
of business
, the license holder shall notify in writing the commissioner
or the commissioner's designee of the license holder's
intended change
[
intent to change the location of a licensed place of business
]. The notice shall include the
new name of the business, the address
of the new location, or the date the business will close.
[
address
of the new location and the name and residence address of the individual in
charge of the place of business.
] Not later than the 10th day after
the completion of the change of location, the license holder shall forward
to the commissioner or the commissioner's designee the name and residence
address of the individual in charge of the new place of business. Notice is
considered adequate if the license holder provides the intent and verification
notices to the commissioner or the commissioner's designee by certified mail,
return receipt requested, mailed to the Texas Department of Health, Bureau
of Food and Drug Safety, 1100 West 49th Street, Austin, Texas 78756-3182.
(i)
Sale of food, drugs, or devices. The provisions
of this section regarding the sale of food, drugs, or devices shall be considered
to include the manufacture, production, processing, packaging, exposure, offer,
possession, and holding of any such article for sale; and the sale, dispensing,
and giving of any such article, and the supplying or applying of any such
articles in the conduct of any food, drug, or device place of business.
]
(a)
]
Manufacturers of foods.
]
manufacturers of
food
] in Texas shall comply with
§§229.211 - 229.221
of this title (relating to Current Good Manufacturing Practice and Good Warehousing
Practice in Manufacturing, Packing, or Holding Human Food)
[
the
minimum standards specified in paragraph (2) of this subsection
] in
addition to the existing standards contained in the following statutes: Health
and Safety Code, Chapters 431, 434, and 438.
(2)
Current good manufacturing practice
in manufacturing, processing, packing, or holding human food. The department
adopts by reference the Current Good Manufacturing Practice in Manufacturing,
Processing, Packing, or Holding Human Food, Code of Federal Regulations, Title
21, Part 110, §§110.3-110.110. Copies are indexed and filed in the
office of the Division of Food and Drugs, Texas Department of Health, 1100
West 49th Street, Austin, Texas 78756-3182, and are available for inspection
during normal working hours.
]
operations
] shall be separated from any living or sleeping
quarters by complete partitioning.
(4)
Potentially hazardous foods. The
internal product temperature of potentially hazardous food shall be 45 degrees
Fahrenheit (7 degrees Centigrade) or below or at an internal temperature of
140 degrees Fahrenheit (60 degrees Centigrade) or above at all times, except
during periods of necessary preparation. Potentially hazardous food means
any food that consists in whole or in part of milk or milk products, eggs,
meat, poultry, fish, shellfish, edible crustacea, or other ingredients including
synthetic ingredients, in a form capable of supporting rapid and progressive
growth of infectious or toxigenic microorganisms. The term does not include
clean, whole, uncracked, odor-free shell eggs or foods which have a pH level
of 4.5 or below or a water activity (Aw) value of 0.85 or less. Frozen foods
shall be kept frozen and shall be stored at a temperature of 0 degrees Fahrenheit
(-18 degrees Centigrade) or below.
]
(5)
] Food labeling. If a person,
firm, or corporation labels an article of food, the label shall meet the requirements
of the Health and Safety Code, Chapter 431.
(b)
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
(13)
(14)
(15)
(16)
(17)
(18)
(19)
(20)
(21)
Chapter 229.
Food and Drug
Subchapter N. Current Good Manufacturing Practice and Good Warehousing Practice in Manufacturing, Packing, or Holding Human Food
Subchapter N. Chemical and Pesticide Tolerance Levels in Food
Chapter 295.
Occupational Health