TITLE health-services

Part I. Texas Department of Health

Chapter 13. Health Planning and Resource Development

Data Collection

25 TAC §§13.11, 13.13, 13.15, 13.17, 13.18, 13.19

The Texas Department of Health proposes amendments to §§13.11, 13.13, 13.15, 13.17, 13.18 and 13.19, concerning hospital financial and utilization reporting and the reporting of charity care and community benefits data from nonprofit hospitals. The amendments will implement Senate Bills 788 and 802, 75th Legislature, 1997, which amend the Health and Safety Code, Chapter 311, and will correct inconsistencies with the enabling legislation.

Section 13.11 revises the purpose of the rules to accurately reflect statutory responsibilities. Section 13.13 includes a reformat of the definition of "nonprofit hospitals" for clarity. Section 13.15 establishes an exemption to hospital financial and utilization reporting. Section 13.17 establishes additional nonprofit hospital reporting requirements for the annual report of the community benefits plan, revises the standards for the provision of charity care and community benefits, specifies and clarifies revised time lines for nonprofit hospital charity care and community benefits reporting, includes requirements for nonprofit hospitals to post charity care notices, expands the definition of "nonprofit hospital" for purposes of charity care and community benefits reporting, deletes a reporting exemption for nonprofit hospitals in a specified county, and provides revisions to existing rule language for clarification purposes. Section 13.18 revises the time frame for implementing compliance activities for hospitals failing to report financial and utilization data, incorporates language consistent with the statute for department implementation of noncompliance activities for hospitals failing to report, and provides revisions to existing rule language for clarification purposes. Section 13.19 corrects an inconsistency with the enabling legislation regarding confidentiality of data.

Dora McDonald, Chief, Bureau of State Health Data and Policy Analysis, has determined that for the first five-year period the sections are in effect, there will be implications to state or local government as a result of administering or enforcing the sections as proposed. For fiscal years ending on or after January 1, 1998, public hospitals that are owned or operated by a political subdivision or municipal corporation of the state, including hospital districts and authorities, will be required to report charity care and community benefits information. Based on a survey of several hospitals, it is estimated that the cost of implementing these rules will range from $1,200 to $10,000 for each public hospital. This estimate is based on direct costs associated with reporting under these sections. Additional indirect costs incurred such as computer system adaptations, the scope of a hospital's community benefit planning activities undertaken, and the development and implementation of revised charity care policies have not been identified and will vary from hospital to hospital. There is no measurable cost to the state of implementing this new data collection function; however, these activities will modify the workload for the department in terms of the collection, processing, and follow-up required to gather this information.

Ms. McDonald 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 enforcing the sections as proposed will be the availability of information necessary to assess the level of charity care and community benefits provided by nonprofit and public hospitals. Economic costs to small businesses will occur if the "nonprofit hospital" is an investor-owned Medicaid disproportionate share hospital with fewer than 100 employees or less than $1 million in annual gross receipts. The adverse economic impact to these small businesses will be the cost of reporting under these sections since these hospitals have not previously been required to report. The cost will be an estimated $1,200 to $10,000 based on a survey of hospitals. The department does not expect these rules to cause the cost of compliance per employee, per hour of labor or per $100 of sales of services to be different between a small business or a large business; however, due to the possibility of a higher volume of charity care performed and reported by a large hospital, the total costs of compliance for a large hospital may be closer to the high end of the range and the total cost for a small hospital may be closer to the lower end. The costs to persons who are required to comply with the sections as proposed will be an estimated $1,200 to $10,000 for reporting. There is no anticipated impact on local employment.

Comments on the proposal may be submitted to Ann Henry, Bureau of State Health Data and Policy Analysis, 1100 West 49th Street, Austin, Texas 78756-3199, (512) 458-7261, Fax (512) 458-7344. Comments will be accepted for 30 days following the publication of this proposal in the Texas Register .

The amendments are authorized under the Health and Safety Code, §104.042(a) which authorizes the Board of Health to adopt rules relating to the collection and dissemination of data from health care facilities necessary to facilitate health planning and resource development; §311.032(b) which mandates the adoption of rules on the collection and reporting of hospital financial and utilization data; and §12.001 which provides the Board of Health with the authority to adopt rules for the performance of every duty imposed by law on the Texas Board of Health, the Texas Department of Health and the Commissioner of Health.

These amendments affect the Health and Safety Code, Chapters 104 and 311.

§13.11.Purpose.

The purpose of the sections in this chapter is to implement Health and Safety Code, Chapter 104, Subchapter D, which requires the department to adopt rules covering the collection of data from health care facilities, such as hospitals, and the dissemination of data to facilitate health planning and resource development; Health and Safety Code, Chapter 311, Subchapters [ Subchapter ] C and D relating to [ which requires the department to adopt rules covering ] the collection and reporting of hospital financial [ , ] and utilization [ , and patient discharge ] data including data regarding the provision of levels of charity care by certain nonprofit hospitals, and the submission of an annual report of a community benefits plan by certain nonprofit hospitals.

§13.13.Definitions.

The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.

Nonprofit hospital

--

(A)

A hospital that is organized as a nonprofit corporation or a charitable trust under the laws of this state or any other state or country and is:

(i)

eligible for tax-exempt bond financing; or

(ii)

exempt from state franchise, sales, ad valorem, or other state or local taxes. [ A hospital that is eligible for tax-exempt bond financing; or exempt from state franchise, sales ad valorem, or other state or local taxes; and organized as a nonprofit corporation or a charitable trust under the laws of this state or any other state or country. For purposes of these sections, a ]

(B)

A "nonprofit hospital" shall not include a hospital that:

(i)

[ (A) ] is exempt from state franchise, sales, ad valorem, or other state or local taxes;

(ii)

[ (B) ] does not receive payment for providing health care services to any inpatients or outpatients from any source including, but not limited to, the patient or any person legally obligated to support the patient, third-party payers, Medicare, Medicaid, or any other federal, state, or local indigent care program; payment for providing health care services does not include charitable donations, legacies, bequests, or grants or payments for research; and

(iii)

[ (C) ] does not discriminate on the basis of inability to pay, race, color, creed, religion, or gender in its provision of services. [ ; or ]

(C)

[ (D) ] A "nonprofit hospital" does not include a hospital that is located in a county with a population under 50,000 where the entire county or the population of the entire county has been designated as a health professional shortage area.

§13.15. Survey Forms.

(a)-(c)

(No change.)

(d)

A hospital may, but is not required to, provide the data required by subsection (b) of this section if the hospital:

(1)

is exempt from state franchise, sales, ad valorem, or other state or local taxes; and

(2)

does not seek or receive reimbursement for providing health care services to patients from any source, including:

(A)

the patient or any person legally obligated to support the patient;

(B)

a third party payor; or

(C)

Medicaid, Medicare, or any other federal, state, or local program for indigent health care.

§13.17.Duties of Nonprofit Hospitals under Health and Safety Code, Chapter 311.

(a)

Annual report [ Report ] of the [ annual ] community benefits plan.

(1)

[ For reports required to be submitted to the Texas Department of Health

(department)

on or after September 1, 1995, the] The annual report of the community benefits plan may be filed with the department on a hospital or hospital system basis.

(2)

For fiscal years ending prior to January 1, 1998, a [ A ] nonprofit hospital or hospital system shall file an annual report of the community benefits plan, as required by Health and Safety Code, §311.046 as it existed prior to 1997 legislative amendments made by SB 788, with the department no later than 120 days after the hospital's or hospital system's fiscal year ends. For fiscal years ending on or after January 1, 1998, a nonprofit hospital or hospital system shall file an annual report of the community benefits plan with the department no later than April 30 of the following year.

(3)

The nonprofit hospital's or hospital system's annual report of the community benefits plan must include, at a minimum : [ , ]

(A)

the hospital's or hospital system's mission statement ; [ , ]

(B)

a disclosure of the health care needs of the community that were considered in developing the community benefits plan ; [ , and ]

(C)

a disclosure of the amount and types of community benefits, including charity care, actually provided. Charity care shall be reported as a separate item from other community benefits ;

(D)

a statement of its total operating expenses computed in accordance with generally accepted accounting principles for hospitals from the most recent completed and audited prior fiscal year of the hospital; and

(E)

a completed worksheet that computes the ratio of cost to charge for the fiscal year referred to in subparagraph (D) of this paragraph and that includes the same requirements as Worksheet 1-A adopted by the department in August 1994 for the 1994 "Annual Statement of Community Benefits Standard".

(4)

For fiscal years ending prior to January 1, 1998, the nonprofit hospital's or hospital system's annual report of the community benefits plan must include the items listed in paragraphs (3)(A), (3)(B) and (3)(C) of this subsection. For fiscal years ending on or after January 1, 1998, the nonprofit hospital's or hospital system's annual report of the community benefits plan must include the items listed in paragraphs (3)(A)-(3)(E) of this subsection.

(5)

For fiscal years ending on or after January 1, 1998, in addition to the annual report of the community benefits plan, a nonprofit hospital or hospital system shall file a completed worksheet as required by paragraph (3)(E) of this subsection no later than ten working days after the date the hospital or hospital system files its Medicare cost report.

(b)

Annual statement of community benefits standard.

(1)

[ For statements required to be submitted to the department on or after September 1, 1995, the ] The annual statement of community benefits standard may be filed with the department on a hospital or hospital system basis.

(2)

For fiscal years ending prior to January 1, 1998, a [ A ] nonprofit hospital or hospital system shall file an annual statement with the department no later than 120 days after the [ end of the ] hospital's or hospital system's fiscal year ends [ stating which of the standards for providing community benefits have been satisfied ]. For fiscal years ending on or after January 1, 1998, a nonprofit hospital or hospital system is required to file an annual statement with the department no later than 120 days after the hospital's or hospital system's fiscal year ends; however, the department will accept the annual statement as part of the acceptance of the annual report of the community benefits plan . The annual statement filed under this subsection shall be based on the most recently completed and audited prior fiscal year of the hospital and shall state which of the standards for providing community benefits has been satisfied . A nonprofit hospital or hospital system may elect to provide community benefits according to any of the following standards:

(A)

charity care and government-sponsored indigent health care are provided at a level which is reasonable in relation to the community needs, as determined through the community needs assessment, the available resources of the hospital or hospital system, and the tax-exempt benefits received by the hospital or hospital system, and other factors that may be unique to the hospital or hospital system, such as the hospital's or hospital system's volume of Medicare and Medicaid patients;

[ (B)

charity care and government sponsored indigent health care are provided in an amount equal to at least 4.0% of the hospital's or hospital system's net patient revenue; ]

(B)

[ (C) ] charity care and government-sponsored indigent health care are provided in an amount equal to at least 100% of the hospital's or hospital system's tax-exempt benefits, excluding federal income tax;

[ (D)

prior to January 1, 1996, charity care and community benefits are provided in a combined amount equal to at least 5.0% of the hospital's or hospital system's net patient revenue, provided that charity care and government-sponsored indigent health care are provided in an amount equal to at least 3.0% of net patient revenue; ] or

(C) [(E)]

[ beginning with the hospital's or hospital system's fiscal year starting after December 31, 1995, ] charity care and community benefits are provided in a combined amount equal to at least 5.0% of the hospital's or hospital system's net patient revenue, provided that charity care and government sponsored indigent health care are provided in an amount equal to at least 4.0% of net patient revenue.

(3)

For purposes of satisfying paragraph (2)(C) [ (2)(E) ] of this subsection, a hospital or hospital system may not change its existing fiscal year unless the hospital or hospital system changes its ownership or corporate structure as a result of a sale or merger.

(4)

A nonprofit hospital or hospital system shall use the form developed by the department for reporting under this section [ and shall submit the form as part of the annual report of the community benefits plan ].

(5)

The department will accept written revisions of the annual statement of community benefits standard for 30 days after the filing date.

(6)

A nonprofit hospital that has been designated as a disproportionate share hospital under the state Medicaid program in the current fiscal year or in either of the previous two fiscal years shall be deemed in compliance with these standards.

(7)

A hospital that satisfies paragraphs (2)(A) or (6) of this subsection shall be excluded in determining a hospital system's compliance with the standards provided in paragraphs (2)(B) and (2)(C) [ - (E) ] of this subsection.

(c)

Reporting.

(1)

The department shall notify nonprofit hospitals in writing that the annual report of a community benefits plan and the statement of community benefits standard must be filed in accordance with these rules [ within 120 days after the end of the hospital's or hospital system's fiscal year. The notification will include a form to be used by nonprofit hospitals or hospital system to file the annual statement of community benefits standard ].

(2)-(3)

(No change.)

(4)

All hospitals or hospital systems shall report [ to the department ] any change of ownership [ or control ] which may effect the nonprofit status of the hospital or hospital system to the Bureau of State Health Data and Policy Analysis at the department.

(d)

(No change.)

(e)

Charity care notice. Each hospital shall provide, to each person who seeks any health care service at the hospital, notice, in appropriate languages, if possible, about the charity care program and how to apply for charity care. Such notice shall also be conspicuously posted in the general waiting area, the waiting area for emergency services, in the business office, and in such other locations as the hospital deems likely to give notice of the charity care program.

(f)

[ (e) ] Exemptions.

[ (1)

A nonprofit hospital that is located in a county with a population under 110,000 which has a hospital district created pursuant to Section 5, Article IX, Texas Constitution, and Chapter 136, Acts of the 55th Legislature, 1957, shall not be required to comply with one or more of the standards set forth in subsection (c) of this section. This exemption expires with a hospital's fiscal starting on or after September 1, 1996. ]

[ (2) ]

A nonprofit hospital is exempt from the reporting requirement in subsection (c) of this section if the hospital is located in a county with a population under 50,000 and in which the entire county or the population of the entire county has been designated as a "health professional shortage area" during the current or any previous fiscal year and has continued to maintain that designation.

(g)

For purposes of this section only, a nonprofit hospital shall include a nonprofit hospital as defined in §13.13 of this title (relating to Definitions) and:

(1)

a Medicaid disproportionate share hospital; or

(2)

a public hospital that is owned or operated by a political subdivision of municipal corporation of the state, including a hospital district or authority.

§13.18.Noncompliance with Reporting Requirements.

(a)

Data reporting.

[ (1)

A hospital that does not time submit requested data to the Texas Department of Health (department) according to the requirements and procedures established in these sections is subject to a civil penalty of not more than $500 for each day of noncompliance, under the provisions of Health and Safety Code, Chapter 104. ]

(1)

[ (2) ] If a hospital does not submit a completed survey form to the Texas Department of Health (department) [ department ] within the 60-day reporting period established in §13.15 of this title (relating to Survey Forms), the department may institute the following procedures.

(A)

The department will notify the entity in writing by certified mail, return receipt requested, that the entity is in noncompliance with department reporting requirements and may be in violation of the Health and Safety Code, Chapter 104. The written notification will also state that the commissioner of health may [ will ] request that the attorney general institute and conduct a suit in the name of the state to recover civil penalties if the hospital fails to submit the requested data to the department within 30 days of the date the entity received [ postmark of ] the notification letter.

(B)

If the department does not received the requested data from the non-responding hospital within the specified time frame, the commissioner of health may [ will ] notify the attorney general in writing of the entity's noncompliance. The department will send a copy of the written notification to the hospital.

(2)

A hospital that does not timely submit requested data to the department according to the requirements and procedures established in these sections is subject to a civil penalty of not more than $500 for each day of noncompliance, under the provisions of Health and Safety Code, Chapter 104.

(b)

Community benefits plans.

(1)

(No change.)

(2)

If a nonprofit hospital or hospital system does not submit a report of the community benefits plan to the department within the [ 120-day ] reporting period established in §13.17 of this title (relating to Duties of Nonprofit Hospitals under Health and Safety Code, Chapter 311 ), the department may institute the following procedures.

(A)

The department will notify the entity in writing by certified mail, return receipt requested, that the entity is in noncompliance with department reporting requirements and may be in violation of the Health and Safety Code, Chapter 311. The written notification will also state that the commissioner of health may [ will ] request that the attorney general institute and conduct a suit in the name of the state to recover civil penalties if the hospital or hospital system fails to submit the report to the department within ten days after receipt of the written notification letter.

(B)

If the department does not receive the report of the community benefits plan from the non-responding hospital or hospital system within the specified time frame, the commissioner of health may [ will ] notify the attorney general in writing of the entity's noncompliance. The department will send a copy of the written notification to the hospital or hospital system.

§13.19. Confidential Data.

(a)

The following data received by the Texas Department of Health (department) from a [ public or private ] hospital is confidential under authority of the Health and Safety Code, Chapters 104 and 311:

(1)-(2)

(No change.)

(b)-(c)

(No change.)

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State, on January 21, 1998.

TRD-9800978

Susan K. Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: March 8, 1998

For further information, please call: (512) 458-7236

Chapter 39. Primary Health Care Services Program

Medically Underserved Community-State Matching Incentive Program

25 TAC §§39.61-39.75

(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 the repeal of §§39.61-39.75, concerning the Medically Underserved Community-State Matching Incentive Program (MIP), through which the department allocates funds to qualified community groups in medically underserved areas to cover certain costs of establishing physicians' primary care practices. Specifically, the sections cover purpose and scope; define terms used in the rules; define eligibility criteria for contributing communities, participating physicians, and state designation as a medically underserved area; describe the procedures for applying for funds, prioritization of need among applicant communities and funding allocation; and provide specifications for related contracts, including requirements for community contribution of funds.

The repeal is required by Senate Bill 913, 75th Legislature, 1997, which directs the Texas Board of Health (board) to transfer its obligations, property, and rights as administrator of the MIP under Health and Safety Code, Chapter 46, to the Center for Rural Health Initiatives (Center) not later than September 1, 1998. The Center's executive board will adopt new rules to administer the MIP in compliance with Health and Safety Code, Chapter 106, as amended by Senate Bill 913.

Dora McDonald, Chief, Bureau of State Health Data and Policy Analysis, has determined that for the first five-year period the repeal is in effect, there will be no fiscal implications for state or local government as a result of the repeal.

Mrs. McDonald also has determined that for each of the first five years the repeal is in effect, the public benefits anticipated are compliance with Senate Bill 913, 75th Legislature, 1997, and continuation of assistance to communities in medically underserved areas when the Center for Rural Health Initiatives begins to administer the MIP. There are no anticipated economic costs to small or large businesses or to persons who will be affected by the repeal. No effect on local employment is anticipated.

Comments on the proposed repeal may be submitted to Dora McDonald, Chief, Bureau of State Health Data and Policy Analysis, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756-3199, (512) 458-7261. Comments will be accepted for 30 days following the date of publication of the proposed repeal in the Texas Register .

The repeal is required by Senate Bill 913, 75th Legislature, 1997, and proposed under Health and Safety Code §12.001(b), which provides the Texas Board of Health (board) with authority to adopt rules for the performance of every duty imposed by law upon the board, the department, and the commissioner of health.

The repeal of §§39.61-39.75 will affect Health and Safety Code, Chapter 106.

§39.61.Introduction.

§39.62.Definitions.

§39.63. Eligibility Criteria for a Contributing Community.

§39.64.Physician Eligibility Criteria.

§39.65.Eligibility Criteria for State Designation as a Medically Underserved Area or Community.

§39.66.Procedures To Apply for Funds.

§39.67.Application Requirements.

§39.68.Evaluation of Application.

§39.69.Contract Award.

§39.70.Methodology for Prioritizing Neediest Communities.

§39.71.Contribution Procedures.

§39.72.Contract.

§39.73.Funding Allocation Procedure.

§39.74.Breach of Contract.

§39.75.Reporting and Monitoring.

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 January 21, 1998.

TRD-9800977

Susan K. Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: March 8, 1998

For further information, please call: (512) 458-7236

Chapter 241. Shellfish Sanitation

Molluscan Shellfish

25 TAC §§241.50-241.100

(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 the repeal of existing §§241.50 - 241.100, and new §§241.50-241.67, concerning Texas molluscan shellfish. Specifically, these sections cover definitions; grounds and arrangements; sanitary controls; water supplies; storage areas; processing of molluscan shellfish; maintenance and cleaning; records and supervision guidelines which are provided by the new federal Shellfish Sanitation Model Ordinance ; and they also include requirements established by the U.S. Food and Drug Administration's Fish and Fishery Products Hazard Analysis and Critical Control Point (HACCP) regulations (Code of Federal Regulations, Title 21, Part 123). This action is necessary because of new federal requirements and recommendations. These rules are essential for the proper regulation of the molluscan shellfish industry.

Richard E. Thompson, Director, Seafood Safety Division, has determined that for each year of the first five-year-period the sections are in effect there will be no fiscal implications for state government as a result of implementing the sections. The current level of inspection will be reduced slightly to allow for the increased time and in-depth coverage of the HACCP inspections. All involved department staff have already participated in training. The effect on state government would be an increase in general revenue if administrative penalties are assessed. There will be no fiscal implications to local governments.

Mr. Thompson 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 enforcing the sections will be better assurance that molluscan shellfish processed in or imported into Texas will be free of disease or other health hazards transmissible by these products. There is no anticipated economic cost to individuals or small businesses because the industry involved was already regulated very stringently under the National Shellfish Sanitation Program. These requirements reflect primarily changes in form rather than new requirements. All currently licensed shellfish dealers have already participated in training. There is no impact on local employment.

Comments on the proposal may be submitted to Richard E. Thompson, R.S., Director, Seafood Safety Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, (512) 719-0215. Comments will be accepted for 30 days following publication of this proposal in the Texas Register . Public hearings to receive comments on the proposed rules will be held on Monday, February 23, 1998, at 7:00 p.m. in the Galveston County Agriculture Extension Service Building, Dickinson, Texas, and on Tuesday, February 24, 1998, at 7:00 p.m. in the Calhoun County Agriculture Building at the fairgrounds on County Road 101, Port Lavaca, Texas.

The repeal is proposed under Health and Safety Code, §§436.112 and 12.001, which provides the 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 will affect Health and Safety Code, Chapter 436.

§241.50.Definitions.

§241.51.Growing Area Classification.

§241.52.Transplanting and Gathering for Depuration.

§241.53.Certification and Enforcement Procedures.

§241.54.Sources of Shellfish.

§241.55.Harvesting and Handling Shellstock.

§241.56.Shellstock Shipping.

§241.57.Plant Location, Grounds, and Arrangements.

§241.58.Dry Storage and Protection of Shellstock.

§241.59.Floors, Walls, and Ceilings.

§241.60.Insect and Vermin Control Measures.

§241.61.Lighting.

§241.62.Heating, Cooling, and Ventilation.

§241.63.Water Supply.

§241.64.Plumbing, Sewage, and Related Facilities.

§241.65.Poisonous or Toxic Materials.

§241.66.Construction of Shucking Benches, Stools, Runs, and Tables.

§241.67.Construction of Utensils and Equipment.

§241.68.General Maintenance and Cleanliness.

§241.69.Cleaning and Sanitizing Equipment and Utensils.

§241.70.Shucking of Shellfish.

§241.71.Shell and Waste Disposal.

§241.72.Single Service Containers.

§241.73.Packing of Shucked Shellfish.

§241.74.Labeling Shucked Shellfish.

§241.75. Refrigeration and Shipping of Shucked Shellfish.

§241.76.Ice.

§241.77.Records.

§241.78.Employee Health.

§241.79.Supervision.

§241.80.Personal Cleanliness.

§241.81.Education and Training.

§241.82.Repacking Shucking Shellfish.

§241.83.Wet Storage.

§241.84.Heat Shock.

§241.85.Depuration Certificate Requirements.

§241.86.Depuration Gathering Permit.

§241.87.Depuration Tank Design and Construction.

§241.88.Depuration Plant Sanitation.

§241.89.Depuration Plumbing, Water Supply, and Related Facilities.

§241.90.Depuration Construction Requirements.

§241.91.Depuration Laboratory Procedures.

§241.92.Depuration Plant Operation.

§241.93.Depuration Shellfish Sampling Procedures.

§241.94.Depuration Process Water Control - Sampling.

§241.95.Depuration Treatment Water - Standards.

§241.96.Depuration Shellfish Meat Standards.

§241.97.Depuration Ultraviolet (UV) Unit.

§241.98.Depuration Shellstock Storage.

§241.99.Tagging and Release of Depurated Shellfish.

§241.100.Depuration Records.

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 January 21, 1998.

TRD-9801019

Susan K. Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: March 8, 1998

For further information, please call: (512) 458-7236

25 TAC §§241.50-241.67

The new sections are proposed under Health and Safety Code, §§436.112 and 12.001, which provides the 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 will affect Health and Safety Code, Chapter 436.

§241.50.Definitions.

The following words and terms, when used in this chapter of this title (relating to Molluscan Shellfish), shall have the following meaning unless the context clearly indicates otherwise.

Air gap

- The unobstructed vertical distance through the free atmosphere between the lowest opening from any pipe or faucet supplying water to a tank, plumbing fixture or other device and the flood level rim of that receptacle.

Approved area

- A classification used to identify a harvest area where harvest for direct marketing is allowed.

Approved source

- A source of molluscan shellfish acceptable to the director (commissioner of health).

Aquaculture

- The cultivation of seed in natural or artificial growing or harvest areas, or the cultivation of molluscan shell stock other than seed in harvest areas.

Assure

- To make certain.

Authorized agent

- An employee of the department who is designated by the director (commissioner of health) to enforce provisions of this chapter of this title (relating to Molluscan Shellfish).

Backflow

- The flow of water or other liquids, mixtures or substances into the distribution pipes of a potable water supply from any source or sources other than the intended source.

Back siphonage

- The flowing back of used, contaminated or polluted water from a plumbing fixture, vessel or other source into potable water supply pipes because of negative pressure in the water supply pipes.

Blower

- A receptacle for washing shucked molluscan shellfish which uses forced air as a means of agitation.

Certificate (molluscan shellfish certificate of compliance)

- A numbered document issued by the Seafood Safety Division which authorizes a dealer to process molluscan shellfish for sale.

Certification or certify

- The issuance of a numbered certificate to a person for a particular activity or group of activities that indicates:

(A)

permission from the department to conduct the activity; and

(B)

initial compliance with the requirements of these rules in this chapter of this title (relating to Molluscan Shellfish).

Certification number

- The unique identification number issued by the department to each dealer for each location. Each certification number shall consist of a one to five digit Arabic number preceded by the two letter State abbreviation and followed by a two letter abbreviation for the type of activity or activities the dealer is qualified to perform in accordance with the following terms:

(A)

Shellstock shipper (SS);

(B)

Shucker/packer (SP);

(C)

Repacker (RP);

(D)

Depuration processor (DP).

Certified location

- A plant or place of business which has been inspected by the Seafood Safety Division and for which a molluscan shellfish certificate of compliance has been issued.

Coliform group

- All of the aerobic and facultative anaerobic, gram negative, nonspore forming, rod shaped bacilli which ferment lactose broth with gas formation within 48 hours at 95 degrees Fahrenheit (35 degrees + 0.5 degrees Centigrade).

Commingle or commingling

- The act of combining different lots of molluscan shell stock or shucked molluscan shellfish.

Commissioner

- The commissioner of health for the State of Texas.

Compliance schedule

- A written schedule that provides a correction time period to eliminate key and other deficiencies.

Conditionally approved area

- A classification used to identify a harvest area which meets the criteria for the approved classification except under certain conditions described in a management plan established by the SSD.

Conditionally restricted area

- A classification used to identify a harvest area which meets the criteria for the restricted classification except under certain conditions described in a management plan established by the SSD.

Container

- The physical material in contact with or immediately surrounding molluscan shellfish that confines it into a single unit.

Corrosion resistant materials

- Materials that maintain their original surface characteristics under normal exposure to the foods being contacted, normal use of cleaning compounds and bactericidal solutions, and other conditions of use.

Critical Control Point (CCP)

- A point, step or procedure in a food process at which control can be applied, and a food safety hazard can as a result be prevented, eliminated or reduced to acceptable levels.

Critical deficiency

- A condition or practice which:

(A)

results in the production of a product that is unwholesome; or

(B)

presents a threat to the health or safety of the consumer.

Critical limit

- The maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate or reduce to an acceptable level the occurrence of the identified food safety hazard.

Cross connection

- An unprotected actual or potential connection between a potable water system and any source or system containing unapproved water or a substance that is not or cannot be approved as safe and potable. Examples include, bypass arrangements, jumper connection, removable sections, swivel or change over devices, or other devices through which backflow could occur.

Cull

- To remove dead or unsafe molluscan shell stock from a lot of molluscan shell stock.

Dealer

- A person to whom certification is issued for the activities of molluscan shell stock shipper, shucker-packer, repacker, or depuration processor.

Department

- The Texas Department of Health, 1100 West 49th Street, Austin, Texas, 78756, or its successor state agency, having the responsibility for the enforcement of laws concerning the safety of the food supply including molluscan shellfish growing area classification and certification of molluscan shellfish dealers.

Depletion

- The removal, under the direct control of the Texas Parks and Wildlife Department, of all existing commercial quantities of market-size molluscan shellfish from a harvest area classified as prohibited.

Depuration or depurate

- The process of reducing the level of bacteria and viruses that may be present in molluscan shellfish by using a controlled aquatic environment as the treatment process.

Depuration plant

- A place where depuration of molluscan shellfish occurs.

Depuration Processor (DP)

- A person who harvests or receives molluscan shell stock from harvest areas in the approved or conditionally approved, restricted, or conditionally restricted classification and submits such molluscan shell stock to an approved depuration process.

Direct marketing

- The sale for human consumption of molluscan shellfish which:

(A)

does not require depuration or relaying prior to sale; or

(B)

has been subjected to depuration or relaying activities.

Director

- The executive head (commissioner of health) of the Texas Department of Health.

Dry storage

- The storage of molluscan shell stock out of water.

Durable material

- Material with the ability to exist for several years without significant deterioration and able to withstand normal daily use associated with molluscan shellfish operations.

Easily cleanable

- A surface which is:

(A)

readily accessible; and

(B)

is made of such materials, has a finish, and is so fabricated that residues may be effectively removed by normal cleaning methods.

Facility

- A structure.

FDA

- The United States Food and Drug Administration or its successor agency, the federal agency in which regulation of foods, including the Cooperative Shellfish Program, is vested.

Food contact surface

- An equipment surface or utensil which normally comes into direct or indirect contact with shucked molluscan shellfish.

Food safety hazard

- Any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.

Gatherer

- Person who takes molluscan shellfish by any means from a growing area designated by the commissioner for delivery to a depuration plant.

GLO

- The Texas General Land Office, 1700 North Congress, Austin, Texas, 78701, or its successor agency, the state agency having the responsibility for the enforcement of laws concerning all state lands, including leasing of wetland bottom for private oyster leases.

Growing area

- Any site which supports or could support the propagation of molluscan shell stock by natural or artificial means.

HACCP

- Hazard Analysis Critical Control Point, a systematic, science-based approach used in food production as a means to assure food safety. The concept is built upon the seven principles identified by the National Advisory Committee on Microbiological Criteria for Foods(1992).

HACCP Plan

- A written document that delineates the formal procedures that a dealer follows to implement the HACCP requirements as adopted by the Interstate Shellfish Sanitation Conference set forth in Code of Federal Regulations, Title 21, §123.6, as amended.

Harvest

- The act of removing molluscan shell stock from growing or harvest areas and its placement on or in a manmade conveyance or other means of transport.

Harvest area

- An area that contains commercial quantities of molluscan shell stock and may include aquaculture sites and facilities.

Harvester

- A person who takes molluscan shell stock by any means from a harvest area.

Heat shock

- The process of subjecting molluscan shell stock to any form of heat treatment prior to shucking, including steam, hot water or dry heat, to facilitate removal of the meat from the shell without substantially altering the physical or organoleptic characteristics of the molluscan shellfish.

Includes or including

- Includes or including by way of illustration and not by way of limitation.

ISSC

- The Interstate Shellfish Sanitation Conference. The ISSC consists of agencies from molluscan shellfish producing and receiving states, FDA, the molluscan shellfish industry, and the National Marine Fisheries Service of the U.S. Department of Commerce.

Key deficiency

- A condition or practice which may result in adulterated, decomposed, misbranded or unwholesome product.

Label

- Any written, printed or graphic matter affixed to or appearing upon any package containing molluscan shellfish.

License

- The document issued by the Texas Parks and Wildlife Department, under the Texas Parks and Wildlife Code, Chapter 47 or Chapter 76, which authorizes a person to harvest or transport molluscan shell stock for commercial sale.

Lot of molluscan shell stock

- A single type of bulk molluscan shell stock or containers of molluscan shell stock of no more than one day's harvest from a single defined harvest area gathered by one or more harvesters.

Lot of molluscan shell stock for depuration

- Molluscan shell stock harvested from a particular area during a single day's harvest and delivered to one depuration plant.

Lot of shucked molluscan shellfish

- A collection of containers of no more than one day's shucked molluscan shellfish product produced under conditions as nearly uniform as possible, and designated by a common container code or marking.

Marina

- Any water area with a structure (docks, basin, floating docks, etc.) which is:

(A)

used for docking or otherwise mooring vessels; and

(B)

constructed to provide temporary or permanent docking space for more than ten boats.

Marine Biotoxin

- Any poisonous compound produced by marine microorganisms and accumulated by molluscan shell stock. Examples include Alexandrium spp . ( Proto gonyaulax species), and Gymnodinium breve .

Market shellfish

- Molluscan shellfish which are, may be, or have been harvested and/or prepared for sale for human consumption as a fresh or frozen product.

May

- Discretionary and is not mandatory or required.

Molluscan shellfish

- All species of:

(A)

oysters, clams or mussels, whether:

(i)

shucked or in the shell;

(ii)

fresh or frozen; and

(iii)

whole or in part.

(B)

scallops in any form, except when the final product form is the adductor muscle only.

Monoculture

- The culture of a single molluscan shellfish species.

MPN

- Most probable number.

Open area

- A molluscan shellfish growing area where the harvesting for sale, harvesting for transplant, or gathering for depuration of molluscan shellfish is allowed. An open area status may be placed on any one of the classified area designations except for a prohibited area.

Open water aquaculture

- The cultivation of molluscan shellfish in natural molluscan shellfish harvest areas.

Other deficiency

- A condition or practice that is not defined as critical or key, but is of a public health significance and, if left uncorrected, could result in a more serious violation.

Pack (packing)

- All activities involved in placing molluscan shellfish in containers.

Person

- Any individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind, government or governmental subdivision or agency, partnership, association, corporation or other legal entity.

Poisonous or deleterious substance

- A toxic substance occurring naturally or added to the environment for which a regulatory tolerance limit or action level has been established in molluscan shellfish to protect public health.

Polyculture

- The cultivation of:

(A)

two or more species of molluscan shellfish; or

(B)

molluscan shellfish with other species in a common environment.

Potable water

- A water supply which is suitable for human consumption. Principal display panel - The part of a label that is most likely to be displayed, presented, shown or examined under customary conditions of retail sale.

Process batch

- A quantity of molluscan shell stock used to fill each separate tank or a series of tanks supplied by a single process water system for a specified depuration cycle in a depuration activity.

Process water

- The water used in the scheduled depuration process.

Prohibited area

- A classification used to identify a harvest area where the harvest of molluscan shell stock for any purpose, except depletion or gathering of seed for aquaculture, is not permitted.

Repacker (RP)

- Any person, other than the original certified shucker-packer, who repackages shucked molluscan shellfish into other containers.

Repacking molluscan shell stock

- The practice of removing molluscan shell stock from containers and placing it into other containers.

Restricted area

- A classification used to identify a harvest area where harvesting shall be by special license and the molluscan shell stock, following harvest, is subjected to a suitable and effective treatment process through transplanting or gathering for depuration.

Safe materials

- Articles manufactured from or composed of materials that may not reasonably be expected to, directly or indirectly, become a component of or otherwise adversely affect the characteristics of any food.

Sanitation control record

- Records that document the monitoring of sanitation practices and conditions.

Sanitize

- To adequately treat food contact surfaces by a process that is effective in:

(A)

destroying vegetative cells of microorganisms of public health significance;

(B)

substantially reducing the numbers of other undesirable microorganisms; and

(C)

not adversely affecting the product or its safety for the consumer.

Seed -

Molluscan shell stock which is less than market size.

Sewage

- Refuse liquids or waste matter, including hand sink drainage.

Sewer

- An artificial, usually subterranean, conduit to carry off sewage and/or surface water.

Sewerage

- The removal and disposal of sewage and surface water by sewers.

Shell stock

- Live molluscan shellfish in the shell.

Shell stock packing

- The process of placing molluscan shell stock into containers for introduction into commerce.

Shellstock Shipper (SS)

- A dealer who grows, harvests, buys, or repacks and sells molluscan shell stock. They are not authorized to shuck molluscan shellfish nor to repack shucked molluscan shellfish. A shell stock shipper may also ship shucked molluscan shellfish.

Shucked shellfish

- Molluscan shellfish, whole or in part, from which one or both shells have been removed.

Shucker/Packer (SP)

- A person who shucks and packs molluscan shellfish. A shucker-packer may act as a shellstock shipper or may repack molluscan shellfish originating from other certified dealers.

SSD

- The Seafood Safety Division of the Texas Department of Health to which responsibility to classify molluscan shellfish growing areas and to regulate harvesting, processing, and/or shipping of molluscan shellfish is delegated.

Take

- Catch, hook, net, snare, trap, kill, or capture by any means, including the attempt to take.

TDA

- The Texas Department of Agriculture, 1700 North Congress, Austin, Texas, 78701, or its successor state agency having responsibility for enforcement of laws concerning licensing of aquaculture.

TNRCC

- The Texas Natural Resource Conservation Commission, 12100 Park 35 Circle, Austin, Texas, 78758, or its successor state agency having the responsibility for the enforcement of laws concerning water supplies and discharges of water or wastewater in Texas.

TPWD

- The Texas Parks and Wildlife Department, 4200 Smith School Road, Austin, Texas, 78744, or its successor state agency having the responsibility for the enforcement of laws concerning harvesting and depletion of molluscan shellfish resources.

Transaction record

- The form or forms used to document each purchase or sale of molluscan shellfish at the wholesale level, and includes molluscan shellfish harvest and sales records, ledgers, purchase records, invoices and bills of lading.

Transplant (transplanting)

- To transfer molluscan shell stock from a harvest area classified as restricted or conditionally restricted or from a conditionally approved area in the closed status to a harvest area classified as approved or conditionally approved for the purpose of reducing pathogens as measured by the coliform indicator group or poisonous or deleterious substances that may be present in the molluscan shell stock by using the ambient environment as the treatment process.

Water closet

- A toilet bowl and its accessories surrounded by walls or partitions.

Wet storage

- The temporary storage, by a dealer, of molluscan shell stock from harvest areas in the approved classification or in the open status of the conditionally approved classification in containers or floats in natural bodies of water or in tanks containing natural or synthetic seawater.

§241.51. Growing Area Classification.

The authority conferred on the commissioner by the Health and Safety Code, §436.101 is delegated to the bureau chief of the Bureau of Food and Drug Safety or his/her designee under the provisions of the Health and Safety Code, §436.003(a). The bureau chief shall:

(1)

designate coastal water (as defined in the rules of the Texas Parks and Wildlife Department, 31 Texas Administrative Code, Chapter 51) for the purposes of taking molluscan shellfish as:

(A)

an approved area;

(B)

a conditionally approved area;

(C)

a restricted area;

(D)

a conditionally restricted area; or

(E)

a prohibited area.

(2)

designate classified growing areas as open areas or closed areas.

§241.52.Shell Stock Transplanting and Gathering for Depuration.

(a)

Any person who wants to transplant molluscan shell stock from a harvest area classified as conditionally approved, restricted, or conditionally restricted shall make application to the TPWD for a permit to transplant molluscan shell stock.

(b)

No person may transplant molluscan shell stock without a valid transplant permit from the TPWD.

(c)

Each person who transplants molluscan shell stock shall provide the following information to the department:

(1)

the source of the molluscan shell stock;

(2)

the quantity of molluscan shell stock;

(3)

the destination private oyster lease of the molluscan shell stock; and

(4)

the date the transplant permit expired or was canceled.

(d)

No person shall harvest transplanted molluscan shell stock until the molluscan shell stock has been in waters meeting the approved area criteria for a minimum consecutive period of 14 days.

(e)

Any person, firm, or corporation engaging wholly or part-time in the business of gathering molluscan shellfish from areas designated by the department for delivery to a controlled depuration plant shall be required to hold a current permit issued specifically for this purpose by the TPWD, with a copy in the files of the department.

(f)

Permits for gathering for depuration shall be granted only subject to the following conditions.

(1)

All gathering and transporting of molluscan shellfish for depuration must be accomplished between sunrise and sunset as set by the National Weather Service for that locale.

(2)

All boats and vehicles used to gather or transport molluscan shellfish for depuration shall be conspicuously marked in a manner established by the TPWD. All boats or vehicles so marked shall be thoroughly cleaned and sanitized and the marking removed prior to use for harvesting or transporting treated molluscan shellfish or other molluscan shellfish approved for harvest or sale.

(3)

Molluscan shellfish gathered for depuration shall not be containerized in any manner resembling normal sales of molluscan shell stock from approved harvest areas. Containers used for normal sales of molluscan shell stock from approved areas shall not be stored on any boat or vehicle used to gather or transport molluscan shellfish for depuration. Containers of untreated molluscan shell stock shall be tagged or labeled as NOT FOR HUMAN CONSUMPTION.

(4)

A copy of the TPWD permit shall be kept on board the vessel at all times during gathering and transporting of molluscan shell stock for depuration.

(5)

All gathering and transporting of molluscan shellfish for depuration shall be conducted under the immediate surveillance of a commissioned officer of the TPWD, or other commissioned officer as provided by law. The responsibility for obtaining this surveillance rests with the depuration plant owner or operator. A commissioned officer shall be present for every ten gatherers or gathering boats or for any portion of 10 gatherers or boats working for any single depuration plant. An officer shall not concurrently serve as surveillance officer for more than one depuration plant. Separate surveillance officers shall be present for gatherers from the same plant working concurrently in more than one geographic area. The surveillance officer shall have all molluscan shell stock under his or her control at all times during transport from the gathering area to the depuration plant. The surveillance officer shall prepare a report stating the gathering area(s), species, and quantity of molluscan shellfish gathered each day by each gatherer under his or her surveillance. One copy of the report shall accompany the molluscan shell stock to the depuration plant and be maintained in the plant files for not less than one year. One copy of the report shall be forwarded to the Texas Department of Health, Seafood Safety Division, 1100 West 49th Street, Austin, Texas 78756.

(6)

All molluscan shellfish gathered under authority of a depuration permit shall be delivered only to the depuration plant specified in the permit, on the day gathered, and shall be depurated or disposed of as waste.

(7)

Molluscan shellfish gathered for depuration shall be protected at all times during gathering and transporting to prevent contamination and undue stress.

(g)

Vessels and all other equipment coming in contact with molluscan shell stock during handling or transport for transplant or depuration shall be thoroughly cleaned before the vessels or equipment are used to transport or handle molluscan shellfish for direct marketing.

§241.53.Molluscan Shellfish Aquaculture.

(a)

The following activities are exempted from the requirements in this section:

(1)

hatcheries;

(2)

nursery products which do not exceed 10% of the market weight; and

(3)

nursery products which are 6 months or more growing time from market size.

(b)

Aquaculture encompasses both open water and land based monoculture and polyculture.

(c)

Any person who performs open water aquaculture or operates an aquaculture facility to raise molluscan shellfish for human consumption shall obtain:

(1)

a permit(s) or authorization from the department, GLO, TPWD, TDA, and/or TNRCC for the activity or for construction and functioning of his facility;

(2)

a harvester's license; and

(3)

certification as a dealer, where necessary.

(d)

Molluscan shellfish aquaculture shall be practiced only in strict compliance with the provisions of the authorization issued by the department for the aquaculture activity. Authorization shall be based on the aquaculturist's written operational plan.

(e)

Prior to beginning his activity, an aquaculturist shall obtain the permission of the department for use of his site and any construction.

(f)

Water quality at any site used for open water or land based aquaculture shall meet the criteria for the approved, conditionally approved, restricted or conditionally restricted classification.

(g)

Molluscan shellfish cultured in any open water or land based system meeting the criteria for the approved classification of a harvest area throughout the culture period may be immediately marketed.

(h)

Any molluscan shellfish raised in aquaculture shall be subjected to relaying or depuration prior to direct marketing if the culture area or facility is located in or using water which is in:

(1)

the closed status of the conditionally approved classification;

(2)

the restricted classification; or

(3)

the open status of the conditionally restricted classification.

(i)

Only drugs sanctioned by the FDA may be used for molluscan shellfish treatment.

(j)

Harvesting, processing, storage, and shipping requirements for molluscan shellfish raised in aquaculture shall be the same as the requirements for wild molluscan shellfish specified in this chapter of this title (relating to Molluscan Shellfish).

(k)

Complete and accurate records shall be maintained for at least two years by the aquaculturist and shall include the:

(1)

source of molluscan shellfish, including seed if the seed is from harvest areas which are not in the approved classification;

(2)

dates of transplanting and harvest; and

(3)

water source, its treatment method, if necessary, and its quality in land based systems.

(l)

Seed may come from any growing area, or from any harvest area in any classification, provided that:

(1)

the source of the seed is approved by the department;

(2)

seed from growing areas or harvest areas in the restricted or prohibited classification has acceptable levels of poisonous or deleterious substances; and

(3)

seed from growing areas or harvest areas in the prohibited classification is cultured for a minimum of six months.

§241.54.Land Based Aquaculture.

(a)

Operational plan. Each land based aquaculture facility shall have a written operational plan. The plan shall be approved by the department prior to its implementation and shall include:

(1)

a description of the design and activities of the culture facility;

(2)

the specific site and boundaries in which molluscan shellfish culture activities will be conducted;

(3)

the types and locations of any structures, including rafts, pens, cages, nets, tanks, ponds, or floats which will be placed in the waters;

(4)

the species of molluscan shellfish to be cultured and harvested;

(5)

if appropriate, the source and species of other organisms to be cultured in any polyculture systems;

(6)

procedures to assure that no poisonous or deleterious substances are introduced into the activities;

(7)

a program of sanitation, maintenance, and supervision to prevent contamination of the final molluscan shellfish products;

(8)

a description of the water source, including the details of any water treatment process or method, if necessary;

(9)

a program to maintain water quality, which includes collection of microbial water samples and their method of analysis and routine temperature and salinity monitoring. The bacterial indicator monitored shall be the same as used for monitoring harvest areas;

(10)

collection of information on the microbial and chemical quality of molluscan shellfish harvested from the aquaculture site;

(11)

collection of data concerning the quality of food production (algae or other) used in the artificial harvest system;

(12)

maintenance of the required records; and

(13)

how molluscan shell stock will be harvested, processed if applicable, and sold.

(b)

Water systems.

(1)

If the aquaculture system is of continuous flow through design, water from a harvest area classified as approved, or in the open status of the conditionally approved classification at all times molluscan shellfish are held, may be used without treatment.

(2)

Water used in land based aquaculture incorporating a closed or recirculating system shall:

(A)

not contaminate molluscan shellfish with residues that would render the product adulterated;

(B)

come from a source meeting the restricted classification criteria at a minimum;

(C)

be maintained, at a minimum, at the bacteriological quality of the restricted classification; and

(D)

be measured at least five times per year.

(3)

If the water in the closed or recirculating system meets the criteria for the conditionally approved classification, the operational plan, prior to molluscan shell stock harvest, shall require, at a minimum:

(A)

collection of three water samples from the tank at least three days apart over a 14 day period; and

(B)

a fecal coliform density of less than 14 MPN per 100 ml in each water sample collected from the holding tank.

(c)

Molluscan shell stock quality.

(1)

Molluscan shell stock cultured in any system meeting the criteria for the approved classification throughout the culture period may be used in direct marketing.

(2)

If the water in a closed or recirculating system is classified as conditionally approved and in the open status, and if the water quality meets a fecal coliform level of less than 14 MPN per 100 ml in each sample collected in the 14 days prior to harvest, the molluscan shell stock may be used in direct marketing.

(3)

Molluscan shell stock cultured in a closed or recirculating system which does not meet the requirements of §241.5(3)(A) and (B) shall be relayed or depurated prior to direct marketing.

§241.55. Polyculture Systems.

(a)

A polyculture system shall:

(1)

meet all requirements in §241.54 of this title (relating to Land Based Aquaculture;

(2)

provide information concerning all sources of and species of all organisms to be cultivated, cultured, and harvested.

(b)

A polyculture system shall include in its operational plan requirements to:

(1)

monitor for human pathogens, animal drugs, and/or other poisonous or deleterious substances that might be associated with polyculture activities; and

(2)

subject all harvested molluscan shell stock to relaying or depuration if human pathogens, animal drugs, and/or other poisonous or deleterious substances exist at levels of public health significance.

§241.56. Molluscan Shell Stock Harvesting and Handling.

(a)

Harvesters. Any harvester who engages in molluscan shell stock packing as defined in this chapter of this title (relating to Molluscan Shellfish) shall:

(1)

be a dealer; or

(2)

pack molluscan shell stock for a dealer.

(b)

Vessels.

(1)

The dealer shall not accept molluscan shell stock unless all vessels used to harvest and transport molluscan shell stock are properly constructed, operated and maintained to prevent contamination, deterioration and decomposition of the molluscan shell stock.

(A)

Decks and storage bins shall be constructed and located to prevent bilge water or polluted overboard water from coming into contact with the molluscan shell stock.

(B)

Bilge pump discharges shall be located so that the discharge shall not come into contact with the molluscan shell stock.

(C)

Bags or other containers used for storing molluscan shell stock shall be clean and fabricated from safe materials.

(D)

Boat decks and storage bins used in the harvest or transport of molluscan shell stock for direct marketing shall be:

(i)

kept clean with potable water or water from a harvest area in the approved classification or in the open status of the conditionally approved classification; and

(ii)

constructed so that water does not stand on the deck or in the storage bin.

(E)

Coverings shall be provided on harvest boats to protect molluscan shell stock from exposure to adverse conditions.

(2)

Cats, dogs, and other animals shall not be allowed on vessels.

(c)

Disposal of human sewage from vessels.

(1)

Human sewage shall not be discharged overboard from a vessel used in the harvesting of molluscan shell stock or from vessels which buy molluscan shell stock, but only into an appropriate sewage disposal system.

(2)

An approved marine sanitation device (MSD), portable toilet or other sewage disposal receptacle shall be provided on the vessel to contain human sewage.

(3)

Portable toilets shall:

(A)

be used only for the purpose intended;

(B)

be secured while on board and located to prevent contamination of molluscan shell stock by spillage or leakage;

(C)

be emptied only into an appropriate sewage disposal system;

(D)

be cleaned and sanitized before being returned to the boat; and

(E)

be cleaned only in equipment which is not used for washing or processing food.

(4)

Use of other receptacles for sewage disposal may be approved by department if the receptacles are:

(A)

constructed of impervious and cleanable materials; and

(B)

meet the requirements in subsection (c)(3) of this section.

(d)

Molluscan shell stock washing.

(1)

Molluscan shell stock shall be washed reasonably free of bottom sediments as soon after harvesting as practicable.

(2)

The harvester shall be primarily responsible for washing the molluscan shell stock.

(3)

If molluscan shell stock washing is not feasible at the time of harvest, the dealer shall assume this responsibility.

(4)

Water used for molluscan shell stock washing shall be obtained from:

(A)

a potable water source; or

(B)

a harvest area in the:

(i)

approved classification; or

(ii)

in the open status of the conditionally approved classification.

(5)

If the harvester or dealer elects to use tanks or a water system to wash molluscan shell stock, the molluscan shell stock washing activity shall be constructed, operated, and maintained in compliance with an approved HACCP plan in accordance with §241.60 of this title (relating to General HACCP Requirements) and §241.61 of this title (relating to General Sanitation Requirements).

(e)

Molluscan shell stock identification.

(1)

Each harvester shall affix a tag to each bag or container of molluscan shell stock which shall be in place while the molluscan shell stock is being transported to a dealer.

(2)

If the molluscan shell stock is harvested at more than one location, each container shall be tagged at its harvest area.

(3)

When the harvester is also the dealer, the harvester has the option to tag the molluscan shellfish with a harvester's tag or a dealer's tag meeting the requirements outlined in §241.56(e) of this title (relating to Molluscan Shell Stock Identification).

(4)

The harvester's tags shall:

(A)

be durable, waterproof and approved by the department prior to use; and

(B)

be at least 2-5/8 by 5-1/4 inches (6.7 by 13.3 cm) in size.

(5)

The harvester's tag shall contain the following indelible, legible information in the order specified:

(A)

the commercial oyster boat captain's license number (issued by TPWD), the captain's name, and any one of the following:

(i)

the oyster boat license number;

(ii)

the boat state registration number; or

(iii)

the documented boat name;

(B)

the date of harvest;

(C)

the most precise identification of the harvest location as is practicable including the initials of the state of harvest, and any department designation of the harvest area by indexing, administrative or geographic designation;

(D)

when the molluscan shell stock has been in wet storage in a dealer's operation, the statement: "THIS PRODUCT IS A PRODUCT OF (NAME OF STATE) AND WAS WET STORED AT (FACILITY CERTIFICATION NUMBER) FROM (DATE) TO (DATE)";

(E)

the type and quantity of molluscan shell stock; and

(F)

the following statement in bold capitalized type on each tag "THIS TAG IS REQUIRED TO BE ATTACHED UNTIL CONTAINER IS EMPTY OR IS RETAGGED AND THEREAFTER KEPT ON FILE FOR 90 DAYS."

(6)

Molluscan shell stock harvested during the period April 1 through October 31 that will not be refrigerated within the Time-To-Refrigeration guidelines required in §241.58 of this title (relating to Molluscan Shell Stock Temperature Control) shall not be harvested before 6:00 a.m. and shall be placed under refrigeration as designated in §241.58 of this title by 8:00 p.m. each day and shall be identified, stored, and processed separately from molluscan shell stock that is refrigerated within these Time-To-Refrigeration guidelines.

(7)

Molluscan shell stock harvested and held exempt from the Time-To-Refrigeration guidelines in paragraph (6) of this subsection shall:

(A)

be tagged with a harvester tag meeting all other requirements that shall also be over stamped on both sides with the words "FOR SHUCKING BY A CERTIFIED DEALER" in ink that shall be neon green in color in letters at least one-half inch in height. This special harvester tag shall be placed on each container of molluscan shell stock at the conclusion of harvesting of this exempt molluscan shell stock and before harvesting of any other molluscan shell stock. This special harvester tag shall remain attached to each container until the molluscan shell stock is shucked;

(B)

not be commingled with any other molluscan shellfish and shall be stored separately on harvest boats and at any certified location; and

(C)

be shucked and placed in containers bearing the consumer information language adopted by the ISSC, or an equivalent approved in writing by the SSD prior to use, unless the invoice and bill of lading for shipment of this exempt molluscan shell stock to another dealer both contain the following statement: "FOR SHUCKING BY A CERTIFIED DEALER". All dealer tags attached to such molluscan shell stock shall be over stamped identical to the harvester tag.

(8)

If the molluscan shell stock is removed from the original bag or container, the tag on the new bag or container shall meet the requirements in subsection (e) of this section.

(f)

Harvester records.

(1)

Each harvester who harvests molluscan shell stock during the period April 1 - October 31 shall maintain records for each date molluscan shell stock is harvested that show the time the first molluscan shell stock is harvested, the time harvesting ends, and the time molluscan shell stock is unloaded from the boat.

(2)

If molluscan shell stock is harvested and held exempt from the Time-To-Refrigeration guidelines in subsection (e) of this section, the harvester records shall also include the time that harvesting of this exempt molluscan shell stock ends and the time that harvesting of other molluscan shell stock begins.

(3)

These records shall be provided to the dealer with the molluscan shell stock and shall be maintained as part of the dealer's records.

(g)

Any molluscan shellfish in possession of a person holding a valid license issued by TPWD under Texas Parks and Wildlife Code, Chapter 47 or Chapter 76, shall be considered to be harvested for human consumption and offered for sale for food in Texas.

(h)

Harvesters shall:

(1)

be responsible for control of their molluscan shell stock until acceptance by a dealer;

(2)

sell their molluscan shell stock only to a currently certified shellfish dealer;

(3)

be required to deliver their molluscan shell stock to a dealer within the day the molluscan shell stock is harvested. For this purpose, a day shall be considered to be a 24 hour period from 12:00 a.m. to 12:00 a.m. the next day. Delivery of the molluscan shell stock means packing the molluscan shell stock into an approved container, transfer of the molluscan shell stock from the boat to a certified location, and acceptance of the molluscan shell stock by the dealer; and

(4)

be required to transport molluscan shell stock on ice or at air temperatures of 45 degrees Fahrenheit or less if the time from unloading the boat until the product is accepted by a dealer and placed under refrigeration at a certified location will exceed two hours.

(i)

If the harvester transports molluscan shell stock other than by boat to a certified location, the harvest boat captain must accompany the molluscan shell stock until acceptance by the dealer.

(j)

It is illegal for harvesters to sell molluscan shell stock directly to the public.

§241.57.Certification Requirements.

(a)

No person shall engage in any activity requiring a certificate in §§241.50-241.67 of this title (relating to Molluscan Shellfish) without having applied for and obtained an annual numbered certificate of compliance pertaining to the particular activity from the department. No certificate will be issued without a HACCP plan in accordance with §241.60 of this title (relating to General HACCP Requirements) which is acceptable to the SSD.

(b)

Dealer certification.

(1)

Shucker/packer. Any person who shucks molluscan shellfish shall be certified as a shucker/packer.

(2)

Repacker.

(A)

Any person who repacks shucked molluscan shellfish shall be certified as a shucker/packer or repacker.

(B)

Any person who repacks molluscan shell stock shall be certified as a shellstock shipper, shucker/packer, or repacker.

(C)

A repacker shall not shuck molluscan shellfish.

(3)

Shellstock shipper. Any person who ships and receives molluscan shell stock in interstate commerce shall be certified as a shellstock shipper, repacker, or shucker/packer.

(c)

Each dealer shall have a Texas business address at which inspections of facilities, activities, equipment, or records can be made.

(d)

Each dealer shall accept molluscan shellfish only if they are taken from areas approved by the department, or obtained from sources outside the State of Texas which are approved by the department. If obtained from sources outside of the State of Texas, the molluscan shellfish must be from areas approved by the appropriate state or other government authorities having jurisdiction and must be obtained from dealers currently certified by the appropriate state or other government authority. Molluscan shellfish obtained from sources other than those outlined in this section shall not be sold, offered for sale, or held for sale.

(e)

Each dealer shall pay the oyster sales fee as assessed by the Texas Health and Safety Code, §436.103. The fee is established at $1.00 per barrel of oyster shell stock. One barrel shall be equal to three containers (sacks, bushels, boxes, etc.) of oyster shell stock. Each container of oyster shell stock shall not weigh more than 100 pounds. Any container weighing more than 100 pounds shall be counted as two containers for purposes of computing the oyster sales fee owed.

(f)

Prior to beginning construction of a new molluscan shellfish processing plant, or major remodeling of an existing molluscan shellfish processing plant (which includes, but is not limited to: any process new to that particular plant; any change of product flow; or any enlarging of the plant structure) complete, legible plans showing the floor plan of the building, with dimensions drawn to scale, location of equipment, doors, floor drains, etc., and written, complete operational procedures for all phases of the activity, including flow of the product, shall be submitted to the SSD for review and approval. Additional plans of the entire premises may be required showing all structures, as well as, all water wells and septic systems with related distances and a statement of specifications as to type, sizes, design, date installed, etc. Plans shall be submitted no less than 30 days prior to initiating a new process or beginning construction. No operations shall be conducted while any inside plant construction or any other construction which has the potential to contaminate the product is occurring. A legibly written or typed application for certification on forms provided by the department must be filed with the SSD each year.

(g)

The application for a shucker/packer or repacker certificate must be accompanied by a written statement of the procedure the applicant will use to determine the SELL BY date for molluscan shellfish packed and shipped from the location listed in the application.

(h)

A certificate and unique number shall be issued by the department only after an inspection of the plant by an authorized agent has revealed that the plant and practices are in compliance with these sections. A certificate and unique number shall be issued to a dealer for each location at which molluscan shellfish operations are to be conducted and a certificate is required.

(i)

The inspection of a previously certified plant which has exhibited operational problems or violations of operational requirements of these sections or had a certificate of compliance revoked shall not be conducted until written, complete operational procedures for all phases of the activity, including flow of the product, are submitted to the SSD for review and approval. An application may be rejected and a certificate of compliance denied based on a history of failure to comply with the requirements of these sections.

(j)

Molluscan shellfish operations by the dealer shall not begin until the department has issued the certificate for that location. Each certificate shall expire automatically at 11:59 p.m. on August 31st following the date of issue. Certificates shall not be transferable.

(k)

After a certificate is issued, unannounced inspections may be conducted at any time the SSD has reason to believe the business may be in operation or that molluscan shellfish may be stored on the premises and at such frequency as may be necessary to assure that adequate operational and sanitary conditions are maintained. All molluscan shellfish at a certified location shall be the responsibility of the dealer at that location, for the purposes of these sections. A copy of the completed inspection form listing written descriptions of the violations observed along with any necessary explanation shall be provided by an authorized agent of department to the most responsible individual present at the firm at the conclusion of the inspection. Any violations of the same requirement found on a consecutive inspection may result in certificate suspension in accordance with subsection (l) of this section. Molluscan shellfish inspections and the SSD forms shall comply with the requirements established in the current National Shellfish Sanitation Program.

(1)

When an inspection detects a critical deficiency the violation shall be corrected during that inspection or the plant must cease production affected by the violation. If production affected by the violation does not voluntarily cease, all molluscan shellfish handled or processed while the violation exists or existed shall be detained pursuant to Health and Safety Code, §436.028.

(2)

When an inspection detects four or more key deficiencies, the dealer shall establish a correction schedule acceptable to the SSD. Follow-up inspection shall determine if the violations have been corrected or are being corrected in accordance with the scheduled correction dates noted on the previous inspection report.

(3)

When an inspection detects other deficiencies or three or less key deficiencies, the deficiencies shall be corrected prior to the next routine inspection.

(l)

The SSD may initiate procedures to suspend or revoke a certificate of compliance as follows.

(1)

The procedures shall be in accordance with the Texas Health and Safety Code, §436.114 and the provisions of the Government Code, Chapter 2001, Administrative Procedure Act, and department formal hearing procedures in Chapter 1 of this title (relating to the Texas Board of Health).

(2)

The grounds for suspension or revocation or assessment of administrative penalties may be any one or more of the following:

(A)

inspection results indicate unsatisfactory conditions in the plant or the existence of a public health hazard;

(B)

the certificate holder or representative refuses to allow an inspection or otherwise interferes with the authorized department agent in the performance of his or her duties; or

(C)

the certificate holder does not have a HACCP plan, has a HACCP plan unacceptable to the SSD, or fails to comply with a HACCP plan which is acceptable to the SSD.

(m)

A dealer whose certificate has been suspended may not process any molluscan shellfish for a period determined by the commissioner.

(n)

A dealer whose certificate has been suspended may not process any molluscan shellfish until the SSD is satisfied that all necessary corrections have been made. A suspension will not be rescinded until an inspection establishes that the firm has corrected all violations which resulted in the suspension and is in full compliance with all applicable criteria of these sections.

(o)

A certificate may be revoked for any of the reasons outlined in subsection (l) of this section or for either of the following: if the violations initiating a suspension fail to be corrected within the time frame established, or if a history of repeated suspensions exists. A dealer whose certificate has been revoked may not be issued a new certificate for 180 days or before the next certification period, whichever is longer, after the date of signing of the final order of revocation. When the department contemplates suspension or revocation, the certificate holder shall be afforded the opportunity for a hearing. Notice of the contemplated action shall be given to the certificate holder by personal service or certified mail, return receipt requested. If no request for a hearing is received by the director of the SSD, within 14 days of personal service or the date of receipt of the notice by the dealer, the allegations contained in the notice are admitted as true, and the department may proceed to take the action set out in the notice.

(p)

When the department determines that administrative penalties are appropriate, proposals for assessment of and hearings on administrative penalties shall be made in accordance with the Texas Health and Safety Code, §436.034; the Government Code, Chapter 2001, Administrative Procedure Act; and the department formal hearing procedures in Chapter 1 of this title. When the department contemplates administrative penalties, the certificate holder or harvester shall be afforded the opportunity for a hearing. Notice of the contemplated action shall be given to the certificate holder or harvester by personal service or certified mail, return receipt requested. If no request for a hearing is received by the director of the SSD, within 14 days of personal service or the date of receipt of the notice by the dealer, the allegations contained in the notice are admitted as true, and the department may proceed to take the action set out in the notice.

(q)

The seriousness of violations shall be categorized by one of the following severity levels. The examples following the severity levels are neither exhaustive nor controlling. They reflect only the seriousness of the violation and not the intent of the violator, the history of the violator, the amount necessary to deter future violations, or efforts to correct the violation.

(1)

Severity Level I - Violations that are of minor public health significance. The following are examples of severity level I violations (other deficiency):

(A)

failure to keep premises clean and have adequate drainage;

(B)

failure to clean and maintain floors, walls, or ceilings;

(C)

failure to provide adequate and properly shielded lighting;

(D)

failure to post hand washing signs at hand washing stations;

(E)

failure to provide blower air intake with approved filter;

(F)

failure to prohibit use of "dip" buckets to rinse hands or knifes;

(G)

failure to use returnable containers only within the plant; and

(H)

failure to restrict shuckers from the packing room and all unauthorized persons from processing areas when operating.

(2)

Severity Level II - Violations that are of more than minor significance, or if left uncorrected, could result in more serious violations. The following are examples of severity level II violations (other deficiency):

(A)

failure to provide or use storage for employee clothing or personal articles;

(B)

failure to have clean, maintained, adequately drained floor;

(C)

failure to provide adequate heating/cooling/ventilation;

(D)

failure to provide adequate quantity of water to facility;

(E)

failure to provide hand washing stations with soap, sanitary towels, and/or waste receptacles with proper lids;

(F)

failure to properly construct, locate, maintain, and/or keep clean all non-food contact surfaces;

(G)

failure to provide detergents, approved sanitizers, brushes, and/or a sanitizer test kit to properly clean and sanitize the facility;

(H)

failure to properly store and/or keep clean single service containers;

(I)

failure to maintain frozen molluscan shellfish at 0 degrees Fahrenheit or less;

(J)

failure to require employees to wear clean outer garments, impermeable gloves/finger cots; to store these items properly; and/or to wear proper hair restraints;

(K)

failure to promptly remove empty molluscan shells or other accumulation; and

(L)

failure to meet plumbing code and/or install water disposal correctly or have adequate drainage where operations discharge water.

(3)

Severity Level III - Violations that are significant and which, if not corrected, could threaten public health. The following are examples of severity level III violations (key deficiency):

(A)

failure to exclude insects, rodents, vermin, and any other animals;

(B)

failure to provide hot and cold water at each sink and lavatory;

(C)

failure to protect plumbing from backflow, backsiphonage, and/or cross contamination;

(D)

failure to have toilets clean, repaired, and/or have self-closing doors;

(E)

failure to properly use, store, separate, and/or label poisonous/toxic materials;

(F)

failure to properly construct, locate, clean, and/or maintain food contact surfaces;

(G)

failure to provide a temperature measuring device in each refrigeration unit;

(H)

failure to wash molluscan shell stock reasonably free of bottom sediments and detritus as soon after harvesting as feasible;

(I)

failure of employees to wash/sanitize hands and/or exhibit good hygienic practices;

(J)

failure to restrict any personnel with infections that may be transmitted through the molluscan shellfish from participating in molluscan shellfish operations; and

(K)

failure to maintain complete and accurate records.

(4)

Severity Level IV - Violations that have a significant adverse impact on public health. The following are examples of severity level IV violations (key deficiency):

(A)

failure to separate operations by partition, space, or time;

(B)

failure to provide adequate refrigeration units;

(C)

failure to clean and sanitize food contact surfaces effectively and within required time frame;

(D)

failure to label molluscan shell stock or properly complete label;

(E)

failure to protect molluscan shell stock from contamination;

(F)

failure to pack into containers with a valid certificate number for that location; comply with label requirements; and/or to use proper date;

(G)

failure to promptly shuck, pack, and protect molluscan shellfish; and

(H)

failure to have responsible, effective, designated person as supervisor.

(5)

Severity Level V - Violations that are most significant and create an imminent hazard to public health. The following are examples of severity level V violations (critical deficiency):

(A)

failure to cease operations when location/plant is flooded;

(B)

failure to protect the water supply from contamination;

(C)

failure to install and/or maintain adequate sewage disposal system;

(D)

failure to process molluscan shellfish from only an approved source;

(E)

failure to maintain molluscan shell stock at the proper temperature;

(F)

failure to obtain approval for wet storage operation;

(G)

failure to keep molluscan shellfish from becoming contaminated;

(H)

failure to cool packed molluscan shellfish to 45 degrees Fahrenheit within two hours of delivery to the packing room;

(I)

failure to maintain packed molluscan shellfish at 45 degrees Fahrenheit or less during storage, repacking, and to cover in ice; and

(J)

failure to provide sanitary ice and/or properly protect it.

(r)

The department may impose differing levels of penalties for different severity level violations.

(1)

Administrative penalties shall be imposed for Severity Level III, IV and V violations. Administrative penalties may be assessed for Severity Level I and II violations when they are combined with those of higher severity level(s) or for repeated violations which could have been prevented by corrective action and for which the dealer or harvester did not take effective corrective action.

(2)

Tables IA and IB show the base administrative penalties and the percentage of base amounts to be proposed based on severity level of violation.

Figure 1: 25 TAC §241.57(r)(2)

Figure 2: 25 TAC §241.57(r)(2)

(3)

Adjustments to the values in Tables IA and IB in paragraph (2) of this subsection may be made for the presence or absence of the following factors:

(A)

prompt identification and reporting;

(B)

corrective action to prevent recurrence;

(C)

compliance history;

(D)

prior notice of similar event; and

(E)

multiple occurrences.

(4)

The penalty may be in an amount not to exceed $25,000 a day for each violation for a person who violates the Health and Safety Code Chapter 436, or a rule in this chapter of this title (relating to Molluscan Shellfish), or an order of the department. Each day a violation continues may be considered a separate violation for purposes of penalty assessment.

(s)

The department may offer a certificate holder or harvester the opportunity to attend a settlement conference to discuss with the SSD, methods and schedules for correcting the violation(s) or to show compliance with applicable provisions of the Health and Safety Code Chapter 436, the rules in this chapter of this title (relating to Molluscan Shellfish), certificate conditions, and any orders of the department issued thereunder, or discuss all such topics. The Office of General Counsel may conduct settlement negotiations.

(t)

Notices of any settlement conference shall be sent by personal service or certified mail, return receipt requested. A settlement conference is not a prerequisite for the action to be taken under subsections (l), (m), (n), (o), or (p) of this section.

(u)

By acceptance of a certificate, the holder agrees to save, hold harmless, and indemnify the State of Texas, the department, and its employees against any and all liability, claims or losses for property damage or personal injury which result in whole or in part from the certificate holder's activities. The State of Texas shall not be held liable for financial losses incurred by the molluscan shellfish transplanters, gatherers, harvesters, plant supervisors, or plant owners due to failure of molluscan shellfish activity, condemnation of molluscan shellfish, loss of molluscan shellfish, or other reasons.

§241.58. Molluscan Shell Stock Temperature Control.

(a)

Molluscan shell stock intended for consumption as raw product shall be placed under ambient refrigeration at 45 degrees Fahrenheit (7.2 degrees Centigrade) or less within the hours specified below:

(1)

20 hours for the months of November, December, January, February, and March;

(2)

14 hours for the month of April; and

(3)

for the months of May through October, as established by the department based on the current Time-To-Refrigeration guidelines adopted by the ISSC.

(b)

The Time-To-Refrigeration guidelines shall be based upon the first molluscan shell stock harvested each day.

(c)

The Time-To-Refrigeration guidelines established for each month shall be in effect from 12:01 a.m. of the first day of the month until 11:59 p.m. of the last day of the month.

(d)

The department may approve other measures proposed by the industry to provide controls equivalent to the Time-To-Refrigeration guidelines matrix.

§241.59.Trucks or Other Vehicles Used to Transport Molluscan Shell Stock to the Original Dealer.

(a)

The harvester or dealer who transports molluscan shell stock from the harvester to the first dealer to handle the product, shall assure that all trucks used to transport molluscan shell stock are properly constructed, operated, and maintained to prevent contamination, deterioration, and decomposition.

(b)

Storage bins on trucks or other vehicles used in the transport of molluscan shell stock for direct marketing shall be:

(1)

kept clean with potable water or water from an approved area or conditionally approved area in the open status; and

(2)

constructed so that water does not stand on the deck or in the storage bin.

(c)

Molluscan shell stock shall be transported in air temperatures inside the truck or other vehicle of 45 degrees Fahrenheit (7.2 degrees Centigrade) or less.

(d)

Mechanical refrigeration units shall be:

(1)

equipped with automatic controls; and

(2)

capable of maintaining the ambient air temperature in the storage area at temperatures of 45 degrees Fahrenheit (7.2 degrees Centigrade) or less.

(e)

Any ice used to cool molluscan shell stock during transport shall be produced and handled in compliance with the sanitation standard operating procedures in accordance with §241.61 of this title (relating to General Sanitation Requirements).

(f)

Cats, dogs, and other animals shall not be allowed in any part of the truck or other vehicle where molluscan shell stock is stored.

§241.60. General HACCP Requirements.

(a)

Every dealer shall conduct a hazard analysis to determine the food safety hazards that are reasonably likely to occur for each kind of molluscan shellfish product processed by that dealer and to identify the preventive measures that the dealer can apply to control those hazards. Such food safety hazards can be introduced both within and outside the processing plant environment, including food safety hazards that can occur before, during, and after harvest. A food safety hazard that is reasonably likely to occur is one for which a prudent dealer would establish controls because experience, illness data, scientific reports, or other information provide a basis to conclude that there is a reasonable possibility that it will occur in the particular type of molluscan shellfish product being processed in the absence of those controls.

(b)

Every dealer shall have, implement, and comply with a written HACCP plan which is acceptable to the SSD. A copy of the plan shall be provided to the SSD upon request. A HACCP plan shall be specific to:

(1)

each location where molluscan shellfish products are processed by that dealer; and

(2)

each kind of molluscan shellfish product processed by the dealer. The plan may group kinds of molluscan shellfish products together, or group kinds of production methods together, if the food safety hazard, critical control points, critical limits, and procedures required to be identified and performed in this section are identical for all molluscan shellfish products so grouped or for all production methods so grouped.

(c)

The HACCP plan shall, at a minimum:

(1)

list the food safety hazards that are reasonably likely to occur, as identified in accordance with subsection (a) of this section and that must be controlled for each molluscan shellfish product. Consideration should be given to whether any food safety hazards are reasonably likely to occur as a result of the following:

(A)

natural toxins;

(B)

microbiological contamination;

(C)

chemical contamination;

(D)

pesticides;

(E)

drug residues;

(F)

unapproved use of direct or indirect food or color additives; and

(G)

physical hazards.

(2)

list the critical control points for each of the identified food safety hazards, including as appropriate:

(A)

critical control points designed to control food safety hazards introduced outside the processing plant environment, including food safety hazards that occur before, during, and after harvest. If the dealer can demonstrate to the department through a hazard analysis that the food safety hazard is not reasonably likely to occur or is otherwise controlled, the critical control point is not required; and

(B)

critical control points designed to control food safety hazards that could be introduced in the processing plant environment. If the dealer can demonstrate to the department through a hazard analysis that the food safety hazard is not reasonably likely to occur, the critical control point is not required;

(3)

list the critical limits that must be met at each of the critical control points;

(4)

list the procedures, and frequency thereof, that will be used to monitor each of the critical control points to ensure compliance with the critical limits;

(5)

include any corrective action plans that have been developed in accordance with this section to be followed in response to deviations from critical limits at critical control points;

(6)

list the verification procedures, and frequency thereof, that the dealer will use in accordance with this section. The records shall contain the actual values and observations obtained during monitoring; and

(7)

provide for a record keeping system that documents the monitoring of the critical control points. The records shall contain the actual values and observations obtained during monitoring.

(d)

The HACCP plan shall be signed and dated by the most responsible individual on site at the processing facility or by a higher level official of the dealer:

(1)

upon initial acceptance;

(2)

upon any modification; and

(3)

upon verification of the plan in accordance with subsection (g)(1)(A) of this section.

(e)

Sanitation controls may be included in the HACCP plan. However, to the extent that they are monitored in accordance with §241.61 of this title (relating to General Sanitation Requirements), they need not be included in the HACCP plan, and vice versa.

(f)

Corrective Actions.

(1)

Whenever a deviation from a critical limit occurs, a dealer shall take corrective action either by:

(A)

following a corrective action plan that is appropriate for the particular deviation; or

(B)

following the procedures in subsection (f) of this section.

(2)

Dealers may develop written corrective action plans, which become part of their HACCP plans in accordance with subsection (c)(5) of this section, by which they predetermine the corrective actions that they will take whenever there is a deviation from a critical limit. A corrective action plan that is appropriate for a particular deviation is one that describes the steps to be taken and assigns responsibility for taking those steps, to ensure that:

(A)

no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation; and

(B)

the cause of the deviation is corrected.

(3)

When a deviation from a critical limit occurs and the dealer does not have a corrective action plan that is appropriate for that deviation, the dealer shall:

(A)

segregate and hold the affected product, at least until the requirements of subsections (f)(3)(B) and (C) of this section are met;

(B)

perform or obtain a review to determine the acceptability of the affected product for distribution. The review shall be performed by an individual or individuals who have adequate training or experience to perform such a review. Adequate training may or may not include training in accordance with this section;

(C)

take corrective action, when necessary, with respect to the affected product to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation;

(D)

take corrective action, when necessary, to correct the cause of the deviation; and

(E)

perform or obtain timely reassessment by an individual or individuals who have been trained in accordance with this section to determine whether the HACCP plan needs to be modified to reduce the risk of recurrence of the deviation, and modify the HACCP plan as necessary.

(4)

All corrective actions taken in accordance with this section shall be fully documented in records that are subject to verification in accordance with subsection (g) of this section and the record keeping requirements of subsection (h) of this section.

(g)

Verification.

(1)

Every dealer shall verify that the HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, and that the plan is being effectively implemented. Verification shall include, at a minimum:

(A)

a reassessment of the adequacy of the HACCP plan whenever any changes occur that could affect the hazard analysis or alter the HACCP plan in any way or at least annually. The reassessment shall be performed by an individual or individuals who have been trained in accordance with subsection (i) of this section. The HACCP plan shall be modified immediately whenever a reassessment reveals that the plan is no longer adequate to fully meet the requirements of subsection (c) of this section. These changes may include:

(i)

raw materials or source of raw materials;

(ii)

product formulation;

(iii)

processing methods or systems;

(iv)

finished product distribution systems; or

(v)

the intended use or consumers of the finished product.

(B)

ongoing verification activities including:

(i)

a review of any consumer complaints that have been received by the dealer to determine whether they relate to the performance of critical control points or reveal the existence of unidentified critical control points;

(ii)

the calibration of process-monitoring instruments; and

(iii)

at the option of the dealer, the performing of periodic end-product or in-process testing.

(C)

a review, including signing and dating, by an individual who has been trained in accordance with subsection (i) of this section, of the records that document:

(i)

the monitoring of critical control points. The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that they document values that are within the critical limits. This review shall occur within one week of the day that the records are made;

(ii)

the taking of corrective actions. The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that appropriate corrective actions were taken in accordance with subsection (f) of this section. This review shall occur within one week of the day that the records are made; and

(iii)

the calibrating of any process monitoring instruments used at critical control points and the performing of any periodic end-product or in-process testing that is part of the dealer's verification activities. The purpose of these reviews shall be, at a minimum, to ensure that the records are complete, and that these activities occurred in accordance with the processor's written procedures. These reviews shall occur within a reasonable time after the records are made.

(2)

Dealers shall immediately follow the procedures in subsection (f) of this section, whenever any verification procedure, including the review of a consumer complaint, reveals the need to take a corrective action.

(3)

The calibration of process-monitoring instruments, and the performing of any periodic end-product and in-process testing, in accordance with (g)(1)(B)(ii) and (iii) of this section shall be documented in records that are subject to the record keeping requirements of subsection (h) of this section.

(h)

Records.

(1)

All records required shall include:

(A)

the name and location of the dealer;

(B)

the date and time of the activity that the record reflects;

(C)

the signature or initials of the person performing the operation; and

(D)

where appropriate, the identity of the product and the production code, if any. Processing and other information shall be entered on records at the time that it is observed.

(2)

All records required shall be retained at the processing facility for at least one year after the date they were prepared in the case of refrigerated products and for at least two years after the date they were prepared in the case of frozen products.

(3)

Records that relate to the general adequacy of equipment or processes being used by a processor, including the results of scientific studies and evaluations, shall be retained at the processing facility for at least two years after their applicability to the product being produced at the facility.

(4)

If the processing facility is closed for a prolonged period between seasonal operations, or if record storage capacity is limited on a processing vessel or at a remote processing site, the records may be transferred to some other reasonably accessible location at the end of the seasonal operations, but shall be immediately produced for official review upon request.

(5)

All records required by subsection (h) of this section and HACCP plans required by subsections (b) and (c) of this section shall be available for official review and copying at reasonable times.

(6)

Tags on containers of molluscan shell stock are not subject to the requirements of this section unless they are used to fulfill the requirements of record keeping.

(7)

The maintenance of records on computers is acceptable, provided that appropriate controls are implemented to ensure the integrity of the electronic data and electronic signatures.

(i)

Training.

(1)

At a minimum, the following functions shall be performed by an individual who has successfully completed training in the application of HACCP principles to molluscan shellfish processing at least equivalent to that received under standardized curriculum recognized as adequate by the FDA or who is otherwise qualified through job experience to perform these functions:

(A)

developing a HACCP plan, which could include adapting a model or generic-type HACCP plan that is appropriate for a specific processor, in order to meet the requirements of subsection (c) of this section;

(B)

reassessing and modifying the HACCP plan in accordance with the corrective action procedures specified in subsection (f)(3)(E) of this section, and the HACCP plan in accordance with the verification activities specified in subsection (g)(1)(B) of this section; and

(C)

performing the record review required by subsection (g)(1)(C) of this section.

(2)

Job experience will qualify an individual to perform these functions if it has provided knowledge at least equivalent to that provided through the standardized curriculum as determined by the SSD.

(3)

The trained individual need not be an employee of the dealer.

§241.61.General Sanitation Requirements.

(a)

Each dealer shall have written sanitation standard operating procedures. A copy of the procedures shall be provided to the SSD upon request. Each dealer shall monitor conditions and practices that are both appropriate to the plant and the food being processed with sufficient frequency to ensure, at a minimum, conformance with the requirements specified in §229.183(a)(2) of this title (relating to Minimum Standards for Licensure) concerning current good manufacturing practice in manufacturing, processing, packing, or holding human food. Copies are indexed and filed in the offices of the SSD, and are available for inspection during normal working hours. The requirements specified in §229.183(a)(2) of this title relate to the following sanitation items:

(1)

safety of water for processing and ice production;

(2)

condition and cleanliness of food contact surfaces;

(3)

prevention of cross contamination;

(4)

maintenance of hand washing, hand sanitizing and toilet facilities;

(5)

protection from adulterants;

(6)

proper labeling, storage, use of toxic compounds;

(7)

control of employees with adverse health conditions; and

(8)

exclusion of pests.

(b)

Each dealer shall maintain sanitation control records that, at a minimum, document the monitoring and corrections prescribed by subsection (a) of this section. These records are subject to the requirements of §241.60(h) of this title (relating to General HACCP Requirements).

(c)

Sanitation controls may be included in the HACCP plan, required by §241.60(b) of this title. However, to the extent that they are monitored in accordance with subsection (a) of this section, they need not be included in the HACCP plan, and vice versa.

§241.62. Dealer Molluscan Shell Stock Identification.

(a)

The dealer shall keep the harvester's tag affixed to each container of molluscan shell stock until the bag or container is:

(1)

shipped; or

(2)

emptied to wash, grade or pack the molluscan shell stock.

(b)

Unless the dealer is also the harvester and has already placed a dealer tag on the container, the dealer shall affix his tag to each container of molluscan shell stock prior to shipment.

(c)

The dealers' tags shall:

(1)

be durable, waterproof and approved by the department prior to use; and

(2)

be at least 2-5/8 by 5-1/4 inches (6.7 by 13.3 cm) in size.

(d)

The dealer's tag shall contain the following indelible, legible information in the order specified below:

(1)

the dealer's name and address;

(2)

the dealer's certification number as assigned by the department and the original shellstock shipper's certification number;

(3)

the date of harvest;

(4)

the most precise identification of the harvest location as is practicable including the initials of the state of harvest, and any department designation of the harvest area by indexing, administrative or geographic designation;

(5)

when the molluscan shell stock has been in wet storage in a dealer's operation, the tag shall state: "THIS PRODUCT IS A PRODUCT OF (NAME OF STATE) AND WAS WET STORED AT (FACILITY CERTIFICATION NUMBER) FROM (DATE) TO (DATE)";

(6)

the type and quantity of molluscan shell stock; and

(7)

the following statements in bold capitalized type on each tag:

(A)

"THIS TAG IS REQUIRED TO BE ATTACHED UNTIL CONTAINER IS EMPTY AND THEREAFTER KEPT ON FILE FOR 90 DAYS"; and

(B)

the consumer information statement adopted by the ISSC or its equivalent as approved by the SSD.

(e)

When both the dealer and harvester tags appear on the container, the dealer's tag is not required to duplicate the information on the harvester's tag.

(f)

If the molluscan shell stock is removed from the original container, the tag on the new container shall meet the requirements of this section.

(g)

When the molluscan shell stock is removed from the original container, the dealer shall:

(1)

keep the harvester tag for 90 days unless records maintained as part of the HACCP plan provide the necessary information to track product to the original harvest location;

(2)

track the harvest area and date of harvest for the molluscan shell stock; and

(3)

maintain the lot identity of all molluscan shell stock during any intermediate stage of processing.

§241.63. Shucked Molluscan Shellfish Labeling.

(a)

If the dealer uses reusable containers to hold or transport shucked molluscan shellfish between activities for the purpose of further processing or packing, the reusable containers are exempt from the labeling requirements in this section. When reusable containers are used, the lot shall be accompanied by a record containing:

(1)

the shuckers-packer's name and certification number;

(2)

the shucking date; and

(3)

the quantity of molluscan shellfish per container and the total number of containers.

(b)

If the dealer uses master shipping cartons, the master cartons are exempt from these labeling requirements when the individual containers within the carton are properly labeled.

(c)

The dealer shall assure that each individual package containing fresh or frozen shucked molluscan shellfish meat is labeled in a legible and indelible form in accordance with applicable federal and state regulations concerning:

(1)

information on the principal display panel; and

(2)

the standard of identity.

(d)

The dealer shall assure that each package containing less than 64 fluid ounces of fresh or frozen molluscan shellfish shall have:

(1)

the shucker-packer's or repacker's certification number on the label; and

(2)

a "SELL BY DATE" which provides a reasonable subsequent shelf-life or the words "BEST IF USED BY" followed by a date when the product would be expected to reach the end of its shelf-life. The date shall consist of the abbreviation for the month and number of the day of the month. For frozen molluscan shellfish, the year will be added to the date.

(e)

The dealer shall provide a "DATE SHUCKED" on all containers of shucked molluscan shellfish with a capacity of 64 fluid ounces (1873 ml) or more. The "DATE SHUCKED" shall:

(1)

for fresh molluscan shellfish, consist of the number of the day of the year (Julian date) or the month and the number of the day of the month;

(2)

for frozen molluscan shellfish, include the year; and

(3)

appear on the lid and either the sidewall or bottom of durable containers; or

(4)

appear on the lid or sidewall of disposable containers.

(f)

The dealer shall label all frozen molluscan shellfish as frozen in type of equal prominence immediately adjacent to the name of the molluscan shellfish.

(g)

If the dealer thaws and repacks frozen molluscan shellfish, the dealer shall label the molluscan shellfish container as previously frozen.

(h)

The dealer shall provide all label information in a legible and indelible form.

(i)

Shucked Molluscan Shellfish. If the dealer elects to repack molluscan shellfish, the dealer shall pack and label all molluscan shellfish in accordance with this section except that the original date of shucking shall be used as the "DATE SHUCKED" or in establishing the "SELL BY DATE".

§241.64.Labeling of Molluscan Shellfish Post-Harvest Processed to Reduce Vibrio vulnificus .

(a)

A dealer may elect to use a process to reduce Vibrio vulnificus levels in molluscan shellfish.

(1)

The dealer shall:

(A)

have a HACCP plan acceptable to the department for the process which includes:

(i)

an end point criteria for the process as non-detectable (<3 MPN/gram) using the FDA approved EIA procedure of Tamplin, et al, as detailed in Chapter 9 of the FDA Bacteriological Analytical Manual, 7th edition, 1992; and

(ii)

a sampling program to demonstrate that the end point criteria is met.

(B)

package and label all molluscan shellfish in accordance with the requirements in this chapter of this title (relating to Molluscan Shellfish) including labeling all molluscan shellfish which has been subjected to the process but which is not frozen in accordance with the molluscan shell stock labeling requirements in §241.62 of this title (relating to Dealer Molluscan Shell Stock Identification); and

(C)

keep records in accordance with the requirements in this chapter of this title (relating to Molluscan Shellfish).

(b)

A dealer who meets the requirements of this section may label product which has been subjected to the reduction process as "Processed to reduce Vibrio vulnificus to non-detectable levels".

§241.65.Shipping Documents and Records.

(a)

Each molluscan shellfish shipment shall be accompanied by a shipping document which contains:

(1)

the name, address, and certification number of the shipping dealer;

(2)

the name and address of the major consignee; and

(3)

the kind and quantity of the molluscan shellfish product.

(b)

The receiving dealer shall:

(1)

maintain in his files a copy of the completed shipping document; and

(2)

make the shipping document available to the department upon request.

(c)

If the shipment is subdivided to different dealers, each receiving dealer shall maintain records sufficient to trace his portion back to the original shipment.

(d)

Each dealer shall have a business address at which transaction records are maintained.

(e)

Each dealer shall maintain complete, accurate and legible records of department required information in a form authorized by the department.

(f)

Transaction records shall be sufficient to:

(1)

document that the molluscan shellfish are from a source authorized under this chapter of this title (relating to Molluscan Shellfish);

(2)

permit a container of molluscan shellfish to be traced back to the specific incoming lot of shucked molluscan shellfish from which it was taken; and

(3)

permit a lot of shucked molluscan shellfish or a lot of molluscan shell stock to be traced back to the harvest area, date of harvest, and if possible, the harvester or group of harvesters.

(g)

Purchases and sales shall be recorded:

(1)

in a permanently bound ledger book; or

(2)

using other recording methods acceptable to and authorized by the department.

(h)

The transaction records shall be retained:

(1)

in the case of fresh molluscan shellfish, for a minimum of one year; and

(2)

in the case of frozen molluscan shellfish, for at least two years or the shelf-life of the product, whichever is longer.

(i)

If computer records are maintained, the department shall approve the format and its use.

§241.66. Tagging of Depurated Molluscan Shellfish.

All containers of treated molluscan shellfish, before being released from the molluscan shellfish treatment plant, shall be suitably tagged or labeled with a uniform tag or label bearing the following information:

(1)

the depuration processor's name and address, including at least the city and state;

(2)

the depuration processor's valid, complete certificate number issued by the Seafood Safety Division (SSD);

(3)

the type of molluscan shell stock;

(4)

the date on which the molluscan shellfish were released from the depuration plant;

(5)

the term "Depurated" in letters as large as the largest other letters printed on the tag or label; and

(6)

the lot code of the treatment process batch.

§241.67. Depuration Records.

(a)

Records containing the following information shall be available at the depuration plant at all times for molluscan shellfish presently undergoing the treatment process:

(1)

name and/or location of gathering area(s);

(2)

copy of permit(s);

(3)

date received;

(4)

quantity of molluscan shellfish received;

(5)

quantity of molluscan shellfish destroyed;

(6)

quantity of molluscan shellfish in tank(s); and

(7)

date and time of initiation of treatment.

(b)

Records containing the following information shall be available at the depuration plant at all times for each lot of molluscan shellfish for which the treatment process has been completed for a period of one year from the date of treatment:

(1)

name and/or location of gathering area(s);

(2)

copy of permit(s);

(3)

date received in plant;

(4)

quantity of molluscan shellfish received;

(5)

quantity of molluscan shellfish destroyed;

(6)

date and time of initiation of treatment;

(7)

date and time of termination of treatment;

(8)

number of hours treated;

(9)

quantity of molluscan shellfish treated;

(10)

quantity of molluscan shellfish destroyed after treatment;

(11)

all laboratory results as specified;

(12)

date released from plant; and

(13)

quantity of molluscan shellfish released.

(c)

The plant supervisor or assistant plant supervisor shall send to the Texas Department of Health, Seafood Safety Division, 1100 W. 49th Street, Austin, Texas 78756, on a weekly basis, a copy of the daily records required in this section and the laboratory analysis results of all molluscan shellfish and water samples completed during each weekly period.

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 January 21, 1998.

TRD-9801018

Susan K. Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: March 8, 1998

For further information, please call: (512) 458-7236