SUMMARY SHEET
SOUTH CAROLINA BOARD OF HEALTH AND ENVIRONMENTAL CONTROL
June 29, 2022
( ) ACTION/DECISION
( X ) INFORMATION
I. TITLE: Healthcare Quality Administrative and Consent Orders.
II. SUBJECT: Healthcare Quality Administrative Orders and Consent Orders for the period of
April 1, 2022, through April 30, 2022.
III. FACTS: For the period of April 1, 2022, through April 30, 2022, Healthcare Quality reports
one (1) Administrative Order and seven (7) Consent Orders totaling $33,300 in assessed monetary
penalties.
Name of
Bureau
Facility, Service,
Provider, or
Equipment Type
Administrative
Orders
Consent
Orders
Assessed
Penalties
Required
Payment
Community
Care
Community Residential
Care Facility (CRCF)
1 2 $15,000 $15,000
Radiological
Health
Radioactive Material
Industrial Licensee
0 1 $5,000 $5,000
Chiropractic X-Ray
Facility
0 1 $1,700 $425
Dental X-Ray Facility 0 1 $1,700 $425
Medical X-Ray Facility 0 1 $9,000 $2,250
Healthcare
Systems and
Services
Paramedic 0 1 $900 $900
TOTAL 1 7 $33,300 $24,000
Submitted By:
Gwen C. Thompson
Deputy Director
Healthcare Quality
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HEALTHCARE QUALITY ENFORCEMENT REPORT
SOUTH CAROLINA BOARD OF HEALTH AND ENVIRONMENTAL CONTROL
June 29, 2022
Bureau of Community Care
Facility Type
Total Number of
Licensed Facilities
Total Number of
Licensed Beds
Community Residential Care Facility (CRCF) 475
21,698
1. Pageland Care Facility – Pageland, SC
Inspections and Investigations: The Department conducted complaint investigations in February 2021 and
September 2021, a routine inspection in May 2021, and routine follow-up inspections in July 2021, October
2021, and November 2021, and found the facility violated regulatory requirements.
Violations: The Department found the facility violated Regulation 61-84, Standards for Licensing
Community Residential Care Facilities, by failing to have documentation of a criminal background check
for a staff member and by not conducting a criminal background check for a staff member prior to
employment. The Department further found the facility failed to:
• Render care and services in accordance with orders from physicians for administering medications.
• Complete annual physical examinations for a resident.
• Have residents’ physician-ordered medications available for administration.
• Properly initial the medication administration records (MARs) as medications were administered.
• Have documented reviews of the MARs at each shift change by outgoing staff members with
incoming staff members.
• Maintain records of receipt, administration, and disposition of all controlled substances in sufficient
detail to enable an accurate reconciliation.
• Have documented reviews of the control sheets at each shift change by outgoing staff members
with incoming staff members.
• Have a written plan to be implemented to ensure the continuation of essential resident support
services.
• Promote conditions that prevent the spread of infectious, contagious, and/or communicable
diseases in compliance with guidelines from the Centers for Disease Control and Prevention
(CDC).
• Have documentation of the second step of a staff member’s two-step Tuberculin Skin Test (TST).
• Ensure a resident admitted with only the first step of the TST completed the second step within 14
days of admission.
• Ensure the facility was free of vermin and offensive odors.
• Ensure that each specific interior area of the facility was clean.
Moreover, the facility failed to maintain plumbing fixtures that require hot water at a temperature between
100 degrees Fahrenheit and 120 degrees Fahrenheit.
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Enforcement Action: The parties agreed to resolve the matter with a consent order. The parties executed a
consent order imposing a civil monetary penalty of $12,000 against the facility. The facility was required
to pay the assessed monetary penalty within thirty (30) days after the execution of the Consent Order.
Remedial Action: The facility has made the required payment, in full, totaling $12,000.
Prior Orders: None in the last five (5) years.
2. MIRCI Group Home I – Columbia, SC
Inspections and Investigations: The Department conducted an investigation in August 2021 and found the
facility violated regulatory requirements.
Violations: The Department found the facility violated Regulation 61-84, Standards for Licensing
Community Residential Care Facilities, by failing to implement its policies and procedures regarding
“Abuse, Neglect, and Exploitation of Persons Served and Crisis Intervention Engagement.” Moreover, the
facility failed to ensure a resident was treated with dignity and respect as defined by the Bill of Rights for
Residents of Long-Term Care Facilities, S.C. Code Section 44-81-40(G).
Enforcement Action: The parties agreed to resolve the matter with a consent order. The parties executed a
consent order imposing a civil monetary penalty of $3,000 against the facility. The facility was required to
pay the assessed monetary penalty within thirty (30) days after the execution of the Consent Order.
Remedial Action: The facility has made the required payment, in full, totaling $3,000.
Prior Orders: None in the last five (5) years.
3. Oakridge Community Care Home #1 – Inman, SC
Inspections and Investigations: On February 14, 2022, the South Carolina Attorney General’s Office,
Medicaid Fraud Control Unit (MFCU), notified the Department regarding the arrest of the administrator
for multiple counts of committing neglect and exploitation of vulnerable adults as well as breach of trust
with fraudulent intent. Upon this notification from the MFCU, the Department inspected the facility. The
Department observed and cited regulatory violations as a result of the inspection.
Violations: The Department found the facility violated Regulation 61-84, Standards for Licensing
Community Residential Care Facilities, by failing to have documentation of criminal background checks
for newly hired staff members. The Department further found the facility failed to:
• Have documentation of accurate and current information for staff members, to include personal,
work, and training background.
• Have in writing assigned duties and responsibilities for all staff members and direct care volunteers
in writing.
• Have documentation of initial and/or annual basic first-aid training for all staff members.
• Have documentation of initial and/or annual vital sign training for the designated staff members.
• Have documentation of initial and/or annual contagious and/or communicable disease training for
all staff members.
• Have documentation of initial and/or annual medication training for all staff members.
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• Have documentation of initial and/or annual specific care training for all staff members.
• Have documentation of initial and/or annual use of restraint techniques training for all staff
members.
• Have documentation of initial and/or annual OSHA standards regarding blood-borne pathogens
training for all staff members.
• Have documentation of initial and/or annual CPR training for the designated staff members.
• Have documentation of initial and/or annual confidentiality of resident information and records for
all staff members.
• Have documentation of initial and/or annual Bill of Rights for Residents of Long-Term Care
Facilities training for all staff members.
• Have documentation of initial and/or annual fire response training for all staff members.
• Have documentation of initial and/or annual emergency procedures and disaster preparedness
training for all staff members.
• Have documentation of initial and/or annual activity training for the designated staff members.
• Have health assessments, including two-step Tuberculin Skin Tests, for staff members.
• Render care and services in accordance with physicians’ orders.
• Have available medications, including controlled substances, and medical supplies as ordered by
physicians.
• Properly initial Medication Administration Records (MARs) as medications were administered.
• Have documented review of MARs at each shift change.
• Ensure all medications were kept in the original containers or packaging.
• Ensure that expired medications were not stored with current medications.
• Maintain records of controlled substances in sufficient detail to enable an accurate reconciliation.
• Have documented reviews of the controlled sheets at each shift change.
• Ensure that food prepared on-site complied with the requirements of Regulation 61-25, Retail Food
Establishments.
• Maintain all equipment and building components in good repair and operating condition.
• Ensure the facility was clean and free from vermin and offensive odors.
• Ensure each interior area of the facility was clean.
• Ensure all exterior areas of the facility were clean.
• Store linen and clothing in a manner to prevent contamination.
Moreover, the facility failed to ensure liquid soap and a sanitary mean of drying hands were provided in
each lavatory used by more than one resident and by allowing communal use of bar soap.
Enforcement Action: On February 15, 2022, the Department issued an emergency suspension order
immediately suspending the license of Oakridge #1 based upon its determination that conditions and
practices existed that constituted an immediate threat to the health, safety, and welfare of the residents.
Pursuant to S.C. Code Section 44-7-320(A)(3), the South Carolina Administrative Law Court (ALC) held
a hearing on February 18, 2022, to determine whether the immediate threatening conditions and practices
continued to exist. On March 1, 2022, the ALC issued its order upholding the emergency suspension. By
certified letter dated March 14, 2022, the Department notified the facility that it was considering an
enforcement action. The Department requested the facility attend an enforcement conference on March 29,
2022, to discuss the violations. The facility did not appear at the March 29, 2022, enforcement conference.
As a result of the foregoing, the Department decided to issue an administrative order revoking the facility’s
license.
Remedial Action: All thirty-seven (37) residents were relocated as of February 17, 2022.
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Prior Orders: The Department took enforcement action against the facility in October 2017. The parties
agreed to resolve the matter with a consent order imposing a monetary penalty of $15,000. The facility
agreed to pay $7,500 of the assessed monetary penalty within thirty (30) days of execution of the Consent
Order. The remaining $4,500 was held in abeyance upon a six-month substantial compliance period. The
facility attended a compliance assistance meeting with the Department.
The Department issued an administrative order against the facility in January 2022 based on several
repeated regulatory violations. The Administrative Order required the facility to pay a civil monetary
penalty of $19,000 within 30 days of the issuance of the Administrative Order. The facility did not pay the
$19,000 civil monetary penalty.
Bureau of Radiological Health
License Type Total Number of Licensees
Radioactive Material Industrial Licensee
136
4. S&ME, Inc. – Mount Pleasant, SC
Inspections and Investigations: On August 31, 2021, the Department was notified that one of the licensee’s
vehicles was stolen while containing licensed radioactive material. The Department conducted an
investigation of the licensee in September 2021 and found the licensee violated regulatory requirements.
Violations: The Department found the licensee failed to comply with Regulation 61-63, Radioactive
Materials (Title A), by failing to control and maintain constant surveillance of material not in storage and
located in an unrestricted area. The licensee’s authorized gauge user stopped and pulled the vehicle to the
side of the road to inspect an item in the area and got out of the vehicle while it was still running. The gauge
user then proceeded to walk approximately seventy-five feet (75 ft.) away from the vehicle to inspect the
item in the area. As the gauge user was performing the inspection, he heard the vehicle rapidly accelerating
behind him and saw that the vehicle had been taken from the side of the road. The vehicle was recovered
later that day along with the licensed radioactive material. The licensee inspected the licensed radioactive
material and determined that it had not been tampered with nor were there any signs of damage.
Enforcement Action: The parties agreed to resolve the matter with a consent order. The parties executed a
consent order imposing a civil monetary penalty of $5,000 against the licensee. The licensee was required
to pay the assessed penalty within thirty (30) days of execution of the Consent Order.
Remedial Action: The licensee has made the required payment, in full, totaling $5,000.
Prior Orders: None in the past five (5) years.
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Registrant Type Total Number of Registered Facilities
Chiropractic X-Ray Facility
492
5. Gittens Chiropractic Clinic, PA. – Florence, SC
Inspections and Investigations: The Department conducted a routine inspection of the registrant in July
2021 and found the registrant violated regulatory requirements.
Violations: The Department found the registrant failed to comply with Regulation 61-64, X-rays (Title B),
by failing to conduct performance testing on medical radiographic x-ray systems annually, a repeat
violation. The registrant failed to conduct equipment performance testing for 2019 and 2020.
Enforcement Action: The parties agreed to resolve the matter with a consent order. The parties executed a
consent order imposing a civil monetary penalty of $1,700 against the registrant. The registrant was required
to pay $425 of the assessed monetary penalty within thirty (30) days of executing the Consent Order. The
remaining balance of $1,275 is stayed upon the timely payment of the $425 and a 24-month compliance
period.
Remedial Action: The registrant has made the required payment, in full, totaling $425.
Prior Orders: None in the past five (5) years.
Registrant Type Total Number of Registered Facilities
Dental X-Ray Facility
1,797
6. Dental Implant Centre – Mount Pleasant, SC
Inspections and Investigations: The Department conducted a routine inspection of the registrant in July
2021 and found the registrant violated regulatory requirements.
Violations: The Department found the registrant failed to comply with Regulation 61-64, X-rays (Title B),
by failing to conduct equipment performance testing on dental x-ray systems (excluding dental computed
tomography and dental hand-held systems) biennially, a repeat violation. The registrant failed to conduct
equipment performance testing on the dental intraoral x-ray systems in 2011, 2016, and 2018.
Enforcement Action: The parties agreed to resolve the matter with a consent order. The parties executed a
consent order imposing a civil monetary penalty of $1,700 against the registrant. The registrant was required
to pay $425 of the assessed monetary penalty within thirty (30) days of executing the Consent Order. The
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remaining balance of $1,275 is stayed upon the timely payment of the $425 and a 36-month compliance
period.
Remedial Action: The registrant has made the required payment, in full, totaling $425.
Prior Orders: None in the past five (5) years.
Registrant Type Total Number of Licensed Facilities
Medical X-Ray Facility
932
7. R. Bauer Vaughters III, MD, Inc. – Aiken, SC
Inspections and Investigations: The Department conducted a routine inspection of the registrant in June
2021 and found the registrant violated regulatory requirements.
Violations: The Department found the registrant failed to comply with Regulation 61-64, X-rays (Title B),
by failing to assure operation of its bone density x-ray system by technicians certified by the South Carolina
Quality Standards Association, a repeat violation. The registrant allowed non-certified persons to operate
the bone density x-ray system.
Enforcement Action: The parties agreed to resolve the matter with a consent order. The parties executed a
consent order imposing a civil monetary penalty of $9,000. The registrant was required to pay $2,250 of
the assessed monetary penalty within thirty (30) days of executing the Consent Order. The remaining
balance of $6,750 is stayed pending timely payment of the required $2,250.
Remedial Action: The registrant has made the required payment, in full, totaling $2,250.
Prior Orders: None in the past five (5) years.
Bureau of Healthcare Systems and Services
Level of Certification Total Number of Certified Paramedics
Paramedic
4,131
8. Timothy Godwin – Paramedic
Inspections and Investigations: The Department conducted an investigation in May 2021 and found that the
paramedic was in violation of regulatory requirements.
8
Violations: The Department determined that the paramedic was in violation of Regulation 61-7, Emergency
Medical Services, for committing misconduct, as defined in S.C. Code Section 44-61-80(F)(6), by
disregarding an appropriate order by a physician concerning emergency treatment and transportation. The
paramedic failed to follow medical control protocols by not starting an intravenous fluid (IV) and
administering a fluid bolus of normal saline as indicated for a patient displaying signs and symptoms of
hyperglycemia. Mr. Godwin also committed misconduct, as defined in S.C. Code Section 44-61-80(F)(8),
while at the scene, the paramedic discontinued care or abandoned the patient without the patient’s consent
or without providing for further administration of care, by an equal or higher medical authority. Moreover,
the paramedic committed misconduct as defined in S.C. Code Section 44-61-80(F), by failing to provide a
patient medical treatment of a quality deemed acceptable by the Department, by failing to treat the patient
in accordance with protocol and by delaying patient transport to the hospital by diverting to the ambulance
station and handing the patient over to another paramedic instead of transporting the patient to the
appropriate hospital.
Enforcement Action: The parties agreed to resolve the matter with a consent order. The parties executed a
consent order assessing a monetary penalty of $900 against the paramedic. The paramedic is required to
pay the full amount of the assessed monetary penalty within thirty (30) days of execution of the Consent
Order. The paramedic agrees to successfully complete a Professional Ethics and Personal Leadership
(PEPL) class as determined by the Department and a refresher class in Advanced Cardiac Life Support
(ACLS) within six months of the execution of the Consent Order. The paramedic shall also be demoted to
an Advanced Emergency Medical Technician (AEMT) and his paramedic certification suspended for a
period of two years upon execution of the Consent Order.
Remedial Action: The paramedic made the required payment, in full, totaling $900. The paramedic has
been issued an AEMT certification. The paramedic has not yet completed the PEPL class or ACLS refresher
class.
Prior Orders: None in past five (5) years.
SUMMARY SHEET
BOARD OF HEALTH AND ENVIRONMENTAL CONTROL
June 29, 2022
_______ ACTION/DECISION
X INFORMATION
1. TITLE: Administrative and Consent Orders issued by the Office of Environmental
Affairs.
2. SUBJECT: Administrative and Consent Orders issued by the Office of Environmental
Affairs during the period April 1, 2022, through May 31, 2022.
3. FACTS: For the reporting period of April 1, 2022, through May 31, 2022, the Office of
Environmental Affairs issued seventy-five (75) Consent Orders with total assessed civil
penalties in the amount of three hundred fifty-seven thousand, three hundred forty-six
dollars and nine cents ($375,346.09). Also, sixteen (16) Administrative Orders with total
assessed civil penalties in the amount of eighty-nine thousand, nine hundred five dollars
($89,905.00) were reported during this period.
Bureau and Program
Area
Administrative
Orders
Assessed
Penalties
Assessed Penalties
Land and Waste
Management
UST Program
4
$67,605.00
$60,270.00
Aboveground Tanks
0
0
0
Solid Waste
1
$21,300.00
$2,580.00
Hazardous Waste
0
0
$21,000.00
Infectious Waste
0
0
$185,300.00
Mining
0
0
$600.00
SUBTOTAL
5
$88,905.00
$269,750.00
Water
Recreational Water
0
0
$1,080.00
Drinking Water
0
0
$2,000.00
Water Pollution
0
0
$40,266.09
Dam Safety
0
0
0
SUBTOTAL
0
0
$43,346.09
Air Quality
SUBTOTAL
0
0
$5,000.00
Environmental Health
Services
Food Safety
1
$1,000.00
$34,750.00
Onsite Wastewater
10
0
$4,500.00
SUBTOTAL
11
$1,000.00
$39,250.00
OCRM
SUBTOTAL
0
0
0
TOTAL
16
$89,905.00
$357,346.09
Submitted by:
_____________________________
Myra C. Reece
Director of Environmental Affairs
ENVIRONMENTAL AFFAIRS ENFORCEMENT REPORT
BOARD OF HEALTH AND ENVIRONMENTAL CONTROL
June 29, 2022
BUREAU OF LAND AND WASTE MANAGEMENT
Underground Storage Tank Enforcement
1) Order Type and Number: Administrative Order 21-0349-UST
Order Date: March 21, 2022
Individual/Entity: Energy Distribution, LLC
Facility: Energy Distribution
Location: 1500 Buncombe Street
Greenville, SC 29615
Mailing Address: Same
County: Greenville
Previous Orders: None
Permit/ID Number: 10885
Violations Cited: The State Underground Petroleum
Environmental Response Bank Act of 1988 (SUPERB Act), S.C. Code Ann. §§ 44-
2-10 et seq. (2018); and South Carolina Underground Storage Tank Control
Regulation, 7 S.C. Code Ann., Regs. 61-92, 280.31(c), 280.34(c), 280.35(a)(2),
280.36(a)(1)(i), 280.36(a)(1)(ii), 280.40(a), 280.40(a)(3), 280.41(b)(1)(i)(B),
280.43(d), 280.44(a), 280.45(b)(1), 280.242(b)(3), 280.242(b)(4), 280.243(c), and
280.245(2012 and Supp. 2020).
Summary: Energy Distribution, LLC (Individual/Entity) owns and operates
underground storage tanks (USTs) in Greenville County, South Carolina. On May 27,
2021, the Department conducted an inspection and issued a Notice of Alleged Violation.
The Individual/Entity has violated the SUPERB Act and South Carolina Underground
Storage Tank Control Regulation as follows: failed to inspect the impressed current system
every sixty (60) days; failed to provide records to the Department upon request; failed to
test overfill prevention equipment at least once every three (3) years to ensure the overfill
prevention equipment is set to activate at the correct level specified in Section 280.20(c);
failed to check and document monthly required equipment walkthrough inspections; failed
to check and document annually required equipment walkthrough inspections; failed to
provide an adequate release detection method; failed to annually test release detection
equipment for proper operation; failed to conduct an annual line tightness test or monitor
pressurized piping monthly; failed to conduct automatic tank gauging (ATG) properly;
failed to check line leak detector function annually; failed to maintain results of annual
operation tests for three (3) years; failed to validate that monthly requirements have been
met; failed to physically visit each assigned facility once a quarter; failed to train Class C
operators before they assume responsibility for the UST facility; and failed to designate
and list all Class C operators.
Action: The Individual/Entity is required to submit: either the most recent twelve
(12) months of ATG records for all USTs at the Facility or tank tightness test results for all
USTs at the Facility and a current passing ATG record for all USTs; line tightness test
results for all USTs; line leak detector function check test results for all USTs; release
detection operability test results for all USTs; overfill prevention equipment operability
test results for all UST overfill devices; proof an impressed current rectifier log has been
initiated and is being properly maintained; and a list of Class C Operators trained and
designated for the Facility by May 24, 2022. The Department has assessed a total civil
penalty in the amount of fourteen thousand, nine hundred seventy dollars ($14,970.00).
The Individual/Entity shall pay a civil penalty in the amount of fourteen thousand, nine
hundred seventy dollars ($14,970.00) by May 24, 2022.
Update: No Request for Review was filed; therefore, the effective date of the Order
is April 9, 2022. This will be referred to Office of General Counsel for further action.
2) Order Type and Number: Administrative Order 21-0601-UST
Order Date: March 21, 2022
Individual/Entity: Virenkumar Patel
Facility: Friarsgate Supermart
Location: 100 North Royal Tower Drive
Irmo, SC 29063-2781
Mailing Address: 236 River Bridge Lane
Lexington, SC 29073
County: Richland
Previous Orders: None
Permit/ID Number: 12482
Violations Cited: The State Underground Petroleum
Environmental Response Bank Act of 1988 (SUPERB Act), S.C. Code Ann. §§ 44-
2-10 et seq. (2018); and South Carolina Underground Storage Tank Control
Regulation, 7 S.C. Code Ann., Regs. 61-92, 280.30(a), 280.36(a)(1)(ii), 280.40(a),
280.41(b)(1)(i)(B), 280.43(d), 280.44(a), 280.93(a), and 280.110(c) (2012 and
Supp. 2020).
Summary: Virenkumar Patel (Individual/Entity) owns and operates underground
storage tanks (USTs) in Richland County, South Carolina. On June 2, 2021, the
Department conducted an inspection and issued a Notice of Alleged Violation to Rashmika
Patel. On September 14, 2021, the Department received notification that a transfer of
ownership had occurred naming Virenkumar Patel as the new owner of the USTs. The
Individual/Entity has violated the SUPERB Act and South Carolina Underground Storage
Tank Control Regulation as follows: failed to maintain spill/overfill prevention equipment;
failed to check and document annually required equipment walkthrough inspections; failed
to provide an adequate release detection method; failed to conduct annual tightness test or
have monthly monitoring of pressurized piping; failed to conduct automatic tank gauging
properly; failed to conduct annual test of automatic line leak detectors; failed to
demonstrate financial responsibility for an UST system; and failed to submit evidence of
financial assurance to the Department upon request.
Action: The Individual/Entity is required to submit: line leak detector function
check test results for the 10,000-gallon regular UST (Tank #2); line tightness test results
for the 10,000-gallon regular UST (Tank #1); current passing automatic tank gauge record
for all USTs at the Facility; proof the overfill prevention equipment for all USTs have been
repaired and/or replaced and subsequent overfill prevention equipment operability test
results for all UST overfill devices; proof a Class A/B Operator/Walkthrough Inspection
log is being properly maintained; and a completed Certificate of Financial Responsibility
form and evidence of financial assurance by May 21, 2022. The Department has assessed
a total civil penalty in the amount of eighteen thousand, nine hundred thirty-five dollars
($18,935.00). The Individual/Entity shall pay a civil penalty in the amount of eighteen
thousand, nine hundred thirty-five dollars ($18,935.00) by May 21, 2022.
Updates: No Request for Review was filed; therefore, the effective date of the
Order is April 7, 2022. Rec’d Financial Responsibility documentation. The Order will be
referred to Office of General Counsel for further action.
3) Order Type and Number: Administrative Order 21-0021-UST
Order Date: March 31, 2022
Individual/Entity: Terratec, Inc.
Facility: Terratec. Inc.
Location: 1350 Methodist Park Road
West Columbia, SC 29170
Mailing Address: Same
County: Lexington
Previous Orders: None
Permit/ID Number: 06089
Violations Cited: The State Underground Petroleum
Environmental Response Bank Act of 1988 (SUPERB Act), S.C. code Ann. § 44-
2-10 et seq. (2018); and South Carolina Underground Storage Tank Control
Regulation, 7 S.C. Code Ann., Regs 61-92, 243.65(a) (2012 & Supp 2020).
Summary: Terratec, Inc. (Individual/Entity) owns an underground storage tank in
Lexington County, South Carolina. On November 24, 2020, the Department conducted a
routine inspection and issued a Notice of Alleged Violation. The Individual/Entity violated
the SUPERB Act and the South Carolina Underground Storage Tank Regulation, as
follows: failed to provide proof the Class A/B operator designated for the Facility
completed Class A/B operator supplemental training by May 26, 2020.
Action: The Individual/Entity is required to: submit certification that the Class
A/B operator designated for the Facility has completed the Class A/B operator
supplemental. The Department has assessed a civil penalty in the amount of one thousand,
five hundred dollars ($1,500.00). The Individual/Entity shall pay a civil penalty in the
amount of one thousand, five hundred dollars ($1,500.00) by May 30, 2022.
Update: No Request for Review was filed; therefore, the effective date of the Order
is April 16, 2022.
4) Order Type and Number: Administrative Order 21-0494-UST
Order Date: April 6, 2022
Individual/Entity: Property Management VDDAB, Ltd.
Facility: Corner Stop 43 SC 671
Location: 3852 Byrnes Drive
St. Stephen, SC 29479
Mailing Address: 2216 India Hook Road
Rock Hill, SC 29732
County: Berkeley
Previous Orders: None
Permit/ID Number: 01213
Violations Cited: The State Underground Petroleum
Environmental Response Bank Act of 1988 (SUPERB Act), S.C. Code Ann. §§ 44-
2-10 et seq. (2018); and South Carolina Underground Storage Tank Control
Regulation, 7 S.C. Code Ann., Regs. 61-92, 280.31(a), 280.70(c), 280.93(a), and
280.110(c) (2012 and Supp. 2020).
Summary: Property Management VDDAB, Ltd. (Individual/Entity) owns and
operates underground storage tanks (USTs) in Berkeley County, South Carolina. On May
19 and July 30, 2021, the Department conducted a file review and issued a Notice of
Alleged Violation (NOAV). The Individual/Entity has violated the SUPERB Act and
South Carolina Underground Storage Tank Control Regulation as follows: failed to operate
and maintain corrosion protection equipment continuously; failed to permanently close a
UST system that has been temporarily out of service for greater than twelve (12) months
and does not meet current corrosion protection standards; failed to demonstrate financial
responsibility for an UST system; failed to submit evidence of financial assurance to the
Department upon request; and failed to pay annual tank registration fees (ATRFs).
Action: The Individual/Entity is required to: submit a completed Certificate of
Financial Responsibility form and evidence of financial assurance; pay ATRFs in the
amount of four hundred eighty-four dollars ($484.00); submit a completed Tank and
Sludge Disposal form for the permanent closure of the USTs at the Facility; and within
sixty (60) days after the USTs have been permanently closed, submit a Closure and
Assessment report by June 6, 2022. The Department has assessed a total civil penalty in
the amount of thirty-two thousand, two hundred dollars ($32,200.00). The
Individual/Entity shall pay a civil penalty in the amount of thirty-two thousand, two
hundred dollars ($32,200.00) by June 6, 2022.
Update: No Request for Review was filed; therefore, the effective date of the Order
is April 23, 2022. The Individual/Entity filed bankruptcy and has been dissolved. The
Order is closed, and the matter referred back to the UST Program.
5) Order Type and Number: Consent Order 21-0562-UST
Order Date: April 6, 2022
Individual/Entity: Hardwick Patel
Facility: Price Shell
Location: 1556 Whiskey Road
Aiken, SC 29801
Mailing Address: 273 Equinox Loop
Aiken, SC 29803
County: Aiken
Previous Orders: None
Permit/ID Number: 12895
Violations Cited: The State Underground Petroleum
Environmental Response Bank Act of 1988 (SUPERB Act), S.C. code Ann. § 44-
2-10 et seq. (2018); and South Carolina Underground Storage Tank Control
Regulation, 7 S.C. Code Ann., Regs 61-92, 280.26(f) (2012 & Supp 2020).
Summary: Hardwick Patel (Individual/Entity) owns underground storage tanks in
Aiken County, South Carolina. On October 1, 2021, the Department conducted an
inspection and issued a Notice of Alleged Violation. The Individual/Entity violated the
SUPERB Act and the South Carolina Underground Storage Tank Regulation, as follows:
received an illegal delivery while tank(s) were under delivery prohibition.
Action: The Individual/Entity has corrected the violations. The Department has
assessed a civil penalty in the amount of five thousand dollars ($5,000.00). The
Individual/Entity is required to pay a civil penalty in the amount of five thousand dollars
($5,000.00) by May 21, 2022.
Update: The civil penalty has been paid in full. The Order is closed.
6) Order Type and Number: Consent Order 22-0001-UST
Order Date: April 6, 2022
Individual/Entity: 7 Swami, LLC
Facility: Lynchburg Grocery
Location: 20 East Willow Grove Road
Lynchburg, SC 29080
Mailing Address: 3201 Strada Angelo
Florence, SC 29501
County: Lee
Previous Orders: None
Permit/ID Number: 17439
Violations Cited: The State Underground Petroleum
Environmental Response Bank Act of 1988 (SUPERB Act), S.C. code Ann. § 44-
2-10 et seq. (2018); and South Carolina Underground Storage Tank Control
Regulation, 7 S.C. Code Ann., Regs 61-92, 280.20(c)(1)(ii) (2012 & Supp 2020).
Summary: 7 Swami, LLC (Individual/Entity) owns underground storage tanks in
Lee County, South Carolina. On October 1, 2021, the Department conducted an inspection
and issued a Notice of Alleged Violation. The Individual/Entity violated the SUPERB Act
and the South Carolina Underground Storage Tank Regulation, as follows: failed to
maintain overfill prevention equipment by having an obstruction in the drop tube.
Action: The Individual/Entity has corrected the violation. The Department has
assessed a total civil penalty in the amount of six thousand dollars ($6,000.00). The
Individual/Entity shall pay a civil penalty in the amount of six thousand dollars ($6,000.00)
in accordance with a promissory note beginning April 20, 2022.
Update: Monthly payments are being made as required towards the civil penalty.
7) Order Type and Number: Consent Order 22-0024-UST
Order Date: April 6, 2022
Individual/Entity: Browns Ferry, LLC
Facility: 51 Express
Location: 7359 Browns Ferry Road
Georgetown, SC 29440
Mailing Address: 1920 West Lucas Street
Florence, SC 29501
County: Georgetown
Previous Orders: None
Permit/ID Number: 12199
Violations Cited: The State Underground Petroleum
Environmental Response Bank Act of 1988 (SUPERB Act), S.C. Code Ann. §§ 44-
2-10 et seq. (2018); and South Carolina Underground Storage Tank Control
Regulation, 7 S.C. Code Ann., Regs. 61-92, 280.20(c)(1)(ii) (2012 and Supp.
2020).
Summary: Browns Ferry, LLC (Individual/Entity) owns and operates underground
storage tanks (USTs) in Georgetown County, South Carolina. On January 11, 2022, the
Department conducted an inspection and issued a Notice of Alleged Violation. The
Individual/Entity has violated the SUPERB Act and South Carolina Underground Storage
Tank Control Regulation as follows: failed to maintain overfill prevention equipment of an
UST system.
Action: The Individual/Entity has corrected the violation. The Department has
assessed a total civil penalty in the amount of six thousand dollars ($6,000.00). The
Individual/Entity shall pay a civil penalty in the amount of six thousand dollars ($6,000.00)
by May 20, 2022.
Update: This Order will be referred to Office of General Counsel for further action.
8) Order Type and Number: Consent Order 22-0085-UST
Order Date: April 21, 2022
Individual/Entity: Spinx Company, LLC
Facility: Spinx 133
Location: 2206 North Main Street
Anderson, SC 29621
Mailing Address: P.O. Box 8624
Greenville, SC 29604
County: Anderson
Previous Orders: None
Permit/ID Number: 00559
Violations Cited: The State Underground Petroleum
Environmental Response Bank Act of 1988 (SUPERB Act), S.C. code Ann. § 44-
2-10 et seq. (2018); and South Carolina Underground Storage Tank Control
Regulation, 7 S.C. Code Ann., Regs 61-92, 280.26(f) (2012 & Supp 2020).
Summary: Spinx Company, LLC (Individual/Entity) operates underground storage
tanks (USTs) in Anderson County, South Carolina. On February 24, 2022, the Department
conducted an inspection and issued a Notice of Alleged Violation. The Individual/Entity
violated the SUPERB Act and the South Carolina Underground Storage Tank Regulation,
as follows: failed to maintain overfill prevention equipment.
Action: The Individual/Entity has corrected all violations. The Department has
assessed a total penalty in the amount of six thousand dollars ($6,000.00). The
Individual/Entity shall pay a total civil penalty in the amount of six thousand dollars
($6,000.00) by June 6, 2022.
Update: The civil penalty has not been paid and a demand letter was sent June 8,
2022.
9) Order Type and Number: Consent Order 22-0097-UST
Order Date: April 21, 2022
Individual/Entity: Rock Tank, Inc.
Facility: Corner Stop 53
Location: 700 Fleming Street
Laurens, SC 29360
Mailing Address: 102 South Broad Street
Clinton, SC 29325
County: Laurens
Previous Orders: None
Permit/ID Number: 11062
Violations Cited: The State Underground Petroleum
Environmental Response Bank Act of 1988 (SUPERB Act), S.C. code Ann. § 44-
2-10 et seq. (2018); and South Carolina Underground Storage Tank Control
Regulation, 7 S.C. Code Ann., Regs 61-92, 280.20(c)(1)(ii) (2012 & Supp 2020).
Summary: Rock Tank, Inc. (Individual/Entity) operates underground storage tanks
(USTs) in Laurens County, South Carolina. On March 23, 2022, the Department conducted
an inspection and issued a Notice of Alleged Violation. The Individual/Entity violated the
SUPERB Act and the South Carolina Underground Storage Tank Regulation, as follows:
failed to maintain overfill prevention equipment.
Action: The Individual/Entity has corrected all violations. The Department has
assessed a total penalty in the amount of six thousand dollars ($6,000.00). The
Individual/Entity shall pay a total civil penalty in the amount of six thousand dollars
($6,000.00) by June 6, 2022.
Update: Civil penalty has been paid in full. The Order is closed.
10) Order Type and Number: Consent Order 22-0081-UST
Order Date: May 3, 2022
Individual/Entity: Padi Reddy
Facility: South Main Express
Location: 400 South Main Street
Lancaster, SC 29720
Mailing Address: 31 Wildeoak Court
Columbia, SC 29223
County: Lancaster
Previous Orders: None.
Permit/ID Number: 05547
Violations Cited: The State Underground Petroleum
Environmental Response Bank Act of 1988 (SUPERB Act), S.C. code Ann. § 44-
2-10 et seq. (2018); and South Carolina Underground Storage Tank Control
Regulation, 7 S.C. Code Ann., 280.93 and 280.110(c), (2012 & Supp 2019).
Summary: Padi Reddy (Individual/Entity) owns underground storage tanks in
Lancaster County, South Carolina. On January 18, 2022, the Department conducted a file
review and issued an NOAV. The Individual/Entity violated the SUPERB Act and the
South Carolina Underground Storage Tank Regulation, as follows: failed to demonstrate
financial responsibility for an UST system and failed to provide financial assurance to the
Department upon request.
Action: The Individual/Entity is required to: submit a completed Certificate of
Financial Responsibility Form and evidence of financial assurance by June 17, 2022. The
Department has assessed a total civil penalty in the amount of eight hundred seventy dollars
($870.00). The Individual/Entity shall pay a civil penalty in the amount of eight hundred
seventy dollars ($870.00).
Update: All requirements of the Order have been met and the civil penalty payment
penalty paid in full. The Order is closed.
11) Order Type and Number: Consent Order 22-0059-UST
Order Date: May 5, 2022
Individual/Entity: MDC Coast 11, LLC
Facility: 7-Eleven 40375
Location: 1515 Highway 17 North
Mt. Pleasant, SC 29464-3308
Mailing Address: 11995 El Camino Real
San Diego, CA 92130
County: Charleston
Previous Orders: None
Permit/ID Number: 01362
Violations Cited: The State Underground Petroleum
Environmental Response Bank Act of 1988 (SUPERB Act), S.C. code Ann. § 44-
2-10 et seq. (2018); and South Carolina Underground Storage Tank Control
Regulation, 7 S.C. Code Ann., Regs 61-92, 280.20(c)1(ii) (2012 & Supp 2020).
Summary: MDC Coast 11, LLC (Individual/Entity) operates underground storage
tanks (USTs) in Charleston County, South Carolina. On February 16, 2022, the
Department conducted an inspection and issued a Notice of Alleged Violation. The
Individual/Entity violated the SUPERB Act and the South Carolina Underground Storage
Tank Regulation, as follows: failed to maintain overfill prevention equipment.
Action: The Individual/Entity has corrected all violations. The Department has
assessed a total penalty in the amount of six thousand dollars ($6,000.00). The
Individual/Entity shall pay a civil penalty in the amount of six thousand dollars ($6,000.00)
by June 18, 2022.
Update: None.
12) Order Type and Number: Consent Order 22-0096-UST
Order Date: May 11, 2022
Individual/Entity: Sai Ram SC, LLC
Facility: EZ Trip 3
Location: 4623 Savannah Highway
North, SC 29169
Mailing Address: 114 McSwain Drive
Columbia, SC 29169
County: Orangeburg
Previous Orders: None
Permit/ID Number: 10631
Violations Cited: The State Underground Petroleum
Environmental Response Bank Act of 1988 (SUPERB Act), S.C. Code Ann. §§ 44-
2-10 et seq. (2018); and South Carolina Underground Storage Tank Control
Regulation, 7 S.C. Code Ann., Regs. 61-92, 280.20(c)(1)(ii) (2012 and Supp.
2020).
Summary: Sai Ram SC, LLC (Individual/Entity) owns and operates underground
storage tanks (USTs) in Orangeburg County, South Carolina. On March 22, 2022, the
Department conducted an inspection and issued a Notice of Alleged Violation (NOAV).
The Individual/Entity has violated the SUPERB Act and South Carolina Underground
Storage Tank Control Regulation as follows: failed to maintain overfill prevention
equipment of an underground storage tank (UST).
Action: The Individual/Entity is required to: submit proof an overfill prevention
equipment device has been installed for Tank #1 and submit subsequent passing overfill
prevention equipment operability test results for Tank #1. The Department has assessed a
total civil penalty in the amount of six thousand dollars ($6,000.00). The Individual/Entity
shall pay a civil penalty in the amount of six thousand dollars ($6,000.00) by June 25, 2022.
Update: None.
13) Order Type and Number: Consent Order 22-0114-UST
Order Date: May 13, 2022
Individual/Entity: Jared Wilson d.b.a. Wilson’s Corner
Store
Facility: Wilson’s Corner Store
Location: 9390 Highway 9
Inman, SC 29349
Mailing Address: Same
County: Spartanburg
Previous Orders: None.
Permit/ID Number: 08655
Violations Cited: The State Underground Petroleum
Environmental Response Bank Act of 1988 (SUPERB Act), S.C. code Ann. § 44-
2-10 et seq. (2018); and South Carolina Underground Storage Tank Control
Regulation, 7 S.C. Code Ann., Regs 61-92, 280.20(c)(1)(ii) (2012 & Supp 2020).
Summary: Jared Wilson d.b.a. Wilson’s Corner Store (Individual/Entity) operates
underground storage tanks (USTs) in Spartanburg County, South Carolina. On April 6,
2022, the Department conducted an inspection and issued a Notice of Alleged Violation.
The Individual/Entity violated the SUPERB Act and the South Carolina Underground
Storage Tank Regulation, as follows: failed to maintain overfill prevention equipment.
Action: The Individual/Entity corrected all violations prior to issuance of the
Order. The Department has assessed a total penalty in the amount of six thousand dollars
($6,000.00). The Individual/Entity shall pay a total civil penalty in the amount of six
thousand dollars ($6,000.00) in accordance with a promissory note. The first promissory
note payment will be due on May 16, 2022, and the final payment will be due on April 16,
2023.
Update: The first installment on the promissory note has been made.
14) Order Type and Number: Consent Order 22-0102-UST
Order Date: May 14, 2022
Individual/Entity: Eddie Defee
Facility: Bulk Plant
Location: 1800 Trade Street
Florence, SC 29503
Mailing Address: 7714 Francis Marion Road
Effingham, SC 29541
County: Florence
Previous Orders: None
Permit/ID Number: 03427
Violations Cited: The State Underground Petroleum
Environmental Response Bank Act of 1988 (SUPERB Act), S.C. Code Ann. §§ 44-
2-10 et seq. (2018); and South Carolina Underground Storage Tank Control
Regulation, 7 S.C. Code Ann., Regs. 61-92, 280.70(a) (2012 and Supp. 2020).
Summary: Eddie Defee (Individual/Entity) owns and operates underground storage
tanks (USTs) in Florence County, South Carolina. On February 8, 2022, the Department
conducted an inspection and issued a Notice of Alleged Violation (NOAV). The
Individual/Entity has violated the SUPERB Act and South Carolina Underground Storage
Tank Control Regulation as follows: failed to maintain corrosion protection or appropriate
release detection on a temporarily closed UST.
Action: The Individual/Entity has corrected the violation. The Department has
assessed a total civil penalty in the amount of four hundred dollars ($400.00). The
Individual/Entity shall pay a total civil penalty in the amount of four hundred dollars
($400.00).
Update: The Individual/Entity paid the assessed civil penalty. The Order is closed.
15) Order Type and Number: Consent Order 22-0112-UST
Order Date: May 27, 2022
Individual/Entity: Shree Sai, LLC
Facility: GS Mini Mart
Location: 668 Main Street
West Columbia, SC 29170
Mailing Address: 7103 Nursery Road
Columbia, SC 29212
County: Lexington
Previous Orders: None
Permit/ID Number: 11789
Violations Cited: The State Underground Petroleum
Environmental Response Bank Act of 1988 (SUPERB Act), S.C. Code Ann. §§ 44-
2-10 et seq. (2018); and South Carolina Underground Storage Tank Control
Regulation, 7 S.C. Code Ann., Regs. 61-92, 280.20(c)(1)(ii) (2012 and Supp.
2020).
Summary: Shree Sai, LLC (Individual/Entity) owns and operates underground
storage tanks (USTs) in Lexington County, South Carolina. On April 5, 2022, the
Department conducted an inspection and issued a Notice of Alleged Violation (NOAV).
The Individual/Entity has violated the SUPERB Act and South Carolina Underground
Storage Tank Control Regulation as follows: failed to maintain overfill prevention
equipment of an UST system.
Action: The Individual/Entity has corrected the violation. The Department has
assessed a total civil penalty in the amount of six thousand dollars ($6,000.00). The
Individual/Entity shall pay a civil penalty in the amount of six thousand dollars ($6,000.00)
by July 11, 2022.
Update: None.
16) Order Type and Number: Consent Order 22-0119-UST
Order Date: May 31, 2022
Individual/Entity: Thomas E. Ragan
Facility: Short Stop Food Mart
Location: 7221 Highway 9
Inman, SC 29349
Mailing Address: Same
County: Spartanburg
Previous Orders: None
Permit/ID Number: 08307
Violations Cited: The State Underground Petroleum
Environmental Response Bank Act of 1988 (SUPERB Act), S.C. code Ann. § 44-
2-10 et seq. (2018); and South Carolina Underground Storage Tank Control
Regulation, 7 S.C. Code Ann., Regs 61-92, 280.20(c)(1)(ii) (2012 & Supp 2020).
Summary: Thomas E. Ragan (Individual/Entity) operates underground storage
tanks (USTs) in Spartanburg County, South Carolina. On April 15, 2022, the Department
conducted an inspection and issued a Notice of Alleged Violation. The Individual/Entity
violated the SUPERB Act and the South Carolina Underground Storage Tank Regulation,
as follows: failed to maintain overfill prevention equipment.
Action: The Individual/Entity has corrected all violations. The Department has
assessed a total penalty in the amount of six thousand dollars ($6,000.00). The
Individual/Entity shall pay a total civil penalty in the amount of six thousand dollars
($6,000.00) by July 15, 2022.
Update: None.
Solid Waste Enforcement
17) Order Type and Number: Administrative Order 22-06-SW
Order Date: April 7, 2022
Individual/Entity: Ladson Wood Recycling, LLC
Facility: Ladson Wood Recycling
Location: 9425 Highway 78
Ladson, SC 29456
Mailing Address: Same
County: Charleston
Previous Orders: 19-10-SW ($8,000.00);
17-32-SW ($9,000.00)
Permit/ID Number: 102745-3001
Violations Cited: South Carolina Solid Waste Policy and
Management Act of 1991, S.C. Code Ann. §§ 44-96-10 et seq. (2002 & Supp.
2018), Solid Waste Management: Compost and Mulch Production from Land-
clearing Debris, Yard Trimmings and Organic Residuals Regulation (Rev. 2008 &
Supp. 2016), Part III.E.1.d., Part III.E.1.e., Part III.E.5.c., Part III.E.6., Part
III.F.1.d., and Part III.F.5., Solid Waste Management: Used Oil Regulation (2012
& Supp. 2019) 279.12.g., 279.22.b., 279.22.c., and 279.22.d., and the Permit #
102745-3001, Section A.4.
Summary: Ladson Wood Recycling, LLC (Individual/Entity), operates a wood
chipping facility located in Charleston County, South Carolina. On February 10, 2022, the
Department issued a Notice of Alleged Violation based on routine inspections of the
facility. The Individual/Entity has violated the South Carolina Solid Waste Policy and
Management Act, the Solid Waste Management: Compost and Mulch Production from
Land-clearing Debris, Yard Trimmings and Organic Residuals Regulation, the Solid Waste
Management: Used Oil Regulation, and the Permit in that the Individual/Entity: exceeded
the permitted 10,000 cubic yards of unprocessed material; accepted unprocessed material
resulting in an excess of the maximum capacity allowed by the Permit; failed to provide
temperature logs to the Department upon request; failed to operate the Facility within the
permitted boundary; failed to prevent standing water on the operational area; and failed to
store used oil in containers that were in good condition, i.e. not leaking, closed, and labeled
.
Action: The Individual/Entity is required to: immediately cease accepting new,
unprocessed material at the facility; reduce the amount of unprocessed material present at
the facility to within the permitted limit of 10,000 cubic yards; remove all unprocessed
material from outside the facility’s permitted footprint, specifically, remove the debris from
under the power lines to the west of the facility; close and label all used oil containers; and
clean up all used oil spilled in the soil surrounding the used oil containment area by digging
out at least six (6) inches of soil in the area where the spills have occurred or until clean
soil is observed, whichever is greater by June 8, 2022. The Department has assessed a civil
penalty of twenty-one thousand, three hundred dollars ($21,300.00). The Individual/Entity
shall pay a civil penalty of twenty-one thousand, three hundred dollars ($21,300.00) by
June 8, 2022.
Update: No Request for Review was filed; therefore, the effective date of the Order
is April 25, 2022. This has been referred to Office of General Counsel for further action.
18) Order Type and Number: Consent Order 22-08-SW
Order Date: May 13, 2022
Individual/Entity: Chester County
Facility: Chester County Transfer Station
Location: 2351 Penden Bridge Road
Chester, South Carolina 29706
Mailing Address: P.O. Drawer 580
Chester, SC 29706
County: Chester
Previous Orders: None
Permit/ID Number: 121001-6001
Violations Cited: South Carolina Solid Waste Policy and
Management Act of 1991, S.C. Code Ann. §§ 44-96-10 et seq. (2002 & Supp.
2018); Solid Waste Management: Transfer of Solid Waste Regulation, C.2. and
F.3.(2012); and the Permit #121001-6001, Preliminary Engineering Report and The
General Operating Plan.
Summary: Chester County (Individual/Entity), operates a Transfer Station located
in Chester County, South Carolina. Based on routine inspections of the Facility, the
Department issued a Notice of Alleged Violations. The Individual/Entity has violated the
South Carolina Solid Waste Policy and Management Act, the Solid Waste Management:
Transfer of Solid Waste Regulation, and the Permit, as follows: failed to manage leachate
at the Facility in accordance with the approved Operating Plan.
Action: The Individual/Entity has corrected all violations. The Department has
assessed a civil penalty in the amount of two thousand, five hundred eighty dollars
($2,580.00). The Individual/Entity shall pay a civil penalty of two thousand, five hundred
eighty dollars ($2,580.00) by June 27, 2022.
Update: The civil penalty has been paid in full. The Order is closed.
Hazardous Waste Enforcement
19) Order Type and Number: Consent Order 22-07-HW
Order Date: April 21, 2022
Individual/Entity: HI-TEC Plating, Inc.
Facility: HI-TEC Plating, Inc.
Location: 219 Hitec Road
Seneca, SC 29678
Mailing Address: P.O. Box 68
Seneca, SC 29679
County: Oconee
Previous Orders: None
Permit/ID Number: SCD 981 759 343
Violations Cited: The South Carolina Hazardous Waste
Management Act, S.C. Code Ann. §§ 44-56-10 et seq. (2018), and the South
Carolina Hazardous Waste Management Regulation, 6 and 7 S.C. Code Ann. Regs.
61-79 (2012 and Supp. 2020).
Summary: HI-TEC Plating, Inc. (Individual/Entity) is a metal finisher providing
precision electroless nickel plating and hard chrome plating at its facility located in Oconee
County, South Carolina. The Department conducted an inspection at the facility on October
27, 2021. The Individual/Entity has violated the South Carolina Hazardous Waste
Management Act and the Hazardous Waste Management Regulations as follows: failed to
transfer hazardous waste from a container in poor condition to a container in good
condition; failed to mark or label containers with the words “Hazardous Waste” and an
indication of the hazards of the contents; failed to submit a copy of the contingency plan
and the quick reference guide to all the local emergency responders; failed to label
universal waste lamps with one of the following phrases: “Universal Waste Lamp(s),” or
“Waste Lamp(s),” or “Used Lamp(s)”; and failed to demonstrate the length of time
universal waste had been accumulated.
Action: The Individual/Entity has corrected the violations. The Department has
assessed a total civil penalty in the amount of four thousand dollars ($4,000.00). The
Individual/Entity is required to pay a civil penalty in the amount of four thousand dollars
($4,000.00) by May 23, 2022.
Update: The civil penalty was paid in full on May 11, 2022. The Order is closed.
20) Order Type and Number: Consent Order 22-08-HW
Order Date: May 11, 2022
Individual/Entity: AkzoNobel Coatings, Inc.
Facility: AkzoNobel Coatings, Inc.
Location: 1872 Highway 9 Bypass West
Lancaster, SC 29720
Mailing Address: Same
County: Lancaster
Previous Orders: None
Permit/ID Number: SCD 000 608 331
Violations Cited: The South Carolina Hazardous Waste
Management Act, S.C. Code Ann. §§ 44-56-10 et seq. (2018), and the South
Carolina Hazardous Waste Management Regulation, 6 and 7 S.C. Code Ann. Regs.
61-79 (2012 and Supp. 2021).
Summary: AkzoNobel Coatings, Inc. (Individual/Entity) is a global paint and
coating company that produces decorative paints and specialty coatings at its facility
located in Lancaster County, South Carolina. The Department conducted an inspection at
the facility on January 13, 2022. The Individual/Entity has violated the South Carolina
Hazardous Waste Management Act and the Hazardous Waste Management Regulations as
follows: failed to accumulate hazardous waste in containers at or near any point of
generation; failed to mark or label containers with the words “Hazardous Waste” and an
indication of the hazards of the contents; failed to remove excess hazardous waste from
satellite accumulation within three (3) consecutive calendar days and date the container
holding the excess with the date the excess amount began accumulating; failed to place
“No Smoking” signs in areas where ignitable or reactive waste was stored; failed to have a
training program directed by a person trained in hazardous waste management; failed to
ensure personnel take part in an annual review of hazardous waste training; failed to
maintain the job title for each position related to hazardous waste management at the
facility and the name of the employee filling that position; failed to maintain a written job
description for each position; failed to maintain a written description of the type and
amount of both introductory and continuing training given to each person; failed to prepare
hazardous waste manifests according to the instructions; failed to submit Quarterly Reports
to the Department that included a description, the EPA hazardous waste number, DOT
hazardous class, and the types and quantities of such wastes as required by the instructions
included with the form; failed to describe and/or include in the facility’s Contingency Plan,
the arrangements agreed to with local emergency responders and a list of all emergency
equipment along with the location and its capabilities; failed to submit a copy of the
contingency plan along with a quick reference guide to all local emergency responders;
failed to label containers of universal waste lamps and contain any lamps in a manner to
prevent a release and to keep such containers closed; and failed to demonstrate the length
of time universal waste had been accumulated from the date it became a waste.
Action: The Individual/Entity has corrected the violations. The Department has
assessed a total civil penalty in the amount of seventeen thousand dollars ($17,000.00).
The Individual/Entity is required to pay a civil penalty in the amount of seventeen thousand
dollars ($17,000.00) by July 11, 2022.
Update: None
Infectious Waste Enforcement
21) Order Type and Number: Consent Order 22-09-IW
Order Date: April 11, 2022
Individual/Entity: Ashley River Tower
Facility: Ashley River Tower
Location: 25 Courtenay Drive
Charleston, SC 29425
Mailing Address: 316 Courtenay Drive
Charleston, SC 29425
County: Charleston
Previous Orders: 20-01-IW ($14,800.00)
Permit/ID Number: SC10-2208G
Violations Cited: The South Carolina Infectious Waste
Management Act, S.C. Code ann. §§ 44-93-10 et seq. (2002); and the South
Carolina Infectious Waste Management Regulation, 8. S.C. Code Ann. Regs. 61-
105 (2010).
Summary: Ashley River Tower (Individual/Entity), under the healthcare system of
the Medical University of South Carolina specializes in digestive health, heart and vascular
care, and cancer care at its facility located in Charleston County, South Carolina. On
September 14, 2021, the Department opened an investigation and conducted site visits on
September 16, 2021, September 24, 2021, September 28, 2021, October 13, 2021, and
October 21, 2021. The Individual/Entity has violated the South Carolina Infectious Waste
Management Act and the South Carolina Infectious Waste Management Regulation as
follows: failed to segregate infectious waste at the point of generation; failed to manage
infectious waste in a manner which prevents exposure to the public or release to the
environment; failed to offer infectious waste for offsite transport only to a transporter
registered with the Department or the U.S. Postal Service; failed to package infectious
waste in accordance with the requirements of R.61-105 Section I to prevent a release; failed
to place and maintain all sharps in a rigid, leak-resistant, and puncture resistant containers;
failed to place, store, and maintain all other types of infectious waste during transport in
rigid or semirigid leak-resistant containers; failed to use containers that had sufficient
strength to prevent bursting and tearing; failed to use plastic bags that were red or orange
color and had sufficient strength to prevent tearing; failed to contain infectious waste in
containers that were appropriate for storage, transportation, and treatment processes; failed
to label containers of infectious waste with the universal biohazard symbol, the Department
issued number of the in-state generator, and the date the container was placed in storage or
sent offsite; failed to treat infectious waste prior to disposal; and failed to report to the
Department within twenty-four (24) hours and investigate and confirm all suspected
releases of infectious waste.
Action: The Individual/Entity has corrected the violations. The Department has
assessed a total civil penalty in the amount of fifty-eight thousand dollars ($58,000.00).
The Individual/Entity shall pay a civil penalty of fifty-eight thousand dollars ($58,000.00)
by May 11, 2022.
Update: Civil penalty has been paid in full. The Order is closed.
22) Order Type and Number: Consent Order 22-10-IW
Order Date: April 11, 2022
Individual/Entity: Medical University of South Carolina
Facility: Medical University of South Carolina
Location: 171 Ashley Avenue
Charleston, South Carolina 29425
Mailing Address: Same
County: Charleston
Previous Orders: 20-02-IW ($14,800.00)
Permit/ID Number: SC10-0031G
Violations Cited: The South Carolina Infectious Waste
Management Act, S.C. Code ann. §§ 44-93-10 et seq. (2002); and the South
Carolina Infectious Waste Management Regulation, 8. S.C. Code Ann. Regs. 61-
105 (2010).
Summary: The Medical University of South Carolina (Individual/Entity), is a
clinical healthcare system centrally located in Charleston County, South Carolina. On
September 14, 2021, the Department opened an investigation and conducted site visits on
September 16, 2021, September 24, 2021, September 28, 2021, October 13, 2021, and
October 21, 2021. The Individual/Entity has violated the South Carolina Infectious Waste
Management Act and the South Carolina Infectious Waste Management Regulation as
follows: failed to segregate infectious waste at the point of generation; failed to manage
infectious waste in a manner which prevents exposure to the public or release to the
environment; failed to offer infectious waste for offsite transport only to a transporter
registered with the Department or the U.S. Postal Service; failed to package infectious
waste in accordance with the requirements of R.61-105 Section I to prevent a release; failed
to place and maintain all sharps in a rigid, leak-resistant, and puncture resistant containers;
failed to place, store, and maintain all other types of infectious waste during transport in
rigid or semirigid leak-resistant containers; failed to use containers that had sufficient
strength to prevent bursting and tearing; failed to use plastic bags that were red or orange
color and had sufficient strength to prevent tearing; failed to contain infectious waste in
containers that were appropriate for storage, transportation, and treatment processes; failed
to label containers of infectious waste with the universal biohazard symbol, the Department
issued number of the in-state generator, and the date the container was placed in storage or
sent offsite; failed to treat infectious waste prior to disposal; and failed to report to the
Department within twenty-four (24) hours and investigate and confirm all suspected
releases of infectious waste.
Action: The Individual/Entity has corrected the violations. The Department has
assessed a total civil penalty in the amount of fifty-eight thousand dollars ($58,000.00).
The Individual/Entity shall pay a civil penalty of fifty-eight thousand dollars ($58,000.00)
by May 11, 2022.
Update: The civil penalty has been paid in full. The Order is closed.
23) Order Type and Number: Consent Order 22-15-IW
Order Date: May 5, 2022
Individual/Entity: Trident Medical Center
Facility: Trident Medical Center
Location: 9330 Medical Plaza Drive
North Charleston, SC 29406
Mailing Address: Same
County: Charleston
Previous Orders: None
Permit/ID Number: SC10-0258G
Violations Cited: The South Carolina Infectious Waste
Management Act, S.C. Code ann. §§ 44-93-10 et seq. (2002); and the South
Carolina Infectious Waste Management Regulation, 8. S.C. Code Ann. Regs. 61-
105 (2010).
Summary: Trident Medical Center (Individual/Entity), is a clinical healthcare
system centrally located in Charleston County, South Carolina. On October 8, 2021, the
Department opened an investigation and conducted site visits on October 8, 2021, October
13, 2021, October 15, 2021, October 20, October 25, 2021, October 29, 2021, November
2, 2021, November 5,2021, and December 15, 2021. The Individual/Entity has violated the
South Carolina Infectious Waste Management Act and the South Carolina Infectious Waste
Management Regulation as follows: failed to segregate infectious waste at the point of
generation; failed to manage infectious waste in a manner which prevents exposure to the
public or release to the environment; failed to offer infectious waste for offsite transport
only to a transporter registered with the Department or the U.S. Postal Service; failed to
package infectious waste in accordance with the requirements of R.61-105 Section I to
prevent a release; failed to place and maintain all sharps in a rigid, leak-resistant, and
puncture resistant containers; failed to place, store, and maintain all other types of
infectious waste during transport in rigid or semirigid leak-resistant containers; failed to
use containers that had sufficient strength to prevent bursting and tearing; failed to use
plastic bags that were red or orange color and had sufficient strength to prevent tearing;
failed to contain infectious waste in containers that were appropriate for storage,
transportation, and treatment processes; failed to label containers of infectious waste with
the universal biohazard symbol, the Department issued number of the in-state generator,
and the date the container was placed in storage or sent offsite; failed to treat infectious
waste prior to disposal; and failed to report to the Department within twenty-four (24) hours
and investigate and confirm all suspected releases of infectious waste.
Action: The Individual/Entity has corrected the violations. The Department has
assessed a total civil penalty in the amount of fifty-five thousand, three hundred dollars
($55,300.00). The Individual/Entity shall pay a civil penalty of fifty-five thousand, three
hundred dollars ($55,300.00) by June 5, 2022.
Update: The civil penalty was paid in full on May 11, 2022. The Order is closed.
24) Order Type and Number: Consent Order 22-11-IW
Order Date: May 17, 2022
Individual/Entity: Naval Health Clinic Charleston
Facility: Naval Health Clinic Charleston
Location: 110 Naval Nuclear Power Training
Command Circle
Goose Creek, SC 29445
Mailing Address: Same
County: Berkeley
Previous Orders: None
Permit/ID Number: SC08-0187G
Violations Cited: The South Carolina Infectious Waste
Management Act, S.C. Code ann. §§ 44-93-10 et seq. (2002); and the South
Carolina Infectious Waste Management Regulation, 8. S.C. Code Ann. Regs. 61-
105 (2010).
Summary: Naval Health Clinic Charleston (Individual/Entity), operates a Military
Health System hospital located in Berkeley County, South Carolina. The Department
conducted an open investigation on November 3, 2021. The Individual/Entity has violated
the South Carolina Infectious Waste Management Act and the South Carolina Infectious
Waste Management Regulation as follows: failed to segregate infectious waste at the point
of generation; failed to properly manage infectious waste; failed to offer infectious waste
for offsite transport only to a registered transporter; failed to package infectious waste in
accordance with the regulations; failed to place, store, and maintain all other types of
infectious waste during transport in rigid or semirigid leak-resistant containers; failed to
contain infectious waste in containers that were appropriate for storage, transportation, and
treatment processes; failed to properly label containers of infectious waste; failed to treat
infectious waste prior to disposal; and failed to report to the Department within twenty-
four (24) hours and investigate and confirm all suspected releases of infectious waste.
Action: The Individual/Entity has corrected the violations. The Department has
assessed a total civil penalty in the amount of fourteen thousand, four hundred dollars
($14,400.00). The Individual/Entity shall pay a civil penalty of fourteen thousand, four
hundred dollars ($14,400.00) by June 16, 2022.
Update: The civil penalty has been paid in full. The Order is closed.
Mining Enforcement
25) Order Type and Number: Consent Order 22-03-MSWM
Order Date: May 27, 2022
Individual/Entity: S&T Recycling, LLC
Facility: S&T Recycling Mine
Location: approximately 2.5 miles northeast of
Lexington, South Carolina, adjacent to US
Highway 378 and 2.75 miles west of its
intersection with Interstate 20
Mailing Address: 5009 Sunset Boulevard
Lexington, SC 29072
County: Lexington
Previous Orders: None
Permit/ID Number: I-001584
Violations Cited: The South Carolina Mining Act, S.C. code
Ann. § 48-20-10 et seq. (2008 & Supp. 2018); South Carolina Mining Regulation
(2012) R.89-280; and the Permit I-002002 Section IX.1.
Summary: S&T Recycling, LLC (Individual/Entity), owns and operates S&T
Recycling Mine in Lexington County, South Carolina. The Department conducted a file
review on December 6, 2021. The Individual/Entity has violated the South Carolina Mining
Act, the Mining Regulation, and the Permit as follows: failed to submit the mining annual
report for fiscal year 2022.
Action: The Individual/Entity is required to: submit the mining annual report for
fiscal year 2022 by July 11, 2022. The Department has assessed a civil penalty in the
amount six hundred dollars ($600.00). The Individual/Entity shall pay a civil penalty of
six hundred dollars ($600.00) by July 11, 2022.
Update: All requirements of the Order have been met. The Order is closed.
BUREAU OF WATER
Recreational Waters Enforcement
26) Order Type and Number: Consent Order 22-013-RW
Order Date: May 17, 2022
Individual/Entity: Ocean Breeze Hospitality, LLC
Facility: Sleep Inn at Harbour View
Location: 909 Highway 17
Little River, SC 29566
Mailing Address: Same
County: Horry
Previous Orders: None
Permit/ID Number: 26-P47-1
Violations Cited: S.C. Code Ann. Regs. 61-51(J)
Summary: Ocean Breeze Hospitality, LLC (Individual/Entity) owns and is
responsible for the proper operation and maintenance of a pool located in Horry County,
South Carolina. The Department conducted inspections on January 12, 2022, and April 5,
2022, and violations were issued for failure to properly operate and maintain. The
Individual/Entity has violated the Public Swimming Pools Regulation as follows:
skimmers were missing weirs; the chlorine level was not within the acceptable range of
water quality standards; the facility address was not posted at the emergency notification
device; and the bound and numbered log book was not maintained on a daily basis.
Action: The Individual/Entity has corrected all violations. The Department has
assessed a total civil penalty in the amount of six hundred eighty dollars ($680.00). The
Individual/Entity shall pay a civil penalty in the amount of six hundred eighty dollars
($680.00) by June 6, 2022.
Update: The civil penalty has been paid and the Order has been closed.
27) Order Type and Number: Consent Order 22-014-RW
Order Date: May 24, 2022
Individual/Entity: University of South Carolina
Facility: Strom Thurmond Wellness and Fitness
Center
Location: 1000 Blossom Street
Columbia, SC 29201
Mailing Address: Same
County: Richland
Previous Orders: None
Permit/ID Number: 40-430-1
Violations Cited: S.C. Code Ann. Regs. 61-51(J)(10)
Summary: The University of South Carolina (Individual/Entity) owns and is
responsible for the proper operation and maintenance of a pool located in Richland County,
South Carolina. The Department issued a Notice of Alleged Violation/Notice of
Enforcement Conference on April 18, 2022, as a result of a review of Department records.
The Individual/Entity has violated the Public Swimming Pools Regulation as follows:
failed to report to the Department in writing, on a Department approved form, any death,
injury, or accident requiring an EMS response, emergency room visit, or hospitalization
within seventy-two hours of the occurrence.
Action: The Department has assessed a total civil penalty in the amount of four
hundred dollars ($400.00). The Individual/Entity shall pay a civil penalty in the amount
of four hundred dollars ($400.00) by June 8, 2022.
Update: The civil penalty has been paid. The Individual/Entity submitted the
required incident report to the Department. The Order has been closed.
Drinking Water Enforcement
28) Order Type and Number: Consent Order 22-015-DW
Order Date: April 21, 2022
Individual/Entity: Tony L. Spires
Facility: Breakaways on 178
Location: 1032 Highway 178
Pelion, SC 29123
Mailing Address: Same
County: Lexington
Previous Orders: None
Permit/ID Number: 3272010
Violations Cited: S.C. Code Ann. Regs. 61-58.7 & 61-58.8.B
Summary: Tony L. Spires (Individual/Entity) owns and is responsible for the proper
operation and maintenance of a public water system (PWS) located in Lexington County,
South Carolina. The Department conducted an inspection on January 28, 2022, and the
PWS was rated unsatisfactory for failure to properly operate and maintain and failure to
provide an emergency preparedness plan. The Individual/Entity has violated the State
Primary Drinking Water Regulation as follows: the insulation inside the well house was
wet and moldy; the sanitary seal and air vent were covered with a PVC cap and the
condition could not be determined; there was exposed wiring that was not in conduit; there
was a rope coming out of the wellhead; there was no check valve; there was no blow-off;
the wellhead piping rattled when the well pump came on; the sample tap was threaded; the
exterior of the storage tank was rusted; a procedures manual with monitoring records,
programs, inspection logs, and a system map was not provided for Department review; and
an emergency preparedness plan was not provided for Department review.
Action: The Individual/Entity is required to: correct the deficiencies by July 1,
2022; submit a completed procedures manual by July 1, 2022; and submit an emergency
preparedness plan by July 1, 2022. The Department has assessed a total civil penalty in the
amount of eight thousand dollars ($8,000.00). The Individual/Entity shall pay a stipulated
penalty in the amount of eight thousand dollars ($8,000.00) should any requirement of the
Order not be met.
Update: The Individual/Entity has hired a professional well drilling and repair
company to correct the deficiencies. The deficiencies have been addressed and the Order
has been closed.
29) Order Type and Number: Consent Order 22-016-DW
Order Date: April 21, 2022
Individual/Entity: Derby Fields Mobile Home Park, LLC
Facility: Derby Fields Mobile Home Park
Location: 205 Jockey Street
Walterboro, SC 29488
Mailing Address: P.O. Box 2301
Walterboro, SC 29488
County: Colleton
Previous Orders: None
Permit/ID Number: 1560015
Violations Cited: S.C. Code Ann. Regs. 61-58.7, 61-58.8.B, &
61-30.G(2)(a)
Summary: Derby Fields Mobile Home Park, LLC (Individual/Entity) owns and is
responsible for the proper operation and maintenance of a public water system (PWS)
located in Colleton County, South Carolina. The Department conducted an inspection on
December 7, 2021, and the PWS was rated needs improvement for failure to properly
operate and maintain; failure to provide an emergency preparedness plan; and failure to
pay the annual Safe Drinking Water Act fee for fiscal year 2022. The Individual/Entity has
violated the State Primary Drinking Water Regulation and the Environmental Protection
Fees Regulation as follows: the sanitary seal was rusted; the well house was in disrepair
and the floor was covered with debris; the well house door was not locked and the door
was in disrepair; there was fiberglass insulation covering the wellhead piping; a procedures
manual with monitoring records, programs, inspection logs, and a system map was not
provided for Department review; an emergency preparedness plan was not provided for
Department review; and the annual Safe Drinking Water Act fee for fiscal year 2022 had
not been paid.
Action: The Individual/Entity is required to: pay the annual Safe Drinking Water
Act fee for fiscal year 2022, which totals two hundred forty dollars and sixty-three cents
($240.63) by April 15, 2022; correct the deficiencies by June 1, 2022; submit a completed
procedures manual by June 1, 2022; and submit an emergency preparedness plan by June
1, 2022. The Department has assessed a total civil penalty in the amount of eight thousand
dollars ($8,000.00). The Individual/Entity shall pay a stipulated penalty in the amount of
eight thousand dollars ($8,000.00) should any requirement of the Order not be met.
Update: The Individual/Entity has paid the annual Safe Drinking Water Act fee for
fiscal year 2022 and hired a professional well drilling and repair company to correct the
deficiencies. The deficiencies have been addressed and the Order has been closed.
30) Order Type and Number: Consent Order 22-018-DW
Order Date: April 28, 2022
Individual/Entity: Draytonville/ Water Works, Inc.
Facility: Draytonville Water District
Location: 3142 Union Highway
Gaffney, SC 29340
Mailing Address: P.O. Box 1256
Gaffney, SC 29342
County: Cherokee
Previous Orders: 20-001-DW ($4,000.00)
Permit/ID Number: 1050011
Violations Cited: S.C. Code Ann. Regs. 61-58.5.P(2)(b)
Summary: Draytonville Water Works, Inc. (Individual/Entity) owns and is
responsible for the proper operation and maintenance of a public water system (PWS)
located in Cherokee County, South Carolina. On March 8, 2022, a violation was issued as
a result of review of monitoring records. The Individual/Entity has violated the State
Primary Drinking Water Regulation as follows: the PWS exceeded the maximum
contaminant level (MCL) for total trihalomethanes.
Action: The Individual/Entity is required to: submit a corrective action plan with a
schedule to address the MCL violation by May 30, 2022. The Department has assessed a
total civil penalty in the amount of eight thousand dollars ($8,000.00). The
Individual/Entity shall pay a stipulated penalty in the amount of eight thousand dollars
($8,000.00) should any requirement of the Order not be met.
Update: The Individual/Entity has received funding to install measures to address
the MCL violation. A corrective action plan was submitted and approved.
31) Order Type and Number: Consent Order 22-019-DW
Order Date: May 12, 2022
Individual/Entity: Georgetown County Water & Sewer
District
Facility: Red Hill
Location: 465 Clearwater Drive
Pawleys Island, SC 29585
Mailing Address: P.O. Box 2730
Pawleys Island, SC 29585
County: Georgetown
Previous Orders: None
Permit/ID Number: 2220007
Violations Cited: S.C. Code Ann. Regs. 61-58.2.B(1)(a) & 61-
58.4.C(5)
Summary: Georgetown County Water & Sewer District (Individual/Entity) owns
and is responsible for the proper operation and maintenance of a public water system
(PWS) located in Georgetown County, South Carolina. The Department conducted an
inspection of the PWS on November 18, 2021, and it was rated unsatisfactory for source
quantity. The Individual/Entity has violated the State Primary Drinking Water Regulation
as follows: failed to provide a minimum of two independent sources of groundwater; and
failed to provide elevated storage.
Action: The Individual/Entity is required to: submit a corrective action plan with a
schedule to address the source quantity deficiencies by June 12, 2022. The Department has
assessed a total civil penalty in the amount of two thousand dollars ($2,000.00). The
Individual/Entity shall pay a civil penalty in the amount of two thousand dollars
($2,000.00) by June 12, 2022.
Update: The civil penalty has been paid. A corrective action plan was submitted
and approved.
32) Order Type and Number: Consent Order 22-020-DW
Order Date: May 27, 2022
Individual/Entity: Kiser & Associates, Inc.
Facility: Maryfield Development
Location: 12 Maryfield Court
Daufuskie Island, SC 29915
Mailing Address: P.O. Box 2030
Bluffton, SC 29910
County: Beaufort
Previous Orders: None
Permit/ID Number: 0750045
Violations Cited: S.C. Code Ann. Regs. 61-58.17.K(1), 61-
58.7, & 61-58.8.B
Summary: Kiser & Associates, Inc. (Individual/Entity) owns and is responsible for
the proper operation and maintenance of a public water system (PWS) located in Beaufort
County, South Carolina. On February 8, 2022, a violation was issued as a result of review
of monitoring records; and the Department conducted an inspection of the PWS on
February 14, 2022, and it was rated unsatisfactory for failure to properly operate and
maintain and failure to provide an emergency preparedness plan. The Individual/Entity has
violated the State Primary Drinking Water Regulation as follows: the PWS tested present
for total coliform and E. coli, which resulted in a violation of the maximum contaminant
level for E. coli; the sanitary seal was rusted; the well pad was covered with debris; there
was no pressure gauge on the distribution line; there was overgrown vegetation around the
well house and storage tank; there were items stored in the well house that were not related
to the operation and maintenance of the PWS; the well house was in disrepair; a procedures
manual with monitoring records, programs, inspection logs, and a system map was not
provided for Department review; and an emergency preparedness plan was not provided
for Department review.
Action: The Individual/Entity is required to: submit an investigative report and a
corrective action plan with a schedule to address the causes of the total coliform and E. coli
present results at the PWS by August 1, 2022; correct the operation and maintenance
deficiencies by August 1, 2022; submit an emergency preparedness plan by August 1,
2022; have the storage tank inspected and submit an inspection report with
recommendations to the Department by August 1, 2022; and complete the
recommendations in the inspection report within ninety days of the date of the report. The
Department has assessed a total civil penalty in the amount of twelve thousand dollars
($12,000.00). The Individual/Entity shall pay a stipulated penalty in the amount of twelve
thousand dollars ($12,000.00) should any requirement of the Order not be met.
Update: None.
Water Pollution Enforcement
33) Order Type and Number: Consent Order 22-022-W
Order Date: April 7, 2022
Individual/Entity: Petrochoice LLC
Facility: Petrochoice LLC WWTF
Location: 1445 Greenleaf Street
Charleston, SC 29405
Mailing Address: Same
County: Charleston
Previous Orders: 20-009-W
22-004-W
Permit/ID Number: SC0047261
Violations Cited: Pollution Control Act, S.C Code Ann § 48-
1-110 (d); Water Pollution Control Permits, S.C. Code Ann Regs. 61-9.122.41 (a)
Summary: Petrochoice LLC (Individual/Entity) is responsible for the proper
operation and maintenance of a wastewater treatment facility (WWTF) located in
Charleston County, South Carolina. On October 28, 2021, a Notice of Alleged Violation
was issued as a result of violations of the permitted discharge limits for pH as reported on
discharge monitoring reports submitted to the Department. The Individual/Entity has
violated the Pollution Control Act and Water Pollution Control Permits Regulation as
follows: failed to comply with the effluent discharge limits of its National Pollutant
Discharge Elimination System permit for pH.
Action: The Individual/Entity is required to: submit a written notification of the
completion date for all corrective actions necessary to resolve the violations by May 7,
2022; conduct a six (6) event compliance confirmation period upon completion of
corrective actions; and implement engineered upgrades to the WWTF should additional
violations be observed during the compliance confirmation period. The Department has
assessed a total civil penalty in the amount of two thousand, eight hundred dollars
($2,800.00). The Individual/Entity shall pay a civil penalty in the amount of two thousand,
eight hundred dollars ($2,800.00) by May 7, 2022.
Update: The Individual/Entity has submitted notification of the corrective action
completion date and payment of the assessed civil penalty. The Order was closed on April
14, 2022.
34) Order Type and Number: Consent Order 22-023-W
Order Date: April 8, 2022
Individual/Entity: David Martin
Facility: Martin Dairy Farm
Location: Pendleton, SC 29670
Mailing Address: 104 Martin Lane
Pendleton, SC 29670
County: Anderson
Previous Orders: None
Permit/ID Number: ND0014184
Violations Cited: Pollution Control Act, S.C. Code Ann. § 48-
1-110 (d) (2008 & Supp. 2019) and Water Pollution Control Permits Regulation,
S.C. Code Ann Regs. 61-9.122.41(a) (2011), and ND0014184
Summary: David Martin (Individual/Entity) owns and is responsible for the proper
operation and maintenance of Martin Dairy Farm, a dairy farm in Anderson County, South
Carolina. On January 11, 2022, a Notice of Alleged Violation (NOAV) was issued as a
result of failure to pay past due annual operating fees to the Department for Fiscal Years
2009 through 2021. The Individual/Entity has violated the Pollution Control Act and Water
Pollution Control Permits Regulations as follows: failure to remit payment for annual
operating fees for Fiscal Years 2009 through 2021.
Action: The Individual/Entity is required to: submit a Close-out Plan developed by
a qualified engineer or initiate action initiate with the Natural Resource Conservation
Service (NRCS) by June 8, 2022, to close-out the lagoon; and submit in the amount of six
hundred and eighteen dollars and seventy-five cents ($618.75), in settlement of all past due
annual operating fees and their associated late fees by June 8, 2022. The Department has
assessed a total civil penalty in the amount of four thousand, thirty-six dollars and nine
cents ($4,036.09). The Individual/Entity shall pay a civil penalty in the amount of four
thousand, thirty-six dollars and nine cents ($4,036.09) by July 7, 2022.
Update: The Individual/Entity failed to submit the requirements of the Order by the
specified due dates. Department staff have attempted to contact the Individual/Entity to
facilitate compliance and such attempts have been unsuccessful. A Notice of Order
Violation/Demand Letter for Compliance is being prepared for this case.
35) Order Type and Number: Consent Order 22-024-W
Order Date: April 21, 2022
Individual/Entity: Dominion Energy SC, Inc
Facility: VC Summer Nuclear Station Off-Site Water
System
Location: 400 Brabham Boulevard
Jenkinsville, SC 29065
Mailing Address: P.O. Box 8, Mail Code 800
Jenkinsville, SC 29065
County: Fairfield
Previous Orders: None
Permit/ID Number: SCG646072
Violations Cited: Pollution Control Act, S.C. Code Ann. § 48-
1-110(d), Water Pollution Control Permits, S.C. Code Ann Regs. 61-9.122.41(a)
and (e)(1), State Environmental Laboratory Certification Regulations, S.C. Code
Ann. Regs 61-68 and National Pollutant Discharge Elimination System (NPDES)
Permit SC0031895.
Summary: Dominion Energy SC, Inc (Individual/Entity) owns and is responsible
for the proper operation and maintenance of the VC Summer Nuclear Station Off-Site
Water System (VC Summer WWTF) in Fairfield County, South Carolina. On January 6,
2022, a Notice of Alleged Violation (NOAV) was issued for failure to use a South Carolina
certified laboratory for analysis of total residual chlorine (TRC) for certain monitoring
periods. The Individual/Entity has violated the Pollution Control Act, Water Pollution
Control Permits Regulations, and State Environmental Laboratory Certification
Regulations as follows: failed to use South Carolina certified laboratory for analysis of
TRC for certain monitoring periods.
Action: The Individual/Entity is required to submit notification by May 6, 2022,
that it is using a South Carolina certified laboratory for the analysis of TRC. The
Department has assessed a total civil penalty in the amount of eight thousand, one hundred
sixty dollars ($8,160.00). The Individual/Entity shall pay a civil penalty in the amount of
four thousand eighty dollars ($4,080.00) by May 21, 2022 and pay a stipulated penalty in
the amount of four thousand eighty dollars ($4,080.00) should any requirement of the Order
not be met.
Update: The Individual/Entity has paid the penalty and submitted documentation
confirming proper TRC sampling and analysis. The Order was closed on May 12, 2022.
36) Order Type and Number: Consent Order 22-025-W
Order Date: April 21, 2022
Individual/Entity: City of Dillon
Facility: Little Pee Dee WWTF
Location: 1 mile east of city limits and half mile
south of state Highway 9
Dillon, SC 29405
Mailing Address: P.O. Box 431
Dillon, SC 29405
County: Dillon
Previous Orders: None
Permit/ID Number: SC0021776
Violations Cited: Pollution Control Act, S.C Code Ann § 48-
1-110 (d); Water Pollution Control Permits, S.C. Code Ann Regs. 61-9.122.41 (a)
Summary: The City of Dillon (Individual/Entity) is responsible for the proper
operation and maintenance of a wastewater treatment facility (WWTF) located in Dillon
County, South Carolina. On January 27, 2022, a Notice of Alleged Violation was issued as
a result of violations of the permitted discharge limits for ammonia-nitrogen (ammonia) as
reported on discharge monitoring reports submitted to the Department. The
Individual/Entity has violated the Pollution Control Act and Water Pollution Control
Permits Regulation as follows: failed to comply with the effluent discharge limits of its
National Pollutant Discharge Elimination System permit for ammonia.
Action: The Individual/Entity is required to: submit a written notification of the
completion date for all corrective actions necessary to resolve the violations by May 21,
2022; conduct a six (6) event compliance confirmation period upon completion of
corrective actions; and implement engineered upgrades to the WWTF should additional
violations be observed during the compliance confirmation period. The Department has
assessed a total civil penalty in the amount of four thousand, nine hundred dollars
($4,900.00). The Individual/Entity shall pay a civil penalty in the amount of four thousand,
nine hundred dollars ($4,900.00) by May 21, 2022.
Update: The Individual/Entity submitted a corrective action plan in response to the
Order and has paid the civil penalty. Department staff is in correspondence with the
Individual/Entity to assist with the proper notification of corrective action being submitted
as required by the Order.
37) Order Type and Number: Consent Order 22-026-W
Order Date: April 27, 2022
Individual/Entity: Lake Shore Vision, LLC
Facility: Haigs Creek Subdivision Phase IX
Location: Located off Emory Road
Kershaw County, SC
Mailing Address: P.O. Box 1605
Columbia, SC 29202
County: Kershaw
Previous Orders: None
Permit/ID Number: SCR10Z5PE
Violations Cited: Pollution Control Act, S.C Code Ann § 48-
1-90 (a); Water Pollution Control Permits, S.C. Code Ann Regs. 61-9.122.41 (a)
and (e).
Summary: Lake Shore Vision, LLC (Individual/Entity) is responsible for land
disturbing activity associated with construction located in Oconee County, South Carolina.
On December 16, 2021, notification of unsatisfactory conditions and an inspection report
was issued to the Individual/Entity as a result of an unsatisfactory Department inspection
of the site. The Individual/Entity has violated the Pollution Control Act and Water
Pollution Control Permits Regulations as follows: failed to maintain stormwater
management, sediment, and erosion controls per the Department approved plans as
required by the Permit.
Action: The Individual/Entity is required to: submit an updated Storm Water
Prevention Plan (SWPPP) by June 26, 2022; submit a report signed by a Professional
Engineer stating the Site is in compliance with the approved SWPPP and submit a notarized
document confirming appropriate inspections are being performed on Site by May 27,
2022; submit a Notice of Termination (NOT) within thirty (30) days of completion of
permanent stabilization of the Site. The Department has assessed a total civil penalty in the
amount of one thousand, fifty dollars ($1,050.00). The Individual/Entity shall pay a civil
penalty in the amount of one thousand, fifty dollars ($1,050.00) due May 27, 2022.
Update: The Individual/Entity has submitted payment of the penalty and has
submitted an updated SWPPP for Department approval
38) Order Type and Number: Consent Order 22-027-W
Order Date: May 5, 2022
Individual/Entity: Centerfield Cooper Solar, LLC
Facility: Centerfield Cooper Solar site
Location: Chesterfield, SC 29709
Mailing Address: 130 Roberts Street, Suite 120
Asheville, NC 28801
County: Chesterfield
Previous Orders: None
Permit/ID Number: SCR10Z4BK
Violations Cited: Pollution Control Act, S.C. Code Ann. § 48-
1-90 (A) and Water Pollution Control Permits Regulation, S.C. Code Ann Regs.
61-9.122.41(a) and (e).
Summary: Centerfield Cooper Solar (Individual/Entity) is responsible for land-
disturbing activities at the Centerfield Cooper Solar construction site (Site), located in
Chesterfield County, South Carolina. On December 6, 2021, a Notice of Alleged Violation
(NOAV) was issued as a result of unsatisfactory conditions observed during Department
inspection of the Site. The Individual/Entity has violated the Pollution Control Act and
Water Pollution Control Permits Regulations as follows: discharged sediment into the
environment other than in compliance with a Department issued permit, failed to comply
with all conditions of the National Pollutant Discharge Elimination System (NPDES)
Permit, and failed to install and maintain all controls in accordance with the approved
stormwater pollution prevention plan (SWPPP).
Action: The Individual/Entity is required to: complete permanent stabilization of
the Site by August 5, 2022; submit a report signed by the Professional Engineer who
prepared the SWPPP by September 5, 2022, stating that the Site is in compliance with the
approved SWPPP and associated NPDES Permit; and submit an approvable and
administratively complete Notice of Termination (NOT) by September 5, 2022. The
Department has assessed a total civil penalty in the amount of eight thousand dollars
($8,000.00). The Individual/Entity shall pay a civil penalty in the amount of eight thousand
dollars ($8,000.00) by June 5, 2022.
Update: The Individual/Entity has submitted payment of the civil penalty.
39) Order Type and Number: Consent Order 22-028-W
Order Date: May 5, 2022
Individual/Entity: Town of Jefferson
Facility: Town of Jefferson WWTF
Location: Off Highway 265
Jefferson, SC 29718
Mailing Address: P.O. Box 306
Jefferson, SC 29718
County: Chesterfield
Previous Orders: 20-027-W ($1,000.00)
19-051-W ($700.00)
Permit/ID Number: SC0024767
Violations Cited: Pollution Control Act, S.C. Code Ann. § 48-
1-110(d), Water Pollution Control Permits, S.C. Code Ann Regs 61-9.122.41(a)
and NPDES Permit SC0024767
Summary: Town of Jefferson (Individual/Entity) owns and is responsible for the
proper operation and maintenance of a wastewater treatment facility (WWTF) in
Chesterfield County, South Carolina. On February 17, 2022, a Notice of Alleged Violation
(NOAV) was issued as a result of ammonia-nitrogen (ammonia) violations reported on
discharge monitoring reports (DMRs) submitted to the Department. The Individual/Entity
has violated the Pollution Control Act and Water Pollution Control Permits Regulations as
follows: failed to comply with the effluent limitations of its National Pollutant Discharge
Elimination System (NPDES) Permit SC0024767.
Action: The Individual/Entity is required to: submit written notification of the
completion date all corrective actions necessary to resolve the effluent violations by June
4, 2022; conduct a six (6) monitoring event compliance confirmation period upon
completion of corrective actions; and implement engineered upgrades to the WWTF should
additional violations be observed during the compliance confirmation period. The
Department has assessed a total civil penalty in the amount of six thousand dollars
($6,000.00). The Individual/Entity shall pay a civil penalty in the amount of six thousand
dollars ($6,000.00) by June 4, 2022.
Update: The Individual/Entity has submitted notification of the corrective action
completion date and has paid the assessed civil penalty.
40) Order Type and Number: Consent Order 22-029-W
Order Date: May 11, 2022
Individual/Entity: Edgefield County Water & Sewer
Authority
Facility: Brooks Street WWTP
Location: On Brooks Street, in Edgefield, SC
Mailing Address: P.O. Box 416
Edgefield, SC 29824
County: Edgefield
Previous Orders: None
Permit/ID Number: SC0025330
Violations Cited: Pollution Control Act, S.C. Code Ann. § 48-
1-110 (d) and Water Pollution Control Permits Regulation, S.C. Code Ann Regs.
61-9.122.41(a)
Summary: Edgefield County Water & Sewer Authority (Individual/Entity) is
responsible for the proper operation and maintenance of a wastewater treatment plant
(WWTP) located on Brooks Street in Edgefield County, South Carolina. On March 4, 2022,
a Notice of Alleged Violation (NOAV) was issued as a result of chronic toxicity (CTOX)
violations reported on discharge monitoring reports (DMRs) submitted to the Department.
The Individual/Entity has violated the Pollution Control Act and Water Pollution Control
Permits Regulations as follows: failed to comply with effluent limitations of NPDES
Permit SC0025330.
Action: The Individual/Entity is required to: submit written notification of the
completion date for all corrective actions necessary to resolve the violations by June 11,
2022; conduct a six (6) monitoring event compliance confirmation period upon completion
of corrective actions; and implement engineered upgrades to the WWTF should additional
violations be observed during the compliance confirmation period. The Department has
assessed a total civil penalty in the amount of five thousand six hundred dollars
($5,600.00). The Individual/Entity shall pay a civil penalty in the amount of five thousand
six hundred dollars ($5,600.00) by June 11, 2022.
Update: The Individual/Entity has submitted notification of the corrective action
completion date and has paid the assessed civil penalty.
41) Order Type and Number: Consent Order 22-030-W
Order Date: May 23, 2022
Individual/Entity: Lowcountry Regional Water System
Facility: Town of Yemassee WWTF
Location: East side of town at the end of Railroad
Avenue
Mailing Address: P.O. Box 647
Hampton, SC 29924-3516
County: Hampton
Previous Orders: None
Permit/ID Number: SC0025950
Violations Cited: Pollution Control Act, S.C Code Ann § 48-
1-110 (d); Water Pollution Control Permits, S.C. Code Ann Regs. 61-9.122.41 (a)
Summary: Lowcountry Regional Water System (Individual/Entity) is responsible
for the proper operation and maintenance of a wastewater treatment facility (WWTF)
located in Hampton County, South Carolina. On September 30, 2021, a Notice of Violation
(NOV) was issued as a result of violations of the permitted discharge limits for ammonia-
nitrogen (ammonia) and ultimate oxygen demand (UOD) as reported on discharge
monitoring reports submitted to the Department. The Individual/Entity has violated the
Pollution Control Act and Water Pollution Control Permits Regulation as follows: failed
to comply with the effluent discharge limits of its National Pollutant Discharge Elimination
System permit.
Action: The Individual/Entity is required to: submit a written notification of the
completion date for all corrective actions necessary to resolve the violations by June 23,
2022; conduct a six (6) event compliance confirmation period upon completion of
corrective actions; and implement engineered upgrades to the WWTF should additional
violations be observed during the compliance confirmation period. The Department has
assessed a total civil penalty in the amount of five thousand six hundred dollars
($5,600.00). The Individual/Entity shall pay a civil penalty in the amount of two thousand
eight hundred ($2,800.00) by June 23, 2022 and pay a stipulated penalty in the amount of
two thousand eight hundred dollars ($2,800.00) should any requirement of the Order not
be met.
Update: None
42) Order Type and Number: Consent Order 22-031-W
Order Date: May 23, 2022
Individual/Entity: Lakeview Steakhouse LLC
Facility: Lakeview Steakhouse WWTF
Location: Off Highway 14 North of Greer
Greer, SC 29651
Mailing Address: P.O. Box 117
Greer, SC 29652
County: Greenville
Previous Orders: None
Permit/ID Number: SC0030465
Violations Cited: Pollution Control Act, S.C. Code Ann. § 48-
1-110(d), Water Pollution Control Permits, S.C. Code Ann Regs. 61-9.122.21(d),
and National Pollutant Discharge Elimination System (NPDES) Permit
SC0030465.
Summary: Lakeview Steakhouse LLC (Individual/Entity) owns and is responsible
for the proper operation and maintenance of a wastewater treatment facility (WWTF) in
Greenville County, South Carolina. On January 10, 2022, a Notice of Violation (NOV) was
issued for failure to reapply for permit coverage within one hundred eighty (180) days
before the existing permit expires. The Individual/Entity has violated the Pollution Control
Act and Water Pollution Control Permits Regulations as follows: failed to submit an
application for renewal of the NPDES Permit at least one hundred eighty (180) days before
the existing permit expires.
Action: The Individual/Entity is required to: continue operating the WWTF in
accordance with the most recent NPDES permit until a new permit becomes effective;
Submit an administratively complete application for renewal of NPDES Permit
SC0030465 by June 30, 2022; and by May 31, 2022 and every thirty (30) days thereafter ,
submit a summary status report on the progression of sampling, testing, and administrative
processes necessary for submission of an administratively complete application for renewal
of NPDES Permit SC0030465. The Department has assessed a total civil penalty in the
amount of one thousand dollars ($1,000.00). The Individual/Entity shall pay a civil penalty
in the amount of one thousand dollars ($1,000.00) by June 22, 2022.
Update: The Individual/Entity has paid the civil penalty in full and submitted
proper summary reports regarding application for permit renewal. The Individual/Entity
has also submitted an administratively complete application for permit renewal.
BUREAU OF AIR QUALITY
43) Order Type and Number: Consent Order 22-009-A
Order Date: April 25, 2022
Individual/Entity: WCC of Mayesville, LLC
Facility: WCC of Mayesville, LLC
Location: 4845 Florence Highway
Mayesville, SC 29104
Mailing Address: P.O. Box 148
Mayesville, SC 29104
County: Sumter
Previous Orders: 17-005-A ($7,650.00)
Permit/ID Number: 2140-0097
Violations Cited: S.C. Code Ann. Regs. 61-30, Section
G(3)(b), and S.C. Code Ann. Regs 61-62.1, Section II, Permit Requirements
Summary: WCC of Mayesville, LLC (Individual/Entity), manufactures
prefabricated wooden cabinets at its facility located Sumter County, South Carolina. On
September 21, 2020, the Department conducted an inspection. The Individual/Entity
violated South Carolina Air Pollution Control Regulation, as follows: failed to pay permit
fees for fiscal years 2018, 2019, 2020, and 2022.
Action: The Individual/Entity is required to: henceforth pay all Air Quality permit
fees and stay up to date on all fiscal year payments; and pay Fiscal Year 2018, 2019, 2020,
and 2022 annual permit fees in the amount of five thousand six hundred and eighty-two
dollars and forty-four cents ($5,682.44) within one hundred and twenty (120) days of the
execution date of this Order.
Update: None
44) Order Type and Number: Consent Order 22-010-A
Order Date: May 12, 2022
Individual/Entity: BJU, Inc., d.b.a. Bob Jones University
Facility: BJU, Inc., d/b/a Bob Jones University
Location: 1700 Wade Hampton Boulevard
Greenville, SC 29614-1000
Mailing Address: Same
County: Greenville
Previous Orders: None
Permit/ID Number: 1200-0245
Violations Cited: S.C. Code Ann. Regs. 61-62.1, Section II,
Permit Requirements
Summary: BJU, Inc., d.b.a. Bob Jones University (Individual/Entity), is a private
university located in Greenville County, South Carolina. On November 17, 2021, a
Department inspector conducted an inspection. The Individual/Entity has violated South
Carolina Air Pollution Control Regulations, as follows: failed to record pressure drop
readings for the dry filters and the dust collector on a daily basis; failed to maintain records
of operation and maintenance checks performed on the dry filters and the dust collector;
failed to provide fuel delivery information or fuel certification records necessary to
determine facility wide NO
x
emissions; and failed to perform the 2020 annual facility
equipment review by the January 31
st
deadline.
Action: The Individual/Entity is required to: comply with all terms and conditions
of State Operating Permit 1200-0245. The Department has assessed a total civil penalty in
the amount of five thousand dollars ($5,000.00). The Individual/Entity shall pay a penalty
in the amount of five thousand dollars ($5,000.00).
Update: The civil penalty was paid in full on May 11, 2022.
BUREAU OF ENVIRONMENTAL HEALTH SERVICES
Food Safety Enforcement
45) Order Type and Number: Administrative Order 22-14-FOOD
Order Date: May 12, 2022
Individual/Entity: Randall Durden and Cassidy Rowe
Facility: Double D’s Dogs and Catering
Location: 625 Cottontail Trail
Myrtle Beach, SC 29588
Mailing Address: 568 George Bishop Parkway
Myrtle Beach, SC 29579
County: Horry
Previous Orders: None
Permit Number: 26-204-14293
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: Double D’s Dogs and Catering (Individual/Entity) is a mobile food unit
located in Horry County, South Carolina. The Department conducted an investigation on
February 16, 2022. The Individual/Entity has violated the South Carolina Retail Food
Establishment Regulation as follows: provided food to the public without a valid permit
issued by the Department.
Action: The Individual/Entity is required to: operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of one thousand dollars
($1,000.00). The Individual/Entity shall pay a civil penalty in the amount of one thousand
dollars ($1,000.00).
Update: On June 16, 2022, the Department issued a payment demand letter for the
outstanding civil penalty.
46) Order Type and Number: Consent Order 22-17-FOOD
Order Date: April 1, 2022
Individual/Entity: Dirty Don’s Oyster Bar & Grill
Facility: Dirty Don’s Oyster Bar & Grill
Location: 661 Main Street
North Myrtle Beach, SC 29582
Mailing Address: Same
County: Horry
Previous Orders: None
Permit Number: 26-206-14162
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: Dirty Don’s Oyster Bar & Grill (Individual/Entity) operates a restaurant
located in Horry County, South Carolina. The Department conducted inspections on June
9, 2021, January 27, 2022, and February 4, 2022. The Individual/Entity has violated the
South Carolina Retail Food Establishment Regulation as follows: failed to provide
individual disposable towels at each hand washing sink or group of adjacent handwashing
sinks.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of four hundred dollars
($400.00). The Individual/Entity shall pay a civil penalty in the amount of four hundred
dollars ($400.00).
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
47) Order Type and Number: Consent Order 22-21-FOOD
Order Date: April 1, 2022
Individual/Entity: Fatz
Facility: Fatz
Location: 942 E. Main Street
Lexington, SC 29072
Mailing Address: 1361 West Wade Hampton Boulevard
Suite F, Box 6
Greer, SC 29650
County: Lexington
Previous Orders: 22-01-FOOD ($800.00)
Permit Number: 32-206-06971
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: Fatz (Individual/Entity) operates a restaurant located in Lexington
County, South Carolina. The Department conducted inspections on November 15, 2021,
December 14, 2021, December 20, 2021, February 8, 2022, February 17, 2022, March 3,
2022, and March 10, 2022. The Individual/Entity has violated the South Carolina Retail
Food Establishment Regulation as follows: failed to keep equipment food contact surfaces
and utensils clean to sight and touch; failed to ensure that time/temperature control for
safety food was maintained at a temperature of 41 degrees F and below or 135 degrees F
and above, except during preparation, cooking, or cooling; failed to maintain the premises
free of insects, rodents, and other pests; failed to ensure that equipment is maintained in a
state of repair and condition that meets the regulation requirements; and failed to ensure
that physical facilities were maintained in good repair.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of two thousand seven
hundred fifty dollars ($2,750.00). The Individual/Entity shall pay a civil penalty in the
amount of two thousand seven hundred fifty dollars ($2,750.00).
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
48) Order Type and Number: Consent Order 22-26-FOOD
Order Date: April 5, 2022
Individual/Entity: Domino’s #5608
Facility: Domino’s #5608
Location: 7400 Garners Ferry Road
Columbia, SC 29209
Mailing Address: 4034 Enterprise Way, Suite 180
Flowery Branch, GA 30542
County: Richland
Previous Orders: None
Permit Number: 40-206-06086
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: Domino’s #5608 (Individual/Entity) operates a restaurant located in
Richland County, South Carolina. The Department conducted inspections on February 18,
2022, February 28, 2022, and March 10, 2022. The Individual/Entity has violated the South
Carolina Retail Food Establishment Regulation as follows: failed to ensure that
time/temperature control for safety food was maintained at a temperature of 41 degrees F
and below or 135 degrees F and above, except during preparation, cooking, or cooling.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of eight hundred dollars
($800.00). The Individual/Entity shall pay a civil penalty in the amount of eight hundred
dollars ($800.00).
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
49) Order Type and Number: Consent Order 22-07-FOOD
Order Date: April 6, 2022
Individual/Entity: Persis Biryani Grill
Facility: Persis Biryani Grill
Location: 1728 Bush River Road
Columbia, SC 29210
Mailing Address: Same
County: Lexington
Previous Orders: None
Permit Number: 32-206-06984
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: Persis Biryani Grill (Individual/Entity) operates a restaurant located in
Lexington County, South Carolina. The Department conducted inspections on February
10, 2022, February 11, 2022, and February 18, 2022. The Individual/Entity has violated
the South Carolina Retail Food Establishment Regulation as follows: failed to ensure that
the handwashing sinks were accessible at all times; and failed to maintain the premises free
of insects, rodents, and other pests.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of four hundred dollars
($400.00). The Individual/Entity shall pay a civil penalty in the amount of four hundred
dollars ($400.00).
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
50) Order Type and Number: Consent Order 22-12-FOOD
Order Date: April 6, 2022
Individual/Entity: Riveras Panaderia
Facility: Riveras Panaderia
Location: 1126 Mack Street
Gaston, SC 29053
Mailing Address: 1807 Decker Boulevard
Columbia, SC 29206
County: Lexington
Previous Orders: None
Permit Number: 32-206-07099
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: Riveras Panaderia (Individual/Entity) operates a restaurant located in
Lexington County, South Carolina. The Department conducted inspections on January 6,
2022, January 11, 2022, January 12, 2022, and January 14, 2022. The Individual/Entity has
violated the South Carolina Retail Food Establishment Regulation as follows: failed to
provide a test kit or other device that accurately measures the concentration of MG/L of
sanitizing solutions.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of eight hundred dollars
($800.00). The Individual/Entity shall pay a civil penalty in the amount of eight hundred
dollars ($800.00).
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
51) Order Type and Number: Consent Order 22-18-FOOD
Order Date: April 7, 2022
Individual/Entity: Sunday Best Jamaican Cuisine
Facility: Sunday Best Jamaican Cuisine
Location: 127 Highway 17 North
North Myrtle Beach, SC 29588
Mailing Address: Same
County: Horry
Previous Orders: None
Permit Number: 26-206-14101
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: Sunday Best Jamaican Cuisine (Individual/Entity) operates a restaurant
located in Horry County, South Carolina. The Department conducted inspections on July
13, 2021, July 23, 2021, February 9, 2022, and February 18, 2022. The Individual/Entity
has violated the South Carolina Retail Food Establishment Regulation as follows: failed
to ensure that time/temperature control for safety food was maintained at a temperature of
41 degrees F and below or 135 degrees F and above, except during preparation, cooking,
or cooling.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of one thousand, six
hundred dollars ($1,600.00). The Individual/Entity shall pay a civil penalty in the amount
of one thousand, six hundred dollars ($1,600.00).
Update: The facility is current on their payment plan.
52) Order Type and Number: Consent Order 22-20-FOOD
Order Date: April 7, 2022
Individual/Entity: Red Rooster Sports Bar
Facility: Red Rooster Sports Bar
Location: 7500 Wilson Boulevard
Columbia, SC 29203
Mailing Address: Same
County: Richland
Previous Orders: None
Permit Number: 40-206-08642
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: Red Rooster Sports Bar (Individual/Entity) operates a restaurant located
in Richland County, South Carolina. The Department conducted inspections on January
28, 2022, February 3, 2022, February 11, 2022, and February 18, 2022. The
Individual/Entity has violated the South Carolina Retail Food Establishment Regulation as
follows: failed to maintain the proper sanitization concentration in a chemical sanitizer
used in a manual or mechanical operation during contact times; and failed to maintain the
premises free of insects, rodents, and other pests.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of eight hundred dollars
($800.00). The Individual/Entity shall pay a civil penalty in the amount of eight hundred
dollars ($800.00).
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
53) Order Type and Number: Consent Order 22-10-FOOD
Order Date: April 13, 2022
Individual/Entity: Anderson Wings, LLC
Facility: Anderson Wings, LLC
Location: 119 Interstate Boulevard
Anderson, SC 29621
Mailing Address: 205 Regency Executive Park Drive
Suite 204
Charlotte, NC 28217
County: Anderson
Previous Orders: 2018-206-01-005 ($1,000.00);
2019-206-01-012 ($1,750.00);
2019-206-01-052 ($500.00)
Permit Number: 04-206-04218
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: Anderson Wings, LLC (Individual/Entity) operates a restaurant located
in Anderson County, South Carolina. The Department conducted inspections on September
30, 2021, January 6, 2022, and January 14, 2022. The Individual/Entity has violated the
South Carolina Retail Food Establishment Regulation as follows: failed to ensure that each
handwashing sink or group of two (2) adjacent handwashing sinks was provided with a
supply of hand cleaning, liquid, powder or bar soap; and failed to ensure that
time/temperature control for safety food was maintained at a temperature of 41 degrees F
and below or 135 degrees F and above, except during preparation, cooking, or cooling.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of one thousand, two
hundred fifty dollars ($1,250.00). The Individual/Entity shall pay a civil penalty in the
amount of one thousand, two hundred fifty dollars ($1,250.00).
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
54) Order Type and Number: Consent Order 22-23-FOOD
Order Date: April 13, 2022
Individual/Entity: Water’s Edge Restaurant
Facility: Water’s Edge Restaurant
Location: 1407 Shrimp Boat Lane
Mount Pleasant, SC 29464
Mailing Address: 56 Wentworth Street, Suite 200
Charleston, SC 29401
County: Charleston
Previous Orders: None
Permit Number: 10-206-11731
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: Water’s Edge Restaurant (Individual/Entity) operates a restaurant
located in Charleston County, South Carolina. The Department conducted inspections on
November 16, 2021, November 23, 2021, January 26, 2022, February 4, 2022, and
February 14, 2022. The Individual/Entity has violated the South Carolina Retail Food
Establishment Regulation as follows: failed to ensure that time/temperature control for
safety food was maintained at a temperature of 41 degrees F and below or 135 degrees F
and above, except during preparation, cooking, or cooling; and failed to maintain the
premises free of insects, rodents, and other pests.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of one thousand, two
hundred dollars ($1,200.00). The Individual/Entity shall pay a civil penalty in the amount
of one thousand, two hundred dollars ($1,200.00).
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
55) Order Type and Number: Consent Order 22-27-FOOD
Order Date: April 19, 2022
Individual/Entity: Kings Sushi II
Facility: Kings Sushi II
Location: 801 Highway 17 North
North Myrtle Beach, SC 29582
Mailing Address: 224 Haley Lane
Conway, SC 29527
County: Horry
Previous Orders: 2018-206-06-014 ($800.00)
Permit Number: 26-206-13150
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: Kings Sushi II (Individual/Entity) operates a restaurant located in Horry
County, South Carolina. The Department conducted inspections on January 7, 2022,
January 14, 2022, and March 7, 2022. The Individual/Entity has violated the South
Carolina Retail Food Establishment Regulation as follows: failed to properly cool cooked
time/temperature control for safety foods; and failed to use effective methods to cool
cooked time/temperature control for safety foods.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of one thousand dollars
($1,000.00). The Individual/Entity shall pay a civil penalty in the amount of one thousand
dollars ($1,000.00).
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
56) Order Type and Number: Consent Order 22-30-FOOD
Order Date: April 19, 2022
Individual/Entity: Scott’s BBQ
Facility: Scott’s BBQ
Location: 2734 Hemingway Highway
Hemingway, SC 29554
Mailing Address: Same
County: Williamsburg
Previous Orders: 2017-206-06-139 ($1,250.00);
2019-206-06-107 ($250.00);
2019-206-06-166 ($1,000.00)
Permit Number: 45-206-00442
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: Scott’s BBQ (Individual/Entity) operates a restaurant located in
Williamsburg County, South Carolina. The Department conducted inspections on October
8, 2021, October 15, 2021, February 16, 2022, February 24, 2022, and March 4, 2022. The
Individual/Entity has violated the South Carolina Retail Food Establishment Regulation as
follows: failed to ensure that time/temperature control for safety food was maintained at a
temperature of 41 degrees F and below or 135 degrees F and above, except during
preparation, cooking, or cooling.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of three thousand
dollars ($3,000.00). The Individual/Entity shall pay a civil penalty in the amount of three
thousand dollars ($3,000.00).
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
57) Order Type and Number: Consent Order 22-29-FOOD
Order Date: April 21, 2022
Individual/Entity: La Vinotinto Restaurant
Facility: La Vinotinto Restaurant
Location: 1311 North Kings Highway
Myrtle Beach, SC 29577
Mailing Address: Same
County: Horry
Previous Orders: None
Permit Number: 26-206-14326
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: La Vinotinto Restaurant (Individual/Entity) operates a restaurant
located in Horry County, South Carolina. The Department conducted inspections on June
23, 2021, July 1, 2021, and March 2, 2022. The Individual/Entity has violated the South
Carolina Retail Food Establishment Regulation as follows: failed to ensure that
time/temperature control for safety food was maintained at a temperature of 41 degrees F
and below or 135 degrees F and above, except during preparation, cooking, or cooling.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of eight hundred dollars
($800.00). The Individual/Entity shall pay a civil penalty in the amount of eight hundred
dollars ($800.00).
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
58) Order Type and Number: Consent Order 22-28-FOOD
Order Date: April 26, 2022
Individual/Entity: Ashe Street Convenience
Facility: Ashe Street Convenience
Location: 63 Ashe Street
Charleston, SC 29403
Mailing Address: Same
County: Charleston
Previous Orders: None
Permit Number: 10-206-08579
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: Ashe Street Convenience (Individual/Entity) operates a restaurant
located in Charleston County, South Carolina. The Department conducted inspections on
February 16, 2022, February 25, 2022, and March 7, 2022. The Individual/Entity has
violated the South Carolina Retail Food Establishment Regulation as follows: failed to
provide a written plan for the restriction, exclusion, and re-instatement of food employees
when they have symptoms and/or diseases that are transmissible through food; failed to
provide a test kit or other device that accurately measures the concentration of MG/L of
sanitizing solutions; and failed to ensure that the retail food establishment had written
procedures for employees to follow when responding to vomiting or diarrheal events, that
involve the discharge of vomitus or fecal matter onto surfaces in the retail food
establishment.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of eight hundred dollars
($800.00). The Individual/Entity shall pay a civil penalty in the amount of eight hundred
dollars ($800.00).
Update: On June 16, 2022, the Department issued a payment demand letter for the
outstanding civil penalty.
59) Order Type and Number: Consent Order 22-33-FOOD
Order Date: April 26, 2022
Individual/Entity: Blue Tolok Grill & Bar, LLC
Facility: Blue Tolok Grill & Bar, LLC
Location: 304 Highway 28 Bypass
Anderson, SC 29624
Mailing Address: Same
County: Anderson
Previous Orders: None
Permit Number: 04-206-04217
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: Blue Tolok Grill & Bar, LLC (Individual/Entity) operates a restaurant
located in Anderson County, South Carolina. The Department conducted inspections on
March 9, 2022, March 15, 2022, and March 22, 2022. The Individual/Entity has violated
the South Carolina Retail Food Establishment Regulation as follows: failed to properly
cool cooked time/temperature control for safety foods; and failed to use effective methods
to cool cooked time/temperature control for safety foods.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of eight hundred dollars
($800.00). The Individual/Entity shall pay a civil penalty in the amount of eight hundred
dollars ($800.00).
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
60) Order Type and Number: Consent Order 22-34-FOOD
Order Date: April 28, 2022
Individual/Entity: Circle K #775
Facility: Circle K #775
Location: 105 Main Road
Charleston, SC 29445
Mailing Address: 1100 Situs Court, Suite 100
Raleigh, NC 27606
County: Charleston
Previous Orders: None
Permit Number: 10-206-09835
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: Circle K #775 (Individual/Entity) operates a restaurant located in
Charleston County, South Carolina. The Department conducted inspections on March 8,
2022, March 18, 2022, March 25, 2022, and April 1, 2022. The Individual/Entity has
violated the South Carolina Retail Food Establishment Regulation as follows: failed to
maintain the premises free of insects, rodents, and other pests.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of eight hundred dollars
($800.00). The Individual/Entity shall pay a civil penalty in the amount of eight hundred
dollars ($800.00).
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
61) Order Type and Number: Consent Order 22-42-FOOD
Order Date: April 28, 2022
Individual/Entity: Black Magic Café
Facility: Black Magic Café
Location: 1130 Folly Road
Charleston, SC 29412
Mailing Address: 2245 Portside Way
Charleston, SC 29407
County: Charleston
Previous Orders: None
Permit Number: 10-206-10219
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: Black Magic Café (Individual/Entity) operates a restaurant located in
Charleston County, South Carolina. The Department conducted inspections on March 22,
2022, March 24, 2022, and March 28, 2022. The Individual/Entity has violated the South
Carolina Retail Food Establishment Regulation as follows: failed to ensure that
time/temperature control for safety foods were maintained at a temperature of 41 degrees
F and below or 135 degrees F and above, except during preparation, cooking, or cooling.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of eight hundred dollars
($800.00). The Individual/Entity shall pay a civil penalty in the amount of eight hundred
dollars ($800.00).
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
62) Order Type and Number: Consent Order 22-35-FOOD
Order Date: May 5, 2022
Individual/Entity: Domino’s
Facility: Domino’s
Location: 621 St. Andrews Road
Columbia, SC 29210
Mailing Address: 4034 Enterprise Way, Suite 180
Flowery Branch, GA 30542
County: Lexington
Previous Orders: None
Permit Number: 32-206-06453
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: Domino’s (Individual/Entity) operates a restaurant located in Lexington
County, South Carolina. The Department conducted inspections on March 16, 2022, March
24, 2022, and April 1, 2022. The Individual/Entity has violated the South Carolina Retail
Food Establishment Regulation as follows: failed to maintain the premises free of insects,
rodents, and other pests.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of four hundred dollars
($400.00). The Individual/Entity shall pay a civil penalty in the amount of four hundred
dollars ($400.00).
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
63) Order Type and Number: Consent Order 22-41-FOOD
Order Date: May 11, 2022
Individual/Entity: McDonald’s #18049
Facility: McDonald’s #18049
Location: 428 South Main Street
Belton, SC 29627
Mailing Address: 3414 Common Street
Lake Charles, LA 70607
County: Anderson
Previous Orders: None
Permit Number: 04-206-04667
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: McDonald’s #18049 (Individual/Entity) operates a restaurant located in
Lexington County, South Carolina. The Department conducted inspections on October 9,
2021, October 27, 2021, March 2, 2022, March 9, 2022, and March 17, 2022. The
Individual/Entity has violated the South Carolina Retail Food Establishment Regulation as
follows: failed to maintain the premises free of insects, rodents, and other pests.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of one thousand, two
hundred dollars ($1,200.00). The Individual/Entity shall pay a civil penalty in the amount
of one thousand, two hundred dollars ($1,200.00).
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
64) Order Type and Number: Consent Order 22-31-FOOD
Order Date: May 13, 2022
Individual/Entity: La Estrella
Facility: La Estrella
Location: 1921 Airport Boulevard
West Columbia, SC 29169
Mailing Address: Same
County: Lexington
Previous Orders: None
Permit Number: 32-206-05018
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: La Estrella (Individual/Entity) operates a restaurant located in
Lexington County, South Carolina. The Department conducted inspections on January 11,
2022, January 24, 2022, March 7, 2022, and March 17, 2022. The Individual/Entity has
violated the South Carolina Retail Food Establishment Regulation as follows: failed to
keep equipment food contact surfaces and utensils clean to sight and touch; failed to
properly cool cooked time/temperature control for safety foods; failed to use effective
methods to cool cooked time/temperature control for safety foods; and failed to ensure that
time/temperature control for safety foods were maintained at a temperature of 41 degrees
F and below or 135 degrees F and above, except during preparation, cooking, or cooling.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of one thousand, eight
hundred dollars ($1,800.00). The Individual/Entity shall pay a civil penalty in the amount
of one thousand, eight hundred dollars ($1,800.00).
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
65) Order Type and Number: Consent Order 22-36-FOOD
Order Date: May 13, 2022
Individual/Entity: Riveras Supermercado
Facility: Riveras Supermercado
Location: 1618 Airport Boulevard
West Columbia, SC 29169
Mailing Address: 1807 Decker Boulevard
Columbia, SC 29206
County: Lexington
Previous Orders: None
Permit Number: 32-211-07191
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: Riveras Supermercado (Individual/Entity) operates a restaurant
located in Lexington County, South Carolina. The Department conducted inspections on
February 22, 2022, March 4, 2022, and March 9, 2022. The Individual/Entity has violated
the South Carolina Retail Food Establishment Regulation as follows: failed to maintain the
premises free of insects, rodents, and other pests; and failed to ensure that refrigerated,
ready-to-eat, time/temperature control for safety foods were discarded if the temperature
and time combination exceeded seven (7) days or if the package was not properly date
marked.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of eight hundred dollars
($800.00). The Individual/Entity shall pay a civil penalty in the amount of eight hundred
dollars ($800.00).
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
66) Order Type and Number: Consent Order 22-62-FOOD
Order Date: May 13, 2022
Individual/Entity: Riveras Supermercado
Facility: Riveras Supermercado
Location: 1618 Airport Boulevard
West Columbia, SC 29169
Mailing Address: 1807 Decker Boulevard
Columbia, SC 29206
County: Lexington
Previous Orders: 22-36-FOOD ($800.00)
Permit Number: 32-211-07191
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: Riveras Supermercado (Individual/Entity) operates a restaurant located
in Lexington County, South Carolina. The Department conducted inspections on February
22, 2022, April 18, 2022, April 19, 2022, April 27, 2022, and May 5, 2022. The
Individual/Entity has violated the South Carolina Retail Food Establishment Regulation as
follows: failed to ensure that a person in charge is certified by a food protection manager
certification program that is recognized by the Conference for Food Protection; failed to
ensure that a person in charge is certified by a food handler certification program that is
recognized by the Conference for Food Protection; and failed to maintain the premises free
of insects, rodents, and other pests.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of three thousand, two
hundred fifty dollars ($3,250.00). The Individual/Entity shall pay a civil penalty in the
amount of three thousand, two hundred fifty dollars ($3,250.00).
Update: On June 16, 2022, the Department issued a payment demand letter for the
outstanding civil penalty.
67) Order Type and Number: Consent Order 22-40-FOOD
Order Date: May 19, 2022
Individual/Entity: Persis Biryani Grill
Facility: Persis Biryani Grill
Location: 1728 Bush River Road
Columbia, SC 29210
Mailing Address: Same
County: Lexington
Previous Orders: 22-07-FOOD ($400.00)
Permit Number: 32-206-06984
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: Persis Biryani Grill (Individual/Entity) operates a restaurant located in
Lexington County, South Carolina. The Department conducted an inspection on April 5,
2022. The Individual/Entity has violated the South Carolina Retail Food Establishment
Regulation as follows: failed to maintain the premises free of insects, rodents, and other
pests.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of five hundred dollars
($500.00). The Individual/Entity shall pay a civil penalty in the amount of five hundred
dollars ($500.00) by June 22, 2022.
Update: If payment is not received by June 22, 2022, the Department will issue a
payment demand letter for the outstanding civil penalty.
68) Order Type and Number: Consent Order 22-39-FOOD
Order Date: May 20, 2022
Individual/Entity: Irene’s of Newberry
Facility: Irene’s of Newberry
Location: 2895 Main Street
Newberry, SC 29108
Mailing Address: Same
County: Newberry
Previous Orders: None
Permit Number: 36-206-01400
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: Irene’s of Newberry (Individual/Entity) operates a restaurant located in
Newberry County, South Carolina. The Department conducted a site visit on April 5, 2022.
The Individual/Entity has violated the South Carolina Retail Food Establishment
Regulation as follows: obscured, covered, defaced, relocated, or removed the grade decal
that was posted by the Department.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of five hundred dollars
($500.00). The Individual/Entity shall pay a civil penalty in the amount of five hundred
dollars ($500.00).
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
69) Order Type and Number: Consent Order 22-32-FOOD
Order Date: May 23, 2022
Individual/Entity: El Titanic American & Mexican
Facility: El Titanic American & Mexican
Location: 605 South Main Street
Belton, SC 29627
Mailing Address: Same
County: Anderson
Previous Orders: 2017-206-01-003 ($800.00);
2018-206-01-001 ($2,000.00);
2018-206-01-056 ($1,000.00);
2019-206-01-067 ($2,750.00)
Permit Number: 04-206-02961
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: El Titanic American & Mexican (Individual/Entity) operates a
restaurant located in Anderson County, South Carolina. The Department conducted
inspections on December 9, 2021, December 15, 2021, February 17, 2022, and March 2,
2022. The Individual/Entity has violated the South Carolina Retail Food Establishment
Regulation as follows: failed to properly cool cooked time/temperature control for safety
foods; and failed to ensure that refrigerated, ready-to-eat, time/temperature control for
safety foods were discarded if the temperature and time combination exceeded seven (7)
days or if the package was not properly date marked.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of two thousand dollars
($2,000.00). The Individual/Entity shall pay a civil penalty in the amount of two thousand
dollars ($2,000.00).
Update: The Individual/Entity is current on their payment plan.
70) Order Type and Number: Consent Order 22-47-FOOD
Order Date: May 23, 2022
Individual/Entity: Fatz
Facility: Fatz
Location: 1615 Sandifer Boulevard
Seneca, SC 29678
Mailing Address: 1361 W. Wade Hampton Blvd., Suite F #6
Greer, SC 29650
County: Oconee
Previous Orders: None
Permit Number: 37-206-01321
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: Fatz (Individual/Entity) operates a restaurant located in Oconee County,
South Carolina. The Department conducted inspections on March 22, 2022, April 1, 2022,
and April 8, 2022. The Individual/Entity has violated the South Carolina Retail Food
Establishment Regulation as follows: failed to maintain the premises free of insects,
rodents, and other pests.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of four hundred dollars
($400.00). The Individual/Entity shall pay a civil penalty in the amount of four hundred
dollars ($400.00) by June 28, 2022.
Update: If payment is not received by June 28, 2022, the Department will issue a
payment demand letter for the outstanding civil penalty.
71) Order Type and Number: Consent Order 22-57-FOOD
Order Date: May 24, 2022
Individual/Entity: Bangkok House
Facility: Bangkok House
Location: 318 North Kings Highway
Myrtle Beach, SC 29577
Mailing Address: Same
County: Horry
Previous Orders: 2017-206-06-034 ($800.00)
Permit Number: 26-206-08947
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: Bangkok House (Individual/Entity) operates a restaurant located in
Horry County, South Carolina. The Department conducted inspections on March 24, 2022,
April 1, 2022, and April 8, 2022. The Individual/Entity has violated the South Carolina
Retail Food Establishment Regulation as follows: failed to maintain the premises free of
insects, rodents, and other pests.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of five hundred dollars
($500.00). The Individual/Entity shall pay a civil penalty in the amount of five hundred
dollars ($500.00).
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
72) Order Type and Number: Consent Order 22-45-FOOD
Order Date: May 26, 2022
Individual/Entity: Bojangles #912
Facility: Bojangles #912
Location: 4131 Clemson Boulevard
Anderson, SC 29621
Mailing Address: 7750 North MacArthur Boulevard, Suite
120-223
Irving, TX 75063
County: Anderson
Previous Orders: 22-04-FOOD ($1,000.00)
Permit Number: 04-206-04727
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: Bojangles #912 (Individual/Entity) operates a restaurant located in
Anderson County, South Carolina. The Department conducted inspections on March 23,
2022, March 29, 2022, and April 7, 2022. The Individual/Entity has violated the South
Carolina Retail Food Establishment Regulation as follows: failed to convey sewage to the
point of disposal through an approved sanitary sewage system or other system, including
use of sewage transport vehicles, waste retention tanks, pumps, pipes, hoses, and
connections that are constructed, maintained, and operated according to law.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of one thousand dollars
($1,000.00). The Individual/Entity shall pay a civil penalty in the amount of one thousand
dollars ($1,000.00) by June 28, 2022.
Update: If payment is not received by June 28, 2022, the Department will issue a
payment demand letter for the outstanding civil penalty.
73) Order Type and Number: Consent Order 22-56-FOOD
Order Date: May 26, 2022
Individual/Entity: Fujisan Sushi
Facility: Fujisan Sushi
Location: 3501 Belle Terre Boulevard
Myrtle Beach, SC 29579
Mailing Address: 1422 Bloomfield Avenue
Sante Fe Springs, CA 90670
County: Horry
Previous Orders: None
Permit Number: 26-206-14380
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: Fujisan Sushi (Individual/Entity) operates a restaurant located in Horry
County, South Carolina. The Department conducted inspections on March 28, 2022, April
7, 2022, and April 15, 2022. The Individual/Entity has violated the South Carolina Retail
Food Establishment Regulation as follows: failed to ensure employees wash hands after
engaging in activities that contaminate their hands; and failed to comply with the Hazard
Analysis and Critical Control Point (HACCP) plan and procedures that are submitted and
approved as a basis for the modification or waiver; and maintain and provide to the
Department, upon request, records that demonstrate the HACCP plan is being employed.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of eight hundred dollars
($800.00). The Individual/Entity shall pay a civil penalty in the amount of eight hundred
dollars ($800.00).
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
74) Order Type and Number: Consent Order 22-60-FOOD
Order Date: May 26, 2022
Individual/Entity: Coastal Crust
Facility: Coastal Crust
Location: 218 Scott Street
Mount Pleasant, SC 29464
Mailing Address: 219 Simmons Street
Mount Pleasant, SC 29464
County: Charleston
Previous Orders: None
Permit Number: 10-206-09744
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: Coastal Crust (Individual/Entity) operates a restaurant located in
Charleston County, South Carolina. The Department conducted inspections on April 4,
2022, April 14, 2022, and April 21, 2022. The Individual/Entity has violated the South
Carolina Retail Food Establishment Regulation as follows: failed to ensure that
time/temperature control for safety food was maintained at a temperature of 41 degrees F
and below or 135 degrees F and above, except during preparation, cooking, or cooling.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of eight hundred dollars
($800.00). The Individual/Entity shall pay a civil penalty in the amount of eight hundred
dollars ($800.00).
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
75) Order Type and Number: Consent Order 22-38-FOOD
Order Date: May 31, 2022
Individual/Entity: Holiday Inn Express & Suites
Facility: Holiday Inn Express & Suites
Location: 300 North Creek Boulevard
Greenwood, SC 29649
Mailing Address: 109 Destination Boulevard
Anderson, SC 29621
County: Greenwood
Previous Orders: None
Permit Number: 24-206-03103
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: Holiday Inn Express & Suites (Individual/Entity) operates a restaurant
located in Greenwood County, South Carolina. The Department conducted inspections on
March 16, 2022, March 24, 2022, and April 1, 2022. The Individual/Entity has violated the
South Carolina Retail Food Establishment Regulation as follows: failed to ensure that
time/temperature control for safety foods were maintained at a temperature of 41 degrees
F and below or 135 degrees F and above, except during preparation, cooking, or cooling.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of eight hundred dollars
($800.00). The Individual/Entity shall pay a civil penalty in the amount of eight hundred
dollars ($800.00) by July 5, 2022.
Update: If payment is not received by July 5, 2022, the Department will issue a
payment demand letter for the outstanding civil penalty.
76) Order Type and Number: Consent Order 22-54-FOOD
Order Date: May 31, 2022
Individual/Entity: San Jose
Facility: San Jose
Location: 1937 Augusta Highway
Lexington, SC 29072
Mailing Address: 107 Maple Road
Lexington, SC 29073
County: Lexington
Previous Orders: None
Permit Number: 32-206-07325
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: San Jose (Individual/Entity) operates a restaurant located in Lexington
County, South Carolina. The Department conducted inspections on November 9, 2021,
March 22, 2022, April 1, 2022, April 8, 2022, and April 29, 2022. The Individual/Entity
has violated the South Carolina Retail Food Establishment Regulation as follows: failed to
ensure that physical facilities were maintained in good repair; and failed to ensure that the
floor and wall junction was coved and closed to no larger than one (1) thirty-second inch
(1 mm).
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of four hundred dollars
($400.00). The Individual/Entity shall pay a civil penalty in the amount of four hundred
dollars ($400.00).
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
77) Order Type and Number: Consent Order 22-61-FOOD
Order Date: May 31, 2022
Individual/Entity: La Bendicion
Facility: La Bendicion
Location: 1251 Boston Avenue
West Columbia, SC 29170
Mailing Address: Same
County: Lexington
Previous Orders: None
Permit Number: 32-206-07278
Violations Cited: S.C. Code Ann. Regs. 61-25
Summary: La Bendicion (Individual/Entity) operates a restaurant located in
Lexington County, South Carolina. The Department conducted inspections on February
15, 2022, February 24, 2022, April 14, 2022, and April 22, 2022. The Individual/Entity has
violated the South Carolina Retail Food Establishment Regulation as follows: failed to
ensure that time/temperature control for safety food was maintained at a temperature of 41
degrees F and below or 135 degrees F and above, except during preparation, cooking, or
cooling.
Action: The Individual/Entity is required to operate and maintain the facility in
accordance with the requirements of all applicable regulations, including S.C. Regs. 61-
25. The Department has assessed a total civil penalty in the amount of one thousand, six
hundred dollars ($1,600.00). The Individual/Entity shall pay a civil penalty in the amount
of one thousand, six hundred dollars ($1,600.00).
Update: The Individual/Entity is current on their payment plan.
On-Site Wastewater Enforcement
78) Order Type and Number: Administrative Order 22-009-OSWW
Order Date: March 15, 2022
Individual/Entity: Tabitha Stancil
Facility: Tabitha Stancil
Location: Eleven Oaks Drive
Westminster, SC 29693
Mailing Address: Multiple
County: Oconee
Previous Orders: None
Permit Number: None
Violations Cited: S.C. Code Ann. Regs. 61-56
Summary: Tabitha Stancil (Individual/Entity) owns property located in Oconee
County, South Carolina. The Department conducted an investigation on December 12,
2021, and observed a camper occupied for more than two hours per day without an
approved means of domestic wastewater treatment and disposal. The Individual/Entity has
violated the South Carolina Onsite Wastewater (OSWW) Systems Regulation as follows:
failed to ensure that any building, dwelling, or other structure occupied for more than two
hours per day was connected to an approved method of domestic wastewater treatment and
disposal.
Action: The Individual/Entity is required to apply for a Permit to construct an
OSWW system within five (5) days; or immediately vacate the camper to eliminate the
flow of domestic wastewater. The Department has assessed a total civil penalty in the
amount of five thousand dollars ($5,000.00). The Individual/Entity shall pay a suspended
penalty in the amount of five thousand dollars ($5,000.00) should any requirement of the
Order not be met.
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
79) Order Type and Number: Administrative Order 22-010-OSWW
Order Date: March 15, 2022
Individual/Entity: Teresa Page
Facility: Teresa Page
Location: Tory Hill Road
Loris, SC 29569
Mailing Address: 11601 Cowpoke Circle
Lusby, MD 29657
County: Horry
Previous Orders: None
Permit Number: None
Violations Cited: S.C. Code Ann. Regs. 61-56
Summary: Teresa Page (Individual/Entity) owns property located in Horry County,
South Carolina. The Department conducted an investigation on February 1, 2022, and
observed a camper being occupied for more than two hours per day without being
connected to an approved method of domestic wastewater treatment and disposal. The
Individual/Entity has violated the South Carolina Onsite Wastewater (OSWW) Systems
Regulation as follows: failed to ensure that a unit, dwelling, or other structure is occupied
for more than two hours per day without being connected to an approved method of
domestic wastewater treatment and disposal.
Action: The Individual/Entity is required to apply for a Permit to construct an
OSWW system within five (5) days; or immediately vacate the camper to eliminate the
flow of domestic wastewater. The Department has assessed a total civil penalty in the
amount of five thousand dollars ($5,000.00). The Individual/Entity shall pay a suspended
penalty in the amount of five thousand dollars ($5,000.00) should any requirement of the
Order not be met.
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
80) Order Type and Number: Administrative Order 22-012-OSWW
Order Date: March 15, 2022
Individual/Entity: Harold Gault
Facility: Harold Gault
Location: 23 Pecan Street
Pacolet, SC 29372
Mailing Address: P.O. Box 244
Pacolet Mills, SC 29373
County: Spartanburg
Previous Orders: None
Permit Number: None
Violations Cited: S.C. Code Ann. Regs. 61-56
Summary: Harold Gault (Individual/Entity) owns property located in Spartanburg
County, South Carolina. The Department conducted an investigation on February 23, 2022,
and observed domestic wastewater discharging onto the surface of the ground. The
Individual/Entity has violated the South Carolina Onsite Wastewater (OSWW) Systems
Regulation as follows: failed to ensure that no septic tank effluent, domestic wastewater,
or sewage was discharged to the surface of the ground without an appropriate permit from
the Department.
Action: The Individual/Entity is required to repair the OSWW system within five
(5) days to effectively stop the discharging of septic tank effluent, domestic wastewater, or
sewage to the surface of the ground; or immediately vacate the residence to eliminate the
flow of domestic wastewater to the OSWW system. The Department has assessed a total
civil penalty in the amount of five thousand dollars ($5,000.00). The Individual/Entity shall
pay a suspended penalty in the amount of five thousand dollars ($5,000.00) should any
requirement of the Order not be met.
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
81) Order Type and Number: Administrative Order 22-013-OSWW
Order Date: March 21, 2022
Individual/Entity: John W. Mize
Facility: John W. Mize
Location: 120 and 121 Dwaine Road
Belton, SC 29627
Mailing Address: 110 Lockaby Drive
Pelzer, SC 29669
County: Anderson
Previous Orders: None
Permit Number: None
Violations Cited: S.C. Code Ann. Regs. 61-56
Summary: John W. Mize (Individual/Entity) owns property located in Anderson
County, South Carolina. The Department conducted an investigation on November 2, 2021
and observed domestic wastewater discharging onto the surface of the ground from a
residence and a camper that was being occupied for more than two hours per day without
being connected to an approved method of domestic wastewater treatment and disposal.
The Individual/Entity has violated the South Carolina Onsite Wastewater (OSWW)
Systems Regulation as follows: failed to ensure that no septic tank effluent, domestic
wastewater, or sewage was discharged to the surface of the ground without an appropriate
permit from the Department; and failed to ensure that any building, dwelling, unit, or other
structure occupied for more than two hours per day was connected to an approved method
of domestic wastewater treatment and disposal.
Action: The Individual/Entity is required to repair the OSWW system and
plumbing within five (5) days to effectively stop the discharging of septic tank effluent,
domestic wastewater, or sewage to the surface of the ground; and apply for a Permit to
Construct an OSWW system for the camper within five (5) days of execution of the order;
or immediately vacate the residence and camper to eliminate the flow of domestic
wastewater to the surface of the ground. The Department has assessed a total civil penalty
in the amount of five thousand dollars ($5,000.00). The Individual/Entity shall pay a
suspended penalty in the amount of five thousand dollars ($5,000.00) should any
requirement of the Order not be met.
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
82) Order Type and Number: Administrative Order 22-014-OSWW
Order Date: March 23, 2022
Individual/Entity: Boscaglia Properties, LLC
Facility: Boscaglia Properties, LLC
Location: 22 Country Meadow Lane
Lexington, SC 29073
Mailing Address: 900 Bonhomme Richard Road
Lexington, SC 29072
County: Lexington
Previous Orders: None
Permit Number: None
Violations Cited: S.C. Code Ann. Regs. 61-56
Summary: Boscaglia Properties, LLC (Individual/Entity) owns property located in
Lexington County, South Carolina. The Department conducted an investigation on
February 2, 2022 and observed domestic wastewater discharging onto the surface of the
ground. The Individual/Entity has violated the South Carolina Onsite Wastewater
(OSWW) Systems Regulation as follows: failed to ensure that no septic tank effluent,
domestic wastewater, or sewage was discharged to the surface of the ground without an
appropriate permit from the Department.
Action: The Individual/Entity is required to repair the OSWW system within five
(5) days to effectively stop the discharging of septic tank effluent, domestic wastewater, or
sewage to the surface of the ground; or immediately vacate the residence to eliminate the
flow of domestic wastewater to the OSWW system. The Department has assessed a total
civil penalty in the amount of five thousand dollars ($5,000.00). The Individual/Entity shall
pay a suspended penalty in the amount of five thousand dollars ($5,000.00) should any
requirement of the Order not be met.
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
83) Order Type and Number: Administrative Order 22-017-OSWW
Order Date: April 19, 2022
Individual/Entity: Cynthia York
Facility: Cynthia York
Location: 66 Executive Drive
Greeleyville, SC 29056
Mailing Address: Same
County: Williamsburg
Previous Orders: None
Permit Number: None
Violations Cited: S.C. Code Ann. Regs. 61-56
Summary: Cynthia York (Individual/Entity) owns property located in
Williamsburg County, South Carolina. The Department conducted an investigation on
February 8, 2022 and observed domestic wastewater discharging onto the surface of the
ground. The Individual/Entity has violated the South Carolina Onsite Wastewater
(OSWW) Systems Regulation as follows: failed to ensure that no septic tank effluent,
domestic wastewater, or sewage was discharged to the surface of the ground without an
appropriate permit from the Department.
Action: The Individual/Entity is required to repair the OSWW system within five
(5) days to effectively stop the discharging of septic tank effluent, domestic wastewater, or
sewage to the surface of the ground; or immediately vacate the residence to eliminate the
flow of domestic wastewater to the OSWW system. The Department has assessed a total
civil penalty in the amount of five thousand dollars ($5,000.00). The Individual/Entity shall
pay a suspended penalty in the amount of five thousand dollars ($5,000.00) should any
requirement of the Order not be met.
Update: A demand letter sent to the Individual/Entity on June 16, 2022.
84) Order Type and Number: Administrative Order 22-018-OSWW
Order Date: April 19, 2022
Individual/Entity: Rickey Steen and Tina Steen
Facility: Rickey Steen and Tina Steen
Location: 99 Cooper Road
Whitmire, SC 29178
Mailing Address: 48 Cooper Road
Whitmire, SC 29178
County: Newberry
Previous Orders: None
Permit Number: None
Violations Cited: S.C. Code Ann. Regs. 61-56
Summary: Rickey Steen and Tina Steen (Individual/Entity) owns property located
in Newberry County, South Carolina. The Department conducted an investigation on
March 8, 2022 and observed domestic wastewater discharging onto the surface of the
ground. The Individual/Entity has violated the South Carolina Onsite Wastewater
(OSWW) Systems Regulation as follows: failed to ensure that no septic tank effluent,
domestic wastewater, or sewage was discharged to the surface of the ground without an
appropriate permit from the Department.
Action: The Individual/Entity is required to repair the OSWW system within five
(5) days to effectively stop the discharging of septic tank effluent, domestic wastewater, or
sewage to the surface of the ground; or immediately vacate the residence to eliminate the
flow of domestic wastewater to the OSWW system. The Department has assessed a total
civil penalty in the amount of five thousand dollars ($5,000.00). The Individual/Entity shall
pay a suspended penalty in the amount of five thousand dollars ($5,000.00) should any
requirement of the Order not be met.
Update: Department staff spoke with the licensed OSWW contractor who stated
he has scheduled the repairs to the OSWW system for the week of June 20
th
, 2022.
85) Order Type and Number: Administrative Order 22-021-OSWW
Order Date: April 19, 2022
Individual/Entity: Christopher Lipscomb and Mary
Lipscomb
Facility: Christopher Lipscomb and Mary Lipscomb
Location: 601 Sharpe Road
Columbia, SC 29203
Mailing Address: Same
County: Richland
Previous Orders: None
Permit Number: None
Violations Cited: S.C. Code Ann. Regs. 61-56
Summary: Christopher Lipscomb and Mary Lipscomb (Individual/Entity) own
property located in Richland County, South Carolina. The Department conducted an
investigation on February 2, 2022 and observed domestic wastewater discharging onto the
surface of the ground. The Individual/Entity has violated the South Carolina Onsite
Wastewater (OSWW) Systems Regulation as follows: failed to ensure that no septic tank
effluent, domestic wastewater, or sewage was discharged to the surface of the ground
without an appropriate permit from the Department.
Action: The Individual/Entity is required to repair the OSWW system within five
(5) days to effectively stop the discharging of septic tank effluent, domestic wastewater, or
sewage to the surface of the ground; or immediately vacate the residence to eliminate the
flow of domestic wastewater to the OSWW system. The Department has assessed a total
civil penalty in the amount of five thousand dollars ($5,000.00). The Individual/Entity shall
pay a suspended penalty in the amount of five thousand dollars ($5,000.00) should any
requirement of the Order not be met.
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
86) Order Type and Number: Administrative Order 22-023-OSWW
Order Date: April 19, 2022
Individual/Entity: Paula Wise, Personal Representative for
the Estate of Anna Wise
Facility: Paula Wise, Personal Representative for the
Estate of Anna Wise
Location: 118 Glasgow Drive
Prosperity, SC 29127
Mailing Address: 1230 Pebblebrook Drive
Newberry, SC 29108
County: Newberry
Previous Orders: None
Permit Number: None
Violations Cited: S.C. Code Ann. Regs. 61-56
Summary: Paula Wise, Personal Representative for the Estate of Anna Wise
Individual/Entity); owns property located in Newberry County, South Carolina. The
Department conducted an investigation on February 22, 2022 and observed domestic
wastewater discharging onto the surface of the ground. The Individual/Entity has violated
the South Carolina Onsite Wastewater (OSWW) Systems Regulation as follows: failed to
ensure that no septic tank effluent, domestic wastewater, or sewage was discharged to the
surface of the ground without an appropriate permit from the Department.
Action: The Individual/Entity is required to repair the OSWW system within five
(5) days to effectively stop the discharging of septic tank effluent, domestic wastewater, or
sewage to the surface of the ground; or immediately vacate the residence to eliminate the
flow of domestic wastewater to the OSWW system. The Department has assessed a total
civil penalty in the amount of five thousand dollars ($5,000.00). The Individual/Entity shall
pay a suspended penalty in the amount of five thousand dollars ($5,000.00) should any
requirement of the Order not be met.
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
87) Order Type and Number: Administrative Order 22-029-OSWW
Order Date: May 12, 2022
Individual/Entity: Tita Investments
Facility: Tita Investments
Location: 316 Starling Drive, Mobile Home #2
Hopkins, SC 29061
Mailing Address: P.O. Box 9286
Columbia, SC 29290
County: Richland
Previous Orders: None
Permit Number: None
Violations Cited: S.C. Code Ann. Regs. 61-56
Summary: Tita Investments (Individual/Entity) owns property located in Richland
County, South Carolina. The Department conducted an investigation on April 4, 2022 and
observed domestic wastewater discharging onto the surface of the ground. The
Individual/Entity has violated the South Carolina Onsite Wastewater (OSWW) Systems
Regulation as follows: failed to ensure that no septic tank effluent, domestic wastewater,
or sewage was discharged to the surface of the ground without an appropriate permit from
the Department.
Action: The Individual/Entity is required to repair the OSWW system within five
(5) days to effectively stop the discharging of septic tank effluent, domestic wastewater, or
sewage to the surface of the ground; or immediately vacate the residence to eliminate the
flow of domestic wastewater to the OSWW system. The Department has assessed a total
civil penalty in the amount of five thousand dollars ($5,000.00). The Individual/Entity shall
pay a suspended penalty in the amount of five thousand dollars ($5,000.00) should any
requirement of the Order not be met.
Update: A licensed contractor is scheduled to repair the week of June 20, 2022.
88) Order Type and Number: Consent Order 22-016-OSWW
Order Date: April 1, 2022
Individual/Entity: Complete Well Drilling and Septic
Tank/Kellie Sharpe
Facility: Complete Well Drilling and Septic
Tank/Kellie Sharpe
Location: Saluda Shores Circle, Lot 40
Leesville, SC 29070
Mailing Address: 1543 Swansea Road
Pelion, SC 29123
County: Saluda
Previous Orders: None
Permit Number: None
Violations Cited: S.C. Code Ann. Regs. 61-56
Summary: Complete Well Drilling and Septic Tank/Kellie Sharpe
(Individual/Entity) Home Comfort Systems, LLC (Individual/Entity) installed an OSWW
system at property located in Saluda County, South Carolina. The Department conducted
an inspection on February 24, 2022 and determined that the OSWW system was installed
inconsistent with the permit and S.C. Reg 61-56. The Individual/Entity has violated the
South Carolina Onsite Wastewater (OSWW) Systems Regulation as follows: installed an
OSWW system outside the requirements of the permit, with the vertical separation between
the deepest point of effluent and the zone of saturation being less than six inches, with less
than seven feet of undisturbed dirt between the wastewater infiltration trenches, and with
less than two feet of earthen buffer between the septic tank and all portions of the adjacent
wastewater infiltration trenches.
Action: The Individual/Entity is required to cease and desist installing OSWW
systems inconsistent with the requirements of the Department issued Permit to Construct
and S.C. Reg 61-56. The Department has assessed a total civil penalty in the amount of
two thousand dollars ($2,000.00). The Individual/Entity shall pay a civil penalty in the
amount of two thousand dollars ($2,000.00).
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
89) Order Type and Number: Consent Order 22-019-OSWW
Order Date: May 5, 2022
Individual/Entity: Michelle Wilson, d.b.a. Wilson’s Septic
Tanks Service
Facility: Michelle Wilson, d.b.a. Wilson’s Septic
Tanks Service
Location: P.O. Box 1506
Hartsville, SC 29551
Mailing Address: Same
County: Darlington
Previous Orders: None
Permit Number: None
Violations Cited: S.C. Code Ann. Regs. 61-56
Summary: Michelle Wilson, d.b.a. Wilson’s Septic Tanks Service
(Individual/Entity) installed three OSWW systems in Darlington County, South Carolina.
The Department conducted a review of documents during January 2022 and determined
that not enough aggregate was installed at all three sites. The Individual/Entity has violated
the South Carolina Onsite Wastewater (OSWW) Systems Regulation as follows: failed to
ensure that all systems for which the licensee is responsible are constructed, repaired, and
cleaned in accordance with S.C. Regulation 61-56 and Permits issued by the Department.
Action: The Individual/Entity is required to cease and desist constructing OSWW
systems not in accordance with S.C. Regulation 61-56 and Permits issued by the
Department. The Department has assessed a total civil penalty in the amount of one
thousand, five hundred dollars ($1,500.00). The Individual/Entity shall pay a civil penalty
in the amount of one thousand, five hundred dollars ($1,500.00).
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
90) Order Type and Number: Consent Order 22-030-OSWW
Order Date: May 5, 2022
Individual/Entity: Calvin Randolph
Facility: Calvin Randolph
Location: 1861 Old Collins Creek Road
McClellanville, SC 29458
Mailing Address: Same
County: Charleston
Previous Orders: None
Permit Number: None
Violations Cited: S.C. Code Ann. Regs. 61-56
Summary: Calvin Randolph (Individual/Entity) installed an OSWW system in
Charleston County, South Carolina. The Department conducted an investigation on
February 9, 2022 and determined that the Individual/Entity does not hold a Department
issued license to construct OSWW systems and that the Department was not contacted to
inspect the installation. The Individual/Entity has violated the South Carolina Onsite
Wastewater (OSWW) Systems Regulation as follows: engaged in the business of
constructing and repairing onsite sewage treatment systems without first applying for,
receiving, and subsequently maintaining a valid license to conduct such activities, as
required by the Department.
Action: The Individual/Entity is required to cease and desist engaging in the
business of constructing and repairing onsite sewage treatment systems without first
applying for, receiving, and subsequently maintaining a valid license to conduct such
activities, as required by the Department. The Department has assessed a total civil penalty
in the amount of five hundred dollars ($500.00). The Individual/Entity shall pay a civil
penalty in the amount of five hundred dollars ($500.00).
Update: On June 15, 2022, Department staff issued a payment demand letter for
the outstanding civil penalty.
91) Order Type and Number: Consent Order 22-033-OSWW
Order Date: May 24, 2022
Individual/Entity: Ivan Rusev, d.b.a. Rock Solid Excavation
Services, LLC
Facility: Ivan Rusev, d.b.a. Rock Solid Excavation
Services, LLC
Location: 140 Wilkins Road
Campobello, SC 29322
Mailing Address: Same
County: Cherokee
Previous Orders: None
Permit Number: None
Violations Cited: S.C. Code Ann. Regs. 61-56
Summary: Ivan Rusev, d.b.a. Rock Solid Excavation Services, LLC
(Individual/Entity) installed an OSWW system in Cherokee County, South Carolina. The
Department conducted an investigation on February 10, 2022 and determined that the
Individual/Entity installed portions of the OSWW system deeper than allowed on the
permit. The Individual/Entity has violated the South Carolina Onsite Wastewater (OSWW)
Systems Regulation as follows: failed to ensure that all systems for which the licensee is
responsible are constructed in accordance with S.C. Regulation 61-56 and permits issued
by the Department.
Action: The Individual/Entity is required to cease and desist allowing systems for
which the licensee is responsible to be constructed in a manner not in accordance with S.C.
Regulation 61-56 and Permits issued by the Department. The Department has assessed a
total civil penalty in the amount of five hundred dollars ($500.00). The Individual/Entity
shall pay a civil penalty in the amount of five hundred dollars ($500.00).
Update: The Individual/Entity has met all requirements of the Order. This Order
has been closed.
* Unless otherwise specified, “Previous Orders” as listed in this report include orders
issued by Environmental Affairs Programs within the last five (5) years.
SUMMARY SHEET
SOUTH CAROLINA BOARD OF HEALTH AND ENVIRONMENTAL CONTROL
June 29, 2022
( X ) ACTION/DECISION
( ) INFORMATION
I. TITLE: Request for Placement of Ganaxolone in Schedule V for Controlled Substances in South
Carolina
II. SUBJECT: Placement of Ganaxolone in Schedule V for Controlled Substances
III. FACTS:
Controlled substances are governed by the South Carolina Controlled Substances Act, Title 44, Chapter 53
of the South Carolina Code of Laws. Schedule V substances are listed in Section 44-53-270 of the South
Carolina Code of Laws. Pursuant to Section 44-53-160, titled “Manner in which changes in schedule of
controlled substances shall be made,” controlled substances are generally designated by the General
Assembly upon recommendation by the Department. Section 44-53-160(C) provides a process for the
Department to expeditiously designate a substance if the federal government has so designated.
South Carolina Code Section 44-53-160(C) states:
If a substance is added, deleted, or rescheduled as a controlled substance pursuant to federal
law or regulation, the department shall, at the first regular or special meeting of the South
Carolina Board of Health and Environmental Control within thirty days after publication
in the federal register of the final order designating the substance as a controlled substance
or rescheduling or deleting the substance, add, delete, or reschedule the substance in the
appropriate schedule. The addition, deletion, or rescheduling of a substance by the
department pursuant to this subsection has the full force of law unless overturned by the
General Assembly. The addition, deletion, or rescheduling of a substance by the
department pursuant to this subsection must be in substance identical with the order
published in the federal register effecting the change in federal status of the substance.
Upon the addition, deletion, or rescheduling of a substance, the department shall forward
copies of the change to the Chairmen of the Medical Affairs Committee and the Judiciary
Committee of the Senate, the Medical, Military, Public and Municipal Affairs Committee,
and the Judiciary Committee of the House of Representatives, and to the Clerks of the
Senate and House, and shall post the schedules on the department's website indicating the
change and specifying the effective date of the change.
On March 18, 2022, the United States Food and Drug Administration (“FDA”) approved a new drug
application (“NDA”) for ZTALMY, an oral suspension of ganaxolone, for the treatment of seizures
associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder in patients two years of age
and older. The Department of Health and Human Services (“HHS”) provided the Drug Enforcement
Administration (“DEA”) with a scheduling recommendation to place ganaxolone and its salts in schedule
V of the Controlled Substances Act (“CSA”).
In accordance with the CSA, as amended by the Improving Regulatory Transparency for New Medical
Therapies Act, DEA is hereby issuing an interim final rule placing ganaxolone, including its salts in
schedule V of the CSA. This rule has an effective date of June 1, 2022, Federal Register, Volume 87,
Number 105, pages 32991-32996; https://www.govinfo.gov/content/pkg/FR-2022-06-01/pdf/2022-
11735.pdf.
IV. ANALYSIS:
Ganaxolone (3α-hydroxy-3β-methyl-5α-pregnan-20-one) is a new molecular entity with central nervous
system activity. Ganaxolone is a neuroactive positive allosteric modulator of gammaaminobutyric acid
type-A receptors and an inhibitory neurosteroidal substance that shares structural features and a
pharmacological mechanism of action with progesterone and schedule IV depressants alfaxalone and
brexanolone.
On March 14, 2022, DEA received from HHS a scientific and medical evaluation entitled “Basis for the
Recommendation to Control Ganaxolone and its Salts in Schedule V of the Controlled Substances Act” and
a scheduling recommendation. Pursuant to 21 U.S.C. 811(b) and (c), this document contained an eight-
factor analysis of the abuse potential, legitimate medical use, and dependence liability of ganaxolone, along
with HHS’s recommendation to control ganaxolone and its salts under schedule V of the CSA.
In response, DEA reviewed the scientific and medical evaluation and scheduling recommendation provided
by HHS, along with all other relevant data, and completed its own eight-factor review pursuant to 21 U.S.C.
811(c). DEA concluded that ganaxolone meets the 21 U.S.C. 812(b)(5) criteria for placement in schedule
V of the CSA. Pursuant to subsection 811(j), and based on HHS’ scheduling recommendation, the approval
of the NDA by HHS/FDA, and DEA’s determination, DEA is issuing this interim final rule to schedule
ganaxolone as a schedule V controlled substance under the CSA.
The CSA lists the findings required to place a drug or other substance in any particular schedule (I, II, III,
IV, or V). 21 U.S.C. 812(b). After consideration of the analysis and recommendation of the Assistant
Secretary for Health of HHS and review of all available data, the Administrator of DEA (“Administrator”),
pursuant to 21 U.S.C. 812(b)(4), finds that:
1) Ganaxolone has a low potential for abuse relative to the drugs or other substances in schedule
IV.
2) Ganaxolone has a currently accepted medical use in treatment in the United States.
3) Abuse of ganaxolone may lead to limited physical dependence or psychological dependence
relative to the drugs or other substances in schedule IV.
V. RECOMMENDATION:
Pursuant to S.C. Code Section 44-53-160(C), the Department recommends placing ganaxolone and its salts
in schedule V and the amendment of Section 44-53-270 of the South Carolina Controlled Substances Act
to include:
( ) Ganaxolone (3α-hydroxy-3β-methyl-5α-pregnan-20-one)
Submitted by:
_______________________________ ___________________________________
Lisa Thomson Gwen Thompson
Director, Bureau of Drug Control Director for Healthcare Quality
Attachment:
Federal Register, Volume 87, Number 105, June 1, 2022
32991
Federal Register / Vol. 87, No. 105 / Wednesday, June 1, 2022 / Rules and Regulations
8
R.J. Reynolds Tobacco Co., No. 6:20–cv–00176
(E.D. Tex. February 10, 2022) (order postponing
effective date), Doc. No. 94.
9
R.J. Reynolds Tobacco Co., No. 6:20–cv–00176
(E.D. Tex. May 10, 2022) (order postponing effective
date), Doc. No. 96.
additional 90 days.
8
On May 10, 2022,
the court issued another order to
postpone the effective date of the final
rule by an additional 90 days.
9
The
court ordered that the new effective date
of the final rule is July 8, 2023. Pursuant
to the court order, any obligation to
comply with a deadline tied to the
effective date is similarly postponed,
and those obligations and deadlines are
now tied to the postponed effective
date.
To the extent that 5 U.S.C. 553 applies
to this action, the Agency’s
implementation of this action without
opportunity for public comment,
effective immediately upon publication
today in the Federal Register, is based
on the good cause exception in 5 U.S.C.
553(b)(B). Seeking public comment is
impracticable, unnecessary, and
contrary to the public interest. The 90-
day postponement of the effective date,
until July 8, 2023, is required by court
order in accordance with the court’s
authority to postpone a rule’s effective
date pending judicial review (5 U.S.C.
705). Seeking prior public comment on
this postponement would have been
impracticable, as well as contrary to the
public interest in the orderly issuance
and implementation of regulations.
Dated: May 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–11568 Filed 5–31–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–990]
Schedules of Controlled Substances:
Placement of Ganaxolone in Schedule
V
AGENCY
: Drug Enforcement
Administration, Department of Justice.
ACTION
: Interim final rule; request for
comments.
SUMMARY
: On March 18, 2022, the
United States Food and Drug
Administration approved a new drug
application for ZTALMY, an oral
suspension of ganaxolone, for the
treatment of seizures associated with
cyclin-dependent kinase-like 5
deficiency disorder in patients two
years of age and older. The Department
of Health and Human Services provided
the Drug Enforcement Administration
with a scheduling recommendation to
place ganaxolone and its salts in
schedule V of the Controlled Substances
Act. In accordance with the Controlled
Substances Act, as amended by the
Improving Regulatory Transparency for
New Medical Therapies Act, Drug
Enforcement Administration is hereby
issuing an interim final rule placing
ganaxolone, including its salts in
schedule V of the Controlled Substances
Act.
DATES
: This rule is effective June 1,
2022. Comments must be submitted
electronically or postmarked on or
before July 1, 2022. Interested persons
may file written comments on this
rulemaking in accordance with 21
U.S.C. 811(j)(3) and 21 CFR 1308.43(g).
Commenters should be aware that the
electronic Federal Docket Management
System will not accept comments after
11:59 p.m. Eastern Time on the last day
of the comment period.
Interested persons may file a request
for a hearing or waiver of a hearing in
accordance with 21 U.S.C. 811(j)(3) and
21 CFR 1308.44. Requests for a hearing
and waivers of an opportunity for a
hearing or to participate in a hearing
must be received on or before July 1,
2022.
ADDRESSES
: To ensure proper handling
of comments, please reference ‘‘Docket
No. DEA–990’’ on all correspondence,
including any attachments.
• Electronic comments: The Drug
Enforcement Administration (DEA)
encourages that all comments be
submitted electronically through the
Federal eRulemaking Portal, which
provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to http://
www.regulations.gov and follow the
online instructions at that site for
submitting comments. Upon completion
of your submission, you will receive a
Comment Tracking Number for your
comment. Submitted comments are not
instantaneously available for public
view on Regulations.gov. If you have
received a Comment Tracking Number,
your comment has been successfully
submitted and there is no need to
resubmit the same comment.
• Paper comments: Paper comments
that duplicate electronic submissions
are not necessary and are discouraged.
Should you wish to mail a paper
comment in lieu of an electronic
comment, it should be sent via regular
or express mail to: Drug Enforcement
Administration, Attn: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, VA
22152.
• Hearing requests: All requests for a
hearing and waivers of participation,
together with a written statement of
position on the matters of fact and law
asserted in the hearing, must be sent to:
Drug Enforcement Administration, Attn:
Hearing Clerk/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152. All
requests for hearing and waivers of
participation should also be sent to: (1)
Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive,
Springfield, Virginia 22152; and (2)
Drug Enforcement Administration, Attn:
DEA Federal Register Representative/
DPW, 8701 Morrissette Drive,
Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT
:
Terrence L. Boos, Drug & Chemical
Evaluation Section, Diversion Control
Division, Drug Enforcement
Administration; Telephone: (571) 362–
3249.
SUPPLEMENTARY INFORMATION
:
Posting of Public Comments
Please note, all comments received in
response to this docket are considered
part of the public record. The Drug
Enforcement Administration (DEA) will
make comments available, unless
reasonable cause is given, for public
inspection online at http://
www.regulations.gov. Such information
includes personal identifying
information (such as your name,
address, etc.) voluntarily submitted by
the commenter. The Freedom of
Information Act applies to all comments
received. If you want to submit personal
identifying information (such as your
name, address, etc.) as part of your
comment, but do not want DEA to make
it publicly available, you must include
the phrase ‘‘PERSONAL IDENTIFYING
INFORMATION’’ in the first paragraph
of your comment. You must also place
all of the personal identifying
information you do not want made
publicly available in the first paragraph
of your comment and identify what
information you want redacted.
If you want to submit confidential
business information as part of your
comment, but do not want DEA to make
it publicly available, you must include
the phrase ‘‘CONFIDENTIAL BUSINESS
INFORMATION’’ in the first paragraph
of your comment. You must also
prominently identify the confidential
business information to be redacted
within the comment.
DEA will generally make available in
publicly redacted form comments
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1
Given the parameters of subsection (j), in DEA’s
view, it would not apply to a reformulation of a
drug containing a substance currently in schedules
II through V for which an NDA has recently been
approved.
2
https://www.accessdata.fda.gov/drugsatfda_
docs/label/2022/215904s000lbl.pdf. Date accessed
March 28, 2022.
containing personal identifying
information and confidential business
information identified, as directed
above. If a comment has so much
confidential business information or
personal identifying information that
DEA cannot effectively redact it, DEA
may not make available publicly all or
part of that comment. Comments posted
to http://www.regulations.gov may
include any personal identifying
information (such as name, address, and
phone number) included in the text of
your electronic submission that is not
identified as confidential as directed
above.
An electronic copy of this document
and supplemental information to this
interim final rule (IFR) are available at
http://www.regulations.gov for easy
reference.
Request for Hearing or Appearance;
Waiver
Pursuant to 21 U.S.C. 811(a), this
action is a formal rulemaking ‘‘on the
record after opportunity for a hearing.’’
Such proceedings are conducted
pursuant to the provisions of the
Administrative Procedure Act (APA), 5
U.S.C. 551–559. 21 CFR 1308.41–
1308.45; 21 CFR part 1316, subpart D.
Interested persons may file requests for
a hearing or notices of intent to
participate in a hearing in conformity
with the requirements of 21 CFR
1308.44(a) or (b), and such requests
must include a statement of the person’s
interests in the proceeding and the
objections or issues, if any, concerning
which the person desires to be heard. 21
CFR 1316.47(a). Any interested person
may file a waiver of an opportunity for
a hearing or to participate in a hearing
together with a written statement
regarding the interested person’s
position on the matters of fact and law
involved in any hearing as set forth in
21 CFR 1308.44(c).
All requests for hearings and waivers
of participation, together with a written
statement of position on the matters of
fact and law involved in such hearing,
must be sent to DEA using the address
information provided above.
Background and Legal Authority
Under the Controlled Substances Act
(CSA), as amended in 2015 by the
Improving Regulatory Transparency for
New Medical Therapies Act (section
2(b) of Publ. L. 114–89), DEA is required
to commence an expedited scheduling
action with respect to certain new drugs
approved by the Food and Drug
Administration (FDA). As provided in
21 U.S.C. 811(j), this expedited
scheduling is required where both of the
following conditions apply: (1) The
Secretary of the Department of Health
and Human Services (HHS) has advised
DEA that a New Drug Application
(NDA) has been submitted for a drug
that has a stimulant, depressant, or
hallucinogenic effect on the central
nervous system (CNS), and that it
appears that such drug has an abuse
potential; and (2) the Secretary of HHS
recommends that DEA control the drug
in schedule II, III, IV, or V pursuant to
21 U.S.C. 811(a) and (b). In these
circumstances, DEA is required to issue
an interim final rule (IFR) controlling
the drug within 90 days.
Subsection (j)(2) states that the 90-day
timeframe starts the later of (1) the date
DEA receives HHS’ scientific and
medical evaluation/scheduling
recommendation, or (2) the date DEA
receives notice of the NDA approval by
HHS. Subsection (j)(3) specifies that the
rulemaking shall become immediately
effective as an IFR without requiring
DEA to demonstrate good cause
therefore. Thus, the purpose of
subsection (j) is to speed the process by
which DEA schedules newly approved
drugs that are currently either in
schedule I or not controlled (but which
have sufficient abuse potential to
warrant control) so that such drugs may
be marketed without undue delay
following FDA approval.
1
Subsection (j)(3) further provides that
the IFR shall give interested persons the
opportunity to comment and to request
a hearing. After the conclusion of such
proceedings, DEA must issue a final rule
in accordance with the scheduling
criteria of 21 U.S.C. 811(b) through (d)
and 812(b).
Ganaxolone (3a-hydroxy-3b-methyl-
5a-pregnan-20-one) is a new molecular
entity (NME) with CNS activity.
Ganaxolone is a neuroactive positive
allosteric modulator of gamma-
aminobutyric acid type-A (GABA-A)
receptors and an inhibitory
neurosteroidal substance that shares
structural features and a
pharmacological mechanism of action
with progesterone and schedule IV
depressants alfaxalone and brexanolone.
On July 20, 2021, Marinus
Pharmaceuticals, Inc. (Sponsor)
submitted an NDA for ganaxolone to
FDA. On March 18, 2022, DEA received
notification that FDA, on the same date,
approved the NDA for ZTALMY
(ganaxolone oral suspension), under
section 505(c) of the Federal Food, Drug,
and Cosmetic Act (FDCA), for the
treatment of seizures associated with
cyclin-dependent kinase-like 5 (CDKL5)
deficiency disorder (CDD) in patients
two years of age and older. Pursuant to
its FDA-approved prescription drug
labeling, ZTALMY is to be administered
orally three times daily (TID) with food
on a titration schedule through a dose-
escalation protocol over the first 3
weeks of drug administration. Patients
weighing 28 kg or less receive a final
dose of 21 mg/kg TID (63 mg/kg/day)
and patients weighing more than 28 kg
receive a final dose of 600 mg TID (1800
mg/day).
2
Determination To Schedule Ganaxolone
On March 14, 2022, DEA received
from HHS a scientific and medical
evaluation entitled ‘‘Basis for the
Recommendation to Control Ganaxolone
and its Salts in Schedule V of the
Controlled Substances Act’’ and a
scheduling recommendation. Pursuant
to 21 U.S.C. 811(b) and (c), this
document contained an eight-factor
analysis of the abuse potential,
legitimate medical use, and dependence
liability of ganaxolone, along with
HHS’s recommendation to control
ganaxolone and its salts under schedule
V of the CSA.
In response, DEA reviewed the
scientific and medical evaluation and
scheduling recommendation provided
by HHS, along with all other relevant
data, and completed its own eight-factor
review pursuant to 21 U.S.C. 811(c).
DEA concluded that ganaxolone meets
the 21 U.S.C. 812(b)(5) criteria for
placement in schedule V of the CSA.
Pursuant to subsection 811(j), and
based on HHS’ scheduling
recommendation, the approval of the
NDA by HHS/FDA, and DEA’s
determination, DEA is issuing this IFR
to schedule ganaxolone as a schedule V
controlled substance under the CSA.
Included below is a brief summary of
each factor as analyzed by HHS and
DEA, and as considered by DEA in its
scheduling action. Please note that both
DEA and HHS analyses are available in
their entirety under ‘‘Supporting
Documents’’ in the public docket for
this IFR at http://www.regulations.gov,
under Docket Number ‘‘DEA–990.’’ Full
analysis of, and citations to, the
information referenced in the summary
may also be found in the supporting and
related material.
1. Its Actual or Relative Potential for
Abuse
Ganaxolone is an NME that has not
been marketed in the United States or
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NFLIS is a comprehensive information system
that includes data from forensic laboratories that
handle more than 96% of an estimated 1.0 million
distinct annual State and local drug analysis cases.
NFLIS includes drug chemistry results from
completed analyses only. While NFLIS data is not
direct evidence of abuse, it can lead to an inference
that a drug has been diverted and abused. See 76
FR 77330, 77332, Dec. 12, 2011. NFLIS data were
queried on January 18, 2022.
any country. Thus, evidence regarding
its diversion, illicit manufacturing, or
deliberate ingestion is currently lacking.
DEA notes that there are no reports of
law enforcement encounters of
ganaxolone in the National Forensic
Laboratory Information System (NFLIS)
database,
3
which collects drug cases
submitted to and analyzed by state and
local forensic laboratories. Ganaxolone
has sedative effects and is likely to have
abuse potential, although less than that
of schedule IV sedatives such as
lorazepam. Thus, it is reasonable to
assume that ganaxolone may be diverted
from legitimate channels, used contrary
to or without medical advice, and
capable of creating hazards to the users
and to the safety of the community. In
preclinical and clinical studies,
ganaxolone produced effects that are
less than that of schedule IV sedative
drugs such as methohexital and
lorazepam. Ganaxolone produced
positive subjective responses and
euphoria-related adverse events (AEs)
that were significantly greater than
placebo, but statistically less than that
of lorazepam (schedule IV) in healthy
humans, nondependent with a history
of recreational use of CNS depressants;
thus, it is likely to be abused for its
sedative effects contrary to medical
advice.
2. Scientific Evidence of Its
Pharmacological Effects, if Known
Ganaxolone shares a pharmacological
profile with other inhibitory
neurosteroids such as alfaxalone and
brexanolone, both schedule IV drugs.
Ganaxolone acts on GABA-A receptors
to enhance the effects of GABA, a major
inhibitory neurotransmitter in the CNS.
Data from in vitro binding studies
showed that ganaxolone had significant
affinity (greater than 96 percent) for the
GABA-chloride channels. Ganaxolone
did not show significant affinity (less
than 50 percent) for 47 other receptor
sites, ion channels, steroid sites, and
enzymes. The sites tested included
abuse-related sites such as dopamine
(D
1
and D
2
), serotonin (1a, 2a, and 2c),
cannabinoid (CB
1
and CB
2
), opioid (mu,
kappa, delta), glutamate (NMDA/AMPA,
phencyclidine, glycine, kainite), and
monoamine transporters (dopamine,
serotonin, or norepinephrine).
Functional activity studies showed that
ganaxolone potentiated GABA-evoked
chloride currents in Xenopus oocytes
expressing human GABA-A receptor
subunits.
In animal studies, orally-administered
ganaxolone’s effect on general
behavioral profile showed that it did not
produce behavioral activity that differed
significantly from the saline-treated
group. However, ganaxolone elicited
time-dependent (6-hour post treatment)
behavior changes such as abnormal gait,
grasping loss, abnormal righting reflex,
and low carriage indicative of the
sedative and muscle relaxation
properties of the drug. Ganaxolone’s
effect on motor coordination was
evaluated in three rotarod studies in
rats. The studies showed that
ganaxolone produced a dose-dependent
increase in the number of rats that failed
to maintain themselves on the rotarod,
indicative of its interference on motor
coordination. Ganaxolone produced a
dose-dependent decrease in locomotor
activity and loss of righting reflex.
In a drug discrimination study using
rats trained to discriminate midazolam
(schedule IV) and saline, oral doses of
ganaxolone (10 and 30 mg/kg) produced
full generalization to midazolam
stimuli. Ganaxolone’s reinforcing
properties were assessed by determining
whether self-administration behavior
was maintained when the drug was
substituted for heroin. Data from this
study showed that ganaxolone self-
administration was much less than that
of methohexital (schedule IV) and
heroin (schedule I) and was numerically
similar to saline. However, ganaxolone
at 0.10 mg/kg/injection dose produced
self-administration that was statistically
significantly greater than saline.
A randomized, double-blind, active-
and placebo-controlled, cross-over study
was conducted to determine the abuse
potential for ganaxolone in healthy,
nondependent, recreational CNS
depressant users. Oral doses of
ganaxolone were compared to an oral
dose of lorazepam (schedule IV, served
as the positive control). The lower and
middle doses of ganaxolone (400 mg
and 800 mg, respectively) produced
responses within or just outside the
acceptable placebo range and were
statistically similar to placebo.
However, the highest dose of
ganaxolone (2000 mg) produced a drug
liking score that was significantly
different from placebo. The three doses
of ganaxolone tested produced drug
liking scores that were significantly
lower than that of lorazepam. In
addition, all three oral doses of
ganaxolone (400, 800, and 2000 mg)
produced responses on all other positive
subjective measures (bipolar visual
analog scale for Overall Drug Liking,
High, Good Effects, and Take Drug
Again) that were statistically less than
those produced by 6 mg oral dose of
lorazepam.
In 23 Phase 1 clinical safety studies
that were conducted using healthy
individuals, eight of the studies showed
that ganaxolone produced euphoria-
related AEs at all doses tested. Of the
eight studies, three were repeat-dose
studies and five were acute-dose
studies. From the three repeat-dose
studies, 24 of 64 subjects who received
ganaxolone reported euphoria-related
AEs at any dose tested, compared to 0
of 17 subjects who received placebo. Of
the five acute-dose studies, euphoria-
related AEs were reported by 8 of the
101 subjects who received ganaxolone at
any dose tested, compared to 1 of 12
subjects who received placebo. Most of
the euphoria-related AEs following
ganaxolone administration were mild in
severity. In Phase 2/3 clinical studies
conducted with ganaxolone in either
epilepsy patients or post-traumatic
stress disorder patients, the degree of
euphoria-related AEs could not be
determined because all subjects in these
studies were concurrently taking
antiepileptic drugs (epilepsy patients) or
benzodiazepines (post-traumatic stress
disorder patients). Because many
antiepileptic drugs and benzodiazepines
are known to produce euphoria and
sedation, and are often controlled in
schedule IV of the CSA, their use in
human subjects confounds interpreting
any ganaxolone euphoria-related AEs
that may be reported during these
clinical studies. However, in one of the
three clinical studies conducted in
patients with migraine, euphoria was
reported in 3 of the 163 subjects who
received a single 750 mg oral dose of
ganaxolone (1.8 percent, 2 moderate, 1
severe), compared to 1 of 164 subjects
who received placebo (0.6 percent, 1
mild).
In summary, ganaxolone produced
incidence of euphoria-related AEs
supportive of its abuse potential. In
animal studies, ganaxolone produced
interoceptive cues that were similar to
those of midazolam, a schedule IV
depressant, and these data are
consistent with the fact that both drugs
share a common mechanism of action
involving positive allosteric modulation
of the GABA-A receptors. In self-
administration studies conducted in
animals, ganaxolone produced
rewarding effects, but its self-
administration was lower than
methohexital (schedule IV) and heroin
(schedule I) injections. As mentioned by
HHS, in clinical studies, ganaxolone
produced an 8.8 percent incidence of
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euphoria-like AEs, including euphoria,
thinking abnormal, feeling drunk, and
depersonalization, across acute doses of
300 to 1,500 mg/day and repeat doses of
400 to 2,250 mg/day, as compared to
that of placebo (2.3 percent) in healthy
individuals.
3. The State of Current Scientific
Knowledge Regarding the Drug or Other
Substance
Ganaxolone, chemically known as 3a-
hydroxy-3b-methyl-5a-pregnan-20-one,
is an NME. It is a structural derivative
of allopregnanolone (also known as
brexanolone, schedule IV). Ganaxolone
is structurally different from
brexanolone by the presence of an extra
methyl group at the 3b-position. It is
insoluble in water, slightly soluble in
methanol, ethanol, isopropanol, ethyl
acetate, and toluene (5 to 25 mg/mL at
20 degrees Celsius), and soluble in N,N-
dimethylacetamide. Ganaxolone is a
drug product formulated as a 50 mg/mL
white to off-white immediate release
oral suspension in water and is
administered by mouth TID with food.
Ganaxolone is absorbed with a time to
peak plasma concentration of 2.0 to 3.0
hours following oral administration. It
undergoes first pass metabolism
following oral administration with 10
percent bioavailability. It is
approximately 99 percent protein bound
in serum and has a terminal half-life at
steady state of about 8–10 hours.
As discussed in the background
section, ganaxolone has an accepted
medical use in the United States.
4. Its History and Current Pattern of
Abuse
There is no information on the history
and current pattern of abuse for
ganaxolone, since it has not been
marketed, legally or illegally, in the
United States or any other country.
There is no evidence of diversion of
ganaxolone that has been distributed for
research, such as for clinical trials. Data
from preclinical and clinical studies
indicate that the abuse potential of
ganaxolone is less than that of schedule
IV CNS depressants such as
methohexital and lorazepam. Consistent
with the fact that ganaxolone is an NME,
the NFLIS database had no records of
encounters by law enforcement.
In summary, pharmacological data on
ganaxolone show that it produces abuse-
related AEs and has an abuse potential
less than that of schedule IV CNS
depressants.
5. The Scope, Duration, and
Significance of Abuse
Data from preclinical and clinical
studies showed that ganaxolone has an
abuse potential that is less than that of
schedule IV depressants. Thus,
ganaxolone has a low potential for abuse
relative to substances in schedule IV. A
search by DEA of the NFLIS database
found no evidence of law enforcement
encounters of ganaxolone in the United
States. Because ganaxolone is a positive
allosteric modulator of GABA-A
receptors and has abuse potential, upon
availability of ganaxolone in the market,
it is likely to be abused.
6. What, if any, Risk There Is to the
Public Health
Ganaxolone’s abuse potential,
although less than that of schedule IV
depressants, is an indication of its
public health risk. As such, upon
availability for marketing, it is likely to
pose risk to public health comparable to
drugs in schedule V. According to
information mentioned in the
prescription product label for ZTALMY
(ganaxolone), concomitant use of
opioids, antidepressants, or other CNS
depressants such as alcohol may
potentiate incidence of somnolence and
sedation in patients receiving
ganaxolone. The abuse of ganaxolone
may present risks to the public health at
a level similar to those associated with
the abuse of CNS depressants.
7. Its Psychic or Physiological
Dependence Liability
Ganaxolone’s psychic and
physiological dependence liability was
assessed using data from a rat physical
dependence study and human data. A
physical dependence study was not
conducted in clinical studies because
abrupt discontinuation of an
antiepileptic drug in epileptic patients
presents serious safety concerns. As
described by HHS, data from a
physiologic dependence study
conducted in rats demonstrated that
chronic administration of ganaxolone
produced a decrease in body weight and
changes in behavior that included
ataxia, rearing, escape attempts from the
cage, increased body tone, increased
locomotor activity, increased reaction to
sound, explosive movements, and
piloerection. Decreases in body weight,
food and water intake, and increased
body temperature were observed upon
discontinuation of ganaxolone. During
ganaxolone discontinuation, 5 of 10 rats
showed behaviors that included
increased locomotor activity, increased
reaction to sound, hunched posture, and
piloerection. Further, since ganaxolone
produced positive subjective responses
and euphoria-related AEs in human
subjects, it is likely that it may produce
psychic dependence.
In summary, data from animal studies
demonstrate that chronic administration
of ganaxolone produces signs or
symptoms of withdrawal upon
discontinuation. Ganaxolone produces
physical dependence.
8. Whether the Substance Is an
Immediate Precursor of a Substance
Already Controlled Under the CSA
Ganaxolone is not an immediate
precursor of any controlled substance,
as defined by 21 U.S.C. 802(23).
Conclusion: After considering the
scientific and medical evaluation and
scheduling recommendation provided
by HHS, and its own eight-factor
analysis, DEA has determined that these
facts and all relevant data constitute
substantial evidence of potential for
abuse of ganaxolone. As such, DEA
hereby schedules ganaxolone as a
controlled substance under the CSA.
Determination of Appropriate Schedule
The CSA lists the findings required to
place a drug or other substance in any
particular schedule (I, II, III, IV, or V).
21 U.S.C. 812(b). After consideration of
the analysis and recommendation of the
Assistant Secretary for Health of HHS
and review of all available data, the
Administrator of DEA (Administrator),
pursuant to 21 U.S.C. 812(b)(5), finds
that:
(1) Ganaxolone has a low potential for
abuse relative to the drugs or other
substances in schedule IV.
Ganaxolone, a neuroactive steroid, is
a positive allosteric modulator of
GABA-A receptors and produces
sedation in general behavioral studies
including rotarod and locomotion
studies. In a drug discrimination study
in animals, ganaxolone generalized to
midazolam (schedule IV), demonstrating
it has GABA-A receptor agonist
properties. In a self-administration
study in animals, ganaxolone self-
administration was significantly
different from saline, but was less than
that of methohexital (schedule IV) and
heroin (schedule I). Ganaxolone
produced positive subjective responses
and euphoria-related AEs less than that
of lorazepam (schedule IV), but greater
than that of placebo in a human abuse
potential study. Furthermore, data from
pharmacokinetic clinical studies show
that ganaxolone produced incidence of
euphoria in 8.8 percent of healthy
individuals as compared to 2.3 percent
incidence following placebo. Therefore,
ganaxolone has some potential for
abuse, but it is low relative to
lorazepam, methohexital and other
substances in schedule IV.
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(2) Ganaxolone has a currently
accepted medical use in treatment in
the United States.
FDA recently approved the NDA for
ZTALMY (ganaxolone) as an oral
adjunctive therapy for the treatment of
an epilepsy condition, cyclin-
dependent, kinase-like 5 deficiency
disorder, in patients aged two years and
older. Thus, ganaxolone has a currently
accepted medical use in treatment in the
United States.
(3) Abuse of ganaxolone may lead to
limited physical dependence or
psychological dependence relative to
the drugs or other substances in
schedule IV.
Ganaxolone shares a similar
pharmacology profile with brexanolone
(schedule IV). Data from a rat physical
dependence study demonstrated that
discontinuation of chronic
administration of ganaxolone produced
withdrawal syndrome. Thus, abuse of
ganaxolone may lead to limited physical
dependence. Further, because
ganaxolone produced positive
subjective responses and euphoria-
related AEs, it may produce psychic
dependence. However, there were fewer
reports of euphoria-related AEs
associated with ganaxolone than
lorazepam (schedule IV). Ganaxolone
may lead to limited physical or
psychological dependence relative to
other substances in schedule IV.
Based on these findings, the
Administrator concludes that
ganaxolone warrants control in schedule
V of the CSA. 21 U.S.C. 812(b)(5).
Requirements for Handling Ganaxolone
Ganaxolone is subject to the CSA’s
schedule V regulatory controls and
administrative, civil, and criminal
sanctions applicable to the manufacture,
distribution, reverse distribution,
dispensing, importing, exporting,
research, and conduct of instructional
activities and chemical analysis with,
and possession involving schedule V
substances, including the following:
1. Registration. Any person who
handles (manufactures, distributes,
reverse distributes, dispenses, imports,
exports, engages in research, or
conducts instructional activities or
chemical analysis with, or possesses), or
who desires to handle, ganaxolone must
be registered with DEA to conduct such
activities pursuant to 21 U.S.C. 822,
823, 957, and 958 and in accordance
with 21 CFR parts 1301 and 1312. Any
person who currently handles or
intends to handle ganaxolone and is not
registered with DEA must submit an
application for registration and may not
continue to handle ganaxolone unless
DEA has approved that application,
pursuant to 21 U.S.C. 822, 823, 957, and
958, and in accordance with 21 CFR
parts 1301 and 1312. These registration
requirements, however, are not
applicable to patients (end users) who
possess ganaxolone pursuant to a lawful
prescription.
2. Disposal of stocks. Any person
unwilling or unable to obtain a schedule
V registration to handle ganaxolone, but
who subsequently does not desire or is
not able to maintain such registration
must surrender all quantities of
currently held ganaxolone, or may
transfer all quantities of currently held
ganaxolone to a person registered with
DEA. Ganaxolone is required to be
disposed of in accordance with 21 CFR
part 1317, in addition to all other
applicable Federal, state, local, and
tribal laws.
3. Security. Ganaxolone is subject to
schedule III–V security requirements for
DEA registrants, and it must be handled
and stored in accordance with 21 CFR
1301.71–1301.77. Non-practitioners
handling ganaxolone must also comply
with the employee screening
requirements of 21 CFR 1301.90–
1301.93. These requirements, however,
are not applicable to patients (end users)
who possess ganaxolone pursuant to a
lawful prescription.
4. Labeling and Packaging. All labels,
labeling, and packaging for commercial
containers of ganaxolone must comply
with 21 U.S.C. 825 and 958(e), and be
in accordance with 21 CFR part 1302.
5. Inventory. Every DEA registrant
who possesses any quantity of
ganaxolone must take an inventory of
ganaxolone on hand, pursuant to 21
U.S.C. 827 and 958, and in accordance
with 21 CFR 1304.03, 1304.04, and
1304.11(a) and (d).
Any person who registers with DEA to
handle ganaxolone must take an initial
inventory of all stocks of controlled
substances (including ganaxolone) on
hand on the date the registrant first
engages in the handling of controlled
substances, pursuant to 21 U.S.C. 827
and 958(e), and in accordance with 21
CFR 1304.03, 1304.04, and 1304.11(a)
and (b).
After the initial inventory, every DEA
registrant must take an inventory of all
stocks of controlled substances
(including ganaxolone) on hand every
two years, pursuant to 21 U.S.C. 827
and 958(e), and in accordance with 21
CFR 1304.03, 1304.04, and 1304.11.
These requirements, however, are not
applicable to patients (end users) who
possess ganaxolone pursuant to a lawful
prescription.
6. Records and Reports. DEA
registrants must maintain records and
submit reports for ganaxolone, pursuant
to 21 U.S.C. 827, 832(a), and 958(e), and
in accordance with 21 CFR 1301.74(b)
and (c) and parts 1304, 1312, and 1317.
7. Prescriptions. All prescriptions for
ganaxolone, or products containing
ganaxolone, must comply with 21
U.S.C. 829, and be issued in accordance
with 21 CFR parts 1306 and 1311,
subpart C.
8. Manufacturing and Distributing. In
addition to the general requirements of
the CSA and DEA regulations that are
applicable to manufacturers and
distributors of schedule V controlled
substances, such registrants should be
advised that (consistent with the
foregoing considerations) any
manufacturing or distribution of
ganaxolone may only be for the
legitimate purposes consistent with the
drug’s labeling, or for research activities
authorized by the FDCA, as applicable,
and the CSA.
9. Importation and Exportation. All
importation and exportation of
ganaxolone must comply with 21 U.S.C.
952, 953, 957, and 958, and be in
accordance with 21 CFR part 1312.
10. Liability. Any activity involving
ganaxolone not authorized by, or in
violation of, the CSA or its
implementing regulations, is unlawful,
and may subject the person to
administrative, civil, and/or criminal
sanctions.
Regulatory Analyses
Administrative Procedure Act
Section 553 of the APA (5 U.S.C. 553)
generally requires notice and comment
for rulemakings. However, 21 U.S.C.
811(j) provides that in cases where a
certain new drug is (1) approved by
HHS, under section 505(c) of the FDCA
and (2) HHS recommends control in
CSA schedule II–V, DEA shall issue an
IFR scheduling the drug within 90 days.
As stated in the legal authority section,
the 90-day time frame is the later of: (1)
The date DEA receives HHS’s scientific
and medical evaluation/scheduling
recommendation, or (2) the date DEA
receives notice of the NDA approval by
HHS. Additionally, subsection (j)
specifies that the rulemaking shall
become immediately effective as an IFR
without requiring DEA to demonstrate
good cause.
Executive Orders 12866 (Regulatory
Planning and Review) and 13563
(Improving Regulation and Regulatory
Review)
In accordance with 21 U.S.C. 811(a)
and (j), this scheduling action is subject
to formal rulemaking procedures
performed ‘‘on the record after
opportunity for a hearing,’’ which are
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conducted pursuant to the provisions of
5 U.S.C. 556 and 557. The CSA sets
forth the procedures and criteria for
scheduling a drug or other substance.
Such actions are exempt from review by
the Office of Management and Budget
(OMB) pursuant to section 3(d)(1) of
Executive Order (E.O.) 12866 and the
principles reaffirmed in E.O. 13563.
Executive Order 12988, Civil Justice
Reform
This regulation meets the applicable
standards set forth in sections 3(a) and
3(b)(2) of E.O. 12988 to eliminate
drafting errors and ambiguity, minimize
litigation, provide a clear legal standard
for affected conduct, and promote
simplification and burden reduction.
Executive Order 13132, Federalism
This rulemaking does not have
federalism implications warranting the
application of E.O. 13132. The rule does
not have substantial direct effects on the
States, on the relationship between the
national government and the States, or
on the distribution of power and
responsibilities among the various
levels of government.
Executive Order 13175, Consultation
and Coordination With Indian Tribal
Governments
This rule does not have tribal
implications warranting the application
of E.O. 13175. It does not have
substantial direct effects on one or more
Indian tribes, on the relationship
between the Federal government and
Indian tribes, or on the distribution of
power and responsibilities between the
Federal government and Indian tribes.
Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA)
(5 U.S.C. 601–612) applies to rules that
are subject to notice and comment
under section 553(b) of the APA. As
noted in the above discussion regarding
the applicability of the APA, DEA is not
required to publish a general notice of
proposed rulemaking. Consequently, the
RFA does not apply to this IFR.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded
Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1501 et seq., DEA has
determined that this action would not
result in any Federal mandate that may
result ‘‘in the expenditure by State,
local, and tribal governments, in the
aggregate, or by the private sector, of
$100,000,000 or more (adjusted
annually for inflation) in any 1 year.’’
Therefore, neither a Small Government
Agency Plan nor any other action is
required under UMRA of 1995.
Paperwork Reduction Act of 1995
This action does not impose a new
collection of information requirement
under the Paperwork Reduction Act of
1995. 44 U.S.C. 3501–3521. This action
would not impose recordkeeping or
reporting requirements on State or local
governments, individuals, businesses, or
organizations. An agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
Congressional Review Act
This rule is not a major rule as
defined by the Congressional Review
Act (CRA), 5 U.S.C. 804. However,
pursuant to the CRA, DEA is submitting
a copy of this IFR to both Houses of
Congress and to the Comptroller
General.
List of Subjects in 21 CFR Part 1308
Administrative practice and
procedure, Drug traffic control,
Reporting and recordkeeping
requirements.
For the reasons set out above, DEA
amends 21 CFR part 1308 as follows:
PART 1308—SCHEDULES OF
CONTROLLED SUBSTANCES
■ 1. The authority citation for 21 CFR
part 1308 continues to read as follows:
Authority: 21 U.S.C. 811, 812, 871(b),
956(b) unless otherwise noted.
■ 2. In §1308.15:
■ a. Redesignate paragraphs (e)(4)
through (6) as paragraphs (e)(5) through
(7); and
■ b. Add new paragraph (e)(4).
The addition reads as follows:
§ 1308.15 Schedule V.
* * * * *
(e) * * *
(4) Ganaxolone (3a-hydroxy-3b-methyl-5a-pregnan-20-one) ........................................................................................................... 2401
* * * * *
Anne Milgram,
Administrator.
[FR Doc. 2022–11735 Filed 5–31–22; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–495]
Schedules of Controlled Substances:
Placement of N-Ethylhexedrone, alpha-
Pyrrolidinohexanophenone, 4-Methyl-
alpha-ethylaminopentiophenone, 4′-
Methyl-alpha-
pyrrolidinohexiophenone, alpha-
Pyrrolidinoheptaphenone, and 4′-
Chloro-alpha-
pyrrolidinovalerophenone in Schedule
I
AGENCY
: Drug Enforcement
Administration, Department of Justice.
ACTION
: Final rule.
SUMMARY
: By this rule, the Drug
Enforcement Administration
permanently places six synthetic
cathinones, as identified in this rule, in
schedule I of the Controlled Substances
Act. These six substances are currently
listed in schedule I pursuant to a
temporary scheduling order. As a result
of this rule, the regulatory controls and
administrative, civil, and criminal
sanctions applicable to schedule I
controlled substances on persons who
handle (manufacture, distribute, reverse
distribute, import, export, engage in
research, conduct instructional
activities or chemical analysis, or
possess) or propose to handle these six
specified controlled substances will
continue to apply.
DATES
: Effective June 1, 2022.
FOR FURTHER INFORMATION CONTACT
:
Terrence L. Boos, Drug and Chemical
Evaluation Section, Diversion Control
Division, Drug Enforcement
Administration; Telephone: (571) 362–
8207.
SUPPLEMENTARY INFORMATION
: In this
rule, the Drug Enforcement
Administration (DEA) is permanently
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SUMMARY SHEET
SOUTH CAROLINA BOARD OF HEALTH AND ENVIRONMENTAL CONTROL
June 29, 2022
( X ) ACTION/DECISION
( ) INFORMATION
I. TITLE: Request for Placement of Methoxetamine in Schedule I for Controlled Substances in South
Carolina
II. SUBJECT: Placement of Methoxetamine in Schedule I for Controlled Substances
III. FACTS:
Controlled substances are governed by the South Carolina Controlled Substances Act, Title 44, Chapter 53
of the South Carolina Code of Laws. Schedule I substances are listed in Section 44-53-190 of the South
Carolina Code of Laws. Pursuant to Section 44-53-160, titled “Manner in which changes in schedule of
controlled substances shall be made,” controlled substances are generally designated by the General
Assembly upon recommendation by the Department. Section 44-53-160(C) provides a process for the
Department to expeditiously designate a substance if the federal government has so designated.
South Carolina Code Section 44-53-160(C) states:
If a substance is added, deleted, or rescheduled as a controlled substance pursuant to federal
law or regulation, the department shall, at the first regular or special meeting of the South
Carolina Board of Health and Environmental Control within thirty days after publication
in the federal register of the final order designating the substance as a controlled substance
or rescheduling or deleting the substance, add, delete, or reschedule the substance in the
appropriate schedule. The addition, deletion, or rescheduling of a substance by the
department pursuant to this subsection has the full force of law unless overturned by the
General Assembly. The addition, deletion, or rescheduling of a substance by the
department pursuant to this subsection must be in substance identical with the order
published in the federal register effecting the change in federal status of the substance.
Upon the addition, deletion, or rescheduling of a substance, the department shall forward
copies of the change to the Chairmen of the Medical Affairs Committee and the Judiciary
Committee of the Senate, the Medical, Military, Public and Municipal Affairs Committee,
and the Judiciary Committee of the House of Representatives, and to the Clerks of the
Senate and House, and shall post the schedules on the department's website indicating the
change and specifying the effective date of the change.
On June 6, 2022, the Administrator of the Drug Enforcement Administration (“DEA”) issued a final rule
placing 2-(ethylamino)-2-(3-methoxyphenyl)cyclohexan-1-one (methoxetamine, MXE), including its salts,
isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible
within the specific chemical designation, in schedule I of the Controlled Substances Act (“CSA”) to enable
the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. This
action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to
schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import,
export, engage in research, conduct instructional activities or chemical analysis with, or possess), or propose
to handle, methoxetamine. This final rule was published on June 6, 2022, with an effective date of July 6,
2022, Federal Register, Volume 87, Number 108, pages 34166-34169;
https://www.govinfo.gov/content/pkg/FR-2022-06-06/pdf/2022-11933.pdf.
IV. ANALYSIS:
Methoxetamine, also known as 2-(ethylamino)-2-(3-methoxyphenyl)cyclohexan-1-one or 2-(3-
methoxyphenyl)-2-(N-ethylamino)cyclohexanone or MXE, belongs to the arylcyclohexylamine class of
drugs with dissociative anesthetic and hallucinogenic properties, similar to phencyclidine (PCP), a schedule
II controlled substance, and ketamine, a schedule III controlled substance. Methoxetamine has no approved
medical use in the United States. In March 2016, the Commission on Narcotic Drugs (“CND”) voted to
place methoxetamine in Schedule II of the 1971 Convention (CND Dec/59/6) during its 59th Session due
to its dependence and abuse potential.
On April 14, 2018, in accordance with 21 U.S.C. 811(b), and in response to DEA’s December 30, 2014,
request and April 14, 2017, submission of additional data, the Department of Health and Human Services
(“HHS”) provided to DEA a scientific and medical evaluation and scheduling recommendation for
methoxetamine. DEA reviewed the scientific and medical evaluation and scheduling recommendation for
schedule I placement provided by HHS, and all other relevant data, pursuant to 21 U.S.C. 811(b) and (c),
and conducted its own analysis under the eight factors stipulated in 21 U.S.C. 811(c). DEA found, under
21 U.S.C. 811(b)(1), that this substance warrants control in schedule I.
After consideration of the public comment, scientific and medical evaluation, and accompanying
recommendation of HHS, and after its own eight-factor evaluation, DEA finds that these facts and all
relevant data constitute substantial evidence of potential for abuse of methoxetamine. DEA is permanently
scheduling methoxetamine as a controlled substance under the CSA.
The CSA establishes five schedules of controlled substances known as schedules I, II, III, IV, and V. The
CSA also specifies the findings required to place a drug or other substance in any particular schedule, 21
U.S.C. 812(b). After consideration of the analysis and recommendation of the Acting Assistant Secretary
for Health of HHS and review of all other available data, the Administrator of DEA, pursuant to 21 U.S.C.
812(b)(1), finds that:
1) Methoxetamine has a high potential for abuse that is comparable to other scheduled substances
such as the ethylamine analog of phencyclidine (PCE; schedule I), the thiophene analog of
phencyclidine (TCP; schedule I), phencyclidine (PCP; schedule II), and ketamine (schedule III).
2) Methoxetamine has no currently accepted medical use in treatment in the United States.
3) There is a lack of accepted safety for use of methoxetamine under medical supervision. Because
methoxetamine has no approved medical use and has not been investigated as a new drug, its safety
for use under medical supervision has not been determined. Therefore, there is a lack of accepted
safety for use of methoxetamine under medical supervision.
V. RECOMMENDATION:
Pursuant to S.C. Code Section 44-53-160(C), the Department recommends placing Methoxetamine in
Schedule I in the same manner as the federal Drug Enforcement Administration. The listing includes its
salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is
possible within the specific chemical designation, to schedule I for controlled substances in South Carolina
and the amendment of Section 44-53-190 of the South Carolina Controlled Substances Act to include:
( ) 2-(ethylamino)-2-(3-methoxyphenyl)cyclohexan-1-one (methoxetamine, MXE)
Submitted by:
_______________________________ ___________________________________
Lisa Thomson Gwen Thompson
Director, Bureau of Drug Control Director for Healthcare Quality
Attachment:
Federal Register, Volume 87, Number 108, June 6, 2022
34166
Federal Register / Vol. 87, No. 108 / Monday, June 6, 2022 / Rules and Regulations
1
As discussed in a memorandum of
understanding entered into by the Food and Drug
Administration (FDA) and the National Institute on
Drug Abuse (NIDA), FDA acts as the lead agency
within HHS in carrying out the Secretary’s
scheduling responsibilities under the Controlled
Substances Act, with the concurrence of NIDA. 50
FR 9518 (March 8, 1985). The Secretary of HHS has
delegated to the Assistant Secretary for Health of
HHS the authority to make domestic drug
scheduling recommendations. 58 FR 35460 (July 1,
1993).
2
21 U.S.C. 811(d)(3).
thus avoid automatic classification in
class III, it would have to comply with
the special controls named in this final
order. The necessary special controls
appear in the regulation codified by this
order. This device is subject to
premarket notification requirements
under section 510(k) of the FD&C Act.
III. Analysis of Environmental Impact
The Agency has determined under 21
CFR 25.34(b) that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
IV. Paperwork Reduction Act of 1995
This final order establishes special
controls that refer to previously
approved collections of information
found in other FDA regulations and
guidance. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3521). The
collections of information in 21 CFR
part 860, subpart D, regarding De Novo
classification have been approved under
OMB control number 0910–0844; the
collections of information in 21 CFR
part 814, subparts A through E,
regarding premarket approval, have
been approved under OMB control
number 0910–0231; the collections of
information in part 807, subpart E,
regarding premarket notification
submissions, have been approved under
OMB control number 0910–0120; the
collections of information in 21 CFR
part 820, regarding quality system
regulation, have been approved under
OMB control number 0910–0073; and
the collections of information in 21 CFR
part 801, regarding labeling, have been
approved under OMB control number
0910–0485.
List of Subjects in 21 CFR Part 876
Medical devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 876 is
amended as follows:
PART 876—GASTROENTEROLOGY–
UROLOGY DEVICES
■ 1. The authority citation for part 876
continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
■ 2. Add §876.5026 to subpart F to read
as follows:
§ 876.5026 Non-implanted electrical
stimulation device for management of
premature ejaculation.
(a) Identification. A non-implanted
electrical stimulation device for
management of premature ejaculation is
intended to be used in patients with
premature ejaculation by delivery of
electrical stimulation to the perineal
muscles and nerves.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) The device must be demonstrated
to be biocompatible.
(2) Performance testing must
demonstrate the electromagnetic
compatibility, electrical safety, and
thermal safety of the device.
(3) Non-clinical performance testing
must demonstrate that the device
performs as intended under anticipated
conditions of use. The following
performance characteristics must be
tested:
(i) Mechanical performance;
(ii) Electrical stimulation parameters;
and
(iii) Battery performance.
(4) Performance testing must support
shelf life by demonstrating continued
device functionality over the identified
shelf life.
(5) Software verification, validation,
and hazard analysis must be performed.
(6) Labeling must include:
(i) Specific instructions regarding safe
placement and correct use of the device;
(ii) Warning(s) against use by patients
with active implanted medical devices;
and
(iii) A shelf life.
Dated: May 26, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–12082 Filed 6–3–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–568]
Schedules of Controlled Substances:
Placement of Methoxetamine (MXE) in
Schedule I
AGENCY
: Drug Enforcement
Administration, Department of Justice.
ACTION
: Final rule.
SUMMARY
: With the issuance of this final
rule, the Drug Enforcement
Administration places 2-(ethylamino)-2-
(3-methoxyphenyl)cyclohexan-1-one
(methoxetamine, MXE), including its
salts, isomers, and salts of isomers
whenever the existence of such salts,
isomers, and salts of isomers is possible
within the specific chemical
designation, in schedule I of the
Controlled Substances Act to enable the
United States to meet its obligations
under the 1971 Convention on
Psychotropic Substances. This action
imposes the regulatory controls and
administrative, civil, and criminal
sanctions applicable to schedule I
controlled substances on persons who
handle (manufacture, distribute, reverse
distribute, import, export, engage in
research, conduct instructional
activities or chemical analysis with, or
possess), or propose to handle,
methoxetamine.
DATES
: Effective July 6, 2022.
FOR FURTHER INFORMATION CONTACT
:
Terrence L. Boos, Drug & Chemical
Evaluation Section, Diversion Control
Division, Drug Enforcement
Administration; Telephone: (571) 362–
3249.
SUPPLEMENTARY INFORMATION
:
Legal Authority
The United States is a party to the
1971 United Nations Convention on
Psychotropic Substances (1971
Convention), February 21, 1971, 32
U.S.T. 543, 1019 U.N.T.S. 175, as
amended. Procedures respecting
changes in drug schedules under the
1971 Convention are governed
domestically by 21 U.S.C. 811(d)(2)–(4).
When the United States receives
notification of a scheduling decision
pursuant to Article 2 of the 1971
Convention indicating that a drug or
other substance has been added to a
specific schedule, the Secretary of the
Department Health and Human Services
(HHS),
1
after consultation with the
Attorney General, shall determine
whether existing legal controls under
subchapter I of the Controlled
Substances Act (CSA) and the Federal
Food, Drug, and Cosmetic Act meet the
requirements of the schedule specified
in the notification with respect to the
specific drug or substance.
2
In the event
that the Secretary of HHS did not
consult with the Attorney General, and
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28 CFR 0.100.
4
Although there is no evidence suggesting that
methoxetamine has a currently accepted medical
use in treatment in the United States, it bears noting
that a drug cannot be found to have such medical
use unless DEA concludes that it satisfies a five-part
test. Specifically, with respect to a drug that has not
been approved by FDA, to have a currently
accepted medical use in treatment in the United
States, all of the following must be demonstrated:
i. The drug’s chemistry must be known and
reproducible; ii. there must be adequate safety
studies; iii. there must be adequate and well-
controlled studies proving efficacy; iv. the drug
must be accepted by qualified experts; and v. the
scientific evidence must be widely available. 57 FR
10499 (1992), pet. for rev. denied, Alliance for
Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135
(D.C. Cir. 1994).
5
21 U.S.C. 812(b)(1).
the Attorney General did not issue a
temporary order, as provided under 21
U.S.C. 811(d)(4), the procedures for
permanent scheduling set forth in 21
U.S.C. 811(a) and (b) control. Pursuant
to 21 U.S.C. 811(a)(1), the Attorney
General may, by rule, schedule or
transfer between any schedules any
drug or other substance, if he finds that
such drug or other substance has a
potential for abuse, and makes the
findings prescribed by 21 U.S.C. 812(b)
to schedule the drug or other substance.
The Attorney General has delegated this
scheduling authority to the
Administrator of the Drug Enforcement
Administration (DEA).
3
Background
Methoxetamine, also known as 2-
(ethylamino)-2-(3-
methoxyphenyl)cyclohexan-1-one or 2-
(3-methoxyphenyl)-2-(N-
ethylamino)cyclohexanone or MXE,
belongs to the arylcyclohexylamine
class of drugs with dissociative
anesthetic and hallucinogenic
properties, similar to phencyclidine
(PCP), a schedule II controlled
substance, and ketamine, a schedule III
controlled substance. Methoxetamine
has no approved medical use in the
United States. In March 2016, the
Commission on Narcotic Drugs (CND)
voted to place methoxetamine in
Schedule II of the 1971 Convention
(CND Dec/59/6) during its 59th Session
due to its dependence and abuse
potential.
DEA and HHS Eight Factor Analyses
On April 14, 2018, in accordance with
21 U.S.C. 811(b), and in response to
DEA’s December 30, 2014, request and
April 14, 2017, submission of additional
data, HHS provided to DEA a scientific
and medical evaluation and scheduling
recommendation for methoxetamine.
DEA reviewed the scientific and
medical evaluation and scheduling
recommendation for schedule I
placement provided by HHS, and all
other relevant data, pursuant to 21
U.S.C. 811(b) and (c), and conducted its
own analysis under the eight factors
stipulated in 21 U.S.C. 811(c). DEA
found, under 21 U.S.C. 811(b)(1), that
this substance warrants control in
schedule I. Both DEA and HHS Eight-
Factor analyses are available in their
entirety under the tab Supporting
Documents of the public docket for this
action at https://www.regulations.gov
under docket number DEA–568.
Notice of Proposed Rulemaking To
Schedule Methoxetamine
On December 7, 2021 (86 FR 69187),
DEA published a notice of proposed
rulemaking (NPRM) to permanently
control methoxetamine in schedule I.
Specifically, DEA proposed to add
methoxetamine to the hallucinogenic
substances list under 21 CFR
1308.11(d). The NPRM provided an
opportunity for interested persons to file
a request for hearing in accordance with
DEA regulations on or before February
7, 2022. No requests for such a hearing
were received by DEA. The NPRM also
provided an opportunity for interested
persons to submit comments on or
before February 7, 2022.
Comments Received
DEA received one comment that
recognized the dangers and public
health risks, and fully supported the
placement of methoxetamine in
schedule I.
DEA Response: DEA appreciates this
comment in support of this rulemaking.
Scheduling Conclusion
After consideration of the public
comment, scientific and medical
evaluation and accompanying
recommendation of HHS, and after its
own eight-factor evaluation, DEA finds
that these facts and all relevant data
constitute substantial evidence of
potential for abuse of methoxetamine.
DEA is permanently scheduling
methoxetamine as a controlled
substance under the CSA.
Determination of Appropriate Schedule
The CSA establishes five schedules of
controlled substances known as
schedules I, II, III, IV, and V. The CSA
also specifies the findings required to
place a drug or other substance in any
particular schedule, 21 U.S.C. 812(b).
After consideration of the analysis and
recommendation of the Acting Assistant
Secretary for Health of HHS and review
of all other available data, the
Administrator of DEA, pursuant to 21
U.S.C. 812(b)(1), finds that:
(1) Methoxetamine has a high
potential for abuse that is comparable to
other scheduled substances such as the
ethylamine analog of phencyclidine
(PCE; schedule I), the thiophene analog
of phencyclidine (TCP; schedule I),
phencyclidine (PCP; schedule II), and
ketamine (schedule III);
(2) Methoxetamine has no currently
accepted medical use in treatment in the
United States. There are no approved
New Drug Applications for
methoxetamine and no known
therapeutic applications for
methoxetamine in the United States.
Therefore, methoxetamine has no
currently accepted medical use in
treatment in the United States.
4
(3) There is a lack of accepted safety
for use of methoxetamine under medical
supervision. Because methoxetamine
has no approved medical use and has
not been investigated as a new drug, its
safety for use under medical supervision
has not been determined. Therefore,
there is a lack of accepted safety for use
of methoxetamine under medical
supervision.
Based on these findings, the
Administrator of DEA concludes that
methoxetamine as well as its salts,
isomers, and salts of isomers whenever
the existence of such salts, isomers, and
salts of isomers is possible warrants
control in schedule I of the CSA.
5
Requirements for Handling
Methoxetamine
Methoxetamine is subject to the CSA’s
schedule I regulatory controls and
administrative, civil, and criminal
sanctions applicable to the manufacture,
distribution, reverse distribution,
import, export, engagement in research,
conduct instructional activities or
chemical analysis with, and possession
of schedule I controlled substances,
including the following:
1. Registration. Any person who
handles (manufactures, distributes,
reverse distributes, imports, exports,
engages in research, or conducts
instructional activities or chemical
analysis with, or possesses), or who
desires to handle, methoxetamine must
be registered with DEA to conduct such
activities pursuant to 21 U.S.C. 822,
823, 957, and 958, and in accordance
with 21 CFR parts 1301 and 1312. Any
person who currently handles
methoxetamine and is not registered
with DEA must submit an application
for registration and may not continue to
handle methoxetamine, unless DEA has
approved that application for
registration pursuant to 21 U.S.C. 822,
823, 957, 958, and in accordance with
21 CFR parts 1301 and 1312.
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6
44 U.S.C. 3501–3521.
2. Disposal of stocks. Any person
unwilling or unable to obtain a schedule
I registration must surrender or transfer
all quantities of currently held
methoxetamine to a person registered
with DEA before the effective date of a
final scheduling action in accordance
with all applicable Federal, State, local,
and tribal laws. Methoxetamine must be
disposed of in accordance with 21 CFR
part 1317, in addition to all other
applicable Federal, State, local, and
tribal laws.
3. Security. Methoxetamine is subject
to schedule I security requirements and
must be handled and stored pursuant to
21 U.S.C. 823, and in accordance with
21 CFR 1301.71–1301.76, as of the
effective date of this final scheduling
action. Non-practitioners handling
methoxetamine must comply with the
employee screening requirements of 21
CFR 1301.90–1301.93.
4. Labeling and Packaging. All labels,
labeling, and packaging for commercial
containers of methoxetamine must
comply with 21 U.S.C. 825, and be in
accordance with 21 CFR part 1302.
5. Quota. Only registered
manufacturers are permitted to
manufacture methoxetamine in
accordance with a quota assigned
pursuant to 21 U.S.C. 826, and in
accordance with 21 CFR part 1303.
6. Inventory. Every DEA registrant
who possesses any quantity of
methoxetamine must take an inventory
of methoxetamine on hand, pursuant to
21 U.S.C. 827 and in accordance with 21
CFR 1304.03, 1304.04, and 1304.11(a)
and (d).
Any person who registers with DEA
must take an initial inventory of all
stocks of controlled substances
(including methoxetamine) on hand on
the date the registrant first engages in
the handling of controlled substances,
pursuant to 21 U.S.C. 827 and in
accordance with 21 CFR 1304.03,
1304.04, and 1304.11(a) and (b).
After the initial inventory, every DEA
registrant must take an inventory of all
controlled substances (including
methoxetamine) on hand every two
years, pursuant to 21 U.S.C. 827 and in
accordance with 21 CFR 1304.03,
1304.04, and 1304.11.
7. Records and Reports. Every DEA
registrant must maintain records and
submit reports for methoxetamine, or
products containing methoxetamine,
pursuant to 21 U.S.C. 827 and in
accordance with 21 CFR 1301.74(b) and
(c) and parts 1304, 1312 and 1317.
Manufacturers and distributors must
submit reports regarding methoxetamine
to the Automation of Reports and
Consolidated Order System pursuant to
21 U.S.C. 827 and in accordance with 21
CFR parts 1304 and 1312.
8. Order Forms. Every DEA registrant
who distributes methoxetamine must
comply with the order form
requirements, pursuant to 21 U.S.C. 828
and 21 CFR part 1305.
9. Importation and Exportation. All
importation and exportation of
methoxetamine must comply with 21
U.S.C. 952, 953, 957, and 958, and in
accordance with 21 CFR part 1312.
10. Liability. Any activity involving
methoxetamine not authorized by, or in
violation of, the CSA or its
implementing regulations, is unlawful,
and may subject the person to
administrative, civil, and/or criminal
sanctions.
Regulatory Analyses
Executive Orders 12866 and 13563
(Regulatory Planning and Review;
Improving Regulation and Regulatory
Review)
In accordance with 21 U.S.C. 811(a),
this final scheduling action is subject to
formal rulemaking procedures
performed ‘‘on the record after
opportunity for a hearing,’’ which are
conducted pursuant to the provisions of
5 U.S.C. 556 and 557. The CSA sets
forth the procedures and criteria for
scheduling a drug or other substance.
Such actions are exempt from review by
the Office of Management and Budget
pursuant to section 3(d)(1) of Executive
Order (E.O.) 12866 and the principles
reaffirmed in E.O. 13563.
Executive Order 12988, Civil Justice
Reform
This regulation meets the applicable
standards set forth in sections 3(a) and
3(b)(2) of E.O. 12988 to eliminate
drafting errors and ambiguity, minimize
litigation, provide a clear legal standard
for affected conduct, and promote
simplification and burden reduction.
Executive Order 13132, Federalism
This rulemaking does not have
federalism implications warranting the
application of E.O. 13132. The proposed
rule does not have substantial direct
effects on the States, on the relationship
between the national government and
the States, or on the distribution of
power and responsibilities among the
various levels of government.
Executive Order 13175, Consultation
and Coordination With Indian Tribal
Governments
This rule does not have tribal
implications warranting the application
of E.O. 13175. It does not have
substantial direct effects on one or more
Indian tribes, on the relationship
between the Federal Government and
Indian tribes, or on the distribution of
power and responsibilities between the
Federal Government and Indian tribes.
Paperwork Reduction Act of 1995
This action does not impose a new
collection of information requirement
under the Paperwork Reduction Act of
1995.
6
Regulatory Flexibility Act
The Administrator of DEA, in
accordance with the Regulatory
Flexibility Act, 5 U.S.C. 601–612, has
reviewed this final rule, and by
approving it, certifies that it will not
have a significant economic impact on
a substantial number of small entities.
DEA is placing the substance
methoxetamine (chemical name: 2-
(ethylamino)-2-(3-
methoxyphenyl)cyclohexan-1-one)),
including its salts, isomers, and salts of
isomers whenever the existence of such
salts, isomers, and salts of isomers is
possible within the specific chemical
designation, in schedule I of the CSA to
enable the United States to meet its
obligations under the 1971 Convention.
This action imposes the regulatory
controls and administrative, civil, and/
or criminal sanctions applicable to
schedule I controlled substances on
persons who handle (manufacture,
distribute, reverse distribute, import,
export, engage in research, conduct
instructional activities or chemical
analysis with, or possess) or propose to
handle methoxetamine.
Based on the review of HHS’s
scientific and medical evaluation and
all other relevant data, DEA determined
that methoxetamine has high potential
for abuse, has no currently accepted
medical use in treatment in the United
States, and lacks accepted safety for use
under medical supervision. DEA’s
research confirms that there is no
legitimate commercial market for
methoxetamine in the United States.
Therefore, this final rule will not have
a significant effect on a substantial
number of small entities.
Unfunded Mandates Reform Act of 1995
On the basis of information contained
in the ‘‘Regulatory Flexibility Act’’
section above, DEA has determined
pursuant to the Unfunded Mandates
Reform Act (UMRA) of 1995 (2 U.S.C.
1501 et seq.) that this final rule would
not result in any Federal mandate that
may result ‘‘in the expenditure by State,
local, and tribal governments, in the
aggregate, or by the private sector, of
$100,000,000 or more (adjusted
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annually for inflation) in any 1 year
* * *.’’ Therefore, neither a Small
Government Agency Plan nor any other
action is required under UMRA of 1995.
Congressional Review Act
This rule is not a major rule as
defined by the Congressional Review
Act (CRA), 5 U.S.C. 804. However,
pursuant to the CRA, DEA is submitting
a copy of the final rule to both Houses
of Congress and to the Comptroller
General.
List of Subjects in 21 CFR Part 1308
Administrative practice and
procedure, Drug traffic control,
Reporting and recordkeeping
requirements.
For the reasons set out above, 21 CFR
part 1308 is amended as follows:
PART 1308—SCHEDULES OF
CONTROLLED SUBSTANCES
■ 1. The authority citation for 21 CFR
part 1308 continues to read as follows:
Authority: 21 U.S.C. 811, 812, 871(b),
956(b), unless otherwise noted.
■ 2. In §1308.11, add paragraph (d)(100)
to read as follows:
§ 1308.11 Schedule I.
* * * * *
(d) * * *
(100) 2-(ethylamino)-2-(3-methoxyphenyl)cyclohexan-1-one (methoxetamine, MXE) .................................................................................. 7286
* * * * *
Anne Milgram,
Administrator.
[FR Doc. 2022–11933 Filed 6–3–22; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF THE TREASURY
Office of Foreign Assets Control
31 CFR Part 587
Publication of Russian Harmful
Foreign Activities Sanctions
Regulations Web General Licenses
25A, 33, 34, and 35
AGENCY
: Office of Foreign Assets
Control, Treasury.
ACTION
: Publication of Web General
Licenses.
SUMMARY
: The Department of the
Treasury’s Office of Foreign Assets
Control (OFAC) is publishing four
general licenses (GLs) issued pursuant
to the Russian Harmful Foreign
Activities Sanctions Regulations: GL
25A, GL 33, GL 34, and GL 35, each of
which was previously issued on OFAC’s
website.
DATES
: GL 25A, GL 33, GL 34, and GL
35 were each issued on May 8, 2022.
See
SUPPLEMENTARY INFORMATION
of this
publication for additional relevant
dates.
FOR FURTHER INFORMATION CONTACT
:
OFAC: Assistant Director for Licensing,
202–622–2480; Assistant Director for
Regulatory Affairs, 202–622–4855; or
Assistant Director for Sanctions
Compliance & Evaluation, 202–622–
2490.
SUPPLEMENTARY INFORMATION
:
Electronic Availability
This document and additional
information concerning OFAC are
available on OFAC’s website:
www.treas.gov/ofac.
Background
OFAC issued GL 25A, GL 33, GL 34,
and GL 35 on May 8, 2022 on its website
to authorize certain transactions
otherwise prohibited by the Russian
Harmful Foreign Activities Sanctions
Regulations, 31 CFR part 587. GL 25A
does not contain an expiration date. GL
33 expires at 12:01 a.m. eastern daylight
time, June 7, 2022. GL 34 expires at
12:01 a.m. eastern daylight time, July 7,
2022. GL 35 expires at 12:01 a.m.
eastern daylight time, August 20, 2022.
The texts of GLs 25A, 33, 34, and 35 are
provided below.
OFFICE OF FOREIGN ASSETS
CONTROL
Russian Harmful Foreign Activities
Sanctions Regulations 31 CFR Part 587
GENERAL LICENSE NO. 25A
Authorizing Transactions Related to
Telecommunications and Certain
Internet-Based Communications
(a) Except as provided in paragraph
(c) of this general license, all
transactions ordinarily incident and
necessary to the receipt or transmission
of telecommunications involving the
Russian Federation that are prohibited
by the Russian Harmful Foreign
Activities Sanctions Regulations, 31
CFR part 587 (RuHSR), are authorized.
(b) Except as provided in paragraph
(c) of this general license, the
exportation or reexportation, sale, or
supply, directly or indirectly, from the
United States or by U.S. persons,
wherever located, to the Russian
Federation of services, software,
hardware, or technology incident to the
exchange of communications over the
internet, such as instant messaging,
videoconferencing, chat and email,
social networking, sharing of photos,
movies, and documents, web browsing,
blogging, web hosting, and domain
name registration services, that is
prohibited by the RuHSR, is authorized.
(c) This general license does not
authorize:
(1) The opening or maintaining of a
correspondent account or payable-
through account for or on behalf of any
entity subject to Directive 2 under
Executive Order (E.O.) 14024,
Prohibitions Related to Correspondent
or Payable-Through Accounts and
Processing of Transactions Involving
Certain Foreign Financial Institutions;
(2) Any debit to an account on the
books of a U.S. financial institution of
the Central Bank of the Russian
Federation, the National Wealth Fund of
the Russian Federation, or the Ministry
of Finance of the Russian Federation;
(3) Any transactions prohibited by
E.O. 14066 or E.O. 14068; or
(4) Any transactions involving Joint
Stock Company Channel One Russia,
Joint Stock Company NTV Broadcasting
Company, or Television Station Russia-
1, unless separately authorized.
(d) Effective May 8, 2022, General
License No. 25, dated April 7, 2022, is
replaced and superseded in its entirety
by this General License No. 25A.
Note to General License No. 25A.
Nothing in this general license relieves
any person from compliance with any
other Federal laws or requirements of
other Federal agencies, including
export, reexport, and transfer (in-
country) licensing requirements
maintained by the Department of
Commerce’s Bureau of Industry and
Security under the Export
Administration Regulations, 15 CFR
parts 730–774.
Andrea M. Gacki
Director, Office of Foreign Assets Control
Dated: May 8, 2022
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