(1) Purpose. These Rules and Regulations (Rules) are promulgated for the purpose of protecting and enhancing the quality of Georgia's environment and of protecting the public health, safety, and well-being of its citizens and of instituting and maintaining a comprehensive Statewide program for the management of regulated substances stored in underground tanks.
(a) These Rules are issued under the authority of the Georgia Underground Storage Tank Act (GUSTA), Official Code of Georgia Annotated (O.C.G.A.) § 12-13-1et seq. (1988), as amended.
3. to determine whether there has been a violation of any of the provisions of GUSTA or these Rules, or any permit or order issued pursuant to GUSTA and these Rules.
(c) In the event any person does not consent to an inspection or investigation, the Director or his authorized representative may seek to obtain a warrant authorizing the inspection or investigation pursuant to O.C.G.A. § 12-13-8(b) and § 12-2-2(d).
(d) EPD or its contractors may enter upon the property of the owner or operator, at such time and in such manner as deemed necessary, to effectuate the necessary corrective action to protect health and the environment.
(e) The Director, an authorized employee of the Department, or an authorized contractor or agent of the Department, upon presentation of his or her credentials, shall have a right to enter upon, to, or through premises of persons subject to GUSTA or premises whereon a release of a regulated substance in violation of GUSTA or the rules and regulations adopted pursuant to GUSTA is reasonably believed to be occurring or is reasonably believed to have previously occurred to investigate, take samples, copy all records relating to storage of regulated substances in underground storage tanks, and inspect for compliance with the requirements imposed under GUSTA or these Rules, or any permit or order issued pursuant to GUSTA or these Rules in order to determine whether such a current release or past release exists and to conduct appropriate corrective action for any release which may currently exist or may have existed.
(a) Any reference in these Rules to standards, procedures, and requirements of Title 40 of the Code of Federal Regulations (40 CFR) Part 280 shall constitute the full adoption by reference of the Part, Subpart, and Paragraph so referenced including any notes and appendices as may be associated, as amended through July 15, 2015, unless otherwise stated.
(b) When used in any such provisions as may be adopted from 40 CFR Part 280: implementing agency or state implementing agency shall mean Environmental Protection Division (EPD); and Regional Administrator or Director of the implementing agency shall mean Director of the Environmental Protection Division. Unless specifically indicated otherwise, any reference to implementation by, submissions to, or inspections, investigations or enforcement by the EPA in such Regulations as may be adopted by reference by these Rules shall be construed to mean EPD unless such interpretation would be inconsistent with the intent of the Georgia Underground Storage Tank Act (GUSTA).
(c) Any reference in 40 CFR Part 280, or in any provisions adopted by reference from 40 CFR Part 280, to EPA forms or reports shall mean EPD forms and reports as may be provided by the Director.
40 CFR 280.10 and 280.11 are hereby incorporated by reference, except each reference to "October 13, 2015" shall be replaced with "December 15, 2017" and each reference to "October 13, 2018" shall be replaced by "December 15, 2020".
(a) "Controlling interest" means direct or indirect ownership of at least 50 percent of the voting stock of another entity.
(b) "Corrective action" means those activities required for response to and cleanup of releases of regulated substances from underground storage tanks, including, but not limited to, initial response, initial abatement measures and site check, initial site characterization, free product removal, investigations for soil and groundwater cleanup, and preparation and implementation of a corrective action plan.
(c) "Department" means the Department of Natural Resources of the State of Georgia.
(d) "Director" means the Director of the Environmental Protection Division of the Department of Natural Resources.
(e) "EPD" means the Environmental Protection Division of the Department of Natural Resources of the State of Georgia.
(f) "Federal Act" means the Solid Waste Disposal Act, 42 U.S.C., § 3152 et seq., as amended, particularly by the Hazardous and Solid Waste Amendments of 1984, Public Law 98-616, 42 USC, § 6991 et seq., as amended by Public Law 99-499, 1986, as further amended by Public Law 109-58, 2005.
(g) "Jobber" means anyone who distributes petroleum product from a bulk storage plant to an UST owner or operator, orpurchases petroleum product from a terminal for distribution to an UST owner or operator.
(h) "Owner" means, in the case of an UST system in use on November 8, 1984, or brought into use or capable of being used after that date, any person who owns an UST system used for or capable of being used for the storage or dispensing of regulated substances and, in the case of any UST system in use before November 8, 1984, but no longer in use or capable of being used on or after November 8, 1984, any person who owned such UST immediately before the discontinuation of its use; provided, however, such term shall not include any person who, without participating in the management of an underground storage tank and otherwise not engaged in petroleum production, refining, and marketing, holds indicia of ownership primarily to protect that person's security interest in the underground storage tank.
(i) "Participating owner or operator" means an owner or operator of an UST who participates in the GUST Trust Fund as a financial assurance mechanism.
(j) "Petroleum" means petroleum, including crude oil or any fraction thereof which is liquid at standard conditions of temperature and pressure (60 degrees Fahrenheit and 14.7 pounds per square inch absolute).
(k) "Petroleum product" means petroleum-based substance comprised of a complex blend of hydrocarbons such as motor fuels, jet fuels, distillate fuel oils, residual fuel oils, lubricants, petroleum solvents, and used oils.
(l) "Plume" means the area of groundwater containing concentrations of petroleum constituents or other regulated substances above Estimated Quantitation Limits as established in Test Methods for Evaluating Solid Waste (United States Environmental Protection Agency, Office of Solid Waste and Emergency Response, SW-846, Third Edition, as revised) or in an alternate method approved by EPD.
(m) "Release Response" means, in addition to certain corrective action activities, those actions taken as initial response, initial abatement measures and site check, initial site characterization, and free product removal.
(1) When referring to an underground storage tank, the removal of an existing UST and the installation of another UST in its place.
(2) When referring to piping, the removal and replacement of 25% or more of the existing piping, as measured along an existing piping run between the submersible pump connection for the pressurized pump system or UST surface for suction pump systems to the bottom of the shear valve below the dispenser.
(o) "Responsibility for" means either the right or authority to close an UST or maintain and repair an UST or take action for compliance with all or part of the requirements of GUSTA and these Rules.
(p) "Terminal" means a bulk storage facility for storing petroleum products supplied by pipeline or marine vessel.
(q) "Third party liability" insofar as GUST Trust Fund usage is concerned means liability for bodily injury or property damage caused directly by a release of petroleum products from an underground storage tank; however, it does not include or mean any liability for bodily injury or property damage to the person or property of the owner of the real property on which the USTs are located.
2. As to property damage, actual physical damage or damage due to specific loss of normal use of property owned by a person other than either the owner or operator of an underground storage tank from which a release has occurred or the landlord of an owner or operator of the underground storage tank from which a release has occurred.
(r) "Trustee" means the Director of the Environmental Protection Division of the Department of Natural Resources.
(1) Any records, reports, or information obtained from any person by the Director under these Rules shall be available to the public for inspection and copying at the expense of the person requesting copies, except that upon a showing satisfactory to the Director by any person that any records, reports, or information or any particular part thereof, to which the Director has access under these rules would, if made public, divulge information entitled to protection or confidentiality under GUSTA, the Director shall consider confidential such information or any particular portion thereof in accordance with the purposes of GUSTA. However, such records, reports, documents, or information may be disclosed to officers, employees or authorized representatives of the United States government or the State of Georgia concerned with carrying out the terms of the Federal Act, or when required by any court in any proceedings under the Federal Act or under GUSTA.
(2) Any claim of confidentiality filed pursuant to this section must be asserted at the time of initial submission of the record, report, or information in question or it shall be deemed waived.
(3) Any claim of confidentiality filed pursuant to this section must be accompanied by a statement of the legal basis supporting the claim of confidentiality.
(a) Each reference to "October 13, 2015" shall be replaced by "December 15, 2017".
(b) Each reference to "April 11, 2016" shall be replaced by "April 7, 2008".
(2) For purposes of performance standards for new UST systems, as required in 40 CFR 280.20, any tank previously installed and subsequently removed must be recertified by the manufacturer or by an authorized representative of the manufacturer or by a Georgia-registered Professional Engineer and shall comply with the secondary containment requirements in accordance with 391-3-15-.05 (1) prior to installation as an UST.
(3) For purposes of notification of USTs, as required in 40 CFR 280.22, owners shall use forms as prescribed by the Director.
(4) Annual Registration of USTs.
(a) The owner or operator of an UST for which notification should have previously been submitted pursuant to O.C.G.A. 12-13-13 and which has not been properly closed in accordance with 391-3-15-.11, but is in use or capable of being used, shall submit to EPD an UST Registration Form by December 31 of each year.
1. Name and address of facility at which USTs are located.
2. Name and address of owner and current Class A and Class B operators of USTs at the facility location in 1. immediately above.
3. Size and identification of USTs at the facility location indicated in 1. above.
(ii) if the mechanism is the Georgia Underground Storage Tank Trust Fund, the financial assurance mechanism used for the $10,000 deductible.
5. Changes in owners, operators, upgrades, replacement of UST systems and changes in service from either the initial notification form filed or from the last annual notification filed, whichever is later.
6. Method of leak detection for lines and USTs and verification that leak detection requirements are being met.
7. Verification that spill and overfill devices and, if applicable, corrosion protection mechanisms are properly installed and operationally functional.
8. Verification that, as of April 7, 2008, all new or replaced USTs, piping or motor fuel dispensers have been properly installed and meet the secondary containment requirements set forth in 391-3-15-.05 (1).
(c) If an UST is brought into service during the year, an Annual UST Registration Certificate for the facility for the year in which the UST was brought into service shall be issued by EPD after the receipt of the initial notification of USTs, as required under paragraph 391-3-15-.05 (1).
(d) The Annual UST Registration Certificate, as provided by EPD, for each underground storage tank facility shall be conspicuously posted and displayed at each UST facility, an alternate location approved by EPD or a copy of such form shall be provided by the facility to each person placing regulated substances into the UST. It shall be a violation of O.C.G.A. 12-13-5 and these Rules to either fail to file an annual UST notification or to fail to conspicuously post and display the Annual UST Registration Certificate at an UST facility or provide a copy such that any person placing regulated substances in an UST can determine that the Annual UST Registration Certificate is current.
(e) No person may place a regulated substance in a regulated UST unless they have verified that the facility has a valid Annual UST Registration Certificate. Such verification shall be performed by December 31 of each year.
(a) Each reference to "October 13, 2015" shall be replaced with "December 15, 2017".
(b) Each reference to "October 13, 2018" shall be replaced by "December 15, 2020".
(2) All records shall be maintained for a minimum period of thirty-six (36) months, unless a longer period is specified in 40 CFR Part 280.
(c) Each reference to "April 11, 2016" shall be replaced by "April 7, 2008".
(d) The recordkeeping requirements in 40 CFR 280.45 shall be conducted in accordance with Rule 391-3-15-.06(2).
(2) Any owner or operator shall, upon request from EPD, certify on forms prescribed by the Director that the UST facility of the owner or operator is in compliance with release detection requirements as promulgated in 40 CFR Part 280, Subpart D.
40 CFR Part 280, Subpart E is hereby incorporated by reference.
(1) 40 CFR Part 280, Subpart F is hereby incorporated by reference.
(2) Corrective action plans (CAPs), Part A for reporting completed release response activities and for summarizing the proposed site investigation, including a schedule for submittal of a CAP - Part B, and Part B for reporting the results of the site investigation and for summarizing the proposed soil and groundwater corrective action objectives and the activities required to meet those objectives, shall be submitted to the Division on such forms as provided by the Environmental Protection Division, Georgia Department of Natural Resources. The plans must include certifications by the UST owner or operator, in the format specified, that the plans are factual and meet all the criteria and requirements of these Rules and other environmental laws and regulations of the State of Georgia. The plans must also be stamped or sealed by a Georgia-registered Professional Engineer or Professional Geologist. The Corrective Action Plan - Part A shall be submitted in lieu of the initial abatement report, the initial site characterization report, and the free product removal report, as referenced by 40 CFR 280.62(b), 280.63(b), and 280.64(d), respectively, and must be submitted to EPD within 60 days after release confirmation.
(iii) Alternate threshold levels, as approved by EPD.
Based on worst-case assumptions for one-dimensional vadose zone and groundwater contaminant fate and transport models.
Based on an assumed distance of 0.5 feet between contaminated soils and the water table.
Based on an assumed distance of 5.0 feet between contaminated soils and the water table.
Estimated Quantitation Limit. The health-based threshold level is less than the laboratory method limit of detection.
Not applicable. The health-based threshold level exceeds the expected soil concentration under free product condition.
In order to protect surface waters, the soil threshold level in Table B may supersede that found in Table A.
In the presence of other petroleum contaminants in concentrations exceeding 1.0 mg/kg the Estimated Quantitation Limit, and hence the soil threshold level, may be substantially greater, as approved by EPD.
In the presence of other petroleum contaminants in concentrations exceeding 1.0 mg/kg, the Estimated Quantitation Limit, and hence the solid threshold level, may be substantially greater, as approved by EPD.
(e) EPD has determined that, because of unique geologic, hydrologic or other site-specific conditions, a Corrective Action Plan - Part B is necessary to adequately protect human health and the environment.
(5) An owner or operator may transport or provide for transportation of petroleum contaminated soil only to storage, treatment or disposal facilities which have all applicable local, state and federal permits and such facility or facilities shall be designated in the applicable corrective action plan.
(6) Upon completion of corrective action, the UST owner or operator must certify in the completion report, in the format specified, that the CAP was implemented completely and correctly and that the objectives of the corrective action have been achieved.
(7) An owner or operator conducting a corrective action with funds from a source other than the Georgia Underground Storage Tank Trust Fund, may remediate contaminated soil or groundwater to more stringent objectives than those of paragraph 391-3-15-.09 (4) at the owner or operator's discretion.
(8) All determinations of petroleum contaminants in soil or groundwater must be performed in conformity with Test Methods for Evaluating Solid Waste (United States Environmental Protection Agency, Office of Solid Waste and Emergency Response, SW-846, Third Edition, as revised) or with an alternate method, as approved by EPD.
The provisons of Rule 391-3-15-.09 shall apply, except that cleanup concentrations for leaked hazardous substances shall be equal to or less than the background level of that constituent in the soil or water immediately prior to the release of that constituent, as measured immediately upgradient of the UST and unaffected by the release, or an alternate concentration limit as established by EPD, or if a hazardous waste when leaked, in accordance with O.C.G.A. 12-8-60, the Georgia Hazardous Waste Management Act, as amended.
(1) 40 CFR Part 280, Subpart G is hereby incorporated by reference.
(2) The owner or operator, or past owner or operator, of an UST system, in service on or after January 1, 1974, but taken out of service or abandoned before December 22, 1988, is not required to conduct closure activities or submit closure documents. However, corrective action is required if contamination is subsequently discovered.
(3) For all UST systems permanently closed after the effective date of these rules, a closure report, prepared on such forms as provided by EPD, must be submitted to EPD by the owner within 45 days of completion of closure.
(1) 40 CFR Part 280, Subpart H is hereby incorporated by reference, excluding 40 CFR 280.100 and 40 CFR 280.101.
(2) 40 CFR Part 280, Subpart I is hereby incorporated by reference.
(3) An owner or operator may satisfy the requirements of financial responsibility, as described in 40 CFR 280.93, for underground storage tanks located in Georgia by participating in the liability limitations and reimbursement benefits of the Georgia Underground Storage Tank (GUST) Trust Fund, in accordance with Rule 391-3-15-.13.
(a) Funding the GUST Trust Fund.
1. Environmental Assurance Fee (EAF). In order to participate in the liability limitations and reimbursement benefits of the GUST Trust Fund, commencing on July 1, 1988, an UST owner or operator shall pay to EPD an EAF on each gallon of petroleum products imported into Georgia. The EAF was 0.1¢ per gallon from July 1, 1988 through September 30, 1991; 0.2¢ per gallon from October 1, 1991 through September 30, 1996; 0.5¢ per gallon from October 1, 1996 through June 30, 2013; and the EAF is 0.75¢ per gallon effective July 1, 2013. This fee is established to assure the funding of emergency, preventive, or corrective actions necessary when public health or safety is, or potentially may be, threatened from a release of regulated substances from an UST and to provide compensation for third-party liability.
(i) Point of EAF Collection. This fee shall be collected by the terminal operator or jobber upon request of the UST owner or operator when the petroleum product is removed from a terminal, or if the petroleum product will never be stored in a terminal in Georgia, then by the importer thereof and paid to EPD. Proof of such payment shall be provided the UST owner or operator by the terminal operator or jobber. Exchanges of petroleum products on a gallon-for-gallon basis within a terminal shall be exempt from this fee. Petroleum product which is subsequently exported from Georgia is exempt from this fee. An UST owner or operator purchasing petroleum products from an out-of-state terminal operator or jobber must remit the EAF directly to EPD, unless the terminal operator or jobber agrees to remit the EAF for the owner or operator.
(ii) Timetable for Remittance. EAFs shall be remitted to EPD quarterly. Terminal operators remitting collected EAFs may be required to provide EPD with a list(s) of owners or operators who elected or declined payment of EAFs. Fees are due to EPD on the 20th day of each October, January, April, and July for the previous three month period. The EAF payment shall be accompanied by such forms as may be prescribed by the Director. If a terminal operator, direct importer or direct pay owner or operator has good cause for an extension of time, he may apply to the Director for additional time to file his EAF payment. Such application must be made to the Director before the payment becomes delinquent and must state all facts giving rise to the necessity for additional time. If the Director grants an extension, such extension may not exceed 30 days.
2. Civil Penalties. All civil penalties recovered by the Director as provided in O.C.G.A. § 12-13-19 shall be paid into the GUST Trust Fund.
(b) Establishing GUST Trust Fund Eligibility.
1. Notification Requirements for UST Systems. In order to participate in the GUST Trust Fund as a financial assurance mechanism, each owner or operator of an UST currently in use must have submitted notification forms as required in Rule 391-3-15-.05(3).
2. Eligibility For Existing UST Systems.
(III) report any known or suspected leaks from an existing UST. Meeting these conditions automatically makes a tank owner or operator a participant in the GUST Trust Fund, and no specific notice to EPD is required to confirm such participation. Any tank owner or operator who elects not to participate in the GUST Trust Fund must make a written declaration of that election to the Director and to the terminal operator or jobber.
(IV) comply with (b)2.(i) of this paragraph.
(V) comply with (b)2.(i) of this paragraph.
(ii) comply with all requirements under the provision of Rule 391-3-15-.13(1)(b)2.(i).
2. Payment of EAF. Payment of EAFs must be made for each UST until such time as closure requirements are satisfied.
(iv) proof of payment of EAFs as required by O.C.G.A. § 12-13-18(a)for the time period prior to September 2000 is presumed from the filing of the Annual Tank Registration form for 2001, in accordance with Rule 391-3-15-.05(4), indicating that the method of Financial Responsibility for the USTs at the time of filing was participation in the GUST Trust Fund as provided in Rule 391-3-15-.12, if payment of the most recent EAF for the registered tank has been made. This presumption shall be overcome and no longer effective if payment of such fees cannot be verified by records of EPD, the station owner, the UST owner or operator, or the terminal operator, maintained in accordance with Rule 391-3-15-.13(1)(c)4.(i) or any other relevant provision of law.
(v) any records as may be required by EPD.
(II) owner or operator is instructed otherwise by EPD.
5. Reporting of Suspected Leaks or Spills. The participating owner or operator shall report to EPD any suspected leak or spill of petroleum product.
6. Loss of GUST Trust Fund Coverage. Whenever the Director has reason to believe that a participating owner or operator has failed to maintain GUST Trust Fund eligibility pursuant to these Rules, the Director shall issue a notice of violation. The participating owner or operator shall have 30 days from receipt of such notice to provide evidence of compliance with all GUST Trust Fund eligibility requirements or take all necessary steps to correct such violation. If, after 30 days, the participating owner or operator fails to resolve the notice of violation, the Director shall issue a notice of termination of GUST Trust Fund eligibility. Within 60 days of such notice of termination, the owner or operator must provide an alternate financial assurance mechanism.
(d) Amount and Scope of GUST Trust Fund Coverage.
1. The GUST Trust Fund will provide, to participating owners or operators, coverage for release response and corrective action, as identified in 40 CFR Part 280, Subpart F, and for compensation of third parties for bodily injury and property damage caused by accidental releases arising from operating regulated petroleum product USTs not to exceed $1 million per occurrence cumulatively. For purposes of Rule 391-3-15-.13, the term "occurrence" shall mean any unexpected or unintended sudden or non-sudden release of petroleum product arising from operating an UST that results in a need for corrective action, bodily injury, or property damage.
(iii) Payments for third-party liability damages, as defined in these Rules, shall never exceed the amount of the GUST Trust Fund coverage as provided in these Rules for any owner or operator and shall not include payments for any claims for attorney's fees for third-party claimants or claims for punitive damages or mental anguish.
(ii) For participating owners or operators of 101 or more petroleum product USTs, $2 million.
3. The participating owner or operator shall be liable for the first $10,000 of release response and corrective action costs and third party liability claims per occurrence and be totally responsible for any replacement or retrofitting or both of affected tanks and associated piping. The participating owner or operator must demonstrate financial responsibility for the first $10,000 of release response and corrective action costs and third party liability claims per occurrence by an allowable financial assurance mechanism as described in 40 CFR 280.95- 280.99, 280.102, and 280.103.
4. The State of Georgia and the GUST Trust Fund shall have no liability for loss of business, damages, or taking of property associated with any release response or corrective action.
5. Whenever the trustee of the GUST Trust Fund determines that all costs eligible for payment, both release response and corrective action costs and third-party liability claims, may exceed the per-occurrence or aggregate coverages, the first priority for payment shall be the corrective action costs necessary to protect human health and the environment. The trustee shall pay third-party liability claims in the order in which the trustee received valid court orders under Rule 391-3-15-.13(1)(h)2.
6. If a corrective action is to be conducted using funds from the Georgia Underground Storage Tank Trust Fund, the corrective action will not extend substantially beyond the target objectives of Rule 391-3-15-.09(4). If a participating owner or operator desires to have the corrective action scope go beyond these objectives, the owner or operator must pay the difference in cost between those objectives and the owner or operator's alternative objectives.
(vi) to provide payments to state contractors for eligible, participating owners and operators who are unable, as determined by the Director, to conduct corrective action for petroleum releases from USTs.
(viii) reimbursement of reasonable costs from the GUST Trust Fund shall be limited as provided in Rule 391-3-15-.13(1)(d).
(IV) the participating owner or operator of a petroleum product UST has stored any petroleum product in such UST which has not been subjected to, nor paid any, EAF imposed in Subsection (a) of O.C.G.A. § 12-13-10.
(III) the participating owner or operator has failed to comply with any provisions of GUSTA or these Rules and such failure has caused, contributed to or otherwise adversely affected the release, or when non-compliance has not directly contributed to or otherwise adversely affected a release and such non-compliance was not or has not been corrected in a timely fashion when directed to do so by the Director.
(II) the current contamination from an existing UST system owned and operated by a participant in the GUST Trust Fund and another source cannot be differentiated, as determined by the Director.
2. Except as otherwise provided for in Subsection (c) of O.C.G.A. § 12-13-11, in the event of any discharge or threatened discharge of a regulated substance, the State or any of its agencies may recover in a civil action from any owner, operator, or other responsible person all costs incurred by the State or any of its agencies or monies from the Federal Leaking Underground Storage Tank (LUST) Trust Fund in the assessment and the cleanup of any release of a regulated substance and all costs incurred in the prevention, abatement, or removal of any threatened discharge of a regulated substance, including reasonable attorney's fees and any other necessary costs of response incurred by the State or any of its agencies. All such monies recovered shall be deposited into the GUST Trust Fund. The State shall have a lien on the property of owners or operators until funds are paid.
2. the trustee has received a valid final court order establishing a judgment against the participating owner or operator for bodily injury or property damage caused by an accidental release of petroleum products from an underground storage tank covered by the GUST Trust Fund financial assurance mechanism and the trustee of the GUST Trust Fund determines that the participating owner or operator has not satisfied the judgment. However, there shall be no liability on the part of the GUST Trust Fund and the trustee thereof unless the trustee shall have been given timely notice by a participating owner or operator of any lawsuit filed by a potential third-party liability claimant, and the trustee has an opportunity to intervene in said lawsuit and defend on behalf of the participating owner or operator with the full cooperation and assistance of the participating owner or operator against any claim which might be asserted by a potential third-party liability claimant for bodily injury or property damage allegedly caused by an accidental release of petroleum products from an underground storage tank covered by the GUST Trust Fund financial assurance mechanism. There shall be no liability for the GUST Trust Fund under this provision should the participating owner or operator fail to provide notice to the trustee within fifteen (15) days of the service of a law suit against the participating owner or operator or fail to cooperate with the trustee in the defense against the claim or should the final judgment presented to the trustee be a default judgment.
(a) GUST Trust Fund Corrective Action for Participating Owners or Operators.
1. Reporting. The participating owner or operator shall report to EPD any suspected leak or spill of petroleum product as required in 40 CFR 280.50, and the participating owner or operator must inform EPD in writing within sixty (60) days of the date of the confirmation of the release of an intent to file a claim for reimbursement against the GUST Trust Fund or an intent to obtain corrective action through the State contractor.
2. Corrective Action by Participating Owner or Operator.
(IV) provide cost projections and a schedule of reimbursements for the proposed site investigation activities.
(IV) require submittal of a Corrective Action Plan - Part B, unless directed by EPD not to submit such plan.
(III) provide cost projections and a schedule of reimbursement for proposed corrective action activities.
(iv) the proposed scopes of work, schedules and cost projections submitted under the Corrective Action Plan - Part A and the Corrective Action Plan - Part B may be modified, and, if approved by EPD in writing, said approval shall amend the Corrective Action Agreement.
3. Corrective Action by State. If the participating owner or operator is unable, as determined by EPD, to perform corrective action, the participating owner or operator of an UST shall be liable for all costs incurred by the State of Georgia as a result of a release of a petroleum product from an UST unless the participating owner or operator enters into a consent agreement with the State as provided for in O.C.G.A. § 12-13-1(c).
(b) Other GUST Trust Fund Corrective Action. Whenever the Director has reason to believe that there is or has been a release of a regulated substance into the environment from an UST, regardless of the time at which storage of such material occurred, and has reason to believe that such release poses a danger to human health or the environment, the Director may obtain corrective action for such release, utilizing funds from the GUST Trust Fund, provided however, that corrective action for regulated substances other than petroleum products shall not be obtained by utilizing funds generated from EAFs.
The enforcement of these Rules and Regulations shall be in accordance with the Georgia Underground Storage Tank Act and the Georgia Administrative Procedure Act. Such enforcement measures include, but are not limited to, administrative orders, court orders, injunctive relief, and civil penalties pursuant to these Acts.
A variance may be granted by the Director only if it is consistent with the requirements of GUSTA and these Rules and consistent with the Federal Act and Regulations promulgated thereunder.
(a) Each UST facility must have a Class A, Class B and Class C Operator designated for each UST system or group of UST systems and shall not operate without a designated operator for each class as herein defined. Should an operator in any class as herein defined either resign or be terminated for any reason, the UST facility must replace the vacated operator with another one in the same class within sixty (60) days or cease operations until such a replacement is designated. The Class A, Class B and Class C Operator may be the same person or multiple persons, provided the person designated to more than one operator class must be trained or meet the responsibilities for each operator class for which that person is designated. The Class A or B Operator does not have to be present at each UST facility at all times. For unmanned UST locations not open to the public where no attendant is present and each dispenser is either key or card controlled, each key or card holder shall be trained to the standards of a Class C Operator; provided however, the operators and owners of that facility are still responsible for the compliance requirements of the UST facility.
(b) In addition to those responsibilities for Class A Operators required by these Rules, the Class A Operator must ensure that appropriately trained individuals operate and maintain the UST systems; maintain appropriate records; conduct required emergency response activities and provide required financial responsibility documentation to EPD as required under these Rules. A Class A Operator must demonstrate to the satisfaction of the Director by passing an EPD authorized test that he or she has sufficient general knowledge of UST system requirements to be able to make informed decisions regarding UST compliance and be able to recognize if Class B or C operators are fulfilling the UST operation, maintenance, notification and record keeping requirements of these Rules and GUSTA, including, but not limited to, spill prevention, overfill prevention, release detection, corrosion protection, emergency response, product compatibility, release and suspected release reporting, temporary and permanent closure requirements, financial responsibility requirements, notification requirements and operator training requirements, for UST facilities as required by these Rules.
(c) In addition to those responsibilities for Class B Operators required by these Rules, the Class B Operator must demonstrate to the satisfaction of the Director through passing an appropriate test as established by EPD a sufficient knowledge of all UST system requirements indicating that he or she can make informed decisions and implement the UST operational, maintenance, notification and reporting requirements of these Rules and GUSTA, including, but not limited to UST system components, UST system component construction, methods of release detection and prevention, corrosion protection, emergency response requirements, product compatibility, reporting and record keeping requirements, product compatibility, reporting and record keeping requirements, delivery prohibition requirements and Class C Operator training requirements, as required by these Rules.
(d) In addition to those responsibilities for Class C Operators as are required by these Rules, the Class C Operator must demonstrate to the satisfaction of the Director, through passing appropriate examination as established by EPD, a sufficient knowledge of all UST system requirements indicating that he or she can make informed decisions and take appropriate actions in response to emergencies or alarms caused by spills or releases from an UST system.
(a) All Class A and Class B Operators of all UST systems regulated under these Rules are required to pass a written examination corresponding to their respective operator classification known as the Georgia UST Operator Examination, as authorized and amended periodically by the Director, which shall determine that the person being tested has the knowledge and skills necessary to be considered as competent to operate UST systems at the operator level for which they have been designated and tested. The Director shall periodically publish the name of the test administrator, contact information, testing locations, testing frequency and a list of the guidance documents and training materials on which the test will be based. The Director shall approve the content of any tests administered by the approved test administrator and the curriculum of any UST operator training courses. This testing of Class A and B Operators must be accomplished for all Class A and B Operators for any UST facility as identified on the Annual Tank Registration as required under Rule 391-3-15-.05(4)(b)2.
(b) Should any Class A or Class B Operator take the Georgia UST Operator Examination and fail to pass the same as certified to the EPD by the test administrator, the operator shall attend and successfully complete an UST Operator training course of the operator's choice; provided, the curriculum of which is based on the list of the guidance documents and training materials as periodically identified by the Director. After successful completion of an UST operator training course, evidenced by appropriate documentation presented to the Georgia UST Operator Test administrator, the operator will be required to retake and pass the Georgia UST Operator Examination.
(c) Fees for the initial and retake of the Georgia UST Operator Examination shall be as set by the test administrator and shall be payable to the test administrator. Fees for training courses shall be set by the training course providers and shall be payable to the training provider.
(d) All new Class A and Class B operators, if not already certified as trained, or subject to the reciprocity provisions hereof, shall be required to pass the Georgia UST Operators Examination within 30 days of taking responsibility of a UST system. After satisfactorily passing the Georgia Underground Storage Tank Operators Exam, the Class A or Class B Operator shall be issued a Certificate from the approved test administrator indicating the name of the test applicant, operator category of the test and the date of the test, which certificate shall expire seven (7) years from the date of issue.
(e) Class C Operators shall receive training in the responsibilities of that class prior to assuming responsibilities of that position. Class C operators shall be trained in the responsibilities of that class by either the Class A or Class B Operators for that facility. The method and curriculum used to train the Class C operator shall be kept onsite at the UST facility and shall specifically identify which employees are considered Class C operators and which have received the Class C operator training. Any Class C operator if not already certified as trained shall be trained as required herein before taking responsibility for a UST system.
(a) All Class A and Class B operators shall be required to retake and pass the Georgia UST Operator Examination once every seven (7) years.
(b) Should EPD determine that a UST facility is out of compliance with significant operational compliance requirements for release detection and release prevention requirements, or financial assurance responsibility requirements as provide in these Rules, the EPD shall require the Class A or Class B operator be trained and re-tested at a minimum for the criteria in which the UST facility was determined to be out of significant operational compliance.
(c) A Certificate of Training may be granted at the discretion of the Director to operators who have received certification from other States whose UST rules are compatible with these Rules and have an approved EPA operator training program and provide reciprocity to Georgia operators in that State.
The Director may investigate the actions of any operator and may revoke or suspend the certificate of an operator when it is found by the Director that in obtaining such certificate the operator has practiced fraud or deception; or that reasonable care, judgment, or the application of knowledge or ability was not used in the performance of the operator's duties; or that the operator is incompetent or unable to perform his duties properly.
It shall be a violation of these Rules for any UST owner to operate or allow to be operated any UST facility owned by that owner without a Class A, Class B or Class C operator being designated and existing for said UST facility as prescribed by these Rules. If any UST owner operates or allows to be operated any UST facility in violation of this Rule, 391-3-15-.16, the current Annual Tank Registration Certificate issued by EPD as required by Rule 391-3-15-.05 may be revoked by the Director.
(c) Each reference to "October 13, 2021" shall be replaced by "December 15, 2023".
(d) Each reference to "October 13, 2022" shall be replaced by "December 15, 2024".


The U.S. Food and Drug Administration (FDA) conducted an inspection at your firm, Salud Natural Entrepreneurs, Inc., located, at the time of the inspection, at 2400 23rd Street in Zion, Illinois, from May 26, 2015, through July 6, 2015. Our inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR 111). These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Federal, Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that the products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
In addition, FDA reviewed your product labels and your website at the Internet address www.nopalinausa.com in February 2016. Based on our review, we have concluded that certain products identified below are in violation of sections 403, 505(a), and/or 502(f)(1) of the Act [21 U.S.C. 343, 355(a), and/or 352(f)(1)]. You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
The FDA reviewed your products labels and your website at www.nopalinausa.com in February 2016, from which website you take orders for your products Aloe Vera Juice, Urinary System Tea, Nopalina Flax Seed Plus Fiber Powder and Capsules, Urcran Cranberry, Aloe Vera With Nopal Juice, Aloe Vera With Nopal And Grape Juice, Aloe Vera Gel, Cardio Support, Fat Burner, Liver Support, Prostate Support, Triple Potency, Uro-Max Formula, Arthritis Formula, Diabetes Formula, Sinusitis Bronchitis Capsules, Urinary System Tea, Respiratory System Tea, Obesy-Tea, Blood Purifier Tea, Diabetes Kit, and Overweight and Cholesterol Kit. The claims on your product labels and your website establish that these products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
Product name implies product is intended for use in the treatment of arthritis.
Product name implies product is intended for use in the treatment of diabetes.
Product name implies product is intended for the treatment of sinusitis and bronchitis.
Product name is an implied drug claim.
“Cholesterol Kit” is an implied drug claim.
Your products are not generally recognized as safe and effective for the above- referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d) and 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
Your Aloe Vera Juice, Nopalina Flax Seed Plus Fiber (in both powder and capsule form), Aloe Vera with Nopal Juice, Aloe Vera With Nopal and Grape Juice, Aloe Vera Gel, Cardio Support, Liver Support, Prostate Support, Triple Potency, Uro-Max Formula, Arthritis Formula, Diabetes Formula, Sinusitis Bronchitis Capsules, Urinary System Tea, Obesy-Tea, Blood Purifier Tea, Diabetes Kit, and Overweight and Cholesterol Kit products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your Aloe Vera Juice, Nopalina Flax Seed Plus Fiber (in both powder and capsule form), Aloe Vera with Nopal Juice, Aloe Vera With Nopal and Grape Juice, Aloe Vera Gel, Cardio Support, Liver Support, Prostate Support, Triple Potency, Uro-Max Formula, Arthritis Formula, Diabetes Formula, Sinusitis Bronchitis Capsules, Urinary System Tea, Obesy-Tea, Blood Purifier Tea, Diabetes Kit, and Overweight and Cholesterol Kit products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction of or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].
The inspection revealed the following significant violations of the CGMP requirements for dietary supplements. These violations cause your dietary supplement products to be adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions which do not meet the CGMP regulations for dietary supplements. Additionally, even if certain of your dietary supplement products did not contain disease claims in their labeling that cause them to be drugs, these products would be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) requirements for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
b. Specifications for each dietary supplement that you manufacture for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement, as required by 21 CFR 111.70(e).
Once you have established the above specifications, you must verify that the specifications are met in accordance with 21 CFR 111.73, and you must make and keep records relating to the specifications you have established, in accordance with 21 CFR 111.95(b).
We acknowledge your response, dated January 27, 2016. We are unable to determine the sufficiency of your response because the specifications documented in your response do not meet the criteria required by 21 CFR 111.70. For example, the component specifications you provided for senna leaves will not determine the required component specifications for identity. The (b)(4) are inadequate identity specifications because they lack the specificity to distinguish other powders of similar characteristics.
2. You failed to implement quality control operation procedures in your manufacturing, packaging, labeling, and holding operations for producing the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.65. Specifically, you have not established or implemented quality control procedures for activities such as ingredient scale calibration, mix time control, and temperature control in juice processing.
3. You failed to prepare a written master manufacturing record (MMR) for each unique formulation of dietary supplement you manufacture and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). For each dietary supplement product you manufacture, including your aloe-based dietary supplement juice products, you must establish complete MMR’s that include the information specified under 21 CFR 111.210. You do not have MMR’s for your aloe-based dietary supplements.
We acknowledge your response, dated January 27, 2016, includes a blank manufacturing record template. However, we are unable to fully evaluate a blank template to determine if your use of the template will satisfy the requirements under 21 CFR 111.205 and 21 CFR 111.210.
4. You failed to prepare a batch production record (BPR) every time you manufacture a batch of a dietary supplement, as required by 21 CFR 111.255(a). Specifically, you do not have BPRs for the production of your aloe-based products. BPRs must include complete information relating to the production and control of each batch in accordance with 21 CFR 111.255(b) and 21 CFR 111.260.
We acknowledge your response, dated January 27, 2016. However, we are unable to evaluate the sufficiency of your response because you failed to provide batch production records.
5. Your firm used equipment that was not maintained to protect components and dietary supplements from being contaminated by any source, as required by 21 CFR 111.27(a)(3)(v). Specifically, your employees used a (b)(4) to move your finished Nopalina Flax Seed Plus Fiber powder from a (b)(4). The distal end of the (b)(4) was observed to be constructed with (b)(4) which was holding the (b)(4). The (b)(4) was observed to be loose and in a state of disrepair and directly over the finished product. An adjacent packaging line was observed to be in a similar state of disrepair.
We acknowledge your response, dated January 27, 2016. However, we are unable to evaluate the sufficiency of your response. We understand from your response that you employed (b)(4) to assist in strengthening the cleaning and sanitization program, and you included with your response a copy of the (b)(4) report, dated 1/19/16, as well as cleaning procedures entitled, “(b)(4)” Procedure 1001.01.1, (b)(4). The documentation you provided, however, failed to provide evidence to show that you are maintaining the equipment to protect components and dietary supplements from being contaminated by any source.
Your Parasitos, Aloe Vera Juice, Diabet-Care and Nopalina Flax Seed Plus Fiber product labels fail to declare all parts of the statement of identity, the net quantity of contents statement, and the Supplement Facts in both English and Spanish.
Your Nopalina Flax Seed Plus Fiber product label fails to declare the FDA disclaimer statement under section 403(r)(6)(C) of the Act in both English and Spanish.
Your Parasitos product label fails to include the part of the plant from which “horsetail” and “buckthorn” are derived.
Your Aloe Vera Juice product label fails to include the part of the plant from which “aloe vera” is derived.
Your Nopalina Flax Seed Plus Fiber product label fails to include the part of the plant from which “edible cactus” is derived.
Your Buzz Recovery Detox Juice product label fails to include the part of the plant from which carqueja, poleo mint, thyme, chamomile, vira vira canchalagua, and blessed thistle are derived.
Your Diabet-Care product fails to include the part of the plant from which nopal and red raspberries are derived.
The Aloe Vera Juice directions of use suggest the consumer drink 2 to 4 fl oz. a day, but the serving size lists 2 fl oz. The serving size listed should be 4 fl oz.
The Buzz Recovery Detox Juice directions of use suggest the consumer take 4 to 8 fl. oz. during and/or after a night of drinking; however, the serving size lists 4 fl. oz. The serving size listed should be 8 fl. oz.
The Diabet-Care directions of use suggest the consumer take 4 capsules with a meal twice daily; however, the serving size lists 1 capsule. The serving size listed should be 4 capsules.
Your Nopalina Flax Seed Plus Fiber product label declares quantitative amount of zero for saturated fat, trans fat, cholesterol and sugars; your Buzz Recovery Detox Juice product label declares quantitative amount of zero for protein; and your Aloe Vera Juice product label declares quantitative amount of zero for total fat, protein and sugars. These (b)(2)-dietary ingredients must not be declared if they are present in amounts that can be declared as zero in accordance with 21 CFR 101.36(b)(2)(i) and 21 CFR 101.9(c).
Your Nopalina Flax Seed Plus Fiber product has incorrectly calculated the percent Daily Value for (b)(2) dietary ingredients, for example, Calcium and Iron, must be calculated as defined in 21 CFR 101.36(b)(2)(iii)(B).
Your Nopalina Flax Seed Plus Fiber product incorrectly declares a percent Daily Value for Omega-3 whereas a Daily Value has not been established for that dietary ingredient. Because of this fact, your product label must declare a symbol for this ingredient that refers to the statement “*Daily Value not Established,” in accordance with 21 CFR 101.36(b)(3)(iv).
Your Nopalina Flax Seed Plus Fiber and Aloe Vera Juice product labels declare 0% Daily Value for (b)(2)-dietary ingredients with established Daily Reference Values where the declared amount is greater than zero. For dietary ingredients for which DRV's have been established, “Less than 1%” or “<1%” must be used to declare the % Daily Value when the quantitative amount of the dietary ingredient by weight is great enough to require that the dietary ingredient be listed, but the amount is so small that the % Daily Value when rounded to the nearest percent is zero, in accordance with 21 CFR 101.36(b)(2)(iii).
Your Buzz Recovery Detox Juice, Nopalina Flax Seed Plus Fiber and Aloe Vera Juice product labels list sodium in the wrong order. Sodium, its quantitative amount by weight per serving, and percent of the daily value should be listed after iron on the Buzz Recovery Detox Juice and Nopalina Flax Seed Plus Fiber labels and after protein on the Aloe Vera Juice label, in accordance with 21 CFR 101.36(b)(2)(i)(B).
Your Buzz Recovery Detox Juice product label lists “Grape juice concentrate 5%.” Amounts of (b)(3)-dietary ingredients shall be expressed using metric measures in accordance with 21 CFR 101.36(b)(3)(ii)(A).
Your Aloe Vera Juice product label claims “Low Calories.” For dietary supplements, claims regarding calories may not be made on products that meet the criteria in 101.60(b)(1) or (b)(2) for "calorie free" or "low calorie" claims except when an equivalent amount of a similar dietary supplement (e.g., another protein supplement) that the labeled food resembles and for which it substitutes, normally exceeds the definition for “low calorie” in 101.60(b)(2).
5. Your dietary supplement products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] in that the labeling on your website is false or misleading. Specifically, your website, www.nopalinausa.com, has the following claim with regard to your dietary supplement products: “Following the provisions of the Civil Procedure of the American Federal Laws, the product has received the Certificate of Good Practice in Manufacturing, given by the Department of Health and Human Services and the Food and Drug Administrations of the United States.” The Department of Health and Human Services does not provide such Certificates of Good Practice in Manufacturing.
Your Diabet-Care product label declares the dietary ingredient “edible cactus” as opposed to the Latin binomial or the standardized common name “prickly pear” as in the reference Herbs of Commerce.
Your Nopalina Flax Seed Plus Fiber product label declares the dietary ingredient “nopal” as opposed to the Latin binomial or the standardized common name “prickly pear” as in the reference Herbs of Commerce.
Your Buzz Recovery Detox Juice product label declares the dietary ingredients “carqueja” and “poleo mint” as opposed to the Latin binomial or the standardized common names “Baccharis trimer”a and “European pennyroyal,” respectively.
Your Buzz Recovery Detox Juice product label declares the dietary ingredients “canchalagua,” “incayuyo” and “vira vira.” These botanical names are not listed in Herbs of Commerce as standardized common names. A botanical ingredient should be declared by the standardized common name noted in Herbs of Commerce or by its Latin binomial name.
7. Your Diabet-Care product is misbranded within the meaning of section 403(s)(2)(A) of the Act [21 U.S.C. §343(s)(2)(A)] in that the label fails to list the name of each ingredient of the supplement that is described in section 201(ff) and the quantity of each such ingredient. For example, your labeling contains ingredient information to suggest that your product contains zinc. However, you do not list this (b)(2)-dietary ingredient and you do not list the quantitative amount by weight per serving and corresponding % Daily Value in the Supplement Facts panel in accordance with 21 CFR 101.36(b)(2).
8. Your Buzz Recovery Detox Juice product is misbranded within the meaning of section 403(s)(2)(A)(ii)(I) of the Act [21 U.S.C. § 343 (s)(2)(A)(ii)(I)] in that the label fails to list the quantitative amount by weight per serving size of all the dietary ingredients as required by 21 CFR 101.36. For example, the label declares the dietary ingredient “iron” but fails to include the quantitative amount by weight per serving size.
9. Your Diabet-Care product is misbranded within the meaning of section 403(u) of the Act [21 U.S.C. § 343(u)] in that it purports to contain ginseng, but the purported ginseng ingredient is not from a plant classified with the genus Panax. Section 403(u) of the Act, added by the Farm Security and Rural Investment Act of 2002 (Pub. L. 107-171), provides that the term "ginseng" may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax. Specifically, your product contains an ingredient identified as Siberian Ginseng (Eleutherococcus senticosus). That ingredient may not be declared under a name that includes the term "ginseng" because it is not from the genus Panax.
The function of the ingredients potassium sorbate in your Buzz Recovery Detox Juice and Aloe Vera Juice products and sodium benzoate and citric acid in your Aloe Vera Juice product is not listed in accordance with 21 CFR 101.22(j).
Your Buzz Recovery Detox Juice product label should not include a heavy bar under the vitamin B12 and before the iron dietary ingredients. Further, the label declares senna leaves tea which is not the common or usual name of an ingredient.
The quantitative amount for sodium must be declared in milligrams (mg) (21 CFR 101.9(c)(4)).
The heading “% Daily Value” and names of the nutrients and the percentage amounts for Total fat, Sodium, Total Carbohydrate, and Protein must be bolded (21 CFR 101.9(d)(1)(iv)).
“Sugars” must be indented (21 CFR 101.9(c)(6)(ii)), and must not declare a percent daily value.
The product labels fail to include the street address of the manufacturer, packer, or distributor as required by 21 CFR 101.5. This may be omitted if shown in a current city directory or telephone directory.
The term “boldo” in the ingredient declaration on the Blood Purifier Tea is not an appropriate common or usual name for boldus (boldo) leaves (21 CFR 172.510(b)).
Ingredient amounts are not permitted as part of the ingredient statement. The percentage of an ingredient may be declared in the statement of ingredients in accordance with 21 CFR 101.4(e).
The product labels for your Blood Purifier Tea, Liver-Gall Bladder Tea, and Urinary System Tea include the term “Herbal Supplement,” which indicates that you intend these products to be dietary supplements. Each of the product labels, however, includes a Nutrition Facts panel rather than a Supplement Facts panel. Because the Nutrition Facts format is used only for conventional foods and dietary supplements must bear nutrition information in the Supplement Facts format [see 101 CFR 101.36], including a Nutrition Facts panel on your product labels represents the products as conventional foods. Under section 201(ff)(2)(B) of the Act [21 U.S.C. 321(ff)(2)(B)], a product that is represented for use as a conventional food does not meet the definition of a dietary supplement. A product that is labeled as a dietary supplement may not also be represented for use as a conventional food. If a product is labeled as a dietary supplement (e.g., by identifying it as an “herbal supplement,” as with your products) but does not meet the definition of a dietary supplement, e.g., because it is represented for use as a conventional food, the product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the description of the product as a dietary supplement is false and misleading. Therefore, if you want to market your Blood Purifier Tea, Liver-Gall Bladder Tea, and Urinary System Tea as dietary supplements, these products may not be represented for use as conventional foods (nor, as stated earlier, promoted for intended uses that cause them to be drugs) and, among other requirements, must meet dietary supplement labeling requirements in 21 CFR Part 101 and dietary supplement CGMP requirements in 21 CFR Part 111. For further information about factors we consider in determining whether a product is a conventional food or dietary supplement, see Guidance for Industry: Distinguishing Liquid Dietary Supplements from Beverages.
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses incurred in connection with FDA's arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Your response should be sent to Carrie Ann Plucinski, Compliance Officer, Food and Drug Administration, 550 W. Jackson Blvd., 15th floor, Chicago, IL 60661. Refer to the Unique Identification Number (CMS Case # 481730) when replying. If you have any questions about the content of this letter, please contact Ms. Plucinski at 312-596-4224.