Authenticated PDF Version (2) After mixing or in combination with any other substance(s). These materials will be referred to throughout this subpart as "materials used in a manner that constitutes disposal".
(b) Products produced for the general public's use that are used in a manner that constitutes disposal and that contain recyclable materials are not presently subject to regulation if the recyclable materials have undergone a chemical reaction in the course of producing the products so as to become inseparable by physical means and if such products meet the applicable treatment standards in Subpart D of Part 268 (or applicable prohibition levels in §268.32 or 7 Del.C., Chapter 63, where no treatment standards have been established) for each recyclable material (i.e., hazardous waste) that they contain and the recycler complies with § 268.7(b)(6) of this chapter.
(a) Owners or operators of facilities that use recyclable materials in a manner that constitutes disposal are regulated under all applicable provisions of Subparts A through N of Parts 264 and 265, and Parts 268, 122, and 124 of these regulations and the notification requirement under 7 Del.C., Chapter 63. (These requirements do not apply to products which contain these recyclable materials under the provisions of §266.20(b) of these regulations.)
Section 266.70 Applicability and requirements.
(2) Subpart B of Part 262 of these regulations (for generators), §263.20 and §263.21 of these regulations (for transporters), and §265.71 and §265.72 of these regulations (for persons who store) of these regulations; and
(3) For precious metals exported to or imported from other countries for recovery, Part 262, Subpart H and §265.12 of these regulations.
Section 266.80 Applicability and requirements.
(iii) All applicable provisions in Subpart B of Part 265 of these regulations except §265.13 (waste analysis).
(v) All applicable provisions in Subpart E of Part 265 of these regulations except §§ 265.71 and 265.72 (dealing with the use of the manifest and manifest discrepancies).
(iii) All applicable provisions in Subpart B of Part 264 of these regulations but not §264.13 (waste analysis).
(v) All applicable provisions in Subpart E of Part 264 of these regulations but not §264.71 or §264.72 (dealing with the use of the manifest and manifest discrepancies).
Section 266.100 Applicability.
(1) Except as provided by paragraph (b)(2) of this section, the standards of this part no longer apply when an affected source demonstrates compliance with the maximum achievable control technology (MACT) requirements of 40 CFR Part 63, Subpart EEE, by conducting a comprehensive performance test and submitting to the EPA Administrator, with a copy to the DNREC Solid and Hazardous Waste Management Section, a Notification of Compliance under 40 CFR §§ 63.1207(j) and 63.1210(d) documenting compliance with the requirements of 40 CFR Part 63, Subpart EEE. Nevertheless, even after this demonstration of compliance with the MACT standards, DNREC hazardous waste permit conditions that were based on the standards of this part will continue to be in effect until they are removed from the permit or the permit is terminated or revoked, unless the permit expressly provides otherwise.
(iv) The applicable requirements of Subparts A through H, BB and CC of Parts 264 and 265 of these regulations.
(1) Used oil burned for energy recovery that is also a hazardous waste solely because it exhibits a characteristic of hazardous waste identified in Subpart C of Part 261 of these regulations. Such used oil is subject to regulation under Part 279 of these regulations;
(2) Gas recovered from hazardous or solid waste landfills when such gas is burned for energy recovery;
(4) Coke ovens, if the only hazardous waste burned is EPA Hazardous Waste No. K087, decanter tank tar sludge from coking operations.
(B) The hazardous waste is burned solely for metal recovery consistent with the provisions of paragraph (d)(2) of this section;
(D) The owner or operator will comply with the sampling and analysis and recordkeeping requirements of this paragraph;
(ii) Sample and analyze the hazardous waste and other feedstocks as necessary to comply with the requirements of this paragraph by using appropriate methods; and
(iii) Maintain at the facility for at least three years records to document compliance with the provisions of this paragraph including limits on levels of toxic organic constituents and Btu value of the waste, and levels of recoverable metals in the hazardous waste compared to normal nonhazardous waste feedstocks.
(2) A hazardous waste meeting either of the following criteria is not processed solely for metal recovery:
(i) The hazardous waste has a total concentration of organic compounds listed in Part 261, Appendix VIII, of these regulations exceeding 500 ppm by weight, as-fired, and so is considered to be burned for destruction. The concentration of organic compounds in a waste as-generated may be reduced to the 500 ppm limit by bona fide treatment that removes or destroys organic constituents. Blending for dilution to meet the 500 ppm limit is prohibited and documentation that the waste has not been impermissibly diluted must be retained in the records required by paragraph (d)(1)(iii) of this section; or
(ii) The hazardous waste has a heating value of 5,000 Btu/lb or more, as-fired, and so is considered to be burned as fuel. The heating value of a waste as-generated may be reduced to below the 5,000 Btu/lb limit by bona fide treatment that removes or destroys organic constituents. Blending for dilution to meet the 5,000 Btu/lb limit is prohibited and documentation that the waste has not been impermissibly diluted must be retained in the records required by paragraph (d)(1)(iii) of this section.
(3) To be exempt from §§ 266.102 through 266.111, an owner or operator of a lead or nickel-chromium or mercury recovery furnace (except for owners or operators of lead recovery furnaces subject to regulation under the Secondary Lead Smelting NESHAP) must provide a one-time written notice to the Secretary identifying each hazardous waste burned and specifying whether the owner or operator claims an exemption for each waste under this paragraph or paragraph (d)(1) of this section. The owner or operator must comply with the requirements of paragraph (d)(1) of this section for those wastes claimed to be exempt under that paragraph and must comply with the requirements below for those wastes claimed to be exempt under this paragraph (d)(3).
(i) The hazardous wastes listed in Appendices XI, XII, and XIII, Part 266, and baghouse bags used to capture metallic dusts emitted by steel manufacturing are exempt from the requirements of paragraph (d)(1) of this section, provided that:
(A) A waste listed in Appendix XI of this part must contain recoverable levels of lead, a waste listed in Appendix XII of this part must contain recoverable levels of nickel or chromium, a waste listed in Appendix XIII of this part must contain recoverable levels of mercury and contain less than 500 ppm of Part 261, Appendix VIII organic constituents, and baghouse bags used to capture metallic dusts emitted by steel manufacturing must contain recoverable levels of metal; and
(B) The waste does not exhibit the Toxicity Characteristic of §261.24 of these regulations for an organic constituent; and
(C) The waste is not a hazardous waste listed in Subpart D of Part 261 of these regulations because it is listed for an organic constituent as identified in Appendix VII of Part 261 of these regulations; and
(D) The owner or operator certifies in the one-time notice that hazardous waste is burned under the provisions of paragraph (d)(3) of this section and that sampling and analysis will be conducted or other information will be obtained as necessary to ensure continued compliance with these requirements. Sampling and analysis shall be conducted according to paragraph (d)(1)(ii) of this section and records to document compliance with paragraph (d)(3) of this section shall be kept for at least three years.
(ii) The Secretary may decide on a case-by-case basis that the toxic organic constituents in a material listed in Appendix XI, XII, or XIII of this part that contains a total concentration of more than 500 ppm toxic organic compounds listed in Appendix VIII, Part 261 of these regulations, may pose a hazard to human health and the environment when burned in a metal recovery furnace exempt from the requirements of this subpart. In that situation, after adequate notice and opportunity for comment, the metal recovery furnace will become subject to the requirements of this subpart when burning that material. In making the hazard determination, the Secretary will consider the following factors:
(C) Whether the acceptable ambient levels established in Appendices IV or V of this part may be exceeded for any toxic organic compound that may be emitted based on dispersion modeling to predict the maximum annual average off-site ground level concentration.
(iii) The owner or operator will comply with the sampling and analysis and recordkeeping requirements of this paragraph; and
(2) Sample and analyze the hazardous waste as necessary to document that the waste contains economically significant amounts of the metals and that the treatment recovers economically significant amounts of precious metal; and
(3) Maintain at the facility for at least three years records to document that all hazardous wastes burned are burned for recovery of economically significant amounts of precious metal.
Section 266.101 Management prior to burning.
(1) Owners and operators of facilities that store or treat hazardous waste that is burned in a boiler or industrial furnace are subject to the applicable provisions of Parts 264, 265, and 122 of these regulations, except as provided by paragraph (c)(2) of this section. These standards apply to storage and treatment by the burner as well as to storage and treatment facilities operated by intermediaries (processors, blenders, distributors, etc.) between the generator and the burner.
(2) Owners and operators of facilities that burn, in an on-site boiler or industrial furnace exempt from regulation under the small quantity burner provisions of §266.108, hazardous waste that they generate are exempt from the regulations of Parts 264, 265, and 122 of these regulations applicable to storage units for those storage units that store mixtures of hazardous waste and the primary fuel to the boiler or industrial furnace in tanks that feed the fuel mixture directly to the burner. Storage of hazardous waste prior to mixing with the primary fuel is subject to regulation as prescribed in paragraph (c)(1) of this section.
Section 266.102 Permit standards for burners.
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(1) General. Owners and operators of boilers and industrial furnaces burning hazardous waste and not operating under interim status must comply with the requirements of this section and §§122.22 and 122.66 of these regulations, unless exempt under the small quantity burner exemption of §266.108.
(2) Applicability of Part 264 standards. Owners and operators of boilers and industrial furnaces that burn hazardous waste are subject to the following provisions of Part 264 of these regulations, except as provided otherwise by this subpart:
(v) In Subpart E (Manifest system, recordkeeping, and reporting), the applicable provisions of §§ 264.71-264.77;
(viii) In Subpart H (Financial requirements), §§ 264.141, 264.142, 264.143, and 264.147-264.151, except that States and the Federal government are exempt from the requirements of Subpart H; and
(1) The owner or operator must provide an analysis of the hazardous waste that quantifies the concentration of any constituent identified in Appendix VIII of Part 261 of these regulations that may reasonably be expected to be in the waste. Such constituents must be identified and quantified if present, at levels detectable by using appropriate analytical procedures. The Appendix VIII, Part 261 constituents excluded from this analysis must be identified and the basis for their exclusion explained. This analysis will be used to provide all information required by this subpart and §122.22 and §122.66 of these regulations and to enable the permit writer to prescribe such permit conditions as necessary to protect human health and the environment. Such analysis must be included as a portion of the Part B permit application, or, for facilities operating under the interim status standards of this subpart, as a portion of the trial burn plan that may be submitted before the Part B application under provisions of §122.66(g) of these regulations as well as any other analysis required by the permit authority in preparing the permit. Owners and operators of boilers and industrial furnaces not operating under the interim status standards must provide the information required by §§ 122.22 or 122.66(c) of these regulations in the Part B application to the greatest extent possible.
(2) Throughout normal operation, the owner or operator must conduct sampling and analysis as necessary to ensure that the hazardous waste, other fuels, and industrial furnace feedstocks fired into the boiler or industrial furnace are within the physical and chemical composition limits specified in the permit.
(1) The owner or operator may burn only hazardous wastes specified in the facility permit and only under the operating conditions specified under paragraph (e) of this section, except in approved trial burns under the conditions specified in §122.66 of these regulations.
(2) Hazardous wastes not specified in the permit may not be burned until operating conditions have been specified under a new permit or permit modification, as applicable. Operating requirements for new wastes may be based on either trial burn results or alternative data included with Part B of a permit application under §122.22 of these regulations.
(3) Boilers and industrial furnaces operating under the interim status standards of §266.103 are permitted under procedures provided by §122.66(g) of these regulations.
(4) A permit for a new boiler or industrial furnace (those boilers and industrial furnaces not operating under the interim status standards) must establish appropriate conditions for each of the applicable requirements of this section, including but not limited to allowable hazardous waste firing rates and operating conditions necessary to meet the requirements of paragraph (e) of this section, in order to comply with the following standards:
(i) For the period beginning with initial introduction of hazardous waste and ending with initiation of the trial burn, and only for the minimum time required to bring the device to a point of operational readiness to conduct a trial burn, not to exceed a duration of 720 hours operating time when burning hazardous waste, the operating requirements must be those most likely to ensure compliance with the emission standards of §§ 266.104 through 266.107, based on the Secretary's engineering judgment. If the applicant is seeking a waiver from a trial burn to demonstrate conformance with a particular emission standard, the operating requirements during this initial period of operation shall include those specified by the applicable provisions of §266.104, §266.105, §266.106, or §266.107. The Secretary may extend the duration of this period for up to 720 additional hours when good cause for the extension is demonstrated by the applicant.
(ii) For the duration of the trial burn, the operating requirements must be sufficient to demonstrate compliance with the emissions standards of §§ 266.104 through 266.107 and must be in accordance with the approved trial burn plan;
(iii) For the period immediately following completion of the trial burn, and only for the minimum period sufficient to allow sample analysis, data computation, submission of the trial burn results by the applicant, review of the trial burn results and modification of the facility permit by the Secretary to reflect the trial burn results, the operating requirements must be those most likely to ensure compliance with the emission standards §§ 266.104 through 266.107 based on the Secretary's engineering judgment.
(iv) For the remaining duration of the permit, the operating requirements must be those demonstrated in a trial burn or by alternative data specified in §122.22 of these regulations, as sufficient to ensure compliance with the emissions standards of §§ 266.104 through 266.107.
(1) General. A boiler or industrial furnace burning hazardous waste must be operated in accordance with the operating requirements specified in the permit at all times where there is hazardous waste in the unit.
(i) DRE standard. Operating conditions will be specified either on a case-by-case basis for each hazardous waste burned as those demonstrated (in a trial burn or by alternative data as specified in §122.22) to be sufficient to comply with the destruction and removal efficiency (DRE) performance standard of §266.104(a) or as those special operating requirements provided by §266.104(a)(4) for the waiver of the DRE trial burn. When the DRE trial burn is not waived under §266.104(a)(4), each set of operating requirements will specify the composition of the hazardous waste (including acceptable variations in the physical and chemical properties of the hazardous waste which will not affect compliance with the DRE performance standard) to which the operating requirements apply. For each such hazardous waste, the permit will specify acceptable operating limits including, but not limited to, the following conditions as appropriate:
(A) Feed rate of hazardous waste and other fuels measured and specified as prescribed in paragraph (e)(6) of this section;
(B) Minimum and maximum device production rate when producing normal product expressed in appropriate units, measured and specified as prescribed in paragraph (e)(6) of this section;
(E) Minimum combustion gas temperature measured at a location indicative of combustion chamber temperature, measured and specified as prescribed in paragraph (e)(6) of this section;
(F) An appropriate indicator of combustion gas velocity, measured and specified as prescribed in paragraph (e)(6) of this section, unless documentation is provided under §122.66 of these regulations demonstrating adequate combustion gas residence time; and
(G) Such other operating requirements as are necessary to ensure that the DRE performance standard of §266.104(a) is met.
(ii) Carbon monoxide and hydrocarbon standards. The permit must incorporate a carbon monoxide (CO) limit and, as appropriate, a hydrocarbon (HC) limit as provided by paragraphs (b), (c), (d), (e) and (f) of §266.104. The permit limits will be specified as follows:
(B) When complying with the alternative CO standard under §266.104(c), the permit limit for CO is based on the trial burn and is established as the average over all valid runs of the highest hourly rolling average CO level of each run, and the permit limit for HC is 20 ppmv (as defined in §266.104(c)(1)), except as provided in §266.104(f).
(C) When complying with the alternative HC limit for industrial furnaces under §266.104(f), the permit limit for HC and CO is the baseline level when hazardous waste is not burned as specified by that paragraph.
(iii) Start-up and shut-down. During start-up and shut-down of the boiler or industrial furnace, hazardous waste (except waste fed solely as an ingredient under the Tier I (or adjusted Tier I) feed rate screening limits for metals and chloride/chlorine, and except low risk waste exempt from the trial burn requirements under §§ 266.104(a)(5), 266.105, 266.106, and 266.107) must not be fed into the device unless the device is operating within the conditions of operation specified in the permit.
(i) Except as provided in paragraphs (e)(3)(ii) and (iii) of this section, the permit shall specify the following operating requirements to ensure conformance with the particulate standard specified in §266.105:
(A) Total ash feed rate to the device from hazardous waste, other fuels, and industrial furnace feedstocks, measured and specified as prescribed in paragraph (e)(6) of this section;
(B) Maximum device production rate when producing normal product expressed in appropriate units, and measured and specified as prescribed in paragraph (e)(6) of this section;
(C) Appropriate controls on operation and maintenance of the hazardous waste firing system and any air pollution control system;
(D) Allowable variation in boiler and industrial furnace system design including any air pollution control system or operating procedures; and
(E) Such other operating requirements as are necessary to ensure that the particulate standard in §266.105(a) is met.
(ii) Permit conditions to ensure conformance with the particulate matter standard shall not be provided for facilities exempt from the particulate matter standard under §266.105(b);
(iii) For cement kilns and light-weight aggregate kilns, permit conditions to ensure compliance with the particulate standard shall not limit the ash content of hazardous waste or other feed materials.
(A) Total feed rate of each metal in hazardous waste, other fuels, and industrial furnace feedstocks measured and specified under provisions of paragraph (e)(6) of this section;
(B) Total feed rate of hazardous waste measured and specified as prescribed in paragraph (e)(6) of this section;
(C) A sampling and metals analysis program for the hazardous waste, other fuels, and industrial furnace feedstocks;
(A) Maximum emission rate for each metal specified as the average emission rate during the trial burn;
(B) Feed rate of total hazardous waste and pumpable hazardous waste, each measured and specified as prescribed in paragraph (e)(6)(i) of this section;
(C) Feed rate of each metal in the following feedstreams, measured and specified as prescribed in paragraphs (e)(6) of this section:
(D) Total feed rate of chlorine and chloride in total feed streams measured and specified as prescribed in paragraph (e)(6) of this section;
(E) Maximum combustion gas temperature measured at a location indicative of combustion chamber temperature, and measured and specified as prescribed in paragraph (e)(6) of this section;
(F) Maximum flue gas temperature at the inlet to the particulate matter air pollution control system measured and specified as prescribed in paragraph (e)(6) of this section;
(G) Maximum device production rate when producing normal product expressed in appropriate units and measured and specified as prescribed in paragraph (e)(6) of this section;
(H) Appropriate controls on operation and maintenance of the hazardous waste firing system and any air pollution control system;
(I) Allowable variation in boiler and industrial furnace system design including any air pollution control system or operating procedures; and
(J) Such other operating requirements as are necessary to ensure that the metals standards under §§ 266.106(c) or 266.106(d) are met.
(A) Maximum emission rate for each metal specified as the average emission rate during the trial burn;
(B) Feed rate of total hazardous waste and pumpable hazardous waste, each measured and specified as prescribed in paragraph (e)(6)(i) of this section;
(C) Feed rate of each metal in the following feedstreams, measured and specified as prescribed in paragraph (e)(6) of this section:
(D) Total feed rate of chlorine and chloride in total feed streams measured and specified prescribed in paragraph (e)(6) of this section;
(E) Maximum combustion gas temperature measured at a location indicative of combustion chamber temperature, and measured and specified as prescribed in paragraph (e)(6) of this section;
(F) Maximum flue gas temperature at the inlet to the particulate matter air pollution control system measured and specified as prescribed in paragraph (e)(6) of this section;
(G) Maximum device production rate when producing normal product expressed in appropriate units and measured and specified as prescribed in paragraph (e)(6) of this section;
(H) Appropriate controls on operation and maintenance of the hazardous waste firing system and any air pollution control system;
(I) Allowable variation in boiler and industrial furnace system design including any air pollution control system or operating procedures; and
(J) Such other operating requirements as are necessary to ensure that the metals standards under §§ 266.106(c) or 266.106(d) are met.
(i) For conformance with the Tier I total chloride and chlorine feed rate screening limits of §266.107(b)(1), the permit will specify the following operating requirements:
(A) Feed rate of total chloride and chlorine in hazardous waste, other fuels, and industrial furnace feedstocks measured and specified as prescribed in paragraph (e)(6) of this section;
(B) Feed rate of total hazardous waste measured and specified as prescribed in paragraph (e)(6) of this section;
(C) A sampling and analysis program for total chloride and chlorine for the hazardous waste, other fuels, and industrial furnace feedstocks;
(ii) For conformance with the Tier II HCl and Cl2 emission rate screening limits under §266.107(b)(2) and the Tier III HCl and Cl2 controls under §266.107(c), the permit will specify the following operating requirements:
(A) Maximum emission rate for HCl and for Cl2 specified as the average emission rate during the trial burn;
(B) Feed rate of total hazardous waste measured and specified as prescribed in paragraph (e)(6) of this section;
(C) Total feed rate of chlorine and chloride in total feed streams, measured and specified as prescribed in paragraph (e)(6) of this section;
(D) Maximum device production rate when producing normal product expressed in appropriate units, measured and specified as prescribed in paragraph (e)(6) of this section;
(E) Appropriate controls on operation and maintenance of the hazardous waste firing system and any air pollution control system;
(F) Allowable variation in boiler and industrial furnace system design including any air pollution control system or operating procedures; and
(G) Such other operating requirements as are necessary to ensure that the HCl and Cl2 standards under §266.107 (b)(2) or (c) are met.
(i) General requirements. As specified in paragraphs (e)(2) through (e)(5) of this section, each operating parameter shall be measured, and permit limits on the parameter shall be established, according to either of the following procedures:
(A) Instantaneous limits. A parameter may be measured and recorded on an instantaneous basis (i.e., the value that occurs at any time) and the permit limit specified as the time-weighted average during all valid runs of the trial burn; or
(1) The limit for a parameter may be established and continuously monitored on an hourly rolling average basis defined as follows:
(i) A continuous monitor is one which continuously samples the regulated parameter without interruption, and evaluates the detector response at least once each 15 seconds, and computes and records the average value at least every 60 seconds.
(ii) An hourly rolling average is the arithmetic mean of the 60 most recent 1-minute average values recorded by the continuous monitoring system.
(2) The permit limit for the parameter shall be established based on trial burn data as the average over all valid test runs of the highest hourly rolling average value for each run.
(ii) Rolling average limits for carcinogenic metals and lead. Feed rate limits for the carcinogenic metals (i.e., arsenic, beryllium, cadmium and chromium) and lead may be established either on an hourly rolling average basis as prescribed by paragraph (e)(6)(i) of this section or on (up to) a 24 hour rolling average basis. If the owner or operator elects to use an average period from 2 to 24 hours:
(A) The feed rate of each metal shall be limited at any time to ten times the feed rate that would be allowed on an hourly rolling average basis;
1) A continuous monitor is one which continuously samples the regulated parameter without interruption, and evaluates the detector response at least once each 15 seconds, and computes and records the average value at least every 60 seconds.
(2) The rolling average for the selected averaging period is defined as the arithmetic mean of one hour block averages for the averaging period. A one hour block average is the arithmetic mean of the one minute averages recorded during the 60-minute period beginning at one minute after the beginning of the preceding clock hour; and
(C) The permit limit for the feed rate of each metal shall be established based on trial burn data as the average over all valid test runs of the highest hourly rolling average feed rate for each run.
(iii) Feed rate limits for metals, total chloride and chlorine, and ash. Feed rate limits for metals, total chlorine and chloride, and ash are established and monitored by knowing the concentration of the substance (i.e., metals, chloride/chlorine, and ash) in each feedstream and the flow rate of the feedstream. To monitor the feed rate of these substances, the flow rate of each feedstream must be monitored under the continuous monitoring requirements of paragraphs (e)(6) (i) and (ii) of this section.
(A) If compliance with all applicable emissions standards of §§ 266.104 through 266.107 is not demonstrated simultaneously during a set of test runs, the operating conditions of additional test runs required to demonstrate compliance with remaining emissions standards must be as close as possible to the original operating conditions.
(B) Prior to obtaining test data for purposes of demonstrating compliance with the emissions standards of §§ 266.104 through 266.107 or establishing limits on operating parameters under this section, the facility must operate under trial burn conditions for a sufficient period to reach steady-state operations. The Secretary may determine, however, that industrial furnaces that recycle collected particulate matter back into the furnace and that comply with an alternative implementation approach for metals under §266.106(f) need not reach steady state conditions with respect to the flow of metals in the system prior to beginning compliance testing for metals emissions.
(C) Trial burn data on the level of an operating parameter for which a limit must be established in the permit must be obtained during emissions sampling for the pollutant(s) (i.e., metals, PM, HCl/Cl2, organic compounds) for which the parameter must be established as specified by paragraph (e) of this section.
(C) An alternate means of control demonstrated (with Part B of the permit application) to provide fugitive emissions control equivalent to maintenance of combustion zone pressure lower than atmospheric pressure.
(ii) Automatic waste feed cutoff. A boiler or industrial furnace must be operated with a functioning system that automatically cuts off the hazardous waste feed when operating conditions deviate from those established under this section. The Secretary may limit the number of cutoffs per an operating period on a case-by-case basis. In addition:
(A) The permit limit for (the indicator of) minimum combustion chamber temperature must be maintained while hazardous waste or hazardous waste residues remain in the combustion chamber,
(B) Exhaust gases must be ducted to the air pollution control system operated in accordance with the permit requirements while hazardous waste or hazardous waste residues remain in the combustion chamber; and
(C) Operating parameters for which permit limits are established must continue to be monitored during the cutoff, and the hazardous waste feed shall not be restarted until the levels of those parameters comply with the permit limits. For parameters that may be monitored on an instantaneous basis, the Secretary will establish a minimum period of time after a waste feed cutoff during which the parameter must not exceed the permit limit before the hazardous waste feed may be restarted.
(iii) Changes. A boiler or industrial furnace must cease burning hazardous waste when changes in combustion properties, or feed rates of the hazardous waste, other fuels, or industrial furnace feedstocks, or changes in the boiler or industrial furnace design or operating conditions deviate from the limits as specified in the permit.
(i) The owner or operator must monitor and record the following, at a minimum, while burning hazardous waste:
(A) If specified by the permit, feed rates and composition of hazardous waste, other fuels, and industrial furnace feedstocks, and feed rates of ash, metals, and total chloride and chlorine;
(B) If specified by the permit, carbon monoxide (CO), hydrocarbons (HC), and oxygen on a continuous basis at a common point in the boiler or industrial furnace downstream of the combustion zone and prior to release of stack gases to the atmosphere in accordance with operating requirements specified in paragraph (e)(2)(ii) of this section. CO, HC, and oxygen monitors must be installed, operated, and maintained in accordance with methods specified in Appendix IX of this part.
(C) Upon the request of the Secretary, sampling and analysis of the hazardous waste (and other fuels and industrial furnace feedstocks as appropriate), residues, and exhaust emissions must be conducted to verify that the operating requirements established in the permit achieve the applicable standards of §§ 266.104, 266.105, 266.106, and 266.107.
(ii) All monitors shall record data in units corresponding to the permit limit unless otherwise specified in the permit.
(iii) The boiler or industrial furnace and associated equipment (pumps, valves, pipes, fuel storage tanks, etc.) must be subjected to thorough visual inspection when it contains hazardous waste, at least daily for leaks, spills, fugitive emissions, and signs of tampering.
(iv) The automatic hazardous waste feed cutoff system and associated alarms must be tested at least once every 7 days when hazardous waste is burned to verify operability, unless the applicant demonstrates to the Secretary that weekly inspections will unduly restrict or upset operations and that less frequent inspections will be adequate. At a minimum, operational testing must be conducted at least once every 30 days.
(v) These monitoring and inspection data must be recorded and the records must be placed in the operating record required by §264.73 of these regulations.
(9) Direct transfer to the burner. If hazardous waste is directly transferred from a transport vehicle to a boiler or industrial furnace without the use of a storage unit, the owner and operator must comply with §266.111.
(10) Recordkeeping. The owner or operator must keep in the operating record of the facility all information and data required by this section until closure of the facility.
(11) Closure. At closure, the owner or operator must remove all hazardous waste and hazardous waste residues (including, but not limited to, ash, scrubber waters, and scrubber sludges) from the boiler or industrial furnace.
Section 266.103 Interim status standards for burners.
(i) The purpose of this section is to establish minimum national standards for owners and operators of "existing" boilers and industrial furnaces that burn hazardous waste where such standards define the acceptable management of hazardous waste during the period of interim status. The standards of this section apply to owners and operators of existing facilities until either a permit is issued under §266.102(d) or until closure responsibilities identified in this section are fulfilled.
(ii) "Existing or in existence" means a boiler or industrial furnace that on or before August 21, 1991 is either in operation burning or processing hazardous waste or for which construction (including the ancillary facilities to burn or to process the hazardous waste) has commenced. A facility has commenced construction if the owner or operator has obtained the Federal, State, and local approvals or permits necessary to begin physical construction; and either:
(B) The owner or operator has entered into contractual obligations-which cannot be canceled or modified without substantial loss-for physical construction of the facility to be completed within a reasonable time.
(iii) If a boiler or industrial furnace is located at a facility that already has a permit or interim status, then the facility must comply with the applicable regulations dealing with permit modifications in §122.42 or changes in interim status in §122.72 of these regulations.
(2) Exemptions. The requirements of this section do not apply to hazardous waste and facilities exempt under §§ 266.100(b), or 266.108.
(3) Prohibition on burning dioxin-listed wastes. The following hazardous waste listed for dioxin and hazardous waste derived from any of these wastes may not be burned in a boiler or industrial furnace operating under interim status: F020, F021, F022, F023, F026, and F027.
(4) Applicability of Part 265 standards. Owners and operators of boilers and industrial furnaces that burn hazardous waste and are operating under interim status are subject to the following provisions of Part 265 of these regulations, except as provided otherwise by this section:
(v) In Subpart E (Manifest system, recordkeeping, and reporting), §§ 265.71-265.77, except that §§ 265.71, 265.72, and 265.76 do not apply to owners and operators of on-site facilities that do not receive any hazardous waste from off-site sources;
(vii) In Subpart H (Financial requirements), §§ 265.141, 265.142, 265.143, and 265.147-265.148, except that States and the Federal government are exempt from the requirements of Subpart H; and
(5) Special requirements for furnaces. The following controls apply during interim status to industrial furnaces (e.g., kilns, cupolas) that feed hazardous waste for a purpose other than solely as an ingredient (see paragraph (a)(5)(ii) of this section) at any location other than the hot end where products are normally discharged or where fuels are normally fired:
(A) The hazardous waste shall be fed at a location where combustion gas temperatures are at least 1800oF;
(B) The owner or operator must determine that adequate oxygen is present in combustion gases to combust organic constituents in the waste and retain documentation of such determination in the facility record;
(D) The hydrocarbon controls of §266.104(c) or paragraph (c)(5) of this section apply upon certification of compliance under paragraph (c) of this section irrespective of the CO level achieved during the compliance test.
(ii) Burning hazardous waste solely as an ingredient. A hazardous waste is burned for a purpose other than solely as an ingredient if it meets either of these criteria:
(A The hazardous waste has a total concentration of nonmetal compounds listed in Part 261, Appendix VIII, of these regulations exceeding 500 ppm by weight, as-fired, and so is considered to be burned for destruction. The concentration of nonmetal compounds in a waste as-generated may be reduced to the 500 ppm limit by bona fide treatment that removes or destroys nonmetal constituents. Blending for dilution to meet the 500 ppm limit is prohibited and documentation that the waste has not been impermissibly diluted must be retained in the facility record; or
(B) The hazardous waste has a heating value of 5,000 Btu/lb or more, as-fired, and so is considered to be burned as fuel. The heating value of a waste as-generated may be reduced to below the 5,000 Btu/lb limit by bona fide treatment that removes or destroys organic constituents. Blending to augment the heating value to meet the 5,000 Btu/lb limit is prohibited and documentation that the waste has not been impermissibly blended must be retained in the facility record.
(6) Restrictions on burning hazardous waste that is not a fuel. Prior to certification of compliance under paragraph (c) of this section, owners and operators shall not feed hazardous waste that has a heating value less than 5,000 Btu/lb, as-generated, (except that the heating value of a waste as-generated may be increased to above the 5,000 Btu/lb limit by bona fide treatment; however, blending to augment the heating value to meet the 5,000 Btu/lb limit is prohibited and records must be kept to document that impermissible blending has not occurred) in a boiler or industrial furnace, except that:
(ii) Hazardous waste may be burned for purposes of compliance testing (or testing prior to compliance testing) for a total period of time not to exceed 720 hours; or
(iii) Such waste may be burned if the Secretary has documentation to show that, prior to August 21, 1991:
(A) The boiler or industrial furnace is operating under the interim status standards for incinerators provided by Subpart O of Part 265 of these regulations, or the interim status standards for thermal treatment units provided by Subpart P of Part 265 of these regulations; and
(B) The boiler or industrial furnace met the interim status eligibility requirements under §122.70 of these regulations for Subpart O or Subpart P of Part 265 of these regulations; and
(iv) Such waste may be burned in a halogen acid furnace if the waste was burned as an excluded ingredient under §261.2(e) of these regulations prior to February 21, 1991 and documentation is kept on file supporting this claim.
(7) Direct transfer to the burner. If hazardous waste is directly transferred from a transport vehicle to a boiler or industrial furnace without the use of a storage unit, the owner and operator must comply with §266.111.
(1) General. The owner or operator must provide complete and accurate information specified in paragraph (b)(2) of this section to the Secretary on or before August 21, 1991, and must establish limits for the operating parameters specified in paragraph (b)(3) of this section. Such information is termed a "certification of precompliance" and constitutes a certification that the owner or operator has determined that, when the facility is operated within the limits specified in paragraph (b)(3) of this section, the owner or operator believes that, using best engineering judgment, emissions of particulate matter, metals, and HCl and Cl2 are not likely to exceed the limits provided by §§ 266.105, 266.106, and 266.107. The facility may burn hazardous waste only under the operating conditions that the owner or operator establishes under paragraph (b)(3) of this section until the owner or operator submits a revised certification of precompliance under paragraph (b)(8) of this section or a certification of compliance under paragraph (c) of this section, or until a permit is issued.
(2) Information required. The following information must be submitted with the certification of precompliance to support the determination that the limits established for the operating parameters identified in paragraph (b)(3) of this section are not likely to result in an exceedance of the allowable emission rates for particulate matter, metals, and HCl and Cl2:
(C) Description of boilers and industrial furnaces burning hazardous waste, including type and capacity of device;
(D) A scaled plot plan showing the entire facility and location of the boilers and industrial furnaces burning hazardous waste; and
(E) A description of the air pollution control system on each device burning hazardous waste, including the temperature of the flue gas at the inlet to the particulate matter control system.
(ii) Except for facilities complying with the Tier I or Adjusted Tier I feed rate screening limits for metals or total chlorine and chloride provided by §§ 266.106 (b) or (e) and 266.107 (b)(1) or (e) respectively, the estimated uncontrolled (at the inlet to the air pollution control system) emissions of particulate matter, each metal controlled by §266.106, and hydrogen chloride and chlorine, and the following information to support such determinations:
(A) The feed rate (lb/hr) of ash, chlorine, antimony, arsenic, barium, beryllium, cadmium, chromium, lead, mercury, silver, and thallium in each feedstream (hazardous waste, other fuels, and industrial furnace feedstocks);
(B) The estimated partitioning factor to the combustion gas for the materials identified in paragraph (b)(2)(ii)(A) of this section and the basis for the estimate and an estimate of the partitioning to HCl and Cl2 of total chloride and chlorine in feed materials. To estimate the partitioning factor, the owner or operator must use either best engineering judgment or the procedures specified in Appendix IX of this part.
(C) For industrial furnaces that recycle collected particulate matter (PM) back into the furnace and that will certify compliance with the metals emissions standards under paragraph (c)(3)(ii)(A), the estimated enrichment factor for each metal. To estimate the enrichment factor, the owner or operator must use either best engineering judgment or the procedures specified in "Alternative Methodology for Implementing Metals Controls" in Appendix IX of this part.
(D) If best engineering judgment is used to estimate partitioning factors or enrichment factors under paragraphs (b)(2)(ii)(B) or (b)(2)(ii)(C) respectively, the basis for the judgment. When best engineering judgment is used to develop or evaluate data or information and make determinations under this section, the determinations must be made by a qualified, registered professional engineer and a certification of his/her determinations in accordance with §122.11(d) of these regulations must be provided in the certification of precompliance.
(iii) For facilities complying with the Tier I or Adjusted Tier I feed rate screening limits for metals or total chlorine and chloride provided by §§ 266.106 (b) or (e) and 266.107 (b)(1) or (e), the feed rate (lb/hr) of total chloride and chlorine, antimony, arsenic, barium, beryllium, cadmium, chromium, lead, mercury, silver, and thallium in each feedstream (hazardous waste, other fuels, industrial furnace feedstocks).
(iv) For facilities complying with the Tier II or Tier III emission limits for metals or HCl and Cl2 (under §§ 266.106 (c) or (d) or 266.107(b)(2) or (c)), the estimated controlled (outlet of the air pollution control system) emissions rates of particulate matter, each metal controlled by §266.106, and HCl and Cl2, and the following information to support such determinations:
(A) The estimated air pollution control system (APCS) removal efficiency for particulate matter, HCl, Cl2, antimony, arsenic, barium, beryllium, cadmium, chromium, lead, mercury, silver, and thallium.
(B) To estimate APCS removal efficiency, the owner or operator must use either best engineering judgment or the procedures prescribed in Appendix IX of this part.
(C) If best engineering judgment is used to estimate APCS removal efficiency, the basis for the judgment. Use of best engineering judgment must be in conformance with provisions of paragraph (b)(2)(ii)(D) of this section.
(v) Determination of allowable emissions rates for HCl, Cl2, antimony, arsenic, barium, beryllium, cadmium, chromium, lead, mercury, silver, and thallium, and the following information to support such determinations:
(5) Attach a US Geological Service topographic map (or equivalent) showing the facility location and surrounding land within 5 km of the facility;
(B) For owners and operators using Tier III site specific dispersion modeling to determine allowable levels under §266.106(d) or §266.107(c), or adjusted Tier I feed rate screening limits under §§ 266.106(e) or 266.107(e):
(3) The dilution factor in micrograms per cubic meter per gram per second of emissions for the maximum annual average off-site (unless on-site is required) ground level concentration (MEI location); and
(vi) For facilities complying with the Tier II or III emissions rate controls for metals or HCl and Cl2, a comparison of the estimated controlled emissions rates determined under paragraph (b)(2)(iv) with the allowable emission rates determined under paragraph (b)(2)(v);
(vii) For facilities complying with the Tier I (or adjusted Tier I) feed rate screening limits for metals or total chloride and chlorine, a comparison of actual feed rates of each metal and total chlorine and chloride determined under paragraph (b)(2)(iii) of this section to the Tier I allowable feed rates; and
(viii) For industrial furnaces that feed hazardous waste for any purpose other than solely as an ingredient (as defined by paragraph (a)(5)(ii) of this section) at any location other than the product discharge end of the device, documentation of compliance with the requirements of paragraphs (a)(5)(i) (A), (B), and (C) of this section.
(ix) For industrial furnaces that recycle collected particulate matter (PM) back into the furnace and that will certify compliance with the metals emissions standards under paragraph (c)(3)(ii) (A) of this section:
(3) Limits on operating conditions. The owner and operator shall establish limits on the following arameters consistent with the determinations made under paragraph (b)(2) of this section and certify (under provisions of paragraph (b)(9) of this section) to the Secretary that the facility will operate within the limits during interim status when there is hazardous waste in the unit until revised certification of precompliance under paragraph (b)(8) of this section or certification of compliance under paragraph (c) of this section:
(i) Feed rate of total hazardous waste and (unless complying with the Tier I or adjusted Tier I metals feed rate screening limits under §266.106(b) or (e)) pumpable hazardous waste;
(A) Total feed streams, except that industrial furnaces that comply with the alternative metals implementation approach under paragraph (b)(4) of this section must specify limits on the concentration of each metal in collected particulate matter in lieu of feed rate limits for total feedstreams;
(B) Total hazardous waste feed, unless complying with the Tier I or Adjusted Tier I metals feed rate screening limits under §266.106(b) or (e); and
(C) Total pumpable hazardous waste feed, unless complying with the Tier I or adjusted Tier I metals feed rate screening limits under §266.106 (b) or (e);
(iv) Total feed rate of ash in total feed streams, except that the ash feed rate for cement kilns and light-weight aggregate kilns is not limited; and
(v) Maximum production rate of the device in appropriate units when producing normal product, unless complying with the Tier I or Adjusted Tier I feed rate screening limits for chlorine under §266.107(b)(1) or (e) and for all metals under §266.106(b) or (e), and the uncontrolled particulate emissions do not exceed the standard under §266.105.
(4) Operating requirements for furnaces that recycle PM. Owners and operators of furnaces that recycle collected particulate matter (PM) back into the furnace and that will certify compliance with the metals emissions controls under paragraph (c)(3)(ii)(A) of this section must comply with the special operating requirements provided in "Alternative Methodology for Implementing Metals Controls" in Appendix IX of this part.
(i) General requirements. Limits on each of the parameters specified in paragraph (b)(3) of this section (except for limits on metals concentrations in collected particulate matter (PM) for industrial furnaces that recycle collected PM) shall be established and continuously monitored under either of the following methods:
(A) Instantaneous limits. A limit for a parameter may be established and continuously monitored and recorded on an instantaneous basis (i.e., the value that occurs at any time) not to be exceeded at any time; or
(B) Hourly rolling average limits. A limit for a parameter may be established and continuously monitored on an hourly rolling average basis defined as follows:
(1) A continuous monitor is one which continuously samples the regulated parameter without interruption, and evaluates the detector response at least once each 15 seconds, and computes and records the average value at least every 60 seconds.
(2) An hourly rolling average is the arithmetic mean of the 60 most recent 1-minute average values recorded by the continuous monitoring system.
(ii) Rolling average limits for carcinogenic metals and lead. Feed rate limits for the carcinogenic metals (arsenic, beryllium, cadmium, and chromium) and lead may be established either on an hourly rolling average basis as prescribed by paragraph (b)(5)(i)(B) or on (up to) a 24 hour rolling average basis. If the owner or operator elects to use an averaging period from 2 to 24 hours:
(A) The feed rate of each metal shall be limited at any time to ten times the feed rate that would be allowed on an hourly rolling average basis;
(1) A continuous monitor is one which continuously samples the regulated parameter without interruption, and evaluates the detector response at least once each 15 seconds, and computes and records the average value at least every 60 seconds.
(2) The rolling average for the selected averaging period is defined as the arithmetic mean of one hour block averages for the averaging period. A one hour block average is the arithmetic mean of the one minute averages recorded during the 60-minute period beginning at one minute after the beginning of preceding clock hour.
(iii) Feed rate limits for metals, total chloride and chlorine, and ash. Feed rate limits for metals, total chlorine and chloride, and ash are established and monitored by knowing the concentration of the substance (i.e., metals, chloride/chlorine, and ash) in each feedstream and the flow rate of the feedstream. To monitor the feed rate of these substances, the flow rate of each feedstream must be monitored under the continuous monitoring requirements of paragraphs (b)(5) (i) and (ii) of this section.
(6) Public notice requirements at precompliance. On or before August 21, 1991, the owner or operator must submit a notice with the following information for publication in a major local newspaper of general circulation and send a copy of the notice to the appropriate units of State and local government. The owner and operator must provide to the Secretary with the certification of precompliance evidence of submitting the notice for publication. The notice, which shall be entitled "Notice of Certification of Precompliance with Hazardous Waste Burning Requirements of 40 CFR 266.103(b)", must include:
(i) Name and address of the owner and operator of the facility as well as the location of the device burning hazardous waste;
(iii) Brief description of the regulatory process required to comply with the interim status requirements of this section including required emissions testing to demonstrate conformance with emissions standards for organic compounds, particulate matter, metals, and HCl and Cl2;
(iv) Types and quantities of hazardous waste burned including, but not limited to, source, whether solids or liquids, as well as an appropriate description of the waste;
(v) Type of device(s) in which the hazardous waste is burned including a physical description and maximum production rate of each device;
(vii) Brief description of the basis for this certification of precompliance as specified in paragraph (b)(2) of this section;
(viii) Locations where the record for the facility can be viewed and copied by interested parties. These records and locations shall at a minimum include:
(A) The administrative record kept by DNREC where the supporting documentation was submitted or another location designated by the Secretary; and
(B) The BIF correspondence file kept at the facility site where the device is located. The correspondence file must include all correspondence between the facility and the Secretary, State and local regulatory officials, including copies of all certifications and notifications, such as the precompliance certification, precompliance public notice, notice of compliance testing, compliance test report, compliance certification, time extension requests and approvals or denials, enforcement notifications of violations, and copies of EPA and State site visit reports submitted to the owner or operator.
(ix) Notification of the establishment of a facility mailing list whereby interested parties shall notify the DNREC that they wish to be placed on the mailing list to receive future information and notices about this facility; and
(x) Location (mailing address) of the DNREC Office, Hazardous Waste Section, where further information can be obtained on regulation of hazardous waste burning.
(7) Monitoring other operating parameters. When the monitoring systems for the operating parameters listed in paragraphs (c)(1)(v through xiii) of this section are installed and operating in conformance with vendor specifications or (for CO, HC, and oxygen) specifications provided by Appendix IX of this part, as appropriate, the parameters shall be continuously monitored and records shall be maintained in the operating record.
(8) Revised certification of precompliance. The owner or operator may revise at any time the information and operating conditions documented under paragraphs (b)(2) and (b)(3) of this section in the certification of precompliance by submitting a revised certification of precompliance under procedures provided by those paragraphs.
(i) The public notice requirements of paragraph (b)(6) of this section do not apply to recertifications.
(ii) The owner and operator must operate the facility within the limits established for the operating parameters under paragraph (b)(3) of this section until a revised certification is submitted under this paragraph or a certification of compliance is submitted under paragraph (c) of this section.
(9) Certification of precompliance statement. The owner or operator must include the following signed statement with the certification of precompliance submitted to the Secretary:
(1) Limits on operating conditions. The owner or operator shall establish limits on the following parameters based on operations during the compliance test (under procedures prescribed in paragraph (c)(4)(iv) of this section) or as otherwise specified and include these limits with the certification of compliance. The boiler or industrial furnace must be operated in accordance with these operating limits and the applicable emissions standards of §§ 266.104(b) through (e), 266.105, 266.106, 266.107, and 266.103(a)(5)(i)(D) at all times when there is hazardous waste in the unit.
(i) Feed rate of total hazardous waste and (unless complying with the Tier I or Adjusted Tier I metals feed rate screening limits under §266.106 (b) or (e)), pumpable hazardous waste;
(1) Facilities that comply with Tier I or Adjusted Tier I metals feed rate screening limits may set their operating limits at the metals feed rate screening limits determined under §266.106(b) or (e); and
(2) Industrial furnaces that must comply with the alternative metals implementation approach under paragraph (c)(3)(ii) of this section must specify limits on the concentration of each metal in the collected particulate matter in lieu of feed rate limits for total feedstreams;
(B) Total hazardous waste feed (unless complying with the Tier I or Adjusted Tier I metals feed rate screening limits under §266.106(b) or (e)); and
(C) Total pumpable hazardous waste feed (unless complying with the Tier I or Adjusted Tier I metals feed rate screening limits under §266.106(b) or (e));
(iii) Total feed rate of chlorine and chloride in total feed streams, except that facilities that comply with Tier I or Adjusted Tier I feed rate screening limits may set their operating limits at the total chlorine and chloride feed rate screening limits determined under §266.107(b)(1) or (e);
(iv) Total feed rate of ash in total feed streams, except that the ash feed rate for cement kilns and light-weight aggregate kilns is not limited;
(v) Carbon monoxide concentration, and where required, hydrocarbon concentration in stack gas. When complying with the CO controls of §266.104(b), the CO limit is 100 ppmv, and when complying with the HC controls of §266.104(c), the HC limit is 20 ppmv. When complying with the CO controls of §266.104(c), the CO limit is established based on the compliance test;
(vi) Maximum production rate of the device in appropriate units when producing normal product, unless complying with the Tier I or Adjusted Tier I feed rate screening limits for chlorine under §266.107(b)(1) or (e) and for all metals under §266.106(b) or (e), and the uncontrolled particulate emissions do not exceed the standard under §266.105;
(vii) Maximum combustion chamber temperature where the temperature measurement is as close to the combustion zone as possible and is upstream of any quench water injection (unless complying with the Tier I or Adjusted Tier I metals feed rate screening limits under §266.106(b) or (e));
(viii) Maximum flue gas temperature entering a particulate matter control device (unless complying with Tier I or Adjusted Tier I metals feed rate screening limits under §266.106(b) or (e) and the total chlorine and chloride feed rate screening limits under §266.107(b) or (e));
(ix) For systems using wet scrubbers, including wet ionizing scrubbers (unless complying with the Tier I or Adjusted Tier I metals feed rate screening limits under §266.106(b) or (e) and the total chlorine and chloride feed rate screening limits under §266.107(b)(1) or (e)):
(B) Minimum scrubber blowdown from the system or maximum suspended solids content of scrubber water; and
(x) For systems using venturi scrubbers, the minimum differential gas pressure across the venturi (unless complying with the Tier I or Adjusted Tier I metals feed rate screening limits under §266.106(b) or (e) and the total chlorine and chloride feed rate screening limits under §266.107(b)(1) or (e));
(xi) For systems using dry scrubbers (unless complying with the Tier I or Adjusted Tier I metals feed rate screening limits under §266.106(b) or (e) and the total chlorine and chloride feed rate screening limits under §266.107(b)(1) or (e)):
(xii) For systems using wet ionizing scrubbers or electrostatic precipitators (unless complying with the Tier I or Adjusted Tier I metals feed rate screening limits under §266.106(b) or (e) and the total chlorine and chloride feed rate screening limits under §266.107(b)(1) or (e)):
(xiii) For systems using fabric filters (baghouses), the minimum pressure drop (unless complying with the Tier I or Adjusted Tier I metals feed rate screening limits under §266.106(b) or (e) and the total chlorine and chloride feed rate screening limits under §266.107(b)(1) or (e)).
(2) Prior notice of compliance testing. At least 30 days prior to the compliance testing required by paragraph (c)(3) of this section, the owner or operator shall notify the Secretary and submit the following information:
(C) Person responsible for conducting compliance test, including company name, address, and telephone number, and a statement of qualifications;
(B) A scaled plot plan showing the entire facility and location of the boiler or industrial furnace;
(3) Hydrocarbon monitor, specifying the minimum temperature of the system and, if the temperature is less than 150oC, an explanation of why a heated system is not used (see paragraph (c)(5) of this section) and a brief description of the sample gas conditioning system.
(E) Indication of whether the stack is shared with another device that will be in operation during the compliance test;
(iii) Information on the testing planned, including a complete copy of the test protocol and Quality Assurance/Quality Control (QA/QC) plan, and a summary description for each test providing the following information at a minimum:
(B) Planned operating conditions, including levels for each pertinent parameter specified in paragraph (c)(1) of this section.
(i) General. Compliance testing must be conducted under conditions for which the owner or operator has submitted a certification of precompliance under paragraph (b) of this section and under conditions established in the notification of compliance testing required by paragraph (c)(2) of this section. The owner or operator may seek approval on a case-by-case basis to use compliance data from one unit in lieu of testing a similar onsite unit. To support the request, the owner or operator must provide a comparison of the hazardous waste burned and other feedstreams, and the design, operation, and maintenance of both the tested unit and similar unit. The Secretary shall provide written approval to use compliance test data in lieu of testing a similar unit if he finds that the hazardous wastes, the devices, and the operating conditions are sufficiently similar, and the data from the other compliance test is adequate to meet the requirements of §266.103(c).
(ii) Special requirements for industrial furnaces that recycle collected PM. Owners and operators of industrial furnaces that recycle back into the furnace particulate matter (PM) from the air pollution control system must comply with one of the following procedures for testing to determine compliance with the metals standards of §266.106(c) or (d):
(A) The special testing requirements prescribed in "Alternative Method for Implementing Metals Controls" in Appendix IX of this part; or
(B) Stack emissions testing for a minimum of 6 hours each day while hazardous waste is burned during interim status. The testing must be conducted when burning normal hazardous waste for that day at normal feed rates for that day and when the air pollution control system is operated under normal conditions. During interim status, hazardous waste analysis for metals content must be sufficient for the owner or operator to determine if changes in metals content may affect the ability of the facility to meet the metals emissions standards established under §266.106(c) or (d). Under this option, operating limits (under paragraph (c)(1) of this section) must be established during compliance testing under paragraph (c)(3) of this section only on the following parameters:
(C) Conduct compliance testing to determine compliance with the metals standards to establish limits on the operating parameters of paragraph (c)(1) of this section only after the kiln system has been conditioned to enable it to reach equilibrium with respect to metals fed into the system and metals emissions. During conditioning, hazardous waste and raw materials having the same metals content as will be fed during the compliance test must be fed at the feed rates that will be fed during the compliance test.
(A) If compliance with all applicable emissions standards of §§ 266.104 through 266.107 is not demonstrated simultaneously during a set of test runs, the operating conditions of additional test runs required to demonstrate compliance with remaining emissions standards must be as close as possible to the original operating conditions.
(B) Prior to obtaining test data for purposes of demonstrating compliance with the applicable emissions standards of §§ 266.104 through 266.107 or establishing limits on operating parameters under this section, the facility must operate under compliance test conditions for a sufficient period to reach steady-state operations. Industrial furnaces that recycle collected particulate matter back into the furnace and that comply with paragraphs (c)(3)(ii)(A) or (B) of this section, however, need not reach steady state conditions with respect to the flow of metals in the system prior to beginning compliance testing for metals.
(C) Compliance test data on the level of an operating parameter for which a limit must be established in the certification of compliance must be obtained during emissions sampling for the pollutant(s) (i.e., metals, PM, HCl/Cl2, organic compounds) for which the parameter must be established as specified by paragraph (c)(1) of this section.
(4) Certification of compliance. Within 90 days of completing compliance testing, the owner or operator must certify to the Secretary compliance with the emissions standards of §§ 266.104(b), (c), and (e), 266.105, 266.106, 266.107, and paragraph (a)(5)(i)(D) of this section. The certification of compliance must include the following information:
(C) Person responsible for conducting compliance testing, including company name, address, and telephone number, and a statement of qualifications;
(F) Person responsible for quality assurance/quality control (QA/QC), title, and telephone number, and statement that procedures prescribed in the QA/QC plan submitted under §266.103(c)(2)(iii) have been followed, or a description of any changes and an explanation of why changes were necessary.
(G) Description of any changes in the unit configuration prior to or during testing that would alter any of the information submitted in the prior notice of compliance testing under paragraph (c)(2) of this section, and an explanation of why the changes were necessary;
(H) Description of any changes in the planned test conditions prior to or during the testing that alter any of the information submitted in the prior notice of compliance testing under paragraph (c)(2) of this section, and an explanation of why the changes were necessary; and
(A) Purpose(s) of test (e.g., demonstrate conformance with the emissions limits for particulate matter, metals, HCl, Cl2, and CO)
(3) Time-weighted average and highest hourly rolling average CO level for each run and for the test;
(4) Highest hourly rolling average HC level, if HC monitoring is required for each run and for the test;
(5) If dioxin and furan testing is required under §266.104(e), time-weighted average emissions for each run and for the test of chlorinated dioxin and furan emissions, and the predicted maximum annual average ground level concentration of the toxicity equivalency factor;
(8) Time-weighted average emissions for the metals subject to regulation under §266.106 for each run and for the test; and
(iii) Comparison of the actual emissions during each test with the emissions limits prescribed by §§ 266.104 (b), (c), and (e), 266.105, 266.106, and 266.107 and established for the facility in the certification of precompliance under paragraph (b) of this section.
(iv) Determination of operating limits based on all valid runs of the compliance test for each applicable parameter listed in paragraph (c)(1) of this section using either of the following procedures:
(A) Instantaneous limits. A parameter may be measured and recorded on an instantaneous basis (i.e., the value that occurs at any time) and the operating limit specified as the time-weighted average during all runs of the compliance test; or
(1) The limit for a parameter may be established and continuously monitored on an hourly rolling average basis defined as follows:
(i) A continuous monitor is one which continuously samples the regulated parameter without interruption, and evaluates the detector response at least once each 15 seconds, and computes and records the average value at least every 60 seconds.
(ii) An hourly rolling average is the arithmetic mean of the 60 most recent 1-minute average values recorded by the continuous monitoring system.
(2) The operating limit for the parameter shall be established based on compliance test data as the average over all test runs of the highest hourly rolling average value for each run.
(C) Rolling average limits for carcinogenic metals and lead. Feed rate limits for the carcinogenic metals (i.e., arsenic, beryllium, cadmium and chromium) and lead may be established either on an hourly rolling average basis as prescribed by paragraph (c)(4)(iv)(B) of this section or on (up to) a 24 hour rolling average basis. If the owner or operator elects to use an averaging period from 2 to 24 hours:
(1) The feed rate of each metal shall be limited at any time to ten times the feed rate that would be allowed on an hourly rolling average basis;
(i) A continuous monitor is one which continuously samples the regulated parameter without interruption, and evaluates the detector response at least once each 15 seconds, and computes and records the average value at least every 60 seconds.
(ii) The rolling average for the selected averaging period is defined as the arithmetic mean of one hour block averages for the averaging period. A one hour block average is the arithmetic mean of the one minute averages recorded during the 60-minute period beginning at one minute after the beginning of preceding clock hour; and
(3) The operating limit for the feed rate of each metal shall be established based on compliance test data as the average over all test runs of the highest hourly rolling average feed rate for each run.
(D) Feed rate limits for metals, total chloride and chlorine, and ash. Feed rate limits for metals, total chlorine and chloride, and ash are established and monitored by knowing the concentration of the substance (i.e., metals, chloride/chlorine, and ash) in each feedstream and the flow rate of the feedstream. To monitor the feed rate of these substances, the flow rate of each feedstream must be monitored under the continuous monitoring requirements of paragraphs (c)(4)(iv) (A) through (C) of this section.
(v) Certification of compliance statement. The following statement shall accompany the certification of compliance:
(5) Special requirements for HC monitoring systems. When an owner or operator is required to comply with the hydrocarbon (HC) controls provided by §266.104(c) or paragraph (a)(5)(i)(D) of this section, a conditioned gas monitoring system may be used in conformance with specifications provided in Appendix IX of this part provided that the owner or operator submits a certification of compliance without using extensions of time provided by paragraph (c)(7) of this section.
(6) Special operating requirements for industrial furnaces that recycle collected PM. Owners and operators of industrial furnaces that recycle back into the furnace particulate matter (PM) from the air pollution control system must:
(i) When complying with the requirements of paragraph (c)(3)(ii)(A) of this section, comply with the operating requirements prescribed in "Alternative Method to Implement the Metals Controls" in Appendix IX of this part; and
(ii) When complying with the requirements of paragraph (c)(3)(ii)(B) of this section, comply with the operating requirements prescribed by that paragraph.
(i) If the owner or operator does not submit a complete certification of compliance for all of the applicable emissions standards of §§ 266.104, 266.105, 266.106, and 266.107 by August 21, 1992, he/she must either:
(A) Stop burning hazardous waste and begin closure activities under paragraph (l) of this section for the hazardous waste portion of the facility; or
(B) Limit hazardous waste burning only for purposes of compliance testing (and pretesting to prepare for compliance testing) a total period of 720 hours for the period of time beginning August 21, 1992, submit a notification to the Secretary by August 21, 1992 stating that the facility is operating under restricted interim status and intends to resume burning hazardous waste, and submit a complete certification of compliance by August 23, 1993; or
(ii) The owner or operator may request a case-by-case extension of time to extend any time limit provided by paragraph (c) of this section if compliance with the time limit is not practicable for reasons beyond the control of the owner or operator.
(A) In granting an extension, the Secretary may apply conditions as the facts warrant to ensure timely compliance with the requirements of this section and that the facility operates in a manner that does not pose a hazard to human health and the environment;
(B) When an owner or operator requests an extension of time to enable the facility to comply with the alternative hydrocarbon provisions of §266.104(f) and obtain a DNREC operating permit because the facility cannot meet the HC limit of §266.104(c) of these regulations:
(i) Determine whether the owner and operator have submitted in a timely manner a complete Part B permit application that includes information required under §122.22(b) of these regulations; and
(ii) Consider whether the owner and operator have made a good faith effort to certify compliance with all other emission controls, including the controls on dioxins and furans of §266.104(e) and the controls on PM, metals, and HCl/Cl2.
(2) If an extension is granted, the Secretary shall, as a condition of the extension, require the facility to operate under flue gas concentration limits on CO and HC that, based on available information, including information in the Part B permit application, are baseline CO and HC levels as defined by §266.104(f)(1).
(8) Revised certification of compliance. The owner or operator may submit at any time a revised certification of compliance (recertification of compliance) under the following procedures:
(i) Prior to submittal of a revised certification of compliance, hazardous waste may not be burned for more than a total of 720 hours under operating conditions that exceed those established under a current certification of compliance, and such burning may be conducted only for purposes of determining whether the facility can operate under revised conditions and continue to meet the applicable emissions standards of §§ 266.104, 266.105, 266.106, and 266.107;
(ii) At least 30 days prior to first burning hazardous waste under operating conditions that exceed those established under a current certification of compliance, the owner or operator shall notify the Secretary and submit the following information:
(B) Operating conditions that the owner or operator is seeking to revise and description of the changes in facility design or operation that prompted the need to seek to revise the operating conditions;
(C) A determination that when operating under the revised operating conditions, the applicable emissions standards of §§ 266.104, 266.105, 266.106, and 266.107 are not likely to be exceeded. To document this determination, the owner or operator shall submit the applicable information required under paragraph (b)(2) of this section; and
(D) Complete emissions testing protocol for any pretesting and for a new compliance test to determine compliance with the applicable emissions standards of §§ 266.104, 266.105, 266.106, and 266.107 when operating under revised operating conditions. The protocol shall include a schedule of pre-testing and compliance testing. If the owner and operator revises the scheduled date for the compliance test, he/she shall notify the Secretary in writing at least 30 days prior to the revised date of the compliance test;
(iii) Conduct a compliance test under the revised operating conditions and the protocol submitted to the Secretary to determine compliance with the applicable emissions standards of §§ 266.104, 266.105, 266.106, and 266.107; and
(1) To minimize emissions of organic compounds, the minimum combustion chamber temperature (or the indicator of combustion chamber temperature) that occurred during the compliance test must be maintained while hazardous waste or hazardous waste residues remain in the combustion chamber, with the minimum temperature during the compliance test defined as either:
(i) If compliance with the combustion chamber temperature limit is based on an hourly rolling average, the minimum temperature during the compliance test is considered to be the average over all runs of the lowest hourly rolling average for each run; or
(ii) If compliance with the combustion chamber temperature limit is based on an instantaneous temperature measurement, the minimum temperature during the compliance test is considered to be the time-weighted average temperature during all runs of the test; and
(2) Operating parameters limited by the certification of compliance must continue to be monitored during the cutoff, and the hazardous waste feed shall not be restarted until the levels of those parameters comply with the limits established in the certification of compliance.
(3) An alternate means of control that the owner or operator can demonstrate provide fugitive emissions control equivalent to maintenance of combustion zone pressure lower than atmospheric pressure. Support for such demonstration shall be included in the operating record.
(1) The owner or operator must monitor and record the following, at a minimum, while burning hazardous waste:
(i) Feed rates and composition of hazardous waste, other fuels, and industrial furnace feed stocks, and feed rates of ash, metals, and total chloride and chlorine as necessary to ensure conformance with the certification of precompliance or certification of compliance;
(ii) Carbon monoxide (CO), oxygen, and if applicable, hydrocarbons (HC), on a continuous basis at a common point in the boiler or industrial furnace downstream of the combustion zone and prior to release of stack gases to the atmosphere in accordance with the operating limits specified in the certification of compliance. CO, HC, and oxygen monitors must be installed, operated, and maintained in accordance with methods specified in Appendix IX of this part.
(iii) Upon the request of the Secretary, sampling and analysis of the hazardous waste (and other fuels and industrial furnace feed stocks as appropriate) and the stack gas emissions must be conducted to verify that the operating conditions established in the certification of precompliance or certification of compliance achieve the applicable standards of §§ 266.104, 266.105, 266.106, and 266.107.
(2) The boiler or industrial furnace and associated equipment (pumps, valves, pipes, fuel storage tanks, etc.) must be subjected to thorough visual inspection when they contain hazardous waste, at least daily for leaks, spills, fugitive emissions, and signs of tampering.
(3) The automatic hazardous waste feed cutoff system and associated alarms must be tested at least once every 7 days when hazardous waste is burned to verify operability, unless the owner or operator can demonstrate that weekly inspections will unduly restrict or upset operations and that less frequent inspections will be adequate. Support for such demonstration shall be included in the operating record. At a minimum, operational testing must be conducted at least once every 30 days.
(4) These monitoring and inspection data must be recorded and the records must be placed in the operating log.
(l) Closure. At closure, the owner or operator must remove all hazardous waste and hazardous waste residues (including, but not limited to, ash, scrubber waters, and scrubber sludges) from the boiler or industrial furnace and must comply with §§ 265.111-265.115 of these regulations.
Section 266.104 Standards to control organic emissions.
(1) General. Except as provided in paragraph (a)(3) of this section, a boiler or industrial furnace burning hazardous waste must achieve a destruction and removal efficiency (DRE) of 99.99% for all organic hazardous constituents in the waste feed. To demonstrate conformance with this requirement, 99.99% DRE must be demonstrated during a trial burn for each principal organic hazardous constituent (POHC) designated (under paragraph (a)(2) of this section) in its permit for each waste feed. DRE is determined for each POHC from the following equation:
Win= Mass feed rate of one principal organic hazardous constituent (POHC) in the hazardous waste fired to the boiler or industrial furnace; and
(2) Designation of POHCs. Principal organic hazardous constituents (POHCs) are those compounds for which compliance with the DRE requirements of this section shall be demonstrated in a trial burn in conformance with procedures prescribed in §122.66 of these regulations. One or more POHCs shall be designated by the Secretary for each waste feed to be burned. POHCs shall be designated based on the degree of difficulty of destruction of the organic constituents in the waste and on their concentrations or mass in the waste feed considering the results of waste analyses submitted with Part B of the permit application. POHCs are most likely to be selected from among those compounds listed in Part 261, Appendix VIII of these regulations that are also present in the normal waste feed. However, if the applicant demonstrates to the Secretary's satisfaction that a compound not listed in Appendix VIII or not present in the normal waste feed is a suitable indicator of compliance with the DRE requirements of this section, that compound may be designated as a POHC. Such POHCs need not be toxic or organic compounds.
(3) Dioxin-listed waste. A boiler or industrial furnace burning hazardous waste containing (or derived from) EPA Hazardous Wastes Nos. F020, F021, F022, F023, F026, or F027 must achieve a destruction and removal efficiency (DRE) of 99.9999% for each POHC designated (under paragraph (a)(2) of this section) in its permit. This performance must be demonstrated on POHCs that are more difficult to burn than tetra-, penta-, and hexachlorodibenzo-p-dioxins and dibenzofurans. DRE is determined for each POHC from the equation in paragraph (a)(1) of this section. In addition, the owner or operator of the boiler or industrial furnace must notify the Secretary of intent to burn EPA Hazardous Waste Nos. F020, F021, F022, F023, F026, or F027.
(4) Automatic waiver of DRE trial burn. Owners and operators of boilers operated under the special operating requirements provided by §266.110 are considered to be in compliance with the DRE standard of paragraph (a)(1) of this section and are exempt from the DRE trial burn.
(5) Low risk waste. Owners and operators of boilers or industrial furnaces that burn hazardous waste in compliance with the requirements of §266.109(a) are considered to be in compliance with the DRE standard of paragraph (a)(1) of this section and are exempt from the DRE trial burn.
(1) Except as provided in paragraph (c) of this section, the stack gas concentration of carbon monoxide (CO) from a boiler or industrial furnace burning hazardous waste cannot exceed 100 ppmv on an hourly rolling average basis (i.e., over any 60 minute period), continuously corrected to 7 percent oxygen, dry gas basis.
(2) CO and oxygen shall be continuously monitored in conformance with "Performance Specifications for Continuous Emission Monitoring of Carbon Monoxide and Oxygen for Incinerators, Boilers, and Industrial Furnaces Burning Hazardous Waste" in Appendix IX of this part.
(3) Compliance with the 100 ppmv CO limit must be demonstrated during the trial burn (for new facilities or an interim status facility applying for a permit) or the compliance test (for interim status facilities). To demonstrate compliance, the highest hourly rolling average CO level during any valid run of the trial burn or compliance test must not exceed 100 ppmv.
(1) The stack gas concentration of carbon monoxide (CO) from a boiler or industrial furnace burning hazardous waste may exceed the 100 ppmv limit provided that stack gas concentrations of hydrocarbons (HC) do not exceed 20 ppmv, except as provided by paragraph (f) of this section for certain industrial furnaces.
(2) HC limits must be established under this section on an hourly rolling average basis (i.e., over any 60 minute period), reported as propane, and continuously corrected to 7 percent oxygen, dry gas basis.
(3) HC shall be continuously monitored in conformance with "Performance Specifications for Continuous Emission Monitoring of Hydrocarbons for Incinerators, Boilers, and Industrial Furnaces Burning Hazardous Waste" in Appendix IX of this part. CO and oxygen shall be continuously monitored in conformance with paragraph (b)(2) of this section.
(4) The alternative CO standard is established based on CO data during the trial burn (for a new facility) and the compliance test (for an interim status facility). The alternative CO standard is the average over all valid runs of the highest hourly average CO level for each run. The CO limit is implemented on an hourly rolling average basis, and continuously corrected to 7 percent oxygen, dry gas basis.
(e) Controls for dioxins and furans. Owners and operators of boilers and industrial furnaces that are equipped with a dry particulate matter control device that operates within the temperature range of 450-750oF, and industrial furnaces operating under an alternative hydrocarbon limit established under paragraph (f) of this section must conduct a site-specific risk assessment as follows to demonstrate that emissions of chlorinated dibenzo-p-dioxins and dibenzofurans do not result in an increased lifetime cancer risk to the hypothetical maximum exposed individual (MEI) exceeding 1 in 100,000:
(1) During the trial burn (for new facilities or an interim status facility applying for a permit) or compliance test (for interim status facilities), determine emission rates of the tetra-octa congeners of chlorinated dibenzo-p-dioxins and dibenzofurans (CDDs/CDFs) using Method 0023A, Sampling Method for Polychlorinated Dibenzo-p-Dioxins and Polychlorinated Dibenzofurans Emissions from Stationary Sources, EPA Publication SW-846, as incorporated by reference in §260.11 of these regulations;
(2) Estimate the 2,3,7,8-TCDD toxicity equivalence of the tetra-octa CDDs/CDFs congeners using "Procedures for Estimating the Toxicity Equivalence of Chlorinated Dibenzo-p-Dioxin and Dibenzofuran Congeners" in Appendix IX of this part. Multiply the emission rates of CDD/CDF congeners with a toxicity equivalence greater than zero (see the procedure) by the calculated toxicity equivalence factor to estimate the equivalent emission rate of 2,3,7,8-TCDD;
(3) Conduct dispersion modeling using methods recommended in Appendix W of Part 51 of 40 CFR ("Guideline on Air Quality Models (Revised)" (1986) and its supplements), the "Hazardous Waste Combustion Air Quality Screening Procedure", provided in Appendix IX of this part, or in Screening Procedures for Estimating the Air Quality Impact of Stationary Sources, Revised (incorporated by reference in §260.11) to predict the maximum annual average off-site ground level concentration of 2,3,7,8-TCDD equivalents determined under paragraph (e)(2) of this section. The maximum annual average concentration must be used when a person resides on-site; and
(4) The ratio of the predicted maximum annual average ground level concentration of 2,3,7,8-TCDD equivalents to the risk-specific dose for 2,3,7,8-TCDD provided in Appendix V of this part (2.2 X 10-7) shall not exceed 1.0.
(1) Hazardous waste is fired only into the kiln and not at any location downstream from the kiln exit relative to the direction of gas flow; and
Section 266.105 Standards to control particulate matter.
(1) Measured pollutant levels must be corrected for the amount of oxygen in the stack gas according to the formula:
(2) For devices that feed normal combustion air, E will equal 21 percent. For devices that feed oxygen-enriched air for combustion (that is, air with an oxygen concentration exceeding 21 percent), the value of E will be the concentration of oxygen in the enriched air.
(3) Compliance with all emission standards provided by this subpart must be based on correcting to 7 percent oxygen using this procedure.
Section 266.106 Standards to control metals emissions.
(1) Noncarcinogenic metals. The feed rates of antimony, barium, lead, mercury, thallium, and silver in all feed streams, including hazardous waste, fuels, and industrial furnace feed stocks shall not exceed the screening limits specified in Appendix I of this part.
(i) The feed rate screening limits for antimony, barium, mercury, thallium, and silver are based on either:
(B) An averaging period of 2 to 24 hours as defined in §266.102(e)(6)(ii) with an instantaneous feed rate limit not to exceed 10 times the feed rate that would be allowed on an hourly rolling average basis; or
(i) The feed rates of arsenic, cadmium, beryllium, and chromium in all feed streams, including hazardous waste, fuels, and industrial furnace feed stocks shall not exceed values derived from the screening limits specified in Appendix I of this part. The feed rate of each of these metals is limited to a level such that the sum of the ratios of the actual feed rate to the feed rate screening limit specified in Appendix I shall not exceed 1.0, as provided by the following equation:
(B) An averaging period of 2 to 24 hours as defined in §266.102(e)(6)(ii) with an instantaneous feed rate limit not to exceed 10 times the feed rate that would be allowed on an hourly rolling average basis.
(ii) The stack height (Ha) may not exceed good engineering practice as specified in 40 CFR 51.100(ii).
(iii) If the TESH for a particular facility is not listed in the table in the appendices, the nearest lower TESH listed in the table shall be used. If the TESH is four meters or less, a value of four meters shall be used.
(4) Terrain type. The screening limits are a function of whether the facility is located in noncomplex or complex terrain. A device located where any part of the surrounding terrain within 5 kilometers of the stack equals or exceeds the elevation of the physical stack height (Ha) is considered to be in complex terrain and the screening limits for complex terrain apply. Terrain measurements are to be made from U.S. Geological Survey 7.5-minute topographic maps of the area surrounding the facility.
(5) Land use. The screening limits are a function of whether the facility is located in an area where the land use is urban or rural. To determine whether land use in the vicinity of the facility is urban or rural, procedures provided in Appendices IX or X of this part shall be used.
(6) Multiple stacks. Owners and operators of facilities with more than one on-site stack from a boiler, industrial furnace, incinerator, or other thermal treatment unit subject to controls of metals emissions under a DNREC operating permit or interim status controls must comply with the screening limits for all such units assuming all hazardous waste is fed into the device with the worst-case stack based on dispersion characteristics. The worst-case stack is determined from the following equation as applied to each stack:
(7) Criteria for facilities not eligible for screening limits. If any criteria below are met, the Tier I and Tier II screening limits do not apply. Owners and operators of such facilities must comply with either the Tier III standards provided by paragraph (d) of this section or with the adjusted Tier I feed rate screening limits provided by paragraph (e) of this section.
(ii) The device has a stack taller than 20 meters and is located such that the terrain rises to the physical height within one kilometer of the facility;
(iii) The device has a stack taller than 20 meters and is located within five kilometers of a shoreline of a large body of water such as an ocean or large lake;
(iv) The physical stack height of any stack is less than 2.5 times the height of any building within five building heights or five projected building widths of the stack and the distance from the stack to the closest boundary is within five building heights or five projected building widths of the associated building; or
(v) The Secretary determines that standards based on site-specific dispersion modeling are required.
(8) Implementation. The feed rate of metals in each feedstream must be monitored to ensure that the feed rate screening limits are not exceeded.
(1) Noncarcinogenic metals. The emission rates of antimony, barium, lead, mercury, thallium, and silver shall not exceed the screening limits specified in Appendix I of this part.
(2) Carcinogenic metals. The emission rates of arsenic, cadmium, beryllium, and chromium shall not exceed values derived from the screening limits specified in Appendix I of this part. The emission rate of each of these metals is limited to a level such that the sum of the ratios of the actual emission rate to the emission rate screening limit specified in Appendix I shall not exceed 1.0, as provided by the following equation:
(3) Implementation. The emission rate limits must be implemented by limiting feed rates of the individual metals to levels during the trial burn (for new facilities or an interim status facility applying for a permit) or the compliance test (for interim status facilities). The feed rate averaging periods are the same as provided by paragraphs (b)(1)(i) and (ii) and (b)(2)(ii) of this section. The feed rate of metals in each feedstream must be monitored to ensure that the feed rate limits for the feedstreams specified under §§ 266.102 or 266.103 are not exceeded.
(4) Definitions and limitations. The definitions and limitations provided by paragraph (b) of this section for the following terms also apply to the Tier II emission rate screening limits provided by paragraph (c) of this section: terrain-adjusted effective stack height, good engineering practice stack height, terrain type, land use, and criteria for facilities not eligible to use the screening limits.
(i) Owners and operators of facilities with more than one onsite stack from a boiler, industrial furnace, incinerator, or other thermal treatment unit subject to controls on metals emissions under a DNREC operating permit or interim status controls must comply with the emissions screening limits for any such stacks assuming all hazardous waste is fed into the device with the worst-case stack based on dispersion characteristics.
(iii) For each metal, the total emissions of the metal from those stacks shall not exceed the screening limit for the worst-case stack.
(1) General. Conformance with the Tier III metals controls must be demonstrated by emissions testing to determine the emission rate for each metal. In addition, conformance with either the Tier III or Adjusted Tier I metals controls must be demonstrated by dispersion modeling to predict the maximum annual average off-site ground level concentration for each metal, and a demonstration that acceptable ambient levels are not exceeded.
(2) Acceptable ambient levels. Appendices IV and V of this part list the acceptable ambient levels for purposes of this rule. Reference air concentrations (RACs) are listed for the noncarcinogenic metals and 10-5 risk-specific doses (RSDs) are listed for the carcinogenic metals. The RSD for a metal is the acceptable ambient level for that metal provided that only one of the four carcinogenic metals is emitted. If more than one carcinogenic metal is emitted, the acceptable ambient level for the carcinogenic metals is a fraction of the RSD as described in paragraph (d)(3) of this section.
(3) Carcinogenic metals. For the carcinogenic metals, arsenic, cadmium, beryllium, and chromium, the sum of the ratios of the predicted maximum annual average off-site ground level concentrations (except that on-site concentrations must be considered if a person resides on site) to the risk-specific dose (RSD) for all carcinogenic metals emitted shall not exceed 1.0 as determined by the following equation:
(4) Noncarcinogenic metals. For the noncarcinogenic metals, the predicted maximum annual average off-site ground level concentration for each metal shall not exceed the reference air concentration (RAC).
(5) Multiple stacks. Owners and operators of facilities with more than one on-site stack from a boiler, industrial furnace, incinerator, or other thermal treatment unit subject to controls on metals emissions under a DNREC operating permit or interim status controls must conduct emissions testing (except that facilities complying with Adjusted Tier I controls need not conduct emissions testing) and dispersion modeling to demonstrate that the aggregate emissions from all such on-site stacks do not result in an exceedance of the acceptable ambient levels.
(6) Implementation. Under Tier III, the metals controls must be implemented by limiting feed rates of the individual metals to levels during the trial burn (for new facilities or an interim status facility applying for a permit) or the compliance test (for interim status facilities). The feed rate averaging periods are the same as provided by paragraphs (b)(1) (i) and (ii) and (b)(2)(ii) of this section. The feed rate of metals in each feedstream must be monitored to ensure that the feed rate limits for the feedstreams specified under §§ 266.102 or 266.103 are not exceeded.
(1) The Secretary may approve on a case-by-case basis approaches to implement the Tier II or Tier III metals emission limits provided by paragraphs (c) or (d) of this section alternative to monitoring the feed rate of metals in each feedstream.
(i) For each noncarcinogenic metal, by back-calculating from the RAC provided in Appendix IV of this part to determine the allowable emission rate for each metal using the dilution factor for the maximum annual average ground level concentration predicted by dispersion modeling in conformance with paragraph (h) of this section; and
(A) Back-calculating from the RSD provided in Appendix V of this part to determine the allowable emission rate for each metal if that metal were the only carcinogenic metal emitted using the dilution factor for the maximum annual average ground level concentration predicted by dispersion modeling in conformance with paragraph (h) of this section; and
(B) If more than one carcinogenic metal is emitted, selecting an emission limit for each carcinogenic metal not to exceed the emission rate determined by paragraph (f)(2)(ii)(A) of this section such that the sum for all carcinogenic metals of the ratios of the selected emission limit to the emission rate determined by that paragraph does not exceed 1.0.
(1) General. Emission testing for metals shall be conducted using Method 0060, Determinations of Metals in Stack Emissions, EPA Publication SW-846, as incorporated by reference in §260.11 of these regulations.
(2) Hexavalent chromium. Emissions of chromium are assumed to be hexavalent chromium unless the owner or operator conducts emissions testing to determine hexavalent chromium emissions using procedures prescribed in Method 0061, Determination of Hexavalent Chromium Emissions from Stationary Sources, EPA Publication SW-846, as incorporated by reference in §260.11 of these regulations.
Section 266.107 Standards to control hydrogen chloride (HCl) and chlorine gas (Cl2) emissions.
(a) General. The owner or operator must comply with the hydrogen chloride (HCl) and chlorine (Cl2) controls provided by paragraph (b), (c), or (e) of this section.
(1) Tier I feed rate screening limits. Feed rate screening limits are specified for total chlorine in Appendix II of this part as a function of terrain-adjusted effective stack height and terrain and land use in the vicinity of the facility. The feed rate of total chlorine and chloride, both organic and inorganic, in all feed streams, including hazardous waste, fuels, and industrial furnace feed stocks shall not exceed the levels specified.
(2) Tier II emission rate screening limits. Emission rate screening limits for HCl and Cl2 are specified in Appendix III of this part as a function of terrain-adjusted effective stack height and terrain and land use in the vicinity of the facility. The stack emission rates of HCl and Cl2 shall not exceed the levels specified.
(3) Definitions and limitations. The definitions and limitations provided by §266.106(b) for the following terms also apply to the screening limits provided by this paragraph: terrain-adjusted effective stack height, good engineering practice stack height, terrain type, land use, and criteria for facilities not eligible to use the screening limits.
(4) Multiple stacks. Owners and operators of facilities with more than one on-site stack from a boiler, industrial furnace, incinerator, or other thermal treatment unit subject to controls on HCl or Cl2 emissions under a DNREC operating permit or interim status controls must comply with the Tier I and Tier II screening limits for those stacks assuming all hazardous waste is fed into the device with the worst-case stack based on dispersion characteristics.
(ii) Under Tier I, the total feed rate of chlorine and chloride to all subject devices shall not exceed the screening limit for the worst-case stack.
(iii) Under Tier II, the total emissions of HCl and Cl2 from all subject stacks shall not exceed the screening limit for the worst-case stack.
(1) General. Conformance with the Tier III controls must be demonstrated by emissions testing to determine the emission rate for HCl and Cl2, air dispersion modeling to predict the maximum annual average off-site ground level concentration for each compound, and a demonstration that acceptable ambient levels are not exceeded.
(2) Acceptable ambient levels. Appendix IV of this part lists the reference air concentrations (RACs) for HCl (7 micrograms per cubic meter) and Cl2 (0.4 micrograms per cubic meter).
(3) Multiple stacks. Owners and operators of facilities with more than one on-site stack from a boiler, industrial furnace, incinerator, or other thermal treatment unit subject to controls on HCl or Cl2 emissions under a DNREC operating permit or interim status controls must conduct emissions testing and dispersion modeling to demonstrate that the aggregate emissions from all such on-site stacks do not result in an exceedance of the acceptable ambient levels for HCl and Cl2.
(d) Averaging periods. The HCl and Cl2 controls are implemented by limiting the feed rate of total chlorine and chloride in all feedstreams, including hazardous waste, fuels, and industrial furnace feed stocks. Under Tier I, the feed rate of total chloride and chlorine is limited to the Tier I Screening Limits. Under Tier II and Tier III, the feed rate of total chloride and chlorine is limited to the feed rates during the trial burn (for new facilities or an interim status facility applying for a permit) or the compliance test (for interim status facilities). The feed rate limits are based on either:
(e) Adjusted Tier I feed rate screening limits. The owner or operator may adjust the feed rate screening limit provided by Appendix II of this part to account for site-specific dispersion modeling. Under this approach, the adjusted feed rate screening limit is determined by back-calculating from the acceptable ambient level for Cl2 provided by Appendix IV of this part using dispersion modeling to determine the maximum allowable emission rate. This emission rate becomes the adjusted Tier I feed rate screening limit.
(f) Emissions testing. Emissions testing for HCl and Cl2 shall be conducted using the procedures described in Methods 0050 or 0051, EPA Publication SW-846, as incorporated by reference in §260.11 of these regulations.
Section 266.108 Small quantity on-site burner exemption.
(2) The maximum hazardous waste firing rate does not exceed at any time 1 percent of the total fuel requirements for the device (hazardous waste plus other fuel) on a total heat input or mass input basis, whichever results in the lower mass feed rate of hazardous waste.
(4) The hazardous waste fuel does not contain (and is not derived from) EPA Hazardous Waste Nos. F020, F021, F022, F023, F026, or F027.
Note: Hazardous wastes that are subject to the special requirements for small quantity generators under §261.5 of these regulations may be burned in an off-site device under the exemption provided by §266.108, but must be included in the quantity determination for the exemption.
(3) The maximum quantity of hazardous waste that the facility may burn per month as provided by §266.108(a)(1).
Section 266.109 Low risk waste exemption.
(i) A minimum of 50 percent of fuel fired to the device shall be fossil fuel, fuels derived from fossil fuel, tall oil, or, if approved by the Secretary on a case-by-case basis, other nonhazardous fuel with combustion characteristics comparable to fossil fuel. Such fuels are termed "primary fuel" for purposes of this section. (Tall oil is a fuel derived from vegetable and rosin fatty acids.) The 50 percent primary fuel firing rate shall be determined on a total heat or mass input basis, whichever results in the greater mass feed rate of primary fuel fired;
(ii) Primary fuels and hazardous waste fuels shall have a minimum as-fired heating value of 8,000 Btu/lb;
(iii) The hazardous waste is fired directly into the primary fuel flame zone of the combustion chamber; and
(iv) The device operates in conformance with the carbon monoxide controls provided by §266.104(b)(1). Devices subject to the exemption provided by this section are not eligible for the alternative carbon monoxide controls provided by §266.104(c).
(2) Procedures to demonstrate that the hazardous waste burning will not pose unacceptable adverse public health effects are as follows:
(i) Identify and quantify those nonmetal compounds listed in Appendix VIII, Part 261 of these regulations that could reasonably be expected to be present in the hazardous waste. The constituents excluded from analysis must be identified and the basis for their exclusion explained;
(ii) Calculate reasonable, worst case emission rates for each constituent identified in paragraph (a)(2)(i) of this section by assuming the device achieves 99.9 percent destruction and removal efficiency. That is, assume that 0.1 percent of the mass weight of each constituent fed to the device is emitted.
(iii) For each constituent identified in paragraph (a)(2)(i) of this section, use emissions dispersion modeling to predict the maximum annual average ground level concentration of the constituent.
(B) Owners and operators of facilities with more than one on-site stack from a boiler or industrial furnace that is exempt under this section must conduct dispersion modeling of emissions from all stacks exempt under this section to predict ambient levels prescribed by this paragraph.
(iv) Ground level concentrations of constituents predicted under paragraph (a)(2)(iii) of this section must not exceed the following levels:
(A) For the noncarcinogenic compounds listed in Appendix IV of this part, the levels established in Appendix IV;
(B) For the carcinogenic compounds listed in Appendix V of this part, the sum for all constituents of the ratios of the actual ground level concentration to the level established in Appendix V cannot exceed 1.0; and
(2) The owner or operator complies with the Tier I or adjusted Tier I metals feed rate screening limits provided by §266.106(b) or (e).
Section 266.110 Waiver of DRE trial burn for boilers.
(3) Mechanical atomization systems. Fuel pressure within a mechanical atomization system and fuel flow rate shall be maintained within the design range taking into account the viscosity and volatility of the fuel;
(4) Rotary cup atomization systems. Fuel flow rate through a rotary cup atomization system must be maintained within the design range taking into account the viscosity and volatility of the fuel.
Section 266.111 Standards for direct transfer.
"Direct transfer equipment" means any device (including but not limited to, such devices as piping, fittings, flanges, valves, and pumps) that is used to distribute, meter, or control the flow of hazardous waste between a container (i.e., transport vehicle) and a boiler or industrial furnace.
"Container" means any portable device in which hazardous waste is transported, stored, treated, or otherwise handled, and includes transport vehicles that are containers themselves (e.g., tank trucks, tanker-trailers, and rail tank cars), and containers placed on or in a transport vehicle.
(2) This section references several requirements provided in Subparts I and J of Parts 264 and 265. For purposes of this section, the term "tank systems" in those referenced requirements means direct transfer equipment as defined in paragraph (b)(1) of this section.
(1) No direct transfer of a pumpable hazardous waste shall be conducted from an open-top container to a boiler or industrial furnace.
(2) Direct transfer equipment used for pumpable hazardous waste shall always be closed, except when necessary to add or remove the waste, and shall not be opened, handled, or stored in a manner that may cause any rupture or leak.
(3) The direct transfer of hazardous waste to a boiler or industrial furnace shall be conducted so that it does not:
(ii) Produce uncontrolled toxic mists, fumes, dusts, or gases in sufficient quantities to threaten human health;
(iii) Produce uncontrolled flammable fumes or gases in sufficient quantities to pose a risk of fire or explosions;
(iv) Damage the structural integrity of the container or direct transfer equipment containing the waste;
(v) Adversely affect the capability of the boiler or industrial furnace to meet the standards provided by §§ 266.104 through 266.107; or
(4) Hazardous waste shall not be placed in direct transfer equipment, if it could cause the equipment or its secondary containment system to rupture, leak, corrode, or otherwise fail.
(ii) Automatic waste feed cutoff to use if a leak or spill occurs from the direct transfer equipment.
(1) Secondary containment. Owners and operators shall comply with the secondary containment requirements of §265.193 of these regulations, except for paragraphs 265.193 (a), (d), (e), and (i) as follows:
(i) For existing direct transfer equipment that does not have secondary containment, the owner or operator shall determine whether the equipment is leaking or is unfit for use. The owner or operator shall obtain and keep on file at the facility a written assessment reviewed and certified by a qualified, registered professional engineer in accordance with §122.11(d) of these regulations that attests to the equipment's integrity by August 21, 1992.
(ii) This assessment shall determine whether the direct transfer equipment is adequately designed and has sufficient structural strength and compatibility with the waste(s) to be transferred to ensure that it will not collapse, rupture, or fail. At a minimum, this assessment shall consider the following:
(A) Design standard(s), if available, according to which the direct transfer equipment was constructed;
(E) Results of a leak test or other integrity examination such that the effects of temperature variations, vapor pockets, cracks, leaks, corrosion, and erosion are accounted for.
(iii) If, as a result of the assessment specified above, the direct transfer equipment is found to be leaking or unfit for use, the owner or operator shall comply with the requirements of §§ 265.196 (a) and (b) of these regulations.
(i) The owner or operator must inspect at least once each operating hour when hazardous waste is being transferred from the transport vehicle (container) to the boiler or industrial furnace:
(A) Overfill/spill control equipment (e.g., waste-feed cutoff systems, bypass systems, and drainage systems) to ensure that it is in good working order;
(B) The above ground portions of the direct transfer equipment to detect corrosion, erosion, or releases of waste (e.g., wet spots, dead vegetation); and
(C) Data gathered from monitoring equipment and leak-detection equipment, (e.g., pressure and temperature gauges) to ensure that the direct transfer equipment is being operated according to its design.
(ii) The owner or operator must inspect cathodic protection systems, if used, to ensure that they are functioning properly according to the schedule provided by §265.195(b) of these regulations.
(iii) Records of inspections made under this paragraph shall be maintained in the operating record at the facility, and available for inspection for at least 3 years from the date of the inspection.
(4) Design and installation of new ancillary equipment. Owners and operators must comply with the requirements of §265.192 of these regulations.
(5) Response to leaks or spills. Owners and operators must comply with the requirements of §265.196 of these regulations.
(6) Closure. Owners and operators must comply with the requirements of §265.197 of these regulations, except for §265.197 (c)(2) through (c)(4).
Section 266.112 Regulation of residues.
(1) Boilers. Boilers must burn at least 50% coal on a total heat input or mass input basis, whichever results in the greater mass feed rate of coal;
(2) Ore or mineral furnaces. Industrial furnaces subject to §261.4(b)(7) must process at least 50% by weight normal, nonhazardous raw materials;
(3) Cement kilns. Cement kilns must process at least 50% by weight normal cement-production raw materials;
(1) Comparison of waste-derived residue with normal residue. The waste-derived residue must not contain Appendix VIII, Part 261 constituents (toxic constituents) that could reasonably be attributable to the hazardous waste at concentrations significantly higher than in residue generated without burning or processing of hazardous waste, using the following procedure. Toxic compounds that could reasonably be attributable to burning or processing the hazardous waste (constituents of concern) include toxic constituents in the hazardous waste, and the organic compounds listed in Appendix VIII of this part that may be generated as products of incomplete combustion. For polychlorinated dibenzo-p-dioxins and polychlorinated dibenzo-furans, analyses must be performed to determine specific congeners and homologues, and the results converted to 2,3,7,8-TCDD equivalent values using the procedure specified in Section 4.0 of Appendix IX of this part.
(i) Normal residue. Concentrations of toxic constituents of concern in normal residue shall be determined based on analyses of a minimum of 10 samples representing a minimum of 10 days of operation. Composite samples may be used to develop a sample for analysis provided that the compositing period does not exceed 24 hours. The upper tolerance limit (at 95% confidence with a 95% proportion of the sample distribution) of the concentration in the normal residue shall be considered the statistically-derived concentration in the normal residue. If changes in raw materials or fuels reduce the statistically-derived concentrations of the toxic constituents of concern in the normal residue, the statistically-derived concentrations must be revised or statistically-derived concentrations of toxic constituents in normal residue must be established for a new mode of operation with the new raw material or fuel. To determine the upper tolerance limit in the normal residue, the owner or operator shall use statistical procedures prescribed in "Statistical Methodology for Bevill Residue Determinations" in Appendix IX of this part.
(ii) Waste-derived residue. Waste-derived residue shall be sampled and analyzed as often as necessary to determine whether the residue generated during each 24-hour period has concentrations of toxic constituents that are higher than the concentrations established for the normal residue under paragraph (b)(1)(i) of this section. If so, hazardous waste burning has significantly affected the residue and the residue shall not be excluded from the definition of a hazardous waste. Concentrations of toxic constituents of concern in the waste-derived residue shall be determined based on analysis of one or more samples obtained over a 24-hour period. Multiple samples may be analyzed, and multiple samples may be taken to form a composite sample for analysis provided that the sampling period does not exceed 24 hours. If more than one sample is analyzed to characterize waste-derived residues generated over a 24-hour period, the concentration of each toxic constituent shall be the arithmetic mean of the concentrations in the samples. No results may be disregarded; or
(i) Nonmetal constituents. The concentration of each nonmetal toxic constituent of concern (specified in paragraph (b)(1) of this section) in the waste-derived residue must not exceed the health-based level specified in Appendix VII of this part, or the level of detection, whichever is higher. If a health-based limit for a constituent of concern is not listed in Appendix VII of this part, then a limit of 0.002 micrograms per kilogram or the level of detection (which must be determined by using appropriate analytical procedures), whichever is higher, must be used. The levels specified in Appendix VII of this part (and the default level of 0.002 micrograms per kilogram or the level of detection for constituents as identified in Note 1 of Appendix VII of this part) are administratively stayed under the condition, for those constituents specified in paragraph (b)(1) of this section, that the owner or operator complies with alternative levels defined as the land disposal restriction limits specified in §268.43 of these regulations for F039 nonwastewaters. In complying with those alternative levels, if an owner or operator is unable to detect a constituent despite documenting use of best good-faith efforts as defined by applicable EPA guidance or standards, the owner or operator is deemed to be in compliance for that constituent. Until new guidance or standards are developed, the owner or operator may demonstrate such good faith efforts by achieving a detection limit for the constituent that does not exceed an order of magnitude above the level provided by §268.43 of these regulations for F039 nonwastewaters. In complying with the §268.43 of these regulations, F039 nonwastewater levels for polychlorinated dibenzo-p-dioxins and polychlorinated dibenzo-furans, analyses must be performed for total hexachlorodibenzo-p-dioxins, total hexachlorodibenzofurans, total pentachlorodibenzo-p-dioxins, total pentachlorodibenzofurans, total tetrachlorodibenzo-p-dioxins, and total tetrachlorodibenzofurans. The stay will remain in effect until further administrative action is taken and notice is published in the FEDERAL REGISTER and the Code of Federal Regulations; and
(ii) Metal constituents. The concentration of metals in an extract obtained using the Toxicity Characteristic Leaching Procedure of §261.24 of these regulations must not exceed the levels specified in Appendix VII of this part; and
(iii) Sampling and analysis. Waste-derived residue shall be sampled and analyzed as often as necessary to determine whether the residue generated during each 24-hour period has concentrations of toxic constituents that are higher than the health-based levels. Concentrations of toxic constituents of concern in the waste-derived residue shall be determined based on analysis of one or more samples obtained over a 24-hour period. Multiple samples may be analyzed, and multiple samples may be taken to form a composite sample for analysis provided that the sampling period does not exceed 24 hours. If more than one sample is analyzed to characterize waste-derived residues generated over a 24-hour period, the concentration of each toxic constituent shall be the arithmetic mean of the concentrations in the samples. No results may be disregarded; and
(2) If the waste-derived residue is compared with normal residue under paragraph (b)(1) of this section:
(ii) Data and information, including analyses of samples as necessary, obtained to determine if changes in raw materials or fuels would reduce the concentration of toxic constituents of concern in the normal residue.
Section 266.200 Applicability.
“Active range" means a military range that is currently in service and is being regularly used for range activities.
"Chemical agents and munitions" are defined as in 50 U.S.C. section 1521(j)(1).
"Explosives or munitions emergency" is as defined in §260.10.
"Explosives or munitions emergency response" is as defined in §260.10.
"Explosives or munitions emergency response specialist" is as defined in §260.10.
"Inactive range" means a military range that is not currently being used, but that is still under military control and considered by the military to be a potential range area, and that has not been put to a new use that is incompatible with range activities.
"Military" means the Department of Defense (DOD), the Armed Services, Coast Guard, National Guard, Department of Energy (DOE), or other parties under contract or acting as an agent for the foregoing, who handle military munitions.
"Military munitions" is as defined in §260.10.
"Military range" means designated land and water areas set aside, managed, and used to conduct research on, develop, test, and evaluate military munitions and explosives, other ordnance, or weapon systems, or to train military personnel in their use and handling. Ranges include firing lines and positions, maneuver areas, firing lanes, test pads, detonation pads, impact areas, and buffer zones with restricted access and exclusionary areas.
"Unexploded ordnance (UXO)" means military munitions that have been primed, fused, armed, or otherwise prepared for action, and have been fired, dropped, launched, projected, or placed in such a manner as to constitute a hazard to operations, installation, personnel, or material and remain unexploded either by malfunction, design, or any other cause.
Section 266.202 Definition of solid waste.
(i) Use in training military personnel or explosives and munitions emergency response specialists (including training in proper destruction of unused propellant or other munitions); or
(ii) Use in research, development, testing, and evaluation of military munitions, weapons, or weapon systems; or
(iii) Recovery, collection, and on‑range destruction of unexploded ordnance and munitions fragments during range clearance activities at active or inactive ranges. However, "use for intended purpose" does not include the on‑range disposal or burial of unexploded ordnance and contaminants when the burial is not a result of product use.
(2) An unused munition, or component thereof, is being repaired, reused, recycled, reclaimed, disassembled, reconfigured, or otherwise subjected to materials recovery activities, unless such activities involve use constituting disposal as defined in §261.2(c)(1), or burning for energy recovery as defined in §261.2(c)(2).
(1) The munition is abandoned by being disposed of, burned, detonated (except during intended use as specified in paragraph (a) of this section), incinerated, or treated prior to disposal; or
(2) The munition is removed from storage in a military magazine or other storage area for the purpose of being disposed of, burned, or incinerated, or treated prior to disposal, or
(3) The munition is deteriorated or damaged (e.g., the integrity of the munition is compromised by cracks, leaks, or other damage) to the point that it cannot be put into serviceable condition, and cannot reasonably be recycled or used for other purposes; or
(1) When transported off range or from the site of use, where the site of use is not a range, for the purposes of storage, reclamation, treatment, disposal, or treatment prior to disposal; or
(2) If recovered, collected, and then disposed of by burial, or landfilling either on or off a range.
Section 266.203 Standards applicable to the transportation of solid waste military munitions.
(1) Waste military munitions that are being transported and that exhibit a hazardous waste characteristic or are listed as hazardous waste under Part 261, are listed or identified as a hazardous waste (and thus are subject to regulation under Parts 260 through 268 and 122), unless all the following conditions are met:
(ii) The waste military munitions must be transported in accordance with the Department of Defense shipping controls applicable to the transport of military munitions;
(iii) The waste military munitions must be transported from a military owned or operated installation to a military owned or operated treatment, storage, or disposal facility; and
(iv) The transporter of the waste must provide oral notice to the Director within 24 hours from the time the transporter becomes aware of any loss or theft of the waste military munitions, or any failure to meet a condition of paragraph (a)(1) of this section that may endanger health or the environment. In addition, a written submission describing the circumstances shall be provided within 5 days from the time the transporter becomes aware of any loss or theft of the waste military munitions or any failure to meet a condition of paragraph (a)(1) of this section.
(2) If any waste military munitions shipped under paragraph (a)(1) of this section are not received by the receiving facility within 45 days of the day the waste was shipped, the owner or operator of the receiving facility must report this non‑receipt to the Secretary within 5 days.
(3) The exemption in paragraph (a)(1) of this section from regulation as hazardous waste shall apply only to the transportation of non‑chemical waste military munitions. It does not affect the regulatory status of waste military munitions as hazardous wastes with regard to storage, treatment or disposal.
(4) The conditional exemption in paragraph (a)(1) of this section applies only so long as all of the conditions in paragraph (a)(1) of this section are met.
Section 266.204 Standards applicable to emergency responses.
Section 266.205 Standards applicable to the storage of solid waste military munitions.
(1) Waste military munitions in storage that exhibit a hazardous waste characteristic or are listed as hazardous waste under Part 261, are listed or identified as a hazardous waste (and thus are subject to regulation under Parts 260 through 279), unless all the following conditions are met:
(ii) The waste military munitions must be subject to the jurisdiction of the Department of Defense Explosives Safety Board (DDESB).
(iii) The waste military munitions must be stored in accordance with the DDESB storage standards applicable to waste military munitions.
(iv) Within 90 days of August 12, 1997 or within 90 days of when a storage unit is first used to store waste military munitions, whichever is later, the owner or operator must notify the Secretary of the location of any waste storage unit used to store waste military munitions for which the conditional exemption in paragraph (a)(1) is claimed.
(v) The owner or operator must provide oral notice to the Secretary within 24 hours from the time the owner or operator becomes aware of any loss or theft of the waste military munitions, or any failure to meet a condition of paragraph (a)(1) that may endanger health or the environment. In addition, a written submission describing the circumstances shall be provided within 5 days from the time the owner or operator becomes aware of any loss or theft of the waste military munitions or any failure to meet a condition of paragraph (a)(1) of this section.
(vi) The owner or operator must inventory the waste military munitions at least annually, must inspect the waste military munitions at least quarterly for compliance with the conditions of paragraph (a)(1) of this section, and must maintain records of the findings of these inventories and inspections for at least three years.
(vii) Access to the stored waste military munitions must be limited to appropriately trained and authorized personnel.
(2) The conditional exemption in paragraph (a)(1) of this section from regulation as hazardous waste shall apply only to the storage of non‑chemical waste military munitions. It does not affect the regulatory status of waste military munitions as hazardous wastes with regard to transportation, treatment or disposal.
(3) The conditional exemption in paragraph (a)(1) of this section applies only so long as all of the conditions in paragraph (a)(1) of this section are met.
(1) Waste military munitions that are chemical agents or chemical munitions and that exhibit a hazardous waste characteristic or are listed as hazardous waste under Part 261, are listed or identified as a hazardous waste and shall be subject to the applicable regulatory requirements of these regulations.
(2) Waste military munitions that are chemical agents or chemical munitions and that exhibit a hazardous waste characteristic or are listed as hazardous waste under Part 261, are not subject to the storage prohibition in RCRA section 3004(j), codified at 268.50.
Section 266.206 Standards applicable to the treatment and disposal of waste military munitions.
Section 266.210 What definitions apply to this subpart?
Agreement State means a state that has entered into an agreement with the NRC under subsection 274b of the Atomic Energy Act of 1954, as amended (68 Stat. 919), to assume responsibility for regulating within its borders byproduct, source, or special nuclear material in quantities not sufficient to form a critical mass.
Certified delivery means certified mail with return receipt requested, or equivalent courier service, or other means, that provides the sender with a receipt confirming delivery.
Director refers to the definition in 40 CFR 270.2.
“Eligible Naturally Occurring and/or Accelerator-produced Radioactive Material (NARM)” is NARM that is eligible for the Transportation and Disposal Conditional Exemption. It is a NARM waste that contains RCRA hazardous waste, meets the waste acceptance criteria of, and is allowed by State NARM regulations to be disposed of at a low-level radioactive waste disposal facility (LLRWDF) licensed in accordance with 10 CFR Part 61 or NRC Agreement State equivalent regulations.
Exempted waste means a waste that meets the eligibility criteria in §266.225 and meets all of the conditions in §266.230, or meets the eligibility criteria in §266.310 and complies with all the conditions in §266.315. Such waste is conditionally exempted from the regulatory definition of hazardous waste described in §261.3.
Hazardous Waste means any material which is defined to be hazardous waste in accordance with §261.3, “Definition of Hazardous Waste.”
Land Disposal Restriction (LDR) Treatment Standards means treatment standards, under Part 268, that a RCRA hazardous waste must meet before it can be disposed of in a RCRA hazardous waste land disposal unit.
License means a license issued by the Nuclear Regulatory Commission, or NRC Agreement State, to users that manage radionuclides regulated by NRC, or NRC Agreement States, under authority of the Atomic Energy Act of 1954, as amended.
Low‑Level Mixed Waste (LLMW) is a waste that contains both low‑level radioactive waste and RCRA hazardous waste.
Low‑Level Radioactive Waste (LLW) is a radioactive waste which contains source, special nuclear, or byproduct material, and which is not classified as high‑level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in Section 11e.(2) of the Atomic Energy Act. (See also NRC definition of “waste” at 10 CFR 61.2)
Mixed Waste means a waste that contains both RCRA hazardous waste and source, special nuclear, or byproduct material subject to the Atomic Energy Act of 1954, as amended.
Naturally Occurring and/or Accelerator‑produced Radioactive Material (NARM) means radioactive materials that:
NRC means the U.S. Nuclear Regulatory Commission.
We or us within this subpart, means the Director as defined in 122.2.
You means a generator, treater, or other handler of low‑level mixed waste or eligible NARM.
Section 266.220 What does a storage and treatment conditional exemption do?
Section 266.225 What wastes are eligible for the storage and treatment conditional exemption?
(1) Store your LLMW waste in tanks or containers in compliance with the requirements of your license that apply to the proper storage of low-level radioactive waste (not including those license requirements that relate solely to record keeping);
(2) Store your LLMW in tanks or containers in compliance with chemical compatibility requirements of a tank or container in §§ 264.177, or 264.199 or §§ 265.177, or 265.199;
(3) Certify that facility personnel who manage stored conditionally exempt LLMW are trained in a manner that ensures that the conditionally exempt waste is safely managed and includes training in chemical waste management and hazardous materials incidents response that meets the personnel training standards found in §265.16(a)(3);
(4) Conduct an inventory of your stored conditionally exempt LLMW at least annually and inspect it at least quarterly for compliance with Part 266, Subpart N; and
(5) Maintain an accurate emergency plan and provide it to all local authorities who may have to respond to a fire, explosion, or release of hazardous waste or hazardous constituents. Your plan must describe emergency response arrangements with local authorities; describe evacuation plans; list the names, addresses, and telephone numbers of all facility personnel qualified to work with local authorities as emergency coordinators; and list emergency equipment.
Section 266.235 What waste treatment does the storage and treatment conditional exemption allow?
(1) If you fail to meet any of the conditions specified in §266.230 you must report to us and the NRC, or the oversight agency in the NRC Agreement State, in writing by certified delivery within 30 days of learning of the failure. Your report must be signed by your authorized representative certifying that the information provided is true, accurate, and complete. This report must include:
(ii) A description of the LLMW (including the waste name, hazardous waste codes and quantity) and storage location at the facility; and
(2) If the failure to meet any of the conditions may endanger human health or the environment, you must also immediately notify us orally within 24 hours and follow up with a written notification within five days. Failures that may endanger human health or the environment include, but are not limited to, discharge of a CERCLA reportable quantity or other leaking or exploding tanks or containers, or detection of radionuclides above background or hazardous constituents in the leachate collection system of a storage area. If the failure may endanger human health or the environment, you must follow the provisions of your emergency plan.
(2) You send us a notice by certified delivery that you are reclaiming the exemption for your LLMW. Your notice must be signed by your authorized representative certifying that the information contained in your notice is true, complete, and accurate. In your notice you must do the following:
(ii) Certify that you have corrected each failure that caused you to lose the exemption for your LLMW and that you again meet all the conditions as of the date you specify.
(iii) Describe plans that you have implemented, listing specific steps you have taken, to ensure the conditions will be met in the future.
(iv) Include any other information you want us to consider when we review your notice reclaiming the exemption.
Section 266.250 What records must you keep at your facility and for how long?
(1) Your initial notification records, return receipts, reports to us of failure(s) to meet the exemption conditions, and all records supporting any reclaim of an exemption;
(3) Your certification that facility personnel who manage stored mixed waste are trained in safe management of LLMW including training in chemical waste management and hazardous materials incidents response; and
Section 266.305 What does the transportation and disposal conditional exemption do?
Section 266.310 What wastes are eligible for the transportation and disposal conditional exemption?
Section 266.320 What treatment standards must your eligible waste meet?
Section 266.325 Are you subject to the manifest and transportation condition in 40 CFR 266.315(b)?
Section 266.330 When does the transportation and disposal exemption take effect?
Section 266.335 Where must your exempted waste be disposed of?
Section 266.340 What type of container must be used for disposal of exempted waste?
Section 266.345 Whom must you notify?
(5) A statement that the exempted waste must be placed in a container according to §266.340 prior to disposal in order for the waste to remain exempt under the transportation and disposal conditional exemption of Part 266, Subpart N.
(7) A certification that all the information provided is true, complete, and accurate. The statement must be signed by your authorized representative.
Section 266.350 What records must you keep at your facility and for how long?
(1) When you fail to meet any of the conditions specified in §266.315 for any of your wastes, you must report to us, in writing by certified delivery, within 30 days of learning of the failure. Your report must be signed by your authorized representative certifying that the information provided is true, accurate, and complete. This report must include:
(ii) A description of the waste (including the waste name, hazardous waste codes and quantity) that lost the exemption; and
(2) If the failure to meet any of the conditions may endanger human health or the environment, you must also immediately notify us orally within 24 hours and follow up with a written notification within 5 days.
(2) You send a notice, by certified delivery, to us that you are reclaiming the exemption for the waste. Your notice must be signed by your authorized representative certifying that the information provided is true, accurate, and complete. The notice must:
(ii) Certify that each failure that caused you to lose the exemption for the waste has been corrected and that you again meet all conditions for the waste as of the date you specify.
(iii) Describe plans you have implemented, listing the specific steps that you have taken, to ensure that conditions will be met in the future.
(iv) Include any other information you want us to consider when we review your notice reclaiming the exemption.
“Evaluated hazardous waste pharmaceutical” means a prescription hazardous waste pharmaceutical that has been evaluated by a reverse distributor in accordance with §266.510(a)(3) and will not be sent to another reverse distributor for further evaluation or verification of manufacturer credit.
(1) Provide preventative, diagnostic, therapeutic, rehabilitative, maintenance or palliative care, and counseling, service, assessment or procedure with respect to the physical or mental condition, or functional status, of a human or animal or that affects the structure or function of the human or animal body; or
(2) Distribute, sell, or dispense pharmaceuticals, including over-the-counter pharmaceuticals, dietary supplements, homeopathic drugs, or prescription pharmaceuticals. This definition includes, but is not limited to, wholesale distributors, third-party logistics providers that serve as forward distributors, military medical logistics facilities, hospitals, psychiatric hospitals, ambulatory surgical centers, health clinics, physicians' offices, optical and dental providers, chiropractors, long-term care facilities, ambulance services, pharmacies, long-term care pharmacies, mail-order pharmacies, retailers of pharmaceuticals, veterinary clinics, and veterinary hospitals. This definition does not include pharmaceutical manufacturers, reverse distributors, or reverse logistics centers.
“Long-term care facility” means a licensed entity that provides assistance with activities of daily living, including managing and administering pharmaceuticals to one or more individuals at the facility. This definition includes, but is not limited to, hospice facilities, nursing facilities, skilled nursing facilities, and the nursing and skilled nursing care portions of continuing care retirement communities. Not included within the scope of this definition are group homes, independent living communities, assisted living facilities, and the independent and assisted living portions of continuing care retirement communities.
“Non-creditable hazardous waste pharmaceutical” means a prescription hazardous waste pharmaceutical that does not have a reasonable expectation to be eligible for manufacturer credit or a nonprescription hazardous waste pharmaceutical that does not have a reasonable expectation to be legitimately used/reused or reclaimed. This includes but is not limited to, investigational drugs, free samples of pharmaceuticals received by healthcare facilities, residues of pharmaceuticals remaining in empty containers, contaminated personal protective equipment, floor sweepings, and clean-up material from the spills of pharmaceuticals.
“Non-pharmaceutical hazardous waste” means a solid waste, as defined in §261.2, that is listed in Part 261 Subpart D, or exhibits one or more characteristics identified in Part 261 Subpart C, but is not a pharmaceutical, as defined in this section.
“Pharmaceutical” means any drug or dietary supplement for use by humans or other animals; any electronic nicotine delivery system (e.g., electronic cigarette or vaping pen); or any liquid nicotine (e- liquid) packaged for retail sale for use in electronic nicotine delivery systems (e.g., pre-filled cartridges or vials). This definition includes, but is not limited to, dietary supplements, as defined by the Federal Food, Drug and Cosmetic Act; prescription drugs, as defined by 21 CFR 203.3(y); over-the-counter drugs; homeopathic drugs; compounded drugs; investigational new drugs; pharmaceuticals remaining in non- empty containers; personal protective equipment contaminated with pharmaceuticals; and clean-up material from spills of pharmaceuticals. This definition does not include dental amalgam or sharps.
“Potentially creditable hazardous waste pharmaceutical” means a prescription hazardous waste pharmaceutical that has a reasonable expectation to receive manufacturer credit and is:
(3) Unexpired or less than one year past expiration date. The term does not include evaluated hazardous waste pharmaceuticals or nonprescription pharmaceuticals including, but not limited to, over-the-counter drugs, homeopathic drugs, and dietary supplements.
“Reverse distributor” means any person that receives and accumulates prescription pharmaceuticals that are potentially creditable hazardous waste pharmaceuticals for the purpose of facilitating or verifying manufacturer credit. Any person, including forward distributors, third-party logistics providers, and pharmaceutical manufacturers, that processes prescription pharmaceuticals for the facilitation or verification of manufacturer credit is considered a reverse distributor.
(ii) Potentially creditable hazardous waste pharmaceuticals if they are not destined for a reverse distributor.
(2) Sections 262.502(a), 266.503, 266.505 through 266.507, and 266.509 of this subpart with respect to the management of potentially creditable hazardous waste pharmaceuticals that are prescription pharmaceuticals and are destined for a reverse distributor.
(1) Pharmaceuticals that are not solid waste, as defined by §261.2, because they are legitimately used/reused (e.g., lawfully donated for their intended purpose) or reclaimed.
(2) Over-the-counter pharmaceuticals, dietary supplements, or homeopathic drugs that are not solid wastes, as defined by §261.2, because they have a reasonable expectation of being legitimately used/reused (e.g., lawfully redistributed for their intended purpose) or reclaimed.
(3) Pharmaceuticals being managed in accordance with a recall strategy that has been approved by the Food and Drug Administration in accordance with 21 CFR Part 7 Subpart C. This subpart does apply to the management of the recalled hazardous waste pharmaceuticals after the Food and Drug Administration approves the destruction of the recalled items.
(4) Pharmaceuticals being managed in accordance with a recall corrective action plan that has been accepted by the Consumer Product Safety Commission in accordance with 16 CFR Part 1115. This subpart does apply to the management of the recalled hazardous waste pharmaceuticals after the Consumer Product Safety Commission approves the destruction of the recalled items.
(5) Pharmaceuticals stored according to a preservation order, or during an investigation or judicial proceeding until after the preservation order, investigation, or judicial proceeding has concluded and/or a decision is made to discard the pharmaceuticals.
(6) Investigational new drugs for which an investigational new drug application is in effect in accordance with the Food and Drug Administration's regulations in 21 CFR Part 312. This subpart does apply to the management of the investigational new drug after the decision is made to discard the investigational new drug or the Food and Drug Administration approves the destruction of the investigational new drug, if the investigational new drug is a hazardous waste.
(7) Household waste pharmaceuticals, including those that have been collected by an authorized collector (as defined by the Drug Enforcement Administration), provided the authorized collector complies with the conditional exemption in §§266.506(a)(2) and 266.506(b).
(a) Notification and withdrawal from this subpart for healthcare facilities managing hazardous waste pharmaceuticals
(1) Notification. A healthcare facility must notify the DNREC Secretary, using the Site Identification Form (EPA Form 8700-12), that it is a healthcare facility operating under this subpart. A healthcare facility is not required to fill out Box 10.B. (Waste Codes for Federally Regulated Hazardous Waste) or Box 10.C. (Waste Codes for State Regulated Hazardous Waste) of the Site Identification Form with respect to its hazardous waste pharmaceuticals. A healthcare facility must submit a separate notification (Site Identification Form) for each site or EPA identification number.
(i) A healthcare facility that already has an EPA identification number must notify the DNREC Secretary, using the Site Identification Form (EPA Form 8700-12), that it is a healthcare facility as part of its next Annual Report, if it is required to submit one; or if not required to submit an Annual Report, within 60 days of the effective date of this subpart, or within 60 days of becoming subject to this subpart.
(ii) A healthcare facility that does not have an EPA identification number must obtain one by notifying the DNREC Secretary, using the Site Identification Form (EPA Form 8700- 12), that it is a healthcare facility as part of its next Annual Report, if it is required to submit one; or if not required to submit an Annual Report, within 60 days of the effective date of this subpart, or within 60 days of becoming subject to this subpart.
(iii) A healthcare facility must keep a copy of its notification on file for as long as the healthcare facility is subject to this subpart.
(2) Withdrawal. A healthcare facility that operated under this subpart but is no longer subject to this subpart, because it is a very small quantity generator under §262.14, and elects to withdraw from this subpart, must notify the DNREC Secretary using the Site Identification Form (EPA Form 8700-12) that it is no longer operating under this subpart. A healthcare facility is not required to fill out Box 10.B. (Waste Codes for Federally Regulated Hazardous Waste) or Box 10.C. (Waste Codes for State Regulated Hazardous Waste) of the Site Identification Form with respect to its hazardous waste pharmaceuticals. A healthcare facility must submit a separate notification (Site Identification Form) for each EPA identification number.
(i) A healthcare facility must submit the Site Identification Form notifying that it is withdrawing from this subpart before it begins operating under the conditional exemption of §262.14.
(ii) A healthcare facility must keep a copy of its withdrawal on file for three years from the date of signature on the notification of its withdrawal.
(b) Training of personnel managing non-creditable hazardous waste pharmaceuticals at healthcare facilities. A healthcare facility must ensure that all personnel that manage non-creditable hazardous waste pharmaceuticals are thoroughly familiar with proper waste handling and emergency procedures relevant to their responsibilities during normal facility operations and emergencies.
(c) Hazardous waste determination for non-creditable pharmaceuticals. A healthcare facility that generates a solid waste that is a non-creditable pharmaceutical must determine whether that pharmaceutical is a hazardous waste pharmaceutical (i.e., it exhibits a characteristic identified in Part 261 Subpart C or is listed in Part 261 Subpart D) in order to determine whether the waste is subject to this subpart. A healthcare facility may choose to manage its non-hazardous waste pharmaceuticals as non- creditable hazardous waste pharmaceuticals under this subpart.
(d) Standards for containers used to accumulate non-creditable hazardous waste pharmaceuticals at
(1) A healthcare facility must place non-creditable hazardous waste pharmaceuticals in a container that is structurally sound, compatible with its contents, and that lacks evidence of leakage, spillage, or damage that could cause leakage under reasonably foreseeable conditions.
(2) A healthcare facility that manages ignitable or reactive non-creditable hazardous waste pharmaceuticals, or that mixes or commingles incompatible non-creditable hazardous waste pharmaceuticals must manage the container so that it does not have the potential to:
(ii) Produce uncontrolled toxic mists, fumes, dusts, or gases in sufficient quantities to threaten human health;
(iii) Produce uncontrolled flammable fumes or gases in sufficient quantities to pose a risk of fire or explosions;
(iv) Damage the structural integrity of the container of non-creditable hazardous waste pharmaceuticals; or
(3) A healthcare facility must keep containers of non-creditable hazardous waste pharmaceuticals closed and secured in a manner that prevents unauthorized access to its contents.
(4) A healthcare facility may accumulate non-creditable hazardous waste pharmaceuticals and non-hazardous non-creditable waste pharmaceuticals in the same container, except that non- creditable hazardous waste pharmaceuticals prohibited from being combusted because of the dilution prohibition of §268.3(c) must be accumulated in separate containers and labeled with all applicable hazardous waste numbers (i.e., hazardous waste codes).
(e) Labeling containers used to accumulate non-creditable hazardous waste pharmaceuticals at healthcare facilities. A healthcare facility must label or clearly mark each container of non-creditable hazardous waste pharmaceuticals with the phrase “Hazardous Waste Pharmaceuticals.”
(f) Maximum accumulation time for non-creditable hazardous waste pharmaceuticals at healthcare facilities.
(1) A healthcare facility may accumulate non-creditable hazardous waste pharmaceuticals on site for one year or less without a permit or having interim status.
(2) A healthcare facility that accumulates non-creditable hazardous waste pharmaceuticals on site must demonstrate the length of time that the non-creditable hazardous waste pharmaceuticals have been accumulating, starting from the date it first becomes a waste. A healthcare facility may make this demonstration by any of the following methods:
(i) Marking or labeling the container of non-creditable hazardous waste pharmaceuticals with the date that the non-creditable hazardous waste pharmaceuticals became a waste;
(ii) Maintaining an inventory system that identifies the date the non-creditable hazardous waste pharmaceuticals being accumulated first became a waste;
(iii) Placing the non-creditable hazardous waste pharmaceuticals in a specific area and identifying the earliest date that any of the non-creditable hazardous waste pharmaceuticals in the area became a waste.
(g) Land disposal restrictions for non-creditable hazardous waste pharmaceuticals. The non-creditable hazardous waste pharmaceuticals generated by a healthcare facility are subject to the land disposal restrictions of Part 268 of these regulations. A healthcare facility that generates non-creditable hazardous waste pharmaceuticals must comply with the land disposal restrictions in accordance with §268.7(a) requirements, except that it is not required to identify the hazardous waste numbers (i.e., hazardous waste codes) on the land disposal restrictions notification.
(h) Procedures for healthcare facilities for managing rejected shipments of non-creditable hazardous waste pharmaceuticals. A healthcare facility that sends a shipment of non-creditable hazardous waste pharmaceuticals to a designated facility with the understanding that the designated facility can accept and manage the waste, and later receives that shipment back as a rejected load in accordance with the manifest discrepancy provisions of §264.72 or §265.72 of these regulations may accumulate the returned non-creditable hazardous waste pharmaceuticals on site for up to an additional 90 days provided the rejected or returned shipment is managed in accordance with paragraphs (d) and (e) of this section. Upon receipt of the returned shipment, the healthcare facility must:
(i) Item 18c of the original manifest, if the original manifest was used for the returned shipment; or
(3) Within 30 days of receipt of the rejected shipment, send a copy of the manifest to the designated facility that returned the shipment to the healthcare facility; and
(4) Within 90 days of receipt of the rejected shipment, transport or offer for transport the returned shipment in accordance with the shipping standards of §266.508(a).
(i) Reporting by healthcare facilities for non-creditable hazardous waste pharmaceuticals
(1) Annual reporting by healthcare facilities. Healthcare facilities are not subject to annual reporting requirements under §262.41, with respect to non-creditable hazardous waste pharmaceuticals managed under this subpart.
(A) If a healthcare facility does not receive a copy of the manifest with the signature of the owner or operator of the designated facility within 60 days of the date the non-creditable hazardous waste pharmaceuticals were accepted by the initial transporter, the healthcare facility must submit:
(1) A legible copy of the original manifest, indicating that the healthcare facility has not received confirmation of delivery, to the DNREC Secretary; and
(2) A handwritten or typed note on the manifest itself, or on an attached sheet of paper, stating that the return copy was not received and explaining the efforts taken to locate the non-creditable hazardous waste pharmaceuticals and the results of those efforts.
(A) If a healthcare facility does not receive a copy of the manifest for a rejected shipment of the non-creditable hazardous waste pharmaceuticals that is forwarded by the designated facility to an alternate facility (using appropriate manifest procedures), with the signature of the owner or operator of the alternate facility, within 60 days of the date the non-creditable hazardous waste was accepted by the initial transporter forwarding the shipment of non-creditable hazardous waste pharmaceuticals from the designated facility to the alternate facility, the healthcare facility must submit:
(1) A legible copy of the original manifest, indicating that the healthcare facility has not received confirmation of delivery, to the DNREC Secretary; and
(2) A handwritten or typed note on the manifest itself, or on an attached sheet of paper, stating that the return copy was not received and explaining the efforts taken to locate the non-creditable hazardous waste pharmaceuticals and the results of those efforts.
(3) Additional reports. The DNREC Secretary may require healthcare facilities to furnish additional reports concerning the quantities and disposition of non-creditable hazardous waste pharmaceuticals.
(j) Recordkeeping by healthcare facilities for non-creditable hazardous waste pharmaceuticals.
(1) A healthcare facility must keep a copy of each manifest signed in accordance with §262.23(a) for three years or until it receives a signed copy from the designated facility which received the non-creditable hazardous waste pharmaceuticals. This signed copy must be retained as a record for at least three years from the date the waste was accepted by the initial transporter.
(2) A healthcare facility must keep a copy of each exception report for a period of at least three years from the date of the report.
(3) A healthcare facility must keep records of any test results, waste analyses, or other determinations made to support its hazardous waste determination(s) consistent with §262.11(f), for at least three years from the date the waste was last sent to on-site or off-site treatment, storage, or disposal. A healthcare facility that manages all of its non-creditable non- hazardous waste pharmaceuticals as non-creditable hazardous waste pharmaceuticals is not required to keep documentation of hazardous waste determinations.
(4) A healthcare facility must keep training records in accordance with §266.502(b) for three years.
(5) The periods of retention referred to in this section are extended automatically during the course of any unresolved enforcement action regarding the regulated activity, or as requested by the DNREC Secretary.
(k) Response to spills of non-creditable hazardous waste pharmaceuticals at healthcare facilities. A healthcare facility must immediately contain all spills of non-creditable hazardous waste pharmaceuticals and manage the spill clean-up materials as non-creditable hazardous waste pharmaceuticals in accordance with the requirements of this subpart.
(l) Accepting non-creditable hazardous waste pharmaceuticals from an off-site healthcare facility that is a very small quantity generator. A healthcare facility may accept non-creditable hazardous waste pharmaceuticals from an off-site healthcare facility that is a very small quantity generator under §262.14, without a permit or without having interim status, provided the receiving healthcare facility:
(1) Is under the control of the same person (as defined in §260.10) as the very small quantity generator healthcare facility that is sending the non-creditable hazardous waste pharmaceuticals off site (“control,” for the purposes of this section, means the power to direct the policies of the healthcare facility, whether by the ownership of stock, voting rights, or otherwise, except that contractors who operate healthcare facilities on behalf of a different person as defined in §260.10 of these regulations shall not be deemed to “control” such healthcare facilities) or has a contractual or other documented business relationship whereby the receiving healthcare facility supplies pharmaceuticals to the very small quantity generator healthcare facility;
(2) Is operating under this subpart for the management of its non-creditable hazardous waste pharmaceuticals;
(3) Manages the non-creditable hazardous waste pharmaceuticals that it receives from off site in compliance with this subpart; and
(4) Keeps records of the non-creditable hazardous waste pharmaceuticals shipments it receives from off site for three years from the date that the shipment is received.
(a) Hazardous waste determination for potentially creditable pharmaceuticals. A healthcare facility that generates a solid waste that is a potentially creditable pharmaceutical must determine whether the potentially creditable pharmaceutical is a potentially creditable hazardous waste pharmaceutical (i.e., it is listed in Part 261 Subpart D or exhibits a characteristic identified in Part 261 Subpart C). A healthcare facility may choose to manage its potentially creditable non-hazardous waste pharmaceuticals as potentially creditable hazardous waste pharmaceuticals under this subpart.
(b) Accepting potentially creditable hazardous waste pharmaceuticals from an off-site healthcare facility that is a very small quantity generator. A healthcare facility may accept potentially creditable hazardous waste pharmaceuticals from an off-site healthcare facility that is a very small quantity generator under §262.14, without a permit or without having interim status, provided the receiving healthcare facility:
(1) Is under the control of the same person, as defined in §260.10, as the very small quantity generator healthcare facility that is sending the potentially creditable hazardous waste
(2) Is operating under this subpart for the management of its potentially creditable hazardous waste pharmaceuticals;
(3) Manages the potentially creditable hazardous waste pharmaceuticals that it receives from off site in compliance with this subpart; and
(4) Keeps records of the potentially creditable hazardous waste pharmaceuticals shipments it receives from off site for three years from the date that the shipment is received.
(c) Prohibition. Healthcare facilities are prohibited from sending hazardous wastes other than potentially creditable hazardous waste pharmaceuticals to a reverse distributor.
(d) Annual Reporting by healthcare facilities. Healthcare facilities are not subject to annual reporting requirements under §262.41 with respect to potentially creditable hazardous waste pharmaceuticals managed under this subpart.
(e) Recordkeeping by healthcare facilities.
(1) A healthcare facility that initiates a shipment of potentially creditable hazardous waste pharmaceuticals to a reverse distributor must keep the following records (paper or electronic) for each shipment of potentially creditable hazardous waste pharmaceuticals for three years from the date of shipment:
(2) The periods of retention referred to in this section are extended automatically during the course of any unresolved enforcement action regarding the regulated activity, or as requested by the DNREC Secretary.
(f) Response to spills of potentially creditable hazardous waste pharmaceuticals at healthcare facilities. A healthcare facility must immediately contain all spills of potentially creditable hazardous waste pharmaceuticals and manage the spill clean-up materials as non-creditable hazardous waste pharmaceuticals in accordance with this subpart.
(a) Potentially creditable hazardous waste pharmaceuticals. A healthcare facility that is a very small quantity generator for both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste may send its potentially creditable hazardous waste pharmaceuticals to a reverse distributor.
(b) Off-site collection of hazardous waste pharmaceuticals generated by a healthcare facility that is a very small quantity generator. A healthcare facility that is a very small quantity generator for both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste may send its hazardous waste pharmaceuticals off site to another healthcare facility, provided:
(2) The very small quantity generator healthcare facility meets the conditions in §262.14(a)(6)(viii) and the receiving large quantity generator meets the conditions in §262.17(f).
(c) Long-term care facilities that are very small quantity generators. A long-term care facility that is a very small quantity generator for both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste may dispose of its hazardous waste pharmaceuticals (excluding contaminated personal protective equipment or clean-up materials) in an on-site collection receptacle of an authorized collector (as defined by the Drug Enforcement Administration) that is registered with the Drug Enforcement Administration provided the contents are collected, stored, transported, destroyed and disposed of in compliance with all applicable Drug Enforcement Administration regulations for controlled substances.
(d) Long-term care facilities with 20 beds or fewer. A long-term care facility with 20 beds or fewer is presumed to be a very small quantity generator subject to §262.14 for both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste and not subject to this subpart, except for §§266.505 and 266.507 and the other optional provisions of this section. The DNREC Secretary has the responsibility to demonstrate that a long-term care facility with 20 beds or fewer generates quantities of hazardous waste that are in excess of the very small quantity generator limits as defined in §260.10. A long-term care facility with more than 20 beds that operates as a very small quantity generator under §262.14 must demonstrate that it generates quantities of hazardous waste that are within the very small quantity generator limits as defined by §260.10.
(a) Conditional exemptions. Provided the conditions of paragraph (b) of this section are met, the following are exempt from Parts 262 through 273 of these regulations:
(1) Hazardous waste pharmaceuticals that are also listed on a schedule of controlled substances by the Drug Enforcement Administration in 21 CFR Part 1308, and
(2) Household waste pharmaceuticals that are collected in a take-back event or program, including those that are collected by an authorized collector (as defined by the Drug Enforcement Administration) registered with the Drug Enforcement Administration that commingles the household waste pharmaceuticals with controlled substances from an ultimate user (as defined by the Drug Enforcement Administration).
(2) Collected, stored, transported, and disposed of in compliance with all applicable Drug Enforcement Administration regulations for controlled substances; and
(3) Destroyed by a method that the Drug Enforcement Administration has publicly deemed in writing to meet their non-retrievable standard of destruction or combusted at one of the following:
(i) A permitted large municipal waste combustor, subject to 40 CFR Part 62 Subpart FFF or applicable state plan for existing large municipal waste combustors, or 40 CFR Part 60 Subpart Eb for new large municipal waste combustors; or
(ii) A permitted small municipal waste combustor, subject to 40 CFR Part 62 Subpart JJJ or applicable state plan for existing small municipal waste combustors, or 40 CFR Part 60 Subpart AAAA for new small municipal waste combustors; or
(iii) A permitted hospital, medical and infectious waste incinerator, subject to 40 CFR Part 62 Subpart HHH or applicable state plan for existing hospital, medical and infectious waste incinerators, or 40 CFR Part 60 Subpart Ec for new hospital, medical and infectious waste incinerators.
(iv) A permitted commercial and industrial solid waste incinerator, subject to 40 CFR Part 62 Subpart III or applicable state plan for existing commercial and industrial solid waste incinerators, or 40 CFR Part 60 Subpart CCCC for new commercial and industrial solid waste incinerators.
(a) Stock, dispensing and unit-dose containers. A stock bottle, dispensing bottle, vial, or ampule (not to exceed 1 liter or 10,000 pills); or a unit-dose container (e.g., a unit-dose packet, cup, wrapper, blister pack, or delivery device) is considered empty and the residues are not regulated as hazardous waste provided the pharmaceuticals have been removed from the stock bottle, dispensing bottle, vial, ampule, or the unit-dose container using the practices commonly employed to remove materials from that type of container.
(b) Syringes. A syringe is considered empty and the residues are not regulated as hazardous waste under this subpart provided the contents have been removed by fully depressing the plunger of the syringe. If a syringe is not empty, the syringe must be placed with its remaining hazardous waste pharmaceuticals into a container that is managed and disposed of as a non-creditable hazardous waste pharmaceutical under this subpart and any applicable federal, state, and local requirements for sharps containers and medical waste.
(c) Intravenous (IV) bags. An IV bag is considered empty and the residues are not regulated as hazardous waste provided the pharmaceuticals in the IV bag have been fully administered to a patient. If an IV bag is not empty, the IV bag must be placed with its remaining hazardous waste pharmaceuticals into a container that is managed and disposed of as a non-creditable hazardous waste pharmaceutical under this subpart, unless the IV bag held non-acute hazardous waste pharmaceuticals and is empty as defined in §261.7(b)(1).
(d) Other containers, including delivery devices. Hazardous waste pharmaceuticals remaining in all other types of unused, partially administered, or fully administered containers must be managed as non- creditable hazardous waste pharmaceuticals under this subpart, unless the container held non-acute hazardous waste pharmaceuticals and is empty as defined in §261.7(b)(1) or (2). This includes, but is not limited to, residues in inhalers, aerosol cans, nebulizers, tubes of ointments, gels, or creams.
(a) Shipping non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals. A healthcare facility must ship non-creditable hazardous waste pharmaceuticals and a reverse distributor must ship evaluated hazardous waste pharmaceuticals off site to a designated facility (such as a permitted or interim status treatment, storage, or disposal facility) in compliance with:
(1) The following pre-transport requirements, before transporting or offering for transport off site:
(i) Packaging. Package the waste in accordance with the applicable Department of Transportation regulations on hazardous materials under 49 CFR Parts 173, 178, and 180.
(ii) Labeling. Label each package in accordance with the applicable Department of Transportation regulations on hazardous materials under 49 CFR Part 172 Subpart E.
(A) Mark each package of hazardous waste pharmaceuticals in accordance with the applicable Department of Transportation (DOT) regulations on hazardous materials under 49 CFR Part 172 Subpart D;
(B) Mark each container of 119 gallons or less used in such transportation with the following words and information in accordance with the requirements of 49 CFR 172.304:
(C) Lab packs that will be incinerated in compliance with §268.42(c) are not required to be marked with EPA Hazardous Waste Number(s), except D004, D005, D006, D007, D008, D010, and D011, where applicable. A nationally recognized electronic system, such as bar coding or radio frequency identification, may be used to identify the EPA Hazardous Waste Number(s).
(iv) Placarding. Placard or offer the initial transporter the appropriate placards according to Department of Transportation regulations for hazardous materials under 49 CFR Part 172 Subpart F.
(i) A healthcare facility shipping non-creditable hazardous waste pharmaceuticals is not required to list all applicable hazardous waste numbers (i.e., hazardous waste codes) in Item 13 of EPA Form 8700-22.
(ii) A healthcare facility shipping non-creditable hazardous waste pharmaceuticals must write the word “PHARMS” in Item 13 of EPA Form 8700-22.
(b) Exporting non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals. A healthcare facility or reverse distributor that exports non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals is subject to Part 262 Subpart H of these regulations.
(c) Importing non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals. Any person that imports non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals is subject to Part 262 Subpart H of these regulations. A healthcare facility or reverse distributor may not accept imported non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals unless they have a permit or interim status that allows them to accept hazardous waste from off site.
(a) Shipping potentially creditable hazardous waste pharmaceuticals. A healthcare facility or a reverse distributor who transports or offers for transport potentially creditable hazardous waste pharmaceuticals off site to a reverse distributor must comply with all applicable U.S. Department of Transportation regulations in 49 CFR Part 171 through 180 for any potentially creditable hazardous waste pharmaceutical that meets the definition of hazardous material in 49 CFR 171.8. For purposes of the Department of Transportation regulations, a material is considered a hazardous waste if it is subject to the Hazardous Waste Manifest Requirements specified in Part 262 of these regulations. Because a potentially creditable hazardous waste pharmaceutical does not require a manifest, it is not considered hazardous waste under the Department of Transportation regulations.
(b) Delivery confirmation. Upon receipt of each shipment of potentially creditable hazardous waste pharmaceuticals, the receiving reverse distributor must provide confirmation (paper or electronic) to the healthcare facility or reverse distributor that initiated the shipment that the shipment of potentially creditable hazardous waste pharmaceuticals has arrived at its destination and is under the custody and control of the reverse distributor.
(c) Procedures for when delivery confirmation is not received within 35 calendar days. If a healthcare facility or reverse distributor initiates a shipment of potentially creditable hazardous waste pharmaceuticals to a reverse distributor and does not receive delivery confirmation within 35 calendar days from the date that the shipment of potentially creditable hazardous waste pharmaceuticals was sent, the healthcare facility or reverse distributor that initiated the shipment must contact the carrier and the intended recipient (i.e., the reverse distributor) promptly to report that the delivery confirmation was not received and to determine the status of the potentially creditable hazardous waste pharmaceuticals.
(d) Exporting potentially creditable hazardous waste pharmaceuticals. A healthcare facility or reverse distributor that sends potentially creditable hazardous waste pharmaceuticals to a foreign destination must comply with the applicable sections of Part 262 Subpart H of these regulations, except the manifesting requirement of §262.83(c), in addition to paragraphs (a) through (c) of this section.
(e) Importing potentially creditable hazardous waste pharmaceuticals. Any person that imports potentially creditable hazardous waste pharmaceuticals into the United States is subject to paragraphs (a) through (c) of this section in lieu of Part 262 Subpart H of these regulations. Immediately after the potentially
(a) Standards for reverse distributors managing potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals.
(1) Notification. A reverse distributor must notify the DNREC Secretary, using the Site Identification Form (EPA Form 8700-12), that it is a reverse distributor operating under this subpart.
(i) A reverse distributor that already has an EPA identification number must notify the DNREC Secretary, using the Site Identification Form (EPA Form 8700-12), that it is a reverse distributor, as defined in §266.500, within 60 days of the effective date of this subpart, or within 60 days of becoming subject to this subpart.
(ii) A reverse distributor that does not have an EPA identification number must obtain one by notifying the DNREC Secretary, using the Site Identification Form (EPA Form 8700- 12), that it is a reverse distributor, as defined in §266.500, within 60 days of the effective date of this subpart, or within 60 days of becoming subject to this subpart.
(2) Inventory by the reverse distributor. A reverse distributor must maintain a current inventory of all the potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals that are accumulated on site.
(i) A reverse distributor must inventory each potentially creditable hazardous waste pharmaceutical within 30 calendar days of each waste arriving at the reverse distributor.
(ii) The inventory must include the identity (e.g., name or national drug code) and quantity of each potentially creditable hazardous waste pharmaceutical and evaluated hazardous waste pharmaceutical.
(iii) If the reverse distributor already meets the inventory requirements of this paragraph because of other regulatory requirements, such as State Board of Pharmacy regulations, the facility is not required to provide a separate inventory pursuant to this section.
(3) Evaluation by a reverse distributor that is not a manufacturer. A reverse distributor that is not a pharmaceutical manufacturer must evaluate a potentially creditable hazardous waste pharmaceutical within 30 calendar days of the waste arriving at the reverse distributor to establish whether it is destined for another reverse distributor for further evaluation or verification of manufacturer credit or for a permitted or interim status treatment, storage, or disposal facility.
(i) A potentially creditable hazardous waste pharmaceutical that is destined for another reverse distributor is still considered a “potentially creditable hazardous waste pharmaceutical” and must be managed in accordance with paragraph (b) of this section.
(ii) A potentially creditable hazardous waste pharmaceutical that is destined for a permitted or interim status treatment, storage or disposal facility is considered an “evaluated hazardous waste pharmaceutical” and must be managed in accordance with paragraph (c) of this section.
(4) Evaluation by a reverse distributor that is a manufacturer. A reverse distributor that is a pharmaceutical manufacturer must evaluate a potentially creditable hazardous waste pharmaceutical to verify manufacturer credit within 30 calendar days of the waste arriving at the facility and following the evaluation must manage the evaluated hazardous waste pharmaceuticals in accordance with paragraph (c) of this section.
(ii) Aging pharmaceuticals. Unexpired pharmaceuticals that are otherwise creditable but are awaiting their expiration date (i.e., aging in a holding morgue) can be accumulated for up to 180 days after the expiration date, provided that the unexpired pharmaceuticals are managed in accordance with paragraph (a) of this section and the container labeling and management standards in §266.510(c)(4)(i) through (vi).
(6) Security at the reverse distributor facility. A reverse distributor must prevent unknowing entry and minimize the possibility for the unauthorized entry into the portion of the facility where potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals are kept.
(i) Examples of methods that may be used to prevent unknowing entry and minimize the possibility for unauthorized entry include, but are not limited to:
(ii) If the reverse distributor already meets the security requirements of this paragraph because of other regulatory requirements, such as Drug Enforcement Administration or State Board of Pharmacy regulations, the facility is not required to provide separate security measures pursuant to this section.
(7) Contingency plan and emergency procedures at a reverse distributor. A reverse distributor that accepts potentially creditable hazardous waste pharmaceuticals from off site must prepare a contingency plan and comply with the other requirements of Part 262 Subpart M of these regulations.
(8) Closure of a reverse distributor. When closing an area where a reverse distributor accumulates potentially creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals, the reverse distributor must comply with §262.17(a)(8)(ii) and (iii).
(i) Unauthorized waste report. A reverse distributor must submit an unauthorized waste report if the reverse distributor receives waste from off site that it is not authorized to receive (e.g., non-pharmaceutical hazardous waste, regulated medical waste). The reverse distributor must prepare and submit an unauthorized waste report to the DNREC Secretary within 45 calendar days after the unauthorized waste arrives at the reverse distributor and must send a copy of the unauthorized waste report to the healthcare facility (or other entity) that sent the unauthorized waste. The reverse distributor must manage the unauthorized waste in accordance with all applicable regulations. The unauthorized waste report must be signed by the owner or operator of the reverse distributor, or its authorized representative, and contain the following information:
(C)The EPA identification number, name, and address of the healthcare facility that shipped the unauthorized waste, if available;
(10) Recordkeeping by reverse distributors. A reverse distributor must keep the following records (paper or electronic) readily available upon request by an inspector. The periods of retention referred to in this section are extended automatically during the course of any unresolved enforcement action regarding the regulated activity, or as requested by the DNREC Secretary.
(ii) A copy of the delivery confirmation and the shipping papers for each shipment of potentially creditable hazardous waste pharmaceuticals that it receives, and a copy of each unauthorized waste report, for at least three years from the date the shipment arrives at the reverse distributor;
(b) Additional standards for reverse distributors managing potentially creditable hazardous waste
pharmaceuticals destined for another reverse distributor. A reverse distributor that does not have a permit or interim status must comply with the following conditions, in addition to the requirements in paragraph (a) of this section, for the management of potentially creditable hazardous waste pharmaceuticals that are destined for another reverse distributor for further evaluation or verification of manufacturer credit:
(1) A reverse distributor that receives potentially creditable hazardous waste pharmaceuticals from a healthcare facility must send those potentially creditable hazardous waste pharmaceuticals to another reverse distributor within 180 days after the potentially creditable hazardous waste pharmaceuticals have been evaluated or follow paragraph (c) of this section for evaluated hazardous waste pharmaceuticals.
(2) A reverse distributor that receives potentially creditable hazardous waste pharmaceuticals from another reverse distributor must send those potentially creditable hazardous waste pharmaceuticals to a reverse distributor that is a pharmaceutical manufacturer within 180 days after the potentially creditable hazardous waste pharmaceuticals have been evaluated or follow paragraph (c) of this section for evaluated hazardous waste pharmaceuticals.
(3) A reverse distributor must ship potentially creditable hazardous waste pharmaceuticals destined for another reverse distributor in accordance with §266.509.
(4) Recordkeeping by reverse distributors. A reverse distributor must keep the following records (paper or electronic) readily available upon request by an inspector for each shipment of potentially creditable hazardous waste pharmaceuticals that it initiates to another reverse distributor, for at least three years from the date of shipment. The periods of retention referred to in this section are extended automatically during the course of any unresolved enforcement action regarding the regulated activity, or as requested by the DNREC Secretary.
(c) Additional standards for reverse distributors managing evaluated hazardous waste pharmaceuticals. A reverse distributor that does not have a permit or interim status must comply with the following conditions, in addition to the requirements of paragraph (a) of this section, for the management of evaluated hazardous waste pharmaceuticals:
(1) Accumulation area at the reverse distributor. A reverse distributor must designate an on-site accumulation area where it will accumulate evaluated hazardous waste pharmaceuticals.
(2) Inspections of on-site accumulation area. A reverse distributor must inspect its on-site accumulation area at least once every seven days, looking at containers for leaks and for deterioration caused by corrosion or other factors, as well as for signs of diversion.
(3) Personnel training at a reverse distributor. Personnel at a reverse distributor that handle evaluated hazardous waste pharmaceuticals are subject to the training requirements of §262.17(a)(7).
(4) Labeling and management of containers at on-site accumulation areas. A reverse distributor accumulating evaluated hazardous waste pharmaceuticals in containers in an on-site accumulation area must:
(iii) Use containers that are made of or lined with materials which will not react with, and are otherwise compatible with, the evaluated hazardous waste pharmaceuticals, so that the ability of the container to contain the waste is not impaired;
(iv) Keep containers closed, if holding liquid or gel evaluated hazardous waste pharmaceuticals. If the liquid or gel evaluated hazardous waste pharmaceuticals are in their original, intact, sealed packaging; or repackaged, intact, sealed packaging, they are considered to meet the closed container standard;
(v) Manage any container of ignitable or reactive evaluated hazardous waste pharmaceuticals, or any container of commingled incompatible evaluated hazardous waste pharmaceuticals so that the container does not have the potential to:
(B) Produce uncontrolled toxic mists, fumes, dusts, or gases in sufficient quantities to threaten human health;
(C) Produce uncontrolled flammable fumes or gases in sufficient quantities to pose a risk of fire or explosions;
(vi) Accumulate evaluated hazardous waste pharmaceuticals that are prohibited from being combusted because of the dilution prohibition of §268.3(c) (e.g., arsenic trioxide
(5) Hazardous waste numbers. Prior to shipping evaluated hazardous waste pharmaceuticals off site, all containers must be marked with the applicable hazardous waste numbers (i.e., hazardous waste codes). A nationally recognized electronic system, such as bar coding or radio frequency identification, may be used to identify the EPA Hazardous Waste Number(s).
(6) Shipments. A reverse distributor must ship evaluated hazardous waste pharmaceuticals that are destined for a permitted or interim status treatment, storage or disposal facility in accordance with the applicable shipping standards in §266.508(a) or (b).
(7) Procedures for a reverse distributor for managing rejected shipments. A reverse distributor that sends a shipment of evaluated hazardous waste pharmaceuticals to a designated facility with the understanding that the designated facility can accept and manage the waste, and later receives that shipment back as a rejected load in accordance with the manifest discrepancy provisions of §264.72 or §265.72 of these regulations, may accumulate the returned evaluated hazardous waste pharmaceuticals on site for up to an additional 90 days in the on-site accumulation area provided the rejected or returned shipment is managed in accordance with §266.510(a) and (c). Upon receipt of the returned shipment, the reverse distributor must:
(A) Item 18c of the original manifest, if the original manifest was used for the returned shipment; or
(iii) Within 30 days of receipt of the rejected shipment of the evaluated hazardous waste pharmaceuticals, send a copy of the manifest to the designated facility that returned the shipment to the reverse distributor; and
(iv) Within 90 days of receipt of the rejected shipment, transport or offer for transport the returned shipment of evaluated hazardous waste pharmaceuticals in accordance with the applicable shipping standards of §266.508(a) or (b).
(8) Land disposal restrictions. Evaluated hazardous waste pharmaceuticals are subject to the land disposal restrictions of Part 268 of these regulations. A reverse distributor that accepts potentially creditable hazardous waste pharmaceuticals from off site must comply with the land disposal restrictions in accordance with §268.7(a) requirements.
(i) Annual reporting by a reverse distributor. A reverse distributor that ships evaluated hazardous waste pharmaceuticals off site must prepare and submit a single copy of an annual report to the DNREC Secretary by March 1 of each year in accordance with §262.41.
(1) If a reverse distributor does not receive a copy of the manifest with the signature of the owner or operator of the designated facility within 35 days of the date the evaluated hazardous waste pharmaceuticals were accepted by the initial transporter, the reverse distributor must contact the transporter or the owner or operator of the designated facility to determine the status of the evaluated hazardous waste pharmaceuticals.
(2) A reverse distributor must submit an exception report to the DNREC Secretary if it has not received a copy of the manifest with the signature of the owner or operator of the designated facility within 45 days of the date the evaluated hazardous waste pharmaceutical was accepted by the initial transporter. The exception report must include:
(i) A legible copy of the manifest for which the reverse distributor does not have confirmation of delivery; and
(ii) A cover letter signed by the reverse distributor, or its authorized representative, explaining the efforts taken to locate the evaluated hazardous waste pharmaceuticals and the results of those efforts.
(1) A reverse distributor that does not receive a copy of the manifest with the signature of the owner or operator of the alternate facility within 35 days of the date the evaluated hazardous waste pharmaceuticals were accepted by the initial transporter must contact the transporter or the owner or operator of the alternate facility to determine the status of the hazardous waste. The 35-day time frame begins the date the evaluated hazardous waste pharmaceuticals are accepted by the transporter forwarding the hazardous waste shipment from the designated facility to the alternate facility.
(2) A reverse distributor must submit an Exception Report to the DNREC Secretary if it has not received a copy of the manifest with the signature of the owner or operator of the alternate facility within 45 days of the date the evaluated hazardous waste pharmaceuticals were accepted by the initial transporter. The 45-day timeframe begins the date the evaluated hazardous waste pharmaceuticals are accepted by the transporter forwarding the hazardous waste pharmaceutical shipment from the designated facility to the alternate facility. The Exception Report must include:
(i) A legible copy of the manifest for which the generator does not have confirmation of delivery; and
(ii) A cover letter signed by the reverse distributor, or its authorized representative, explaining the efforts taken to locate the evaluated hazardous waste pharmaceuticals and the results of those efforts.
(i) A reverse distributor must keep a log (written or electronic) of the inspections of the on-site accumulation area, required by paragraph (c)(2) of this section. This log must be retained as a record for at least three years from the date of the inspection.
(iii) A reverse distributor must keep a copy of each annual report for at least three years from the due date of the report.
(iv)A reverse distributor must keep a copy of each exception report for at least three years from the submission of the report.
(v) A reverse distributor must keep records to document personnel training, in accordance with §262.17(a)(7)(iv).
(vi) All records must be readily available upon request by an inspector. The periods of retention referred to in this section are extended automatically during the course of any unresolved enforcement action regarding the regulated activity, or as requested by the DNREC Secretary.
(d) When a reverse distributor must have a permit. A reverse distributor is an operator of a hazardous waste treatment, storage, or disposal facility and is subject to the requirements of Parts 264 and 265 and the permit requirements of Part 122, if the reverse distributor:
Values for use in urban areas Values for use in rural areas