reglab/statecodes huggingface dataset:
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 19 - AMBIENT AIR QUALITY STANDARDS AND AIR POLLUTION CONTROL › Section 28-19-717 - Control of volatile organic compound (VOC) emissions from commercial bakery ovens in Johnson and Wyandotte counties

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) Definitions.
			 The following terms shall have the meanings provided below for the purposes of
			 this regulation.
(1) "Baker's percent" means,
			 for a given ingredient, the weight of that ingredient per 100 pounds of flour,
			 expressed as a percentage.
(2)
			 "Commercial bakery oven facility" means an establishment that is primarily
			 engaged in the manufacture, for sale at wholesale or retail, of fresh or frozen
			 bread, bread-type rolls, or dry bakery products, including biscuits, crackers,
			 or cookies, in which the products are made using yeast leavening.
(3) "Spike yeast" means any yeast added to
			 the dough beyond the initial yeast added to the dough.
(4) "Spiking time" means the elapsed time
			 between the addition of the spike yeast to the dough and the placement of the
			 dough into the oven.
(5) "Yeast
			 action time" means the elapsed time between the initial addition of the yeast
			 and the placement of the dough into the oven.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 19 - AMBIENT AIR QUALITY STANDARDS AND AIR POLLUTION CONTROL › Section 28-19-720 - New source performance standards

Current through Register Vol.
			 43, No. 28, July 11, 2024
(a) 40 C.F.R. part 60 and its appendices, as
			 revised on July 1, 2017, are hereby adopted by reference except for the
			 following:
(1) Provisions that are not
			 delegable by the USEPA to the state or for which only the USEPA administrator
			 retains authority, including the subparts, sections, and paragraphs containing
			 any of the following:
(A) Alternative methods
			 of compliance approvable only by the USEPA administrator;
(B) emission guidelines;
(C) delegation of authority;
(D) hearing and appeal procedures;
(E) requirements regulating any stationary
			 source located outside of Kansas; or
(F) requirements regulating any geographic
			 area located outside of Kansas; and
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 19 - AMBIENT AIR QUALITY STANDARDS AND AIR POLLUTION CONTROL › Section 28-19-721 - Existing municipal solid waste landfills; definitions

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) The definitions
			 at 40 CFR
			 §60.751, as in effect on July 1, 1996,
			 are adopted by reference for the purposes of K.A.R. 28-19-721 through
			 28-19-727.
(b) The definition of
			 "municipal solid waste landfill" or "MSW landfill" is as defined in K.A.R.
			 28-19-200.
(c) Unless the context
			 clearly indicates otherwise, the following meanings shall be given to these
			 terms as they appear in 40 CFR part 60.
(1)
			 The term "administrator" shall mean the secretary or the secretary's authorized
			 representative.
(2) The term
			 "United States environmental protection agency" or any term referring to the
			 United States environmental protection agency shall mean the department.
(3) The term "state" shall mean
			 the state of Kansas.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 19 - AMBIENT AIR QUALITY STANDARDS AND AIR POLLUTION CONTROL › Section 28-19-722 - Existing municipal solid waste landfills; applicability, permits

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) Except as
			 otherwise provided in subsection (b) of this regulation, the provisions of
			 K.A.R. 28-19-721 through 28-19-727 apply to each existing municipal solid waste
			 landfill that meets all of the following criteria.
(1) Construction, reconstruction, or
			 modification of the MSW landfill commenced before May 30, 1991.
(2) The MSW landfill has accepted waste at
			 any time since November 8, 1987, or has additional design capacity available
			 for future waste deposition.
(3)
			 The MSW landfill has a design capacity greater than or equal to 2.5 million
			 megagrams or 2.5 million cubic meters as determined using the methods provided
			 in 40 CFR
			 §60.754(a)(1), as in
			 effect on July 1, 1996, which is adopted by reference for the purposes of
			 K.A.R. 28-19-721 through 28-19-727.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 19 - AMBIENT AIR QUALITY STANDARDS AND AIR POLLUTION CONTROL › Section 28-19-723 - Existing municipal solid waste landfills; initial and periodic reporting

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) The owner or
			 operator of an existing MSW landfill that meets the criteria of K.A.R.
			 28-19-722(a) shall prepare and submit to the department an initial design
			 capacity report within 90 days of the effective date of this regulation. The
			 report shall be prepared in accordance with the requirements of
			 40 CFR
			 §60.757(a)(2), as in
			 effect on July 1, 1996, which is hereby adopted by reference.
(b) The owner or operator of an existing MSW
			 landfill that meets the criteria of K.A.R. 28-19-722(a) shall prepare and
			 submit to the department amended design capacity reports in accordance with the
			 requirements of 40 CFR
			 §60.757(a)(3), as in
			 effect on July 1, 1996, which is hereby adopted by reference.
(c) In meeting the requirements of this
			 regulation, the owner or operator may calculate design capacity as required in
			 subsections (a) and (b) of this regulation in either megagrams or cubic meters
			 for comparison with the corresponding exemption values. Any density conversions
			 and any assumptions made shall be documented and submitted with the initial
			 design capacity report.
(d) If the
			 landfill is permanently closed, a closure notification shall be submitted to
			 the department as provided for in CFR §60.75(d), as adopted by K.A.R.
			 28-19-726.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 19 - AMBIENT AIR QUALITY STANDARDS AND AIR POLLUTION CONTROL › Section 28-19-724 - Existing municipal solid waste landfills; NMOC test methods and procedures

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) The owner or
			 operator of an existing MSW landfill that meets the criteria of K.A.R.
			 28-19-722(a) shall calculate the nonmethane organic compound (NMOC) emissions
			 from the landfill using the test methods and procedures contained in
			 40 CFR
			 §60.754(a)(1), as
			 adopted by K.A.R. 28-19-722.
(b)
			 If the initial calculated NMOC emission rate is less than 50 megagrams per
			 year, the owner or operator shall meet these requirements:
(1) recalculate the emission rate annually
			 using the procedures specified in
			 40 CFR
			 §60.754(a)(1) as
			 adopted by K.A.R. 28-19-722, until such time as the calculated NMOC emission
			 rate is equal to or greater than 50 megagrams per year, or the landfill is
			 closed; and
(2) submit an annual
			 emission report to the department, except as provided for in
			 40 CFR
			 §60.757(9b)(1)(ii), as
			 adopted by K.A.R. 28-19-726.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 19 - AMBIENT AIR QUALITY STANDARDS AND AIR POLLUTION CONTROL › Section 28-19-725 - Existing municipal solid waste landfills; collection and control systems

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) Gas collection
			 and control. The owner or operator of an existing MSW landfill required to
			 install gas collection and control equipment based on the determination made
			 pursuant to K.A.R. 28-19-724 shall be required to meet these provisions:
(1) submit to the department a collection and
			 control system design plan that meets the requirements of
			 40 CFR §
										60.752(b)(2)(i), as in
			 effect on July 1, 1996, which is hereby adopted by reference;
(2) install a collection and control system
			 that meets the requirements of
			 40 CFR
			 §60.752(b)(2)(ii), as
			 in effect on July 1, 1996, which is hereby adopted by reference;
(3) route all collected gas to a control
			 system that complies with the requirements of
			 40 CFR
			 §60.725(b)(2)(iii), as
			 in effect on July 1, 1996, which is hereby adopted by reference; and
(4) comply with the collection and control
			 system capping and removal requirements of
			 40 CFR §
										60.752(b)(2)(v), as in
			 effect on July 1, 1996, which is hereby adopted by reference.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 19 - AMBIENT AIR QUALITY STANDARDS AND AIR POLLUTION CONTROL › Section 28-19-726 - Existing MSW landfills; record-keeping and reporting

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) The owner or
			 operator of an existing municipal solid waste landfill subject to the
			 requirements of K.A.R. 28-19-721 through 28-19-727 shall comply with the
			 record-keeping requirements contained in
			 40 CFR §
									60.758, as in effect on July 1, 1996, which
			 is hereby adopted by reference.
(b) Each owner or operator of an existing
			 municipal solid waste landfill subject to the requirements of K.A.R.
			 28-19-722(a) shall comply with the reporting requirements of
			 40 CFR
			 §60.757(b) through (g),
			 as in effect on July 1, 1996, which is hereby adopted by reference.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 19 - AMBIENT AIR QUALITY STANDARDS AND AIR POLLUTION CONTROL › Section 28-19-727 - Existing MSW landfills; time for compliance

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) Except as
			 provided in subsection (b) of this regulation, the planning, awarding of
			 contracts, and installation of MSW landfill air emissions collection and
			 control systems shall be accomplished within 30 months of the effective date of
			 these regulations.
(b) Each
			 existing landfill that meets the criteria of K.A.R. 28-19-722(a), but that has
			 an NMOC emission rate of fewer than 50 megagrams per year on the effective date
			 of these municipal solid waste landfill air emissions regulations shall
			 accomplish the planning, awarding of contracts, and installation of collection
			 and control equipment within 30 months of the date when the criterion of an
			 NMOC emissions rate greater than or equal to 50 megagrams per year is first
			 met. This determination shall be made pursuant to the requirements of K.A.R.
			 28-19-724.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 19 - AMBIENT AIR QUALITY STANDARDS AND AIR POLLUTION CONTROL › Section 28-19-729 - Standards for hospital/medical/infectious waste incinerators

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) Applicability.
			 Except as otherwise provided in subsection (b) of this regulation, the
			 requirements of the "hospital/medical/infectious waste incinerators"
			 regulations, K.A.R. 28-19-729 through K.A.R. 28-19-729h, shall apply to each
			 individual "hospital/medical/infectious waste incinerator," or "HMIWI," as
			 defined in K.A.R. 28-19-729a, for which construction commenced on or before
			 June 20, 1996.
(b) Exceptions.
(1) The requirements of K.A.R. 28-19-729
			 through 28-19-729h shall not apply to HMIWI during periods when the HMIWI is
			 burning only pathological waste, low-level radioactive waste, or
			 chemotherapeutic wastes, as defined in K.A.R. 28-19-729a, or any combination of
			 only these waste types, under all of the following conditions:
(A) The owner or operator of the HMIWI
			 notifies the department in writing of an exemption claim under this subsection.
(B) The owner or operator of the
			 HMIWI keeps records, on a calendar quarter basis, of the times, including start
			 and ending times, when only pathological, low-level radioactive, or
			 chemotherapeutic wastes, or a combination of only these wastes, are burned.
(C) The owner or operator of the
			 HMIWI maintains the records for agency inspections in accordance with the
			 provisions of K.A.R. 28-19-729h.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 19 - AMBIENT AIR QUALITY STANDARDS AND AIR POLLUTION CONTROL › Section 28-19-729a - Hospital/medical/infectious waste incinerators; definitions

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) The definitions
			 in 40 C.F.R.
			 60.51c, as in effect on July 1, 1998, are
			 adopted by reference.
(b) "HMIWI"
			 or "hospital/medical/infectious waste incinerator" is defined in
			 40 C.F.R.
			 60.51c.
(c) "Small rural hospital/medical/infectious
			 waste incinerator" means a small HMIWI, as defined in
			 40 C.F.R.
			 60.51c, that burns less than 2,000 pounds of
			 "hospital or medical/infectious waste" per week and is located more than 50
			 miles from the boundary of the nearest standard metropolitan statistical area
			 (SMSA).
(d) "Standard metropolitan
			 statistical area" (SMSA) means, for the purposes of these HMIWI regulations,
			 the following:
(1) In Kansas:
(A) The Topeka SMSA comprised of Shawnee
			 county;
(B) the Lawrence SMSA
			 comprised of Douglas county;
(C)
			 the Wichita SMSA comprised of Butler, Harvey, and Sedgick counties; and
(D) the Kansas City SMSA comprised
			 of Johnson, Leavenworth, Miami, and Wyandotte counties;
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 19 - AMBIENT AIR QUALITY STANDARDS AND AIR POLLUTION CONTROL › Section 28-19-729b - Hospital/medical/infectious waste incinerators; emission standards

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a)
(1) The owner or operator of a
			 "hospital/medical/infectious waste incinerator," or HMIWI, subject to these
			 HMIWI regulations shall not cause or permit emissions from the HMIWI to exceed
			 a visible contaminant emission greater than 10 percent opacity during a
			 six-minute block average, measured as specified in
			 40 C.F.R.
			 60.56c as adopted in K.A.R. 28-19-729g.
(2) The owner or operator of any
			 HMIWI subject to these regulations shall not cause or permit emissions from the
			 HMIWI of any pollutants to exceed the emission limits listed in Table 1 of this
			 regulation, measured as specified in
			 40 C.F.R.
			 60.56c, as adopted in K.A.R. 28-19-729g.
For Table see Agency.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 19 - AMBIENT AIR QUALITY STANDARDS AND AIR POLLUTION CONTROL › Section 28-19-729c - Standards for hospital/medical/infectious waste incinerators; compliance schedule

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) Except as
			 otherwise provided in subsection (b) of this regulation, the owner or operator
			 of each HMIWI subject to the emission limits in K.A.R. 28-19-729b shall comply
			 with all of the applicable requirements of K.A.R. 28-19-729 through 28-19-729h
			 on or before the date one year after the effective date of EPA's approval of
			 the state's HMIWI plan.
(b)
(1) The owner or operator of an HMIWI may
			 petition the department for an extension to the compliance date specified in
			 subsection (a) of this regulation. This petition shall be prepared in
			 accordance with the provisions of subsection (c) of this regulation.
(2) The compliance date for each HMIWI for
			 which a compliance date extension petition is approved shall be no later than
			 September 15, 2002.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 19 - AMBIENT AIR QUALITY STANDARDS AND AIR POLLUTION CONTROL › Section 28-19-729d - Hospital/medical/infectious waste incinerators; operation, operator training, and qualification standards

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a)
(1) For the purposes of these regulations, a
			 "trained and qualified HMIWI operator" or "HMIWI operator" means a person who
			 has completed the requirements of subsections (b) and (c) of this regulation,
			 and who maintains the qualifications in accordance with the requirements of
			 subsection (e) as required.
(2) A
			 trained and qualified HMIWI operator either shall be at the HMIWI facility at
			 all times or shall be generally able to reach the facility within one hour at
			 all times the incinerator is in operation.
(3) Any HMIWI subject to these regulations
			 shall be operated only by a trained and qualified HMIWI operator, or by a
			 person or persons working under the direct supervision of a trained and
			 qualified HMIWI operator.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 19 - AMBIENT AIR QUALITY STANDARDS AND AIR POLLUTION CONTROL › Section 28-19-729e - Hospital/medical/infectious waste incinerators; waste management plan

Current through Register Vol. 43, No. 28, July 11,
			 2024
The owner or operator of the HMIWI facility shall prepare a
				waste management plan in accordance with
				40 C.F.R.
				60.55c, as in effect on July 1, 1998, which
				is hereby adopted by reference.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 19 - AMBIENT AIR QUALITY STANDARDS AND AIR POLLUTION CONTROL › Section 28-19-729f - Hospital/medical/infectious waste incinerators; inspections

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) The owner or
			 operator of each small rural HMIWI subject to this regulation, as defined in
			 K.A.R. 28-19-729a(c), shall conduct an initial equipment inspection of the
			 HMIWI within one year from the date the department receives EPA approval of the
			 state's HMIWI plan.
(b) At a
			 minimum, the owner or operator shall perform the following:
(1) Inspect all burners, pilot assemblies,
			 and pilot sensing devices for proper operation, and clean the pilot flame
			 sensor, as necessary;
(2) ensure
			 proper adjustment of primary and secondary chamber combustion air, and adjust
			 as necessary;
(3) inspect hinges
			 and door latches, and lubricate as necessary;
(4) inspect dampers, fans, and blowers for
			 proper operation;
(5) inspect
			 HMIWI door and door gaskets for proper sealing;
(6) inspect motors for proper operation;
(7) inspect primary chamber
			 refractory lining, and clean and repair or replace the lining as necessary;
(8) inspect the incinerator shell
			 for corrosion and hot spots;
(9)
			 inspect the secondary and tertiary chambers and stack, and clean as necessary;
(10) inspect the mechanical
			 loader, including limit switches, for proper operation, if applicable;
(11) visually inspect the waste
			 bed grates, and repair or seal, or both, as appropriate;
(12) for the burn cycle that follows the
			 inspection, document that the incinerator is operating properly and make any
			 necessary adjustments;
(13)
			 inspect air pollution control devices for proper operation, if applicable;
(14) inspect waste heat boiler
			 systems to ensure proper operation, if applicable;
(15) inspect bypass stack components;
(16) ensure proper calibration of
			 thermocouples, sorbent feed systems, and any other monitoring equipment; and
(17) generally observe that the
			 equipment is maintained in good operating condition.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 19 - AMBIENT AIR QUALITY STANDARDS AND AIR POLLUTION CONTROL › Section 28-19-729g - Hospital/medical/infectious waste incinerators; compliance, performance testing, and monitoring guidelines

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a)
(1) Except as provided in subsection (b) of
			 this regulation, each individual HMIWI subject to these regulations shall meet
			 the compliance and performance testing requirements in
			 40 C.F.R.
			 60.56c, as in effect on July 1, 1998, which
			 is adopted by reference except for the fugitive emissions testing requirements
			 in 40 C.F.R.
			 60.56c(b)(12) and (c)(3).
(2) To meet the testing
			 requirements of paragraph (a)(1) of this regulation, the operator or owner of
			 each HMIWI shall use the appropriate test methods listed in
			 40 C.F.R.
			 60.56c and adopted in K.A.R. 28-19-720.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 19 - AMBIENT AIR QUALITY STANDARDS AND AIR POLLUTION CONTROL › Section 28-19-729h - Hospital/medical/infect ious waste incinerators; reporting and recordkeeping

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) Except as
			 otherwise provided in subsection (b) of this regulation, the owner or operator
			 of an HMIWI that is subject to these regulations shall meet the reporting and
			 recordkeeping requirements listed in
			 40 C.F.R.
			 60.58c(b), (c), (d), (e), and
			 (f), as in effect on July 1, 1998 and hereby
			 adopted by reference, excluding
			 40 C.F.R.
			 60.58c(b)(2)(ii), fugitive
			 emissions, and (b)(7), siting.
(b)
			 The owner or operator of each small rural HMIWI subject to the emission limits
			 in K.A.R. 28-19-729b shall comply with the following reporting and
			 recordkeeping requirements:
(1) The owner or
			 operator of the small rural HMIWI shall maintain records of the annual
			 equipment inspections, any required maintenance, and any repairs not completed
			 within 10 days of an inspection or the time frame established by the department
			 pursuant to K.A.R. 28-19-729f(c).
(2) The owner or operator of the small rural
			 HMIWI shall submit an annual report, signed by the facility manager, containing
			 information recorded in accordance with paragraph (b)(1) of this regulation no
			 later than March 1 following the calendar year in which data were collected.
(3) The owner or operator shall
			 send subsequent annual reports no later than 12 calendar months following the
			 previous report.
(4) Once the unit
			 is subject to the department's class I air operating permit program, the owner
			 or operator shall submit these reports semiannually.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 19 - AMBIENT AIR QUALITY STANDARDS AND AIR POLLUTION CONTROL › Section 28-19-735 - National emission standards for hazardous air pollutants

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) 40 C.F.R. part
			 61 and its appendices, as in effect on July 1, 2010, are adopted by reference
			 except for the following:
(1) The following
			 sections in subpart A:
(A) 61.04;
(B) 61.16; and
(C) 61.17;
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 19 - AMBIENT AIR QUALITY STANDARDS AND AIR POLLUTION CONTROL › Section 28-19-750 - Hazardous air pollutants; maximum achievable control technology

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) 40 C.F.R. part
			 63 and its appendices, as in effect on July 1, 2010, are adopted by reference,
			 except for the following:
(1) The following
			 sections in subpart A:
(A) 63.6(f)(1), (g),
			 (h)(1), and (h)(9);
(B)
			 63.7(e)(2)(ii) and (f);
(C)
			 63.8(f);
(D) 63.10(f);
(E) 63.12;
(F) 63.13;
(G) in 63.14(b)(27), the phrase "and table 5
			 to subpart DDDDD of this part";
(H)
			 63.14(b)(35), (39) through (53), and (55) through (62);
(I) in 63.14(i)(1), the phrase "table 5 to
			 subpart DDDDD of this part"; and
(J) 63.15;
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 19 - AMBIENT AIR QUALITY STANDARDS AND AIR POLLUTION CONTROL › Section 28-19-750a - Consolidated federal air regulations; synthetic organic chemical manufacturing industry

Current through Register Vol. 43, No. 28,
			 July 11, 2024
(a) 40
			 C.F.R. part 65 and its appendices, as in effect on July 1, 2010, are adopted by
			 reference except for the following sections in subpart A:
(1) 65.9;
(2) 65.10; and
(3) 65.14.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 19 - AMBIENT AIR QUALITY STANDARDS AND AIR POLLUTION CONTROL › Section 28-19-752a - Hazardous air pollutants; limitations applicable to construction of new major sources or reconstruction of existing major sources

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) Applicability.
(1) For the purpose of this regulation,
			 40 C.F.R. §
										63.40, as in effect as of July 1, 1997 is
			 adopted by reference.
(2) Except
			 as otherwise provided by 40
			 C.F.R. §
										63.40(c), (e), and
			 (f), this regulation shall apply to the owner
			 or operator of each proposed new major source of hazardous air pollutants
			 (HAPs) and the owner or operator of each existing major source of hazardous air
			 pollutants for which reconstruction is proposed.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 19 - AMBIENT AIR QUALITY STANDARDS AND AIR POLLUTION CONTROL › Section 28-19-753 - Hazardous air pollutants; limitations applicable to sources for which the USEPA fails to meet certain deadlines

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) This regulation
			 shall be applicable to a source only if the USEPA fails to promulgate an
			 emission standard for the category or subcategory applicable to the source
			 within the time-frame scheduled by the USEPA at 58 FR 63941, December 3, 1993.
(b) Within 18 months after the
			 date the emission limitation was to be promulgated by the USEPA, the owner or
			 operator of a major source to which the emission limitation would apply, shall
			 file with the department an application to modify the operating permit of the
			 major source. As part of the application to modify the operating permit, the
			 owner or operator shall:
(1) determine the
			 applicable emission limitation for the source pursuant to subsection (c) of
			 this regulation;
(2) specify how
			 the applicable emission limitation was determined;
(3) specify the manner in which the emissions
			 unit or stationary source will meet the applicable emission limitation; and
(4) commit to test methods and
			 procedures to demonstrate compliance with the applicable emission limitation.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 19 - AMBIENT AIR QUALITY STANDARDS AND AIR POLLUTION CONTROL › Section 28-19-800 - General conformity of federal actions

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) 40 CFR part 93,
			 subpart B, as promulgated on November 30, 1993, is adopted by reference, except
			 for 40 CFR
			 93.151 and
			 40 CFR
			 93.160(f) which are deleted.
(b) Unless the context clearly
			 indicates otherwise:
(1) the term "state"
			 shall mean the state of Kansas; and
(2) the terms "applicable implementation
			 plan" or "applicable SIP" shall refer to the Kansas state air implementation
			 plan.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 19 - AMBIENT AIR QUALITY STANDARDS AND AIR POLLUTION CONTROL › Section 28-19-801 - Transportation conformity

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) The provisions
			 of this regulation shall apply:
(1) to areas
			 of the state which have been identified as not meeting the national primary
			 ambient air quality standard for ozone in the manner prescribed by the
			 provisions of section 107(d) of the federal clean air act, 42 U.S.C. §
			 7407, as promulgated at 40 CFR part 81, as in effect July 1, 1986 and amended
			 at 51 Fed. Reg. 25,202, July 11, 1986; and
(2) with respect to emissions of ozone
			 precursors.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 21 - FOOD, DRUGS AND COSMETICS › Section 28-21-200 - Drugs; name

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) The name by
			 which a drug is designated shall be clearly distinguishing and differentiating
			 from any name recognized in an official compendium unless such drug complies in
			 identity with the identity prescribed in an official compendium under such
			 recognized name.
(b) The term
			 "drug defined in an official compendium" means a drug having the identity
			 prescribed for a drug in an official compendium.
(c) A statement that a drug defined in an
			 official compendium differs in strength, quality, or purity from the standard
			 of strength, quality, or purity set forth for such drug in an official
			 compendium shall show all the respects in which such drug so differs, and the
			 extent of each such difference.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 21 - FOOD, DRUGS AND COSMETICS › Section 28-21-201 - Drugs and devices; labeling, misbranding

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) Among
			 representations in the labeling of a drug or device which render such drug or
			 device misbranded is a false or misleading representation with respect to
			 another drug or device or a food or cosmetic.
(b) The labeling of a drug which contains two
			 or more ingredients may be misleading by reason (among other reasons) of the
			 designation of such drug in such labeling by a name which includes or suggests
			 the name of one or more but not all such ingredients, even though the names of
			 all such ingredients are stated elsewhere in the labeling.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 21 - FOOD, DRUGS AND COSMETICS › Section 28-21-202 - Drugs and devices; labeling requirements

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) If a drug or
			 device is not manufactured by the person whose name appears on the label, the
			 name shall be qualified by a phrase which reveals the connection such person
			 has with such drug or device, such as "manufactured for and packed by _____,"
			 "distributed by _____,"
or other similar phrase which expresses the facts.
(b) The statement of the
			 place of business shall include the street address, if any, of such place,
			 unless such street address is shown in a current city directory or telephone
			 directory.
(c) Where a person
			 manufactures, packs, or distributes a drug or device at a place other than his
			 principal place of business, the label may state the principal place of
			 business in lieu of the actual place where each package of such drug or device
			 was manufactured or packed or is to be distributed, if such statement is not
			 misleading in any particular.
(d)
			 The requirement that the label shall contain the name and place of business of
			 the manufacturer, packer, or distributor shall not be considered to relieve any
			 drug or device from the requirement that its label shall not be misleading in
			 any particular.
(e)
(1) The statement of the quantity of the
			 contents of a package of a drug shall reveal the quantity of such drug in the
			 package, exclusive of wrappers and other material packed with such drug.
(2) The statement shall be
			 expressed in the terms of weight, measure, numerical count, or a combination of
			 numerical count and weight or measure, which are generally used by consumers
			 and users of such drug to express quantity thereof and which give accurate
			 information as to such quantity. But if no general usage in expressing accurate
			 information as to the quantity of such drug exists among consumers and users
			 thereof, the statement of the quantity of a drug which is not in tablet,
			 capsule, ampule, or other unit form shall be in terms of weight if the drug is
			 solid, semisolid, or viscous, or in terms of measure if the drug is liquid; the
			 statement of the quantity of a drug which is in such unit form shall be in
			 terms of the numerical count of such units, supplemented, when necessary to
			 give accurate information as to the quantity of such drug in the package, by
			 such statement (in such terms, manner, and form as are not misleading) of the
			 weight or measure of such units, or of the quantity of each active ingredient
			 in each such unit, as will give such information.
(3) The statement of the quantity of a device
			 shall be expressed in terms of numerical count.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 21 - FOOD, DRUGS AND COSMETICS › Section 28-21-203 - Drugs and devices; forms of making required statements

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) A word,
			 statement, or other information required by or under authority of the act to
			 appear on the label may lack that prominence and conspicuousness required by
			 K.S.A.
			 65-669(c) by reason (among
			 other reasons) of:
(1) The failure of such
			 word, statement, or information to appear on the part or panel of the label
			 which is presented or displayed under customary conditions of purchase;
(2) The failure of such word,
			 statement, or information to appear on two or more parts or panels of the
			 label, each of which has sufficient space therefor, and each of which is so
			 designed as to render it likely to be, under customary conditions of purchase,
			 the part or panel displayed;
(3)
			 The failure of the label to extend over the area of the container or package
			 available for such extension, so as to provide sufficient label space for the
			 prominent placing of such word, statement, or information;
(4) Insufficiency of label space (for the
			 prominent placing of such word, statement, or information) resulting from the
			 use of label space for any word, statement, design, or device which is not
			 required by or under authority of the act to appear on the label;
(5) Insufficiency of label space (for the
			 prominent placing of such word, statement, or information) resulting from the
			 use of label space to give materially greater conspicuousness to any other
			 word, statement, or information, or to any design or device; or
(6) Smallness or style of type in which such
			 word, statement, or information appears, insufficient background contrast
			 obscuring designs or vignettes, or crowding with other written, printed, or
			 graphic matter.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 21 - FOOD, DRUGS AND COSMETICS › Section 28-21-204 - Habit-forming drugs; label requirements

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a)
(1) The name of a substance or derivative
			 required to be borne on the label of a drug by
			 K.S.A.
			 65-669(d) shall be the
			 common or usual name of such substance or derivative, unless it is designated
			 solely by a name recognized in an official compendium and such designation
			 complies with the provisions of
			 K.S.A.
			 65-669(c).
(2) A statement on the label of a drug of the
			 name of a constituent, which constituent is a chemical derivative of a
			 substance named in
			 K.S.A.
			 65-669(d), shall show the
			 substance from which such constituent is derived and that such constituent is a
			 derivative thereof.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 21 - FOOD, DRUGS AND COSMETICS › Section 28-21-205 - Drugs; statement of ingredients and proportion

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a)
(1) The name of an ingredient, substance,
			 derivative, or preparation required by
			 K.S.A.
			 65-669(e) (1) (ii) to be
			 borne on the label of a drug shall be the name thereof, which is listed in
			 K.S.A.
			 65-669(e) (1) (ii), or, if
			 not so listed, shall be a specific name and not a collective name. But if an
			 ingredient is an article the name of which is recognized in an official
			 compendium and such article complies with the specifications set forth therefor
			 in such compendium, such ingredient may be designated on the label of such drug
			 by the common or usual name under which such specifications are so set forth.
(2) Where an ingredient contains a
			 substance the quantity or proportion of which is required by
			 K.S.A.
			 65-669(e) (1) (ii) to appear
			 on the label, and such ingredient is not a derivative or preparation of such
			 substance as defined in paragraph (b) (1) of this section, the label shall
			 bear, in conjunction with the name of the ingredient, a statement of the
			 quantity or proportion of such substance in such drug.
(3) An abbreviation or chemical formula shall
			 not be considered to be a common or usual name. The name "acetophenetidin"
			 shall be considered to be the same as the name "acetphenetidin," "aminopyrine"
			 the same as "amidopyrine." The name "alcohol" without qualification, means
			 ethyl alcohol.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 21 - FOOD, DRUGS AND COSMETICS › Section 28-21-206 - Drugs and devices; directions for use

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) Adequate
			 directions for use. "Adequate directions for use" means directions under which
			 the layman can use a drug or device safely and for the purposes for which it is
			 intended. Directions for use may be inadequate because (among other reasons) of
			 omission, in whole or in part, or incorrect specifications of:
(1) Statements of all conditions, purposes,
			 or uses for which such drug or device is intended, including conditions,
			 purposes, or uses for which it is prescribed, recommended, or suggested in its
			 oral, written, printed, or graphic advertising, and conditions, purposes, or
			 uses for which the drug or device is commonly used; except that such statements
			 shall not refer to conditions, uses, or purposes for which the drug or device
			 can be safely used only under the supervision of a practitioner licensed by law
			 and for which it is advertised solely to such practitioner.
(2) Quantity of dose (including usual
			 quantities for each of the uses for which it is intended and usual quantities
			 for persons of different ages and different physical conditions).
(3) Frequency of administration or
			 application.
(4) Duration of
			 administration or application.
(5)
			 Time of administration or application (in relation to time of meals, time of
			 onset of symptoms, or other time factors).
(6) Route or method of administration or
			 application.
(7) Preparation for
			 use (shaking, dilution, adjustment of temperature, or other manipulation or
			 process).
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 21 - FOOD, DRUGS AND COSMETICS › Section 28-21-251 - Manufacturing practice

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) The criteria in
			 each section of this regulation shall apply in determining whether the methods
			 used in, or the facilities or controls used for, the manufacture, processing,
			 packing, or holding of the product conform to or are operated or administered
			 in conformity with current good manufacturing practice to assure that the
			 product meets the requirements as to safety and has the identity and strength
			 and meets the quality and purity characteristics which it purports or is
			 represented to possess.
(b) The
			 regulations in this part permit the use of precision automatic, mechanical, or
			 electronic equipment in the production and control of amygdalin (laetrile) when
			 adequate inspection and checking procedures are used to assure proper
			 performance.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 21 - FOOD, DRUGS AND COSMETICS › Section 28-21-252 - Personnel

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) The personnel
			 responsible for directing the manufacture and control of amygdalin (laetrile)
			 shall be adequate in number and background of education, training and
			 experience, or combination thereof, to assure that the product has the safety,
			 identity, strength, quality, and purity that it purports to possess. All
			 personnel shall have capabilities commensurate with their assigned functions, a
			 thorough understanding of the manufacturing or control operations they perform,
			 the necessary training or experience, and adequate information concerning the
			 reason for application of pertinent provisions of this part to their respective
			 functions.
(b) Any person shown at
			 any time (either by medical examination or supervisory observation) to have an
			 apparent illness or open lesions that may adversely affect the safety or
			 quality of the product shall be excluded from direct contact with the product
			 until the condition is corrected. All employees shall be instructed to report
			 to supervisory personnel any condition that may have such an adverse effect on
			 the product.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 21 - FOOD, DRUGS AND COSMETICS › Section 28-21-253 - Buildings or facilities

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) Buildings shall
			 be maintained in a clean and orderly manner and shall be of suitable size,
			 construction, and location to facilitate adequate cleaning, maintenance, and
			 proper operations in the manufacturing, processing, packing, labeling, or
			 holding of amygdalin (laetrile). The buildings shall:
(1) Provide adequate space for:
(A) Orderly placement of equipment and
			 materials to minimize any risk of mixups between different drugs, drug
			 components, in-process materials, packaging materials, or labeling, and to
			 minimize the possibility of contamination.
(B) The receipt, storage, and withholding
			 from use of components pending sampling, identification, and testing prior to
			 release by the materials approval unit for manufacturing or packaging.
(C) The holdings of rejected
			 components prior to disposition to preclude the possibility of their use in
			 manufacturing or packaging procedures for which they are unsuitable.
(D) The storage of components, containers,
			 packaging materials, and labeling.
(E) Any manufacturing and processing
			 operations performed.
(F) Any
			 packaging or labeling operations.
(G) Storage of finished products.
(H) Control and production-laboratory
			 operations.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 21 - FOOD, DRUGS AND COSMETICS › Section 28-21-254 - Equipment

Current through Register Vol. 43, No. 28, July 11,
			 2024
(a) Equipment used
			 for the manufacture, processing, packing, labeling, holding, testing, or
			 control of amygdalin (laetrile) shall be maintained in a clean and orderly
			 manner and shall be of suitable design, size, construction, and location to
			 facilitate cleaning, maintenance, and operation for its intended purpose. The
			 equipment shall:
(1) Be so constructed that
			 all surfaces that come into contact with the product shall not be reactive,
			 additive, or absorptive so as to alter the safety, identity, strength, quality,
			 or purity of amygdalin (laetrile) or its components beyond the official or
			 other established requirements.
(2) Be so constructed that any substances
			 required for operation of the equipment, such as lubricants or coolants, do not
			 contact the product so as to alter the safety, identity, strength, quality, or
			 purity of the substance or its components beyond the official or other
			 established requirements.
(3) Be
			 constructed and installed to facilitate adjustment, disassembly, cleaning and
			 maintenance to assure the reliability of control procedures, uniformity of
			 production, and exclusion from the product of contaminants from previous and
			 current operations that might affect the safety, identity, strength, quality,
			 or purity of amygdalin (laetrile) beyond the official or other established
			 requirements.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 21 - FOOD, DRUGS AND COSMETICS › Section 28-21-257 - Product containers and their packaging materials

Current through Register Vol. 43, No. 28, July 11,
			 2024
Suitable specifications, test methods, cleaning procedures,
				and, when indicated, sterilization procedures shall be used to assure that
				containers, closures, and other component parts of packages are suitable for
				their intended use. Product containers for amygdalin (laetrile) shall be
				cleansed with water which has been filtered through a non-fiber-releasing
				filter. Product containers and their components shall not be reactive,
				additive, or absorptive so as to alter the safety, identity, strength, quality,
				or purity of the product or its components beyond the official or established
				requirements and shall provide adequate protection against external factors
				that can cause deterioration or contamination of the product.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 21 - FOOD, DRUGS AND COSMETICS › Section 28-21-258 - Laboratory controls

Current through Register Vol. 43, No. 28, July 11,
			 2024
Laboratory controls shall include the establishment of
				scientifically sound and appropriate specifications, standards, and test
				procedures to assure that components, in-processed drugs, and finished products
				conform to appropriate standards of identity, strength, quality and purity.
				Laboratory controls shall include:
(1) The establishment of master records
			 containing appropriate specifications for the acceptance of each lot of the
			 components, product containers, and their components used in the production and
			 packaging and description of the sampling and testing procedures used for them.
			 Said samples shall be representative and adequately identified. Such record
			 shall also provide for appropriate retesting of the components, product
			 containers, and their components subject to deterioration.
(2) A reserve sample of all active
			 ingredients is required.
(3) The
			 establishment of master records, when needed, containing specifications and a
			 description of sampling and testing procedures for in-process amygdalin
			 (laetrile) preparations. Such samples shall be adequately representative and
			 properly identified.
(4) The
			 establishment of master records containing a description of sampling procedures
			 and appropriate specifications for finished products. Such shall be adequately
			 representative and properly identified.
(5) Adequate provisions for checking the
			 identity and strength of amygdalin (laetrile) for all active ingredients and
			 for assuring:
(A) Sterility of amygdalin
			 (laetrile) purported to be sterile and freedom from objectionable
			 micro-organisms for those products which should be so by virtue of their
			 intended use.
(B) The absence of
			 pyrogens for those products purporting to be pyrogen-free.
(C) That the release pattern of sustained
			 release products is tested by laboratory methods to assure conformance to the
			 release specifications.
Kansas Administrative Regulations › Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT › Article 21 - FOOD, DRUGS AND COSMETICS › Section 28-21-259 - Stability

Current through Register Vol. 43, No. 28, July 11,
			 2024
There shall be assurance of the stability of finished amygdalin
				(laetrile) products. This stability shall be:
(1) Determined by reliable, meaningful, and
			 specific test methods.
(2)
			 Determined on products in the same container-closure system in which they are
			 marketed.
(3) Determined on any
			 dry drug product that is to be reconstituted at the time of dispensing (as
			 directed in its labeling), as well as on the reconstituted product.
(4) Recorded and maintained in such manner
			 that the stability data may be utilized in establishing product expiration
			 dates.