RULE 102.	DEFINITIONS
		(Adopted 10/18/1971, revised 1/12/1976, readopted 10/23/1978, revised 7/11/1989, 7/10/1990, 7/30/1991, 7/18/1996, 4/17/1997, 1/21/1999, 5/20/1999, 6/19/2003, 1/20/2005, 6/19/2008, 1/15/2009, 9/20/2010, 1/20/2011, 3/17/2011, 6/21/2012, and 8/25/2016)

These definitions apply to the entire rulebook. Definitions specific to a given rule are defined in that rule or in the first rule of the relevant regulation. Except as otherwise specifically provided in these Rules where the context otherwise indicates, words used in these Rules are used in exactly the same sense as the same words are used in Division 26 of the Health and Safety Code.

    "Actual Emission Reductions" means a reduction of actual emissions from the stationary source selected for emission offsets, from a baseline which is representative of normal operations approved by the Air Pollution Control Officer. This baseline shall be determined in accordance with Rule 804.E.

    "Aerosol Product" means a hand-held, non-refillable container that expels pressurized product by means of a propellant-induced force.

    "Affected Pollutants" means all pollutants for which an ambient air quality standard has been established by the Environmental Protection Agency or the Air Resources Board and the precursors to such pollutants, all pollutants regulated by the Environmental Protection Agency under the Clean Air Act or by the Air Resources Board under the Health and Safety Code, including but not limited to: reactive organic compounds, nitrogen oxides, sulfur oxides, PM10, PM2.5, carbon monoxide, total suspended particulates, ethylene, lead, asbestos, beryllium, mercury, vinyl chloride, fluorides, sulfuric acid mist, hydrogen sulfide, total reduced sulfur, and reduced sulfur compounds. Also, all of the pollutants which the Environmental Protection Agency after notice and opportunity for public comment, or the Air Resources Board, or the District after public hearing, determine may have a significant adverse effect on the environment, the public health, or the public welfare.

    "Agricultural Burning" means "agricultural burning" as defined in Health and Safety Code Section 39011.

    "Agricultural Operations" means the growing and harvesting of crops or raising of fowl or animals for the primary purpose of making a profit, providing a livelihood, or conducting agricultural research or instruction by an educational institution. Agricultural operations do not include the processing or distribution of crops or fowl.

    "Air Contaminant" includes, but is not limited to, smoke, charred paper, dust soot, grime, carbon, noxious acids, fumes, gases, odors, or particulate matter, or any combination thereof.

    "Air Pollutant" means "Affected Pollutant" as defined in this rule.

    "Air Quality Impact Analysis" means the use of an air quality simulation model, based on specified assumptions and data, to predict the maximum impact of the pollutant in areas over land and water accessible to the public.

    "Air Quality Increment" means an increment of allowable air quality degradation, beyond the baseline air quality level.

    "Air Quality Related Value" means a feature or property of an area that is affected in some way by the air pollution in issue. Identified values are visibility, odor, flora, fauna, soil, water, geologic features and cultural resources.

    "Alternative Diesel Fuel" means any fuel used in a compression ignition engine that is not commonly or commercially known, sold, or represented by the supplier as diesel fuel No. 1-D or No. 2-D, pursuant to the specifications in ASTM D 975, "Standard Specification for Diesel Fuel Oils," ASTM International, or an alternative fuel, and does not require engine or fuel system modifications for the engine to operate, although minor modifications (e.g., recalibration of the engine fuel control) may enhance performance. Examples of alternative diesel fuels include, but are not limited to, biodiesel; Fischer-Tropsch fuels; emulsions of water in diesel fuel; and fuels with a fuel additive, unless:

       1.	the additive is supplied to the engine fuel by an on-board dosing mechanism, or
       2.	the additive is directly mixed into the base fuel inside the fuel tank of the engine, or
       3.	the additive and base fuel are not mixed until engine fueling commences, and no more additive plus base fuel combination is mixed than required for a single fueling of a single engine.

    "Ambient Air Quality Standards" means those standards set by the State or Federal governments. For the purpose of rules submitted to the Environmental Protection Agency for inclusion in the State Implementation Plan, all references to "ambient air quality standards" shall be interpreted as national ambient air quality standards.

    "Application Equipment" means a device or equipment used to apply solvent, sealant, adhesive, coating, ink, or polyester resin materials.

    "ASTM" means American Society for Testing and Materials. In 2001, the American Society for Testing and Materials officially changed its name to "ASTM International."

    "Atmosphere" means the air that envelopes or surrounds the earth. Where air pollutants are emitted into a building not designed specifically as a piece of air pollution control equipment, such emission into the building shall be considered an emission into the atmosphere.

    "Attainment Pollutant" means any affected pollutant which is not a nonattainment pollutant. For the purposes of this definition greenhouse gases are not attainment pollutants.

    "Authority to Construct" means a permit issued by the Control Officer for activities described in Rule 201.A.

    "Avionic Equipment" means any electronic system used on any aircraft, aerospace vehicle, satellite, or space vehicle.

    "Best Available Control Technology" means, for nonattainment pollutants, "Best Available Control Technology" as it is described in Section D.2 of Rule 802. For attainment pollutants, "Best Available Control Technology" is as described in Section D.3 of Rule 802, New Source Review.

    "Best Available Retrofit Control Technology" means "Best Available Retrofit Control Technology" as defined in Health and Safety Code Section 40406.

    "Board" means the Air Pollution Control Board of the Air Pollution Control District of Santa Barbara County.

    "Boundary Line" means, for source emission purposes, a separation such as a fence, abutment or device that restricts public entry to any given area containing a source of emissions by locked gate or attendant. If no boundary restriction exists, or if such boundary restriction includes habitations occupied or regularly used by humans, the boundary line shall be deemed to be such distance from a source of emissions as the evaluating officer deems appropriate for measurements to be best taken, but not closer than 100 feet from such source.

    "Burn Day" A "No Burn Day" means any day on which agricultural burning is prohibited by the Air Resources Board or the District. A "Permissive Burn Day" means any day on which agricultural burning is not prohibited by the Air Resources Board. The District may declare any Permissive Burn Day designated by the State Air Resources Board to be a No Burn Day if necessary to maintain suitable air quality.

    "California Coastal Waters" means that area between the California coastline and a line starting at the California-Oregon border at the Pacific Ocean,

	thence to 42.0 N	125.5 W
	thence to 41.0 N	125.5 W
	thence to 40.0 N	125.5 W
	thence to 39.0 N	125.0 W
	thence to 38.0 N	124.5 W
	thence to 37.0 N	123.5 W
	thence to 36.0 N	122.5 W
	thence to 35.0 N	121.5 W
	thence to 34.0 N	120.5 W
	thence to 33.0 N	119.5 W
	thence to 32.5 N	118.5 W
	and ending at the California-Mexico border at the Pacific Ocean.

    "Capture Efficiency" means the percentage by weight of affected pollutants delivered to a control device divided by the weight of total affected pollutants generated by the source.

    "Carbon Adsorber" means a bed of activated carbon into which an air-solvent gas-vapor stream is routed and which adsorbs the solvent on the carbon.

    "Catalytic Incinerator" means any device that burns reactive organic compounds or toxic air contaminants in air using a material that increases the rate of combustion without itself undergoing a net chemical change in the process. Common catalyst materials include but are not limited to, platinum alloys, chromium, copper oxide, and cobalt.

    "CFR" means the Code of Federal Regulations, an official compilation of federal regulations generated by federal administrative agencies.

    "Class I Area" means any area having air quality or air quality related values requiring special protection, and which has been designated Class I by a federal or state authority empowered to make such designation.

    "Class I Impact Area" means all lands outside of a Class I area but within a 10 kilometer (6.2 miles) distance beyond the boundary of a Class I area, or other areas established by the Control Officer based on standard meteorological techniques such as hourly wind roses, frequency distribution of atmospheric wind classes, morning and afternoon mixing depths and any other meteorological or geographical considerations needed to establish the Class I impact area.

    "Class II Area" means any area not designated as a Class I or Class III Area pursuant to 40 CFR 51.166(e)

    "Clean Air Act" means, unless otherwise indicated, the federal Clean Air Act as amended, 42 United States Code 7401, et seq.

    "Coating" means a material applied onto or impregnated into a substrate for protective, decorative, or functional purposes. Such materials include, but are not limited to, paints, varnishes, sealers, and stains.

    "Combustible Refuse" is any solid or liquid combustible waste material containing carbon in a free or combined state.

    "Combustion Contaminants" are particulate matter discharged into the atmosphere from the burning of any kind of material containing carbon in a free or combined state.

    "Compression Ignition Engine" means a type of reciprocating, internal combustion engine that is not a spark ignition engine.

    "Condensed Fumes" means minute solid particles generated by the condensation of vapors from solid matter after volatilization from the molten state, sublimation, distillation, calcination, or chemical reaction, when these processes create air-borne particles.

    "Construction" means any physical change or change in the method of operation (including fabrication, erection, installation, or modification of an emission unit) which would result in a change in actual emissions or the source's potential to emit.

    "Contiguous Property" means two or more parcels of land with a common boundary or point or separated solely by a public roadway or other public right of way.

    "Control Device" means any destruction and/or recovery equipment used to destroy or recover affected pollutant emissions generated by a regulated operation.

    "Control Device Efficiency" means the percentage of affected pollutants entering a control device that is not present in the exhaust to the atmosphere of that control device.

    "Control Officer" means the Air Pollution Control Officer of the Air Pollution Control District of Santa Barbara County.

    "Cured Adhesive, Cured Coating, or Cured Ink" means an adhesive, coating, or ink that is dry to the touch.

    "Days" means calendar days unless otherwise stated. Where any deadline prescribed by these Rules and Regulations falls on a weekend or state or federal holiday, the deadline shall be the first business day after the weekend or holiday.

    "Degreaser" means a "Solvent Cleaning Machine" as defined in this rule.

    "Derated" means any physical change to an emission unit to physically limit and restrict the equipment's power rating from the power rating specified by the manufacturer on the date of initial manufacture of the equipment.

    "Diesel Engine" means a type of internal combustion engine that uses low-volatility petroleum fuel and fuel injectors and initiates combustion using compression ignition (as opposed to spark ignition that is used with gasoline engines).

    "District" means the Santa Barbara County Air Pollution Control District unless otherwise specifically indicated.

    "Dual-Fuel Engine" means any compression ignition engine that is engineered and designed to operate on a combination of alternative fuels, such as compressed natural gas (CNG) or liquefied petroleum gas (LPG) and diesel fuel or an alternative diesel fuel. These engines have two separate fuel systems, which inject both fuels simultaneously into the engine combustion chamber.

    "Dusts" are minute solid particles released into the air by natural forces or by mechanical process such as crushing, grinding, milling, drilling, demolishing, shoveling, conveying, covering, bagging, sweeping, etc.

    "Effective Stack Height" means the height equal to the lesser of 1) 30 meters, or 2) H + 1.5 L, where H is the height of, and L is the lesser dimension (height or width) of, the source, or nearby structure, or, 3) such other height as is demonstrated to ensure that emissions do not result in excessive pollutant concentrations in the immediate vicinity of the source as a result of atmospheric downwash, eddies, or wakes which may be created by the source, nearby structures or terrain.

    "Electronic Components" means the portions of an assembly, including, but not limited to: circuit card assemblies, printed wire assemblies, printed circuit boards, soldered joints, ground wires, bus bars, magnetic tapes and tape drive mechanisms, discs and disc drive mechanisms, electro-optical devices (e.g., optical filters, sensor assemblies, infrared sensors, charged coupled devices, thermal electric coolers, and vacuum assemblies), solid state components, semiconductors (e.g., diodes, zeners, stacks, rectifiers, integrated microcircuits, transistors, solar cells, light sensing devices, and light-emitting devices), and other electrical fixtures, except for the actual cabinet in which the components are housed.

    "Electrostatic Spray" means any method of applying a spray coating in which an electrical charge is applied to the coating and the substrate is grounded. The coating is attracted to the substrate by the electrostatic potential between them.

    "Emission Reduction Credit" means an actual emission reduction of specific type and quantity that is registered with the District in accordance with Rule 806, Emission Reduction Credits.

    "Emission Reduction Credit Certificate" means a document that represents emission reduction credits registered in the Source Register, is transferable, is initially issued by the District to a source that qualifies its actual emission reductions for registration in the Source Register by meeting the requirements of Rule 806, Emission Reduction Credits.

    "Emission Unit" means any identifiable piece of equipment or activity that is part of a stationary source which emits or would have the potential to emit any affected pollutant.

    "Enclosed Cleaning System" means any application equipment cleaner (e.g., an enclosed gun washer) that totally encloses spray guns, cups, nozzles, bowls, and other parts during solvent washing, rinsing, and draining procedures. An enclosed cleaning system for cleaning application equipment is not a solvent cleaning machine.

    "Exempt Compound" means any compound listed as an exempt compound in the definition of "Reactive Organic Compound." Tertiary-butyl acetate (also known as t-butyl acetate or tBAc) shall be considered exempt as a reactive organic compound only for purposes of reactive organic compound emissions limitations or reactive organic compound content requirements and shall be considered a reactive organic compound for purposes of all recordkeeping, emissions reporting, photochemical dispersion modeling, and inventory requirements which apply to reactive organic compounds.

    "Federally Enforceable" means all limitations and conditions which are enforceable by the Administrator of the Environmental Protection Agency.

    "Flexographic Printing" means any printing method in which the image area is raised relative to the non-image area and utilizes flexible rubber or other elastomeric plate and rapid drying liquid inks.

    "Fluid System" means a power transmission system that uses the force of flowing liquids and gases to transmit power. Fluid systems include hydraulic systems and pneumatic systems.

    "Fluorinated Gases" means a compound that contains fluorine and exists in a gaseous state at 25 degrees Celsius and 1 atmosphere of pressure. Fluorinated gases include, but are not limited to:

       1.	hexafluoroethane (C2F6), (CFC-116),
       2.	octafluoropropane (C3F8), (PFC 218),
       3.	octafluorocyclopentene (C5F8), (PFC C-1418),
       4.	tetrafluoromethane (CF4), (CFC-14),
       5.	trifluoromethane (CHF3), (HFC-23),
       6.	difluoromethane (CH2F2), (HFC-32),
       7.	octafluorocyclobutane (c-C4F8), (RC 318),
       8.	octafluorotetrahydrofuran (C4F8O),
       9.	hexafluoro-1,3-butadiene (C4F6),
       10.	carbon fluoride oxide (COF2),
       11.	nitrogen trifluoride (NF3), and
       12.	sulfur hexafluoride (SF6).

    "Forest Management Burning" means the use of open fires, as part of forest management practice, to remove forest debris. Forest management practices include timber operations, silvicultural practices and forest protection practices.

    "Fuel" means any substance that is burned, combusted, or incinerated in an engine, boiler, heater, burner, steam generator, process heater, flare, thermal oxidizer, or any other combustion unit, and which includes, but is not limited to, gasoline, natural gas, field gas, produced gas, waste gas, methane, digester gas, landfill gas, contaminated soil/water cleanup gaseous effluent, ethane, propane, butane, liquefied petroleum gas (LPG), jet propellants, diesel fuels, and distillate fuels.

    "Fuel Additive" means any substance designed to be added to fuel or fuel systems or other engine-related engine systems such that it is present in-cylinder during combustion and has any of the following effects: decreased emissions, improved fuel economy, increased performance of the engine; or assists diesel emission control strategies in decreasing emissions, or improving fuel economy or increasing performance of the engine.

    "Fugitive Emission" means an emission which could not reasonably pass into the atmosphere through a stack, chimney, vent or other functionally equivalent opening.

    "Gasoline" means any organic liquid (including petroleum distillates and methanol) having a Reid vapor pressure, as measured using California Code of Regulations, Title 13, Division 3, Chapter 5, Article 4, section 2297, "Test Method for the Determination of the Reid Vapor Pressure Equivalent Using an Automated Vapor Pressure Test Instrument," of 4.0 pounds per square inch or greater and used as a motor vehicle fuel or any fuel which is commonly or commercially known or sold as gasoline, including aviation gasoline.

    "Grams of Reactive Organic Compound Per Liter of Material" means the weight of reactive organic compound per volume of material and can be calculated by the following equation:

                                                                                Ws - Ww - We
            Grams of reactive organic compounds per liter of material    =
                                                                                Vm

            Where:		Ws	=	Weight of volatile compounds in grams
            		Ww 	= 	Weight of water in grams
            		We	=	Weight of exempt compounds in grams
            		Vm 	= 	Volume of material in liters

    "Greenhouse Gas" or "Greenhouse Gases" means "Greenhouse gas" or "greenhouse gases" as defined in Health and Safety Code Section 38505(g).

    "Hazardous Air Pollutant" means any substance listed in or pursuant to Section 112(b) of the Clean Air Act.

    "Hearing Board" means the Hearing Board provided for in Section 40801 of the Health and Safety Code as appointed by the Air Pollution Control Board of Santa Barbara County.

    "High-Precision Optics" means any optical element used in an electro-optical device that is designed to sense, detect, or transmit light energy, including specific wavelengths of light energy and changes in light energy levels.

    "Higher Heating Value" means the total heat liberated per mass of fuel burned (British thermal unit per pound), when fuel and dry air at standard conditions undergo complete combustion and all resulting products are brought to their standard states at standard conditions. "Gross heating value" shall have the same meaning as "higher heating value."

    "Internal Combustion Engine" means an engine in which both the heat energy and the ensuing mechanical energy are produced inside the engine. Internal combustion engines include gas turbines, spark ignition, and compression ignition engines.

    "Janitorial Cleaning" means the cleaning of building or facility components including, but not limited to, floors, ceilings, walls, windows, doors, stairs, bathrooms, furnishings, and exterior surfaces of office equipment; excluding the cleaning of work areas associated with:

       1.	 research and development, manufacturing, and repair activities; and

       2. 	laboratory tests and analyses (including quality assurance and quality control activities) and bench scale projects.

    "Large Source" means any stationary source that does not meet the criteria of a Small Source or a Medium Source as determined by the Control Officer:

    "Major Modified Stationary Source" means a modification at an existing major source which:
      1. 	will have emission increases greater than significance levels promulgated in 40 CFR 51.165 and 40 CFR 52.21, or
      2. 	is located within 10 kilometers of a Class I area and the modification causes an impact greater than or equal to 1 microgram per cubic meter on that Class I area .

    "Major Stationary Source" means a stationary source of air pollutants which emits or has the potential to emit one hundred tons per year or more of any pollutant.

    "Medium Source" means any stationary source that is not a Small Source and where:
       1. 	The Permitted Emissions for the stationary source will be less than all of the values listed below:
                  Reactive Organic Compounds		10.0 tons/year,
                  Oxides of Nitrogen (as NO2)		10.0 tons/year,
                  Particulate Matter less than 10 microns	10.0 tons/year
                  Total Suspended Particulate Matter		10.0 tons/year
                  Sulfur Oxides (as SO2)			10.0 tons/year,
                  Carbon Monoxide 			25.0 tons/year
                  and
       2.	The proposed source does not trigger any toxics review requirements, Negative Declaration or Environmental Impact Report where the District is the lead agency pursuant to CEQA, federal NSPS or NESHAPS, federal operating permit program requirements (with the exception of General Permits) and is not located within 1,000 feet of the outer boundary of a school site.

    "Modification" means any physical change in, or any change in method of operation of, or addition to an existing stationary source or any change in hours of operation or production rate which would necessitate a change in permit conditions, except that routine maintenance or repair shall not be considered a physical change. Unless previously limited by federally enforceable permit condition, the following shall not be considered changes in method of operation:

      1.	An increase in the production rate or hours of operation if such increase does not exceed the operating design capacity or the actual demonstrated capacity of the stationary source as approved by the Control Officer.
      2.	A change in operator or ownership of a source.
      3.	Use of an alternate fuel or raw material, provided that such use is expressly authorized on the Permit to Operate.

      A reconstructed source shall be treated as a new stationary source.

    "Multiple-Chamber Incinerator" is any article, machine, equipment, contrivance, structure or part of a structure, used to dispose of combustible refuse by burning, consisting of three or more refractory lined combustion furnaces in series, physically separated by refractory walls, interconnected by gas passage ports or ducts and employing adequate design parameters necessary for maximum combustion of the material to be burned. The refractories shall have a Pyrometric Cone equivalent of at least 17, tested according to the method described in the American Society for Testing Materials, Method C-24.

    "Natural Draft Opening" means any opening in a room, building, or total enclosure that remains open during operation of the facility and that is not connected to a duct in which a fan is installed. The rate and direction of the natural draft through such an opening is a consequence of the difference in pressures on either side of the wall containing the opening.

    "Natural Gas" means gas which meets General Order 58-A of the Public Utilities Commission.

    "New Source" means any stationary source, which will emit any air contaminant not previously emitted at that location.

    "Nonattainment Pollutant" means any pollutant as well as precursors of such pollutants that have been designated "nonattainment" by the U.S. Environmental Protection Agency or that have been designated "nonattainment" by the California Air Resources Board for Santa Barbara County.

    "Open Burning in Agricultural Operations" in the growing of crops or raising of fowl or animals means:
        1.	The burning in the open of materials produced wholly from operations in the growing and harvesting of crops or raising of fowl or animals for the primary purpose of making a profit, or providing of livelihood, or of conducting agricultural research or instruction by an educational institution and
        2.	In connection with operations qualifying under Subdivision 1:
			a.	The burning of grass and weeds in or adjacent to fields in cultivation or being prepared for cultivation; and
			b.	The burning of material not produced wholly from such operations, but which are intimately related to the growing or harvesting of crops and which are used in the field, such as fertilizer and pesticide sacks or containers, where the sacks or containers are emptied and burned in the field.

    "Operating Parameter Value" means any minimum or maximum value established for a control equipment or process parameter which, if achieved by itself or in combination with one or more other operating parameter values, determines that an owner or operator has continued to comply with an applicable emission limitation.

    "Organic Materials" are defined as chemical compounds of carbon excluding carbon monoxide, carbon dioxide, carbonic acid, metallic carbides, metallic carbonates and ammonium carbonate.

    "Organic Solvents" means organic materials, including diluents and thinners which are liquid at standard conditions and which are used as, dissolvers, viscosity reducers or cleaning agents, except that such materials which exhibit a boiling point, as measured using ASTM D 1078-05, "Standard Test Method for Distillation Range of Volatile Organic Liquids," ASTM International, higher than 220F at 0.5 millimeter mercury absolute pressure or having an equivalent vapor pressure shall not be considered to be organic solvents unless exposed to temperatures exceeding 220F.

    "Outer Continental Shelf Source" means "Outer Continental Shelf Source" as defined by Section 2 of the Outer Continental Shelf Lands (43 U.S.C. Section 1331, et seq).

    "Overall Efficiency" means the emission reduction, expressed as a percentage that results from the combined effect of capture and control of affected pollutants (capture efficiency multiplied by control efficiency).

    "Particulate Matter" is any material, except uncombined water, which exists in a finely divided form as a liquid or solid at standard conditions.

     "Permit to Operate" means the written permission, with any specified conditions required, that must be obtained from the Control Officer before any article, machine, equipment or other contrivance, the use of which may cause, increase, eliminate, reduce, or control the issuance of air contaminants before it may be operated or used.

    "Person" means any person, firm, association, organization, partnership, business trust, corporation, company, contractor, supplier, installer, user, or owner, or any federal, state or local governmental agency, or public district or any officer or employee thereof.

    "PM10" means Particulate Matter with aerodynamic diameter smaller than or equal to 10 microns. Gaseous emissions which condense to form PM10 shall also be counted as PM10.

    "PM2.5" means Particulate Matter with aerodynamic diameter smaller than or equal to 2.5 microns. Gaseous emissions which condense to form PM2.5 shall also be counted as PM2.5.

    "Photochemically Reactive Solvent" means any organic solvent with an aggregate of more than 20 percent of its total volume composed of the chemical compounds classified below or which exceeds any of the following individual percentage composition limitations, referred to the total volume of organic solvent;
        1.	combination of hydrocarbons, alcohols, aldehydes, esters, ethers or ketones, having an olefinic or cyclolefinic type of unsaturation: 5 percent, or
        2.	combination of aromatic compounds with 8 or more carbon atoms to the molecule, except ethylbenzene: 8 percent, or
        3.	combination of ethylbenzene, ketones having branched hydrocarbon structures, trichloroethylene or toluene: 20 percent.
       Whenever any organic solvent or any constituent of an organic solvent may be classified from its chemical structure into more than one of the above groups of organic compounds, it shall be considered as a member of the most reactive chemical group, i.e., that group having the least allowable percent of the total volume of organic solvents.

    "Photoresist Coating" means any coating applied directly to a substrate to protect surface areas when chemical milling, etching, or other chemical surface operations are performed on the substrate.

    "Pollutant" means "Affected Pollutant" as defined in this rule.

    "Portable Internal Combustion Engine" means any internal combustion engine that is portable, meaning it is carried or moved from one location to another in the normal course of business. Indicia of portability shall include, but are not limited to, wheels, skids, carrying handles, dolly, trailer, vessel, or platform. "Portable internal combustion engine" does not include an engine used to propel nonroad equipment or a motor vehicle of any kind, including, but not limited to, a heavy duty vehicle. The engine is not portable if:

        1. 	the engine or its replacement is attached to a foundation, or if not so attached, will reside at the same location for more than 12 consecutive months. The period during which the engine is maintained at a storage facility shall be excluded from the residency time determination. Any engine, such as a back-up or stand-by engine, that replace engine(s) at a location, and is intended to perform the same or similar function as the engine(s) being replaced, will be included in calculating the consecutive time period. In that case, the cumulative time of all engine(s), including the time between the removal of the original engine(s) and installation of the replacement engine(s), will be counted toward the consecutive time period; or

        2. 	the engine remains or will reside at a location for less than 12 consecutive months if the engine is located at a seasonal source and operates during the full annual operating period of the seasonal source, where a seasonal source is a stationary source that remains in a single location on a permanent basis (at least two years) and that operates at that single location at least three months each year; or

        3. 	the engine is moved from one location to another in an attempt to circumvent the portable residence time requirements.

    "Potential to Emit" means the maximum capacity of the stationary source to emit a pollutant, including fugitive emissions, under its physical and operational design. Any physical or operational limitation on the capacity of the source to emit a pollutant, including air pollution control equipment and restrictions on hours of operation or on the type or amount of material combusted, stored, or processed, shall be treated as part of its design only if the limitation is legally and practically enforceable. Secondary emissions do not count in determining the potential to emit.

    "Precursor" means any directly emitted pollutant that, when released into the atmosphere, forms or causes to be formed or contributes to the formation of a secondary pollutant for which an ambient air quality standard has been adopted, or whose presence in the atmosphere will contribute to the violation of one or more ambient air quality standards. The following precursor/pollutant relationships shall be used for purposes of these Rules and Regulations:

Precursor
Secondary Pollutant
Reactive Organic Compounds

Ozone
The organic fraction of PM10
Oxides of Nitrogen

Ozone
Nitrogen Dioxide
The nitrate fraction of PM10 and PM2.5
Oxides of Sulfur

Sulfates
Sulfur Dioxide
The sulfate fraction of PM10 and PM2.5

    "Process Weight Per Hour" means the total Process Weight divided by the number of hours in one complete operation from the beginning of any given process to the completion thereof, excluding any time during which the equipment is idle. "Process Weight" is the total weight of all materials introduced into any specific process which may cause any discharge into the atmosphere. Solid fuels charged will be considered as part of the process weight, but liquid and gaseous fuels and combustion air will not.

    "Quarterly" means, unless otherwise indicated, January through March, April through June, July through September, and October through December.

    "Range Improvement Burning" means the use of open fires to remove vegetation for a wildlife, game or livestock habitat or for the initial establishment of an agricultural practice on previously uncultivated land.

    "Rated Brake Horsepower" means the continuous brake horsepower rating specified for the engine by the manufacturer or listed on the original nameplate of the unit, unless otherwise physically limited and specified by a condition on the engine's Permit to Operate.

    "Reactive Organic Compound" means any compound containing at least one (1) atom of carbon, except for the following exempt compounds:
        1.	acetone
        2.	ammonium carbonate
        3.	carbon dioxide
        4.	carbon monoxide
        5.	carbonic acid
        6.	dimethyl carbonate
        7.	ethane
        8.	metallic carbides or carbonates
        9.	methane
        10.	methyl acetate
        11.	methyl chloroform (1,1,1-trichloroethane)
        12.	methyl formate; HCOOCH3
        13.	cyclic, branched, or linear completely methylated siloxane compounds
        14.	methylene chloride
        15.	parachlorobenzotrifluoride
        16.	perchloroethylene (tetrachloroethylene)
        17.	the following four classes of perfluorocarbon (PFC) compounds:
            a.	cyclic, branched, or linear, completely fluorinated alkanes,
            b.	cyclic, branched, or linear, completely fluorinated ethers with no unsaturations,
            c.	cyclic, branched, or linear, completely fluorinated tertiary amines with no unsaturations, and
            d.	sulfur containing perfluorocarbons with no unsaturations and with sulfur bonds only to carbon and fluorine.
        18.	propylene carbonate
        19.	tertiary-butyl acetate; C6H12O2 ("acetic acid, 1,1-dimethylethyl ester")
            Tertiary-butyl acetate (also known as t-butyl acetate or tBAc) shall be considered exempt as a reactive organic compound only for purposes of reactive organic compound emissions limitations or reactive organic compound content requirements and shall be considered a reactive organic compound for purposes of all recordkeeping, emissions reporting, photochemical dispersion modeling, and inventory requirements which apply to reactive organic compounds.
        20.	CFC-11 (trichlorofluoromethane)
        21.	CFC-12 (dichlorodifluoromethane)
        22.	CFC-113 (1,1,2-trichloro-1,2,2-trifluoroethane)
        23.	CFC-114 (1,2-dichloro 1,1,2,2-tetrafluoroethane)
        24.	CFC-115 (chloropentafluoroethane)
        25.	HCFC-22 (chlorodifluoromethane)
        26.	HCFC-31 (chlorofluoromethane)
        27.	HCFC-123 (1,1,1-trifluoro 2,2-dichloroethane)
        28.	HCFC-123a (1,2-dichloro-1,1,2-trifluoroethane)
        29.	HCFC-124 (2-chloro-1,1,1,2-tetrafluoroethane)
        30.	HCFC-141b (1,1-dichloro 1-fluoroethane)
        31.	HCFC-142b (1-chloro-1,1 difluoroethane)
        32.	HCFC-151a (1-chloro-1-fluoroethane)
        33.	HCFC-225ca (3,3-dichloro-1,1,1,2,2-pentafluoropropane)
        34.	HCFC-225cb (1,3-dichloro-1,1,2,2,3-pentafluoropropane)
        35.	HFC-23 (trifluoromethane)
        36.	HFC-32 (difluoromethane)
        37.	HFC-43-10mee (1,1,1,2,3,4,4,5,5,5-decafluoropentane)
        38.	HFC-125 (pentafluoroethane)
        39.	HFC-134 (1,1,2,2-tetrafluoroethane)
        40.	HFC-134a (1,1,1,2-tetrafluoroethane)
        41.	HFC-143a (1,1,1-trifluoroethane)
        42.	HFC-152a (1,1-difluoroethane)
        43.	HFC-161 (ethylfluoride)
        44.	HFC-227ea (1,1,1,2,3,3,3-heptafluoropropane)
        45.	HFC-236ea (1,1,1,2,3,3-hexafluoropropane)
        46.	HFC-236fa (1,1,1,3,3,3-hexafluoropropane)
        47.	HFC-245ca (1,1,2,2,3-pentafluoropropane)
        48.	HFC-245ea (1,1,2,3,3-pentafluoropropane)
        49.	HFC-245eb (1,1,1,2,3-pentafluoropropane)
        50.	HFC-245fa (1,1,1,3,3-pentafluoropropane)
        51.	HFC-365mfc (1,1,1,3,3-pentafluorobutane)
        52.	HFE-7000; n-C3F7OCH3; (1,1,1,2,2,3,3-heptafluoro-3-methoxy-propane)
        53.	HFE-7100; (CF3)2CFCF2OCH3; (2-(difluoromethoxymethyl)-1,1,1,2,3,3,3-heptafluoropropane) or C4F9OCH3; (1,1,1,2,2,3,3,4,4-nonafluoro-4-methoxy-butane)
        54.	HFE-7200; (CF3)2CFCF2OC2H5; (2-(ethoxydifluoromethyl)-1,1,1,2,3,3,3-heptafluoropropane) or C4F9OC2H5; (1-ethoxy-1,1,2,2,3,3,4,4,4-nonafluorobutane)
        55.	HFE-7300; (1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy- 4-trifluoromethyl-pentane)
        56.	HFE-7500; (3-ethoxy- 1,1,1,2,3,4,4,5,5,6,6,6-dodecafluoro-2- (trifluoromethyl) hexane)

    Rule 202.D.10.l.1 requires an Authority to Construct and Permit to Operate when using more than one gallon per year per stationary source of any one of the following exempt compounds:
 (6)	dimethyl carbonate,
(37)	HFC-43-10mee,
(12)	methyl formate,
(50)	HFC-245fa,
(33)	HCFC-225ca,
(51)	HFC-365mfc, or
(34)	HCFC-225cb,
(53)	HFE-7100 [(CF3)2CFCF2OCH3 or C4F9OC2H5]
    Rule 202.D.10.l.2 requires an Authority to Construct and Permit to Operate when using more than one gallon per year per stationary source of: (19) tertiary-butyl acetate.
    The one gallon per year per stationary source limit is a per compound limit for each compound in aggregate for the entire stationary source and includes any amounts of the compound used in mixed or diluted product.

    "Reactive Organic Compound Composite Partial Pressure" means the sum of the partial pressures of compounds defined as reactive organic compounds. Reactive organic compound composite pressure shall be calculated as follows:

      Where:   Wi 	=	Weight of the "i"th reactive organic compound, in grams
             Ww 	=	Weight of water, in grams
             We 	=	Weight of the "e"th exempt compound, in grams
             MWi 	=	Molecular weight of the "i"th reactive organic compound, in grams per grams-mole
             MWw 	=	Molecular weight of water, in grams per grams-mole
             MWe 	=	Molecular weight of the "e"th exempt compound, in grams per grams-mole
             PPc 	=	Reactive organic compound composite partial pressure at 20 degrees Celsius, in
            		millimeters of mercury
             VPi 	=	Vapor pressure of the "i"th reactive organic compound at 20 degrees Celsius, in millimeters of mercury

    "Reasonable Further Progress" means annual incremental reductions in emissions of the relevant air pollutant and its precursors required to ensure attainment of the applicable air quality standard by the applicable date.

    "Reconstructed Source" means any source undergoing reconstruction where fixed capital costs of the new components exceeds fifty percent (50%) of the fixed capital cost of a comparable entirely new source. Fixed capital cost means the capital needed to provide all depreciable components.

    "Regulation" means one of the major subdivisions of the Rules of the Air Pollution Control District of Santa Barbara County.

    "Rotogravure Printing" means any printing process where the image area is etched or engraved relative to the surface of the image cylinder. Ink is transferred from minute etched wells on a plate cylinder to a substrate, which is supported by an impression roller, with excess ink removed by a doctor blade. The substrate is fed through the printing press in continuous rolls.

    "Rule" means a rule of the Air Pollution Control District of Santa Barbara County.

    "Scientific Instrument" means an instrument, including the components, assemblies, and subassemblies used in their manufacture, and associated accessories and reagents, that is used for the detection, measurement, analysis, separation, synthesis, or sequencing of various compounds.

    "Section" means section of the Health and Safety Code of the State of California unless some other statute is specifically mentioned.

    "Secondary Emissions" means emissions which would occur as a result of the construction or operation of a stationary source or modification, impact the same general area, but do not come from the source itself. Secondary emissions include emissions from any offsite support facility which would not be constructed or increase its emissions except as a result of the construction or operation of the source or modification. Secondary emissions do not include any emissions which come directly from a mobile source such as emissions from the tailpipe of a motor vehicle, from a train, or from a vessel.

    "Small Source" means a stationary source that meets the following criteria as determined by the Control Officer:

        1. 	The Permitted Emissions from the stationary source will be less than each of the values listed below:

              Reactive Organic Compounds			5.0 tons/year,
              Oxides of Nitrogen (as NO2)			5.0 tons/year,
              Particulate Matter less than 10 microns		5.0 tons/year
              Total Suspended Particulate Matter		5.0 tons/year
              Sulfur Oxides (as SO2)				5.0 tons/year,
              Carbon Monoxide 				25.0 tons/year
              and

        2.	The proposed source does not trigger any toxics review requirements, Negative Declaration or Environmental Impact Report where the District is the lead agency pursuant to CEQA, federal NSPS or NESHAPS, federal operating permit program requirements (with the exception of General Permits) and is not located within 1,000 feet of the outer boundary of a school site, and
        3.	The permit application must deal exclusively with equipment that is listed by the Control Officer as certified and must not require a source test to demonstrate compliance, and
        4.	The applicant must be willing to accept standard permit conditions as established by the Control Officer.

    "Solvent" means "Organic Solvent" as defined in this rule.
     "Solvent Cleaning" means any activity, operation, or process (including, but not limited to, surface preparation, cleanup, or wipe cleaning) performed outside of a solvent cleaning machine, that uses solvent to remove uncured adhesives, uncured coatings, uncured inks, uncured polyester resin material, uncured sealant, or other contaminants, including, but not limited to, dirt, soil, oil, lubricants, coolants, moisture, fingerprints, and grease, from parts, products, tools, machinery, application equipment, and general work areas. Cleaning spray equipment used for the application of coating, adhesive, ink, polyester resin material, or sealant is also considered to be solvent cleaning irrespective of the spray material being cured.

    "Solvent Cleaning Machine" means any device or piece of equipment that uses solvent liquid or vapor to remove soils, moisture, or other contaminants from the surfaces of materials. Types of solvent cleaning machines include, but are not limited to, batch cold, batch vapor, in-line cold, in-line vapor, remote reservoir, and gas-path solvent cleaners, as defined in Rule 321, Solvent Cleaning Machines and Solvent Cleaning. Buckets, pails, and beakers with capacities of 3.785 liters (1.00 gallon) or less are not considered solvent cleaning machines. However, the use of such a container or similar containers (e.g., hand-held spray bottles) with a solvent for cleaning is considered to be solvent cleaning. Any device or piece of equipment used exclusively for stripping shall not be considered to be a solvent cleaning machine.

    "South Coast Air Quality Management District Method 303-91, "Determination of Exempt Compounds," August 1996," means the test method adopted by and in effect by the South Coast Air Quality Management District on June 21, 2012.

    "South Coast Air Quality Management District Method 313-91, "Determination of Volatile Organic Compounds by Gas Chromatography-Mass Spectrometry," June 1993," means the test method adopted by and in effect by the South Coast Air Quality Management District on June 21, 2012.

    "Space Vehicle" means any man-made device, either manned or unmanned, designed for operation beyond earth's atmosphere. This definition includes integral equipment such as models, mock-ups, prototypes, molds, jigs, tooling, hardware jackets, and test coupons. Also included is auxiliary equipment associated with test, transport, and storage, which through contamination can compromise the space vehicle performance.

    "Spark Ignition Engine" means a gasoline-fueled engine or other engine with a spark plug (or other sparking device) and with operating characteristics significantly similar to the theoretical Otto combustion cycle. Spark ignition engines usually use a throttle to regulate intake air flow to control power during normal operation.

    "Specialty Equipment" means portable engines used to power equipment located in the Outer Continental Shelf or State Territorial Waters that satisfy all of the following conditions:

        1.	The portable engine is ineligible for registration in the State Portable Equipment Registration Program; and

        2.	A similar portable engine or equipment unit capable of performing the specialty work is not registered in the State Portable Equipment Registration Program or, if registered is not available for use; and

        3.	The portable engine/equipment unit performs a unique function or activity outside the normal scope of drilling or construction activities; and

        4.	The equipment will be used for less than 500 hours per stationary source in any calendar year and emit not more than 10 tons per stationary source of oxides of nitrogen, oxides of sulfur, reactive organic compounds, or particulate matter in any calendar year; and

        5.	Use of the equipment is not recurrent from year to year.

    "Specialty Equipment Emergency Use" means that conditions giving rise to the use of the specialty equipment were due to 1) conditions beyond the reasonable control of the stationary source, including but not limited to the breakdown of essential drilling or construction equipment, and 2) the use of the specialty equipment is necessary to complete essential short-term projects.

    "Standard Conditions" for gases means a temperature of 60 degrees Fahrenheit (15.6 degrees Celsius) and a pressure of 14.7 pounds per square inch absolute (760 mm of Mercury). Results of all analyses and tests shall be calculated and reported at this temperature and pressure.

    "Stationary Source" means any building, structure, facility, or installation which emits or may emit any affected pollutant directly or as a fugitive emission. "Fugitive emissions" means those emissions of pollutants which could not reasonably pass through a stack, chimney, vent or other functionally equivalent opening.

       "Installation" includes any operation, article, machine, equipment, contrivance, or grouping of equipment belonging to the same two-digit standard industrial classification code, which emits or may emit any affected pollutant, and located on one or more contiguous properties and under common control.

       "Building, structure, or facility" includes all pollutant-emitting activities including those located in California coastal waters adjacent to the District boundaries and those areas of Outer Continental Shelf waters for which the District is the corresponding onshore area which:

 belong to the same industrial grouping

 are located on one or more contiguous or adjacent properties (except for activities located in California coastal waters or are on the Outer Continental Shelf), and

 are under the same or common ownership, operation, or control or which are owned or operated by entities which are under common control.

            Pollutant emitting activities shall be considered as part of the same industrial grouping if they are part of a common production process. (Common production process includes industrial processes, manufacturing processes, and any connected processes involving a common raw material.)

      "Common operations" includes operations which are related through dependent processes, storage or transportation of the same or similar products or raw material. Emissions from all marine vessels, including cargo carriers, servicing or associated with a stationary source shall be considered emissions from the stationary source while operating within:

           the District, including California Coastal Waters adjacent to the District (Figure 102);

           the Outer Continental Shelf for which the District is the corresponding onshore area; and

           25 miles of an Outer Continental Shelf source for which the District is the corresponding onshore area.

      The emissions from marine vessels, including cargo carriers, shall include reactive organic compound vapors that are displaced into the atmosphere; fugitive emissions; combustion emissions in the waters described above; and emissions from the loading and unloading of cargo. The term "Cargo Carrier" shall not include trains or vehicles.

    As applied to an attainment pollutant, "stationary source" shall be interpreted to mean facility wide. The term "installation" shall have the same meaning as "building, structure, or facility."

    Figure 102. MAP DEPICTING THE CALIFORNIA COASTAL WATERS ADJACENT TO THE
              SANTA BARBARA COUNTY AIR POLLUTION CONTROL DISTRICT

    "Stripping" means the use of solvent to remove materials such as cured adhesives, cured inks, cured sealants, cured or dried paints, cured or dried paint residues, or temporary protective coatings.

    "Surface Preparation" means the removal of contaminants such as dust, soil, oil, grease, moisture, etc., prior to application of an adhesive, coating, ink, polyester resin material, or sealant.

    "Temporary Total Enclosure" means any total enclosure that is constructed for the sole purpose of measuring the emissions from an affected source that are not delivered to an emission control device. A temporary total enclosure must be constructed and ventilated (through stacks suitable for testing) so that it has minimal impact on the performance of the permanent emission capture system. A temporary total enclosure will be assumed to achieve total capture of fugitive emissions if it meets the requirements found in 40 CFR Section 63.750(g)(4) and if all natural draft openings are at least four duct or hood equivalent diameters away from each exhaust duct or hood. Alternatively, the owner or operator may apply to the Control Officer for approval of a temporary enclosure on a case-by-case basis.

    "Thermal Incinerator" means any device that burns reactive organic compounds or toxic air contaminants in air by direct application of heat. Thermal incinerators are usually equipped with burners, refractory lined chambers, heat recovery equipment, and process controllers.

    "Total Enclosure" means any permanent structure that is constructed around a gaseous emission source so that all gaseous pollutants emitted from the source are collected and ducted through a control device, such that 100 percent capture efficiency is achieved. There are no fugitive emissions from a total enclosure. The only openings in a total enclosure are forced makeup air and exhaust ducts and any natural draft openings such as those that allow raw materials to enter and exit the enclosure for processing. All access doors or windows are closed during routine operation of the enclosed source. Brief, occasional openings of such doors or windows to accommodate process equipment adjustments are acceptable, but if such openings are routine or if an access door remains open during the entire operation, the access door must be considered a natural draft opening. The average inward face velocity across the natural draft openings of the enclosure shall be calculated including the area of such access doors. The drying oven itself may be part of the total enclosure. An enclosure that meets the requirements found in 40 CFR Section 63.750(g)(4) is a permanent total enclosure.

    "Total Suspended Particulates" means "Particulate Matter" as defined in this rule.

    "Toxic Air Contaminant" means "Toxic Air Contaminant" as defined in Health and Safety Code Section 39655.

    "Transfer Efficiency" means the ratio of the weight of coating solids adhering to the object being coated to the weight of coating solids used in the application process, expressed as a percentage.

    "Waste Solvent Residue" means sludge that may contain dirt, oil, metal particles, and/or other undesirable waste products concentrated after heat distillation of solvent either in a solvent cleaning machine itself or after distillation in a separate still.

    "Wipe Cleaning" means a solvent cleaning activity performed by hand rubbing an absorbent material such as a rag, paper, sponge, brush, or cotton swab containing solvent.

    "Zones of Santa Barbara County"

       1.	The Northern Zone of Santa Barbara County is defined as that portion of Santa Barbara County described in Section 60103(b) of Title 17 of the California Administrative Code as written on December 21, 1968 (Register 68, No. 48), State waters located offshore of that portion of Santa Barbara County lying north of the latitude of the mouth of Jalama Creek and those areas of the Outer Continental Shelf waters for which the District has been designated the corresponding onshore area by the Environmental Protection Agency.

2.	The Southern Zone of Santa Barbara County is defined as that portion of Santa Barbara County described in Section 60104(c) of Title 17 of the California Administrative Code as written on December 21, 1968 (Register 68, No. 48), State waters located offshore of that portion of Santa Barbara County lying south of the latitude of the mouth of Jalama Creek and those areas of the Outer Continental Shelf waters for which the District has been designated the corresponding onshore area by the Environmental Protection Agency.


[Federal Register Volume 88, Number 59 (Tuesday, March 28, 2023)]
[Notices]
[Pages 18319-18321]
[FR Doc No: 2023-06374]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-4843]

Soft (Hydrophilic) Daily Wear Contact Lenses--Performance
Criteria for Safety and Performance Based Pathway; Guidance for
Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Soft (Hydrophilic)
Daily Wear Contact Lenses--Performance Criteria for Safety and
Performance Based Pathway; Guidance for Industry and Food and Drug
Administration Staff.'' The device-specific guidance identified in this
notice was developed in accordance with the final guidance entitled
``Safety and Performance Based Pathway.''

DATES: The announcement of the guidance is published in the Federal
Register on March 28, 2023.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-4843 for ``Soft (Hydrophilic) Daily Wear Contact Lenses--
Performance Criteria for Safety and Performance Based Pathway; Guidance
for Industry and Food and Drug Administration Staff.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20

and other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Soft (Hydrophilic) Daily Wear Contact Lenses--Performance Criteria
for Safety and Performance Based Pathway; Guidance for Industry and
Food and Drug Administration Staff'' to the Office of Policy, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in
processing your request.

FOR FURTHER INFORMATION CONTACT: Jason Ryans, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1613, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This device-specific guidance document provides performance
criteria for premarket notification (510(k)) submissions to support the
optional Safety and Performance Based Pathway, as described in the
guidance entitled ``Safety and Performance Based Pathway.'' \1\ As
described in that guidance, substantial equivalence is rooted in
comparisons between new devices and predicate devices. However, the
Federal Food, Drug, and Cosmetic Act does not preclude FDA from using
performance criteria to facilitate this comparison. If a legally
marketed device performs at certain levels relevant to its safety and
effectiveness, and a new device meets those levels of performance for
the same characteristics, FDA could find the new device as safe and
effective as the legally marketed device. Instead of reviewing data
from direct comparison testing between the two devices, FDA could
support a finding of substantial equivalence with data demonstrating
the new device meets the level of performance of an appropriate
predicate device(s). Under this optional Safety and Performance Based
Pathway, a submitter could satisfy the requirement to compare its
device with a legally marketed device by, among other things,
independently demonstrating that the device's performance meets
performance criteria as established in the above-listed guidance,
rather than using direct predicate comparison testing for some of the
performance characteristics.
---------------------------------------------------------------------------

    \1\ Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-based-pathway.
---------------------------------------------------------------------------

    A notice of availability of the draft guidance appeared in the
Federal Register of March 4, 2020 (85 FR 12788). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including clarifying the recommended contact lens
thickness for spectral transmittance and ultraviolet transmittance
performance testing. Additionally, clarification has been included to
describe how this guidance relates to FDA's special controls guidance
document entitled ``Premarket Notification [510(k)] Guidance Document
for Class II Daily Wear Contact Lenses.'' \2\
---------------------------------------------------------------------------

    \2\ Available at: https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/class-ii-daily-wear-contact-lenses-premarket-notification-510k-guidance-document
---------------------------------------------------------------------------

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Soft (Hydrophilic) Daily Wear Contact
Lenses.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov and https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to
download an electronic copy of ``Soft (Hydrophilic) Daily Wear Contact
Lenses--Performance Criteria for Safety and Performance Based Pathway;
Guidance for Industry and Food and Drug Administration Staff'' may send
an email request to [email protected] to receive an electronic
copy of the document. Please use the document number GUI00019022 and
complete title to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in the following FDA regulations, guidance, and forms
have been approved by OMB as listed in the following table:

------------------------------------------------------------------------
                                                           OMB  control
21 CFR part; guidance; or FDA form          Topic               No.
------------------------------------------------------------------------
807, subpart E....................  Premarket                  0910-0120
                                     notification.
``Requests for Feedback on Medical  Q-submissions.......       0910-0756
 Device Submissions: The Pre-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff''.
------------------------------------------------------------------------

    Dated: March 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-06374 Filed 3-27-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 54 (Wednesday, March 20, 2013)]
[Rules and Regulations]
[Pages 17079-17080]
[FR Doc No: 2013-06115]

-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-1167; Directorate Identifier 2012-NE-36-AD;
Amendment 39-17396; AD 2013-06-01]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce Deutschland Ltd & Co KG
Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Rolls-Royce Deutschland Ltd & Co KG (RRD) models Tay 620-15 and Tay
650-15 turbofan engines. This AD was prompted by RRD recalculating the
Declared Safe Cyclic Life (DSCL) for certain low-pressure compressor
(LPC) rotor disc assemblies operating to the Plan D Flight Mission.
This AD requires removing the affected LPC rotor disc assemblies at a
new lower recalculated DSCL. We are issuing this AD to prevent failure
of the LPC rotor disc assembly, uncontained engine failure, and damage
to the airplane.

DATES: This AD becomes effective April 24, 2013.

ADDRESSES: The Docket Operations office is located at Docket Management
Facility, U.S. Department of Transportation, 1200 New Jersey Avenue
SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-
0001.

FOR FURTHER INFORMATION CONTACT: Frederick Zink, Aerospace Engineer,
Engine Certification Office, FAA, Engine & Propeller Directorate, 12
New England Executive Park, Burlington, MA 01803; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on December 13, 2012
(77 FR 74123). That NPRM proposed to correct an unsafe condition for
the specified products. The Mandatory Continuing Airworthiness
Information states:

    The Tay 650-15 and Tay 650-15/10 engine Time Limits Manual
Chapter 05-10-01 contains maximum approved life limitations,
identified as Declared Safe Cyclic Life (DSCL) for Low Pressure
Compressor (LPC) rotor disc assemblies Part Number (P/N) JR31198A
and P/N JR34563A operated to the Plan D Flight Mission, which has
been recalculated to a lower value.
    Decreased DSCL of LPC rotor disc assemblies P/N JR31198A and P/N
JR34563A may affect these disc assemblies installed in Tay 650-15
and Tay 650-15/10 engines as well as in Tay 620-15 and Tay 620-15/20
engines.
    Failure to take decreased DSCL of affected LPC rotor disc
assemblies into account could lead to affected part failure and
consequent release of high energy debris potentially resulting in
damage to, and/or reduced control of, the aeroplane.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (77 FR 74123, December 13,
2012).

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting the AD as proposed (77 FR 74123,
December 13, 2012).

Costs of Compliance

    We estimate that this AD will affect four engines installed on
airplanes of U.S. registry. We also estimate that it will require four
hours to perform the actions required by this AD. The average labor
rate is $85 per hour. Prorated life for the disc assembly is
approximately $650 per disc. Based on these figures, we estimate the
cost of this AD on U.S. operators to be $3,960.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (phone:<PHONE_NUMBER>) is provided in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2013-06-01 Rolls-Royce Deutschland Ltd & Co KG (RRD) (formerly
Rolls-Royce plc): Docket No. FAA-2012-1167; Directorate Identifier
2012-NE-36-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective April 24,
2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to RRD models Tay 620-15 and Tay 650-15 turbofan
engines with a low-pressure compressor (LPC) rotor disc assembly,
part number (P/N) JR31198A or P/N JR34563A, installed.

(d) Reason

    This AD was prompted by RRD recalculating the Declared Safe
Cyclic Life for certain LPC rotor disc assemblies operating to the
Plan D Flight Mission. We are issuing this AD to prevent failure of
the LPC rotor disc assembly, uncontained engine failure, and damage
to the airplane.

(e) Actions and Compliance

    Unless already done, do the following. For engines that have
operated to the Plan D Flight Mission configuration, remove the LPC
rotor disc assembly from service before accumulating 18,700 engine
flight cycles. Do not return to service nor approve for return to
service any engine with the affected discs installed that exceeds
18,700 engine flight cycles.

(f) Alternative Methods of Compliance (AMOCs)

    The Manager, Engine Certification Office, FAA, may approve AMOCs
for this AD. Use the procedures found in 14 CFR 39.19 to make your
request.

(g) Related Information

    (1) For more information about this AD, contact Frederick Zink,
Aerospace Engineer, Engine Certification Office, FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington, MA
01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Refer to European Aviation Safety Agency AD 2012-0204, dated
October 1, 2012, and RRD Alert Service Bulletin TAY-72-A1772, dated
August 9, 2012, for related information.
    (3) For service information identified in this AD, contact
Rolls-Royce Deutschland Ltd & Co KG, Eschenweg 11 Dahlewitz 15827,
Blankenfelde-Mahlow, Germany; phone: +49 0 33-7086-1944; fax: +49 0
33-7086-3276.
    (4) You may view this service information at the FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington,
MA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

(h) Material Incorporated by Reference

    None.

    Issued in Burlington, Massachusetts, on March 8, 2013.
Colleen M. D'Alessandro,
Acting Manager, Engine & Propeller Directorate, Aircraft Certification
Service.
[FR Doc. 2013-06115 Filed 3-19-13; 8:45 am]
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