Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 27, 2003 1 For the reasons set out in the preamble, title 40, chapter I of the Code of Federal Regulations is amended as follows:

PART 51  [ AMENDED]

1. The authority citation for part 51 continues to read as follows:

Authority: 23 U. S. C. 101; 42 U. S. C. 7401 7671q.

Subpart I  [ Amended]

2. Section 51.165 is amended:

a. By revising paragraph ( a)( 1)( v)( C)( 1).

b. By adding paragraphs ( a)( 1)( xliii) through ( xlvi),

and paragraphs ( h) and ( i).

The revision and additions read as follows:

§ 51.165 Permit requirements.

( a) * * *

( 1) * * *

( v) * * *

( C) * * *

( 1) Routine maintenance, repair and replacement.

Routine maintenance, repair and replacement shall include,

but not be limited to, any activity( s) that meets the requirements of the equipment replacement provisions contained in paragraph ( h) of this section.

* * * * * Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 27, 2003 2 ( xliii)( A) In general, process unit means any collection of structures and/ or equipment that processes,

assembles, applies, blends, or otherwise uses material inputs to produce or store an intermediate or a completed product. A single stationary source may contain more than one process unit, and a process unit may contain more than one emissions unit.

( B) Pollution control equipment is not part of the process unit, unless it serves a dual function as both process and control equipment. Administrative and warehousing facilities are not part of the process unit.

( C) For replacement cost purposes, partscomponents shared between two or more process units are proportionately allocated based on capacity.

( D) The following list identifies the process units at specific categories of stationary sources.

( 1) For a steam electric generating facility, the process unit consists of those portions of the plant that contribute directly to the production of electricity. For example, at a pulverized coal fired facility, the process unit would generally be the combination of those systems from the coal receiving equipment through the emission stack ( excluding post combustion pollution controls), including Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 27, 2003 3 the coal handling equipment, pulverizers or coal crushers,

feedwater heaters, ash handling, boiler, burners,

turbinegenerator set, condenser, cooling tower, water treatment system, air preheaters, and operating control systems. Each separate generating unit is a separate process unit.

( 2) For a petroleum refinery, there are several categories of process units: those that separate and/ or distill petroleum feedstocks; those that change molecular structures; petroleum treating processes; auxiliary facilities, such as steam generators and hydrogen production units; and those that load, unload, blend or store intermediate or completed products.

( 3) For an incinerator, the process unit would consist of components from the feed pit or refuse pit to the stack,

including conveyors, combustion devices, heat exchangers and steam generators, quench tanks, and fans.

( xliv) Functionally equivalent partcomponent means a partcomponent that serves the same purpose as the replaced partcomponent.

( xlv) Fixed capital cost means the capital needed to provide all the depreciable components. " Depreciable components" refers to all components of fixed capital cost and is calculated by subtracting land and working capital Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 27, 2003 4 from the total capital investment, as defined in paragraph ( a)( 1)( xlvi) of this section.

( xlvi) Total capital investment means the sum of the following: all costs required to purchase needed process equipment ( purchased equipment costs); the costs of labor and materials for installing that equipment ( direct installation costs); the costs of site preparation and buildings; other costs such as engineering, construction and field expenses, fees to contractors, startup and performance tests, and contingencies ( indirect installation costs); land for the process equipment; and working capital for the process equipment.

* * * * *

( h) Equipment Replacement Provision. RWithout regard to other considerations, routine maintenance, repair and replacement includes, but is not limited to, the replacement of any partcomponent of a process unit with an identical or functionally equivalent partcomponent( s), and all maintenance and repair activities that are part of the replacement activity, without regard to other considerations, provided that all of the requirements in paragraphs ( h)( 1) through ( 3) of this section are met. A repair or maintenance activity is part of a replacement Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 27, 2003 5 activity if it is conducted in conjunction with the replacement.

( 1) Capital Cost threshold for Equipment Replacement ( i) For an electric utility steam generating unit, as defined in 51.165( a)( 1)( xx), the fixed capital cost of the replacement partcomponent( s) plus the cost of any associated maintenance and repair activities that are part of the replacement shall not exceed 20 percent of the replacement value of the process unit, at the time the equipment is replaced.

( ii) For a process unit that is not an electric utility steam generating unit the fixed capital cost of the replacement partcomponent( s) plus the cost of any associated maintenance and repair activities that are part of the replacement shall not exceed 20 percent of the replacement value of the process unit, at the time the equipment is replaced.

( iii) In determining the replacement value of the process unit; and, except as otherwise allowed under paragraph ( h)( 1)( ivii) of this section, the owner or operator shall basedetermine the replacement value of the process unit on an estimate of the fixed capital cost of constructing a new process unit, or on the current appraised Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 27, 2003 6 value of the process unit.

( ivii) As an alternative to paragraph ( h)( 1)( iiiii) of this section for determining the replacement value of a process unit, an owner or operator may choose to use insurance value ( where the insurance value covers only complete replacement), investment value adjusted for inflation, or another accounting procedure if such procedure is based on Generally Accepted Accounting Principles,

provided that the owner or operator sends a notice to the reviewing authority. The first time that an owner or operator submits such a notice for a particular process unit, the notice may be submitted at any time, but any subsequent notice for that process unit may be submitted only at the beginning of the process unit's fiscal year.

Unless the owner or operator submits a notice to the reviewing authority, then paragraph ( h)( 1)( iiiii) of this section will be used to establish the replacement value of the process unit. Once the owner or operator submits a notice to use an alternative accounting procedure, the owner or operator must continue to use that procedure for the entire fiscal year for that process unit. In subsequent fiscal years, the owner or operator must continue to use this selected procedure unless anand until the owner or Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 27, 2003 7 operator sends another notice is sent to the reviewing authority selecting another procedure consistent with this paragraph or paragraph ( h)( 1)( iiiii) of this section at the beginning of such fiscal year.

( 2) Basic Design Parameters. The replacement does not change the basic design parameter( s) of the process unit to which the activity pertains.

( i) Except as provided in paragraph ( h)( 2)( iii) of this section, for a process unit at a steam electric generating facility, the owner or operator may select as its basic design parameters either maximum hourly heat input and maximum hourly fuel consumption rate or maximum hourly electric output rate and maximum steam flow rate. When establishing fuel consumption specifications in terms of weight or volume, the minimum fuel quality based on British Thermal Units content shall be used for determining the basic design parameter( s) for a coal fired electric utility steam generating unit.

( ii) Except as provided in paragraph ( h)( 2)( iii) of this section, the basic design parameter( s) for any process unit that is not at a steam electric generating facility are maximum rate of fuel or heat input, maximum rate of material input, or maximum rate of product output. Combustion Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 27, 2003 8 process units will typically use maximum rate of fuel input.

For sources having multiple end products and raw materials,

the owner or operator must select the appropriate parameter for the dominant emission source of the process unitshould consider the primary product or primary raw material when selecting a basic design parameter.

( iii) If the owner or operator believes the basic design parameter( s) in paragraphs ( h)( 2)( i) and ( ii) of this section is not appropriate for a specific industry or type of process unit, the owner or operator may propose to the reviewing authority an alternative basic design parameter( s)

for the source's process unit( s). If the reviewing authority approves of the use of an alternative basic design parameter( s), the reviewing authority shall issue a permit that is legally enforceable that records such basic design parameter( s) and requires the owner or operator to comply with such parameter( s).

( iv) The owner or operator shall use credible information, such as results of historic maximum capability tests, design information from the manufacturer, or engineering calculations, in establishing the magnitude of the basic design parameter( s) specified in paragraphs ( h)( 2)( i) and ( ii) of this section. Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 27, 2003 9 ( v) If design information is not available for a process unit, then the owner or operator shall determine the process unit's basic design parameter( s) using the maximum value achieved by the process unit in the five year period immediately preceding the planned activity.

( vi) Efficiency of a process unit is not a basic design parameter.

( 3) The replacement activity shall not cause the process unit to exceed any emission limitation, or operational limitation that has the effect of constraining emissions, that applies to the process unit and that is legally enforceable. Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 27, 2003 10 3. Section 51.166 is amended:

a. By revising paragraph ( b)( 2)( iii)( a).

b. By adding paragraphs ( b)( 53) through ( 56), and paragraphs ( y) and ( z).

The revision and additions read as follows:

§ 51.166 Prevention of significant deterioration of air quality.

( b) * * *

( 2) * * *

( iii) * * *

( a) Routine maintenance, repair and replacement.

Routine maintenance, repair and replacement shall include,

but not be limited to, any activity( s) that meets the requirements of the equipment replacement provisions contained in paragraph ( y) of this section.

* * * * *

( 53)( i) In general, process unit means any collection of structures and/ or equipment that processes, assembles,

applies, blends, or otherwise uses material inputs to produce or store an intermediate or a completed product. A single stationary source may contain more than one process unit, and a process unit may contain more than one emissions unit. Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 27, 2003 11 ( ii) Pollution control equipment is not part of the process unit, unless it serves a dual function as both process and control equipment. Administrative and warehousing facilities are not part of the process unit.

( iii) For replacement cost purposes, partscomponents shared between two or more process units are proportionately allocated based on capacity.

( iv) The following list identifies the process units at specific categories of stationary sources.

( a) For a steam electric generating facility, the process unit consists of those portions of the plant that contribute directly to the production of electricity. For example, at a pulverized coal fired facility, the process unit would generally be the combination of those systems from the coal receiving equipment through the emission stack ( excluding post combustion pollution controls), including the coal handling equipment, pulverizers or coal crushers,

feedwater heaters, ash handling, boiler, burners,

turbinegenerator set, condenser, cooling tower, water treatment system, air preheaters, and operating control systems. Each separate generating unit is a separate process unit.

( b) For a petroleum refinery, there are several categories of process units: those that separate and/ or Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 27, 2003 12 distill petroleum feedstocks; those that change molecular structures; petroleum treating processes; auxiliary facilities, such as steam generators and hydrogen production units; and those that load, unload, blend or store intermediate or completed products.

( c) For an incinerator, the process unit would consist of components from the feed pit or refuse pit to the stack,

including conveyors, combustion devices, heat exchangers and steam generators, quench tanks, and fans.

( 54) Functionally equivalent partcomponent means a partcomponent that serves the same purpose as the replaced partcomponent.

( 55) Fixed capital cost means the capital needed to provide all the depreciable components. " Depreciable components" refers to all components of fixed capital cost and is calculated by subtracting land and working capital from the total capital investment, as defined in paragraph ( b)( 56) of this section.

( 56) Total capital investment means the sum of the following: all costs required to purchase needed process equipment ( purchased equipment costs); the costs of labor and materials for installing that equipment ( direct installation costs); the costs of site preparation and Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 27, 2003 13 buildings; other costs such as engineering, construction and field expenses, fees to contractors, startup and performance tests, and contingencies ( indirect installation costs); land for the process equipment; and working capital for the process equipment.

* * * * *

( y) Equipment Replacement Provision. RoutineWithout regard to other considerations, routine maintenance, repair and replacement includes, but is not limited to, the replacement of any partcomponent of a process unit with an identical or functionally equivalent partcomponent( s), and all maintenance and repair activities that are part of the replacement activity, without regard to other considerations, provided that all of the requirements in paragraphs ( y)( 1) through ( 3) of this section are met. A repair or maintenance activity is part of a replacement activity if it is conducted in conjunction with the replacement.

( 1) Capital Cost threshold for Equipment Replacement ( i) For an electric utility steam generating unit, as defined in 51.166( b)( 30), the fixed capital cost of the replacement partcomponent( s) plus the cost of any associated maintenance and repair activities that are part of the Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 27, 2003 14 replacement shall not exceed 20 percent of the replacement value of the process unit, at the time the equipment is replaced.

( ii) For a process unit that is not an electric utility steam generating unit the fixed capital cost of the replacement partcomponent( s) plus the cost of any associated maintenance and repair activities that are part of the replacement shall not exceed 20 percent of the replacement value of the process unit, at the time the equipment is replaced.

( iii) In determining the replacement value of the process unit; and, except as otherwise allowed under paragraph ( y)( 1)( ivii) of this section, the owner or operator shall basedetermine the replacement value of the process unit on an estimate of the fixed capital cost of constructing a new process unit, or on the current appraised value of the process unit.

( ivii) As an alternative to paragraph ( y)( 1)( iiiii) of this section for determining the replacement value of a process unit, an owner or operator may choose to use insurance value ( where the insurance value covers only complete replacement), investment value adjusted for inflation, or another accounting procedure if such procedure Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 27, 2003 15 is based on Generally Accepted Accounting Principles,

provided that the owner or operator sends a notice to the reviewing authority. The first time that an owner or operator submits such a notice for a particular process unit, the notice may be submitted at any time, but any subsequent notice for that process unit may be submitted only at the beginning of the process unit's fiscal year.

Unless the owner or operator submits a notice to the reviewing authority, then paragraph ( y)( 1)( iiiii) of this section will be used to establish the replacement value of the process unit. Once the owner or operator submits a notice to use an alternative accounting procedure, the owner or operator must continue to use that procedure for the entire fiscal year for that process unit. In subsequent fiscal years, the owner or operator must continue to use this selected procedure unless anand until the owner or operator sends another notice is sent to the reviewing authority selecting another procedure consistent with this paragraph or paragraph ( y)( 1)( iiiii) of this section at the beginning of such fiscal year.

( 2) Basic Design Parameters. The replacement does not change the basic design parameter( s) of the process unit to which the activity pertains. Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 27, 2003 16 ( i) Except as provided in paragraph ( y)( 2)( iii) of this section, for a process unit at a steam electric generating facility, the owner or operator may select as its basic design parameters either maximum hourly heat input and maximum hourly fuel consumption rate or maximum hourly electric output rate and maximum steam flow rate. When establishing fuel consumption specifications in terms of weight or volume, the minimum fuel quality based on British Thermal Units content shall be used for determining the basic design parameter( s) for a coal fired electric utility steam generating unit.

( ii) Except as provided in paragraph ( y)( 2)( iii) of this section, the basic design parameter( s) for any process unit that is not at a steam electric generating facility are maximum rate of fuel or heat input, maximum rate of material input, or maximum rate of product output. Combustion process units will typically use maximum rate of fuel input.

For sources having multiple end products and raw materials,

the owner or operator must select the appropriate parameter for the dominant emission source of the process unitshould consider the primary product or primary raw material when selecting a basic design parameter.

( iii) If the owner or operator believes the basic Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 27, 2003 17 design parameter( s) in paragraphs ( y)( 2)( i) and ( ii) of this section is not appropriate for a specific industry or type of process unit, the owner or operator may propose to the reviewing authority an alternative basic design parameter( s)

for the source's process unit( s). If the reviewing authority approves of the use of an alternative basic design parameter( s), the reviewing authority shall issue a permit that is legally enforceable that records such basic design parameter( s) and requires the owner or operator to comply with such parameter( s).

( iv) The owner or operator shall use credible information, such as results of historic maximum capability tests, design information from the manufacturer, or engineering calculations, in establishing the magnitude of the basic design parameter( s) specified in paragraphs ( y)( 2)( i) and ( ii) of this section.

( v) If design information is not available for a process unit, then the owner or operator shall determine the process unit's basic design parameter( s) using the maximum value achieved by the process unit in the five year period immediately preceding the planned activity.

( vi) Efficiency of a process unit is not a basic design parameter. Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 27, 2003 18 ( 3) The replacement activity shall not cause the process unit to exceed any emission limitation, or operational limitation that has the effect of constraining emissions, that applies to the process unit and that is legally enforceable. Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 27, 2003 19 PART 52  [ Amended]

1. The authority citation for part 52 continues to read as follows:

Authority: 42 U. S. C. 7401, et seq.

Subpart A  [ Amended]

2. Section 52.21 is amended:

a. By revising paragraph ( b)( 2)( iii)( a).

b. By adding paragraphs ( b)( 55) through ( 58), and paragraphs ( cc) and ( dd).

The revision and additions read as follows:

§ 52.21 Prevention of significant deterioration of air quality.

( b) * * *

( 2) * * *

( iii) * * *

( a) Routine maintenance, repair and replacement.

Routine maintenance, repair and replacement shall include,

but not be limited to, any activity( s) that meets the requirements of the equipment replacement provisions contained in paragraph ( cc) of this section.

* * * * *

( 55)( i) In general, process unit means any collection of structures and/ or equipment that processes, assembles, Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 27, 2003 20 applies, blends, or otherwise uses material inputs to produce or store an intermediate or a completed product. A single stationary source may contain more than one process unit, and a process unit may contain more than one emissions unit.

( ii) Pollution control equipment is not part of the process unit, unless it serves a dual function as both process and control equipment. Administrative and warehousing facilities are not part of the process unit.

( iii) For replacement cost purposes, partscomponents shared between two or more process units are proportionately allocated based on capacity.

( iv) The following list identifies the process units at specific categories of stationary sources.

( a) For a steam electric generating facility, the process unit consists of those portions of the plant that contribute directly to the production of electricity. For example, at a pulverized coal fired facility, the process unit would generally be the combination of those systems from the coal receiving equipment through the emission stack ( excluding post combustion pollution controls), including the coal handling equipment, pulverizers or coal crushers,

feedwater heaters, ash handling, boiler, burners, turbine Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 27, 2003 21 generator set, condenser, cooling tower, water treatment system, air preheaters, and operating control systems. Each separate generating unit is a separate process unit.

( b) For a petroleum refinery, there are several categories of process units: those that separate and/ or distill petroleum feedstocks; those that change molecular structures; petroleum treating processes; auxiliary facilities, such as steam generators and hydrogen production units; and those that load, unload, blend or store intermediate or completed products.

( c) For an incinerator, the process unit would consist of components from the feed pit or refuse pit to the stack,

including conveyors, combustion devices, heat exchangers and steam generators, quench tanks, and fans.

( 56) Functionally equivalent partcomponent means a partcomponent that serves the same purpose as the replaced partcomponent.

( 57) Fixed capital cost means the capital needed to provide all the depreciable components. " Depreciable components" refers to all components of fixed capital cost and is calculated by subtracting land and working capital from the total capital investment, as defined in paragraph ( b)( 58) of this section. Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 27, 2003 22 ( 58) Total capital investment means the sum of the following: all costs required to purchase needed process equipment ( purchased equipment costs); the costs of labor and materials for installing that equipment ( direct installation costs); the costs of site preparation and buildings; other costs such as engineering, construction and field expenses, fees to contractors, startup and performance tests, and contingencies ( indirect installation costs); land for the process equipment; and working capital for the process equipment.

* * * * *

( cc) EquipmenWithout Replacement Provision. Rregard to other considerations, routine maintenance, repair and replacement includes, but is not limited to, the replacement of any partcomponent of a process unit with an identical or functionally equivalent partcomponent( s), and all maintenance and repair activities that are part of the replacement activity, without regard to other considerations, provided that all of the requirements in paragraphs ( cc)( 1) through ( 3) of this section are met. A repair or maintenance activity is part of a replacement activity if it is conducted in conjunction with the replacement. Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 27, 2003 23 ( 1) Capital Cost threshold for Equipment Replacement ( i) For an electric utility steam generating unit, as defined in 52.21( b)( 31), the fixed capital cost of the replacement partcomponent( s) plus the cost of any associated maintenance and repair activities that are part of the replacement shall not exceed 20 percent of the replacement value of the process unit, at the time the equipment is replaced.

( ii) For a process unit that is not an electric utility steam generating unit the fixed capital cost of the replacement partcomponent( s) plus the cost of any associated maintenance and repair activities that are part of the replacement shall not exceed 20 percent of the replacement value of the process unit, at the time the equipment is replaced.

( iii) In determining the replacement value of the process unit; and, except as otherwise allowed under paragraph ( cc)( 1)( ivii) of this section, the owner or operator shall basedetermine the replacement value of the process unit on an estimate of the fixed capital cost of constructing a new process unit, or on the current appraised value of the process unit.

( ivii) As an alternative to paragraph ( cc)( 1)( iiiii) Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 27, 2003 24 of this section for determining the replacement value of a process unit, an owner or operator may choose to use insurance value ( where the insurance value covers only complete replacement), investment value adjusted for inflation, or another accounting procedure if such procedure is based on Generally Accepted Accounting Principles,

provided that the owner or operator sends a notice to the reviewing authority. The first time that an owner or operator submits such a notice for a particular process unit, the notice may be submitted at any time, but any subsequent notice for that process unit may be submitted only at the beginning of the process unit's fiscal year.

Unless the owner or operator submits a notice to the reviewing authority, then paragraph ( cc)( 1)( iiiii) of this section will be used to establish the replacement value of the process unit. Once the owner or operator submits a notice to use an alternative accounting procedure, the owner or operator must continue to use that procedure for the entire fiscal year for that process unit. In subsequent fiscal years, the owner or operator must continue to use this selected procedure unless anand until the owner or operator sends another notice is sent to the reviewing authority selecting another procedure consistent with this Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 27, 2003 25 paragraph or paragraph ( cc)( 1)( iiiii) of this section at the beginning of such fiscal year.

( 2) Basic Design Parameters. The replacement does not change the basic design parameter( s) of the process unit to which the activity pertains.

( i) Except as provided in paragraph ( cc)( 2)( iii) of this section, for a process unit at a steam electric generating facility, the owner or operator may select as its basic design parameters either maximum hourly heat input and maximum hourly fuel consumption rate or maximum hourly electric output rate and maximum steam flow rate. When establishing fuel consumption specifications in terms of weight or volume, the minimum fuel quality based on British Thermal Units content shall be used for determining the basic design parameter( s) for a coal fired electric utility steam generating unit.

( ii) Except as provided in paragraph ( cc)( 2)( iii) of this section, the basic design parameter( s) for any process unit that is not at a steam electric generating facility are maximum rate of fuel or heat input, maximum rate of material input, or maximum rate of product output. Combustion process units will typically use maximum rate of fuel input.

For sources having multiple end products and raw materials, Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 27, 2003 26 the owner or operator must select the appropriate parameter for the dominant emission source of the process unitshould consider the primary product or primary raw material when selecting a basic design parameter.

( iii) If the owner or operator believes the basic design parameter( s) in paragraphs ( cc)( 2)( i) and ( ii) of this section is not appropriate for a specific industry or type of process unit, the owner or operator may propose to the reviewing authority an alternative basic design parameter( s) for the source's process unit( s). If the reviewing authority approves of the use of an alternative basic design parameter( s), the reviewing authority shall issue a permit that is legally enforceable that records such basic design parameter( s) and requires the owner or operator to comply with such parameter( s).

( iv) The owner or operator shall use credible information, such as results of historic maximum capability tests, design information from the manufacturer, or engineering calculations, in establishing the magnitude of the basic design parameter( s) specified in paragraphs ( cc)( 2)( i) and ( ii) of this section.

( v) If design information is not available for a process unit, then the owner or operator shall determine the Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 27, 2003 27 process unit's basic design parameter( s) using the maximum value achieved by the process unit in the five year period immediately preceding the planned activity.

( vi) Efficiency of a process unit is not a basic design parameter.

( 3) The replacement activity shall not cause the process unit to exceed any emission limitation, or operational limitation that has the effect of constraining emissions, that applies to the process unit and that is legally enforceable.


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES DATE: September 12, 2003 SUBJECT: Fenthion Response to LCMCD Comments TO: Fenthion RED Team FROM: Jackie Mosby, Acting Branch Chief Reregistration Branch 1 Special Review and Reregistration Division During the comment period for Bayer Environmental Science's ( Bayer) voluntary cancellation request for its fenthion registrations, the Agency received three sets of comments in support of the cancellation. After the close of the comment period, but before the Agency made its final determination on the cancellation request, the Agency received one additional set of comments. The additional set of comments supports the continued registration of fenthion products. The Agency reviewed all of the comments and decided to grant Bayer's voluntary cancellations. Please see the Federal Register Notice titled " Fenthion; Product Registrations Cancellation Order" ( FRL 7324 2) for details on the cancellation order. This memorandum specifically responds to the set of comments in support of continuing the fenthion registrations.

The submitter of the comments provided the following reasons for supporting the continued registration of fenthion:

1. No Adverse Effects Associated with Use of Fenthion The commenter made the statement that " Lee County Mosquito Control District, Fort Myers, Florida, has been applying fenthion for adult mosquito control since July 2, 1965, without any adverse effects to the environment, including birds." The commenter cites as evidence the fact that fenthion has been sprayed in the area around or adjacent to the J. N. " Ding" Darling National Wildlife Refuge, located on Sanibel Island, for ten years, and there have been no bird kills in the refuge associated with the spraying of fenthion.

Agency Response The Agency commends the commenter for its diligence in spraying and compliance with the label directions. As such, there should be no incidents on the refuge as long as fenthion is being applied according to the label directions. Spraying is not allowed over the refuge, and drift into that area should not be occurring; therefore, there should be no incidents, as there is no exposure. The real question concerning risk to birds is whether birds that are in sprayed areas are adversely affected. The information provided on the Ding Darling refuge is not probative of that point.

Non target species ( i. e. birds) in areas where fenthion is sprayed, however, could be adversely affected. The Agency's Interim Reregistration Eligibility Decision ( IRED) on fenthion concluded that acute dietary risk to birds from mosquito adulticide applications was " high" based on available information. The Agency also found " that fenthion spraying, especially repeated at frequent intervals, may cause mortality in a variety of bird species."

The IRED also discusses a number of incidents of bird mortality resulting from the spraying of fenthion. The IRED focuses particularly on incidents reported by the US Fish and Wildlife Service ( FWS) that occurred on Marco Island. According to the FWS, spraying of fenthion resulted in mortality of at least 16 bird species over approximately an eleven month time span. See memorandum by W. Erickson, re: Fenthion Marco Island Incidents. The Agency is also aware of a number of other bird incidents related to fenthion. See memorandum from M. Powell to K. David, re: Addendum to EFED's IRED Chapter for Fenthion, Based on Incident Reports ( July 31, 1996).

EPA does not believe that the information provided on the J. N. " Ding" Darling National Wildlife Refuge demonstrates that fenthion does not present an unreasonable risk of adverse effects to birds.

2. More Than One Pesticide for Mosquito Control Needed The commenter stated that there are " few tools for public that public health vector control specialists currently have available for adult mosquito control." The commenter stated that there are two products available that are equally efficacious for public health control, fenthion and naled, but that both are necessary in rotation in order to avoid pest resistence issues.

Agency Response The Agency agrees with the commenter that naled is an efficacious and appropriate alternative to fenthion. The Agency also agrees that it is useful to have more than one " tool" available to address a pest problem. However, when the Agency considered the risks and benefits for fenthion, as required by the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), the risks posed to birds and aquatic invertebrates were found to outweigh the benefits from its use.

3. There Are Problems with the Alternatives to Fenthion The commenter stated that alternatives other than naled, such as synthetic pyrethroids and malathion may not be used in Lee County, Florida, or in the case of natural pyrethrins, are in limited supply. Agency Response The Agency addressed the issue of alternatives to fenthion in the IRED ( see IRED Sections IV. E and IV. F). The Agency agrees with the commenter that there may be drawbacks to several of the alternatives; however, naled is an efficacious and appropriate alternative to fenthion, as used in Lee County. FIFRA does not require that multiple alternatives to a pesticide exist in order for the Agency to issue a cancellation order under FIFRA § 6( f).

4. CDC and HHS Appear to Support the Continued Use of Fenthion The commenter stated a Department of Health and Human Services ( HHS) in the Centers for Disease Control and Prevention ( CDC) official, Dr. Duane Gubler, stated that the loss of a single mosquito control tool would " seriously compromise" the CDC's ability to " prevent and control vector borne disease in the [ United States]."

The commenter also stated that the Agency cannot cancel fenthion, in light of its obligations under FIFRA § 4( n) to consult, when requested by the registrant, with the HHS before approving a request for a voluntary cancellation.

Agency Response Bayer requested, pursuant to FIFRA § 4( n), that EPA consult with HHS before canceling its fenthion registrations. After consulting with HHS, EPA may determine that the benefits of the public health or vector control pesticide are so significant as to warrant a commitment by HHS to conduct ( or arrange to conduct) studies needed to support continued registration of the pesticide. EPA sent a letter to CDC requesting consultation and inviting CDC to submit additional information on fenthion. EPA received a response from HHS, dated August 1, 2003, stating that it does not take exception to our decision to cancel fenthion, but indicating that more than one tool should remain available for mosquito control. EPA believes it has fulfilled its consultation requirement under FIFRA § 4( n).

EPA understands that individuals within HHS and CDC may support the continued registration of fenthion; however, even considering available information from HHS and CDC, EPA has yet to find fenthion eligible for reregistration. The Agency does not believe the commenter has provided sufficient justification to merit denying the voluntary cancellation request.

5. Outstanding Data Requirements The commenter stated that there have been discrepancies between the data gaps EPA identified in the IRED and the studies EPA has included in the Data Call In ( DCI) notices. The commenter suggested that there were no outstanding data requirements on which EPA could have pursued suspension or cancellation under FIFRA § 4( n) or § 6( b). The commenter also appeared to suggest that this confusion led Bayer to conclude that it did not have an economic stake in the fenthion registrations. The commenter referenced three studies in particular: developmental neurotoxicity, ecotoxicity, and worker exposure.

Agency Response With respect to the studies the commenter referenced, EPA notes the following:

Developmental neurotoxicity  as the commenter points out, this study was included in a 1999 DCI. Bayer's fenthion registrations were subject to this DCI, and Bayer was required to conduct the study. The commenter suggests that because Bayer went on to cancel the food uses associated with fenthion, the study is not necessary; however, EPA has never waived this data requirement for the fenthion registrations. Therefore, it is still a data gap and would need to be addressed in order for Bayer to continue its fenthion registrations.

Ecotoxicity and worker exposure  while these studies were listed as data gaps in the IRED, EPA decided not to issue a DCI for them, due to the fact that Bayer requested voluntary cancellation of all its fenthion registrations. However, if another registrant chose to apply for a fenthion registration in the future, and EPA determined that the application for registration met the standard for registration and was eligible for reregistration, EPA would either issue a DCI at that time, require that the data gaps be filled before registering the product, or, if appropriate, condition the registration on the fulfillment of the outstanding data gaps.

The Agency is not privy to all the factors, economic and otherwise, Bayer considered in deciding to request voluntary cancellation. In determining whether to grant a voluntary cancellation request, it is immaterial whether EPA could have cancelled the product on its own initiative. Furthermore, EPA does not believe that its failure to issue a DCI for a pesticide ( or potential confusion over data gaps) is a reason to deny a voluntary cancellation request. As noted above, EPA has fulfilled its obligation under FIFRA § 4( n).