[Federal Register Volume 62, Number 63 (Wednesday, April 2, 1997)]
[Proposed Rules]
[Pages 15754-15791]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7625]



[[Page 15753]]

_______________________________________________________________________

Part II





Environmental Protection Agency





_______________________________________________________________________



40 CFR Part 63



National Emission Standards for Hazardous Air Pollutants 
Pharmaceuticals Production; Proposed Rule

Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / 
Proposed Rules

[[Page 15754]]



ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[AD-FRL-5802-8]
RIN-2060-AE83


National Emission Standards for Hazardous Air Pollutants 
Pharmaceuticals Production

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule and notice of public hearing.

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

SUMMARY: The proposed standard would reduce air emissions of hazardous 
air pollutants (HAP) from existing and new facilities that manufacture 
pharmaceutical products. The agency intends that this proposed rule 
will have a common technology basis with a rule yet to be issued by 
EPA's Office of Water (OW); this will allow coordinated and cost 
effective compliance planning by the industry. In addition to 
soliciting comments on various aspects of the proposed rule, this 
document also solicits comments on possible approaches for the OW rule.
    The major HAP emitted by facilities covered by this proposed rule 
include methylene chloride, methanol, toluene, and hydrogen chloride. 
Methylene chloride is considered to be a human carcinogen and the other 
pollutants can cause noncancer health effects in humans. The proposed 
rule is estimated to reduce HAP emissions from existing facilities by 
22,000 megagrams per year (Mg/yr). It also reduces volatile organic 
compound (VOC) emissions.

DATES: Comments. Comments must be received on or before June 2, 1997.
    Public Hearing. If anyone contacts EPA requesting to speak at a 
public hearing by April 23, 1997, a public hearing will be held on May 
2, 1997 beginning at 10 a.m. Persons interested in attending the 
hearing should call Ms. Marguerite Thweatt at (919) 541-5673 to verify 
that a hearing will be held.
    Request to Speak at Hearing. Persons wishing to present oral 
testimony must contact EPA by April 23, 1997, by contacting Ms. 
Marguerite Thweatt.

ADDRESSES: Comments. Comments should be submitted (in duplicate, if 
possible) to: Air Docket Section (LE-131), Attention: Docket No. A-96-
03, U.S. Environmental Protection Agency, 401 M Street SW., Washington, 
DC 20460. The EPA requests that separate copies also be sent to the 
appropriate contact persons listed below. The public hearing, if 
required, will be held at the EPA's Office of Administration 
Auditorium, Research Triangle Park, North Carolina.

SUPPLEMENTARY INFORMATION: The information contained in this notice is 
also on the Technology Transfer Network (TTN). The TTN, EPA's 
electronic bulletin board, provides information and technology exchange 
in various areas of air pollution control. The service is free, except 
for the cost of a telephone call. Dial (919) 541-5472 for up to a 
14,400 bps modem transfer. In addition, the basis and purpose document 
(BPD), containing much of the rationale for these proposed standards, 
is also available on the TTN. The supplementary information document 
(SID) for the proposed standard, which contains a compilation of 
technical memoranda, may be obtained from the docket (entry 
#<greek-I><greek-I>-<greek-B>-1).
    Docket. Docket No. A-96-03, containing supporting information used 
in developing the proposed standards, is available for public 
inspection and copying between 8:30 a.m. and 3:30 p.m., Monday through 
Friday, at EPA's Air Docket Section, Waterside Mall, Room 1500, 1st 
Floor, 401 M Street SW., Washington, DC 20460. A reasonable fee may be 
charged for copying.
    For information concerning the MACT standard, contact Mr. Randy 
McDonald at (919) 541-5402, Organic Chemicals Group, Emission Standards 
Division (MD-13), U.S. Environmental Protection Agency, Research 
Triangle Park, North Carolina 27711. For further information concerning 
the effluent limitation guidelines pretreatment standards and new 
source performance standards, contact Dr. Frank H. Hund, at (202) 260-
7786, Engineering and Analysis Division (4303), U.S. Environmental 
Protection Agency, 401 M Street SW., Washington, DC. 20460.
    Regulated entities. Entities potentially regulated are those which 
produce pharmaceutical products and intermediates and are located at 
facilities that are major sources as defined in section 112 of the CAA. 
Regulated categories and entities include:

------------------------------------------------------------------------
            Category                        Regulated entities          
------------------------------------------------------------------------
Industry........................  <bullet> Producers of material        
                                   described by the SIC code 283.       
                                  <bullet> Producers of fermentation,   
                                   biological or natural extraction,    
                                   chemical synthesis, and formulation  
                                   products regulated by the Food and   
                                   Drug Administration.                 
                                  <bullet> Producers of components      
                                   (excluding excipients) of a          
                                   pharmaceutical formulations or       
                                   intermediates used in the production 
                                   of a pharmaceutical product.         
------------------------------------------------------------------------
This table is not intended to be exhaustive, but rather provides a guide
  for readers regarding entities likely to be regulated by this action. 
  This table lists the types of entities that EPA is now aware could    
  potentially be regulated by this action. Other types of entities not  
  listed in the table could also be regulated. To determine whether your
  facility, company, business, organization, etc., is regulated by this 
  action, you should carefully examine the applicability criteria in    
  Sec.  63.1250 of the rule. If you have questions regarding the        
  applicability of this action to a particular entity, consult the      
  person listed in the preceding FOR FURTHER INFORMATION CONTACT        
  section.                                                              

    The information presented in this preamble is organized as follows:

I. List of Source Categories
II. Background
    A. Summary of Considerations Made in Developing this Rule
    B. Regulatory Background
III. Authority for National Emission Standards for Hazardous Air 
Pollutants (NESHAP) Decision Process
    A. Source of Authority for NESHAP Development
    B. Criteria for Development of NESHAP
IV. Summary of Proposed Standards
    A. Source Categories to be Regulated
    B. Pollutants to be Regulated and Associated Environmental and 
Health Benefits
    C. Affected Sources
    D. Format of the Standards
    E. Basis and Level of Proposed Standards
    F. Compliance and Performance Test Provisions
    G. Monitoring Requirements
    H. Reporting and Recordkeeping Requirements
V. Summary Of Environmental, Energy, Cost, and Economic Impacts
    A. Facilities Affected by These NESHAP
    B. Air Impacts
    C. Water and Solid Waste Impacts
    D. Energy Impacts
    E. Cost Impacts
    F. Economic Impacts
VI. Emissions Averaging
VII. Regulation of the Pharmaceutical Manufacturing Industry Under 
the Clean Water Act
VIII. Solicitation of Comments
IX. Administrative Requirements
    A. Public Hearing
    B. Docket
    C. Executive Order 12866
    D. Enhancing the Intergovernmental Partnership Under Executive 
Order 12875
    E. Paperwork Reduction Act
    F. Regulatory Flexibility Act
    G. Unfunded Mandates
    H. Miscellaneous

[[Page 15755]]

I. List of Source Categories

    Section 112 of the amended Act requires that EPA evaluate and 
control emissions of HAP. The control of HAP is achieved through 
promulgation of emission standards under sections 112(d) and 112(f) and 
work practice and equipment standards under section 112(h) for 
categories of sources that emit HAP. On July 16, 1992, EPA published an 
initial list of major and area source categories to be regulated (57 FR 
31576). Included on that list were major sources emitting HAP from 
pharmaceuticals production.
    Production methods used in the manufacture of pharmaceutical 
products include both batch and continuous operations, although batch 
operations make up a majority of the processes. The sizes of the 
facilities range from those that make one product at the rate of 
several hundred kilograms per year (kg/yr) to those that produce 
numerous intermediates and final products on the scale of thousands of 
kilograms (megagrams [Mg]) per year. Air emissions of HAP compounds 
originate from breathing and withdrawal losses from storage tanks, 
venting of process vessels, leaks from piping and equipment used to 
transfer HAP compounds (equipment leaks), and volatilization of HAP 
from wastewater streams. Pollutants (HAP) emitted from the production 
processes include a range of compounds, including VOC. Among the most 
prevalent are methylene chloride and methanol, which account for nearly 
70 percent of all HAP emissions from this industry. Detailed 
information describing manufacturing processes and emissions can be 
found in the Basis and Purpose Document.
    As of 1992, over 80 U.S. companies at 270 facilities were producing 
pharmaceutical products. Manufacturing operations covered by this 
NESHAP include chemical synthesis, formulation, fermentation, and 
extraction processes and are generally classified under standard 
industrial classification 283. An estimated 101 facilities are 
considered to be major sources according to the CAA criterion of having 
the potential to emit 10 tons per year of any one HAP or 25 tons per 
year of combined HAP, based on 1992 emissions data. The proposed 
standard would apply to all major sources that produce pharmaceuticals. 
Area sources would not be subject to this standard.

II. Background

A. Summary of Considerations Made in Developing This Rule

    This regulation reduces emissions of many of the HAP listed in 
section 112(b)(1) of the CAAA. The alternatives considered in the 
development of this regulation, including those alternatives selected 
as standards for new and existing sources, are based on process and 
emissions data received from the existing facilities known by the EPA 
to be in operation.
    Regulatory alternatives more stringent than the MACT floor (minimum 
control level) were selected when they were judged to be reasonable, 
considering cost, nonair impacts, and energy requirements.
    The proposed standards give existing affected sources 3 years from 
the date of promulgation to comply. This is the maximum amount of time 
allowed by the Act. New affected sources are required to comply with 
the standard upon startup.
    Included in the proposed rule are methods for determining initial 
compliance as well as monitoring, recordkeeping and reporting 
requirements. All of these components are necessary to ensure that 
affected sources will comply with the standards both initially and over 
time. However, the EPA has made every effort to simplify the 
requirements in the rule. The EPA has also attempted to maintain 
consistency with existing regulations by either incorporating text from 
existing regulations or referencing the applicable sections.
    In addition, this rule contains an important and innovative 
pollution prevention alternative for the pharmaceutical industry that 
provides an option to reduce solvent consumption in lieu of installing 
end-of-pipe controls. The EPA has developed a regulation that provides 
a pollution prevention compliance alternative to the traditional 
control requirements, and the EPA encourages the pharmaceutical 
industry to meet the CAA requirements through its use. This alternative 
demonstrates EPA's commitment to developing regulations that are cost 
effective and flexible, and that reduce monitoring, recordkeeping, and 
reporting burdens.
    Representatives from other interested EPA offices and programs, 
including State and Regional environmental agency personnel, and 
representatives from industry participated in the regulatory 
development process as MACT partnership members. For example, Region 
II, acting as the lead, worked closely with the States of New York and 
New Jersey as well as the pharmaceutical industry in developing the 
pollution prevention alternative. The partnership members were given 
opportunities to review and comment on the regulation prior to 
proposal. Several issues presented in the solicitation of comments 
section reflect these comments. Industry, regulatory authorities, and 
environmental groups will have another opportunity to comment on the 
proposed standards and provide additional information during the public 
comment period.

B. Regulatory Background

    The proposed rule implements section 112(d) of the Clean Air Act 
(CAA) amendments of 1990, which require the Administrator to regulate 
emissions of HAP listed in section 112(b) of the CAA. The intent of 
this rule is to protect the public health by requiring new and existing 
major sources to reduce generation of emissions by using pollution 
prevention strategies or to control emissions to the level achievable 
by the maximum achievable control technology (MACT), taking into 
consideration the cost of achieving such emission reductions, any 
nonair quality and other air quality related health and environmental 
impacts, and energy requirements.
    In 1978, EPA published a control techniques document entitled 
``Control of Volatile Organic Emissions from Manufacture of Synthesized 
Pharmaceutical Products,'' EPA-450/2-78-029. The control technique 
guidelines document (CTG) contains a presumptive norm for reasonably 
available control technology (RACT) for the manufacturing operations 
covered under SIC Codes 2833 and 2834. This proposed rule does not 
affect the presumptive RACT guidelines, although a portion of emissions 
sources are covered by both the proposed regulation and the CTG 
document.
    In 1994, EPA promulgated National Emission Standards for Hazardous 
Air Pollutants for Certain Processes Subject to the Negotiated 
Regulation for Equipment Leaks. Pharmaceutical processes, defined as 
processes that synthesize pharmaceutical intermediates or final 
products using carbon tetrachloride or methylene chloride as a reactant 
or process solvent, are subject to this rule. The EPA is proposing 
today to require control of leaking components that are currently not 
subject to the Negotiated Regulation for Equipment Leaks, but that 
contain HAP and are associated with processes in this source category.

[[Page 15756]]

III. Authority for National Emission Standards for Hazardous Air 
Pollutants (NESHAP) Decision Process

A. Source of Authority for NESHAP Development

    Section 112 of the Clean Air Act gives the Environmental Protection 
Agency the authority to establish national standards to reduce air 
emissions from sources that emit one or more HAP. Section 112(b) 
contains a list of HAP to be regulated by NESHAP. Section 112(c) 
directs the Agency to use this pollutant list to develop and publish a 
list of source categories for which NESHAP will be developed; this list 
was published in the Federal Register on July 16, 1992 (57 FR 31576). 
The Agency must list all known categories and subcategories of ``major 
sources'' that emit one or more of the listed HAP. A major source is 
defined in section 112(a) as any stationary source or group of 
stationary sources located within a contiguous area and under common 
control that emits or has the potential to emit in the aggregate, 
considering controls, 10 tons per year or more of any one HAP or 25 
tons per year or more of any combination of HAP.

B. Criteria for Development of NESHAP

    The NESHAP are to be developed to control HAP emissions from both 
new and existing sources according to the statutory directives set out 
in section 112(d) of the Act. The statute requires the standards to 
reflect the maximum degree of reduction in emissions of HAP that is 
achievable for new or existing sources. This control level is referred 
to as the ``maximum achievable control technology'' (MACT). The 
selection of MACT must reflect consideration of the cost of achieving 
the emission reduction, any nonair quality health and environmental 
impacts, and energy requirements for control levels more stringent than 
the floor (described below).
    The MACT floor is the least stringent level for MACT standards. For 
new sources, the standards for a source category or subcategory ``shall 
not be less stringent than the emission control that is achieved in 
practice by the best controlled similar source, as determined by the 
Administrator'' (section 112(d)(3)). Existing source standards should 
be no less stringent than the average emission limitation achieved by 
the best performing 12 percent of the existing sources for categories 
and subcategories with 30 or more sources or the average emission 
limitation achieved by the best performing 5 sources for categories or 
subcategories with fewer than 30 sources (section 112(d)(3)). The 
determination of the MACT floor for existing sources under today's rule 
is that the average emission limitation achieved by the best performing 
sources is based on a measure of central tendency, such as the 
arithmetic mean, median, or mode. The determination of percentage 
reduction in the production-indexed consumption factors used in the 
pollution prevention alternative is based on the criteria that the 
alternative must achieve emissions reductions equivalent to what would 
have been achieved by complying with the MACT.

IV. Summary of Proposed Standards

A. Source Categories to be Regulated

    The proposed standards would regulate HAP emissions from 
pharmaceutical production facilities that are determined to be major 
sources. The standards would apply to existing sources as well as new 
sources.

B. Pollutants to be Regulated and Associated Environmental and Health 
Benefits

    Pharmaceutical production facilities emit an estimated 34,000 Mg/yr 
of organic and inorganic HAP's. Organic HAP's include methylene 
chloride, methanol, toluene, dimethylformamide, and hexane as well as 
other HAP's. Hydrogen chloride is an inorganic HAP emitted by this 
industry. The proposed rule would reduce HAP emissions from 
pharmaceutical facilities by 65 percent. Some of these pollutants are 
considered to be carcinogenic, and all can cause toxic health effects 
following exposure, including nausea, headaches, and possible 
reproductive effects. The EPA does recognize that the degree of adverse 
effects to human health can range from mild to severe. The extent and 
degree to which the human health effects may be experienced is 
dependent upon (1) the ambient concentration observed in the area 
(e.g., as influenced by emission rates, meteorological conditions, and 
terrain), (2) the frequency of and duration of exposures, (3) 
characteristics of exposed individuals (e.g., genetics, age, pre-
existing health conditions, and lifestyle) which vary significantly 
with the population, and (4) pollutant specific characteristics 
(toxicity, half-life in the environment, bioaccumulation, and 
persistence).
    Most of the organic HAP's emitted from this industry are classified 
as VOC. The proposed emission controls for HAP's will reduce non-HAP 
VOC emissions as well. Emissions of VOC have been associated with a 
variety of health and welfare impacts. Volatile organic compound 
emissions, together with nitrogen oxides, are precursors to the 
formation of tropospheric ozone. Exposure to ambient ozone is 
responsible for a series of public health impacts, such as alterations 
in lung capacity; eye, nose, and throat irritation; nausea; and 
aggravation of existing respiratory disease. Among the welfare impacts 
from exposure to ambient ozone include damage to selected commercial 
timber species and economic losses for commercially valuable crops such 
as soybeans and cotton.
    Hydrogen chloride is listed under section 112(r) of the CAA. The 
intent of section 112(r), Prevention of Accidental Releases, is to 
focus on chemicals that pose a significant hazard to the community 
should an accident occur, to prevent their accidental release, and to 
minimize consequences should a release occur. Hydrogen chloride, along 
with the other substances listed under section 112(r)(3), is listed 
because it is known to cause, or may be reasonably anticipated to cause 
death, injury, or serious adverse effects to human health or the 
environment (see 59 FR 4478, January 31, 1994). Sources that handle 
hydrogen chloride in greater quantities than the established threshold 
quantity under section 112(r)(5) will be subject to the risk management 
program requirements under section 112(r)(7) (see 58 FR 54190, October 
20, 1993).
    In essence, the MACT standards mandated by the CAA will ensure that 
all major sources of air toxic emissions achieve the level of control 
already being achieved by the better controlled and lower emitting 
sources in each category. This approach provides assurance to citizens 
that each major source of toxic air pollution will be required to 
effectively control its emissions. In addition, the emission reductions 
achieved by these proposed standards, when combined with the reductions 
achieved by other MACT standards, will contribute to achieving the 
primary goal of the CAA, which is to ``protect and enhance the quality 
of the Nations's air resources so as to promote the public health and 
welfare and the productive capacity of its population'' (the CAA, 
section 101(b)(1)).

C. Affected Sources

    Emission points identified from pharmaceuticals production include 
process vents, equipment leaks, storage tanks, wastewater collection 
and treatment systems, and heat exchange systems.
    The affected source for the purpose of this regulation is the 
facility-wide collection of process vents, storage

[[Page 15757]]

tanks, wastewater and associated treatment residuals, heat exchange 
systems, cooling towers, and equipment components that are associated 
with pharmaceutical manufacturing operations. Based on this definition 
of affected source, new sources are created by reconstructing existing 
sources or constructing new ``greenfield'' facilities. Also, if an 
additional pharmaceutical manufacturing process unit(s) is added to a 
plant site that is a major source, the addition will be subject to the 
requirements for a new source provided that the addition meets the 
definition of construction in Sec. 63.2 of subpart A (General 
Provisions); the new unit has the potential to emit 10 tons per year or 
more of any one HAP or 25 tons per year or more of any combination of 
HAP; and the process unit(s) is dedicated.

D. Format of the Standards

    The standards for process vents are presented in a combination of 
percent reduction and mass limit format. Facilities will have the 
option of using any control technology, as long as the HAP reductions 
or mass limitations are achieved. The format of the standards for 
storage tanks are a combination of equipment standard and performance 
standard--tanks which require control are required to be fitted with 
floating roofs or with add-on devices meeting a percent removal 
requirement. The standards for wastewater emission sources offer two 
alternative formats for achieving compliance, a percent removal, or the 
use of reference control technologies. Equipment leak standards are in 
the form of equipment/work practice standards. Facilities would be 
required to implement the program specified in the proposed regulation 
to achieve compliance with the standard.
    An alternative pollution prevention standard is also being 
proposed. This standard can be met in lieu of meeting separate 
standards for the four emission source types associated with each 
pharmaceutical production process. The format for this alternative 
standard is in a kg HAP consumption reduction per kg product format.

E. Basis and Level of Proposed Standards

    Detailed information describing the approach used to determine MACT 
floors and regulatory alternatives for the pharmaceuticals production 
source category can be found in the basis and purpose document.
    The proposed standards for existing and new affected sources are 
summarized in Table 1. The MACT standard for most existing process 
vents was set at the floor level of control. The MACT floor was 
determined from the 12 facilities that represented the best performing 
12 percent of the existing 101 major sources. The floor was calculated 
to be 93 percent control facility-wide. The proposed standards would 
require existing sources to reduce emissions from the sum of all vents 
within a process to 900 kg/yr (2,000 pounds per year [lb/yr]), 
considering control, or meet an overall process control level of 93 
percent. Both calculations meet the requirements of the floor as 
determined on a facility wide basis. Additionally, a regulatory 
alternative beyond the floor was developed that requires 98 percent 
control of some large vents. An applicability cutoff was developed for 
this alternative based on a linear equation relating vent flowrate and 
HAP load. The cost of this alternative above the floor is $1,000/Mg and 
was judged to be reasonable. Process vents meeting the annual emissions 
and flowrate criteria are required to achieve 98 percent control, 
independent of the overall 93 percent requirement.

                                                Table 1.--Proposed Standards for New and Existing Sources                                               
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Applicability                                      Requirement                  
         Emission source           New or existing?  ---------------------------------------------------------------------------------------------------
                                                        Applicability level             Cutoff             Control efficiency         Emission limit    
--------------------------------------------------------------------------------------------------------------------------------------------------------
Process.........................  New...............  Processes..............  <gr-thn-eq>400 lb/yr     98%                      .......................
                                                                                uncontrolled.                                                           
                                  Existing..........  Processes..............  <gr-thn-eq>2,000 lb/yr   93%; 98% for individual  2,000 lb/yr.           
                                                                                controlled.              vents meeting cutoff                           
                                                                                                         based on flow and                              
                                                                                                         emissions.                                     
Storage tanks...................  New and existing..  <gr-thn-eq>10,000 gal    <gr-thn-eq>1.9 psia      90%                      .......................
                                                       and <20,000 gal.         vapor pressure of                                                       
                                                                                liquid stored.                                                          
                                                      <gr-thn-eq>20,000......  <gr-thn-eq>1.9 psia      95%....................                         
                                                                                vapor pressure of                                                       
                                                                                liquid stored.                                                          
Wastewater......................  New and existing..  >1 Mg/yr total HAP load  <gr-thn-eq>1,300 ppm at  99% reduction of Table                          
                                                       from all POD within a    POD of Table 2 HAP.      2 HAP.                                         
                                                       process or any single                                                                            
                                                       POD.                                                                                             
                                                                               <gr-thn-eq>5,200 ppmw    99% reduction of Table                          
                                                                                at POD of total HAP      2 HAP.                                         
                                                                                load.                                                                   
                                                                                                        90% reduction of Table                          
                                                                                                         3 HAP.                                         
                                                                                                        95% reduction of total                          
                                                                                                         HAP using biotreatment.                        
                                                      >1 Mg/yr total HAP load  <gr-thn-eq>10,000 ppmw   99% reduction of Table                          
                                                       from facility.           at POD of total HAP      2 HAP.                                         
                                                                                load.                                                                   
                                                                                                        90% reduction of Table                          
                                                                                                         3 HAP.                                         
                                                                                                        95% reduction of total                          
                                                                                                         HAP using biotreatment.                        
                                  New...............  >1 Mg/yr total HAP load  <gr-thn-eq>110,000 ppmw  99% reduction of Table                          
                                                       from all POD within a    at POD of Table 3 HAP.   3 HAP.                                         
                                                       process or any single                                                                            
                                                       POD.                                                                                             
Equipment leaks.................  New and existing..  All components in HAP    .......................  LDAR program...........                         
                                                       service excluding                                                                                
                                                       components covered by                                                                            
                                                       subpart H.                                                                                       
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 15758]]

    The MACT standard for process vents at new sources was set at the 
floor level of control. The MACT floor was determined from the best 
controlled similar source and is based on the most stringent control 
level achieved for both chemical synthesis and formulation type 
processes. The proposed standards for new sources would require 98 
percent control of process vents with uncontrolled emissions greater 
than 180 kg/yr (400 lb/yr).
    The MACT floor for small, medium, and large storage tanks is 90 
percent control for tanks storing liquids with total HAP vapor pressure 
greater than or equal to 1.9 psia at existing sources. The floor was 
determined from the twelve facilities that had the highest control 
level for storage tanks. The EPA evaluated the impacts of a regulatory 
alternative beyond the floor that would require 95 percent control of 
tanks greater than or equal to 20,000 gallons. Floating roof technology 
has been demonstrated to achieve 95 percent control and is considerably 
less expensive than add-on control; and it can be applied to 20,000 
gallon tanks. Therefore, there is no additional cost for the regulatory 
alternative above the floor. The MACT for new sources is set at the 
same level as the MACT for existing sources because it has been 
determined that no facility is controlling tanks beyond the level 
required by the regulatory alternative for existing sources; therefore 
MACT would be no less stringent than the floor. The proposed standards 
would require existing and new sources to control storage tanks having 
volumes greater than or equal to 38 cubic meters (m\3\) (10,000 
gallons), and storing material with a vapor pressure of greater than or 
equal to 13.1 kPa (1.9 psi). The proposed standards require that tanks 
with capacities greater than or equal to 38 m\3\ and less than 75 m\3\ 
be controlled to a level of 90 percent and tanks greater than or equal 
to 75 m\3\ be controlled to 95 percent. One of the following control 
systems can be applied to meet these requirements:
    1. An internal floating roof with specified seals and fittings;
    2. An external floating roof with specified seals and fittings;
    3. An external floating roof converted to an internal floating roof 
with specified seals and fittings; or
    4. A closed vent system with the appropriate 90 or 95 percent 
efficient control device.
    The MACT floor for wastewater at existing sources was determined to 
be 54 percent control of HAP from the total wastewater streams at the 
top twelve facilities. The EPA calculated HAP concentration cutoffs for 
wastewater streams, cutoffs above which steam stripping of wastewater 
streams would result in a level of control as stringent as the floor. 
This approach is similar to the HON and allows for the control of those 
wastewater streams containing the most significant amount of HAP. The 
cutoffs represent the MACT floor level of control. The proposed 
standards would require existing sources to control wastewater with the 
following characteristics at the point of determination (POD):
    1. Streams having partially soluble HAP compound concentrations of 
1,300 ppmw or greater and a total yearly process HAP load of 1 Mg/yr or 
greater or any single POD load of 1 Mg/yr or greater;
    2. Streams having a combined total HAP concentration of 5,200 ppmw 
or greater and a total yearly process HAP load of 1 Mg/yr or greater or 
any single POD load of 1 Mg/yr or greater; or
    3. Streams having a total HAP concentration of 10,000 ppmw with a 
total facility HAP load of 1 Mg/yr or greater.
    The proposed standards require that the control of wastewater 
emissions be accomplished in one of the following manners:
    1. Using a design biotreatment system for soluble HAP;
    2. Demonstrating removals achieving 99 percent by weight of 
partially soluble compounds, and 90 percent by weight of soluble 
compounds, from treatment systems; or
    3. Demonstrating a removal of 95 percent by weight of total organic 
HAP from treatment systems.
    For new sources, the MACT floor for wastewater is based on a 
facility that currently incinerates a significant percentage of 
wastewater containing HAP's in an incinerator combusting a mixture of 
wastes. The proposed standards would require the same applicability and 
control requirements described above for existing sources plus require 
an increased removal of solubles (from 90 to 99 percent) for streams 
having a soluble HAP concentration of 110,000 ppmw at any of the load 
criteria (1 Mg/yr total HAP from the process, POD, or facility).
    The MACT floor for equipment leaks was found to be negligible for 
new and existing sources. The regulatory alternative above the floor is 
the implementation of a leak detection and repair program, patterned 
after 40 CFR part 63 subpart H. The cost of the regulatory alternative 
was estimated to be $1,000/Mg and was judged to be reasonable. The 
proposed standards would require that new and existing sources 
implement a leak detection and repair (LDAR) program that is modified 
from the program specified in the Negotiated Regulation for Equipment 
Leaks (40 CFR part 63, subpart H) to apply specifically to the 
pharmaceutical industry. The LDAR program specified under subpart H 
requires specific equipment modifications and work practices that 
reduce emissions from equipment leaks. Modifications to this program 
for this rule include the lessening of the monitoring frequency for 
pumps from monthly to quarterly monitoring (based on the specific data 
from pharmaceutical manufacturing operations) and the treatment of 
emissions from receivers and surge control vessels in the process vent 
provisions. In response to comments received from industry during the 
standard development process, EPA will consider consolidating the 
equipment leaks program specified in this subpart (appendix GGGA) with 
the part of the 40 CFR part 63 subpart H LDAR program that applies to 
pharmaceutical facilities after promulgation of subpart GGG. The EPA is 
currently in the process of separately proposing clarifying changes to 
certain provisions of 40 CFR part 63 subpart H, among them, provisions 
relating to the monitoring requirements for unsafe and difficult to 
monitor components. Lastly, based on current industry comments that 
suggest minimal use of a Quality Improvement Plan (QIP) at 
pharmaceutical plants, EPA is considering eliminating the requirement 
of implementing a QIP for the pharmaceutical rule in favor of allowing 
more frequent monitoring when nominal leakage rates are exceeded and is 
soliciting comments on whether the QIP should be included in the 
subpart GGG LDAR program.
1. Alternative Pollution Prevention Standard
    The proposed rule also includes a pollution prevention (P2) 
alternative standard that meets the requirement of the MACT floor and 
can be implemented in lieu of the requirements described above for 
existing sources. Two options included in the alternative standard are 
described in Table 2. The P2 options were developed to provide a way 
for facilities to comply with the MACT standard by reducing overall 
consumption of HAP in their processes. This alternative does not apply 
to HAP that are used as reactants. In the first option, which is 
applicable to existing processes, owners and operators can satisfy the 
MACT requirements for all emission source types associated with each 
process by demonstrating that the

[[Page 15759]]

production-indexed consumption of HAP has decreased by 75 percent from 
a baseline set no earlier than the 1987 calendar year. The production-
indexed consumption factor is expressed as kg HAP consumed/kg product 
produced. The numerator in the kg/kg factor is the total consumption of 
material, which describes all the different areas where material can be 
consumed, either through losses to the environment, consumption in the 
process as a reactant, or otherwise destroyed. Consumption, rather than 
emissions, is tracked because it can be used as a true measure of 
pollution prevention; any decrease in consumption for the same unit of 
product generated must involve some type of increase in process 
efficiency, including reduction of waste, increased product yield, and 
in-process recycling. Because HAP are used generally as solvents in 
this industry, reductions in consumption can be generally associated 
with reductions in losses to air, water, or solid waste.

                    Table 2.--Alternative P2 Standard                   
------------------------------------------------------------------------
             Option                      Description of P2 option       
------------------------------------------------------------------------
1...............................  Demonstrate a 75% reduction in the kg 
                                   consumption/kg production factor from
                                   a baseline year of 1987.             
2...............................  Demonstrate a 50% reduction in the kg/
                                   kg and additional reduction from add-
                                   on control equivalent to yield 75%   
                                   overall reduction in kg/kg.          
------------------------------------------------------------------------

    The second option also uses the production-indexed consumption 
factor and is also applied to existing processes. It encourages and 
allows owners and operators to supplement reductions achieved with P2 
with add-on controls. The EPA believes that such an option will provide 
greater flexibility and cost efficiency to the operators who already 
may have some add-on controls. Owners and operators must demonstrate 
reductions in the kg/kg factor of 50 percent via P2 measures and the 
remaining 25 percent by add-on controls. A total reduction of 75 
percent will be required under both P2 options.

F. Compliance and Performance Test Provisions

1. Proposed Standards
    a. Process Vents. To determine compliance with the percent 
reduction requirement for pharmaceutical process vents, uncontrolled 
and controlled emissions from all process vents within the process 
shall be quantified to demonstrate the appropriate overall reduction 
requirements (93 percent or 98 percent). For process vents controlled 
by devices handling less than 10 tons per year, the owner or operator 
can either test or use calculational methodologies to determine the 
uncontrolled and controlled emission rates from individual process 
vents. For process vents controlled by devices handling more than 10 
tons per year, tests are required to determine the reduction efficiency 
of each device. Performance test provisions have been structured to 
account for the worst case emissions for devices controlling streams 
with batch characteristics. Control devices that have previously been 
tested under conditions required by this standard and condensers are 
exempt from performance testing.
    b. Storage Tanks and Wastewater. For demonstrating compliance with 
various requirements, the proposed rule allows the owners or operators 
to either conduct performance tests or to document compliance using 
engineering calculations. Appropriate compliance and monitoring 
provisions are specified in the regulation.
    c. Equipment Leaks. To determine compliance with the standard for 
equipment leaks, facilities will have to demonstrate that a LDAR 
program meeting the requirements of the LDAR program specified in the 
rule is in use.
2. Pollution Prevention Alternative Standards
    Initial demonstration of compliance with the P2 alternative 
standards would be accomplished by documenting yearly quantities of HAP 
raw materials and products using available records, including standard 
purchasing and accounting records, and calculating the kg/kg values. 
Procedures are also specified to demonstrate that the required 
reductions are achieved by the control devices used to meet option 2.

G. Monitoring Requirements

1. Actual Standards
    Monitoring is required by the proposed standards to determine 
whether a source is in compliance on an ongoing basis. This monitoring 
is done either by continuously measuring emission reductions directly 
or by continuously measuring a site-specific operating parameter, the 
value of which is established by the owner or operator during the 
initial compliance determination. The operating parameter value is 
defined as the minimum or maximum value established for a control 
device or process parameter that, if achieved on a daily average by 
itself or in combination with one or more other operating parameter 
values, determines that an owner or operator is complying with the 
applicable emission standards. These parameters are required to be 
monitored at 15-minute intervals throughout the operation of the 
control device. For devices controlling streams totaling less than 1 
ton/yr, only a site-specific periodic verification that the devices are 
operating as designed is required to demonstrate continuous compliance. 
Owners and operators must determine the most appropriate method of 
verification and propose this method to the Agency for approval in the 
precompliance report, which is due 1 year prior to the compliance date 
of the standard.
2. Alternative Standard
    Owners and operators electing to use the P2 alternative can 
demonstrate ongoing compliance by calculating a monthly rolling average 
of the kg HAP/kg factor for each applicable process or portions of the 
process. In addition, owners and operator electing to use P2 Option 2 
would have to monitor the emission reduction obtained through the use 
of traditional controls using the methods described above.

H. Reporting and Recordkeeping Requirements

    The owner or operator of any pharmaceutical source subject to these 
standards would be required to fulfill all reporting requirements 
outlined in the General Provisions to 40 CFR part 63. A table included 
in the proposed rule designates which sections of subpart A apply to 
the proposed rule. Specific recordkeeping and reporting requirements 
for each type of emission point are also included in the proposed rule.

V. Summary of Environmental, Energy, Cost, and Economic Impacts

A. Facilities Affected by These NESHAP

    These NESHAP would affect pharmaceutical production facilities that 
are major sources in themselves, or constitute a portion of a major 
source. There are 270 existing facilities manufacturing 
pharmaceuticals, 101 of which were assumed to be major sources for the 
purpose of developing these standards and calculating impacts. The 
expected rate of growth for the pharmaceutical industry is expected to 
be 2.4 percent per year through 1998.

B. Air Impacts

    The proposed standards would reduce HAP emissions from existing 
sources by 22,000 (Mg/yr) (24,000 tons per year (tons/yr)) from the 
baseline level, a reduction of 65 percent from baseline,

[[Page 15760]]

and 75 percent from uncontrolled. These reductions would also occur if 
facilities elect to implement the alternative pollution prevention 
standard. The proposed standard would also reduce VOC emissions.

C. Water and Solid Waste Impacts

    Much of the steam stripping operations will result in recoverable 
material. However, the new source requirement for very rich soluble 
HAP-containing wastewater is expected to generate solid waste. An 
average of 900 tons per year per facility was estimated to determine 
impacts.

D. Energy Impacts

    The proposed standards for the pharmaceuticals source category 
would require an additional energy usage of 2,400 x 10\9\ British 
thermal units per year (Btu/yr).

E. Cost Impacts

    The emission reductions that would be required by this regulation 
could be met using one or more of several different techniques. To 
determine costs, certain control scenarios were assumed. The scenarios 
used in costing were judged to be the most feasible scenarios possible 
for meeting the requirements of the proposed standards from a technical 
and cost standpoint. The total control cost includes the capital cost 
to install the control device, the costs involved in operating the 
control device, and costs associated with monitoring the device to 
ensure compliance. Monitoring costs include the cost to purchase and 
operate monitoring devices, as well as reporting and recordkeeping 
costs required to demonstrate compliance. Nationwide, the total annual 
cost of this standard to the industry for existing and new sources is 
approximately $62 million and $11 million respectively. The EPA 
believes that monitoring, reporting, and recordkeeping costs will be 
substantially reduced for the facilities opting to comply via the P2 
option. Additionally, EPA also believes that overall control costs will 
also be substantially reduced as a result of compliance with the P2 
option.

F. Economic Impacts

    The economic impact analysis of this standard shows that the 
estimated price increase from compliance with the recommended standard 
for process vents, storage tanks, and wastewater is 1.1 percent. 
Estimated reduction in market output is 1.9 percent.
    No plant closures are expected from compliance with this set of 
alternatives. For more information, consult the economic impact report 
entitled ``Economic Analysis of Air Pollution Regulation Regulations: 
Pharmaceutical Industry, August 1996.''

VI. Emissions Averaging

    Emissions averaging is being considered as part of this rule. The 
rule includes provisions that permit emissions averaging within 
existing process vent and storage tank planks. The industry is 
interested in emissions averaging for only these two emission point 
types. The provisions consist of a streamlined version of the Hazardous 
Organic NESHAP (HON) emissions averaging provisions (40 CFR part 63 
subpart G) modified specifically for the pharmaceutical industry. 
However, the constraints are essentially the same as those contained in 
the HON.

VII. Regulation of the Pharmaceutical Manufacturing Industry Under the 
Clean Water Act

    The Clean Water Act (CWA) and a recent settlement agreement (see 59 
FR 25869) require EPA to develop effluent limitations guidelines and 
standards regulations for certain industrial categories. The 
Pharmaceutical Manufacturing Industry is one of the categories required 
to be regulated by this settlement agreement. The EPA's most recent 
regulatory proposal for the pharmaceutical industry was on May 2, 1995 
(60 FR 21592.)
    In the May 2, 1995 proposal, EPA proposed best available technology 
(BAT) economically achievable and new source performance standards 
(NSPS) regulations for 53 volatile and semivolatile organic pollutants 
of which 17 are HAP. The Agency also proposed PSES and PSNS for 45 
volatile organic pollutants of which 16 are HAP. (Air emissions of HAP 
by major sources will be controlled by this MACT rule provided that the 
wastewater streams containing the HAP meet concentration criteria for 
soluble and partially soluble HAP in today's proposal.)
    The EPA identified the following industry subcategories in the 
proposed effluent guidelines: Fermentation (A), biological and natural 
extraction (B), chemical synthesis (C) and formulation (D).
    The proposed BAT end-of-pipe limitations would control the 
discharge of 17 HAP and 36 non-HAP at both A and C and B and D 
manufacturing facilities. The technology basis for the BAT limitations 
for A and C subcategory facilities was in-plant steam stripping 
followed by advanced biological treatment while the technology basis of 
the BAT limitations for B and D subcategory facilities was advanced 
biological treatment. Since these proposed limitations are set at the 
end-of-pipe, they would not prevent air emissions of these pollutants 
prior to discharge.
    Also proposed in the May 2, 1995 notice (see coproposal A) were 
PSES for 8 HAP and 4 non-HAP set in-plant at a point roughly equivalent 
to the MACT standards point of determination while PSES for 8 other HAP 
and 25 non-HAP were proposed at the end-of-pipe discharge point. The 
technology basis for the HAP and non-HAP pollutants alike was steam 
stripping. Under coproposal B, only in-plant PSES for the eight HAP 
would be established. The Agency decided to establish an in-plant 
monitoring point for 12 highly volatile pollutants (including the 8 
HAP) because measuring compliance at the end-of-pipe monitoring point 
was not considered practical for these pollutants due to the high 
potential for air stripping associated with them and commingling with 
other process wastewater not containing any of the 12 pollutants. As is 
the case with the BAT end-of-pipe limitations, the end-of-pipe proposed 
PSES would not prevent air emissions of HAP at facilities prior to the 
discharge point to the municipal sewer systems.
    The MACT standards being proposed today will control HAP emissions 
(if promulgated) at major source pharmaceutical plants with steam 
stripping as the reference control technology. The EPA is considering 
revising the BAT limitations for subcategories A and C based on only 
advanced biological treatment performance data. This would in effect 
shift control of HAP air emissions and wastewater pollutant discharges 
of the HAP to the MACT standards. With regard to control of non-HAP at 
major sources, the Agency believes that the significant reductions in 
HAP emissions required by the proposed MACT standards will also result 
in incidental reductions in non-HAP air emissions because many non-HAP 
are found in the same wastewater streams as the HAP, and thus will be 
steam stripped along with the HAP. While control of air emissions of 
HAP and non-HAP VOC's will be addressed to some extent under the CAA, 
additional control of water discharges of the VOC's from direct 
dischargers needs to be addressed under the Clean Water Act using as a 
basis the BAT limitations and NSPS proposed on May 2, 1995.
    The MACT standards being proposed today would apply to select 
streams at 60, out of a possible 259, pharmaceutical indirect 
dischargers deemed to be major sources of air

[[Page 15761]]

emissions. Only those streams which meet the flow and concentration 
cutoffs established for HAP would require control. Assuming that EPA's 
pass-through analysis does not change and coproposal A is chosen, EPA 
estimates that today's proposed MACT rule would reduce the load of 
VOC's to POTW's from pharmaceutical manufacturing plants by 
approximately 48 percent. Part or all of the remainder of the pollutant 
loadings to POTW's may need to be controlled by additional pretreatment 
requirements. The Agency is considering three options for setting 
pretreatment standards (PSES and PSNS) to address HAP and non-HAP 
wastewater pollutant discharges not controlled by today's proposed MACT 
standard.
    Under the first option (which has been suggested by commenters), 
compliance with today's MACT standards would constitute compliance with 
final PSES and PSNS for all manufacturing subcategories. However, since 
compliance with the MACT regulation requires only one demonstration by 
the facility, EPA is considering some form of regular monitoring to 
verify compliance with wastewater discharge standards. Facilities could 
either monitor for individual HAP or non-HAP on a regular basis or for 
some indicator pollutant parameter whose regulatory compliance level 
would be established at the same time that MACT rule compliance 
demonstration is performed. This option would result in control of 
about 48 percent of the VOC pollutant load that is currently being 
discharged to POTW's by pharmaceutical facilities.
    Under the second option, and in addition to the MACT regulations on 
selected streams at 60 indirect dischargers, EPA would establish 
pretreatment standards for the streams and pollutants not controlled by 
the MACT regulations. The level of control dictated by these additional 
standards would be the same level as that of the MACT standards (90 
percent reduction for soluble organics and 99 percent for partially 
soluble organics). The pretreatment standards could either be in the 
form of percent reduction requirements for individual pollutants or 
single number standards resulting from the application of the MACT 
percent reduction requirements. The EPA estimates that this option 
would reduce the discharge of pollutants to POTW's by an additional 45 
percent over the first option.
    The third option would involve promulgating the coproposal A 
pretreatment standards for all indirect dischargers at the end-of-pipe 
regulatory point. These pretreatment standards would apply to all 
streams at facilities designated as major sources regardless of whether 
the streams were within the concentration cutoffs for HAP and would be 
established for all pollutants which pass-through. The level of control 
dictated by these standards would be the coproposal A level with the 
exception that standards for 12 pollutants which were established in-
plant will now be set at the end-of-pipe and adjusted downward to 
account for dilution due to mixing with other waste streams. Other 
changes in parameters or limitations may result from the evaluation of 
comments and receipt of additional performance data. Using the proposed 
limitations, EPA estimates that this option would reduce the discharge 
of pollutants to POTW's by an additional 29 percent over the first 
option.
    The EPA is considering revising its pass-through analysis for water 
soluble, biodegradable pollutants such as methanol, acetone, 
isopropanol and ethanol based on approaches suggested by commenters on 
the May 2, 1995 pharmaceutical proposal as well as the approaches used 
in the Pesticide Chemicals Manufacturing and Organic Chemicals, 
Plastics, and Synthetic Fibers (OCPSF) rulemakings. In general, 
pollutants are considered to pass-through POTW's if the average percent 
removal achieved by well operated POTW's is less than that achieved by 
the BAT model treatment systems. The EPA is considering specifically 
the methodology modifications employed in the evaluation for phenol, a 
biodegradable water soluble pollutant as discussed in the Pesticides 
and OCPSF rulemakings (see 59 FR 50638, 50664-65, September 28, 1993 
and 58 FR 36872, 36885-86, July 9, 1993). Among the modifications 
suggested by the commenters were: (1) Using only data from acclimated 
POTW systems to determine POTW removal; (2) finding no pass-through for 
pollutants if the differential between the model BAT percent removal 
and the POTW percent removal for a pollutant is less than 5 percent 
and; (3) utilizing a higher Henry's Law Constant cutoff when pass 
through is determined by the volatile override approach (pollutants 
which have a higher Henry's Law Constant value than the cutoff are 
presumed to pass-through using this methodology).
    The Agency is reevaluating its proposed pass-through analysis 
because of the comments received concerning it and to be more 
consistent with today's proposed MACT standards for soluble organic HAP 
which allows the biodegradation achieved by POTW's to be included in 
the compliance demonstration for these pollutants. Today's MACT 
standards require a demonstration of at least a 90 percent reduction in 
air emissions from wastewater of water soluble biodegradable HAP. As a 
result, a finding of pass-through may result in duplicative and 
somewhat inconsistent control (by water and air regulations) for some 
pollutants. The EPA solicits comments on possible revisions to its 
pass-through methodology as applied to water soluble, biodegradable 
pollutants.
    The EPA is soliciting comments on approaches for revising the 
limitations for direct and indirect dischargers in the proposed 
effluent guidelines for the pharmaceutical industry (60 FR 21592, May 
2, 1995). The intent of all of these approaches is to integrate the 
regulation of emissions into the air and waters of the United States. 
If EPA develops any additional data related to the possible revisions, 
those data will be made available to the public.
    The EPA may proceed with final action on the effluent guidelines, 
taking into account comments and data received in response to this 
notice.

VIII. Solicitation of Comments

    The Administrator welcomes comments from interested persons on any 
aspect of the proposed rule, and on any statement in the preamble or 
the referenced supporting documents. The proposed rule was developed on 
the basis of information available. The Administrator is specifically 
requesting factual information that may support either the approach 
taken in the proposed standards or an alternate approach. In order to 
receive proper consideration, documentation or data should be provided. 
This section requests comments on specific issues identified during the 
development of the standard. Additionally, EPA is soliciting comments 
regarding the interaction of this standard with the Title V operating 
permits program.
    The EPA is requesting comments and data on establishing the 
applicability of process vent control requirements on a process basis, 
as opposed to an equipment or facility basis. The basis and purpose 
document included in the administrative record outlines the rationale 
for establishing applicability on a process basis. Second, the EPA is 
soliciting general comments on the adequacy of emission estimation 
procedures to determine compliance for batch processes. Comments from 
State partnership members indicate that some batch operations, such as 
distillation, may contribute to considerably more emissions than would 
otherwise be

[[Page 15762]]

predicted. In some cases, unless 100 percent capture is achieved by the 
condenser acting as a recovery device on boiling operations, there may 
be uncontrolled emissions that are not being estimated. The State 
partnership members recommend that facilities compare their HAP mass 
balance to estimated HAP losses. When large discrepancies exist, the 
facility may need to monitor large process condensers. Third, the EPA 
is soliciting comments on the definition of a pharmaceutical product 
and isolated intermediate. In particular, whether Standard Industrial 
Classification code #283 and coverage by the Food and Drug 
Administration (FDA) rules are adequate to identify a pharmaceutical 
process covered by this regulation. The proposed rule considers 
isolated intermediates to be the same as pharmaceutical products in 
applicability determinations, e.g., the 2,000 lb/yr cutoff applies to 
isolated intermediates. The EPA is soliciting comments on the 
definition of isolated intermediates and the appropriateness of 
applying the cutoff to isolated intermediates. Fourth, EPA is 
soliciting comment on the adequacy and appropriateness of the new 
source MACT requirements for process vents. As set out in the basis and 
purpose document, EPA set the cutoff and level of control for the floor 
based on its analysis of the data showing that the characteristics of 
the emission streams are similar. The industry, however, believes that 
the basis of the cutoff is not representative of the industry as a 
whole. The EPA will consider other proposals for setting the cutoff at 
a less stringent level, taking into consideration statutory and 
regulatory requirements.
    The EPA is soliciting comments on several aspects of performance 
testing and monitoring. The rule currently requires performance testing 
to document efficiencies for control devices that are used to reduce 
uncontrolled emissions of 10 tons per year or more. The rule currently 
requires that the performance test be conducted under ``worst-case'' 
conditions and provides for three options--absolute, representative, 
and hypothetical worst-case. The rule also allows for testing during 
normal operations. However, because of the noncontinuous, batch nature 
of processing in this industry, testing under normal conditions may not 
indicate control device performance under more challenging conditions. 
Therefore, the proposed rule requires that the test conditions be 
defined and operation be limited by those conditions that existed 
during testing. The rule requires that the test conditions be defined 
in the Precompliance report and characterized by the HAP composition 
and conditions of vent stream entering the control device. It is 
because of the batch nature of processing in this industry that the EPA 
has a higher level of confidence in a facility's compliance with the 
standard if the performance of the control device has been tested under 
worst-case conditions. Therefore, testing under less rigorous, normal 
conditions limits the range of vent stream conditions for which initial 
compliance has been demonstrated. The EPA is soliciting comments on 
appropriate test conditions to be defined for different types of 
control devices, especially scrubbers and carbon adsorbers.
    The proposed rule provides for parametric monitoring to comply with 
the standard and includes specific operating parameters to be 
monitored. The EPA is soliciting comments on the use of alternative 
parameters without the requirement of prior notification in the 
Precompliance report. Parameters other than those specified in the rule 
that could be used to demonstrate compliance include: (1) or 
condensers, coolant temperature and flow (only with emissions testing), 
(2) for scrubbers, measurement of pressure drop or scrubber fluid 
composition, and (3) for carbon adsorbers, periodic vent testing and/or 
predetermined scheduled replacement. The EPA is soliciting comment on 
the adequacy of these parameters for demonstrating continuous 
compliance with the rule.
    An issue raised by industry associated with parametric monitoring 
is related to the setting of a parameter based on an initial compliance 
determination at conditions which represent the upper limit (with 
regard to achievable control) of conditions that will be encountered 
during the course of operations. The concern is that the rule 
effectively requires a control level that is greater than the standard 
because the control devices will presumably achieve higher control on 
conditions that are below this upper limit, which may occur frequently 
in this industry because of the predominance of batch processes. The 
EPA has tried to resolve this issue by allowing owners and operators to 
set more than one parameter level for a given control device for 
processes or portions of processes not requiring control levels as high 
as the worst-case or upper limit. These parametric levels are required 
to be defined in advance in the Notification of compliance report. If 
more than one level is set, owners and operators must make a 
determination of compliance with the standards based on what processes 
or emission characteristics are routed to the device at the time in 
which a monitoring reading is taken. Additionally, the determination of 
an exceedance is based on a maximum of 24 hours worth of data, or 96 
15-minute readings, per process. Therefore, readings outside of 
acceptable ranges can be averaged in with readings that are within 
range and effectively normalized. The EPA believes that the approach 
taken offers the industry needed flexibility while preserving the 
assurance of continuous compliance.
    Another issue raised by industry is related to predictability of 
operations. The industry believes that nondedicated, multiproduct 
facilities using control devices other than condensers (and, perhaps, 
combustion devices) for multiple vents may not be able to anticipate 
all possible operating scenarios for which a separate parametric level 
would need to be set. The industry has given the example of a scrubber 
that is used to control emissions from multiple processes. The 
parametric level that represents compliance with the applicable 
standard for each process may change depending on what is happening in 
each process and they argue it would be essentially impossible to 
predict the exact scrubber flow needed to achieve compliance at any 
given time. The industry has requested that the standard provide that 
an excursion from a parametric level does not automatically constitute 
a violation of the rule, but instead triggers reporting requirements 
that initiate a permitting authority's review to decide whether the 
excursion resulted in a violation for this type situation. The EPA has 
generally taken the position that ``after-the-fact'' justification of 
excursions is not an appropriate compliance strategy. Based on 
currently available information, the EPA has not seen a need to change 
this position. The proposed rule allows the facility flexibility in 
establishing the parameter monitoring level based on tests, engineering 
assessments, and/or manufacturers recommendations if included in the 
Precompliance report and approved. The EPA believes it is necessary to 
know the HAP load going to the control device to be able to properly 
operate the device to meet the emission limit (the agency has concerns 
about the industry's stated inability to predict or know the HAP load 
at certain times). In cases where the owner cannot predict exactly what 
is going to the control device over time, the standard provides for 
doing testing under conditions worse than average to cover

[[Page 15763]]

periods of uncertainty. In fact this is the reason for the focus on 
worst-case in the rule. The EPA is seeking comment on this part of the 
rule.
    Related to testing and monitoring are management of change issues. 
The EPA is soliciting general comments on the clarity of the rule as it 
applies to process changes. Management of change issues are also 
related to title V of the Clean Air Act.
    Currently, the Notification of Compliance report is the compliance 
``blueprint'' for implementation of the standard. All information 
regarding documentation of the facility's compliance status with regard 
to the standard should be included in this report. Process 
descriptions, emission estimates, control device performance 
documentation, and continuous compliance demonstration strategies, 
including monitoring, are to be presented in the report. This report 
could be incorporated by reference into the facility's title V permit. 
If a change occurred at the facility which required the submittal of 
additional information, or if the plant chose to revise procedures that 
had been previously documented in the notification, this information 
would be submitted in quarterly reports, thus ensuring that the 
notification and associated reports would always contain the most 
current compliance strategy for the facility. Only changes requiring 
site-specific approval, such as the use of a monitoring parameter that 
was not specifically identified in the standard, would trigger some 
significant review action under title V. This would allow the facility 
enough flexibility to change processes, operating, and compliance 
procedures as necessary without prior approval, if the changes were 
straightforward, and would assure that the compliance plan for the 
facility would always be current. The EPA is also soliciting comments 
on the incorporation by reference of the Notification of Compliance 
report into the title V permit, and comments on the types of changes 
that should trigger review actions under title V.

IX. Administrative Requirements

A. Public Hearing

    A public hearing will be held, if requested, to discuss the 
proposed standard in accordance with section 307(d)(5) of the Clean Air 
Act. Persons wishing to make oral presentation on the proposed 
standards for pharmaceutical production processes should contact EPA at 
the address given in the ADDRESSES section of this preamble. Oral 
presentations will be limited to 15 minutes each. Any member of the 
public may file a written statement before, during, or within 30 days 
after the hearing. Written statements should be addressed to the Air 
Docket Section address given in the ADDRESSES section of this preamble 
and should refer to Docket No. A-96-03.
    A verbatim transcript of the hearing and written statements will be 
available for public inspection and copying during normal working hours 
at EPA's Air Docket Section in Washington, DC (see ADDRESSES section of 
this preamble).

B. Docket

    The docket is an organized and complete file of all the information 
submitted to or otherwise considered by EPA in the development of this 
proposed rulemaking. The principal purposes of the docket are:
    1. To allow interested parties to readily identify and locate 
documents so that they can intelligently and effectively participate in 
the rulemaking process; and
    2. To serve as the record in case of judicial review (except for 
interagency review materials (section 307(d)(7)(A))).

C. Executive Order 12866

    Under Executive Order 12866, (58 FR 51735 (October 4, 1993)) the 
Agency must determine whether the regulatory action is ``significant'' 
and therefore subject to Office of Management and Budget (OMB) review 
and the requirements of this Executive Order. The Order defines 
``significant regulatory action'' as one that is likely to result in a 
rule that may:
    1. Have an annual effect on the economy of $100 million or more or 
adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or Tribal governments or 
communities;
    2. Create a serious inconsistency or otherwise interfere with an 
action taken or planned by another agency;
    3. Materially alter the budgetary impact of entitlements, grants, 
user fees, or loan programs or the rights and obligations of recipients 
thereof; or
    4. Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
this Executive Order.
    Pursuant to the terms of the Executive Order, the OMB has notified 
the EPA that it considers this a ``significant regulatory action'' 
within the meaning of the Executive Order. The EPA submitted this 
action to the OMB for review. Changes made in response to suggestions 
or recommendations from the OMB were documented and included in the 
public record.

D. Enhancing the Intergovernmental Partnership Under Executive Order 
12875

    In compliance with Executive Order 12875, EPA has involved State 
governments in the development of this rule. These governments will be 
required to implement the rule. They will collect permit fees which 
will be used to offset the resource burden of implementing the rule. 
Representatives of six State governments are members of the MACT 
partnership. This partnership group was consulted throughout the 
development of this proposed regulation. Comments from the partnership 
members were carefully considered. In addition, all States are 
encouraged to comment on this proposed rule during the public comment 
period, and the EPA intends to fully consider these comments in the 
final rulemaking.

E. Paperwork Reduction Act

    The information collection requirements in this proposed rule have 
been submitted for approval to OMB under the Paperwork Reduction Act, 
44 U.S.C. 3501 et seq. An Information Collection Request (ICR) document 
has been prepared by EPA (ICR No. 1781.01), and a copy may be obtained 
from Sandy Farmer, Information Policy Branch, U. S. Environmental 
Protection Agency, 401 M Street SW. (2137), Washington, DC 20460, or by 
calling 202-260-2740. The public reporting burden for this collection 
of information is estimated to average 4,800 hours per respondent for 
the first year and 2,600 hours per respondent for each of the second 
and third years, including time for reviewing instructions, searching 
existing data sources, gathering and maintaining the data needed, and 
completing and reviewing the collection of information.
    Send comments regarding the burden estimate or any other aspect of 
this collection of information, including suggestions for reducing this 
burden, to Chief, Information Policy Branch, 2137, U. S. Environmental 
Protection Agency, 401 M Street SW., Washington, DC 20503, marked 
``Attention: Desk Officer for EPA.'' The final rule will respond to any 
OMB or public comments on the information collection requirements 
contained in this proposal.

F. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) provides that, whenever an 
agency promulgates a final rule under 5 U.S.C.

[[Page 15764]]

553, after being required to publish a general notice of proposed 
rulemaking, an agency must prepare a final regulatory flexibility 
analysis unless the head of the agency certifies that the final rule 
will not have a significant economic impact on a substantial number of 
small entities. Pursuant to section 605(b) of the Regulatory 
Flexibility Act, 5 U.S.C. 605(b), I certify that this rule will not 
have a significant impact on a substantial number of small entities.
    The EPA analyzed the potential impact of the rule on small entities 
and determined that only 16 of 56 pharma-ceutical producing firms are 
small entities--not a substantial number of entities. Of these 16 
firms, only four will experience an increase in costs as a result of 
the promulgation of today's rule that are greater than 1 percent of 
revenues. Therefore, the Agency did not prepare an initial regulatory 
flexibility analysis.
    Although the statute does not require EPA to prepare an RFA because 
the Administrator has certified that the rule will not have a 
significant economic impact on a substantial number of small entities, 
EPA did undertake a limited assessment, to the extent it could, of 
possible outcomes and the economic effect of these on small 
pharmaceutical entities. The initial version of that evaluation is 
available in the administrative record for today's action.

G. Unfunded Mandates

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public 
Law 104-4, establishes requirements for Federal agencies to assess the 
effects of their regulatory actions on State, local, and Tribal 
governments, and the private sector. Under section 202 of the UMRA, EPA 
generally must prepare a written statement, including a cost-benefit 
analysis, for proposed and final rules with ``Federal mandates'' that 
may result in expenditures to State, local, and Tribal governments, in 
the aggregate, or to the private sector, of $100 million or more in any 
1 year. Before promulgating an EPA rule for which a written statement 
is needed, section 205 of the UMRA generally requires EPA to identify 
and consider a reasonable number of regulatory alternatives and adopt 
the least costly, most cost effective or least burdensome alternative 
that achieves the objectives of the rule. The provisions of section 205 
do not apply when they are inconsistent with applicable law. Moreover, 
section 205 allows EPA to adopt an alternative other than the least 
costly, most cost effective or least burdensome alternative if the 
Administrator publishes with the final rule an explanation why that 
alternative was not adopted. Before EPA establishes any regulatory 
requirements that may significantly or uniquely affect small 
governments, including Tribal governments, it must have developed under 
section 203 of the UMRA a small government agency plan. The plan must 
provide for notifying potentially affected small governments, enabling 
officials of affected small governments to have meaningful and timely 
input in the development of EPA regulatory proposals with significant 
Federal intergovernmental mandates, and informing, educating, and 
advising small governments on compliance with the regulatory 
requirements.
    The EPA has determined that the proposed standards do not include a 
Federal mandate that may result in estimated costs of, in the 
aggregate, $100 million or more to either State, local or Tribal 
governments, or to the private sector, nor do the standards 
significantly or uniquely impact small governments, because they 
contain no requirements that apply to such governments or impose 
obligations upon them. Therefore, the requirements of the Unfunded 
Mandates Act do not apply to this final rule.

H. Miscellaneous

    In accordance with section 117 of the Act, publication of this 
proposal was preceded by consultation with appropriate advisory 
committees, independent experts, and Federal departments and agencies. 
The Administrator will welcome comments on all aspects of the proposed 
regulation, including health, economic and technical issues, and on the 
proposed test methods.
    This regulation will be reviewed 8 years from the date of 
promulgation. This review will include an assessment of such factors as 
evaluation of the residual health and environmental risks, any overlap 
with other programs, the existence of alternative methods, 
enforceability, improvements in emission control technology and health 
data, and the recordkeeping and reporting requirements.

List of Subjects in 40 CFR Part 63

    Environmental protection, Air pollution control, Hazardous 
substances, Reporting and recordkeeping requirements.

    Dated: March 20, 1997.
Carol M. Browner,
Administrator.

    For the reasons set out in the preamble, title 40, chapter I, part 
63 of the Code of Federal Regulations is proposed to be amended as 
follows:

PART 63--NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS 
FOR SOURCE CATEGORIES

    1. The authority citation for part 63 continues to read as follows:

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

    2. It is proposed that part 63 be amended by adding subpart GGG to 
read as follows:

Subpart GGG--National Emission Standards for Pharmaceuticals Production

Sec.
63.1250 Applicability.
63.1251 Definitions.
63.1252 Standards.
63.1253 Test methods and compliance procedures.
63.1254 Monitoring requirements.
63.1255 Recordkeeping requirements.
63.1256 Reporting requirements.
63.1257 Delegation of authority.
Table 1 to subpart GGG--General Provisions Applicability to Subpart 
GGG
Table 2 to subpart GGG--Partially Soluble HAPs
Table 3 to subpart GGG--Soluble HAPs
Appendix A to Subpart GGG--Equipment Leaks

Subpart GGG--National Emission Standards for Pharmaceuticals


Sec. 63.1250  Applicability.

    (a) Except as specified in paragraph (d) of this section, the 
provisions of this subpart apply to pharmaceutical manufacturing 
operations located at a major source of hazardous air pollutant 
emissions.
    (b) The affected source subject to this subpart is the facility-
wide collection of pharmaceutical process vents, storage tanks, 
wastewater and associated treatment residuals, heat exchange systems, 
cooling towers, and equipment components (pumps, compressors, 
agitators, pressure relief devices, sampling connection systems, open-
ended valves or lines, valves, connectors, and instrumentation systems) 
associated with pharmaceutical manufacturing operations.
    (c) If an additional pharmaceutical manufacturing process unit(s) 
is added to a plant site that is a major source, as defined in section 
112(a) of the Act, the addition shall be subject to the requirements 
for a new source in this subpart if: It is an addition that meets the 
definition of construction in Sec. 63.2 of subpart A of this part; the 
addition has the potential to emit 10 tons per year or more of any HAP 
or 25 tons per year or more of any combination of

[[Page 15765]]

HAP, unless the Administrator establishes a lesser quantity; and the 
process unit(s) is dedicated to the manufacture of a single product or 
isolated intermediate.
    (d) Table 1 specifies the provisions of subpart A that apply to an 
owner or operator of an affected source subject to this subpart, and 
clarifies specific provisions in subpart A as necessary for this 
subpart.
    (e) The provisions of this subpart do not apply to research and 
development facilities.
    (f) The compliance dates for affected sources are as follows:
    (1) An owner or operator of an existing affected source must comply 
with the provisions of this subpart within 3 years after the effective 
date of the standard.
    (2) An owner or operator of a new or reconstructed affected source 
must comply with the provisions of this subpart immediately upon 
startup.
    (3) Notwithstanding the requirements of paragraphs (f)(1) and (2) 
of this section, a new source which commences construction or 
reconstruction after April 2, 1997 and before effective date of final 
rule shall not be required to comply with such promulgated standard 
until 3 years after the date of promulgation if:
    (i) The promulgated standard is more stringent than the proposed 
standard; and
    (ii) The owner or operator complies with the standard as proposed 
during the 3-year period immediately after the effective date.
    (g) For batch processes, the provisions of this subpart also apply 
during startup and shutdown. Periods of malfunction are regulated 
according to Sec. 63.6 of subpart A.
    (h) This subpart applies to all equipment leak emissions in the 
source category not covered by 40 CFR part 63 subpart I, which requires 
the implementation of subpart H requirements for components in 
methylene chloride and carbon tetrachloride service in pharmaceutical 
chemical synthesis operations. The requirements proposed in this rule 
do not affect the requirements of subpart I or H for these components. 
Only components not currently identified and affected by subpart I are 
considered in this standard.


Sec. 63.1251  Definitions.

    Terms used in this subpart are defined in the Act, in subpart A of 
this part, or in this section. If the same term is defined in subpart A 
of this part and in this section, it shall have the meaning given in 
this section for the purposes of subpart GGG.
    Air pollution control device means equipment installed on a process 
vent storage tank, wastewater treatment exhaust stack, or combination 
thereof that reduces the mass of HAP emitted to the air. Examples 
include incinerators, carbon adsorption units, condensers, and gas 
absorbers. Process condensers are not considered air pollution control 
devices.
    Batch cycle refers to manufacturing an intermediate or product from 
start to finish in a batch unit operation.
    Batch emission episode means a discrete venting episode that may be 
associated with a single unit operation. A unit operation may have more 
than one batch emission episode. For example, a displacement of vapor 
resulting from the charging of a vessel with HAP will result in a 
discrete emission episode that will last through the duration of the 
charge and will have an average flowrate equal to the rate of the 
charge. If the vessel is then heated, there will also be another 
discrete emission episode resulting from the expulsion of expanded 
vapor. Both emission episodes may occur in the same vessel or unit 
operation. There are possibly other emission episodes that may occur 
from the vessel or other process equipment, depending on process 
operations.
    Batch operation or Batch process means a noncontinuous operation 
involving intermittent or discontinuous feed into equipment, and, in 
general, involves the emptying of the equipment after the batch 
operation ceases and prior to beginning a new operation. Addition of 
raw material and withdrawal of product do not occur simultaneously in a 
batch operation.
    Closed-vent system means a system that is not open to the 
atmosphere and is composed of piping, ductwork, connections, and, if 
necessary, flow inducing devices that transport gas or vapor from an 
emission point to a control device or back into the process.
    Combustion device means an individual unit of equipment, such as a 
flare, incinerator, process heater, or boiler, used for the combustion 
of HAP vapors.
    Consumption means the makeup quantity of HAP entering a process 
that are not used as reactant. The quantity of material used as 
reactant is the theoretical amount needed assuming a 100 percent 
stoichiometric conversion. Makeup is the net amount of material that 
must be added to the process to replenish losses.
    Container, as used in the wastewater provisions, means any portable 
waste management unit that has a capacity greater than or equal to 0.1 
m\3\ in which a material is stored, transported, treated, or otherwise 
handled. Examples of containers are drums, hoses, barrels, tank trucks, 
barges, dumpsters, tank cars, dump trucks, and ships.
    Continuous process means a process where the inputs and outputs 
flow continuously throughout the duration of the process. Continuous 
processes are typically steady state.
    Continuous seal means a seal that forms a continuous closure that 
completely covers the space between the wall of the storage vessel and 
the edge of the floating roof. A continuous seal may be a vapor-
mounted, liquid-mounted, or metallic shoe seal.
    Controlled HAP emissions means the quantity of HAP discharged to 
the atmosphere. If no air pollution control devices are present, 
controlled emissions are the same as uncontrolled emissions.
    Cover, as used in the wastewater provisions, means a device or 
system which is placed on or over a waste management unit containing 
wastewater or residuals so that the entire surface area is enclosed and 
sealed to minimize air emissions. A cover may have openings necessary 
for operation, inspection, and maintenance of the waste management unit 
such as access hatches, sampling ports, and gauge wells provided that 
each opening is closed and sealed when not in use. Examples of covers 
include a fixed roof installed on a wastewater tank, a lid installed on 
a container, and an air-supported enclosure installed over a waste 
management unit.
    External floating roof means a pontoon-type or double-deck type 
cover that rests on the liquid surface in a storage vessel or waste 
management unit with no fixed roof.
    Fill or filling means the introduction of hazardous air pollutant 
into a storage vessel or the introduction of a wastewater stream or 
residual into a waste management unit, but not necessarily to complete 
capacity.
    Fixed roof means a cover that is mounted on a waste management unit 
or storage vessel in a stationary manner and that does not move with 
fluctuations in liquid level.
    Floating roof means a cover consisting of a double deck, pontoon 
single deck, internal floating cover or covered floating roof, which 
rests upon and is supported by the liquid being contained, and is 
equipped with a closure seal or seals to close the space between the 
roof edge and waste management unit or storage vessel wall.

[[Page 15766]]

    Hard-piping means tubing that is manufactured and properly 
installed using good engineering judgment and standards, such as ANSI 
B31-3.
    Individual drain system means the stationary system used to convey 
wastewater streams or residuals to a waste management unit. The term 
includes hard piping, all process drains and junction boxes, together 
with their associated sewer lines and other junction boxes, manholes, 
sumps, and lift stations, conveying wastewater streams or residuals. A 
segregated stormwater sewer system, which is a drain and collection 
system designed and operated for the sole purpose of collecting 
rainfall-runoff at a facility, and which is segregated from all other 
individual drain systems, is excluded from this definition.
    Internal floating roof means a cover that rests or floats on the 
liquid surface (but not necessarily in complete contact with it) inside 
a storage vessel or waste management unit that has a permanently 
affixed roof.
    Isolated intermediate means any intermediate that is removed from 
process equipment for temporary or permanent storage or transferred to 
shipping containers.
    Junction box means a manhole or access point to a wastewater sewer 
system line or a lift station.
    Liquid-mounted seal means a foam liquid-filled seal mounted in 
contact with the liquid between the wall of the storage vessel or waste 
management and the floating roof. The seal is mounted continuously 
around the vessel or unit.
    Maximum true vapor pressure means the equilibrium partial pressure 
exerted by the total organic HAP in the stored or transferred liquid at 
the temperature equal to the highest calendar-month average of the 
liquid storage or transferred temperature for liquids stored or 
transferred above or below the ambient temperature or at the local 
maximum monthly average temperature as reported by the National Weather 
Service for liquids stored or transferred at the ambient temperature, 
as determined:
    (1) In accordance with methods described in American Petroleum 
Institute Publication 2517, Evaporative Loss From External Floating-
Roof Tanks (incorporated by reference as specified in Sec. 63.14 of 
subpart A of this part); or
    (2) As obtained from standard reference texts; or
    (3) As determined by the American Society for Testing and Materials 
Method D2879-83 (incorporated by reference as specified in Sec. 63.14 
of subpart A of this part); or
    (4) Any other method approved by the Administrator.
    Metallic shoe seal or mechanical shoe seal means a metal sheet that 
is held vertically against the wall of the storage vessel by springs, 
weighted levers, or other mechanisms and is connected to the floating 
roof by braces or other means. A flexible coated fabric (envelope) 
spans the annular space between the metal sheet and the floating roof.
    Partially soluble HAP means a HAP listed in Table 2 of this 
subpart.
    Pharmaceutical manufacturing process unit (PMPU) means any 
processing equipment assembled to process materials and manufacture a 
pharmaceutical product and associated storage tanks, wastewater 
management units, or components such as pumps, compressors, agitators, 
pressure relief devices, sampling connection systems, open-ended valves 
or lines, valves, connectors, and instrumentation systems that are used 
in the manufacturing of a pharmaceutical product.
    Pharmaceutical manufacturing operations include PMPU's and other 
processes and operations as well as associated equipment such as heat 
exchange systems that are located at a facility for the purpose of 
manufacturing pharmaceuticals.
    Pharmaceutical product means any material described by the standard 
Industrial Classification (SIC) Code 283, or any other fermentation, 
biological or natural extraction, or chemical synthesis product 
regulated by the Food and Drug Administration, including components 
(excluding excipients) of pharmaceutical formulations, or intermediates 
used in the production of a pharmaceutical product.
    Point of determination means the point where a wastewater stream 
exits the process or processes, storage tank, or equipment. The POD may 
be at the equipment or following the last recovery device.
    Process means a logical grouping of processing equipment which 
collectively function to produce a pharmaceutical product or isolated 
intermediate. A process may consist of one or more unit operations. For 
the purpose of this subpart, process includes all or a combination of 
reaction, recovery, separation, purification, or other activity, 
operation, manufacture, or treatment which are used to produce a 
product or isolated intermediate. The physical boundaries of a process 
are flexible, providing a process ends with a product or isolated 
intermediate, or with cessation of onsite processing. Nondedicated 
solvent recovery and nondedicated formulation operations are considered 
single processes that are used to recover or formulate numerous 
materials and/or products.
    Process condenser means a condenser whose primary purpose is to 
recover material as an integral part of a unit operation. The condenser 
must support a vapor-to-liquid phase change for periods of source 
equipment operation that are above the boiling or bubble point of 
substance(s). Examples of process condensers include distillation 
condensers, reflux condensers, process condensers in line prior to the 
vacuum source, and process condensers used in stripping or flashing 
operations.
    Process tank means a tank that is physically located within the 
bounds of a process that is used to collect material discharged from a 
feedstock storage tank or unit operation within the process and 
transfer this material to another unit operation within the process or 
a product storage tank. Surge control vessels and bottoms receivers 
that fit these conditions are considered process tanks.
    Process vent means a vent from a unit operation through which a 
HAP-containing gas stream is, or has the potential to be, released to 
the atmosphere. Examples of process vents include, but are not limited 
to, vents on condensers used for product recovery, bottom receivers, 
surge control vessels, reactors, filters, centrifuges, and process 
tanks. Process vents do not include vents on storage tanks regulated 
under Sec. 63.1252(b), vents on wastewater emission sources regulated 
under Sec. 63.1252(d), or pieces of equipment regulated under 
Sec. 63.1252(e).
    Production-indexed HAP consumption factor is the result of dividing 
the annual consumption of total HAP by the annual production rate, per 
process.
    Production-indexed volatile organic compound (VOC) consumption 
factor is the result of dividing the annual consumption of total VOC by 
the annual production rate, per process.
    Publicly owned treatment works (POTW) means any devices and systems 
used in the storage, treatment, recycling, and reclamation of municipal 
sewage or industrial wastes of a liquid nature as defined in section 
212(2)(A) of the Clean Water Act, as amended (33 U.S.C. 1292(2)(A)). A 
POTW includes the treatment works, intercepting sewers, outfall sewers, 
sewage collection systems, pumping, power, and other equipment. The 
POTW is defined at 40 CFR 403.3(0).
    Reactor means a device or vessel in which one or more chemicals or

[[Page 15767]]

reactants, other than air, are combined or decomposed in such a way 
that their molecular structures are altered and one or more new organic 
compounds are formed.
    Recovery device means an individual unit of equipment used for the 
purpose of recovering chemicals for fuel value (i.e., net positive 
heating value), use, reuse, or for sale for fuel value, use, or reuse. 
Air pollution control devices are not recovery devices. Process 
condensers are recovery devices. Other examples of equipment that may 
be recovery devices include organic removal devices such as decanters, 
strippers, or thin-film evaporation units.
    Research and development facility means research or laboratory 
operations whose primary purpose is to conduct research and development 
into new processes and products, where the operations are under the 
close supervision of technically trained personnel, and is not engaged 
in the manufacture of products for commercial sale, except in a de 
minimis manner.
    Residual means any HAP-containing liquid or solid material that is 
removed from a wastewater stream by a waste management unit or 
treatment process that does not destroy organics (nondestructive unit). 
Examples of residuals from nondestructive wastewater management units 
are: The organic layer and bottom residue removed by a decanter or 
organic-water separator and the overheads from a steam stripper or air 
stripper. Examples of materials which are not residuals are: Silt; mud; 
leaves; bottoms from a steam stripper or air stripper; and sludges, 
ash, or other materials removed from wastewater being treated by 
destructive devices such as biological treatment units and 
incinerators.
    Sewer line means a lateral, trunk line, branch line, or other 
conduit including, but not limited to, grates, trenches, etc., used to 
convey wastewater streams or residuals to a downstream waste management 
unit.
    Single-seal system means a floating roof having one continuous seal 
that completely covers the space between the wall of the storage vessel 
and the edge of the floating roof. This seal may be a vapor-mounted, 
liquid-mounted, or metallic shoe seal.
    Soluble HAP means a HAP listed in Table 3 of this subpart.
    Storage tank means a tank or other vessel that is used to store 
organic liquids that contain one or more HAP. The following are not 
considered storage tanks for the purposes of this subpart:
    (1) Vessels permanently attached to motor vehicles such as trucks, 
railcars, barges, or ships;
    (2) Pressure vessels designed to operate in excess of 204.9 
kilopascals and without emissions to the atmosphere;
    (3) Vessels storing organic liquids that contain HAP only as 
impurities;
    (4) Wastewater storage tanks; and
    (5) Process tanks.
    Surface impoundment means a waste management unit which is a 
natural topographic depression, manmade excavation, or diked area 
formed primarily of earthen materials (although it may be lined with 
manmade materials), which is designed to hold an accumulation of liquid 
wastes or waste containing free liquids. A surface impoundment is used 
for the purpose of treating, storing, or disposing of wastewater or 
residuals, and is not an injection well. Examples of surface 
impoundments are equalization, settling, and aeration pits, ponds, and 
lagoons.
    Treatment process means a specific technique that removes or 
destroys the organics in a wastewater or residual stream such as a 
stream stripping unit, thin-film evaporation unit, waste incinerator, 
biological treatment unit, or any other process applied to wastewater 
streams or residuals to comply with Sec. 63.138 of this subpart. Most 
treatment processes are conducted in tanks. Treatment processes are a 
subset of waste management units.
    Uncontrolled HAP emissions means a gas stream containing HAP which 
has exited the last recovery device, but which has not yet been 
introduced into an air pollution control device to reduce the mass of 
HAP in the stream. If the process vent is not routed to an air 
pollution control device, uncontrolled emissions are those HAP 
emissions released to the atmosphere.
    Unit operation means those processing steps that occur within 
distinct equipment that are used, among other things, to prepare 
reactants, facilitate reactions, separate and purify products, and 
recycle materials. Equipment used for these purposes includes but is 
not limited to reactors, distillation columns, extraction columns, 
absorbers, decanters, dryers, condensers, and filtration equipment.
    Vapor-mounted seal means a continuous seal that completely covers 
the annular space between the wall, the storage vessel or waste 
management unit and the edge of the floating roof and is mounted such 
that there is a vapor space between the stored liquid and the bottom of 
the seal.
    Volatile organic compounds are defined in 40 CFR part 51, 
Sec. 51.100.
    Wastewater means water containing partially soluble or soluble HAP 
that is discarded from equipment that is part of the affected source 
and that is not exempted by the provisions of Sec. 63.1252(d)(2). For 
the purposes of this subpart, noncontact cooling water is not 
considered a wastewater stream.
    Waste management unit means a component, piece of equipment, 
structure, or transport mechanism in conveying, storing, treating, or 
disposing of wastewater streams or residuals. Examples of waste 
management units include wastewater tanks, air flotation units, surface 
impoundments, containers, oil-water or organic-water separators, 
individual drain systems, biological treatment units, waste 
incinerators, and organic removal devices such as steam and air 
stripper units, and thin film evaporation units. If such equipment is 
used for recovery then it is part of a pharmaceutical process and is 
not a waste management unit.
    Wastewater tank means a stationary waste management unit that is 
designed to contain an accumulation of wastewater or residuals and is 
constructed primarily of nonearthen materials (e.g., wood, concrete, 
steel, plastic) which provide structural support. Wastewater tanks used 
for flow equalization are included in this definition.
    Water seal controls means a seal pot, p-leg trap, or other type of 
trap filled with water (e.g., flooded sewers that maintain water levels 
adequate to prevent air flow through the system) that creates a water 
barrier between the sewer line and the atmosphere. The water level of 
the seal must be maintained in the vertical leg of a drain in order to 
be considered a water seal.


Sec. 63.1252  Standards.

    (a) Each owner or operator of any affected source subject to the 
provisions of this subpart shall control HAP emissions to the level 
specified in this section on and after the compliance dates specified 
in Sec. 63.1250 of this subpart.
    (b) Storage tanks:
    (1) The owner or operator of a storage tank meeting the criteria of 
paragraph (b)(1)(i) of this section is subject to the requirements of 
paragraph (b)(2) of this section. The owner or operator of a storage 
tank meeting the criteria of paragraph (b)(1)(ii) of this section is 
subject to the requirements of paragraph (b)(3) of this section.
    (i) A storage tank with a design capacity greater than or equal to 
38 m\3\

[[Page 15768]]

(10,000 gallons) but less than 75 m\3\ (20,000 gallons), and storing a 
liquid for which the maximum true vapor pressure of total HAP is 
greater than or equal to 13.1 kPa (1.9 psia).
    (ii) A storage tank with a design capacity greater than or equal to 
75 m\3\ storing a liquid for which the maximum true vapor pressure of 
total HAP is greater than or equal to 13.1 kPa.
    (2) The owner or operator of a storage tank shall equip the 
affected storage tank with either a fixed roof with internal floating 
roof, an external floating roof, an external floating roof converted to 
an internal floating roof, or a closed vent system with control device 
that reduces inlet emissions of total HAP by 90 percent or greater, as 
demonstrated through the test methods and procedures in 
Sec. 63.1253(c).
    (3) The owner or operator of a storage tank shall equip the 
affected storage tank with either a fixed roof with internal floating 
roof, an external floating roof, an external floating roof converted to 
an internal floating roof, or a closed vent system with control device 
that meets the requirements of paragraphs (b)(3)(i) and (b)(3)(ii) of 
this section.
    (i) Except as provided in paragraph (b)(3)(ii) of this section, the 
control device shall be designed and operated to reduce inlet emissions 
of total HAP by 95 percent or greater, as demonstrated through the test 
methods and procedures in Sec. 63.1253(c).
    (ii) If the owner or operator can demonstrate that a control device 
installed on a storage tank on or before April 2, 1997, is designed to 
reduce inlet emissions of total HAP by greater than or equal to 90 
percent but less than 95 percent, then the control device is required 
to be operated to reduce inlet emissions of total HAP by 90 percent or 
greater, as demonstrated through the test methods and procedures in 
Sec. 63.1253(c).
    (c) Process vents:
    (1) The owner or operator of an existing affected source must 
comply with the process vent requirements of paragraphs (c)(2) and 
(c)(4) of this section or the requirements of paragraphs (c)(3) and 
(c)(4) of this section. The owner or operator of a new affected source 
must comply with the process vent requirements of paragraph (c)(5) of 
this section. Compliance with the required emission reductions shall be 
demonstrated through the applicable test methods and compliance 
procedures described in Sec. 63.1253 of this subpart.
    (2) Annual controlled HAP emissions shall not exceed 900 kilograms 
per year (2,000 pounds per year) from the sum of all process vents 
within a process that do not meet the criteria specified in paragraph 
(c)(4)(i) of this section.
    (3) Annual uncontrolled HAP emissions from the sum of all process 
vents within a process that do not meet the criteria specified in 
paragraph (c)(4)(i) of this section shall be reduced by 93 percent or 
greater.
    (4) Annual uncontrolled HAP emissions from each process vent 
meeting the requirements of paragraph (c)(4)(i) of this section and not 
meeting the requirements of paragraph (c)(4)(ii) of this section shall 
be reduced by 98 percent or greater.
    (i) Process vents having a flowrate equal to or less than the 
flowrate calculated when multiplying the annual uncontrolled HAP 
emissions, in lb/yr, by 0.02 and subtracting 1,000 according to the 
following equation:

FR = 0.02*(HL)-1,000

Where:

FR = flowrate, scfm,
HL = yearly uncontrolled HAP emissions, lb/yr;

    (ii) If the owner or operator can demonstrate that a control 
device, installed on a process vent subject to the requirements of 
paragraph (c)(4)(i) of this section on or before April 2, 1997, was 
designed to reduce uncontrolled HAP emissions of total HAP by greater 
than or equal to 93 percent but less than 98 percent, then the control 
device is required to be operated to reduce inlet emissions of total 
HAP by 93 percent or greater.
    (5) If the annual uncontrolled HAP emissions from the sum of all 
the process vents within a process is greater than 180 kg/yr (400 lb/
yr) then the owner or operator shall reduce annual uncontrolled HAP 
emissions from the sum of all process vents within a process by 98 
percent.
    (d) Wastewater:
    (1) The owner or operator of a new or existing affected source 
discharging wastewater with the concentrations described in paragraphs 
(d)(1)(i) through (d)(1)(v) of this section at the point of 
determination (POD) must comply with the provisions of paragraphs 
(d)(3) through (d)(4)(ii) of this section. The owner or operator of a 
new source discharging wastewater with concentrations described in 
paragraph (d)(1)(vi) of this section at the POD must comply with the 
provisions of paragraph (d)(4)(i) or (d)(4)(ii)(A) and (d)(4)(iii) of 
this section.
    (i) Wastewater containing partially soluble HAP at a total 
concentration of greater than 1,300 parts per million by weight (ppmw) 
from any POD within a process with a total yearly load of soluble and/
or partially soluble HAP of greater than 1 megagram per year (Mg/yr).
    (ii) Wastewater containing partially soluble and/or soluble HAP at 
a total concentration of greater than 5,200 ppmw from any POD within a 
process with a total yearly load of soluble and/or partially soluble 
HAP of greater than 1 Mg/yr of total HAP.
    (iii) Wastewater with a concentration of partially soluble and/or 
soluble HAP of greater than 10,000 ppmw total HAP at facilities that 
discharge greater than 1 Mg/yr of soluble and/or partially soluble HAP 
in the total yearly volume of all wastewaters generated.
    (iv) Wastewater containing partially soluble HAP at a total 
concentration of greater than 1,300 parts per million by weight (ppmw) 
from any single POD with a total yearly load of soluble and/or 
partially soluble HAP of greater than 1 Mg/yr.
    (v) Wastewater containing partially soluble and/or soluble HAP at a 
total concentration of greater than 5,200 ppmw from any single POD with 
a total yearly load of soluble and/or partially soluble HAP from any 
single POD of greater than 1 Mg/yr.
    (vi) Wastewater containing soluble HAP at a total concentration of 
greater than 110,000 ppmw from any POD within a process or from any 
single POD with a total yearly load of soluble and/or partially soluble 
HAP of greater than 1 Mg/yr of total HAP.
    (2) The following wastewaters are not subject to the wastewater 
provisions of this part:
    (i) Stormwater from segregated sewers;
    (ii) Water from fire-fighting and deluge systems, including testing 
of such systems;
    (iii) Spills; and
    (iv) Water from safety showers.
    (3) An owner or operator of a facility shall comply with the 
requirements of Secs. 63.133 through 63.137, and the control device 
requirements and inspection requirements of Secs. 63.139 and 63.148, 
respectively, of subpart G for each waste management unit or treatment 
process that receives an affected wastewater. The affected wastewater 
for purposes of this subpart is synonymous with the ``Group 1'' 
identification for wastewater used in the provisions of subpart F and 
G. Also for the purposes of this subpart, tanks for which it can be 
demonstrated that less than 5 percent of the total soluble and/or 
partially soluble HAP is emitted from a wastewater tank described in 
Sec. 63.133(a)(1), in addition to a tank with surface agitation, shall 
be equipped with a fixed roof. The owner or operator shall also comply 
with the treatment

[[Page 15769]]

requirements specified in paragraphs (d)(4) or (d)(5) of this section 
for each affected wastewater stream.
    (4) Each affected wastewater stream shall be treated by one of the 
following methods:
    (i) Recycle to the process in accordance with the requirements 
specified in Sec. 63.138(f). Once a wastewater stream is returned to 
the process, the wastewater stream is no longer subject to this 
section.
    (ii) Treat using a waste management unit or treatment process which 
meets conditions in paragraph (d)(4)(ii)(A) and (B) or (C) of this 
section:
    (A) Reduces, by removal or destruction, the total mass of each 
individual partially soluble HAP by 99 percent, as determined by the 
procedures specified in Sec. 63.145(c), 63.145(d), or 63.138(j); or to 
a level less than 50 parts per million by weight of total partially 
soluble HAP as determined by the procedures specified in 
Sec. 63.145(b). This option shall not be used when the treatment 
process is a biological treatment process, or when the wastewater 
stream is designated as a Group 1 wastewater stream as specified in 
Sec. 63.132(e). Dilution shall not be used to achieve compliance with 
this option. Treatment process residuals shall be treated according to 
Sec. 63.138(h) or Sec. 63.138(m).
    (B) Reduces, by removal or destruction, the total mass of each 
individual soluble HAP by 90 percent, as determined by the procedures 
specified in Secs. 63.145(c), 63.145(d), or Sec. 63.138(j). Treatment 
process residuals shall be treated according to Sec. 63.138(h) or 
Sec. 63.138(m).
    (C) Reduces, by biological treatment, the mass of total soluble and 
partially soluble HAP in wastewater for all pharmaceutical processes at 
the facility by 95 percent, as determined by the procedures specified 
in 40 CFR part 63 appendix C.
    (iii) Treat using a waste management unit or treatment process 
which reduces, by removal or destruction, the total mass of each 
soluble HAP by 99 percent, as determined by the procedures specified in 
Secs. 63.145(c), 63.145(d), or Sec. 63.138(j). Treatment process 
residuals shall be treated according to Sec. 63.138(h) or 
Sec. 63.138(m).
    (5) As an alternative to the treatment requirements in paragraph 
(d)(4)(ii)(B) of this section, an owner or operator may elect to treat 
affected wastewaters containing soluble HAP and less than 50 ppmw 
partially soluble HAP in the following manner if it can be demonstrated 
that less than 5 percent of the total soluble HAP is emitted from the 
municipal sewer system:
    (i) Treat in an enhanced biological treatment system that meets all 
of the following criteria:
    (A) The biological treatment system is an aerated treatment unit(s) 
that contains biomass suspended in water followed by a clarifier that 
removes biomass from the treated water and recycles the recovered 
biomass to the aeration unit;
    (B) The mixed liquor volatile suspended solids (biomass) is greater 
than 1 kg/m\3\ homogeneously distributed throughout each aeration unit;
    (C) The biomass in the enhanced biotreatment system is suspended 
and aerated in the water of the aeration unit(s) by either submerged 
air flow or mechanical agitation; and
    (D) The enhanced biotreatment system is in compliance with 
requirements of the permitting authority.
    (ii) Treat in a publicly-owned treatment works (POTW) that meets 
all of the following criteria:
    (A) The POTW uses biological treatment that meets the criteria of 
paragraph (d)(5)(i) of this section.
    (B) The POTW is in compliance with the General Pretreatment 
Regulations in 40 CFR part 403, including any applicable categorical 
pretreatment standards, and has pretreatment permit or equivalent 
approval under the authority of 40 CFR part 403.
    (C) The POTW is in compliance with all applicable pretreatment 
standards adopted at 40 CFR part 439.
    (6) For each treatment process used to comply with the requirements 
of paragraph (d)(4) of this section, the owner or operator shall comply 
with Sec. 63.138(i), (k), and (l).
    (7) Except as provided in paragraph (d)(7)(i) and (ii) of this 
section, the owner or operator shall not discharge a separate phase 
that can be isolated through gravity separation from the aqueous phase 
to a wastewater management or treatment unit.
    (i) Owners and operators discharging a separate organic phase shall 
separate and treat the organic according to Sec. 63.138(h).
    (ii) Owners and operators shall treat any aqueous phases having the 
characteristics of paragraphs (d)(1)(i) through (d)(1)(iv) of this 
section according to the requirements of paragraphs (d)(3) through 
(d)(6) of this section.
    (e) Equipment leaks: The owner or operator shall comply with the 
requirements of Appendix A to this subpart GGG.
    (f) Planned routine maintenance: The specifications and 
requirements in paragraphs (b) and (c) of this section for control 
devices do not apply during periods of planned routine maintenance. 
Maintenance wastewaters meeting the criteria for control as specified 
in paragraph (d)(1) of this section shall be treated in accordance with 
the requirements of paragraphs (d)(3) through (d)(7) of this section.
    (g) Periods of planned routine maintenance of the control device, 
during which the control device does not meet the specifications of 
paragraphs (b) and (c) of this section, as applicable, shall not exceed 
240 hours per year.
    (h) Pollution prevention alternative: Except as provided in 
paragraph (h)(1) of this section, owners and operators may choose to 
meet the pollution prevention alternative requirement specified in 
either paragraph (h)(2) or (h)(3) of this section for any process, in 
lieu of the requirements specified in paragraphs (b), (c), (d), and (e) 
of this section. Compliance with paragraphs (h)(2) and (h)(3) of this 
section shall be demonstrated through the procedures in 
Sec. 63.1253(f).
    (1) Processes emitting HAP that are generated in the process must 
be controlled according to the requirements of paragraphs (b), (c), 
(d), and (e) of this section.
    (2) The production-indexed HAP consumption factor (kg HAP consumed/
kg produced) shall be reduced by 75 percent from an average baseline 
established no earlier than the 1987 calendar year, or the first year 
thereafter in which the process was operational and data are available. 
No increase in the production-indexed VOC consumption factor for the 
applicable period of demonstration shall occur.
    (3) Both requirements specified in paragraphs (h)(3)(i) and (ii) of 
this section are met.
    (i) The production-indexed HAP consumption factor (kg HAP consumed/
kg produced) shall be reduced by 50 percent from an average baseline 
established no earlier than the 1987 calendar year, or the first year 
thereafter in which the process was operational and data is available. 
No increase in the production-indexed VOC consumption factor for the 
applicable period of demonstration shall occur.
    (ii) The total process HAP emissions shall be reduced from an 
uncontrolled baseline by an amount, in kg/yr, that, when divided by the 
annual production rate, in kg, will yield a value of at least 25 
percent of the average baseline HAP production-indexed consumption 
factor established in paragraph (h)(3)(i) of this section. The annual 
reduction in HAP

[[Page 15770]]

air emissions must be due to the use of the following control devices:
    (A) Combustion control devices such as incinerators, flares or 
process heaters.
    (B) Recovery control devices such as condensers and carbon 
adsorbers whose recovered product is destroyed or shipped offsite for 
destruction.
    (C) Any control device that does not ultimately allow for recycling 
of material back to the process.
    (D) Any control device for which the owner or operator can 
demonstrate that the use of the device in controlling HAP emissions 
will have no effect on the production-indexed consumption factor for 
the process.
    (i) Heat exchange systems: Except as provided in paragraph (i)(2) 
of this section, owners and operators of affected sources shall comply 
with the requirements in paragraphs (i)(1) of this section for heat 
exchange systems that cool process equipment or materials used in 
pharmaceutical manufacturing operations.
    (1) The heat exchange system shall be treated according to the 
provisions of Sec. 63.104.
    (2)(i) The monitoring frequency shall be no less than quarterly.
    (ii) The owner or operator of heat exchange systems which meet 
current good manufacturing practice (CGMP) requirements at 21 CFR part 
211 may elect to use the physical integrity of the reactor as the 
surrogate indicator of heat exchange system leaks.
    (j) Emissions averaging provisions: With the exception of 
paragraphs (j)(1) through (j)(5) of this section, owners or operators 
of storage tanks or processes subject to paragraph (b) or (c) of this 
section may choose to comply with the emission standards in paragraph 
(b) or (c) of this section by using emissions averaging requirements 
specified in Sec. 63.1253(h) or (i) of this subpart for any storage 
tank or process.
    (1) A State may restrict the owner or operator of an existing 
source to use only the procedures in Sec. 63.1252(b) and (c) to comply 
with the emission standards where State Authorities prohibit averaging 
of HAP emissions.
    (2) Emission sources subject to the requirements of paragraphs 
(b)(3)(ii) and (c)(2), (c)(4), and (c)(5) of this section may not be 
included in any averaging group.
    (3) Processes which have been permanently shutdown or storage tanks 
permanently taken out of HAP service may not be included in any 
averaging group.
    (4) Processes and storage tanks already controlled on or before 
November 15, 1990 may not be included in an emissions averaging group, 
except where the level of control is increased after November 15, 1990. 
In these cases, the uncontrolled emissions shall be the controlled 
emissions as calculated on November 15, 1990 for the purpose of 
determining the uncontrolled emissions as specified in Sec. 63.1253(h) 
and (i) of this subpart.
    (5) Emission points controlled to comply with a State or Federal 
rule other than this subpart, unless the level of control has been 
increased after November 15, 1990 above what is required by the other 
State or Federal rule. Only the control above what is required by the 
other State or Federal rule will be credited. However, if an emission 
point has been used to generate emissions averaging credit in an 
approved emissions average, and the point is subsequently made subject 
to a State or Federal rule other than this subpart, the point can 
continue to generate emissions averaging credit for the purpose of 
complying with the previously approved average.
    (6) Not more than 20 processes and 20 tanks at an affected source 
may be included in an emissions averaging group.
    (7) Compliance with the emissions standards in paragraph (b) of 
this section shall be satisfied when the overall percent reduction 
efficiency is greater than or equal to 90 percent for those tanks 
meeting the requirements of paragraph (b)(1)(i) of this section and 95 
percent for those tanks meeting the requirements of paragraph 
(b)(1)(ii) of this section, as demonstrated using the test methods and 
compliance procedures specified in Sec. 63.1253(h) of this subpart.
    (8) Compliance with the emissions standards in paragraph (c) of 
this section shall be satisfied when the overall percent reduction 
efficiency is greater than or equal to 93 percent, as demonstrated 
using the test methods and compliance procedures specified in 
Sec. 63.1253(i) of this subpart.


Sec. 63.1253  Test methods and compliance procedures.

    (a) Emissions testing or engineering evaluations, as specified in 
paragraphs (c), (d), (e), and (f) of this section, are required to 
demonstrate initial compliance with Sec. 63.1252 (b), (c), (d), and (h) 
respectively, of this subpart.
    (b) Test methods: When testing is conducted to measure emissions 
from an affected source, the test methods specified in paragraphs 
(b)(1) through (b)(9) of this section shall be used.
    (1) EPA Method 1 or 1A of appendix A of part 60 is used for sample 
and velocity traverses.
    (2) EPA Method 2, 2A, 2C, or 2D of appendix A of part 60 is used 
for velocity and volumetric flow rates.
    (3) EPA Method 3 of appendix A of part 60 is used for gas analysis.
    (4) EPA Method 4 of appendix A of part 60 is used for stack gas 
moisture.
    (5) EPA Methods 2, 2A, 2C, 2D, 3, and 4 shall be performed, as 
applicable, at least twice during each test period.
    (6) Methods 25A, 26 and/or Methods 18 and 25A, as appropriate, of 
appendix A of part 60 shall be used to determine the HAP concentration 
of air exhaust streams.
    (7) Test conditions and durations shall be as specified in 
paragraphs (b)(7)(i) through (b)(7)(v) of this section, as appropriate.
    (i) Testing of process vents on equipment operating as part of a 
continuous process will consist of three l-hour runs. Gas stream 
volumetric flow rates shall be measured every 15 minutes during each 1-
hour run. The HAP concentration shall be determined from samples 
collected in an integrated sample over the duration of each l-hour test 
run, or from grab samples collected simultaneously with the flow rate 
measurements (every 15 minutes). If an integrated sample is collected 
for laboratory analysis, the sampling rate shall be adjusted 
proportionally to reflect variations in flow rate. For continuous gas 
streams, the emission rate used to determine compliance shall be the 
average emission rate of the three test runs.
    (ii) Testing of process vents on equipment where the flow of 
gaseous emissions is intermittent (batch operations) shall include 
testing for the worst-case episode or aggregated episodes in the batch 
cycle or cycles (in the event that equipment may be manifolded and 
vented through a common stack) or testing under normal conditions, 
provided that the operation of the device is limited to those 
conditions that existed during testing under representative worst-case 
or normal conditions. Testing shall be conducted at absolute worst-case 
conditions, representative worst-case conditions, hypothetical worst-
case conditions, or normal conditions as required by paragraph 
(d)(3)(iii) of this section. Gas stream volumetric flow rates shall be 
measured at 15-minute intervals. The HAP or TOC concentration shall be 
determined from samples collected in an integrated sample over the 
duration of the test, or from grab samples collected simultaneously 
with the flow rate measurements (every 15 minutes). If an integrated 
sample is collected for laboratory analysis, the sampling rate

[[Page 15771]]

shall be adjusted proportionally to reflect variations in flow rate. 
The absolute worst-case, representative worst-case, or hypothetical 
worst-case conditions shall be characterized by the criteria presented 
in paragraphs (b)(7)(ii) (A), (B), and (C) of this section. In all 
cases, a site-specific plan shall be submitted to the administrator for 
approval prior to testing in accordance with Sec. 63.7(c). The test 
plan shall include the emissions profile described in paragraph 
(b)(7)(iii) of this section.
    (A) Absolute worst-case conditions are defined by any of the 
criteria presented in paragraphs (b)(7)(ii) (A) (1) through (3) of this 
section.
    (1) The period in which the inlet to the control device will 
contain at least 50 percent of the maximum HAP load (in lb) capable of 
being vented to the control device over any 8 hour period. An emission 
profile as described in paragraph (b)(7)(iii) of this section shall be 
used to identify the 8-hour period that includes the maximum projected 
HAP load.
    (2) A 1-hour period of time in which the inlet to the control 
device will contain the highest HAP mass loading rate, in lb/hr, 
capable of being vented to the control device. An emission profile as 
described in paragraph (b)(7)(iii) of this section shall be used to 
identify the 1-hour period of maximum HAP loading.
    (3) If a condenser is used as a control device, absolute worst-case 
conditions shall represent a 1-hour period of time in which the gas 
stream capable of being vented to the condenser will require the 
maximum heat removal capacity, in Btu/hr, to cool the stream to a 
temperature that, upon calculation of HAP concentration, will yield the 
required removal efficiency for the process. The calculation of maximum 
heat load shall be based on the emission profile described in paragraph 
(b)(7)(iii) of this section and a concentration profile that will allow 
calculation of sensible and latent heat loads.
    (B) Representative worst-case conditions are defined by any of the 
criteria presented in paragraph (b)(7)(ii)(A) (1) through (2) of this 
section. Representative worst-case conditions shall include the worst-
case process as well as any other processes that are emitting to the 
control device during the test.
    (1) A 1-hour period of time that contains the highest HAP mass 
loading rate, in lb/hr, from a single process;
    (2) If a condenser is used as the control device, the 1-hour period 
of time in which the vent from a single process will require the 
maximum heat removal capacity, in BTU/hr, to cool the stream to a 
temperature that, upon calculation of HAP concentration, will yield the 
required removal efficiency for the process.
    (C) Hypothetical worst-case conditions are simulated test 
conditions that, at a minimum, contain the highest total average hourly 
HAP load of emissions that would be predicted to be vented to the 
control device from the emissions profile described in paragraph 
(b)(7)(iii) of this section.
    (iii) For batch operations, the owner or operator may choose to 
perform tests only during those periods of the worst-case conditions 
that the owner or operator selects to control as part of achieving the 
required emission reduction. The owner or operator must develop an 
emission profile for the vent to the control device, based on either 
process knowledge, engineering analyses, or test data collected, to 
identify the appropriate test conditions. The emission profile must 
include average HAP loading rate (in lb/hr) versus time for all 
emission episodes within processes that could contribute to the vent 
stack for a period of time that is sufficient to include all processes 
venting to the stack. Examples of information that could constitute 
process knowledge include calculations based on material balances, and 
process stoichiometry. Previous test results may be used provided the 
results are still relevant to the current process vent stream 
conditions. The average hourly HAP loading rate may be calculated by 
first dividing the HAP emissions from each episode by the duration of 
each episode, in hours, and selecting the highest hourly block average.
    (iv) For testing of process vents of duration greater than 8 hours, 
the owner or operator is required to perform a maximum of 8 hours of 
testing. The test period must include the one hour period in which the 
highest HAP loading rate, in lb/hr, is predicted by the emission 
profile.
    (v) For testing durations of greater than 1 hour, the emission rate 
from a single test run may be used to determine compliance. For testing 
durations less than or equal to 1 hour, testing shall include three 1-
hour runs.
    (8) For emission streams controlled using condensers, a direct 
measurement of condenser outlet gas temperature to be used in 
predicting upper concentration limits at saturated conditions is 
allowed in lieu of concentration measurements described in paragraph 
(b)(6) of this section.
    (9) Wastewater analysis shall be conducted in accordance with 
paragraph (b)(9)(i) or (b)(9)(ii) of this section.
    (i) Use the equations in paragraphs (b)(9)(i) (A) and (B) of this 
section to determine the total HAP concentration of a wastewater 
stream.
    (A) The following equation shall be used to calculate the HAP 
concentration of an individually speciated HAP.
[GRAPHIC] [TIFF OMITTED] TP02AP97.000

Where:

C<INF>i=HAP concentration of the individually-speciated organic HAP in 
the wastewater, parts per million by weight.
C<INF>C=concentration of the organic HAP (i) in the gas stream, parts 
per million by volume on a dry basis
M<INF>S=mass of sample, milligrams
MW=molecular weight of the organic HAP (i), grams per gram-mole
24.055=ideal gas molar volume at 293 deg. Kelvin and 760 millimeters of 
mercury, liters per gram-mole
P<INF>i=barometric pressure at the time of sample analysis, millimeters 
mercury absolute
760=reference or standard pressure, millimeters mercury absolute
293=reference or standard temperature,  deg.Kelvin
T<INF>i=sample gas temperature at the time of sample analysis, 
deg.Kelvin
t=actual purge time minutes
L=actual purge rate liters per minute
10\3\=conversion factor, milligrams per gram

    (B) Total HAP concentration can be determined by summing the HAP 
concentrations of all individually speciated organic HAP in the 
wastewater.
[GRAPHIC] [TIFF OMITTED] TP02AP97.001

Where:


[[Page 15772]]


C<INF>stream=total HAP concentration of wastewater stream
n=number of individual organic HAP (i) in the wastewater stream
C<INF>i=HAP concentration of individual HAP (i) calculated according to 
the procedures in paragraph (b)(7)(i)(A) of this section

    (ii) Use a test method or results from a test method that measures 
HAP concentrations in the wastewater, and that has been validated 
according to section 5.1 or 5.3 of Method 301 of 40 CFR part 63 
appendix A.
    (iii) Use Methods 624, 625, 1624, 1625, and 8270, and the 
alternative validation procedures presented in Sec. 63.144.
    (c) Compliance with storage tank provisions. The owner or operator 
of an affected storage tank shall demonstrate compliance with 
Secs. 63.1252(b)(2) and 63.1252(b)(3)(i) and (ii), as applicable, by 
fulfilling the requirements of either paragraph (c)(1) or (c)(2) or 
(c)(3) of this section.
    (1) To demonstrate compliance with the percent reduction 
requirement of Sec. 63.1252(b)(2) or Sec. 63.1252(b)(3) (i) or (ii), 
the mass rate of total HAP (E<INF>i, E<INF>o) shall be computed.
    (i) The following equations shall be used:
    [GRAPHIC] [TIFF OMITTED] TP02AP97.002
    
Where:

C<INF>ij, C<INF>oj=concentration of sample component j of the gas 
stream at the inlet and outlet of the control device, respectively, dry 
basis, parts per million by volume
E<INF>i, E<INF>o=mass rate of total HAP at the inlet and outlet of the 
control device, respectively, dry basis, kilogram per hour
M<INF>ij, M<INF>oj=molecular weight of sample component j of the gas 
stream at the inlet and outlet of the control device, respectively, 
gram/gram-mole
Q<INF>i, Q<INF>o=flow rate of gas stream at the inlet and outlet of the 
control device, respectively, dry standard cubic meter per minute
K<INF>2=constant, 2.494 x 10<SUP>-\6\ (parts per million)<SUP>-\1\ 
(gram-mole per standard cubic meter) (kilogram/gram) (minute/hour), 
where standard temperature is 20 deg.C

    (ii) The percent reduction in total HAP shall be calculated as 
follows: where:
[GRAPHIC] [TIFF OMITTED] TP02AP97.003

Where:

R=control efficiency of control device, percent
E<INF>i=mass rate of total HAP at the inlet to the control device as 
calculated under paragraph (c)(1)(i) of this section, kilograms organic 
HAP per hour
E<INF>o=mass rate of total HAP at the outlet of the control device, as 
calculated under paragraph (c)(1)(i) of this section, kilograms organic 
HAP per hour
    (iii) A performance test is not required to be conducted if the 
control device used to comply with Sec. 63.1252(b) (storage tank 
provisions) is also used to comply with Sec. 63.1252(c) (process vent 
provisions), and compliance with Sec. 63.1252(c) has been demonstrated 
in accordance with paragraph (d)(2) of this section.
    (2) To demonstrate compliance with the percent reduction 
requirement of Sec. 63.1252(b)(2) or Sec. 63.1252(b)(3)(i) or (ii), a 
design evaluation shall be prepared. The design evaluation shall 
include documentation demonstrating that the control device being used 
achieves the required control efficiency during reasonably expected 
maximum filling rate. This documentation is to include a description of 
the gas stream which enters the control device, including flow and 
organic HAP content under varying liquid level conditions, and the 
information specified in paragraphs (c)(2)(i) through (c)(2)(v) of this 
section, as applicable.
    (i) If the control device receives vapors, gases or liquids, other 
than fuels, from emission points other than storage vessels subject to 
this subpart, the efficiency demonstration is to include consideration 
of all vapors, gases, and liquids, other than fuels, received by the 
control device.
    (ii) If an enclosed combustion device with a minimum residence time 
of 0.5 seconds and a minimum temperature of 760 deg.C is used to meet 
the emission reduction requirement specified in Sec. 63.1252(b)(2)(i) 
(or (ii)), documentation that those conditions exist is sufficient to 
meet the requirements of paragraph (c)(2) of this section.
    (iii) Except as provided in paragraph (c)(2)(ii) of this section, 
for thermal incinerators, the design evaluation shall include the 
autoignition temperature of the organic HAP, the flow rate of the 
organic HAP emission stream, the combustion temperature, and the 
residence time at the combustion temperature.
    (iv) For carbon adsorbers, the design evaluation shall include the 
affinity of the organic HAP vapors for carbon, the amount of carbon in 
each bed, the number of beds, the humidity of the feed gases, the 
temperature of the feed gases, the flow rate of the organic HAP 
emission stream, the desorption schedule, the regeneration stream 
pressure or temperature, and the flow rate of the regeneration stream. 
For vacuum desorption, pressure drop shall be included.
    (v) For condensers, the design evaluation shall include the final 
temperature of the organic HAP vapors, the type of condenser, and the 
design flow rate of the organic HAP emission stream.
    (3) If the owner or operator of an affected source chooses to 
comply with the provisions of Sec. 63.1252(b)(2) or Sec. 63.1252(b)(3) 
by installing a floating roof, the owner or operator shall comply with 
the procedures described in 40 CFR 63.119(b), (c), (d), and 63.120.
    (d) Compliance with process vent provisions. An owner or operator 
of an affected source complying with the process vent standards in 
Sec. 63.1252(c) shall demonstrate compliance using the procedures 
described in paragraphs (d)(1) through (d)(4) of this section.
    (1) Except as provided in paragraph (d)(4) of this section, 
compliance with the process vent standards in Sec. 63.1252(c) shall be 
demonstrated using the procedures specified in paragraphs (d)(1)(i) 
through (v), as applicable.
    (i) Compliance with Sec. 63.1252(c)(2) is demonstrated when the 
controlled emissions of HAP from the sum of all process vents within a 
process that do not meet the criteria specified in 
Sec. 63.1252(c)(4)(ii) is less than or equal to 2,000 pound per year. 
Controlled emissions of HAP shall be determined using the procedures 
described in paragraph (d)(3) of this section.
    (ii) Compliance with Sec. 63.1252(c)(3) is demonstrated when the 
annual uncontrolled HAP emissions from the sum of all process vents 
within a process that do not meet the criteria specified in 
Sec. 63.1252(c)(4)(ii) is reduced by 93 percent. This demonstration 
shall be based on controlled emissions of HAP determined using the 
procedures described in paragraph (d)(3) of this section and 
uncontrolled emissions of HAP determined using the procedures described 
in paragraph (d)(2) of this section or by controlling the process vents 
using a device meeting the criteria specified in paragraph (d)(4) of 
this section.
    (iii) Compliance with Sec. 63.1252(c)(5) is demonstrated when the 
annual

[[Page 15773]]

uncontrolled HAP emissions from all process vents within a process is 
reduced by 98 percent, or when the sum of uncontrolled HAP emissions of 
all process vents within a process is less than or equal to 180 kg/yr 
(400 lb/yr). This demonstration shall be based on controlled emissions 
of HAP determined using the procedures described in paragraph (d)(3) of 
this section and uncontrolled emissions of HAP determined using the 
procedures described in paragraph (d)(2) of this section or by 
controlling the process vents using a device meeting the criteria 
specified in paragraph (d)(4) of this section.
    (iv) Compliance with Sec. 63.1252(c)(4) is demonstrated when the 
annual uncontrolled HAP emissions from each process vent meeting the 
requirements of Sec. 63.1252(c)(4)(i) is reduced by 98 percent. This 
demonstration shall be based on controlled emissions of HAP determined 
using the procedures described in paragraph (d)(3) of this section and 
uncontrolled emissions of HAP determined using the procedures described 
in paragraph (d)(2) of this section or by controlling the process vents 
using a device meeting the criteria specified in paragraph (d)(4) of 
this section.
    (v) Compliance with Sec. 63.1252(c)(4)(ii) is demonstrated when the 
annual uncontrolled HAP emissions from each process vent meeting the 
requirements of Sec. 63.1252(c)(4)(ii) is reduced by 93 percent. This 
demonstration shall be based on controlled emissions of HAP determined 
using the procedures described in paragraph (d)(3) of this section and 
uncontrolled emissions of HAP determined using the procedures described 
in paragraph (d)(2) of this section or by controlling the process vents 
using a device meeting the criteria specified in paragraph (d)(4) of 
this section.
    (2) An owner or operator of an affected source complying with the 
emission limitation required by Sec. 63.1252(c)(2), or emissions 
reductions specified in Sec. 63.1252(c)(3), (c)(4), or (c)(5) of this 
subpart for each process vent within a process, shall calculate 
uncontrolled emissions according to the procedures described in 
paragraph (d)(2)(i) or (d)(2)(ii) of this section, as appropriate.
    (i) Owners or operators shall determine uncontrolled emissions of 
HAP using measurements and/or calculations for each batch emission 
episode within each unit operation according to the engineering 
evaluation methodology in paragraphs (d)(2)(i)(A) through (d)(2)(i)(E) 
of this section. Individual HAP partial pressures in multicomponent 
systems shall be determined by the following methods: If the components 
are miscible in one another, use Raoult's law to calculate the partial 
pressures; if the solution is a dilute aqueous mixture, use Henry's law 
to calculate partial pressures; if Raoult's law or Henry's law are not 
appropriate or available, use experimentally obtained activity 
coefficients or models such as the group-contribution models, to 
predict activity coefficients, or assume the components of the system 
behave independently and use the summation of all vapor pressures from 
the HAP as the total HAP partial pressure. Chemical property data can 
be obtained from standard reference texts.
    (A) Emissions from vapor displacement due to transfer of material 
shall be calculated according to equation (1):
[GRAPHIC] [TIFF OMITTED] TP02AP97.004

Where:

E = mass emission rate
y<INF>i = saturated mole fraction of HAP in the vapor phase
V = volume of gas displaced from the vessel
R = ideal gas law constant
T = temperature of the vessel vapor space; absolute
P<INF>T = pressure of the vessel vapor space
MW = molecular weight of the HAP

    (B) Emissions from purging shall be calculated using equation (1), 
except that for purge flow rates greater than 100 standard cubic feet 
per minute (scfm), the mole fraction of HAP will be assumed to be 25 
percent of the saturated value.
    (C) Emissions caused by the heating of a vessel shall be calculated 
using the procedures in either paragraph (d)(2)(i) (C)(1), (C)(2), or 
(C)(3) of this section, as appropriate.
    (1) If the final temperature to which the vessel contents is heated 
is lower than 50 deg. K below the boiling point of the HAP in the 
vessel, then emissions shall be calculated using the equations (2) 
through (5) in paragraphs (d)(2)(i) (C)(1)(i) through (iv) of this 
section.
    (i) The mass of HAP emitted per episode shall be calculated as 
follows:
[GRAPHIC] [TIFF OMITTED] TP02AP97.005

Where:

E = mass of HAP vapor displaced from the vessel being heated
(P<INF>i)T<INF>n = partial pressure of each HAP in the vessel headspace 
at initial (n=1) and final (n=2) temperature
Pa<INF>1 = initial gas pressure in the vessel
Pa<INF>2 = final gas pressure
MW<INF>HAP = the average molecular weight of HAP present in the vessel

    (ii) The moles of gas displaced is represented by:
    [GRAPHIC] [TIFF OMITTED] TP02AP97.006
    
Where:

<greek-D><greek-ee> = number of lb-moles of gas displaced
V = volume of free space in the vessel
R = ideal gas law constant
Pa<INF>1 = initial gas pressure in the vessel
Pa<INF>2 = final gas pressure
T<INF>1 = initial temperature of vessel
T<INF>2 = final temperature of vessel

    (iii) The initial and final pressure of the noncondensable gas in 
the vessel shall be calculated according to the following equation:
[GRAPHIC] [TIFF OMITTED] TP02AP97.007

Where:

Pa<INF>n = partial pressure of gas in the vessel headspace at initial 
(n=1) and final (n=2) temperature
P<INF>atm = atmospheric pressure
(P<INF>i)T<INF>n = partial pressure of each condensable volatile 
organic compound (including HAP) in the vessel headspace at the initial 
temperature (n=1) and final (n=2) temperature

    (iv) The average molecular weight of HAP in the displaced gas shall 
be calculated as follows:

[[Page 15774]]

[GRAPHIC] [TIFF OMITTED] TP02AP97.008


where n is the number of different HAP compounds in the emission 
stream.
    (2) If the vessel contents are heated to a temperature greater than 
50 deg.K below the boiling point, then emissions from the heating of a 
vessel shall be calculated as the sum of the emissions calculated in 
accordance with paragraphs (d)(2)(i) (C)(2)(i) and (C)(2)(ii) of this 
section.
    (i) For the interval from the initial temperature to the 
temperature 50 deg.K below the boiling point, emissions shall be 
calculated using Equation 2, where T<INF>2 is the temperature 50 deg.K 
below the boiling point.
    (ii) For the interval from the temperature 50 deg.K below the 
boiling point to the final temperature, emissions shall be calculated 
as the summation of emissions for each 5 deg.K increment, where the 
emission for each increment shall be calculated using Equation 2.
    (A) If the final temperature of the heatup is lower than 5 deg.K 
below the boiling point, the final temperature for the last increment 
shall be the final temperature of the heatup, even if the last 
increment is less than 5 deg.K.
    (B) If the final temperature of the heatup is higher than 5 deg.K 
below the boiling point, the final temperature for the last increment 
shall be the temperature 5 deg.K below the boiling point, even if the 
last increment is less than 5 deg.K.
    (C) If the vessel contents are heated to the boiling point and the 
vessel is not operating with a process condenser, the final temperature 
for the final increment shall be the temperature 5 deg.K below the 
boiling point, even if the last increment is less than 5 deg.K.
    (3) If the vessel is operating with a process condenser, and the 
vessel contents are heated to the boiling point, the primary condenser 
is considered part of the process. Emissions shall be calculated as the 
sum of Equation 2, which calculates emissions due to heating the vessel 
contents to the temperature of the gas exiting the condenser, and 
Equation 1, which calculates emissions due to the displacement of the 
remaining saturated noncondensable gas in the vessel. The final 
temperature in Equation 2 shall be set equal to the exit gas 
temperature of the process condenser. In Equation 1, V shall be set 
equal to the free space volume, and T<INF>2 shall be set equal to the 
condenser exit gas temperature.
    (D) Emissions from depressurization shall be calculated using the 
procedures in paragraphs (d)(2)(i) (D)(1) through (D)(5) of this 
section.
    (1) The moles of HAP vapor initially in the vessel are calculated 
using the ideal gas law as follows:
[GRAPHIC] [TIFF OMITTED] TP02AP97.009

Where:

Y<INF>HAP = mole fraction of HAP (the sum of the individual HAP 
fractions, <greek-S>Y<INF>i)
V = free volume in the vessel being depressurized
P<INF>1 = initial vessel pressure
R = gas constant
T = vessel temperature, absolute units

    (2) The moles of noncondensable gas present initially in the vessel 
are calculated as follows:
[GRAPHIC] [TIFF OMITTED] TP02AP97.010

Where:

V = free volume in the vessel being depressurized
P<INF>nc1 = initial partial pressure of the noncondensable gas, 
P<INF>1-<greek-S>P<INF>i
R = gas law constant, K
T = temperature, absolute units

    (3) The moles of noncondensable gas present at the end of 
depressurization are calculated as follows:
[GRAPHIC] [TIFF OMITTED] TP02AP97.011

Where:

V = free volume in the vessel being depressurized
P<INF>NC2 = Final partial pressure of the noncondensable gas, 
P<INF>2-<greek-S>P<INF>i
R = gas law constant
T = temperature, absolute

    (4) The moles of HAP emitted during the depressurization are 
calculated by taking an approximation of the average ratio of moles of 
HAP to moles of noncondensable and multiplying by the total moles of 
noncondensables released during the depressurization, or:
[GRAPHIC] [TIFF OMITTED] TP02AP97.012

Where:

n<INF>HAP = moles of HAP emitted

    (5) The moles of HAP emitted can be converted to a mass rate using 
the following equation:
[GRAPHIC] [TIFF OMITTED] TP02AP97.013

Where:

Er<INF>voc = emission rate of the HAP
MW<INF>voc = molecular weight of the HAP
t = time of the depressurization

    (E) Emissions from vacuum systems may be calculated if the air 
leakage rate is known or can be approximated, using the following 
equation:
[GRAPHIC] [TIFF OMITTED] TP02AP97.014

Where:

E<INF>r = rate of HAP emission, in lb/hr
P<INF>system = absolute pressure of receiving vessel or ejector outlet 
conditions, if there is no receiver
P<INF>i* = vapor pressure of the HAP at the receiver temperature, in 
mmHg
La = total air leak rate in the system, lb/hr
29 = molecular weight of air, lb/lbmole

    (ii) For emission episodes in which the owner or operator can 
demonstrate that the methods in paragraph (d)(2)(i) of this section are 
not appropriate according to paragraph (d)(2)(iii) of this section, 
owners and operators shall calculate uncontrolled emissions by 
conducting an engineering assessment which includes, but is not limited 
to, the following:
    (A) Previous test results provided the tests are representative of 
current operating practices at the process unit.
    (B) Bench-scale or pilot-scale test data representative of the 
process under representative operating conditions.
    (C) Maximum flow rate, HAP emission rate, concentration, or other 
relevant parameter specified or implied within a permit limit 
applicable to the process vent.
    (D) Design analysis based on accepted chemical engineering 
principles, measurable process parameters, or

[[Page 15775]]

physical or chemical laws or properties. Examples of analytical methods 
include, but are not limited to:
    (1) Use of material balances based on process stoichiometry to 
estimate maximum organic HAP concentrations,
    (2) Estimation of maximum flow rate based on physical equipment 
design such as pump or blower capacities,
    (3) Estimation of HAP concentrations based on saturation 
conditions.
    (E) All data, assumptions, and procedures used in the engineering 
assessment shall be documented in accordance with Sec. 63.1255(b). Data 
or other information supporting a finding that the emissions estimation 
equations are inappropriate shall be reported in the Notification of 
Compliance Status.
    (iii) The emissions estimation equations in paragraph (d)(2)(i) of 
this section shall be considered inappropriate for estimating emissions 
for a given batch emissions episode if one or more of the criteria in 
paragraphs (d)(2)(iii)(A) and (d)(2)(iii)(B) of this section are met.
    (A) Previous test data are available that show a greater than 20 
percent discrepancy between the test value and the estimated value.
    (B) The owner or operator can demonstrate to the Administrator 
through any other means that the emissions estimation equations are not 
appropriate for a given batch emissions episode.
    (3) Owners and operators shall determine controlled emissions using 
measurements and/or calculations for each process vent using the 
control efficiency calculated from each device that controls process 
vents with total emissions of less than 10 tons per year, before 
control, according to the design evaluation described in paragraph 
(d)(3)(i) of this section, or using the emission estimation equations 
described in paragraph (d)(2) of this section, as appropriate. Owners 
and operators shall determine controlled emissions for each process 
vent using the control efficiency determined from each device that 
controls process vents with total emissions of greater than 10 tons per 
year, before control, by conducting a performance test on the control 
device as described in paragraphs (d)(3)(ii) through (iv) of this 
section, or by using the results of a previous performance test as 
described in paragraph (d)(5) of this section. Owners and operators are 
not required to conduct performance tests for devices described in 
paragraphs (d)(4) and (d)(5) of this section that control total 
emissions of greater than 10 tons per year, before control.
    (i) The design evaluation shall include documentation demonstrating 
that the control device being used achieves the required control 
efficiency during the emission episodes in which it is functioning in 
reducing emissions. This documentation is to include a description of 
the gas stream which enters the control device, including flow and HAP 
concentration, and the information specified in paragraphs (c)(2)(i) 
through (c)(2)(v) of this section, as applicable.
    (ii) The performance test shall be conducted by performing emission 
testing on the inlet and outlet of the control device following the 
test methods and procedures of Sec. 63.1253(b). Concentrations shall be 
calculated from the data obtained through emission testing according to 
the following procedures:
    (A) The total HAP concentration (C<INF>HAP) is the sum of the 
concentrations of the individual HAP and shall be computed for each run 
using the following equation:
[GRAPHIC] [TIFF OMITTED] TP02AP97.015

Where:

C<INF>HAP = concentration of total HAP, dry basis, parts per million by 
volume
C<INF>ji = concentration of individual HAP j of sample i, dry basis, 
parts per million by volume
n = number of HAP in the sample
x = number of samples in the sample run

    (B) The concentration of total HAP shall be corrected to 3 percent 
oxygen if a combustion device is the control device. The emission rate 
correction factor for excess air, based on the integrated sampling and 
analysis procedures of Method 3B of 40 CFR part 60, appendix A shall be 
used to determine the oxygen concentration (%0<INF>2d). The samples 
shall be taken during the same time that the total HAP samples are 
taken. The concentration corrected to 3 percent oxygen (C<INF>c) shall 
be computed as:
[GRAPHIC] [TIFF OMITTED] TP02AP97.016

where:

C<INF>c=concentration of organic HAP corrected to 3 percent oxygen, dry 
basis, parts per million by volume
C<INF>m=concentration of organic HAP, dry basis, parts per million by 
volume
%0<INF>2d=concentration of oxygen, dry basis, percent by volume

    (iii) Performance testing shall be conducted under the following 
conditions:
    (A) For all control devices, the owner or operator shall test over 
absolute or hypothetical worst-case conditions, or over normal 
conditions, provided the operation of the devices is limited to the 
conditions that existed during testing. For testing during normal 
conditions, test conditions and their corresponding operating limits 
shall be established in the precompliance report and characterized 
according to stream composition, temperature, and flowrate. The owner 
or operator must demonstrate in the precompliance report that emission 
stream conditions entering the control device shall be within the test 
conditions at all times.
    (B) For thermal incinerators, the owner or operator may also choose 
to test over representative worst-case conditions; however, if the 
owner or operator chooses to test over representative worst-case 
conditions, the maximum allowable vent stream flowrate into the thermal 
incinerator is restricted to the level for which it was designed. The 
design basis of the incinerator shall be included as part of the 
Notification of Compliance Status.
    (iv) The owner or operator may elect to conduct more than one 
performance test on the control device for the purpose of establishing 
operating conditions associated with a range of achievable control 
efficiencies.
    (4) An owner or operator is not required to conduct a performance 
test when a control device specified in paragraphs (d)(4)(i) through 
(4)(iii) of this section is used to comply with the emission reductions 
required by Sec. 63.1252(c)(4) or (c)(5) of this subpart.
    (i) A boiler or process heater with a design heat input capacity of 
44 megawatts or greater.
    (ii) A boiler or process heater where the vent stream is introduced 
with the primary fuel or is used as the primary fuel.
    (iii) A boiler or process heater burning hazardous waste for which 
the owner or operator:
    (A) Has been issued a final permit under 40 CFR part 270 and 
complies with the requirements of 40 CFR part 266, subpart H, or
    (B) Has certified compliance with the interim status requirements 
of 40 CFR part 266, subpart H.
    (5) An owner or operator is not required to conduct a performance 
test for the following:
    (i) Any control device for which a previous performance test was 
conducted, provided the test was conducted using the same procedures

[[Page 15776]]

specified in Sec. 63.1253(b) of this subpart over conditions typical of 
the appropriate worst-case, as defined in paragraph (d)(3)(iii)(A) of 
this section, or typical of normal operations, as defined in paragraph 
(d)(3)(iii)(A) of this section and restricted to the conditions 
described therein. The results of the previous performance test shall 
be used to demonstrate compliance.
    (ii) A condenser system that is equipped with a temperature sensor 
and recorder, such that the condenser exit gas temperature can be 
measured at 15-minute intervals when the condenser is functionning in 
cooling a vent stream. The condenser exit gas temperature shall be used 
to calculate removal efficiency of the condenser in demonstrating 
compliance.
    (e) Compliance with wastewater provisions.
    (1) An owner or operator of a wastewater stream shall comply with 
paragraphs (e)(1)(i) through (1)(iii) of this section in determining 
streams that are exempt from the control requirements of 
Sec. 63.1252(d).
    (i) Compliance is demonstrated when the concentration of partially 
soluble HAP is less than 1,300 ppmw at the POD, or the concentration of 
total HAP is less than 5,200 ppmw at the POD, as measured or estimated 
using one of the procedures described in paragraphs (e)(1)(i) (A) 
through (C) of this section.
    (A) The concentration of partially soluble HAP, soluble HAP, or 
total HAP shall be measured using methods validated under the 
procedures described in paragraphs (b)(8)(ii) and (iii) of this 
section.
    (B) The concentration of partially soluble HAP, soluble HAP, or 
total HAP shall be calculated based on knowledge of the process 
wastewater. The owner or operator shall provide sufficient information 
to document concentrations. Examples of information that could 
constitute such knowledge include material balances, records of 
chemical purchases, process stoichiometry, or previous test results 
provided the results are still representative of current operating 
practices at the process unit(s).
    (C) The concentration of partially soluble HAP, soluble HAP, or 
total HAP shall be calculated based on bench scale or pilot-scale test 
data. The owner or operator shall provide sufficient information to 
demonstrate that the bench-scale or pilot-scale test concentration data 
are representative of actual HAP concentrations. The owner or operator 
shall also provide documentation describing the testing protocol, and 
the means by which sample variability and analytical variability were 
accounted for in the determination of HAP concentrations.
    (ii) Compliance is demonstrated when the total HAP load calculated 
by summing the load from all POD's at a facility is less than 1 Mg/yr. 
The total wastewater load shall be calculated by converting the 
concentration of partially soluble HAP, soluble HAP, or total HAP, as 
appropriate from a concentration (ppmw), to a measure of the kg of HAP 
per liter of wastewater. The load shall be calculated by multiplying 
the kilograms of HAP per liter by the total liters of wastewater per 
year at the POD. The total liters of wastewater discharged per year 
shall be demonstrated through the records required by Sec. 63.1255(b) 
of this subpart.
    (iii) Compliance is demonstrated for each stream with a 
concentration exceeding 1,300 ppmw partially soluble HAP or 5,200 ppmw 
total HAP at the POD, but less than 10,000 ppmw total HAP at the POD, 
and the HAP load at the POD or the total HAP load calculated from 
summing the load from all POD's within a process is less than 1 Mg/yr. 
Concentrations may be measured or estimated using the procedures 
described in paragraphs (e)(1)(i)(A) through (C) of this section.
    (2) Compliance with the control requirements of Sec. 63.1252(d)(4) 
is demonstrated through the procedures outlined in Secs. 63.145(b), 
63.145(c), 63.145(d), 63.138(j) or 63.145(i) as appropriate.
    (3) Compliance with the control device requirements for devices 
used to comply with the provisions in Secs. 63.133 through 63.138 is 
demonstrated by compliance with the provisions of Sec. 63.139(d).
    (4) Compliance with the inspection requirements for vapor 
collection systems, closed vent systems, fixed roofs, covers, or 
enclosures is demonstrated by compliance with the provisions of 
Sec. 63.148.
    (5) Compliance with the inspection requirements for wastewater 
tanks, surface impoundments, containers, individual drain systems, and 
oil-water separators is demonstrated through the provisions of 
Sec. 63.143.
    (f) Pollution prevention alternative standard: The owner or 
operator shall demonstrate compliance with Sec. 63.1252(h)(2) of this 
subpart using the procedures described in paragraph (f)(1) of this 
section. The owner or operator shall demonstrate compliance with 
Sec. 63.1252(h)(3) of this subpart using the procedures described in 
paragraph (f)(2) of this section.
    (1) Compliance is demonstrated when the annual kg/kg factor, 
calculated according to the procedure in paragraphs (f)(1)(i) and (iii) 
of this section, is reduced to a value equal to or less than 25 percent 
of the baseline factor calculated according to the procedure in 
paragraph (f)(1)(i) and (ii) of this section.
    (i) The production-indexed HAP consumption factors shall be 
calculated by dividing annual consumption of total HAP by the annual 
production rate, per process. The production-indexed total VOC 
consumption factor shall be calculated by dividing annual consumption 
of total VOC by the annual production rate, per process.
    (ii) The baseline factor is calculated from yearly production and 
consumption data for the first 12-month period of time for which data 
was available, to begin no earlier than January 1, 1987.
    (iii) The annual factor is calculated on the following bases:
    (A) For continuous processes, the annual factor shall be calculated 
every 30 days for the 12-month period preceding the 30th day (30-day 
rolling average).
    (B) For batch processes, the annual factor shall be calculated 
every 10 batches for the 12-month period preceding the 10th batch (10-
batch rolling average).
    (2) Compliance is demonstrated when the requirements of paragraphs 
(f)(2)(i) through (iv) of this section are met.
    (i) The annual kg/kg factor, calculated according to the procedure 
in paragraphs (f)(1)(i) and (f)(1)(iii) of this section, is reduced to 
a value equal to or less than 50 percent of the baseline factor 
calculated according to the procedure in paragraphs (f)(1)(i) and 
(f)(1)(ii) of this section.
    (ii) The yearly reduction, in kg HAP/yr, associated with add-on 
controls that meet the criteria of Secs. 63.1252(h)(3)(ii)(A) through 
(D), is equal to or greater than the mass of HAP calculated by the 
following equation:
[GRAPHIC] [TIFF OMITTED] TP02AP97.017


[[Page 15777]]


where:

[kg/kg]<INF>b = the baseline production-indexed consumption factor, in 
kg/kg
[kg produced]<INF>a = the annual production rate, in kg/yr
[kg reduced]<INF>a = the annual reduction required by add-on controls, 
in kg/yr

    (iii) Demonstration that the criteria in Secs. 63.1252(h)(3)(ii)(A) 
through (D) are met shall be accomplished through a description of the 
control device and of the material streams entering and exiting the 
control device.
    (iv) The annual reduction achieved by the add-on control shall be 
quantified using the methods described in Sec. 63.1253(d).
    (g) Planned maintenance: The owner or operator shall demonstrate 
compliance with the requirements of Sec. 63.1252(b), and (c) of this 
subpart by including in each Periodic Report required by Sec. 63.1256 
of this subpart the periods of planned routine maintenance specified by 
date and time (planned routine maintenance of a control device, during 
which the control device does not meet the specifications of 
Sec. 63.1252 of this subpart, as applicable, shall not exceed 240 hours 
per year).
    (h) Compliance with storage tank provisions by using emissions 
averaging: An owner or operator with two or more affected storage tanks 
may demonstrate compliance with Sec. 63.1252(b)(2) and 
Sec. 63.1252(b)(3)(i) and (ii), as applicable, by fulfilling the 
requirements of paragraphs (h)(1) through (4) or paragraphs (h)(1), 
(2), (5) and (6) of this section, as appropriate.
    (1) The owner or operator shall develop and submit for approval an 
Implementation Plan containing all the information required in 
Sec. 63.1255(f) of this subpart 18 months prior to the compliance date 
of the standard. The Administrator shall have 60 days to approve or 
disapprove the emissions averaging plan after which time the plan shall 
be considered approved.
    (2) The annual mass rate of total organic HAP (E<INF>Ti, E<INF>To) 
shall be calculated for each storage tank included in the emissions 
average using the requirements specified in either paragraph (c)(1) or 
(c)(2) or (c)(3) of this section.
    (3) The following equations shall be used to calculate total HAP 
emissions for those tanks subject to Sec. 63.1252(b)(1)(i):
[GRAPHIC] [TIFF OMITTED] TP02AP97.018

where:

E<INF>ij = yearly mass rate of total organic HAP at the inlet of the 
control device for tank j
E<INF>oj = yearly mass rate of total organic HAP at the outlet of the 
control device for tank j
E<INF>Ti = total yearly uncontrolled emissions
E<INF>To = total yearly controlled emissions
n = number of tanks included in the emissions average

    (4) The overall percent reduction efficiency shall be calculated as 
follows:
[GRAPHIC] [TIFF OMITTED] TP02AP97.019

where:

R = overall percent reduction efficiency.
D = discount factor = 1.1 for all controlled storage tanks.

    (5) The following equations shall be used to calculate total HAP 
emissions for those tanks subject to Sec. 63.1252(b)(1)(ii):
[GRAPHIC] [TIFF OMITTED] TP02AP97.020

Where:

E<INF>ij = yearly mass rate of total organic HAP at the inlet of the 
control device for tank j
E<INF>oj = yearly mass rate of total organic HAP at the outlet of the 
control device for tank j
E<INF>Ti = total yearly uncontrolled emissions
E<INF>To = total yearly controlled emissions
n = number of tanks included in the emissions average

    (6) The overall percent reduction efficiency shall be calculated as 
follows:
[GRAPHIC] [TIFF OMITTED] TP02AP97.021

Where:

R = overall percent reduction efficiency
D = discount factor = 1.1 for all controlled storage tanks

    (i) Compliance with process vent provisions by using emissions 
averaging:
    An owner or operator with two or more affected processes complying 
with Sec. 63.1252(c) by using emissions averaging shall demonstrate 
compliance with paragraphs (i)(1), (2) and (3) of this section.
    (1) The owner or operator shall develop and submit for approval an 
Implementation Plan 18 months prior to the compliance date of the 
standard containing all the information required in Sec. 63.1255(f) of 
this subpart. The Administrator shall have 60 days to approve or 
disapprove the emissions averaging plan. The plan shall be considered 
approved if the administrator either approves the plan in writing, or 
fails to disapprove the plan in writing. The 60 day period shall begin 
when the administrator receives the request. If the request is denied, 
the owner or operator must still be in compliance with the standard by 
the compliance date.
    (2) Owners or operators shall calculate uncontrolled and controlled 
emissions of HAP by using the methods specified in paragraph (d)(2) or 
(d)(3) of this section for each process included in the emissions 
average.
    (i) The following equations shall be used to calculate total HAP 
emissions:
[GRAPHIC] [TIFF OMITTED] TP02AP97.022

Where:

E<INF>Ui = yearly uncontrolled emissions from process i
E<INF>Ci = yearly controlled emissions for process i
E<INF>TU = total yearly uncontrolled emissions
E<INF>TC = total yearly controlled emissions
n = number of processes included in the emissions average

    (3) The overall percent reduction efficiency shall be calculated as 
follows:
[GRAPHIC] [TIFF OMITTED] TP02AP97.023

Where:

R = overall percent reduction efficiency
D = discount factor = 1.1 for all controlled emission points

Sec. 63.1254  Monitoring requirements.

    (a) The owner or operator of any existing, new, or reconstructed 
affected source shall provide evidence of continued compliance with the 
standard. During the initial compliance demonstration, maximum or 
minimum operating parameters, as appropriate, shall be established for 
emission sources that will indicate the source is in compliance. Test 
data, calculations, or information from the evaluation of the

[[Page 15778]]

control device design shall be used to establish the operating 
parameter. If the operating parameter to be established is a maximum 
and if performance testing has been required, the value of the 
parameter shall be the average of the maximum values from each of the 
three test runs. If the operating parameter to be established is a 
minimum and if performance testing has been required, the value of the 
parameter shall be the average of the minimum values from each of the 
three test runs. Parameter values for process vents from batch 
operations shall be determined as specified in paragraph (b)(1) and (2) 
of this section. The owner or operator shall operate processes and 
control devices within these parameters to ensure continued compliance 
with the standard. Monitoring parameters are specified for continuous 
process vent control scenarios in paragraphs (a)(1) through (7) of this 
section.
    (1) For all control devices that are used to control process vent 
streams totaling less than 1 ton/yr HAP emissions, before control, 
monitoring shall consist of a periodic verification that the device is 
operating properly. This verification shall include, but not be limited 
to, a periodic demonstration that the unit is working as designed. This 
demonstration shall be included in the precompliance report, to be 
submitted 12 months prior to the compliance date of the standard.
    (2) For affected sources using water scrubbers that are used to 
control process vent streams totaling greater than 1 ton/yr HAP, before 
controls, the owner or operator shall establish a minimum scrubber 
water flow rate as a site-specific operating parameter which must be 
measured and recorded every 15 minutes. The affected source will be 
considered to be out of compliance if the scrubber water flow rate, 
averaged over the operating day, is below the minimum value established 
during the initial compliance demonstration.
    (3) For affected sources using condensers that are used to control 
process vent streams totaling greater than 1 ton/yr, before controls, 
the owner or operator shall establish the maximum condenser outlet gas 
temperature as a site-specific operating parameter which must be 
measured and recorded every 15 minutes. The affected source will be 
considered to be out of compliance if the condenser outlet gas 
temperature, averaged over the operating day, is greater than the 
maximum value established during the initial compliance demonstration.
    (4) For affected sources using carbon adsorbers that are used to 
control process vent streams totaling greater than 1 ton/yr, before 
controls, the owner or operator shall establish a maximum outlet HAP 
concentration as the site-specific operating parameter which must be 
measured and recorded every 15 minutes. The affected source will be 
considered to be out of compliance if the outlet HAP concentration, 
averaged over the operating day, is greater than the maximum value 
established during the initial compliance demonstration.
    (5) For affected sources using flares that are used to control 
process vent streams totaling greater than 1 ton/yr, before controls, 
the presence of the pilot flame shall be monitored every 15 minutes. 
The affected source will be considered to be out of compliance upon 
loss of pilot flame.
    (6) For each wastewater management unit, treatment process, or 
control device used to comply with Secs. 63.138 and 63.139, the owner 
or operator shall comply with either paragraph (a)(6)(i) or (a)(6)(ii) 
of this section.
    (i) The owner or operator shall monitor the parameters specified in 
Tables 11, 12, or 13 of subpart 63.
    (ii) The owner or operator shall submit a request for approval to 
monitor alternative parameters according to the procedures specified in 
Sec. 63.1256(a)(2)(i).
    (7) For affected sources using combustion devices that are used to 
control process vents totaling greater than 1 ton/yr, before controls, 
the owner or operator shall monitor the temperature of the gases 
exiting the combustion chamber as the site-specific operating parameter 
which must be measured and recorded every 15 minutes. The affected 
sources will be considered to be out of compliance if the chamber 
temperature averaged over the operating day, is greater than the 
maximum value established during the initial compliance demonstration.
    (b) The owner or operator of any existing, new, or reconstructed 
affected source that chooses to comply with the emission limit or 
emission reduction requirement for batch process vents and combined 
streams from process vents and storage tanks shall provide evidence of 
continued compliance with the standard. As part of the initial 
compliance demonstrations for batch process vents and storage tanks, 
test data, compliance calculations, or information from the control 
device design evaluation shall be used to establish a maximum or 
minimum level of a relevant operating parameter for each control device 
that the owner or operator selects to operate as part of achieving the 
required emission reduction or emission limitation. The owner or 
operator shall operate processes and control devices within these 
parameters to ensure continued compliance with the standard.
    (1) For devices that are used to control batch process vent streams 
totaling less than 1 ton/yr HAP emissions, before control, monitoring 
shall consist of a periodic verification that the device is operating 
properly. This verification shall include, but not be limited to, a 
periodic demonstration that the unit is working as designed. This 
demonstration shall be included in the precompliance report, to be 
submitted 12 months prior to the compliance date of the standard.
    (2) For batch process vents that are routed to a device that 
receives HAP in excess of 1 ton per year, before control, the level(s) 
shall be established in accordance with paragraphs (b)(2)(i) through 
(iv) of this section.
    (i) If more than one batch emission episode or more than one 
portion of a batch emission episode has been selected to be controlled, 
a single level for the batch cycle(s) or process(es) shall be 
calculated from the initial compliance demonstration. The appropriate 
parameter shall be determined for the worst-case conditions, as 
determined in Sec. 63.1253(b)(7)(ii) and (b)(7)(iii) selected to be 
controlled. The average parameter monitoring level for the cycle(s) or 
process(es) shall be based on the parameter value determined from the 
worst-case conditions.
    (ii) Instead of establishing a single level for the batch cycle(s) 
or process(es), as described in paragraph (b)(2)(i) of this section, an 
owner or operator may establish separate levels for each batch emission 
episode, or portion thereof, selected to be controlled.
    (iii) For devices controlling at least 10 tons per year for which a 
performance test is required, the owner or operator may establish the 
parametric monitoring level(s) based on the performance test 
supplemented by engineering assessments and manufacturer's 
recommendations. Performance testing is not required to be conducted 
over the entire range of expected parameter values. The rationale for 
the specific level for each parameter, including any data and 
calculations used to develop the level(s) and a description of why the 
level indicates proper operation of the control device shall be 
provided in the Precompliance report. The procedures specified in this 
section have not been approved by the Administrator and determination 
of the parametric monitoring level using these procedures is subject to 
review and approval by the Administrator.

[[Page 15779]]

    (iv) For devices controlling at least 10 tons per year for which a 
performance test is conducted at routine conditions, the owner or 
operator shall establish the parametric monitoring level(s) at 
conditions of the test. The level(s) established shall be provided in 
the notification of compliance status report.
    (3) If the sum of HAP emissions, before control, routed to the 
device is greater than 1 tons/yr, the appropriate parameter shall be 
monitored at 15-minute intervals for the entire period in which the 
control device is functioning in achieving required removals.
    (4) Affected sources with condensers on process vents shall 
establish the maximum condenser outlet gas temperature as a site-
specific operating parameter, which, except as provided in paragraph 
(b)(3) of this section, must be measured every 15 minutes or at least 
once for batch emission episodes less than 15 minutes in duration. The 
affected source will be considered to be out of compliance if the 
condenser outlet gas temperature, averaged over the operating day for 
each process is greater than the value established during the initial 
compliance demonstration.
    (5) For affected sources using water scrubbers, the owner or 
operator shall establish a minimum scrubber water flow rate as a site-
specific operating parameter which, except as provided in paragraph 
(b)(3) of this section, must be measured and recorded every 15 minutes, 
or at least once for batch emission episodes less than 15 minutes in 
duration. The affected source will be considered to be out of 
compliance if the scrubber water flow rate, averaged over the operating 
day for each process, is below the minimum flow rate established during 
the initial compliance demonstration.
    (6) For affected sources using carbon adsorbers or having 
uncontrolled process vents, the owner or operator shall establish a 
maximum outlet HAP concentration as the site-specific operating 
parameter which, except as provided in paragraph (b)(3) of this 
section, must be measured and recorded every 15 minutes, or at least 
once for batch emission episodes of duration shorter than 15 minutes. 
The affected source will be considered to be out of compliance if the 
outlet HAP concentration, averaged over the operating day for each 
process, is greater than the value established during the initial 
compliance demonstration.
    (7) For affected sources using flares, the presence of the pilot 
flame shall be monitored every 15 minutes, or at least once for batch 
emission episodes less than 15 minutes in duration. The affected source 
will be considered to be out of compliance upon loss of pilot flame.
    (8) For affected sources using combustion devices, the temperature 
of the gases exiting the combustion chamber shall be monitored every 15 
minutes, or at least once for episodes less than 15 minutes in 
duration. The affected source will be considered out of compliance if 
the combustion chamber temperature, averaged over the operating day for 
each process, is less than the value established during the initial 
compliance demonstration.
    (c) An owner or operator may request approval to monitor parameters 
other than those required by paragraphs (a)(2) through (7) and 
paragraphs (b)(5) through (8) of this section. The request shall be 
submitted according to the procedures specified in Sec. 63.8(f) of 
subpart A or included in the Precompliance report.
    (d) Periods of time when monitoring measurements exceed the 
parameter values as well as periods of inadequate monitoring data do 
not constitute a violation if they occur during a startup, shutdown, or 
malfunction, and the facility follows its startup, shutdown, and 
malfunction plan.
    (e) The owner or operator of any affected source complying with the 
requirements of appendix GGGA of this section shall meet the monitoring 
requirements described in the appendix.
    (f) The owner or operator of any affected source that chooses to 
comply with the requirements of Secs. 63.1252(h)(2) and (3) shall 
calculate rolling average values of kg HAP consumption per kg 
production and kg VOC consumption per kg production. The owner or 
operator will be considered out of compliance if either rolling average 
kg/kg factor exceeds the value established in Sec. 63.1253(f)(1)(ii).
    (g) Owners or operators of any affected source that chooses to 
comply with the requirements of Sec. 63.1252(j) shall meet all 
monitoring requirements specified in Sec. 63.1254 (a), (b), (c), and 
(d), as applicable, for all processes and storage tanks included in the 
emissions average.


Sec. 63.1255  Recordkeeping requirements.

    (a) The owner or operator of any affected source shall keep records 
of daily values of equipment operating parameters specified to be 
monitored under Sec. 63.1254, or specified by the Administrator. 
Records shall be kept in accordance with the requirements of applicable 
paragraphs of Sec. 63.10 of subpart A of this part, as specified in the 
General Provisions applicability table of this subpart. The owner or 
operator shall keep records up-to-date and readily accessible.
    (1) A daily (24-hour) average shall be calculated as the average of 
all values for a monitored parameter recorded during the operating day.
    (2) The operating day shall be the period defined in the operating 
permit or the Notification of Compliance Status in Sec. 63.9(h). It may 
be from midnight to midnight or another continuous 24-hour period.
    (3) For every operating day in which the daily average value for an 
operating parameter is outside its established range, the owner or 
operator must keep records of each parameter value reading taken during 
the day on which the excursion occurred.
    (4) For processes subject to Sec. 63.1252(h), records shall be 
maintained of rolling average values of kg HAP/kg production and kg 
VOC/kg production.
    (b) The owner or operator of any affected source that complies with 
the standards for process vents, storage tanks, and wastewater systems 
shall maintain up-to-date, readily accessible records of the following 
information to document that HAP emissions or HAP loadings (for 
wastewater) are below the limits specified in Sec. 63.1252:
    (1) The emissions per batch for each process.
    (2) The wastewater concentrations per POD and process.
    (3) The number of batches per year for each batch process.
    (4) The operating hours per year for continuous processes.
    (5) The number of tank turnovers per year.
    (c) The owner or operator of any affected source implementing the 
leak detection and repair program specified in appendix A of this 
subpart, shall implement the recordkeeping requirements in appendix A 
to this subpart. All records shall be retained for a period of 5 years, 
in accordance with the requirements of 40 CFR 63.10(b)(1).
    (d) For unit operations occurring more than once per day, 
exceedances of established parameter limits shall result in no more 
than one violation per operating day for each monitored item of 
equipment utilized in the unit operation.
    (e) For certain items of monitored equipment used for more than one 
type of unit operation in the course of an operating day, exceedances 
shall result in no more than one violation per operating day, per item 
of monitored equipment, for each type of unit operation in which the 
item is in service.

[[Page 15780]]

    (f) Owners or operators of any affected source that chooses to 
comply with the requirements of Sec. 63.1252(j) shall maintain up-to-
date records of the following information:
    (1) An Implementation Plan which shall include in the plan, for all 
process vents and storage tanks included in each of the averages, the 
information listed in paragraphs (f)(1)(i) through (f)(1)(v) of this 
section.
    (i) The identification of all process vents and storage tanks in 
each emissions average.
    (ii) The uncontrolled and controlled emissions of HAP and the 
overall percent reduction efficiency as determined in Secs. 63.1253(h) 
(1) through (6) or Secs. 63.1253(i) (1) through (3) as applicable.
    (iii) The calculations used to obtain the uncontrolled and 
controlled HAP emissions and the overall percent reduction efficiency.
    (iv) The estimated values for all parameters required to be 
monitored under Sec. 63.1254(g) for each process and storage tank 
included in an average. These parameter values, or as appropriate, 
limited ranges for parameter values, shall be specified as enforceable 
operating conditions for the operation of the process or storage tank. 
Changes to the parameters must be reported as required by 
Sec. 63.1256(d).
    (v) A statement that the compliance demonstration, monitoring, 
inspection, recordkeeping and reporting provisions in Secs. 63.1253(h) 
and (i), Sec. 63.1254(g), and Sec. 63.1256(d) that are applicable to 
each emission point in the emissions average will be implemented 
beginning on the date of compliance.
    (2) The Implementation Plan must demonstrate that the emissions 
from the processes and storage tanks proposed to be included in the 
average will not result in greater hazard or, at the option of the 
operating permit authority, greater risk to human health or the 
environment than if the processes and storage tanks were controlled 
according to the provisions in Sec. 63.1252(b) or (c).
    (i) This demonstration of hazard or risk equivalency shall be made 
to the satisfaction of the operating permit authority.
    (A) The Administrator may require owners and operators to use 
specific methodologies and procedures for making a hazard or risk 
determination.
    (B) The demonstration and approval of hazard or risk equivalency 
shall be made according to any guidance that the Administrator makes 
available for use or any other technically sound information or 
methods.
    (ii) An emissions averaging plan that does not demonstrate hazard 
or risk equivalency to the satisfaction of the Administrator shall not 
be approved. The Administrator may require such adjustments to the 
emissions averaging plan as are necessary in order to ensure that the 
average will not result in greater hazard or risk to human health or 
the environment than would result if the emission points were 
controlled according to Sec. 63.1252 (b) or (c).
    (iii) A hazard or risk equivalency demonstration must:
    (A) Be a quantitative, comparative chemical hazard or risk 
assessment;
    (B) Account for differences between averaging and non-averaging 
options in chemical hazard or risk to human health or the environment; 
and
    (C) Meet any requirements set by the Administrator for such 
demonstrations.
    (3) Records as specified in paragraphs (a), (b) and (d) of this 
section.
    (4) A calculation of the overall percent reduction efficiency as 
specified in Sec. 63.1253(h) and (i) of this subpart for the last 
quarter and the prior four quarters.


Sec. 63.1256  Reporting requirements

    (a) The owner or operator of any affected source that elects to 
comply with the emission limit or emission reduction requirements for 
process vents, storage tanks, and wastewater systems, shall comply with 
the reporting requirements of applicable paragraphs of 40 CFR 63.9 and 
63.10, as specified in the General Provisions applicability table.
    (1) The Notification of Compliance Status report required under 
Sec. 63.9 shall be submitted within 150 days of the compliance date and 
shall include:
    (i) The results of any applicability determinations, emission 
calculations, or analyses used to identify and quantify HAP emissions 
from applicable sources.
    (ii) The results of emissions profiles, performance tests, 
engineering analyses, design evaluations, or calculations used to 
demonstrate compliance. For performance tests, results should include 
descriptions of sampling and analysis procedures and quality assurance 
procedures.
    (iii) Descriptions of monitoring devices, monitoring frequencies, 
and the values of monitored parameters established during the initial 
compliance determinations, including data and calculations to support 
the levels established.
    (2) The precompliance report shall be submitted 12 months prior to 
the compliance date of the standard. For new sources, the Precompliance 
report shall be submitted to the Administrator with the application for 
approval of construction or reconstruction. The Administrator shall 
have 60 days to approve or disapprove the plan. The plan shall be 
considered approved if the administrator either approves the plan in 
writing, or fails to disapprove the plan in writing. The 60 day period 
shall begin when the administrator receives the request. If the request 
is denied, the owner or operator must still be in compliance with the 
standard by the compliance date. The Precompliance report shall 
include:
    (i) Requests for approval to use alternative monitoring parameters 
or requests to set monitoring parameters according to 
Sec. 63.1254(b)(2)(iii).
    (ii) Descriptions of how the control devices subject to 
Secs. 63.1254(a)(1) and 63.1254(b)(1) will be checked to verify that 
they are operating as designed.
    (iii) A description of test conditions and limits of operation for 
control devices tested under normal conditions, and the corresponding 
monitoring parameter values.
    (b) The owner or operator shall also submit to the Administrator, 
as part of the quarterly excess emissions and continuous monitoring 
system performance report and summary report required by 40 CFR 
63.10(e)(3), the following recorded information.
    (1) Reports of monitoring data, including 15-minute monitoring 
values as well as daily average values of monitored parameters for all 
operating days when the average values were outside the ranges 
established in the Notification of Compliance Status or operating 
permit.
    (2) Reports of the duration of periods when monitoring data is not 
collected for each excursion caused by insufficient monitoring data. An 
excursion means any of the two cases listed in paragraphs (b)(2)(i) or 
(b)(2)(ii) of this section. For a control device where multiple 
parameters are monitored, if one or more of the parameters meets the 
excursion criteria in paragraphs (a)(2)(i) or (a)(2)(ii) of this 
section, this is considered a single excursion for the control device.
    (i) When the period of control device operation is 4 hours or 
greater in an operating day and monitoring data are insufficient to 
constitute a valid hour of data, as defined in paragraph (b)(2)(iii) of 
this section, for at least 75 percent of the operating hours.
    (ii) When the period of control device operation is less than 4 
hours in an operating day and more than one of the hours during the 
period of operation does not constitute a valid hour of data due to 
insufficient monitoring data.
    (iii) Monitoring data are insufficient to constitute a valid hour 
of data, as

[[Page 15781]]

used in paragraphs (b)(2)(i) and (b)(2)(ii) of this section, if 
measured values are unavailable for any of the 15-minute periods within 
the hour.
    (3) Whenever a process change, as defined in 40 CFR 63.115(e), is 
made that causes the emission rate from a de minimis emission point to 
become a process vent with an emission rate of 1 pound per year or 
greater, or a change in any of the information submitted in the 
Notification of Compliance Report, the owner or operator shall submit a 
report within 180 calendar days after the process change. The report 
may be submitted as part of the next summary report required under 40 
CFR 63.10(e)(3). The report shall include:
    (i) A description of the process change.
    (ii) The results of the recalculation of the emission rate.
    (iii) Revisions to any of the information reported in the original 
Notification of compliance under Sec. 63.1256(a)(1).
    (iv) Information required by the Notification of compliance under 
Sec. 63.1256(a)(1) for changes involving the addition of processes or 
equipment.
    (c) The owner or operator of any affected source implementing the 
leak detection and repair program specified in subpart H of this part, 
shall implement the reporting requirements in 40 CFR 63.182. Copies of 
all reports shall be retained as records for a period of 5 years, in 
accordance with the requirements of 40 CFR 63.10(b)(1).
    (d) Owners or operators of any affected source that chooses to 
comply with the requirements of Sec. 63.1252(j) shall submit all 
information as specified in Sec. 63.1255(f) for each process or storage 
tank included in the emissions average. The owner or operator shall 
also submit to the administrator all information as specified in 
paragraph (b) of this section for each process or storage tank included 
in the emissions average.
    (1) The reports must also include the information listed in 
paragraphs (c)(1)(i) through (c)(1)(iv) of this section:
    (i) Any changes of the processes or storage tanks included in the 
average.
    (ii) The calculation of the overall percent reduction efficiency 
for the reporting period.
    (iii) Changes to the Implementation Plan which affect the 
calculation methodology of uncontrolled or controlled emissions or the 
hazard or risk equivalency determination.
    (iv) Any changes to the parameters monitored according to 
Sec. 63.1254(g).
    (2) Every 4th quarter report shall include the results according to 
Sec. 63.1255(f)(4) to demonstrate the emissions averaging provisions of 
Secs. 63.1252(j), 63.1253(h) and (i), 63.1254(g), and 63.1255(f) are 
satisfied.


Sec. 63.1257  Delegation of authority [Reserved]

                    Table 1 to Subpart GGG.--General Provisions Applicability To Subpart GGG                    
----------------------------------------------------------------------------------------------------------------
      Reference to subpart A           Applies to  subpart GGG                         Comment                  
----------------------------------------------------------------------------------------------------------------
Sec.  63.1(a)(1).................  Yes............................  Additional terms defined in Sec.  63.1251.  
Sec.  63.1(a)(2).................  Yes............................  ............................................
Sec.  63.1(a)(3).................  Yes............................  ............................................
Sec.  63.1(a)(4).................  Yes............................  Subpart GGG specifies applicability of each 
                                                                     paragraph in subpart A to subpart GGG.     
Sec.  63.1(a)(5).................  N/A............................  Reserved.                                   
Sec.  63.1(a)(6).................  Yes............................  ............................................
Sec.  63.1(a)(7).................  Yes............................  ............................................
Sec.  63.1(a)(8).................  No.............................  Discusses State programs.                   
Sec.  63.1(a)(9).................  N/A............................  Reserved.                                   
Sec.  63.1(a)(10)................  Yes............................  ............................................
Sec.  63.1(a)(11)................  Yes............................  ............................................
Sec.  63.1(a)(12)-(14)...........  Yes............................  ............................................
Sec.  63.1(b)(1).................  No.............................  Sec.  63.1250 of subpart GGG specifies      
                                                                     applicability.                             
Sec.  63.1(b)(2).................  Yes............................  ............................................
Sec.  63.1(b)(3).................  Yes............................  ............................................
Sec.  63.1(c)(1).................  Yes............................  Subpart GGG specifies applicability of each 
                                                                     paragraph in subpart A to sources subject  
                                                                     to subpart GGG.                            
Sec.  63.1(c)(2).................  No.............................  Area sources are not subject to subpart GGG.
Sec.  63.1(c)(3).................  N/A............................  Reserved.                                   
Sec.  63.1(c)(4).................  Yes............................  ............................................
Sec.  63.1(c)(5).................  Yes............................  ............................................
Sec.  63.1(d)....................  N/A............................  Reserved.                                   
Sec.  63.1(e)....................  Yes............................  ............................................
Sec.  63.2.......................  Yes............................  Additional terms are defined in Sec.        
                                                                     63.1251 of subpart GGG; when overlap       
                                                                     between subparts A and GGG occurs, subpart 
                                                                     GGG takes precedence.                      
Sec.  63.3.......................  Yes............................  Other units used in subpart GGG are defined 
                                                                     in that subpart.                           
Sec.  63.4(a)(1)-(3).............  Yes............................  ............................................
Sec.  63.4(a)(4).................  N/A............................  Reserved.                                   
Sec.  63.4(a)(5).................  Yes............................  ............................................
Sec.  63.4(b)....................  Yes............................  ............................................
Sec.  63.4(c)....................  Yes............................  ............................................
Sec.  63.5(a)....................  Yes............................  Except replace the terms ``source'' and     
                                                                     ``stationary source'' in Sec.  63.5(a)(1)  
                                                                     of subpart A with ``affected source''.     
Sec.  63.5(b)(1).................  Yes............................  ............................................
Sec.  63.5(b)(2).................  N/A............................  Reserved.                                   
Sec.  63.5(b)(3).................  Yes............................  ............................................
Sec.  63.5(b)(4).................  Yes............................  ............................................
Sec.  63.5(b)(5).................  Yes............................  ............................................
Sec.  63.5(b)(6).................  Yes............................  ............................................
Sec.  63.5(c)....................  N/A............................  Reserved.                                   
Sec.  63.5(d)(1)(i)..............  Yes............................  ............................................
Sec.  63.5(d)(1)(ii).............  Yes............................  ............................................

[[Page 15782]]

                                                                                                                
Sec.  63.5(d) (1)(iii)...........  Yes............................  ............................................
Sec.  63.5(d)(2).................  Yes............................  ............................................
Sec.  63.5(d)(3)-(4).............  Yes............................  ............................................
Sec.  63.5(e)....................  Yes............................  ............................................
Sec.  63.5(f)(1).................  Yes............................  Except replace ``source'' in Sec.           
                                                                     63.5(f)(1) of subpart A with ``affected    
                                                                     source''.                                  
Sec.  63.5(f)(2).................  Yes............................  ............................................
Sec.  63.6(a)....................  Yes............................  ............................................
Sec.  63.6(b)(1)-(2).............  No.............................  Subpart GGG specifies compliance dates.     
Sec.  63.6(b)(3)-(4).............  Yes............................  ............................................
Sec.  63.6(b)(5).................  Yes............................  ............................................
Sec.  63.6(b)(6).................  N/A............................  Reserved.                                   
Sec.  63.6(b)(7).................  Yes............................  ............................................
Sec.  63.6(c)(1)-(2).............  Yes............................  Except replace ``source'' in Sec.           
                                                                     63.6(c)(1)-(2) of subpart A with ``affected
                                                                     source''.                                  
Sec.  63.6(c)(3)-(4).............  N/A............................  Reserved.                                   
Sec.  63.6(c)(5).................  Yes............................  ............................................
Sec.  63.6(d)....................  N/A............................  Reserved.                                   
Sec.  63.6(e)....................  Yes............................  ............................................
Sec.  63.6(f)(1).................  Yes............................  ............................................
Sec.  63.6(f)(2)(i)-(ii).........  Yes............................  ............................................
Sec.  63.6(f)(2)(iii)............  Yes............................  ............................................
Sec.  63.6(f)(2)(iv).............  Yes............................  ............................................
Sec.  63.6(f)(3).................  Yes............................  ............................................
Sec.  63.6(g)....................  Yes............................  An alternative standard has been proposed;  
                                                                     however, affected sources will have the    
                                                                     opportunity to demonstrate other           
                                                                     alternatives to the Administrator.         
Sec.  63.6(h)....................  No.............................  Subpart GGG does not contain any opacity or 
                                                                     visible emissions standards.               
Sec.  63.6(i)(1).................  Yes............................  ............................................
Sec.  63.6(i)(2).................  Yes............................  Except replace ``source'' in Sec.           
                                                                     63.6(2)(i) and (ii) of subpart A with      
                                                                     ``affected source''.                       
Sec.  63.6(i)(3).................  Yes............................  ............................................
Sec.  63.6(i)(4)(i)..............  Yes............................  ............................................
Sec.  63.6(i)(4)(ii).............  Yes............................  ............................................
Sec.  63.6(i)(5)-(14)............  Yes............................  ............................................
Sec.  63.6(i)(15)................  N/A............................  Reserved.                                   
Sec.  63.6(i)(16)................  Yes............................  ............................................
Sec.  63.6(j)....................  Yes............................  ............................................
Sec.  63.7(a)(1).................  Yes............................  Subpart GGG specifies required testing and  
                                                                     compliance procedures.                     
Sec.  63.7(a)(2)(i)-(vi).........  Yes............................  ............................................
Sec.  63.7(a)(2) (vii)-(viii)....  N/A............................  Reserved.                                   
Sec.  63.7(a)(2) (ix)............  Yes............................  ............................................
Sec.  63.7(a)(3).................  Yes............................  ............................................
Sec.  63.7(b)(1).................  Yes............................  ............................................
Sec.  63.7(b)(2).................  Yes............................  ............................................
Sec.  63.7(c)....................  Yes............................  ............................................
Sec.  63.7(d)....................  Yes............................  Except replace ``source'' in Sec.  63.7(d)  
                                                                     of subpart A with ``affected source''.     
Sec.  63.7(e)(1).................  Yes............................  Subpart GGG also contains test methods      
                                                                     specific to pharmaceutical sources.        
Sec.  63.7(e)(2).................  Yes............................  ............................................
Sec.  63.7(e)(3).................  Yes............................  Subpart GGG specifies test methods and      
                                                                     procedures.                                
Sec.  63.7(f)....................  Yes............................  ............................................
Sec.  63.7(g)(1).................  Yes............................  ............................................
Sec.  63.7(g)(2).................  N/A............................  Reserved.                                   
Sec.  63.7(g)(3).................  Yes............................  ............................................
Sec.  63.7(h)(1)-(2).............  Yes............................  ............................................
Sec.  63.7(h)(3)(i)..............  Yes............................  ............................................
Sec.  63.7(h)(3) (ii)-(iii)......  Yes............................  ............................................
Sec.  63.7(h)(4)-(5).............  Yes............................  ............................................
Sec.  63.8(a)(1).................  Yes............................  ............................................
Sec.  63.8(a)(2).................  Yes............................  ............................................
Sec.  63.8(a)(3).................  N/A............................  Reserved.                                   
Sec.  63.8(a)(4).................  Yes............................  ............................................
Sec.  63.8(b)(1).................  Yes............................  ............................................
Sec.  63.8(b)(2).................  No.............................  Subpart GGG has CMS requirements.           
Sec.  63.8(b)(3).................  Yes............................  ............................................
Sec.  63.8(c)(1)(i)..............  Yes............................  ............................................
Sec.  63.8(c) (1)(ii)............  Yes............................  ............................................
Sec.  63.8(c) (1)(iii)...........  Yes............................  ............................................
Sec.  63.8(c)(2)-(3).............  Yes............................  ............................................
Sec.  63.8(c)(4)-(8).............  No.............................  Subpart GGG specifies monitoring            
                                                                     frequencies.                               
Sec.  63.8(d)....................  Yes............................  ............................................
Sec.  63.8(e)....................  Yes............................  ............................................
Sec.  63.8(f)(1).................  Yes............................  ............................................
Sec.  63.8(f)(2).................  Yes............................  ............................................
Sec.  63.8(f)(3).................  Yes............................  ............................................

[[Page 15783]]

                                                                                                                
Sec.  63.8(f)(4).................  Yes............................  ............................................
Sec.  63.8(f)(5).................  Yes............................  ............................................
Sec.  63.8(f)(6).................  Yes............................  ............................................
Sec.  63.8(g)....................  Yes............................  ............................................
Sec.  63.9(a)....................  Yes............................  ............................................
Sec.  63.9(b)(1) (i)-(ii)........  Yes............................  ............................................
Sec.  63.9(b) (1)(iii)...........  Yes............................  ............................................
Sec.  63.9(b)(2).................  Yes............................  ............................................
Sec.  63.9(b)(3).................  Yes............................  ............................................
Sec.  63.9(b)(4).................  Yes............................  ............................................
Sec.  63.9(b)(5).................  Yes............................  ............................................
Sec.  63.9(c)....................  Yes............................  ............................................
Sec.  63.9(d)....................  Yes............................  ............................................
Sec.  63.9(e)....................  No.............................  ............................................
Sec.  63.9(f)....................  No.............................  ............................................
Sec.  63.9(g)....................  No.............................  ............................................
Sec.  63.9(h)(1)-(3).............  Yes............................  ............................................
Sec.  63.9(h)(4).................  N/A............................  Reserved.                                   
Sec.  63.9(h)(5)-(6).............  Yes............................  ............................................
Sec.  63.9(i)....................  Yes............................  ............................................
Sec.  63.9(j)....................  Yes............................  ............................................
Sec.  63.10(a)...................  Yes............................  ............................................
Sec.  63.10(b)(1)................  Yes............................  ............................................
Sec.  63.10(b)(2)................  No.............................  Subpart GGG specifies recordkeeping         
                                                                     requirements.                              
Sec.  63.10(b)(3)................  Yes............................  ............................................
Sec.  63.10(c)(1)-(6)............  Yes............................  ............................................
Sec.  63.10(c)(7)-(8)............  Yes............................  ............................................
Sec.  63.10(c)(9)-(15)...........  Yes............................  ............................................
Sec.  63.10(d)(1)................  Yes............................  Subpart GGG specifies performance test      
                                                                     reporting requirements.                    
Sec.  63.10(d)(2)................  Yes............................  Subpart GGG specifies performance test      
                                                                     reporting requirements.                    
Sec.  63.10(d)(3)................  No.............................  ............................................
Sec.  63.10(d)(4)................  Yes............................  ............................................
Sec.  63.10(d)(5)................  Yes............................  ............................................
Sec.  63.10(e)(1)-(2)............  Yes............................  ............................................
Sec.  63.10(e)(3)................  Yes............................  ............................................
Sec.  63.10(e)(4)................  Yes............................  ............................................
Sec.  63.10(f)...................  Yes............................  ............................................
Sec.  63.11-Sec.  63.15..........  Yes............................  ............................................
----------------------------------------------------------------------------------------------------------------


             Table 2 to Subpart GGG.--Partially Soluble HAP             
------------------------------------------------------------------------
                                Compound                                
-------------------------------------------------------------------------
1,1,1-Trichloroethane (methyl chloroform)                               
1,1,2,2-Tetrachloroethane                                               
1,1,2-Trichloroethane                                                   
1,1-Dichloroethylene (vinylidene chloride)                              
1,2-Dibromoethane                                                       
1,2-Dichloroethane (ethylene dichloride)                                
1,2-Dichloropropane                                                     
1,3-Dichloropropene                                                     
2,4,5-Trichlorophenol                                                   
2-Butanone (mek)                                                        
2-Nitropropane                                                          
4-Methyl-2-pentanone (mibk)                                             
Acetaldehyde                                                            
Acrolein                                                                
Acrylonitrile                                                           
Allyl chloride                                                          
Benzene                                                                 
Benzyl chloride                                                         
Biphenyl                                                                
Bromoform (tribromomethane)                                             
Bromomethane                                                            
Butadiene                                                               
Carbon disulfide                                                        
Chlorobenzene                                                           
Chloroethane (ethyl chloride)                                           
Chloroform                                                              
Chloromethane                                                           

[[Page 15784]]

                                                                        
Chloroprene                                                             
Cumene                                                                  
Dichloroethyl ether                                                     
Dinitrophenol                                                           
Ethyl acrylate                                                          
Ethylbenzene                                                            
Ethylene oxide                                                          
Hexachlorobenzene                                                       
Hexachlorobutadiene                                                     
Hexachloroethane                                                        
Methyl methacrylate                                                     
Methyl-t-butyl ether                                                    
Methylene chloride                                                      
N,N-dimethylaniline                                                     
Naphthalene                                                             
Phosgene                                                                
Propionaldehyde                                                         
Propylene oxide                                                         
Styrene                                                                 
Tetrachloroethene (perchloroethylene)                                   
Tetrachloromethane (carbon tetrachloride)                               
Toluene                                                                 
Trichlorobenzene (1,2,4-)                                               
Trichloroethylene                                                       
Triethylamine                                                           
Trimethylpentane                                                        
Vinyl acetate                                                           
Vinyl chloride                                                          
Xylene (m)                                                              
Xylene (o)                                                              
Xylene (p)                                                              
N-hexane                                                                
P-dichlorobenzene                                                       
------------------------------------------------------------------------


                         Table 3.--Soluble HAP's                        
------------------------------------------------------------------------
                                Compound                                
-------------------------------------------------------------------------
1,1-Dimethylhydrazine                                                   
1,4-Dioxane                                                             
Acetonitrile                                                            
Acetophenone                                                            
Diethyl sulfate                                                         
Dimethyl sulfate                                                        
Dinitrotoluene                                                          
Epichlorohydrin                                                         
Ethylene glycol dimethyl ether                                          
Ethylene glycol monobutyl ether acetate                                 
Ethylene glycol monomethyl ether acetate                                
Isophorone                                                              
Methanol (methyl alcohol)                                               
Nitrobenzene                                                            
Toluidene                                                               
------------------------------------------------------------------------

Appendix A to Subpart GGG--Equipment Leaks

Sec. GGGA-1  General Equipment Leak Requirements

    (a) The provisions of this appendix apply to pumps, compressors, 
agitators, pressure relief devices, sampling connection systems, 
open-ended valves or lines, valves, connectors, instrumentation 
systems, control devices, and closed-vent systems required by this 
subpart that are intended to operate in organic hazardous air 
pollutant service 300 hours or more during the calendar year within 
a source subject to the provisions of this subpart.
    (b) After the compliance date for a process, equipment to which 
this subpart applies that are also subject to the provisions of:
    (1) 40 CFR part 60 will be required to comply only with the 
provisions of this subpart.
    (2) 40 CFR part 61 will be required to comply only with the 
provisions of this subpart.
    (c) [Reserved]
    (d) The provisions in Sec. 63.1(a)(3) of subpart A of this part 
do not alter the provisions in paragraph (b) of this section.
    (e) Lines and equipment not containing process fluids are not 
subject to the provisions of this appendix. Utilities, and other 
nonprocess lines, such as heating and cooling systems which do not 
combine their materials with those in the processes they serve, are 
not considered to be part of a process.
    (f) The provisions of this appendix do not apply to bench-scale 
processes, regardless of whether the processes are located at the 
same plant site as a process subject to the provisions of this 
subpart.
    (g) Each piece of equipment to which this appendix applies shall 
be identified such

[[Page 15785]]

that it can be distinguished readily from equipment that is not 
subject to this appendix. Identification of the equipment does not 
require physical tagging of the equipment. For example, the 
equipment may be identified on a plant site plan, in log entries, or 
by designation of process boundaries by some form of weatherproof 
identification. If changes are made to the affected source subject 
to the leak detection requirements, equipment identification for 
each type of component shall be updated, if needed, within 15 
calendar days of the end of each monitoring period for that 
component.
    (h) Equipment that is in vacuum service is excluded from the 
requirements of this appendix.
    (i) Equipment that is in organic HAP service, but is in such 
service less than 300 hours per calendar year, is excluded from the 
requirements of this appendix if it is identified as required in 
Sec. GGGA-8(j) of this appendix.
    (j) When each leak is detected by visual, audible, or olfactory 
means, or by monitoring as described in 63.180 (b) or (c), the 
following requirements apply:
    (1) A weatherproof and readily visible identification, marked 
with the equipment identification number, shall be attached to the 
leaking equipment.
    (2) The identification on a valve or connector in light liquid 
or gas/vapor service may be removed after it has been monitored as 
specified in Sec. GGGA-6(f)(3), Sec. 63.174(e), and 
Sec. 63.175(e)(7)(i)(D), and no leak has been detected during the 
follow-up monitoring.
    (3) The identification on equipment, except on a valve or 
connector in light liquid or gas/vapor service, may be removed after 
it has been repaired.

Sec. GGGA-2  Definitions

    Bench-scale batch process means a batch process (other than a 
research and development facility) that is capable of being located 
on a laboratory bench top. This bench-scale equipment will typically 
include reagent feed vessels, a small reactor and associated product 
separator, recovery and holding equipment. These processes are only 
capable of producing small quantities of product.
    Closed-loop system means an enclosed system that returns process 
fluid to the process and is not vented to the atmosphere except 
through a closed-vent system.
    Closed-purge system means a system or combination of system and 
portable containers, to capture purged liquids. Containers must be 
covered or closed when not being filled or emptied.
    Connector means flanged, screwed, or other joined fittings used 
to connect two pipe lines or a pipe line and a piece of equipment. A 
common connector is a flange. Joined fittings welded completely 
around the circumference of the interface are not considered 
connectors for the purpose of this regulation. For the purpose of 
reporting and recordkeeping, connector means joined fittings that 
are not inaccessible, ceramic, or ceramic-lined as described in 
Sec. GGGA-3(a)(7) and Sec. GGGA-7(c).
    Control device, for purposes of this appendix, means any 
equipment used for recovering or oxidizing organic hazardous air 
pollutant vapors. Such equipment includes, but is not limited to, 
absorbers, carbon adsorbers, condensers, flares, boilers, and 
process heaters.
    Double block and bleed system means two block valves connected 
in series with a bleed valve or line that can vent the line between 
the two block valves.
    Duct work means a conveyance system such as those commonly used 
for heating and ventilation systems. It is often made of sheet metal 
and often has sections connected by screws or crimping. Hard-piping 
is not ductwork.
    Equipment, for purposes of this appendix, means each pump, 
compressor, agitator, pressure relief device, sampling connection 
system, open-ended valve or line, valve, connector, surge control 
vessel, bottoms receiver, and instrumentation system in organic 
hazardous air pollutant service; and any control devices or closed-
vent systems required by this subpart.
    First attempt at repair means to take action for the purpose of 
stopping or reducing leakage of organic material to the atmosphere.
    Flow indicator means a device which indicates whether gas flow 
is, or whether the valve position would allow gas flow to be 
present, in a line.
    In gas/vapor service means that a piece of equipment in organic 
hazardous air pollutant service contains a gas or vapor at operating 
conditions.
    In heavy liquid service means that a piece of equipment in 
organic hazardous air pollutant service is not in gas/vapor service 
or in light liquid service.
    In light liquid service means that a piece of equipment in 
organic hazardous air pollutant service contains a liquid that meets 
the following conditions:
    1. The vapor pressure of one or more of the organic compounds is 
greater than 0.3 kilopascals at 20  deg.C;
    2. The total concentration of the pure organic compounds 
constituents having a vapor pressure greater than 0.3 kilopascals at 
20  deg.C is equal to or greater than 20 percent by weight of the 
total process stream; and
    3. The fluid is a liquid at operating conditions.

    (Note: Vapor pressures may be determined by the methods 
described in 40 CFR 60.485(e)(1).)

    In liquid service means that a piece of equipment in organic 
hazardous air pollutant service is not in gas/vapor service.
    In organic hazardous air pollutant or in organic HAP service 
means that a piece of equipment either contains or contacts a fluid 
(liquid or gas) that is at least 5 percent by weight of total 
organic HAP's as determined according to the provisions of 
Sec. 63.180(d). The provisions of Sec. 63.180(d) also specify how to 
determine that a piece of equipment is not in organic HAP service.
    In vacuum service means that equipment is operating at an 
internal pressure which is at least 5 kilopascals below ambient 
pressure.
    In-situ sampling systems means nonextractive samplers or in-line 
samplers.
    Initial startup means the first time a new or reconstructed 
source begins production. Initial startup does not include operation 
solely for testing equipment. Initial startup does not include 
subsequent startups (as defined in this section) of processes 
following malfunctions or process shutdowns.
    Instrumentation system means a group of equipment components 
used to condition and convey a sample of the process fluid to 
analyzers and instruments for the purpose of determining process 
operating conditions (e.g., composition, pressure, flow, etc.). 
Valves and connectors are the predominant type of equipment used in 
instrumentation systems; however, other types of equipment may also 
be included in these systems. Only valves nominally 0.5 inches and 
smaller, and connectors nominally 0.75 inches and smaller in 
diameter are considered instrumentation systems for the purposes of 
this subpart. Valves greater than nominally 0.5 inches and 
connectors greater than nominally 0.75 inches associated with 
instrumentation systems are not considered part of instrumentation 
systems and must be monitored individually.
    Liquids dripping means any visible leakage from the seal 
including dripping, spraying, misting, clouding, and ice formation. 
Indications of liquid dripping include puddling or new stains that 
are indicative of an existing evaporated drip.
    Nonrepairable means that it is technically infeasible to repair 
a piece of equipment from which a leak has been detected without a 
process shutdown.
    Open-ended valve or line means any valve, except pressure relief 
valves, having one side of the valve seat in contact with process 
fluid and one side open to atmosphere, either directly or through 
open piping.
    Plant site means all contiguous or adjoining property that is 
under common control, including properties that are separated only 
by a road or other public right-of-way. Common control includes 
properties that are owned, leased, or operated by the same entity, 
parent entity, subsidiary, or any combination thereof.
    Pressure release means the emission of materials resulting from 
the system pressure being greater than the set pressure of the 
pressure relief device. This release can be one release or a series 
of releases over a short time period due to a malfunction in the 
process.
    Pressure relief device or valve means a safety device used to 
prevent operating pressures from exceeding the maximum allowable 
working pressure of the process equipment. A common pressure relief 
device is a spring-loaded pressure relief valve. Devices that are 
actuated either by a pressure of less than or equal to 2.5 psig or 
by a vacuum are not pressure relief devices.
    Process shutdown means a work practice or operational procedure 
that stops production from a process or part of a process during 
which it is technically feasible to clear process material from a 
process or part of a process consistent with safety constraints and 
during which repairs can be effected. An unscheduled work practice 
or operational procedure that stops production from a process or 
part of a process for less than 24 hours is not a process

[[Page 15786]]

shutdown. An unscheduled work practice or operational procedure that 
would stop production from a process or part of a process for a 
shorter period of time than would be required to clear the process 
or part of the process of materials and start up the process, and 
would result in greater emissions than delay of repair of leaking 
components until the next scheduled process shutdown, is not a 
process shutdown. The use of spare equipment and technically 
feasible bypassing of equipment without stopping production are not 
process shutdowns.
    Repaired means that equipment is adjusted, or otherwise altered, 
to eliminate a leak as defined in the applicable sections of this 
appendix.
    Sampling connection system means an assembly of equipment within 
a process unit used during periods of representative operation to 
take samples of the process fluid. Equipment used to take nonroutine 
grab samples is not considered a sampling connection system.
    Sensor means a device that measures a physical quantity or the 
change in a physical quantity, such as temperature, pressure, flow 
rate, pH, or liquid level.
    Set pressure means the pressure at which a properly operating 
pressure relief device begins to open to relieve atypical process 
system operating pressure.
    Startup means the setting in operation of a piece of equipment 
or a control device that is subject to this subpart.

Sec. GGGA-3  References

    (a) The owner or operator of a source subject to this appendix 
shall comply with the following sections of subpart H, except that 
references to Sec. 63.160 and Sec. 63.162 shall mean Sec. GGGA-1 of 
this appendix; references to Sec. 63.161 shall mean Sec. GGGA-2 of 
this appendix; references to Sec. 63.163 and Sec. 63.173 shall mean 
Sec. GGGA-4 of this appendix; references to Sec. 63.167 shall mean 
Sec. GGGA-5 of this appendix; references to Sec. 63.168 shall mean 
Sec. GGGA-6 of this appendix; references to Sec. 63.170 shall be 
included in the requirements set forth in Sec. 63.1252(c); 
references to Sec. 63.171 shall mean Sec. GGGA-3(a)(5) of this 
appendix; references to Sec. 63.172 shall mean Sec. GGGA-3(a)(6) of 
this appendix; references to Sec. 63.181 shall mean Sec. GGGA-8 of 
this appendix; and references to Sec. 63.182 shall mean Sec. GGGA-9 
of this appendix. The term ``process unit'' as used in subpart H 
shall be considered to be defined the same as ``process'' for 
sources subject to this subpart GGG:
    (1) Sec. 63.164, Compressors;
    (2) Sec. 63.165, Pressure relief devices in gas/vapor service;
    (3) Sec. 63.166, Sampling connection systems;
    (4) Sec. 63.169, Pumps, valves, connectors, and agitators in 
heavy liquid service; instrumentation systems; and pressure relief 
devices in liquid service;
    (5) Sec. 63.171, Delay of repair, except
    Section 63.171(a) shall be changed to read: Delay of repair of 
equipment for which leaks have been detected is allowed if one of 
the following conditions exist:
    (i) Sec. 63.171(a)(1) is added to read: The repair is 
technically infeasible without a process shutdown. Repair of this 
equipment shall occur by the end of the next scheduled process 
shutdown.
    (ii) Sec. 63.171(a)(2) is added to read: The owner or operator 
determines that repair personnel would be exposed to an immediate 
danger if attempting to repair without a process shutdown. Repair of 
this equipment shall occur by the end of the next scheduled process 
shutdown.
    (6) Sec. 63.172, Closed-vent systems and control devices, for 
closed-vent systems used to comply with this subpart, and for 
control devices used to comply with this appendix only, except
    (i) Sec. 63.172(k) and (l) shall not apply. Instead, references 
to these paragraphs shall mean Sec. GGGA-7.
    (ii) Owners or operators may, instead of complying with the 
provisions of Sec. 63.172(f), design a closed-vent system to operate 
at a pressure below atmospheric pressure. The system shall be 
equipped with at least one pressure gage or other pressure 
measurement device that can be read from a readily accessible 
location to verify that negative pressure is being maintained in the 
closed-vent system when the associated control device is operating.
    (7) Sec. 63.174, Connectors, except
    (i) Sec. 63.174(f) and (g) shall not apply. Instead, references 
to these paragraphs shall mean Sec. GGGA-7.
    (ii) Days that the connector are not in organic HAP service 
shall not be considered part of the 3 month period in 
Sec. 63.174(e).
    (8) Sec. 63.175, Quality improvement program for valves, except
    (i) Sec. 63.175(a) is changed to read: An owner or operator may 
elect to comply with one of the alternative quality improvement 
programs specified in paragraphs (d) and (e) of this section. The 
decision to use one of these alternative provisions to comply with 
the requirements of Sec. 63.168(d)(1)(ii) of this subpart must be 
made during the second year of compliance for existing and new 
processes.
    (ii) The ``start of Phase III'' shall mean the ``compliance 
date'' as specified in Sec. 63.1250. The phrase ``of Phase III'' 
shall mean ``after the compliance date'' as specified in 
Sec. 63.1250.
    (9) Sec. 63.176, Quality improvement program for pumps, except
    (i) Sec. 63.176(a) is changed to read: If, on a 1-year rolling 
average, the greater of either 10 percent of the pumps in a process 
(or affected source) or three pumps in a process (or affected 
source) leak, the owner or operator may elect to comply with the 
requirements of this section as specified. The decision to use this 
provision to comply with the requirements of Sec. 63.163(d)(2) of 
this subpart must be made during the second year of compliance for 
existing and new processes.
    (ii) Sec. 63.176(a)(1) and (2), and (d)(8) shall not apply.
    (10) Sec. 63.177, Alternative means of emission limitation: 
General;
    (11) Sec. 63.178, Alternative means of emission limitation: 
Batch processes;
    (12) Sec. 63.179, Alternative means of emission limitation: 
Enclosed-vented process units;
    (13) Sec. 63.180, Test methods and procedures, except 
Sec. 63.180(b)(4)(ii)(A-C) are replaced by (b)(4)(ii) that reads: A 
mixture of methane and air at concentration of approximately, but 
less than, 10,000 parts per million methane for agitators; 2,000 
parts per million for pumps; and 500 parts per million for all other 
equipment, except as provided in paragraph (b)(4)(iii) of this 
section.

Sec. GGGA-4  Standards: Pumps in Light Liquid Service and Agitators 
in Gas/Vapor Service and in Light Liquid Service

    (a) The provisions of this section apply to each pump that is in 
light organic HAP liquid service, and to each agitator in organic 
HAP gas/vapor service or in light organic HAP liquid service.
    (b)(1) Each pump and agitator subject to this section shall be 
monitored quarterly to detect leaks by the method specified in 
Sec. 63.180(b) of this subpart, except as provided in Sec. 63.177, 
Sec. GGGA-7, and paragraphs (e) through (i) of this section.
    (2) The instrument reading, as determined by the method as 
specified in Sec. 63.180(b), that defines a leak is:
    (i) For agitators, an instrument reading of 10,000 parts per 
million or greater.
    (ii) For pumps, an instrument reading of 2,000 parts per million 
or greater.
    (3) Each pump and agitator shall be checked by visual inspection 
each calendar week for indications of liquids dripping from the pump 
or agitator seal. If there are indications of liquids dripping from 
the seal, a leak is detected.
    (c)(1) When a leak is detected, it shall be repaired as soon as 
practicable, but not later than 15 calendar days after it is 
detected, except as provided in paragraph (c)(3) of this section or 
Sec. GGGA-3(a)(5) of this appendix.
    (2) A first attempt at repair shall be made no later than 5 
calendar days after the leak is detected. First attempts at repair 
include, but are not limited to, the following practices where 
practicable:
    (i) Tightening of packing gland nuts.
    (ii) Ensuring that the seal flush is operating at design 
pressure and temperature.
    (d) For pumps:
    (1) The owner or operator shall decide no later than the first 
monitoring period whether to calculate percent leaking pumps on a 
process basis or on an affected source-wide basis. Once the owner or 
operator has decided, all subsequent percent calculations shall be 
made on the same basis.
    (2) If, calculated on a 1-year rolling average, the greater of 
either 10 percent of the pumps in a process or three pumps in a 
process leak, the owner or operator shall either:
    (i) Monitor each pump once per month; or
    (ii) Implement a quality improvement program for pumps that 
complies with the requirements of Sec. 63.176 and monitor quarterly.
    (3) The number of pumps at a process shall be the sum of all the 
pumps in organic HAP service, except that pumps found leaking in a 
continuous process within 1 quarter after startup of the pump shall 
not count in the percent leaking pumps calculation for that one 
monitoring period only.
    (4) Percent leaking pumps shall be determined by the following 
equation:

%P<INF>L=[(P<INF>L-P<INF>S)/(P<INF>T-P<INF>S)] x 100

Where:


[[Page 15787]]


%P<INF>L=Percent leaking pumps
P<INF>L=Number of pumps found leaking as determined through 
quarterly monitoring as required in paragraphs (b)(1) and (b)(2) of 
this section.
P<INF>T=Total pumps in organic HAP service, including those meeting 
the criteria in paragraphs (e) and (f) of this section.
P<INF>S=Number of pumps leaking within 1 quarter of startup during 
the current monitoring period.

    (e) Each pump or agitator equipped with a dual mechanical seal 
system that includes a barrier fluid system is exempt from the 
requirements of paragraphs (a) through (d) of this section, provided 
the following requirements are met:
    (1) Each dual mechanical seal system is:
    (i) Operated with the barrier fluid at a pressure that is at all 
times greater than the pump/agitator stuffing box pressure; or
    (ii) Equipped with a barrier fluid degassing reservoir that is 
connected by a closed-vent system to a control device that complies 
with the requirements of Sec. GGGA-3(a)(6); or
    (iii) Equipped with a closed-loop system that purges the barrier 
fluid into a process stream.
    (2) The barrier fluid is not in light liquid service.
    (3) Each barrier fluid system is equipped with a sensor that 
will detect failure of the seal system, the barrier fluid system, or 
both.
    (4) Each pump/agitator is checked by visual inspection each 
calendar week for indications of liquids dripping from the pump/
agitator seal.
    (i) If there are indications of liquids dripping from the pump/
agitator seal at the time of the weekly inspection, the pump/
agitator shall be monitored as specified in Sec. 63.180(b) to 
determine if there is a leak of organic HAP in the barrier fluid.
    (ii) If an instrument reading of 2,000 parts per million or 
greater is measured for pumps, or 10,000 parts per million or 
greater is measured for agitators, a leak is detected.
    (5) Each sensor as described in paragraph (e)(3) of this section 
is observed daily or is equipped with an alarm unless the pump is 
located within the boundary of an unmanned plant site.
    (6)(i) The owner or operator determines, based on design 
considerations and operating experience, criteria applicable to the 
presence and frequency of drips and to the sensor that indicates 
failure of the seal system, the barrier fluid system, or both.
    (ii) If indications of liquids dripping from the pump/agitator 
seal exceed the criteria established in paragraph (e)(6)(i) of this 
section, or if, based on the criteria established in paragraph 
(e)(6)(i) of this section, the sensor indicates failure of the seal 
system, the barrier fluid system, or both, a leak is detected.
    (iii) When a leak is detected, it shall be repaired as soon as 
practicable, but not later than 15 calendar days after it is 
detected, except as provided in Sec. GGGA-3(a)(5) of this appendix.
    (iv) A first attempt at repair shall be made no later than 5 
calendar days after each leak is detected.
    (f) Any pump/agitator that is designed with no externally 
actuated shaft penetrating the pump/agitator housing is exempt from 
the requirements of paragraphs (a) through (c) of this section.
    (g) Any pump/agitator equipped with a closed-vent system capable 
of capturing and transporting any leakage from the seal or seals 
back to the process or to a control device that complies with the 
requirements of Sec. GGGA-3(a)(6) is exempt from the requirements of 
paragraphs (b) through (e) of this section.
    (h) Any pump/agitator that is located within the boundary of an 
unmanned plant site is exempt from the weekly visual inspection 
requirement of paragraphs (b)(3) and (e)(4) of this section, and the 
daily requirements of paragraph (e)(5) of this section, provided 
that each pump/agitator is visually inspected as often as 
practicable and at least monthly.
    (i) If more than 90 percent of the pumps at a process meet the 
criteria in either paragraph (e) or (f) of this section, the process 
is exempt from the requirements of paragraph (d) of this section.

Sec. GGGA-5  Standards: Open-Ended Valves or Lines

    (a)(1) Each open-ended valve or line shall be equipped with a 
cap, blind flange, plug, or a second valve, except as provided in 
Sec. 63.177 and paragraph (d) of this section.
    (2) The cap, blind flange, plug, or second valve shall seal the 
open end at all times except during operations requiring process 
fluid flow through the open-ended valve or line, or during 
maintenance or repair. The cap, blind flange, plug, or second valve 
shall be in place within 1 hour of cessation of operations requiring 
process fluid flow through the open-ended valve or line, or within 1 
hour of cessation of maintenance or repair.
    (b) Each open-ended valve or line equipped with a second valve 
shall be operated in a manner such that the valve on the process 
fluid end is closed before the second valve is closed.
    (c) When a double block and bleed system is being used, the 
bleed valve or line may remain open during operations that require 
venting the line between the block valves but shall comply with 
paragraph (a) of this section at all other times.
    (d) Open-ended valves or lines in an emergency shutdown system 
which are designed to open automatically in the event of a process 
upset are exempt from the requirements of paragraphs (a), (b) and 
(c) of this section.
    (e) Open-ended valves or lines containing materials which would 
autocatalytically polymerize or, would prevent an explosion, serious 
overpressure, or other safety hazard if capped or equipped with a 
double block and bleed system as specified in paragraphs (a) through 
(c) of this section are exempt from the requirements of paragraph 
(a) through (c) of this section.

Sec. GGGA-6  Standards: Valves in Gas/Vapor Service and in Light 
Liquid Service

    (a) The provisions of this section apply to valves that are 
either in gas organic HAP service or in light liquid organic HAP 
service.
    (1) For existing and new affected sources, all valves subject to 
this section shall be monitored, except as provided in Sec. 63.177 
and Sec. GGGA-7, by no later than 1 year after the compliance date.
    (b) The owner or operator of a source subject to this appendix 
shall monitor all valves, except as provided in Sec. 63.177 and 
Sec. GGGA-7, at the intervals specified in paragraph (d) of this 
section and shall comply with all other provisions of this section, 
except as provided in Sec. GGGA-3(a)(5), Sec. 63.178, and 
Sec. 63.179.
    (1) The valves shall be monitored to detect leaks by the method 
specified in Sec. 63.180(b).
    (2) An instrument reading of 500 parts per million or greater 
defines a leak.
    (c) [Reserved]
    (d) After conducting the initial survey required in paragraph 
(a)(1) of this section, the owner or operator shall monitor valves 
for leaks at the intervals specified below:
    (1) At processes with 2 percent or greater leaking valves, 
calculated according to paragraph (e) of this section, the owner or 
operator shall either:
    (i) Monitor each valve once per month; or
    (ii) Implement a quality improvement program for valves that 
complies with the requirements of Sec. 63.175(d) or (e) and monitor 
quarterly.
    (2) At processes with less than 2 percent leaking valves, the 
owner or operator shall monitor each valve once each quarter, except 
as provided in paragraphs (d)(3) and (d)(4) of this section.
    (3) At processes with less than 1 percent leaking valves, the 
owner or operator may elect to monitor each valve once every 2 
quarters.
    (4) At processes with less than 0.5 percent leaking valves, the 
owner or operator may elect to monitor each valve once every 4 
quarters.
    (e)(1) Percent leaking valves at a process shall be determined 
by the following equation:

%V<INF>L=[V<INF>L/(V<INF>T+V<INF>C)] x 100

Where:

%V<INF>L=Percent leaking valves.
V<INF>L=Number of valves found leaking excluding nonrepairables as 
provided in paragraph (e)(3)(i) of this section.
V<INF>T=Total valves monitored, in a monitoring period excluding 
valves monitored as required by (f)(3) of this section.
V<INF>C=Optional credit for removed valves=0.67 x net number (i.e., 
total removed-total added) of valves in organic HAP service removed 
from process after the effective date for existing processes, and 
after the date of initial startup for new sources. If credits are 
not taken, then V<INF>C=0.

    (2) For use in determining monitoring frequency, as specified in 
paragraph (d) of this section, the percent leaking valves shall be 
calculated as a rolling average of two consecutive monitoring 
periods for monthly, quarterly, or semiannual monitoring programs; 
and as an average of any three out of four consecutive monitoring 
periods for annual monitoring programs.
    (3)(i) Nonrepairable valves shall be included in the calculation 
of percent leaking valves the first time the valve is identified as 
leaking and nonrepairable and as required to

[[Page 15788]]

comply with paragraph (e)(3)(ii) of this section. Otherwise, a 
number of nonrepairable valves (identified and included in the 
percent leaking calculation in a previous period) up to a maximum of 
1 percent of the total number of valves in organic HAP service at a 
process may be excluded from calculation of percent leaking valves 
for subsequent monitoring periods.
    (ii) If the number of nonrepairable valves exceeds 1 percent of 
the total number of valves in organic HAP service at a process, the 
number of nonrepairable valves exceeding 1 percent of the total 
number of valves in organic HAP service shall be included in the 
calculation of percent leaking valves.
    (f)(1) When a leak is detected, it shall be repaired as soon as 
practicable, but no later than 15 calendar days after the leak is 
detected, except as provided in Sec. GGGA-3(a)(5) of this appendix.
    (2) A first attempt at repair shall be made no later than 5 
calendar days after each leak is detected.
    (3) When a leak is repaired, the valve shall be monitored at 
least once within the first 3 months after its repair. Days that the 
valve are not in organic HAP service shall not be considered part of 
this 3-month period.
    (g) First attempts at repair include, but are not limited to, 
the following practices where practicable:
    (1) Tightening of bonnet bolts,
    (2) Replacement of bonnet bolts,
    (3) Tightening of packing gland nuts, and
    (4) Injection of lubricant into lubricated packing.
    (h) Any equipment located at a plant site with fewer than 250 
valves in organic HAP service in the affected source is exempt from 
the requirements for monthly monitoring and a quality improvement 
program specified in paragraph (d)(1) of this section. Instead, the 
owner or operator shall monitor each valve in organic HAP service 
for leaks once each quarter, or comply with paragraphs (d)(3) or 
(d)(4) of this section.

Sec. GGGA-7  Unsafe To Monitor, Difficult To Monitor, and 
Inaccessible Equipment

    (a) Equipment subject to this appendix shall not be required to 
comply with the monitoring requirements of this appendix if it meets 
the definition of difficult to monitor or unsafe to monitor as 
specified in paragraphs (b) or (c) of this section. Agitators and 
connectors will also be subject to the inaccessible to monitor 
requirements in paragraph (d) of this section. Specific paragraphs 
that will no longer apply to such equipment are as follows:
    (1) For pumps and agitators, Secs. GGGA-4 (b), (c), and (d) 
shall not apply.
    (2) For valves, Sec. GGGA-6 (b), (c), (d), (e), and (f) shall 
not apply.
    (3) For closed-vent systems, Sec. 63.172(f) (1) and (2), and (g) 
shall not apply.
    (4) For connectors, Sec. 63.174 (b), (c), (d), and (e) shall not 
apply.
    (b) Equipment that is designated, as described in Sec. GGGA-
8(b)(7) of this appendix, as unsafe-to-monitor is subject to the 
exemptions of paragraph (a) of this section if:
    (1) The owner or operator of the equipment determines that it is 
unsafe to monitor because monitoring personnel would be exposed to 
an immediate danger as a consequence of complying with the 
paragraphs referenced in (a)(1) through (4) of this section.
    (2) The owner or operator has a written plan that requires 
monitoring of the equipment as frequently as practicable during 
safe-to-monitor times, but not more frequently than the periodic 
monitoring schedule otherwise applicable.
    (c) Equipment that is designated, as described in Sec. GGG-
8(b)(7) of this appendix, as difficult to monitor is subject to the 
exemptions of paragraph (a) of this section if:
    (1) The owner or operator of the equipment determines that the 
equipment cannot be monitored without elevating the monitoring 
personnel more than 2 meters above a support surface or it is not 
accessible at anytime in a safe manner;
    (2) The process unit within which the equipment is located is an 
existing source or the owner or operator designates less than 3 
percent of the total number of valves in a new source as difficult 
to monitor; and
    (3) The owner or operator of the equipment follows a written 
plan that requires monitoring of the equipment at least once per 
calendar year.
    (d) Agitators and connectors designated as inaccessible are 
subject to the exemptions of paragraph (a) of this section if:
    (1) The equipment is inaccessible because it is:
    (i) Buried;
    (ii) Insulated in a manner that prevents access to the equipment 
by a monitor probe;
    (iii) Obstructed by equipment or piping that prevents access to 
the equipment by a monitor probe;
    (iv) Unable to be reached from a wheeled scissor-lift or 
hydraulic-type scaffold which would allow access to equipment up to 
7.6 meters (25 feet) above the ground;
    (v) Not able to be accessed at any time in a safe manner to 
perform monitoring. Unsafe access includes, but is not limited to, 
the use of a wheeled scissor-lift on unstable or uneven terrain, the 
use of a motorized man-lift basket in areas where an ignition 
potential exists, or access would require near proximity to hazards 
such as electrical lines, or would risk damage to equipment.
    (2) For pumps, agitators, and valves, the process within which 
the equipment is located is an existing source or the owner or 
operator designates less than 3 percent of the total number of 
components of that type (e.g., pumps, agitators, or valves) in a new 
source as inaccessible; and
    (3) If any inaccessible equipment is observed by visual, 
audible, olfactory, or other means to be leaking, the leak shall be 
repaired as soon as practicable, but no later than 15 calendar days 
after the leak is detected, except as provided in Sec. GGGA-8 of 
this appendix.

Sec. GGGA-8  Recordkeeping Requirements

    (a) An owner or operator of more than one process subject to the 
provisions of this appendix may comply with the recordkeeping 
requirements for these processes in one recordkeeping system if the 
system identifies with each record the program being implemented 
(e.g., quarterly monitoring, quality improvement) for each type of 
equipment. All records and information required by this section 
shall be maintained in a manner that can be readily accessed at the 
plant site. This could include physically locating the records at 
the plant site or accessing the records from a central location by 
computer at the plant site.
    (b) Except as provided in paragraph (e) of this section and in 
paragraph GGGA-1(i), the following information pertaining to all 
equipment subject to the requirements in this appendix shall be 
recorded:
    (1)(i) A list of identification numbers for equipment (except 
connectors exempt from monitoring and recordkeeping identified in 
Sec. 63.174 and instrumentation systems) subject to the requirements 
of this appendix. Equipment need not be individually identified if 
all equipment in a designated area or length of pipe subject to the 
provisions of this appendix are identified as a group, and the 
number of components of each type of equipment (pumps, valves, etc.) 
subject is indicated. The list for each type of equipment shall be 
complete no later than the completion of the initial survey required 
for that component. The list of identification numbers shall be 
updated, if needed, to incorporate equipment changes within 15 
calendar days of the completion of each monitoring survey for the 
type of equipment component monitored.
    (ii) A schedule for monitoring connectors subject to the 
provisions of Sec. 63.174(a) and valves subject to the provisions of 
Sec. GGGA-6(d) of this appendix.
    (iii) Physical tagging of the equipment to indicate that it is 
in organic HAP service is not required. Equipment subject to the 
provisions of this appendix may be identified on a plant site plan, 
in log entries, or by other appropriate methods.
    (2)(i) A list of identification numbers for equipment that the 
owner or operator elects to equip with a closed-vent system and 
control device, under the provisions of Sec. GGGA-4(g), 
Sec. 63.164(h), or Sec. 63.165(c).
    (ii) A list of identification numbers for compressors that the 
owner or operator elects to designate as operating with an 
instrument reading of less than 500 parts per million above 
background, under the provisions of Sec. 63.164(i).
    (3)(i) A list of identification numbers for pressure relief 
devices subject to the provisions in Sec. 63.165(a).
    (ii) A list of identification numbers for pressure relief 
devices equipped with rupture disks, under the provisions of 
Sec. 63.165(d).
    (4) Identification of instrumentation systems subject to the 
provisions of this appendix. Individual components in an 
instrumentation system need not be identified.
    (5) The owner or operator may develop a written procedure that 
identifies the conditions that justify a delay of repair. The 
written procedures may be included as part of the startup/shutdown/
malfunction plan, required by Sec. 63.6(e)(3), for the source or may 
be part of a separate document that is maintained at the plant site. 
In such cases, reasons for delay of repair may be documented by 
citing the relevant sections of the written procedure.

[[Page 15789]]

    (6) The following information shall be recorded for each dual 
mechanical seal system:
    (i) Design criteria required in Secs. GGGA-4(e)(6)(i) and 
63.164(e)(2), and an explanation of the design criteria; and
    (ii) Any changes to these criteria and the reasons for the 
changes.
    (7) The following information pertaining to all equipment 
subject to the requirements of Sec. GGGA-7, and all equipment 
subject to the requirements of Sec. GGGA-3(a)(5)(iii) shall be 
recorded:
    (i) Identification of equipment designated as unsafe to monitor, 
difficult to monitor, or inaccessible and the plan for monitoring or 
inspecting this equipment.
    (8)(i) A list of valves removed from and added to the process, 
as described in Sec. GGGA-6(e)(1) of this appendix, if the net 
credits for removed valves is expected to be used.
    (ii) A list of connectors removed from and added to the process, 
as described in Sec. 63.174(i)(1), and documentation of the 
integrity of the weld for any removed connectors, as required in 
Sec. 63.174(j). This is not required unless the net credits for 
removed connectors is expected to be used.
    (9) For batch processes that the owner or operator elects to 
monitor as provided under Sec. 63.178(c), a list of equipment added 
to batch product processes since the last monitoring period required 
in Secs. 63.178(c)(3)(ii) and (3)(iii). This list must be completed 
for each type of equipment within 15 calendar days of the completion 
of the each monitoring survey for the type of equipment monitored.
    (c) For visual inspections of equipment subject to the 
provisions of this appendix (e.g., Secs. GGGA-4(b)(3), GGGA-
4(e)(4)(i)), the owner or operator shall document that the 
inspection was conducted and the date of the inspection. The owner 
or operator shall maintain records as specified in paragraph (d) of 
this section for leaking equipment identified in this inspection, 
except as provided in paragraph (e) of this section. These records 
shall be retained for 2 years.
    (d) When each leak is detected as specified in Secs. GGGA-4 and 
63.164; Secs. GGGA-6 and 63.169; and Secs. 63.172 and 63.174 of this 
subpart, the following information shall be recorded and kept for 2 
years:
    (1) The instrument and the equipment identification number and 
the operator name, initials, or identification number.
    (2) The date the leak was detected and the date of first attempt 
to repair the leak.
    (3) The date of successful repair of the leak.
    (4) If postrepair monitoring is required, maximum instrument 
reading measured by Method 21 of 40 CFR part 60, appendix A after it 
is successfully repaired or determined to be nonrepairable.
    (5) ``Repair delayed'' and the reason for the delay if a leak is 
not repaired within 15 calendar days after discovery of the leak.
    (i) The owner or operator may develop a written procedure that 
identifies the conditions that justify a delay of repair. In such 
cases, reasons for delay of repair may be documented by citing the 
relevant sections of the written procedure.
    (ii) If delay of repair was caused by depletion of stocked 
parts, there must be documentation that the spare parts were 
sufficiently stocked onsite before depletion and the reason for 
depletion.
    (6) If repairs were delayed, dates of process shutdowns that 
occur while the equipment is unrepaired.
    (7)(i) If the alternative in Sec. 63.174(c)(1)(ii) is not in use 
for the monitoring period, identification, either by list, location 
(area or grouping), or tagging of connectors disturbed since the 
last monitoring period required in Sec. 63.174(b), as described in 
Sec. 63.174(c)(1).
    (ii) The date and results of follow-up monitoring as required in 
Sec. 63.174(c). If identification of disturbed connectors is made by 
location, then all connectors within the designated location shall 
be monitored.
    (8) The date and results of the monitoring required in 
Sec. 63.178(c)(3)(i) for equipment added to a batch process since 
the last monitoring period required in Secs. 63.178(c)(3)(ii) and 
(c)(3)(iii). If no leaking equipment is found in this monitoring, 
the owner or operator shall record that the inspection was 
performed. Records of the actual monitoring results are not 
required.
    (9) Copies of the periodic reports as specified in Sec. GGGA-
9(d) of this appendix, if records are not maintained on a 
computerized data base capable of generating summary reports from 
the records.
    (e) The owner or operator of a batch product process who elects 
to pressure test the batch product process equipment train to 
demonstrate compliance with this appendix is exempt from the 
requirements of paragraphs (b), (c), (d), and (f) of this section. 
Instead, the owner or operator shall maintain records of the 
following information:
1(1) The identification of each product, or product code, produced 
during the calendar year. It is not necessary to identify individual 
items of equipment in a batch product process equipment train.
    (2) Records demonstrating the proportion of the time during the 
calendar year the equipment is in use in a batch process that is 
subject to the provisions of this subpart. Examples of suitable 
documentation are records of time in use for individual pieces of 
equipment or average time in use for the process unit. These records 
are not required if the owner or operator does not adjust monitoring 
frequency by the time in use, as provided in Sec. 63.178(c)(3)(iii).
    (3) Physical tagging of the equipment to identify that it is in 
organic HAP service and subject to the provisions of this appendix 
is not required. Equipment in a batch product process subject to the 
provisions of this appendix may be identified on a plant site plan, 
in log entries, or by other appropriate methods.
    (4) The dates of each pressure test required in Sec. 63.178(b), 
the test pressure, and the pressure drop observed during the test.
    (5) Records of any visible, audible, or olfactory evidence of 
fluid loss.
    (6) When a batch product process equipment train does not pass 
two consecutive pressure tests, the following information shall be 
recorded in a log and kept for 2 years:
    (i) The date of each pressure test and the date of each leak 
repair attempt.
    (ii) Repair methods applied in each attempt to repair the leak.
    (iii) The reason for the delay of repair.
    (iv) The expected date for delivery of the replacement equipment 
and the actual date of delivery of the replacement equipment.
    (v) The date of successful repair.
    (f) The dates and results of each compliance test required for 
compressors subject to the provisions in Sec. 63.164(i) and the 
dates and results of the monitoring following a pressure release for 
each pressure relief device subject to the provisions in 
Secs. 63.165(a) and (b). The results shall include:
    (1) The background level measured during each compliance test.
    (2) The maximum instrument reading measured at each piece of 
equipment during each compliance test.
    (g) The owner or operator shall maintain records of the 
information specified in paragraphs (g)(1) through (g)(3) of this 
section for closed-vent systems and control devices subject to the 
provisions of Sec. GGGA-3(a)(6). The records specified in paragraph 
(g)(1) of this section shall be retained for the life of the 
equipment. The records specified in paragraphs (g)(2) and (g)(3) of 
this section shall be retained for 2 years.
    (1) The design specifications and performance demonstrations 
specified in paragraphs (g)(1)(i) through (g)(1)(iv) of this 
section.
    (i) Detailed schematics, design specifications of the control 
device, and piping and instrumentation diagrams.
    (ii) The dates and descriptions of any changes in the design 
specifications.
    (iii) The flare design (i.e., steam-assisted, air assisted, or 
nonassisted) and the results of the compliance demonstration 
required by Sec. 63.11(b) of subpart A of this part.
    (iv) A description of the parameter or parameters monitored, as 
required in Sec. GGGA-3(a)(6)(e), to ensure that control devices are 
operated and maintained in conformance with their design and an 
explanation of why that parameter (or parameters) was selected for 
the monitoring.
    (2) Records of operation of closed-vent systems and control 
devices.
    (i) Dates and durations when the closed-vent systems and control 
devices required in Sec. GGGA-4 and Secs. 63.164 through 63.166 are 
not operated as designed as indicated by the monitored parameters, 
including periods when a flare pilot light system does not have a 
flame.
    (ii) Dates and durations during which the monitoring system or 
monitoring device is inoperative.
    (iii) Dates and durations of startups and shutdowns of control 
devices required in Sec. GGGA-4 and Secs. 63.164 through 63.166.
    (3) Records of inspections of closed-vent systems subject to the 
provisions of Sec. 63.172.
    (i) For each inspection conducted in accordance with the 
provisions of Sec. 63.172(f)(1) or (f)(2) during which no leaks were 
detected, a record that the inspection was performed, the date of 
the inspection, and a statement that no leaks were detected.
    (ii) For each inspection conducted in accordance with the 
provisions of Sec. 63.172(f)(1) or (f)(2) during which leaks

[[Page 15790]]

were detected, the information specified in paragraph (d) of this 
section shall be recorded.
    (h) Each owner or operator of equipment subject to the 
requirements of Secs. 63.175 and 63.176 shall maintain the records 
specified in paragraphs (h)(1) through (h)(9) of this section for 
the period of the quality improvement program for the equipment.
    (1) For owners or operators who elect to use a reasonable 
further progress quality improvement program, as specified in 
Sec. 63.175(d):
    (i) All data required in Sec. 63.175(d)(2).
    (ii) The percent leaking valves observed each quarter and the 
rolling average percent reduction observed in each quarter.
    (iii) The beginning and ending dates while meeting the 
requirements of Sec. 63.175(d).
    (2) For owners or operators who elect to use a quality 
improvement program of technology review and improvement, as 
specified in Sec. 63.175(e):
    (i) All data required in Sec. 63.175(e)(2).
    (ii) The percent leaking valves observed each quarter.
    (iii) Documentation of all inspections conducted under the 
requirements of Sec. 63.175(e)(4), and any recommendations for 
design or specification changes to reduce leak frequency.
    (iv) The beginning and ending dates while meeting the 
requirements of Sec. 63.175(e).
    (3) For owners or operators who elect to use the pump quality 
improvement program as specified in Sec. 63.176:
    (i) All data required in Sec. 63.176(d)(2).
    (ii) The rolling average percent leaking pumps.
    (iii) Documentation of all inspections conducted under the 
requirements of Sec. 63.176(d)(4), and any recommendations for 
design or specification changes to reduce leak frequency.
    (iv) The beginning and ending dates while meeting the 
requirements of Sec. 63.176(d).
    (4) If a leak is not repaired within 15 calendar days after 
discovery of the leak, the reason for the delay and the expected 
date of successful repair.
    (5) Records of all analyses required in Secs. 63.175(e) and 
63.176(d). The records will include the following:
    (i) A list identifying areas associated with poorer than average 
performance and the associated service characteristics of the 
stream, the operating conditions and maintenance practices.
    (ii) The reasons for rejecting specific candidate superior 
emission performing valve or pump technology from performance 
trials.
    (iii) The list of candidate superior emission performing valve 
or pump technologies, and documentation of the performance trial 
program items required under Secs. 63.175(e)(6)(iii) and 
63.176(d)(6)(iii).
    (iv) The beginning date and duration of performance trials of 
each candidate superior emission performing technology.
    (6) All records documenting the quality assurance program for 
valves or pumps as specified in Secs. 63.175(e)(7) and 63.176(d)(7).
    (7) Records indicating that all valves or pumps replaced or 
modified during the period of the quality improvement program are in 
compliance with the quality assurance requirements in 
Sec. 63.175(e)(7) and Sec. 63.176(d)(7).
    (8) Records documenting compliance with the 20 percent or 
greater annual replacement rate for pumps as specified in 
Sec. 63.176(d)(8).
    (9) If exempted by Sec. 63.175(e)(6)(v) or Sec. 63.176(d)(6)(v), 
information and data to show the corporation has fewer than 100 
employees, including employees providing professional and technical 
contracted services.
    (i) Information, data, and analysis used to determine that a 
piece of equipment or process is in heavy liquid service shall be 
recorded. Such a determination shall include an analysis or 
demonstration that the process fluids do not meet the criteria of 
``in light liquid or gas service.'' Examples of information that 
could document this include, but are not limited to, records of 
chemicals purchased for the process, analyses of process stream 
composition, engineering calculations, or process knowledge.
    (j) Identification, either by list, location (area or group) of 
equipment in organic HAP service less than 300 hours per year 
subject to the provisions of this appendix.
    (k) Owners and operators choosing to comply with the 
requirements of Sec. 63.179 shall maintain the following records:
    (1) Identification of the process(es) and the organic HAP's they 
handle.
    (2) A schematic of the process, enclosure, and closed-vent 
system.
    (3) A description of the system used to create a negative 
pressure in the enclosure to ensure that all emissions are routed to 
the control device.

Sec. GGGA-9 Reporting Requirements

    (a) Each owner or operator of a source subject to this appendix 
shall submit the reports listed in paragraphs (a)(1) through (a)(5) 
of this section. Owners or operators requesting an extension of 
compliance shall also submit a report as described in Sec. 63.6 of 
subpart A.
    (1) An Initial Notification as described in Sec. 63.9 of subpart 
A, and
    (2) A Notification of Compliance Status described in paragraph 
(c) of this section,
    (3) Periodic Reports described in paragraph (d) of this section, 
and
    (4) [Reserved]
    (5) [Reserved]
    (b) Each owner or operator of a source subject to this appendix 
shall submit a Notification of Compliance Status within 90 days 
after the compliance dates specified in Sec. 63.1250(e).
    (1) The notification shall provide the information listed in 
paragraphs (b)(1)(i) through (b)(1)(iii) of this section for each 
process subject to the requirements of Secs. GGGA-3 through GGGA-8 
of this appendix.
    (i) Process identification.
    (ii) Approximate number of each equipment type (e.g., valves, 
pumps) in organic HAP service, excluding equipment in vacuum 
service.
    (iii) Method of compliance with the standard (for example, 
``monthly leak detection and repair'' or ``equipped with dual 
mechanical seals'').
    (2) The notification shall provide the information listed in 
paragraphs (b)(2)(i) and (b)(2)(ii) of this section for each process 
subject to the requirements of Sec. 63.178(b).
    (i) Batch products or product codes subject to the provisions of 
this appendix, and
    (ii) Planned schedule for pressure testing when equipment is 
configured for production of products subject to the provisions of 
this appendix.
    (3) The notification shall provide the information listed in 
paragraphs (b)(3)(i) and (b)(3)(ii) of this section for each process 
subject to the requirements in Sec. 63.179.
    (i) Process identification.
    (ii) A description of the system used to create a negative 
pressure in the enclosure and the control device used to comply with 
the requirements of Sec. GGGA-3(a)(6).
    (4) Any change in the information submitted under this paragraph 
(b) shall be provided to the Administrator as a part of subsequent 
Periodic Reports. Section 63.9(j) shall not apply to the 
Notification of Compliance Status described in this paragraph (b).
    (c) The owner or operator of a source subject to this appendix 
shall submit Periodic Reports.
    (1) A report containing the information in paragraphs (c)(2), 
(c)(3), and (c)(4) of this section shall be submitted semiannually 
starting 6 months after the Notification of Compliance Status, as 
required in paragraph (b) of this section. The first periodic report 
shall cover the first 6 months after the compliance date specified 
in Sec. 63.1250(e). Each subsequent periodic report shall cover the 
6 month period following the preceding period.
    (2) For equipment complying with the provisions of Secs. GGGA-3 
through GGGA-8 of this appendix, the summary information listed in 
paragraphs (i) through (xii) of this paragraph for each monitoring 
period during the 6-month period.
    (i) The number of valves for which leaks were detected as 
described in Sec. GGGA-6(b) of this appendix, the percent leakers, 
and the total number of valves monitored;
    (ii) The number of valves for which leaks were not repaired as 
required in Sec. GGGA-6(f) of this appendix, identifying the number 
of those that are determined nonrepairable;
    (iii) The number of pumps and agitators for which leaks were 
detected as described in Sec. GGGA-4(b) of this appendix, the 
percent leakers, and the total number of pumps and agitators 
monitored;
    (iv) The number of pumps and agitators for which leaks were not 
repaired as required in Sec. GGGA-4(c) of this appendix;
    (v) The number of compressors for which leaks were detected as 
described in Sec. 63.164(f);
    (vi) The number of compressors for which leaks were not repaired 
as required in Sec. 63.164(g);
    (vii) The number of connectors for which leaks were detected as 
described in Sec. 63.174(a), the percent of connectors leaking, and 
the total number of connectors monitored;
    (viii) The number of connectors for which leaks were not 
repaired as required in Sec. 63.174(d), identifying the number of 
those that are determined nonrepairable;

[[Page 15791]]

    (ix) The facts that explain any delay of repairs and, where 
appropriate, why a process shutdown was technically infeasible.
    (x) The results of all monitoring to show compliance with 
Secs. 63.164(i), 63.165(a), and 63.172(f) conducted within the 
semiannual reporting period.
    (xi) If applicable, the initiation of a monthly monitoring 
program under either Secs. GGGA4-(d)(2)(i) or GGGA-6(d)(1)(i) of 
this appendix, or a quality improvement program under either 
Sec. 63.175 or 63.176.
    (xii) If applicable, notification of a change in connector 
monitoring alternatives as described in Sec. 63.174(c)(1).
    (3) For owners or operators electing to meet the requirements of 
Sec. 63.178(b), the report shall include the information listed in 
paragraphs (i) through (v) of this paragraph for each process.
    (i) Batch product process equipment train identification;
    (ii) The number of pressure tests conducted;
    (iii) The number of pressure tests where the equipment train 
failed either the retest or two consecutive pressure tests;
    (iv) The facts that explain any delay of repairs; and
    (v) The results of all monitoring to determine compliance with 
Sec. 63.172(f) of this subpart.
    (4) Any revisions to items reported in earlier Notification of 
Compliance Status, if the method of compliance has changed since the 
last report or any other changes to the information reported has 
occurred.

[FR Doc. 97-7625 Filed 4-1-97; 8:45 am]
BILLING CODE 6560-50-P