[Federal Register Volume 63, Number 182 (Monday, September 21, 1998)]
[Rules and Regulations]
[Pages 50280-50386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-23168]



[[Page 50279]]

_______________________________________________________________________

Part II





Environmental Protection Agency





_______________________________________________________________________



40 CFR Parts 9 and 63



National Emission Standards for Hazardous Air Pollutants for Source 
Categories: Pharmaceuticals Production; Final Rule

  Federal Register / Vol. 63, No. 182 / Monday, September 21, 1998 /  
Rules and Regulations  

[[Page 50280]]



ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 63

[AD-FRL-6135-6]
RIN-2060-AE83


National Emission Standards for Hazardous Air Pollutants for 
Source Categories: Pharmaceuticals Production

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This action promulgates national emission standards for 
hazardous air pollutants (NESHAP) to reduce air emissions of hazardous 
air pollutants (HAP) from existing and new facilities that manufacture 
pharmaceutical products. The Agency intends that this promulgated rule 
will have a common technology basis with a rule promulgated this date 
under the Clean Water Act (CWA) and published elsewhere in this issue 
of the Federal Register; this will allow coordinated and cost effective 
compliance planning by the industry. The standards implement section 
112 of the Clean Air Act (CAA) as amended in 1990. The standards apply 
to major source facilities which produce pharmaceutical products.
    The major HAP emitted by facilities covered by this final rule 
include methylene chloride, methanol, toluene, and hydrogen chloride. 
Methylene chloride is considered to be a probable human carcinogen and 
the other pollutants can cause noncancer health effects in humans. The 
promulgated rule is estimated to reduce HAP emissions from existing 
facilities by 22,000 megagrams per year (Mg/yr) (24,000 tons per year 
[tons/yr]). It also reduces volatile organic compound (VOC) emissions.

DATES: This regulation is effective on September 21, 1998. The 
incorporation by reference of certain publications listed in the 
regulation is approved by the Director of the Office of the Federal 
Register as of September 21, 1998. See the SUPPLEMENTARY INFORMATION 
section concerning judicial review.

ADDRESSES: Docket. Docket No. A-96-03, containing supporting 
information used in developing the 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 FURTHER INFORMATION CONTACT: For information concerning the final 
CAA 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 CWA 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. For information concerning applicability and 
rule determinations, contact your State or local representative or the 
appropriate EPA regional representatives. For a listing of EPA regional 
contacts, see the following SUPPLEMENTARY INFORMATION section.

SUPPLEMENTARY INFORMATION: An electronic version of documents from the 
Office of Air and Radiation (OAR) are available through EPA's OAR 
Technology Transfer Network Web site (TTNWeb). The TTNWeb is a 
collection of related Web sites containing information about many areas 
of air pollution science, technology, regulation, measurement, and 
prevention. The TTNWeb is directly accessible from the Internet via the 
World Wide Web at the following address, ``http://www.epa.gov/ttn''. 
Electronic versions of this preamble and rule are located under the OAR 
Policy and Guidance Information Web site, ``http://www.epa.gov/ttn/
oarpg/'', under the Federal Register Notices section. If more 
information on the TTNWeb is needed, contact the Systems Operator at 
(919) 541-5384.
    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...............................   Facilities described by the SIC codes 2833 and 2834 and NAICS 
                                          codes 32541 and 325412.                                               
                                          Producers of finaished dosage forms of drugs, for example,    
                                          tablets, capsules, solutions, that contain an active ingredient       
                                          generally, but not necessarily, in association with inactive          
                                          ingredients.                                                          
                                          Producers of components whose intended primary use is to      
                                          furnish pharmacological activity or other direct effect in the        
                                          diagnosis, cure, mitigation, treatment, or prevention of disease, or  
                                          to affect the structure or any function of the body of humans or other
                                          animals.                                                              
----------------------------------------------------------------------------------------------------------------

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, contact the 
appropriate Regional representative:

Region I

NESHAP (MACT) Coordinator, U.S. EPA Region I, John F. Kennedy Federal 
Building, One Congress Street, Boston, MA 02203-001, (617) 565-3438

Region II

Umesh Dholakia, U.S. EPA Region II, 290 Broadway Street, New York, NY 
10007-1866, (212) 637-4023 (Umesh), (212) 637-4065 (Yue-On)

Region III

Bernard Turlinski, U.S. EPA Region III, 841 Chestnut Building, 
Philadelphia, PA 19107, (215) 566-2150

Region IV

Lee Page, U.S. EPA Region IV, Atlanta Federal Center, 61 Forsyth Street 
SW, Atlanta, GA 30303-3104, (404) 562-9131

Region V

Bruce Varner, U.S. EPA Region V, 77 West Jackson Boulevard, Chicago, IL 
60604-3507, (312) 886-6793

Region VI

Robert Todd, U.S. EPA Region VI, First Interstate Bank Tower @ Fountain 
Place, 1445 Ross Avenue, 12th Floor, Suite 1200, Dallas, TX 75202-2733, 
(214) 665-2156

[[Page 50281]]

Region VII

Richard Tripp, U.S. EPA Region VII, Air Toxics Coordinator, 726 
Minnesota Avenue, Kansas City, KS 66101, (913) 551-7566

Region VIII

Ann Marie Patrie, U.S. EPA Region VIII, Air Toxics Coordinator, 999 
18th Street, Suite 500, Denver, CO 80202-2466, (303) 312-6524

Region IX

Nahid Zoueshtiagh, U.S. EPA Region IX, Air Division-6, 75 Hawthorne 
Street, San Francisco, CA 94105, (415) 744-1261

Region X

Andrea Wullenweber, U.S. EPA Region X, Air Toxics Coordinator, 1200 
Sixth Avenue, Seattle, WA 98101, (206) 553-8760
    Judicial review. Under section 307(b)(1) of the Act, judicial 
review of NESHAP is available only by filing a petition for review in 
the U.S. Court of Appeals for the District of Columbia Circuit within 
60 days of today's publication of this final rule. Under section 
307(b)(2) of the Act, the requirements that are the subject of today's 
notice may not be challenged later in civil or criminal proceedings 
brought by the EPA to enforce these requirements. The information 
presented in this preamble is organized as follows:

I. List of Source Categories
II. Background
    A. Summary of Considerations Made in Developing These Standards
    B. Regulatory Background
    C. Regulation of the Pharmaceutical Manufacturing Industry Under 
the Clean Water Act
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 Promulgated Standards
    A. Source Categories to be Regulated
    B. Pollutants to be Regulated and Associated Environmental and 
Health Benefits
    C. Affected Sources
    D. Storage Tank Provisions
    E. Process Vent Provisions
    F. Wastewater Provisions
    G. Equipment Leaks
    H. Pollution Prevention Alternative
    I. Heat Exchange Provisions
    J. Emissions Averaging Provisions
    K. Alternative Standard
    L. Test Methods and Compliance Procedures
    M. Monitoring Requirements
    N. Recordkeeping and Reporting Requirements
V. Summary of Environmental, Energy, Cost, and Economic Impacts
    A. Air Impacts
    B. Water and Solid Waste Impacts
    C. Energy Impacts
    D. Cost Impacts
    E. Economic Impacts
VI. Major Comments and Changes to the Proposed Standards
    A. Applicability Provisions and Definitions
    B. Storage Tank Provisions
    C. Process Vent Provisions
    D. Wastewater Provisions
    E. Equipment Leak Provisions
    F. Pollution Prevention Alternative
    G. Alternative Standard
    H. Testing Provisions and Compliance Demonstrations
I. Equations
    J. Monitoring Requirements
    K. Recordkeeping and Reporting Requirements
    L. Management of Change
VII. Technical Amendment to 40 CFR Part 9
VIII. Administrative Requirements
    A. Docket
    B. Executive Order 12866
    C. Enhancing the Intergovernmental Partnership Under Executive 
Order 12875
    D. Paperwork Reduction Act
    E. Regulatory Flexibility Act
    F. Unfunded Mandates
    G. Submission to Congress and the Comptroller General Office
    H. National Technology Transfer and Advancement Act
    I. Executive Order 13045

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 pharmaceutical 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 emitted from the production processes include a 
range of organic compounds, including VOC and several specific HAP. 
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 located in Docket A-96-
03, Item No. III-B-01.
    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/yr of any one HAP or 25 tons/yr of 
combined HAP, based on 1992 emissions data. Today's final standard 
applies to all major sources that produce pharmaceutical products. Area 
sources are not subject to this standard.

II. Background

A. Summary of Considerations Made in Developing These Standards

    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 maximum achievable 
control technology (MACT) floor (minimum control level) were selected 
when they were judged to be reasonable, considering cost, nonair 
impacts, and energy requirements.
    Today's final rule gives 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 today's final 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 comply with the standards both initially and over 
time. However, the

[[Page 50282]]

EPA has made every effort to simplify the requirements in the final 
rule. In addition, EPA has significantly reduced the amount of cross-
referencing to other rules included in today's final standards at the 
request of facilities affected by these standards.
    In addition, this rule contains an important and innovative 
pollution prevention alternative for the pharmaceutical industry that 
provides an option to reduce HAP emissions through reductions in HAP 
solvent consumption as opposed to 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 
and had the opportunity to comment on the proposed standards and to 
provide additional information during the public comment period that 
followed proposal.
    The standards were proposed in the Federal Register on April 2, 
1997 [62 FR 15754]. The preamble to the proposed standards and the 
basis and purpose document (Docket Item III-B-01) described the 
rationale for the proposed standards. Public comments were solicited at 
the time of proposal. To provide interested persons the opportunity for 
oral presentation of data, views, or arguments concerning the proposed 
standards, a public hearing was offered at proposal. However, the 
public did not request a hearing and, therefore, one was not held. The 
public comment period was from April 2, 1997 to July 2, 1997. More than 
40 letters were received during the comment period. Commenters included 
industry representatives and State agencies. The comments were 
carefully considered, and changes were made in the proposed standards 
when determined by the EPA to be appropriate. A detailed discussion of 
these comments and responses can be found in the promulgation 
background information document (BID) which is located in Docket No. A-
96-03, Item V-B-01, which is referenced in the ADDRESSES section of 
this preamble. The promulgation BID (summary of comments and responses 
document) serves as the basis for the revisions that have been made to 
the standards between proposal and promulgation. Section VI of this 
preamble discusses these major changes.

B. Regulatory Background

    Today's final 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. Today's final rule does not 
affect the presumptive RACT guidelines, although a portion of emissions 
sources are covered by both today's final 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. Today's final rule 
requires control of leaking components that are currently not subject 
to the Negotiated Regulation for Equipment Leaks, but that contain and/
or transport HAP and are associated with processes in this source 
category. Today's rule also allows sources subject to the Negotiated 
Regulation to comply with the LDAR provisions of this rule.

C. 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 the pharmaceutical manufacturing industry.
    On May 2, 1995 at 60 FR 21592, the 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 pretreatment 
standards for existing sources (PSES) and performance standards for new 
sources (PSNS) for 45 volatile organic pollutants of which 16 are HAP. 
The technology basis for the volatile organic limitations were based on 
steam stripping and advanced biological treatment. The proposed NSPS 
and PSNS differed from BAT and PSES, respectively, in that they were 
based on steam stripping plus distillation.
    In the April 2, 1997 proposal EPA indicated that it was considering 
changing the BAT technology basis to advanced biological treatment 
only. The EPA also described three options under consideration for 
setting PSES and PSNS to address HAP and non-HAP wastewater pollutant 
discharges not controlled by the MACT standards. Under the first option 
compliance with the MACT standards would constitute compliance with 
PSES and PSNS. Option 2 involved compliance with the MACT standards 
plus additional PSES based on the performance data base for the 1995 
proposed PSES for all volatile organic pollutants except alcohols and 
related pollutants, and Option 3 was the same as Option 2 except the 
additional pollutants included alcohols and related pollutants.
    On August 8, 1997, at 62 FR 42720, the EPA published a Notice of 
Availability (NOA) to allow public comment on the data received since 
the May 2, 1995 CWA proposal and to further develop and revise options 
for the control of volatile organic pollutant discharges presented in 
the April 2, 1997 MACT proposal. The EPA provided the results of an EPA 
sampling study designed to provide information concerning the pass-
through analysis for water soluble organic pollutants such as methanol 
and provided a discussion thereafter of the final pass-through analysis 
that EPA would be performing with respect to these and other

[[Page 50283]]

pollutants. The EPA also presented revisions to the pretreatment 
options (Options 2 and 3) which were first suggested in the CWA section 
of the April 2, 1997 MACT proposal.
    Elsewhere in today's Federal Register EPA is publishing final 
effluent limitation guideline and standards under the Clean Water Act 
for the pharmaceutical manufacturing point source category.

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 EPA 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/yr or 
more of any one HAP or 25 tons/yr 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 Promulgated Standards

A. Source Categories to be Regulated

    Today's final rule regulates HAP emissions from pharmaceutical 
production facilities that are determined to be major sources. These 
standards apply to existing sources as well as new sources. The final 
standards for existing and new source are summarized in Table 1.

BILLING CODE 6560-50-P

                                                    Table 1.--Standards for New and Existing Sources                                                    
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Applicability                                                               
           Emission point               New or existing?   ----------------------------------------------                   Requirement                 
                                                             Applicability Level           Cutoff                                                       
--------------------------------------------------------------------------------------------------------------------------------------------------------
Process vents......................  New..................  Processes............  >400 lb HAP/yr         98 percent control or 20 ppmv TOC and 20 ppmv 
                                                                                    uncontrolled.          hydrogen halide and halogen outlet limit.    
                                     Existing.............  Processes............  2,000 lb    93 percent control or 2,000 lb HAP/yr or 20   
                                                                                    HAP/yr controlled.     ppmv TOC and 20 ppmv hydrogen halide and     
                                                                                                           halogen outlet limit (if there are any vents 
                                                                                                           in a process not manifolded to the control   
                                                                                                           device, process must still meet 93 percent   
                                                                                                           control); and 98 percent* for individual     
                                                                                                           vents (within a process) meeting cutoff based
                                                                                                           on flow and emissions or 20 ppmv TOC and 20  
                                                                                                           ppmv hydrogen halide and halogen outlet      
                                                                                                           limit.                                       
Storage tanks......................  New and existing.....  10,000 gal  1.9 psia    90 percent control or 20 ppmv TOC and 20 ppmv 
                                                             and <20,000 gal.       vapor pressure of      hydrogen halide and halogen outlet limit.    
                                                                                    liquid stored.                                                      
                                                            20,000 gal  1.9 psia    95 percent control or 20 ppmv TOC and 20 ppmv 
                                                                                    vapor pressure of      hydrogen halide and halogen outlet limit**   
                                                                                    liquid stored.                                                      
Wastewater.........................  New and existing.....  >Mg/yr total HAP load  1,300 ppm   99 percent reduction of Table 2 HAP.          
                                                             from all POD from      at POD of Table 2                                                   
                                                             PMPU.                  HAP.                                                                
                                                                                   5,200 ppmw  99 percent reduction of Table 2 HAP.          
                                                                                    at POD of total HAP   90 percent reduction of Table 3 HAP.          
                                                                                    load.                 95 percent reduction of total HAP using       
                                                                                                           biotreatment.                                
                                                            >1 Mg/yr total HAP     10,000      99 percent reduction of Table 2 HAP.          
                                                             load from facility.    ppmw at POD of total  90 percent reduction of Table 3 HAP.          
                                                                                    HAP load.             95 percent reduction of total HAP using       
                                                                                                           biotreatment.                                
                                     New..................  >1 Mg/yr total HAP     110,000     99 percent reduction of Table 3 HAP and       
                                                             load from all POD      ppmw at POD of Table   existing source requirements.                
                                                             from PMPU.             3 HAP.                                                              

[[Page 50284]]

                                                                                                                                                        
Equipment leaks....................  New and existing.....  All components in HAP                         LDAR program.                                 
                                                             service.                                                                                   
--------------------------------------------------------------------------------------------------------------------------------------------------------
*For process vents controlled to 93 percent prior to April 2, 1997, no additional control is required.                                                  
**For tanks controlled to 90 percent prior to April 2, 1997, no additional control is required.                                                         


BILLING CODE 6560-50-M

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. Organic HAP include methylene chloride, 
methanol, toluene, dimethylformamide, and hexane as well as other HAP. 
Hydrogen chloride is an inorganic HAP emitted by this industry. Today's 
final rule reduces 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 emitted from this industry are classified 
as VOC. The emission controls for HAP 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. 
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 would pose a significant hazard to the 
community in the event of an accident, 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) are 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 today's final 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 
subject to this subpart is any pharmaceutical manufacturing operation, 
as defined in Sec. 63.1251 of today's final rule, that meets the 
following criteria: (1) it manufactures a pharmaceutical product, as 
defined in Sec. 63.1251; (2) it is located at a plant site that is a 
major source as defined in section 112(a) of the Act; and (3) it 
processes, uses, or produces HAP. Based on this definition of affected 
source, new sources are created by reconstructing existing sources, 
constructing new ``greenfield'' facilities, or constructing an addition 
to an existing source which is a dedicated pharmaceutical manufacturing 
process unit (PMPU) and exceeds 10 tons/yr of an individual HAP or 25 
tons/yr of combined HAP. Reconfigurations of existing equipment do not 
constitute ``construction'' and therefore NSM would not be triggered 
under this circumstance. Therefore, a new affected source subject to 
this subpart is any affected source for which construction or 
reconstruction commenced after April 2, 1997, and the standard was 
applicable at the time of construction or reconstruction, or any PMPU 
that is dedicated to manufacturing a single product that has the 
potential to emit 10 tons per year of any one HAP or 25 tons per year 
of combined HAP, for which construction commenced after April 2, 1997.
    The PMPU is defined according to the equipment used to make a 
pharmaceutical product. The PMPU also includes storage tanks that are 
associated with the process.

D. Storage Tank Provisions

    Today's final standards require existing and new sources to control 
emissions from storage tanks having volumes greater than or equal to 38 
cubic meters (m3) (10,000 gallons), and storing material 
with a vapor pressure of greater than or equal to 13.1 kPa (1.9 psi). 
The final standards require that emissions from storage tanks with 
capacities greater than or equal to 38 m3 (10,000 gallons) 
and less than 75 m3 (20,000 gallons) be reduced by 90 
percent. Emissions from storage tanks greater than or equal to 75 
m3 (20,000 gallons) must be reduced by 95 percent.

[[Page 50285]]

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 final rule also includes an alternative standard for any 
storage tank vents that are routed to an add-on control device. Under 
the alternative standard, an owner or operator may choose to comply 
with a total organic compound (TOC) and hydrogen halide and halogen 
limit of 20 ppmv or less, measured prior to dilution and at the outlet 
of the control device. The alternative standard is discussed in more 
detail in sections IV.K and VI.G of this preamble and is included in 
Sec. 63.1253(d) of the final rule. Today's final rule does not provide 
for vapor balancing systems to be used as an alternative means of 
control for storage tanks.

E. Process Vent Provisions

    The MACT standard for most existing process vents was set at the 
floor level of control, which was determined to be 93 percent control. 
The final standards 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. The 2,000 lb/yr compliance option is limited to 
seven processes per year per facility. Additionally, a regulatory 
alternative beyond the floor was selected that requires 98 percent 
control of some large emission vents. Individual process vents 
(manifolded or nonmanifolded) meeting the annual emissions and flow 
rate criteria are required to achieve 98 percent control, independent 
of the overall 93 percent requirement. (Those process vents achieving 
93 percent control prior to April 2, 1997 are not required to meet the 
98 percent control requirement.) 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. Today's final standards for new sources 
require 98 percent control of vents in a process that has uncontrolled 
emissions greater than 182 kg/yr (400 lb/yr).
    An alternative standard for process vents was added to the final 
rule [see Sec. 63.1254(c)]. Under the alternative standard, an owner or 
operator may choose to comply with a TOC and hydrogen halide and 
halogen limit of 20 ppmv or less, measured prior to dilution and at the 
outlet of the control device. If only a portion of the process vents 
associated with a process comply with the alternative standard, then 
the remaining process vents must be controlled to the levels required 
by the standards (e.g., 93 percent for the sum of remaining vents and/
or 98 percent control of some individual vents for existing sources and 
98 percent control of the sum of remaining vents for new sources).
    The process vent and storage tank standards also contain provisions 
for complying in essentially the same manner as is described by the 
alternative standard--by routing streams to control devices achieving 
an outlet concentration of TOC and hydrogen halide and halogen limit of 
20 ppmv or less, measured prior to dilution. These provisions differ 
from those described under the Alternative standard only in the 
monitoring options available.

F. Wastewater Provisions

    The MACT floor for wastewater at existing sources was determined to 
be 54 percent control of HAP emissions from wastewater. The EPA 
calculated HAP concentration cutoffs for wastewater streams, 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 
hazardous organic NESHAP (HON) and allows for the control of those 
wastewater streams containing the most significant amount of HAP. The 
final standards 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 PMPU HAP load of 1 Mg/yr or greater;
    2. Streams having a combined total HAP concentration of 5,200 ppmw 
or greater and a total PMPU load of 1 Mg/yr or greater;
    3. Streams having a total HAP concentration of 10,000 ppmw with a 
total facility HAP load of 1 Mg/yr or greater; or
    The final standards require that air emissions from wastewater 
collection systems be suppressed and that wastewater is treated. 
Compliance is demonstrated by one of the following methods:
    1. Using an enhanced biotreatment system for soluble HAP;
    2. Demonstrating removals achieving 99 percent by weight of 
partially soluble HAP compounds, and 90 percent by weight of soluble 
HAP 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 in an incinerator combusting a mixture of 
wastes. The final standards require the same applicability and control 
requirements described above for existing sources and 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 PMPU, or facility).
    A de minimis HAP concentration and flow rate exemption was added to 
today's final rule. Streams containing less than 5 ppmw of partially 
soluble and/or soluble HAP and a total yearly load of 0.05 kg/yr of 
partially soluble and/or soluble HAP are not considered wastewater, and 
thus, are exempted from the wastewater provisions in today's final 
rule.

G. Equipment Leaks

    Today's final rule contains revisions to the proposed equipment 
leak requirements that were originally based on subpart H (of the HON 
rule). The final rule primarily contains changes to the standards for 
valves and connectors in gas/vapor service and light liquid service. 
The standards for valves in gas/vapor service and in light liquid 
service were changed as follows: the requirement to implement a quality 
improvement program and all references to Sec. 63.175 have been 
removed; an allowance for monitoring every 2 years for those processes 
with less than 0.25 percent leaking valves has been added; an allowance 
for valve subgrouping was also added; the equation used to determine 
the percent of leaking valves in a process was changed to eliminate the 
optional credit for valves removed, Vc; and the rolling average of 
leaking valves was revised so that it is calculated as an average of 
the last 3 monitoring periods for annual or biannual monitoring 
programs. The monitoring schedule for connectors in gas/vapor service 
and light liquid service was revised to allow for decreased monitoring 
for those components with the lowest leak rates. For leak rates less 
than 0.25, the monitoring frequency for connectors is

[[Page 50286]]

now once every 8 years. Finally, the equipment leak provisions were 
removed from appendix GGGA to Section 63.1255.

H. Pollution Prevention Alternative

    Today's final standards include a pollution prevention (P2) 
alternative standard that meets the MACT floor for existing sources and 
can be implemented in lieu of meeting the requirements for existing 
process vents, storage tanks, wastewater streams and equipment leaks. 
The P2 alternative only applies to existing sources and includes two 
options which are shown in Table 2. Under option 1, owners or operators 
can satisfy the requirements for all emission source types associated 
with each pharmaceutical manufacturing process unit (PMPU) by 
demonstrating that the production-indexed consumption of HAP has 
decreased by at least 75 percent from a baseline set no earlier than 
the 1987 calendar year. The production indexed HAP consumption factor 
is expressed as kg HAP consumed/kg product produced. Under the second 
P2 option, owners or operators must demonstrate at least a 50 percent 
reduction in the production indexed HAP consumption factor, plus an 
additional amount of reduction in HAP emissions through the use of add-
on controls, such that the overall reduction in HAP emissions is at 
least 75 percent from the baseline period.

                    Table 2.--Alternative P2 Standard                   
------------------------------------------------------------------------
            Option                      Description of P2 option        
------------------------------------------------------------------------
1.............................  Demonstrate at least a 75 percent       
                                 reduction in the kg consumption/kg     
                                 production factor from a baseline      
                                 period.                                
2.............................  Demonstrate at least a 50 percent       
                                 reduction in the kg/kg factor, plus an 
                                 additional reduction from add-on       
                                 control equivalent to at least a 75    
                                 percent overall reduction in the kg/kg 
                                 factor from baseline.                  
------------------------------------------------------------------------

    The following restrictions also apply to the pollution prevention 
standards in today's final rule. For any reduction in the production-
indexed HAP consumption factor that is achieved by reducing a HAP that 
is also a VOC, an equivalent reduction in the production-indexed VOC 
consumption factor is required. For any reduction in the production-
indexed HAP consumption factor that is achieved by reducing a HAP that 
is not a VOC, the production-indexed VOC consumption factor may not be 
increased. Also, the final rule allows owners or operators of PMPU's 
that generate HAP emissions to qualify for the pollution prevention 
alternative, provided that the HAP emissions generated in the PMPU are 
reduced to the required levels for process vents, storage tanks, 
wastewater streams and equipment leaks specified in Secs. 63.1252 
through 63.1256 of today's final standards. The baseline production-
indexed HAP and VOC consumption factors must be based on consumption 
and production values averaged over the time period from startup of the 
process until the present time (assuming the process has been in 
operation at least 1 full year), or the first 3 years of operation 
(beginning no earlier than 1987), whichever is the lesser time period. 
Processes that began operation after April 2, 1997 are not eligible for 
the P2 alternative.
    Today's final standards also require owners and operators complying 
with the P2 standard to submit a P2 Demonstration Summary as part of 
the Precompliance Notification Report that describes how the P2 
alternative will be applied at their facilities. The minimum data 
requirements for the P2 Demonstration Summary are listed in 
Sec. 63.1257(f) of today's final rule.

I. Heat Exchange Provisions

    Today's final standards for heat exchange systems are unchanged 
from proposal. Owners or operators must comply with the heat exchange 
provisions listed in the HON at Sec. 63.104 with two exceptions: (1) 
the monitoring frequency shall be no less than quarterly, and (2) 
owners or operators of heat exchange systems that 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 around reactors.

J. Emissions Averaging Provisions

    The emissions averaging provisions in today's final rule are 
unchanged from proposal. The final rule allows emissions averaging 
among process vents and among storage tanks at existing sources. 
Restrictions on the use of emissions averaging are listed in 
Sec. 63.1252(d) of today's final rule and are essentially the same as 
those contained in the HON. The alternative standard (see following 
section K) is not to be included in the emissions averaging provisions 
and/or calculations.

K. Alternative Standard

    For owners or operators of affected sources that treat emissions 
with an add-on control device, an alternative standard has been added 
under Secs. 63.1253(d) (storage tanks) and 63.1254(c) (process vents). 
To comply with today's alternative standard(s), the control device must 
achieve an outlet, undiluted TOC concentration, as calibrated based on 
methane or the predominant HAP, of 20 ppmv or less and a hydrogen 
halide and halogen concentration of 20 ppmv or less, as demonstrated 
through the test methods and procedures in Sec. 63.1257 and monitoring 
provisions in Sec. 63.1258. The applicability level is the control unit 
and all sources vented to the control unit which is considered one 
regulated entity. Because the applicability of this standard is focused 
on the control device, this scenario is considered one regulated entity 
with regard to the number of violations that would apply if there is an 
exceedance of the 20 ppmv TOC and 20 ppmv hydrogen halide and halogen 
outlet concentration limit(s). The remaining process vents within a 
process not controlled by the alternative standard must be controlled 
to the percent reduction required by the standards.

L. Test Methods and Compliance Procedures

    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/yr, 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/yr, tests are 
required to determine the reduction efficiency of each device. 
Performance test provisions require testing under worst-case 
conditions, but the final rule provides flexibility in determining 
these worst-case conditions. Control devices that have previously been 
tested under conditions required by this standard and condensers are 
exempt from emissions testing. Testing is not required for devices used 
to control emission streams from storage or wastewater sources 
exclusively. However, if testing is conducted, then the same methods 
apply.

M. Monitoring Requirements

    Monitoring is required in the final rule to determine whether a 
source is in compliance on an ongoing basis. This monitoring is done 
either by continuously measuring emission

[[Page 50287]]

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 a single point at either a minimum or 
maximum value established for a control device that, if achieved on a 
daily average or block 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 operating limits. These 
parameters are required to be monitored at 15-minute intervals 
throughout the operation of the control device for devices controlling 
greater than 1 tons/yr. 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 6 months prior to 
the compliance date of the standard. The monitoring requirements apply 
to all control devices, even those used exclusively for storage tanks 
or wastewater sources.

N. Recordkeeping and Reporting Requirements

    Table 1 to subpart GGG was revised to clarify the specific 
requirements of the final rule and the referenced requirements in the 
General Provisions. A summary column describing the requirements of 
each part of the General Provisions has been added to Table 1 and 
additional comments address wording issues and exceptions to the 
General Provisions language.

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

    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.

A. Air Impacts

    Today's final standards will reduce HAP emissions from existing 
sources by 22,000 Mg/yr (24,000 tons/yr) from the baseline level, a 
reduction of 65 percent from baseline, and 75 percent from 
uncontrolled. These reductions also will occur if facilities elect to 
implement the alternative pollution prevention standard. Since many of 
the HAP emitted by the pharmaceutical industry are also VOC, today's 
final standards also will reduce VOC emissions.

B. 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. The EPA 
estimates that an average of 900 tons of solid waste per year per 
facility will be generated as a result of today's final standards. 
However, biological treatment is a possible means of compliance.

C. Energy Impacts

    Today's final standards for the pharmaceuticals source category 
will require an additional energy usage of 2,400  x  10\9\ British 
thermal units per year (Btu/yr).

D. Cost Impacts

    The emission reductions required by this regulation can be achieved 
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 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 $64 million and 
$11 million, respectively (1998 dollars). To estimate these annual 
costs, capital costs were annualized over 10 years (with no delay for 
installation). (The annual costs presented in the preamble to the 
effluent limitations guidelines and standards are lower than the above 
costs because they are based on a longer annualization period. Costs 
for the effluent guidelines limitations and standards are annualized 
over 16 years (a 1-year installation period plus a 15-year project 
life). As a result, annual costs for existing sources in the preamble 
to the effluent limitations guidelines and standards (referred to as 
pretax annualized costs for the MACT standards rule for all facilities) 
are reported at $58.4 million.) The EPA believes that monitoring, 
reporting, and recordkeeping costs will be substantially reduced for 
those facilities that choose to comply with today's final rule through 
either the P2 option or the alternative standard of 20 ppm TOC and 20 
ppm hydrogen halides and halogens.

E. Economic Impacts

    The economic impact analysis of this standard shows that the 
estimated price increase from compliance with the recommended standards 
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. Major Comments and Changes to the Proposed Standards

    In response to comments received on the proposed standards, changes 
have been made to the final standards. While some of these changes are 
clarifications designed to make EPA's intent clearer, many of them are 
significant changes to the requirements of the proposed standards. A 
summary of the substantive comments and/or changes made since proposal 
are described in the following sections. Detailed responses to public 
comments are included in the promulgation BID: Summary of Public 
Comments and Responses (Docket Item No. V-B-01). Additional information 
on the final standards is contained in the docket for this rulemaking 
(see ADDRESSES section of this preamble).

A. Applicability Provisions and Definitions

1. General Applicability: Definition of Pharmaceutical Product
    At proposal, pharmaceutical product was defined as ``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.'' Many commenters stated that, based on the 
proposed definition of pharmaceutical product, the general 
applicability of the standard is too broad, ambiguous, and

[[Page 50288]]

appears to overlap with other MACT standards that cover the chemical 
industry. Comments on the definition of pharmaceutical product focused 
on the following four areas: (1) the use of Standard Industrial 
Classification (SIC) codes, (2) the scope of products regulated by the 
FDA, (3) the meaning of the term ``intermediates,'' and (4) the 
exclusion of specific products/processes.
    Many commenters suggested that instead of referencing SIC code 283, 
the definition of pharmaceutical product should be narrowed to include 
only SIC codes 2833 and 2834 because facilities classified under these 
two SIC codes produce pharmaceuticals as their primary product, and 
were the source of information and data that formed the basis for the 
proposed rule. Two other commenters stated that the use of SIC codes or 
the new North American Industrial Classification System (NAICS) codes 
in defining pharmaceutical products was inappropriate because of the 
ambiguous nature of SIC and NAICS code applicability, and that instead 
of using SIC or NAICS codes, the definition should clearly describe the 
characteristics of the processes that are subject to the rule. One of 
the commenters also provided a recommended definition of pharmaceutical 
product based upon the definition of ``drug product'' already 
established by the Food and Drug Administration at 21 CFR 210.3 
(Current Good Manufacturing Practice in Manufacturing, Processing, 
Packing, or Holding of Drugs).
    Many commenters stated that the inclusion of the phrase, 
``regulated by the Food and Drug Administration'' should be deleted 
from the definition of pharmaceutical products because many nondrug 
products such as cosmetics, food additives, plastics (food contact 
films) and dietary supplements, are regulated by the FDA and could be 
interpreted as being pharmaceutical products based on the proposed 
definition of pharmaceutical product. However, another commenter 
requested that EPA expand the definition of pharmaceutical products to 
include products regulated by the U.S. Department of Agriculture (USDA) 
as well as the FDA because the pharmaceutical industry produces animal 
biologics using the same processes used to produce human biologics, and 
therefore, HAP emitted from the production of animal biologics also 
should be regulated as part of the pharmaceutical NESHAP.
    Many commenters stated that the use of the term ``intermediates'' 
in the definition of pharmaceutical product was confusing and brings 
many unintended chemicals and processes into the pharmaceutical NESHAP; 
and therefore, the term should be either clarified or deleted from the 
definition of pharmaceutical product. One commenter stated that 
inclusion of the term, ``intermediate,'' in the definition of 
pharmaceutical product makes it unclear how far back in the 
manufacturing chain a regulated entity must look when determining 
applicability. Many commenters stated that operations that manufacture 
raw materials (such as acids and solvents) that are not precursors to 
active ingredients in pharmaceutical products should not be regulated 
as part of the pharmaceutical NESHAP. Several commenters stated that 
the rule should only apply to processes which produce materials which 
exclusively or primarily are used to make drug active ingredients. 
Another commenter stated that EPA needs to clarify that intermediates 
already regulated by the HON are excluded from the pharmaceutical 
NESHAP.
    Four commenters requested that EPA specifically exclude certain 
``nonpharmaceutical products'' from the definition of pharmaceutical 
product. One commenter expressed concern that due to the inclusion of 
SIC code 2835 and the phrase, ``regulated by the FDA,'' in the 
pharmaceutical product definition, equipment used to manufacture 
medical devices or substances used in the manufacture of medical 
devices could be subject to the pharmaceutical NESHAP instead of the 
miscellaneous organic NESHAP (MON). Therefore, the commenter requested 
that ``medical devices'' be specifically excluded from the definition 
of pharmaceutical product. A second commenter stated that the rule 
should not apply to specialty chemical manufacturers who occasionally 
engage in tolling a pharmaceutical intermediate. The commenter further 
stated that tolling of pharmaceutical intermediates could be driven 
overseas if U.S. specialty chemical opera tions require long lead times 
to identify MACT requirements, develop compliance systems, and amend 
title V requirements. A third commenter suggested that EPA exclude 
contract manufacturing from the pharmaceutical rule, and allow it to be 
covered by the MON. The fourth commenter requested that EPA 
specifically exclude ``color additives and other inactive ingredients'' 
from the definition of pharmaceutical product because the commenter 
interpreted EPA's exclusion of excipients from the definition of 
pharmaceutical product to mean that the pharmaceutical NESHAP was only 
intended to cover active ingredients. The fourth commenter also 
provided a definition of excipients developed by the International 
Pharmaceutical Excipients Council.
    The EPA considered all of the above comments and revised the 
definition of pharmaceutical product based on these and other 
considerations. The rationale for the revised definition is presented 
below.
    The EPA agrees with the commenters that SIC codes may be ambiguous, 
were not developed with environmental regula tion in mind, and may not 
reflect individual processes within a facility, and therefore, that the 
use of SIC codes to define pharmaceutical product may introduce 
unintended ambiguity into applicability determinations. Also, EPA 
believes that the use of the newer NAICS codes in defining 
applicability would result in the same problems with ambiguity and 
intended use. However, based on industry survey responses, EPA 
recognizes that facilities primarily claiming SIC codes 2833 and 2834 
and/or NAICS codes 325411 and 325412 produce medicinals and 
pharmaceuticals as their primary products. Therefore, for the sake of 
clarity and consistent with the survey responses, EPA has retained the 
SIC Codes and added the NAICS codes in the definition of pharmaceutical 
product.
    The EPA also agrees that the term ``regulated by FDA'' is also 
ambiguous. As noted by one commenter, in 21 CFR section 207.10(e), FDA 
exempts from registration and drug listing, ``manufacturers of harmless 
inactive ingredients that are excipients, coloring, flavorings, 
emulsifiers, lubricants, preservatives, or solvents that become 
components of drugs, and who otherwise would not be required to 
register under this part.'' The EPA agrees that some of the processes 
used to manufacture such substances were not intended for coverage by 
this rule, and that was the intent of including the phrase ``regulated 
by FDA'' in the definition of pharmaceutical product in the proposed 
rule. Based on the comments, EPA believes that a less ambiguous way to 
define pharmaceutical product would be to base it on definitions 
contained in 21 CFR 210.3 (Current Good Manufacturing Practice in 
Manufacturing, Processing, or Holding of Drugs; General) for drug 
product or active ingredient. These definitions capture formulation 
products as well as pharmaceutical active ingredients and their 
precursors.

[[Page 50289]]

    The proposed rule also was intended to cover intermediates that are 
manufactured prior to the final processing steps in which a compound 
becomes a pharma ceutical product. However, EPA recognizes the 
difficulty associated with defining an intermediate, especially the 
point at which a chemical becomes associated with pharma ceutical 
manufacturing. Because the pharmaceutical industry is characterized by 
numerous processes that may be conducted prior to the actual synthesis 
and isolation of active ingredients, EPA rejects the notion that, in 
order to simplify applicability, only those processes yielding active 
ingredients should be covered by the rule. Rather, EPA agrees with the 
suggestion that the rule be based on the primary intended use of the 
materials manufactured. By defining applicability according to primary 
use as pharmaceutical products or as their precursors, intermediates 
that are further processed to become active ingredients or drug 
components are covered. Therefore, in order to clarify the boundaries 
of the coverage of such precursors or intermediates, the definition of 
process was changed in the final rule to clarify that the provisions of 
the subpart apply to materials whose ``primary use'' is as a 
pharmaceutical product or precursor.
    The ``primary use'' approach also addresses the comment regarding 
the exclusion of contract manufacturing from the pharmaceutical rule. 
Simply put, contract manufacturers will be subject to this standard 
during periods when they manufacture a pharmaceutical product. To 
simplify the determination of applicability for facilities that conduct 
contract manufacturing, some commenters suggested that the rule apply 
to processes whose primary product is a pharmaceutical active 
ingredient. The concept of primary product has been used in past 
regulations (e.g., HON, P&R IV, etc.) and was not considered in the 
proposed rule because there was a conscious effort to disengage 
production equipment from products manufactured. Because the standards 
are process-based, the intent of the proposal was to cover the 
production of pharmaceutical products, regardless of what pieces of 
equipment were used to manufacture them in the course of a year. 
Conceptually, the primary product definition makes sense for process 
lines that can be used to manufacture more than one product. In the 
pharmaceutical manufacturing industry, however, process equipment is 
reconfigured such that the same pieces of equipment may not always be 
part of the same process line. Under the current concept of primary 
product that appears in other rules, it would still be difficult to 
determine the primary product of a nondedicated process, because not 
all the same equipment would be associated with the ``process.'' 
However, by reverting back to the concept of ``primary use,'' owners 
and operators can clearly delineate applicability based on the intended 
use of materials they manufacture, and not the equipment they are 
manufactured in.
    The revised definition for pharmaceutical product in today's final 
rule borrows heavily from definitions contained in 21 CFR 210.3 
(Current Good Manufacturing Practice in Manufacturing, Processing, or 
Holding of Drugs; General). The revised definition of pharmaceutical 
product and a new definition for primary use are shown below. Also, 
definitions for ``active ingredient,'' ``component,'' and ``excipient'' 
have been included in today's final rule.
    Pharmaceutical product means: (1) any material described by the 
standard industrial classification (SIC) code 2833 or 2834; (2) any 
material whose manufacturing process is described by the north american 
industrial classification system (NAICS) code 325411 or 325412; (3) a 
finished dosage form of a drug, for example, a tablet, capsule, 
solution, etc., that contains an active ingredient generally, but not 
necessarily, in association with inactive ingredients; or (4) any 
component whose intended primary use is to furnish pharmacological 
activity or other direct effect in the diagnosis, cure, mitigation, 
treatment, or prevention of disease, or to affect the structure or any 
function of the body of man or other animals (the term does not include 
excipients, but includes drug components such as raw starting materials 
or precursors that undergo chemical change or processing before they 
become active ingredients).
    Primary use means the single largest use of a material.
    For reasons described above and in response to related comments, 
the applicability language in Sec. 63.1250(a) also has been changed in 
the final rule such that the rule only applies to those pharmaceutical 
manufacturing operations that meet the following criteria: (1) they 
manufacture a pharmaceutical product, as defined in section 63.1251, 
(2) they are located at a plant site that is a major source as defined 
in section 112(a) of the Act, and (3) they process, use, or produce 
HAP. The third criterion was included in response to one commenter's 
concern that, while the rule covers all processes at a facility which 
is determined to be major source, some processes at those major sources 
do not emit HAP. The commenter also stated that although this situation 
may not pose a significant compliance problem, the lack of an exclusion 
for these non-HAP emitting processes posed an unwarranted regulatory 
burden. The EPA agreed with the commenter, and modified the 
applicability of the rule as described above.
2. Definition of PMPU and Pharmaceutical Manufacturing Operations
    The EPA received several comments on the proposed definitions of 
PMPU and pharmaceutical manufacturing operations. At proposal, PMPU was 
defined as ``any processing equipment assembled to process materials 
and manufacture a pharmaceutical product and associated storage tanks, 
waste-water 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 were defined to ``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.''
    One commenter stated that having both ``pharmaceutical 
manufacturing operation'' and PMPU in the proposed rule was confusing 
and redundant. The commenter stated that by having both terms, the rule 
implies that the definition of PMPU does not cover all of the equipment 
to be regulated by subpart GGG. The commenter further stated that the 
inclusion of the phrase ``associated equipment'' in the pharmaceutical 
manufacturing operations definition was unclear because the definition 
of PMPU already covers ``associated'' equipment. The commenter also 
stated that heat exchangers were given as an example of ``associated 
equipment'' under the definition of pharmaceutical manufacturing 
operation, but not included as an example in the definition of PMPU. 
For these reasons, the commenter suggested that the definition of 
pharmaceutical manufacturing operation be deleted entirely, and that 
heat exchangers be added to the list of examples of ``associated 
equipment'' in the PMPU definition.

[[Page 50290]]

    Two commenters stated that wastewater management units should not 
be included in the definition of PMPU. One commenter stated that 
wastewater management units are not subject to the standard, but 
instead are used to comply with the standard. This commenter also 
pointed out that neither the HON's definition of chemical manufacturing 
process unit (CMPU) nor the Polymers and Resin I NESHAP definition of 
elastomer product process unit (EPPU) includes wastewater management 
units. The commenter further stated that including wastewater 
management units in the definition of PMPU could be interpreted to 
require new source MACT at an existing wastewater management unit if a 
new, major, dedicated PMPU is built that will contribute wastewaters to 
that unit. Another commenter stated that packaging operations (e.g., 
``placement of dose forms, such as tablets, into containers, and 
assembly, closure, and labeling of these containers'') are not 
pharmaceutical manufacturing operations, and thus, should be explicitly 
excluded from the definition of pharmaceutical manufacturing 
operations.
    Many commenters stated that the definition of PMPU should be 
modified to make it clear that a PMPU is a group of equipment. These 
commenters were concerned that, as written, the definition of PMPU 
could be interpreted to mean that an individual piece of equipment 
constitutes a PMPU, and thus, the addition of a single piece of 
equipment to an existing dedicated process line could trigger new 
source MACT.
    Many commenters stated that a PMPU should be identified by its 
primary product and suggested adding language to the definition that 
makes it clear that PMPU's manufacture pharmaceutical products as their 
primary product.
    After consideration of the above comments on the definitions of 
pharmaceutical manufacturing operations and PMPU, EPA has decided to 
retain both terms, but with some modifications. The terms 
``Pharmaceutical Manufacturing Operations'' and ``Pharmaceutical 
Manufacturing Process Unit (PMPU)'' were not intended in the proposed 
rule to refer to the same sources entirely. While the term 
``Pharmaceutical Manufacturing Operations'' is the broadest term used 
in the rule and covers all emission sources within a given facility 
that are the direct or indirect result of pharmaceutical manufacturing, 
the term ``PMPU'' was intended to encompass each process unit within 
the facility and its associated equipment. Therefore, the 
pharmaceutical manufacturing operations encompasse all PMPU's at a 
given facility as well as equipment that is not included in individual 
PMPU's. In the proposed rule, the PMPU was used exclusively to define 
new source applicability in Sec. 63.1250(c). In today's final rule, 
PMPU's also have replaced ``processes'' in the pollution prevention 
standard, and therefore, PMPU's serve several functions in the final 
rule. The PMPU also serves as the basis of the wastewater cutoffs for 
the standard, at 1 Mg/yr applicability HAP load per PMPU. The EPA 
believes that the broader term for pharmaceutical manufacturing 
operations is necessary to include sources that cannot be associated 
with single PMPU's.
    By including wastewater management units in the definition of PMPU 
at proposal, EPA intended that all wastewater streams and residuals 
would be considered part of the PMPU. The EPA reviewed the definition 
of process and PMPU for consistency with the HON and other MACT 
standards. Wastewater management units are subject to the standard, but 
manage wastewater from several PMPU. However, wastewater generated in a 
PMPU is not specifically defined as part of the PMPU, but rather can be 
associated with it. This convention is analogous to process vent 
emissions; although they are not specifically identified as part of the 
PMPU, a PMPU may generate process vent emissions. In deciding whether 
the PMPU has the potential to emit 10 or 25 tons of HAP, all emissions 
from all sources associated with the PMPU, including process vents and 
wastewater, must be considered. Therefore, the definition of PMPU was 
modified to not specify wastewater streams, residuals, and wastewater 
management units, as part of the PMPU.
    Although EPA recognizes that rarely will one piece of equipment 
comprise a PMPU, the Agency disagrees with the commenters that a PMPU 
must always be defined as a group of equipment. The definition of PMPU 
in today's final rule, however, includes the term, ``process'' which is 
defined as a ``logical grouping of processing equipment which 
collectively function to produce a pharmaceutical product'' and ``may 
consist of one or more unit operations.'' However, a PMPU is not always 
associated with specific groupings of equipment associated with a given 
process. (See also section VI.A.3 of this preamble and Sec. 63.1252 of 
the final rule for a complete definition of process.)
    In response to suggestions that EPA define a PMPU by its primary 
product, the EPA has included a primary use concept in the definition 
of pharmaceutical product in the final rule as discussed previously in 
section VI.A.1, above. Based on the comments discussed above and 
related comments, the definitions of PMPU and pharmaceutical 
manufacturing operations in today's final rule are as follows:
    Pharmaceutical manufacturing process unit (PMPU) means the process, 
as defined in this subpart, and any associated storage tanks, equipment 
identified in Sec. 63.1252(f), and 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 means the facility-wide 
collection of PMPU's and any other equipment such as heat exchanger 
systems or cooling towers, that are not associated with an individual 
PMPU, but that are located at a facility for the purpose of 
manufacturing pharmaceutical products and are under common control.
3. Definition of Process
    The EPA received a number of comments on the proposed definition of 
process. At proposal, process was defined as ``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 purposes 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.''
    Many commenters requested that the definition of process be 
clarified to indicate that Quality Assurance and Quality Control (QA/
QC) laboratories are not considered part of the process. These 
commenters were concerned that, although it may be clear that QA/QC 
labs are not ``processing equipment'' or ``an activity or an operation 
used to produce a product,'' the words, ``or

[[Page 50291]]

other activity, operation,'' may lead to confusion as to whether QA/QC 
labs are part of the process. The commenters suggested that EPA 
explicitly exclude QA/QC labs from the definition of process because 
QA/QC laboratories emit insignificant quantities of HAP, and therefore, 
time-consuming nonapplicability demonstrations could be avoided.
    Several commenters recommended that EPA include storage tanks in 
the definition of process so that sources that choose to comply using 
the pollution prevention alternative are not exempted from the storage 
tank requirements in Sec. 63.1252(b) of the proposed rule. The 
commenters stated that emissions from storage tanks may be significant, 
and that sources should be required to comply with the storage tank 
standards under all circumstances.
    Many commenters requested that EPA modify the definition of process 
to clarify how the process vent provisions will apply to formulation 
facilities. These commenters were concerned that the use of the term 
``nondedicated'' in reference to formulation facilities results in 
confusion as to how to apply the standard. The commenters pointed out 
that, unlike equipment used in pharmaceutical chemical synthesis 
facilities, equipment in a formulation facility are only used to 
formulate products, and therefore, formulation facilities are 
``dedicated'' to formulation operations. However, the commenters also 
pointed out that the equipment at the formulation facility is used to 
produce many different products, and therefore, is ``nondedicated.'' 
For these reasons, the commenters recommended that, for formulation 
operations, the term, ``nondedicated,'' be applied to the equipment 
within the facility and not the facility itself. The commenters also 
requested that for formulation operations, EPA limit the definition of 
process to formulation activities within a contiguous area (such as a 
formulation building or a contiguous area within a multipurpose 
building in which formulation takes place). The commenters cited 
examples where separate formulation operations are located at the same 
plant site, but are physically separate, and thus would require 
separate emission control systems.
    Another commenter was concerned that use of the term 
``nondedicated'' could be interpreted as including solvent recovery or 
formulation operations that process small quantities of pharmaceutical-
related materials, but whose primary use is for a process subject to 
another MACT rule. The commenter recommended that this issue be 
resolved by (1) deleting the term ``nondedicated'' from the proposed 
definition of process, and (2) adding the phrase, ``whose primary use 
is associated with the manufacture of pharmaceutical products'' after 
the word ``operations'' in the last sentence of the proposed definition 
of process.
    One commenter suggested that the phrase ``or isolated 
intermediate'' (used throughout the definition) be deleted because 
``processes produce products,'' but ``portions of processes produce 
intermediates.'' The commenter further explained that although the 
product of one process may be used as a raw material in another 
process, the product serving as the raw material is not typically 
thought of as an intermediate.
    The EPA has modified the definition of process in the final rule in 
response to the comments described above. The EPA agrees with the 
commenters that QA/QC laboratories are not part of the process, and the 
definition of process in the final rule excludes QA/QC laboratories.
    To clarify EPA's intention that storage tanks be included as part 
of the pollution prevention alternative, and in response to the 
comments regarding the perceived exclusion of storage tanks from the P2 
alternative, today's final rule includes storage tanks in the 
definition of PMPU and refers to PMPU's instead of ``processes'' in the 
pollution prevention provisions (see also section V.A.2 of this 
preamble--Definition of PMPU and Pharmaceutical Manufacturing 
Operations, and section VI.F--Pollution Prevention Alternative).
    The EPA disagrees with the commenters who believe that the term, 
``nondedicated,'' as applied to formulation facilities, should be 
applied to the equipment within the facility and not to the facility 
itself. As explained in section VI.A.1 of this preamble, the 
pharmaceutical NESHAP regulates processes, not equipment, and the 
concept of primary use is applied to the pharmaceutical product, not to 
the equipment used to manufacture the product. However, today's final 
rule clarifies the intent of the proposed rule with regard to 
formulation and solvent recovery operations: those operations occurring 
within a contiguous area are to be considered as single processes, 
regardless of the final product of that formulation or recovery 
operation.
    The EPA agrees with the suggestions provided by one commenter to 
delete all references to ``isolated intermediate'' and has incorporated 
these comments into the definition of process in the final rule. Also, 
the definition of pharmaceutical product in the final rule (see section 
VI.A.1--General Applicability: Definition of Pharmaceutical Product) 
states that pharmaceutical product ``includes drug components such as 
raw starting materials or precursors that undergo chemical change or 
processing before they become active ingredients.'' Therefore, drug 
components such as raw materials and precursors, which are themselves 
products of processes, are defined as products, rather than 
``intermediates,'' thus eliminating the need for the concept of 
``intermediates'' (see also section VI.A.6--Definition of Isolated 
Intermediate).
    For the reasons stated above, the definition of ``process'' in 
today's final rule is as follows:
    Process means all equipment which collectively function to produce 
a pharmaceutical product. A process may consist of one or more unit 
operations. For the purposes 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 pharmaceutical product. Cleaning operations are considered 
part of the process. The holding of the pharmaceutical product in tanks 
or other holding equipment for more than 30 consecutive days, or 
transfer of the pharmaceutical product to containers for shipment, 
marks the end of a process, and the tanks are considered part of the 
PMPU that produced the stored material. When material from one unit 
operation is used as the feedstock for the production of two or more 
different pharmaceutical products, the unit operation is considered the 
endpoint of the process that produced the material, and the unit 
operations into which the material is routed mark the beginning of the 
other processes. Nondedicated recovery devices located within a 
contiguous area within the affected source are considered single 
processes. Nondedicated formulation operations occurring within a 
contiguous area are considered single processes. Quality Assurance and 
Quality Control laboratories are not considered part of any process.
    The revised definition of process provided above clarifies when a 
process ends. The EPA selected 30 days as a reasonable period of time, 
beyond which, if a material has not been further processed or reacted, 
a process can be considered complete for the purposes of this subpart. 
Applicability determinations and control requirements would be more 
difficult without such a time frame. The definition of process is a key 
element of the rule because most of the

[[Page 50292]]

applicability and compliance determinations are based on the process, 
as a unit. Because of concerns that processes could be artificially 
divided into smaller portions of processes in order to meet the 2,000 
lb/yr limit, EPA limited the number of processes per facility that can 
comply with the 2,000 lb/yr limit to seven per year. However, EPA also 
added that processes with very low emissions (less than 100 lb/yr HAP, 
uncontrolled) would not be counted as part of the seven process limit. 
These limitations and exemptions are currently under review and may be 
revised at a later time.
4. Definition of Process Vent
    The EPA received several comments on the proposed definition of 
process vent, primarily related to the following two issues: (1) the 
establishment of a de minimis level or cutoff below which controls 
would not be required and (2) how the rule applies to process vents 
that are manifolded together. At proposal, process vent was defined as 
``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).''
    Many commenters requested that EPA modify the definition of process 
vent to exempt any vent that contains a gas stream with less than 50 
ppmv HAP averaged over the unit operation. These commenters cited 40 
CFR part 63.113(g) of the HON, which exempts vents with less than 50 
ppmv from monitoring or any other provisions of sections 63.114 through 
63.118. One of these commenters provided a cost analysis, using EPA's 
recently released biofilter cost model, for an existing fermentation 
operation, the emissions from which typically contain less than 50 ppmv 
methanol. The cost effectiveness of biofiltration for this scenario was 
estimated to be $27,000/Mg, with a percent control of 60 percent (i.e., 
from 50 ppmv to 20 ppmv, EPA's established practical limit of control), 
a value that the commenter stated was ``clearly unreasonable.'' The 
commenter further stated that for fermenter and fermenter preparation 
vents, a cutoff of 100 to 200 ppmv could be justified (as opposed to 50 
ppmv) and requested that EPA consider such a cutoff.
    Two commenters stated that the proposed definition of process vent 
implies that every process vent is connected to a single piece of unit 
operations equipment, which often is not the case at multiproduct, 
multibatch facilities. One of the commenters suggested that the 
definition include a statement indicating that ``multiproduct 
facilities having multiple production trains may have large numbers of 
process vents, which could discharge directly to the atmosphere; 
discharge through a dedicated control equipment; or which can be 
manifolded from many process units into a common header leading to a 
common control equipment.'' The other commenter stated that compliance 
with the process vent standards would be more difficult and expensive 
if the definition of process vent included the combined or commingled 
vents from several pieces of unit operations equipment, rather than 
just one piece of equipment. This commenter also questioned if standard 
industrial hygiene type exhaust pickups and general room ventilation 
exhaust points are meant to be included in the definition of process 
vents. The commenter pointed out that those types of systems may 
exhaust through a stack, which may be interpreted as being an emission 
point, but noted that some states do not consider these emission points 
for the purposes of Title V permits. The commenter stated that, if 
these emission points were not considered in developing the MACT 
floors, they should not be included as process vents, and requested 
clarification from EPA.
    As explained in section VI.C of this preamble, the definition of 
process vent in today's final rule includes a de minimis cutoff for 
uncontrolled and undiluted vent streams of 50 ppmv HAP. Regarding 
multiple vents (from the same process) being manifolded together into a 
common header, the Agency considers the common header in this rule to 
be a single process vent, and has revised the definition of process 
vent to reflect this view. In response to one commenter's question 
about whether or not industrial hygiene exhausts and general room 
ventilation exhausts would meet the definition of process vent, these 
sources would not be considered process vents if they are under the 50 
ppmv HAP cutoff. Based on the changes discussed above, the definition 
of process vent in the final rule is as follows:
    Process vent means a vent from a unit operation or vents from 
multiple unit operations within a process that are manifolded together 
into a common header, 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. Emission streams 
that are undiluted and uncontrolled containing less than 50 ppmv HAP, 
as determined through process knowledge, test data using Methods 18 of 
40 CFR part 60, appendix A, or any other test method that has been 
validated according to the procedures in Method 301 or appendix A of 
this part, are not considered process vents. Process vents do not 
include vents on storage tanks regulated under Sec. 63.1253, vents on 
wastewater emission sources regulated under Sec. 63.1256, or pieces of 
equipment regulated under Sec. 63.1255.
5. Definition of Process Condenser
    The EPA received numerous comments on the proposed definition of 
process condenser. These comments primarily dealt with the dual role of 
condensers as both process condensers and air pollution control 
devices, and in which category recirculating condensation systems 
should be class ified. At proposal, process condenser was defined as 
``a condenser whose primary purpose is to recover material as an 
integral part of a unit operation. The condenser must support vapor-to-
liquid phase change for periods of source equipment operation that are 
above the boiling or bubble point of substances(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.''
    Many commenters took issue with the phrase ``integral part of a 
unit operation'' and ``process condensers in line prior to the vacuum 
source.'' These commenters cited examples where it could be concluded 
that a condenser is not integral to a process because it does not 
perform any necessary process function. The commenters also stated that 
if there were two condensers in series prior to a vacuum source, and 
the first condenser effected a phase change, then the second condenser 
should be considered an air pollution control device, even though it is 
located ``prior to a vacuum source.''
    Three commenters suggested that the intended use be considered when 
determining whether a condenser is a process condenser or an air 
pollution control device. Two of these commenters stated that, ``if the 
condenser is acting as a control unit, so

[[Page 50293]]

that its presence is intended to prevent chemicals from reaching the 
uncontrolled environment; if the materials collected are led towards 
management and disposal systems; and if the collected materials are in 
no way used, reused, nor sold for fuel value, then the condenser is 
serving as a control unit regardless of the fact that the bubble point 
is met or not at the source.'' The other commenter disagreed with the 
condition that to be a process condenser, 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 the substance(s). This 
commenter pointed out that under the proposed definition, the same 
condenser will sometimes be a process condenser and sometimes an air 
pollution control device, and tracking when the condenser switches from 
one to the other would be burdensome. Therefore, the commenter 
recommended that the facility which operates the condenser (and knows 
the process best) be allowed to determine whether it is a process 
condenser or an air pollution control device.
    Another commenter suggested that EPA distinguish between process 
condensers and condensers serving as air pollution control devices by 
including a specific temperature limit (i.e., 20 deg.C) such that 
condensers that lower the temperature of the exit gas stream to a 
colder temperature would be considered air pollution control devices 
instead of process condensers.
    Many commenters requested that EPA specifically address process 
condensers that belong to recirculating drying systems. Most commenters 
stated that condensers in recirculating drying systems should be 
considered pollution control devices. However, one commenter stated 
that recirculating condensation systems should be defined as neither 
process condensers nor air pollution control devices, but defined 
separately, with ``management systems to account for their pollution 
prevention effects to be worked out at a later date for the promulgated 
standard.'' The major concern of all of these commenters, however, was 
that under the proposed definition, the recirculating condensation 
systems would be considered process condensers, and thus, the 
uncontrolled emissions and resulting emissions reductions would be 
considerably lower than if the condenser was considered an air 
pollution control device. Even though these systems generate 
considerably lower emissions as compared to once-through systems, 
owners and operators could not take advantage of the high emission 
reductions in the process vent standard that requires 93 percent 
control or 2,000 lb/yr after control from the entire process.
    The EPA disagrees with the suggestion that the owner or operator 
should be allowed to determine whether a condenser is a process 
condenser or an air pollution control device based on ``intended use.'' 
Because one of the formats of the process vent standard requires that a 
reduction from uncontrolled emissions be applied across a process 
(i.e., achieve a 93 percent reduction in emissions from the process), 
EPA is concerned about the opportunity for crediting reductions 
achieved by condensing boiling streams on other sources in the process. 
In fact, in requesting data from industry (which was later used to set 
the MACT floor), the MACT partnership specifically confirmed from 
responders that the data reported was based on the definition of 
process condenser as described in the proposed rule. Therefore, EPA has 
retained the intent of the proposed definition, but has made clarifying 
changes. The definition of process condenser in the final rule is as 
follows:
    Process condenser means a condenser whose primary purpose is to 
recover material as an integral part of a process. The condenser must 
support a vapor-to-liquid phase change for periods of source equipment 
operation that are at or above the boiling or bubble point of 
substance(s) at the liquid surface. Examples of process condensers 
include distillation condensers, reflux condensers, and condensers used 
in stripping or flashing operations. In a series of condensers, all 
condensers up to and including the first condenser with an exit gas 
temperature below the boiling or bubble point of the substance(s) at 
the liquid surface are considered to be process condensers. All 
condensers in line prior to a vacuum source are included in this 
definition.
    The EPA also rejects the suggestion to use 20 deg.C as a 
temperature cutoff in determining whether a condenser is a process 
condenser or an air pollution control device. Because of the 
differences in the chemical and physical properties of substances used 
in the manufacture of pharmaceutical products, one temperature cannot 
be used to represent all processes; in some cases, a condenser 
operating at 20 deg.C could actually be an air pollution control device 
and not a process condenser. Finally, EPA disagrees with the requests 
that condensers in recirculating drying systems be considered as 
pollution control devices or defined separately. Emissions from the 
recirculating drying systems only occur during periodic 
depressurizations, and these uncontrolled emissions may be low enough 
such that the process may be under the 2,000 lb/yr cutoff. Processes 
with recirculating drying systems also may be able to take advantage of 
the pollution prevention standard.
6. Definition of Isolated Intermediate
    At proposal, isolated intermediate was defined as ``any 
intermediate that is removed from the process equipment for temporary 
or permanent storage or transferred to shipping containers.'' The 
concept of an intermediate was also included in the proposed definition 
of pharmaceutical product which contained a reference to 
``intermediates used in the production of pharmaceutical products (see 
section VI.A.1 of this preamble). One commenter on the proposed rule 
stated that EPA should not use or define the term, ``isolated 
intermediate,'' in the pharmaceutical NESHAP. (The same commenter also 
stated that the term, ``isolated intermediate,'' should be removed from 
the definition of process [see also section VI.A.3--Definition of 
Process].) The commenter pointed out that the term is ``peculiar to the 
Toxic Substances Control Act (TSCA), where a long history of 
interpretation has been developed,'' and if EPA uses this same term in 
the pharmaceutical NESHAP, ``inconsistencies in interpretation will be 
inevitable.''
    Many other commenters suggested that the definition of isolated 
intermediate be modified so that the physical removal of an 
intermediate from the process equipment is not required as a condition 
for meeting the definition of isolated intermediate. These commenters 
pointed out that, in some cases, an intermediate may remain in a 
storage tank or other retention equipment prior to being used in a 
different process step, and without ever being removed from either set 
of process equipment. The commenters further stated that the fact that 
retention tanks are used as separation lines as an alternative to 
storing the material in drums or separate containers ``is a matter of 
convenience.'' Therefore, the commenters recommended the following 
modified definition of isolated intermediate:
    Isolated intermediate means any intermediate that is stored in 
storage tanks or other holding equipment for later use, or that is 
transferred to containers for shipment or storage.
    After considering these and other related comments (see section 
VI.A.3 of this preamble), EPA has deleted the

[[Page 50294]]

term, ``isolated intermediate,'' from the definition of process to 
avoid confusion and emphasize that products are the end result of 
processes. Therefore, isolated intermediates are no longer defined or 
referred to in today's final rule. Also, the definition of process in 
the final rule incorporates the commenters' suggestion above regarding 
the fact that physical removal of the ``product'' from the process 
equipment should not be a required condition for meeting the definition 
of ``product.'' In addition, the definition of process in the final 
rule specifies when a process ``ends.''
7. Research and Development Facilities
    Many commenters expressed support for the proposed definition of 
research and development facilities because it draws a clear 
distinction between activities related to manufacturing (which are 
covered under today's final pharmaceutical production NESHAP) and those 
related to research and development (which are not covered by today's 
final rule). The commenters further stated that such a clear 
distinction is necessary because pharmaceutical manufacturing 
operations and research and development activities are often located at 
the same site. Many commenters requested that EPA make it clear that 
pilot plants are not subject to the proposed pharmaceutical standards 
if they meet the definition of ``research and development facility.'' 
In determining whether an operation of facility constitutes a research 
and development facility, it is EPA's intention that owners and 
operators and implementing agencies should refer to the definition of 
research and development facility which appears in Section 112(c)(7) of 
the Clean Air Act, rather than relying on existing company designations 
or facility names. For example, if a pilot plant is collocated with 
pharmaceutical manufacturing operations that are subject to this 
subpart, and the pilot plant meets the criteria outlined in the 
definition of research and development facility, then the pilot plant 
would not be subject to this subpart.
    Two commenters were concerned that the term ``de minimis,'' as it 
is used in the definition of research and development facility, was not 
defined in the proposed rule. One of the commenters stated that, 
without clarification (of de minimis) the definition will lead to 
exhaustive and potentially contentious negotiations between sources and 
regulatory agencies, and may result in inequitable exemption decisions 
at similar facilities located in different jurisdictions. The commenter 
also pointed out that some States have included more specific 
provisions, such as limiting the number of products produced, 
establishing maximum daily emission rates, or requiring segregation of 
the R&D activities from the production areas. Although EPA recognizes 
the concerns of the commenters, today's final rule does not establish a 
de minimis level for research and development facilities. The EPA does 
not have sufficient data to establish a de minimis level, and 
therefore, such determinations will have to be made by the applicable 
permitting authorities. Also, EPA is in the process of collecting 
background information on the various segments of research and 
development facilities nationwide and is considering development of a 
NESHAP for one or more of these segments in the future.
8. Consistency With Other Rules
    The EPA received numerous comments regarding the potential for 
overlapping regulations. Commenters were strongly opposed to the idea 
of the same sources being subject to multiple regulations and asked EPA 
to clarify which regulations applied to pharmaceutical manufacturing 
operations.
    The EPA has identified several potential areas in which today's 
final standards, the RCRA standards (subpart AA or CC), and/or subpart 
I of 40 CFR part 63 could apply to the same situation. To avoid 
inconsistent requirements, the EPA has tried to make the regulatory 
language as specific as possible as to which regulation(s) the owner or 
operator must comply with to satisfy the requirements of all regulatory 
programs. For example, if an air pollution control device is subject to 
the pharmaceuticals production NESHAP and RCRA requirements, 
Sec. 63.1250(h)(2) of today's final rule states that the owner or 
operator may elect to comply with the monitoring, recordkeeping and 
reporting requirements of either rule, as long as they identify which 
rule's requirements they have selected in the Notification of 
Compliance Status report. However, if the owner/operator elects to go 
with RCRA requirements, there may be additional (minimal) reporting 
requirements.
    Similarly, Secs. 63.1250(h)(1), (3) and (h)(4) address overlap with 
other MACT standards, subpart Kb (the NSPS for organic liquid storage 
tanks), and subpart I (the negotiated regulation for equipment leaks). 
After the compliance date for today's final rule for pharmaceuticals 
production, an affected source subject to Subpart I is required to 
comply only with the provisions of today's final rule. For sources 
subject to other MACT standards and NSPS Kb, reporting requirements may 
be streamlined to the extent that the rules are consistent.

B. Storage Tank Provisions

    The proposed and final standards for storage tanks with capacities 
greater than 20,000 gallons (i.e., reduce HAP emissions by at least 95 
percent) represent a control level that is beyond the MACT floor. In 
deciding to go beyond the MACT floor, EPA determined that floating roof 
technology was less costly than condensers (which represented the MACT 
floor technology and 90 percent control) and resulted in greater 
emission reductions. Many commenters stated that the proposed 
requirements for storage tanks with capacities greater than or equal to 
20,000 gallons represent an increase in stringency (beyond the MACT 
floor) without precedent. These commenters suggested that 90 percent 
control of HAP emissions was more appropriate and consistent with the 
storage tank provisions of similar rules (e.g., the HON and 40 CFR 60, 
Subpart Kb). The commenters also questioned EPA's assumption that 
floating roof technology could and would be used to reduce emissions 
from storage tanks, given the general lack of storage tanks at 
pharmaceutical manufacturing facilities that are fitted with floating 
roofs and the use of horizontal storage tanks (which cannot be fitted 
with floating roofs) at some facilities.
    In addition, commenters requested that EPA include in the final 
rule: (1) an exemption for storage tanks emitting less than 500 lb/yr 
of HAP (an alternative that was considered and then dropped during the 
regulatory review .process), and (2) a provision that allows vapor 
balancing systems as an alternative means of control. The commenters 
reviewed what was gained by dropping the 500 lb/yr cutoff alternative 
and concluded that in the top 12 percent of storage tanks, the 
associated emissions that would not be controlled under the 500 lb/yr 
cutoff alternative are 2,710 lb/yr (or 150 lb/yr/ tank). Based on an 
annualized cost of $142,500/yr (to control the 2,710 lb/yr), the 
commenters determined that the cost effectiveness of controlling the 
emissions from storage tanks with emissions less than 500 lb/yr would 
be $115,913/Mg. The commenters further stated that the EPA has 
authority under the law to establish de minimis provisions for 
exceptions from statutory directives when the benefits of regulation 
are significantly outweighed by the associated costs and other

[[Page 50295]]

burdens, and the 500 lb/yr cutoff alternative meets the criteria for 
establishing such a de minimis provision, especially considering the 
fact that the proposed storage tank provisions represent a control 
level above the MACT floor.
    Many commenters stated that the rule should specify that vapor 
balancing systems meet the requirements of the storage tank provisions. 
The commenters stated that vapor balancing systems are effective, 
relatively easy to use, capable of achieving control efficiencies as 
high as 90 to 98 percent, and are accepted under other rules (both NSPS 
and NESHAP), and therefore, should be accepted in the pharmaceutical 
NESHAP. One commenter also pointed out that, when vapor balancing is 
used (i.e., the storage tank vapor space is routed to the truck), the 
source of pollution is the vapor content of the truck; however, when 
the storage tank is vented to a control device, there are two sources 
of pollution: the HAP vapor from the truck and secondary pollutants 
from the control device. The same commenter recommended that the State 
of New Jersey requirements for vapor control (7:27-16.4 VOC Transfer 
Operations, Other Than Gasoline) be incorporated into the storage tank 
provisions.
    In response to the comments on the proposed storage tank 
provisions, today's final rule does not include provisions for vapor 
balancing of storage tanks. However, this issue will be addressed in 
the Organic Liquids distribution MACT standard. The MACT floor for 
storage tanks was determined to be 90 percent control of HAP from 
storage tanks and did not cover tank truck vapor. The EPA also 
considered the commenters' request for a 500 lb/yr cutoff, but rejected 
it because a sufficient number of small storage tanks in service at 
pharmaceutical manufacturing facilities are controlled, and the 500 lb/
yr cutoff represents an alternative that is less stringent than the 
MACT floor, and thus, is not acceptable. The control level for storage 
tanks with capacities greater than or equal to 20,000 gallons in the 
final rule is the same as proposed level (i.e., 95 percent). As 
explained in the Basis and Purpose Document (see Docket A-96-03, Item 
No. III-B-01 ), EPA chose 95 percent control (as opposed to the MACT 
floor) for storage tanks greater than 20,000 gallons because floating 
roof technology has been demonstrated to achieve 95 percent control and 
is considerably less expensive than other technologies. Although 
floating roofs currently may not be in use on storage tanks in the 
pharmaceutical industry, EPA is not aware of any technical obstacles to 
their use, except in the case of horizontal tanks. Also, owners or 
operators still have the option of using add-on controls instead of 
floating roofs.

C. Process Vent Provisions

    The EPA received numerous comments on the proposed standards for 
process vents. Comments focused on the following areas: (1) 
establishment of a concentration-based applicability cutoff, (2) 
implementation of the 98 percent control requirement, (3) new source 
MACT for process vents, and (4) compliance periods.
1. Applicability Cutoff
    Many commenters suggested that EPA establish a concentration 
threshold below which an emission stream would not be considered a 
process vent, and thus would be exempt from further applicability 
determinations, control or monitoring requirements. The commenters 
recommended a de minimis concentration of 50 ppmv or 50 ppmw for 
process vents.
    After consideration of the above recommendations and comments 
related to the alternative standard (see section VI.G of this 
preamble), EPA decided to establish a de minimis cutoff for process 
vents equal to 50 ppmv HAP, based on uncontrolled, undiluted emissions. 
The de minimis cutoff is incorporated into the definition of process 
vent, which states that uncontrolled, undiluted emission streams 
containing less than 50 ppmv HAP are not considered process vents.
2. Implementation of the 98 Percent Control Requirement
    Today's final rule requires facilities to apply an equation in 
Sec. 63.1254(a)(3) to determine if emissions from the process vent must 
be controlled by 98 percent as opposed to 93 percent. The applicability 
equation uses two variables, vent flow and yearly uncontrolled HAP 
emissions, to calculate a flow rate. The calculated flow rate is then 
compared to the process vent's actual flow rate, and if the actual flow 
rate is less than or equal to the calculated flow rate, the process 
vent requires 98 percent control. A number of commenters believe that 
the 98 percent control applicability equation should be deleted because 
it will create a significant recordkeeping burden, will be practically 
impossible to implement, and will significantly hamper operational 
flexibility.
    The major concern noted by the commenters was that the 
applicability equation, though fairly straight-forward for dedicated 
single-product processes, is extremely difficult if not impossible to 
apply to multipurpose nondedicated processes. The commenters stated 
that, because nondedicated processes use individual pieces of equipment 
to make numerous products over the course of a year, the emission 
stream characteristics of the associated process vents will change 
depending on the product being manufactured, and thus, the 
recordkeeping requirements for a single process vent would be 
burdensome. The commenters also pointed out that a facility may have 
200 to 300 individual process vents.
    Another concern raised by the commenters was that a slight variance 
from forecasted production could result in a process vent previously 
required to control emissions by 93 percent to become subject to the 98 
percent control requirement, and the affected facility would not have 
sufficient lead time to upgrade their control equipment from 93 to 98 
percent. The commenters were concerned that such uncertainties will 
hamper operational flexibility because facilities will be forced to 
impose limitations on production to ensure that they will not trigger 
98 percent control. The commenters also stated that applying the 
applicability equation to manifolded vents would further complicate 
matters because more sources emitted through the same vent will result 
in greater variability of vent stream characteristics.
    The commenters also requested that if EPA retains the 98 percent 
control requirement for existing process vents in the final rule, that 
Sec. 63.1252(c)(4) in the proposed rule be revised to clearly describe 
how to apply the 98 percent control applicability equation. Commenters 
noted that using the past actual annual HAP emissions versus projected 
annual HAP emissions in the applicability equation is an issue because 
the production of many products varies from year to year, and 
historical and forecasted annual HAP emission estimates may be very 
different. The commenters also were concerned that the proposed rule 
did not clearly establish how to determine the process vent's actual 
flow rate, which will be compared to the applicability equation's 
calculated flow rate. Finally, the commenters suggested that EPA 
specify that the applicability equation applies to individual pieces of 
equipment in a formulation facility. The commenters were concerned with 
how the applicability equation would be applied to nondedicated 
formulation facilities. The commenters pointed out that nondedicated 
formulation facilities often use multiple pieces of the same equipment 
to perform one operation

[[Page 50296]]

(e.g., six tray dryers), and not all of these pieces of equipment will 
be used to produce every product in the formulation facility (i.e., not 
all trays of the dryer are always used).
    After considering the comments above, EPA decided to retain the 98 
percent control requirement for existing process vents that meet the 
applicability criteria. (For those process vents already controlled to 
93 percent prior to April 2, 1997, no additional control is necessary.) 
The applicability equation applies to individual process vents within a 
process; however today's final rule considers manifolded process vents 
within each process to constitute a single process vent. With the 
exception of formulation operations and recovery devices, the 
definition of process is based on the product manufactured, not the 
equipment used to manufacture it. Therefore, the determination of which 
vents require control to the 98 percent level for nondedicated process 
vents should be straightforward; namely, owners and operators need to 
anticipate the total uncontrolled HAP emissions per year from each vent 
from each process, and the average flow rate of the vent. The total 
uncontrolled emissions should be based on the potential number of 
batches per year that the facility can run for each process. Based on 
this projection, the owner or operator can decide whether to install or 
use an existing 98 percent control device or limit the number of 
batches to stay below the applicability threshold. Today's final rule 
also requires facilities to keep track of the number of batches of 
products they make each year to show that their number of batches is 
less than the number needed to trigger 98 percent.
    In response to the commenters' request, the average flow rate has 
been clarified in the final rule to mean the weighted average flow rate 
of the emission events contributing to the process vent. For solvent 
recovery or formulation operations, the definition of process in 
today's final rule has been clarified to include all operations within 
a contiguous area; therefore, for these operations, a single process 
may be associated with several products. Like other processes, the 
application of the 98 percent control applicability equation should be 
based on individual process vents or manifolded vents. Thus, if each 
piece of equipment that is located at a formulation facility, 
considering processes by contiguous areas, has a separate vent, then 
the applicability equation is applied to each vent separately; however, 
if the vents from each piece of equipment are manifolded together, then 
they are treated as one process vent and the equation is applied to the 
aggregated flow.
    As part of the rationale for retaining the 98 percent requirement, 
EPA notes that this level of control is imposed only on vents that have 
the potential to emit 25 tons/yr or more, on an uncontrolled basis. 
Secondly, the applicability equation is indexed on cost-effectiveness. 
Streams that are too dilute for cost effective control would not, per 
the equation, be required to be controlled. Third, process vents 
already controlled to levels of 93 percent or greater prior to April 2, 
1997, would be grandfathered and not required to increase controls to 
98 percent. The EPA believes that after these considerations are made, 
only very large streams that are cost effective to control to 98 
percent will trigger the 98 percent control requirement.
3. New Source MACT for Process Vents
    At proposal, new source MACT for process vents was set at 98 
percent control for process vents with uncontrolled emissions greater 
than or equal to 400 lb/yr. The rationale for the 400 lb/yr cutoff 
(uncontrolled) was that it represented the smallest controlled process 
considered to be a similar source. Many commenters stated that the 
standard for new process vents should include a 2,000 lb/yr controlled 
emissions compliance alternative, because it is unreasonable and 
unwarranted to require vents with low HAP emissions to achieve 98 
percent control. The commenters agreed with EPA's conclusion that 98 
percent control represents the best controls in practice for certain 
sources; however, the commenters believe that the applicability cutoff 
for new source MACT for process vents is legally flawed because the 
cutoff did not consider two of the four process types in the industry 
(fermentation and extraction). The commenters also stated that the 
process on which the 400 lb/yr cutoff is based is not representative of 
the industry's processes because the process emits primarily one HAP 
(methanol) and is controlled by a dedicated scrubber and appears to be 
only a portion of a process based on the EPA's definition of process in 
the proposed rule. Citing other rules that set new source MACT as the 
average level of control achieved by sources using new source MACT 
control technology, the commenters performed an analysis of the MACT 
floor data base and determined that the average level of controlled 
emissions from the best-performing 12 plants was approximately 1,400 
lb/yr. The commenters excluded two processes from their analysis that 
had uncontrolled emissions greater than 1 million lb/yr because these 
processes are much larger than the typical pharmaceutical manufacturing 
process and would skew the data. According to the commenters, if these 
two (larger) processes are included in the analysis, the average level 
of controlled emissions from the best-performing 12 plants would equal 
6,400 lb/yr.
    The EPA has reviewed the data used to set the MACT floor for 
process vents at new sources. Based on this review, the EPA has 
concluded that the data support the level of the proposed standard for 
new sources.
    The EPA based the 98 percent control requirement on the 26 
processes (under the proposed definition) at 7 plants in the data base 
that achieve or exceed this control level. These processes include 
dedicated and nondedicated formulation, chemical synthesis, and 
fermentation processes. The EPA has concluded that these processes are 
representative of the control challenges faced by the industry despite 
the fact that the data do not include an extraction process. The EPA 
has further concluded that the 98 percent control level achieved at the 
best controlled processes is applicable to all four process types.
    The EPA does not believe that the variation in exhaust gas 
characteristics among the four types of processes in the industry is 
significant enough to warrant individual evaluation of achievable 
control levels. In any case, extraction processes are typically 
solvent-intensive, resulting in the highest average HAP concentration 
of the four types of processes. High HAP concentrations are conducive 
to high percent control levels.
    The commenters suggested that the EPA adopt a 2,000 lb/yr actual 
emissions compliance alternative to account for variability within the 
industry. The commenters based this alternative on the average level of 
controlled emissions from 24 of the processes in the data base that 
achieve 98 percent control or greater. (The commenters excluded the 
other two processes in the data base because they were atypically 
large.) The EPA does not believe that the analysis presented by the 
commenters is an appropriate basis for a new source compliance 
alternative. First, while the commenters imply that the alternative is 
needed to account for variability in the control level that is 
achievable by the wide variety of pharmaceutical processes, the 
analysis does not address control efficiency at all. Because the 
commenters evaluated only processes that achieve at least 98

[[Page 50297]]

percent control, only variability in uncontrolled emissions truly 
figures into the analysis. Second, the alternative standard suggested 
by the commenters is not equivalent to the percent reduction standard 
and would result in greater total emissions of HAP from the industry. 
Finally, the EPA analyses cited as precedents address different 
situations and provide scant support for the commenters' analysis.
    While the EPA has rejected the alternative standard suggested by 
the commenters, the final rule provides a 20 ppmv outlet concentration 
alternative to 98 percent control for process vents at new sources. 
This alternative addresses the primary impediment to achieving 98 
percent control, i.e., low inlet concentration gas streams.
    The EPA based the proposed applicability cutoff for new source 
process vents on the smallest representative process in the data base 
that achieves 98 percent control or greater. The commenters questioned 
whether this operation actually qualifies as an entire process under 
the proposed definition of ``process'' and whether the operation is 
representative of processes in the industry. Although the EPA continues 
to believe that the formulation operation selected as the basis for the 
proposed cutoff is a process under the proposed definition, it may not 
qualify as a process under the final definition because nondedicated 
formulation operations occurring within a contiguous area are now 
considered single processes. Consequently, the EPA has reanalyzed the 
data based on the final definition of ``process.'' In light of the new 
analysis, it is no longer relevant whether the process upon which the 
proposed cutoff was based is representative of the industry.
    The new analysis was similar to the original analysis. After 
revising the data base of well-controlled sources to conform to the 
final definition of ``process,'' the EPA identified the smallest 
processes that are controlled by 98 percent or more. As in the previous 
analysis, formulation and chemical synthesis processes are the smallest 
processes. Two chemical synthesis processes, one emitting 85 lb/yr 
uncontrolled and another emitting 304 lb/yr uncontrolled, were 
identified as achieving control of 98 percent. Although these processes 
were reported as individual (single) processes, EPA summed emissions 
from both, since the product name listed for each was very similar, and 
EPA wanted to be conservative. The total uncontrolled emissions from 
the sum of these two processes is 390 lb/yr, which is the same level of 
emissions as the proposed cutoff. Therefore, the EPA has established in 
the final rule the new source process applicability cutoff of 400 lb/yr 
of uncontrolled HAP.
    Despite the fact that no fermentation or extraction processes were 
among the smallest well-controlled processes, the EPA believes that the 
analysis is representative of the control capabilities of all process 
types. As discussed previously, the EPA has concluded that the gas 
streams generated by the four types of processes in this industry are 
similar enough that an individual analysis by process type is not 
warranted. Fermentation and extraction processes are typically much 
larger than formulation and chemical synthesis processes. Thus, the 
absence of fermentation and extraction processes in the list of the 
smallest well-controlled processes is the result of this size 
differential, not a difference in the control level that can be 
achieved. In fact, the average uncontrolled HAP concentration of 
fermentation and extraction process vents exceeds those of formulation 
and chemical synthesis process vents. Higher concentrations are more 
conducive to high percent control.
    Practically speaking, new source MACT will apply to low HAP-
emitting processes only at new facilities, where the minimum control 
requirement is 98 percent for all processes. (At existing sites, new 
source MACT will apply only to dedicated new PMPU's with a potential to 
emit 10 tons/yr of a single HAP or 25 tons/yr of all HAP combined.) 
Thus, sources will not be faced with the need to install 98 percent-
efficient controls dedicated to small new processes, which could be 
very costly for a small amount of emission reduction. Instead, the EPA 
expects that sources will achieve the new source MACT standard using 
large control devices that treat multiple manifolded gas streams. 
Because this is the control situation most typically found for the 
small processes in EPA's data base of well-controlled sources, the EPA 
believes that the final rule's applicability cutoff accurately reflects 
what will be achievable at new sources in this industry.
4. Compliance Period
    Several commenters stated that they support the proposed annual 
compliance period for process vents and noted the inconsistency with 
the daily continuous compliance provisions. If the final rule includes 
a shorter compliance period, the commenters have stated that either the 
standards must be adjusted to avoid an increase in stringency above the 
floor or a demonstration must be made that the increased stringency 
(i.e., going above the floor) is justified according to the 
requirements of the Clean Air Act. The EPA, in the final rule, has 
clarified the compliance period of the standard to be either on a 24-
hour basis, or on a batch cycle or ``block'' basis. Additionally, 
compliance periods for emissions averaging are on a quarterly basis, 
while compliance periods for the P2 standard are on an annual basis, as 
calculated on a monthly or 10-batch rolling average. An annual 
compliance period for the standards was determined by EPA to be too 
difficult to implement. The annual compliance period implies that 
owners and operators could control processes to varying degrees during 
the course of a year, as long as the yearly percent reduction target 
could be met. While this format would offer flexibility to owners and 
operators that would want to change control strategies to accommodate 
production scheduling and operational changes, EPA believes that the 
demonstration of compliance over such an extended time period would 
result in delayed compliance determinations and the possibility for 
extended periods of violations. The EPA notes that the final rule 
offers some flexibility to owners and operators in addressing 
variability within the processes themselves by providing numerous 
compliance options. Therefore, EPA does not believe that by clarifying 
the final rule to reflect a daily compliance period, the stringency of 
the standard was increased.

D. Wastewater Provisions

1. MACT Floor
    The EPA estimated that 101 pharmaceuticals facilities would be 
major sources subject to the rule. The MACT floor is based on available 
information about control levels at all of these sources. One commenter 
asserted that the applicability section of the proposed rule covers 
more types of facilities than those in the original MACT floor 
analysis, and thus the MACT floor should be recalculated. The EPA did 
not recalculate the MACT floor because, as noted in section VI.A.1 of 
this preamble, the applicability in the final rule is clarified to 
eliminate the likelihood that the rule would apply to types of 
facilities other than those represented in the 101 in the initial 
analysis.
2. DeMinimis Cutoff in Definition of Wastewater
    The final rule includes de minimis cutoffs for determining if a 
water stream is wastewater. One commenter requested that HAP 
concentration and

[[Page 50298]]

flow rate cutoffs be added, as in the HON. The commenter contended that 
the burden to characterize streams with very small HAP loadings would 
be excessive without such cutoffs. For the final rule, EPA revised the 
definition of wastewater to include de minimis HAP cutoffs of 5 ppmw 
and 0.05 kg/yr, which is consistent with the HON. Although the owner or 
operator is given some flexibility in the methods used to characterize 
these streams, the Administrator may require the owner or operator to 
validate this information through sampling and analysis or other 
appropriate means.
3. Cross-References to the HON
    The wastewater provisions in the proposed rule contained numerous 
cross-references to the wastewater provisions in Secs. 63.132 through 
63.148 of the HON. Many commenters requested that the applicable 
provisions from the HON be included in the final rule because the 
extensive cross-referencing made the proposed rule hard to understand 
and would likely be hard to implement. Some comments also noted that 
many cross references were not consistent with the most current version 
of the HON. To address these concerns, EPA decided to incorporate the 
applicable provisions from the HON in the final rule. These provisions 
include the emission suppression requirements from Secs. 63.133 through 
63.137, the control device requirements from Sec. 63.139, the general 
procedures for determining compliance from Sec. 63.145, many of the 
compliance options for treatment systems and control devices from 
Secs. 63.138 and 63.145 (additional information about compliance 
options is provided in section VI.D.4), the inspection and monitoring 
provisions from Secs. 63.143 and 63.148, the requirements for certain 
liquid streams in open systems within a PMPU from Sec. 63.149, and the 
tables that are referenced from all of these sections.
4. Additional Treatment Options for Demonstrating Compliance
    Several commenters requested that the rule include additional 
treatment options for demonstrating compliance. Some comments requested 
that all of the options in the HON be added to the rule. Other comments 
specifically requested that the rule allow treatment in RCRA units and 
that a concentration limit be developed for soluble HAP. In response to 
the comments, EPA included additional treatment options in the final 
rule that are consistent with the standards. All of the RCRA options 
from the HON were added because treatment in these units will meet the 
standards. A concentration option of 520 ppmw for soluble HAP was added 
because this level is consistent with the 90 percent reduction 
requirement for soluble HAP.
    Four options from the HON were not added to the final rule. The 
design steam stripper option was not added because the available 
stripper designs that were used to estimate impacts have not been 
tested in the field. The percent mass removal/destruction option based 
on fraction removed (Fr) values was not added because the Fr values 
would be identical to the percent reduction option. The 1 Mg/yr option 
was not added because any facility with wastewater containing a load of 
total partially soluble and/or soluble HAP less than 1 Mg/yr would have 
no affected wastewater streams. The required mass removal options were 
not included because wastewater discharges from batch pharmaceutical 
processes are much more variable than those from continuous SOCMI 
processes; therefore, the required mass removal is likely to be 
different at any given time, and is not likely to correlate well with 
the actual mass removal in the treatment unit at a given time.
5. General Compliance Procedures
    The proposed rule cross-referenced the specific procedures in the 
HON for determining compliance with the standards when using various 
types of treatment units (i.e., noncombustion, combustion, or 
biological), but the general procedures used to determine compliance 
that are applicable to any performance test (or design evaluation) were 
not cross-referenced. Several commenters requested that these general 
procedures also be included in the rule. Specifically, the commenters 
requested that the rule specify that: (1) performance tests be 
conducted under representative operating conditions, (2) treatment may 
be conducted using a series of treatment devices, (3) treatment may be 
conducted offsite or in onsite treatment units not owned by the source, 
and (4) any biological units in compliance with the standards need not 
be covered and vented. Commenters also requested that the rule include: 
(1) procedures for the preparation and installation of testing 
equipment and (2) requirements for compounds that do not need to be 
considered in performance tests or design evaluations. The final rule 
includes all of these provisions; however, clarification of two points 
is provided below.
    Clarification of the provision for testing under representative 
operating conditions is provided because the commenters misinterpreted 
the meaning of this provision in the HON. This provision requires a 
facility to conduct a single performance test under representative 
operating conditions. If actual operating conditions vary, such that 
there are multiple representative operating conditions, the owner or 
operator must supplement the test results with modeling and/or 
engineering assessments to demonstrate that the standard is met over 
the entire range of operating conditions. Testing under representative 
operating conditions does not mean the standard is an average that may 
be exceeded under certain conditions.
    A clarification of the provision that allows open biological 
treatment units to be uncovered is also provided. Except for enhanced 
biological treatment units used to treat certain wastewater streams, an 
owner or operator demonstrates compliance for open biological treatment 
units by conducting a performance test and following the procedures in 
appendix C of part 63. If these procedures show the fraction 
biodegraded meets or exceeds the applicable control level, the 
treatment unit need not be covered. An enhanced biological treatment 
unit that is used to treat wastewater containing soluble HAP and less 
than 50 ppmw of partially soluble HAP is exempt from the performance 
test requirements and need not be covered.
6. Default Biodegradation Rate for Methanol
    One commenter urged EPA to revise the default methanol 
biodegradation rate constant that is used in Table 37 of subpart G of 
the HON because it cannot be scientifically supported with available 
data. Based on data from a number of studies, the commenter concluded 
that the rate in the proposed rule is low by a factor of 10 to 100. The 
commenter noted that the geometric mean of the rates from the available 
studies was 8.6 L/g MLVSS-hr, and the lower bound of the 90 percent 
confidence interval was 3.5 L/g MLVSS-hr. The commenter also cited data 
in the scientific literature that show hexachlorobenzene, 
chlorobenzene, nitrobenzene, and biphenol (other list 1 compounds) to 
be less biodegradable than methanol, whereas Table 37 of the HON shows 
methanol to be less biodegradable than the other compounds.
    The data submitted by the commenter show considerable variability, 
but they also show the higher biodegradation rate constants tend to 
correspond with higher methanol concentrations in the wastewater. The 
EPA concluded that a

[[Page 50299]]

methanol biodegradation rate constant higher than the default is 
appropriate for pharmaceutical facilities that are direct dischargers 
because they tend to treat wastewater with higher methanol 
concentrations than indirect dischargers or facilities in other 
industries. The final rule allows these facilities to use a methanol 
biodegradation rate constant of 3.5 L/g MLVSS-hr, the lower bound of 
the 90 percent confidence interval; this is a conservative value that 
minimizes the likelihood that the biodegradation rate will be 
overestimated.
7. Maintenance Wastewater
    The wastewater provisions apply to both process and maintenance 
wastewater. Commenters requested that maintenance wastewater provisions 
be less stringent than those for process wastewater, as in the HON. 
According to one commenter, the same conveyance systems and controls 
are not practical or cost effective for maintenance wastewater. The EPA 
did not change the maintenance wastewater provisions because 
maintenance wastewater is a potential source of significant emissions. 
Furthermore, procedures to estimate maintenance wastewater 
characteristics should be the same as those for most process wastewater 
because both consist of batch discharges.
8. Control Requirements for Wastewater Tanks
    The rule requires that wastewater tanks have either a fixed roof or 
additional controls, depending on tank design and/or operating 
characteristics. A number of commenters expressed confusion over these 
provisions and offered their interpretations or preferences to clarify 
the provisions. Under the rule, wastewater tanks that have a capacity 
of less than 75 m3, a capacity between 75 and 151 
m3 that contain material with a vapor pressure less than 
13.1 kPa, or a capacity greater than or equal to 151 m3 that 
contain material with a vapor pressure less than 5.2 kPa are required 
to have a fixed roof unless the wastewater in the tank is heated, 
treated with an exothermic reaction, or sparged. If any of these three 
conditions is not satisfied, the owner or operator must install a 
floating roof or use control techniques that achieve equivalent 
emission reductions. These provisions match those in the HON. The 
proposed rule also included an additional provision that caused the 
confusion for the commenters. The intent of the provision was to exempt 
wastewater tanks from the additional control provisions, but not the 
fixed roof requirement, if the owner or operator demonstrates that the 
total partially soluble and/or soluble HAP emissions from a fixed roof 
tank that is heated, treated with an exothermic reaction, or sparged 
are less than 5 percent higher than the emissions would be in the 
absence of these activities. This additional provision is rewritten in 
the final rule to improve clarity.
9. Compliance Requirements for Biological Treatment Units
    The EPA received numerous comments on the initial compliance 
procedures and monitoring requirements for enhanced biological 
treatment units. Some commenters requested that compliance 
demonstrations be based on parameters related to soluble HAP removal, 
not general compliance with all NPDES permit limits; the commenters 
suggested monitoring for surrogate parameters like COD, BOD, and/or 
TSS. Some commenters stated that EPA's definition of significant 
noncompliance in appendix A of 40 CFR 123.45 should be used as the 
basis for defining acceptable enhanced biotreatment operation for both 
POTW's and direct dischargers. One commenter stated that compliance 
provisions should focus on the indirect discharger, not the POTW; for 
example, the indirect discharger should be in compliance with the 
pretreatment provisions in 40 CFR 403 and 439. Several commenters 
stated that the provision allowing discharge to an enhanced biological 
treatment unit at a POTW only if the indirect discharger demonstrates 
that less than 5 percent of the soluble HAP in the wastewater from the 
POD's is emitted from the municipal sewer system is unnecessary and 
burdensome.
    The compliance procedures for biological treatment units are 
rewritten in the final rule for clarity, simplification, and as noted 
above, to eliminate cross-references to the HON. Because the changes 
are extensive, all of the compliance procedures and monitoring 
requirements for biological treatment units, not just the issues raised 
by the commenters, are summarized below.
    Onsite or offsite biological treatment units may be used to comply 
with the standards for soluble HAP, and onsite biological treatment 
units may be used to comply with the standard for total soluble and 
partially soluble HAP. The compliance requirements vary depending on 
the concentration of partially soluble HAP in the wastewater, whether 
the treatment unit is open or closed, whether the biological treatment 
unit is enhanced, and whether the wastewater is treated onsite or 
offsite.
    If wastewater containing soluble HAP and any concentration of 
partially soluble HAP is treated in an open, onsite biological 
treatment unit that does not meet the definition of an enhanced 
biological treatment unit, the owner or operator must conduct an 
initial performance test to determine the fraction biodegraded 
(fbio) in the unit; the fbio for the compounds 
may be calculated using any of the procedures in appendix C to 40 CFR 
part 63, except procedure 3 (inlet and outlet concentration 
measurements). As noted in section VI.D.5, the treatment unit may 
remain open if the fraction biodegraded meets or exceeds the level of 
the standard. For a closed biological treatment system, the owner or 
operator may follow the same procedure; alternatively, the owner or 
operator of a closed biological treatment unit may conduct either a 
design evaluation using procedure 3 or a performance test to determine 
the mass reduction of soluble HAP (or total soluble and partially 
soluble HAP) in the unit. Under the proposed rule, the owner or 
operator of open and closed biological treatment units would have been 
required to specify appropriate monitoring parameters in the 
Notification of Compliance Status Report, subject to approval of the 
permitting authority. Based on consideration of the comments, EPA 
decided to specify continuous monitoring requirements for TSS and BOD 
in the final rule. To be in compliance, the TSS and BOD concentrations 
must not exceed the TSS and BOD criteria in 40 CFR 439 more frequently 
than, or by amounts greater than, allowed by the noncompliance 
reporting criteria in 40 CFR 123.45, appendix A.
    If wastewater containing soluble HAP and more than 50 ppmw of 
partially soluble HAP is treated in an onsite, enhanced biological 
treatment system, the compliance procedures are the same as described 
above, except that the fbio for soluble compounds may be 
calculated using either the default for first order biodegradation 
constants or any of the procedures in appendix C of 40 CFR part 63. As 
noted in section VI.D.6, the owner or operator may use a biodegradation 
rate constant of 3.5 L/g MLVSS-hr for methanol. The owner or operator 
also must monitor for TSS and BOD as described above. In addition, to 
demonstrate continuous compliance with the 1 kg/m3 level in 
the definition of enhanced biological treatment unit, the owner or 
operator must monitor the concentration of MLVSS.

[[Page 50300]]

    If wastewater containing soluble HAP and less than 50 ppmw of 
partially soluble HAP is treated in an onsite, enhanced biological 
treatment unit, the owner or operator is exempt from the performance 
test requirement for the treatment unit. Monitoring for TSS, BOD, and 
biomass is required as described above.
    Wastewater containing soluble HAP and less than 50 ppmw of 
partially soluble HAP may be transferred for offsite treatment or 
onsite treatment in a unit not owned by the source. Before the source 
may transfer such wastewater, the transferee must submit to EPA written 
certification that the transferee will manage and treat any affected 
wastewater or residuals in accordance with the requirements of the 
rule. The initial compliance procedures and monitoring requirements to 
show continuous compliance are the same as for similar onsite units 
treating the same wastewater. In response to the comments, EPA 
reexamined emissions from municipal sewer systems and determined that 
the major potential for emissions is from the headworks. Thus, if the 
wastewater is discharged to a POTW, the final rule requires the owner 
or operator to demonstrate that less than 5 percent of HAPs are lost. 
However, if the headworks at the POTW are covered, no such 
demonstration is required. The same emission suppression requirements 
apply if the wastewater is discharged for treatment in any other type 
of offsite treatment unit or onsite treatment unit not owned by the 
source.
10. Control Requirements for Individual Drain Systems
    The rule requires emission suppression and control measures for all 
individual drain systems that manage affected wastewater or residuals 
onsite. Several commenters requested that EPA exempt individual drain 
systems from these requirements, and allow them to be vented to the 
atmosphere, if they either manage wastewater that contains only soluble 
HAP compounds and de minimis amounts of partially soluble HAP compounds 
or demonstrate that emissions from the individual drain system and 
associated wastewater tanks are less than 5 percent of the loading in 
the affected wastewater. The commenter's rationale for this request was 
that: (1) a PhRMA study of municipal sewers, which was submitted to 
EPA, showed the potential emissions from individual drain systems that 
manage wastewater containing primarily soluble HAP are low; (2) the 
control is not cost effective; and (3) emissions of combustion products 
would increase because facilities would meet the requirement with steam 
strippers or incinerators.
    For wastewater, EPA determined that MACT consists of hard-piping to 
a steam stripper. Because this configuration was determined to be a 
reasonable MACT floor requirement, any alternative must achieve 
equivalent emission reductions. As in the HON, a covered individual 
drain system is considered equivalent to hard piping. Thus, EPA did not 
change the requirements for individual drain systems in the final rule.

E. Equipment Leak Provisions

    Several commenters raised a number of issues related to equipment 
leaks and EPA's proposed requirements for the LDAR program developed 
for the pharmaceutical manufacturing industry. The proposed general 
equipment leak requirements were based on subpart H (from the HON rule) 
and included slight changes tailored for the pharmaceutical industry. 
Some commenters were confused by the requirements and others were 
concerned that some facilities will be subject to two different LDAR 
programs because some pharmaceutical manufacturing operations are 
already subject to subpart I (which requires compliance with subpart H 
of the HON for components at pharmaceutical production processes that 
use carbon tetrachloride or methylene chloride). Today's final rule 
clarifies EPA's intent that affected sources that are subject to 
today's final rule and subpart I of 40 CFR part 63 will no longer be 
required to comply with subpart I after the compliance dates for 
today's final rule. Many commenters argued that EPA is bound by the 
subpart I regulatory negotiation and therefore, is not allowed to 
expand the LDAR requirements to include any HAP other than carbon 
tetrachloride and methylene chloride. The Clean Air Act requires that 
EPA regulate all major sources of HAP. The regulatory negotiations 
conducted in the development of subpart I included only a certain 
fraction of components from the industry because that was the extent of 
information that EPA had at the time the negotiations were conducted. 
The Agency does not agree that the negotiated rule for equipment leaks 
precludes further regulation of equipment leaks for pharmaceutical 
manufacturing operations.
    Some of the changes and assumptions made in estimating the 
uncontrolled emissions for the industry used in determining the 
proposed LDAR requirements were questioned by the commenters. A group 
of commenters disapproved of the Agency's revised method to estimate 
uncontrolled emissions using the uncontrolled SOCMI average emission 
factors. The commenters argued that none of the studies used in 
developing the SOCMI emission factors involved pharmaceutical 
manufacturing operations.
    Commenters also questioned EPA's assumptions and data used in some 
of the LDAR cost calculations. In general, commenters stated that the 
actual cost-effectiveness value associated with the proposed LDAR 
program was much higher than EPA's estimate due to overestimated 
emission reductions and underestimated costs. In response to these 
comments, the Agency reviewed its cost analysis and recalculated the 
cost effectiveness of several LDAR programs. The most acceptable 
program, in terms of cost effectiveness, is based on requirements 
similar to those of other recent regulations for similar manufacturing 
industries and the provisions developed for the SOCMI Consolidated Air 
Rule (CAR) which is yet to be proposed. The most significant difference 
between the CAR equipment leaks subpart and the proposed equipment 
leaks provisions is the innovative approach taken in the CAR to 
monitoring valves and connectors for leaks.
    The CAR program significantly reduces the amount of burden 
associated with monitoring these types of equipment for leaks without 
increasing the emissions of regulated pollutants to the environment. In 
calculating the impacts of requiring an LDAR program meeting the 
requirements of the CAR, EPA calculated monitoring costs based on 
established guidance and calculated uncontrolled emissions using 
initial leak frequencies reported from the industry. The details of 
this analysis are included in the project docket (A-96-03) as Item No. 
IV-B-5. The EPA, in reassessing industry leak data, addressed many of 
the concerns of the commenters relative to the inclusion or exclusion 
of specific data.
    Using as a starting point leak data that was confirmed as initial 
survey data by PhRMA, EPA reviewed the data base and further defined 
the pool of data. Some data from PhRMA's compilation was revised to 
reflect reported leak definitions, also, some data was excluded based 
on the facility's explanation of frequency of monitoring and calculated 
leak rates and the conclusion that the leak rates did not indeed 
reflect initial monitoring data. The resulting initial leak rate data 
was

[[Page 50301]]

1.45 percent for valves, 6.88 percent for pumps, and 1.5 percent for 
connectors.
    The subsequent leak rates are a critical parameter in calculating 
the overall cost effectiveness of any LDAR program. Limited data were 
available to determine the leak rates at pharmaceutical manufacturing 
frequencies after the application of LDAR. Therefore, EPA assumed that 
the equipment leak frequency occurrence rate after implementation of 
LDAR was equal to the performance levels required in the draft CAR, 
that repairs were 100 percent effective, and that there were no 
recurrences of leaks. For the CAR rule, where several performance 
levels and corresponding monitoring schedules are available, occurrence 
rates were based on the best performance levels and longest monitoring 
intervals available. For flanges and valves, this performance level is 
0.25 percent leakers. The corresponding monitoring interval for flanges 
is once every 8 years; for valves, it is once every 2 years. For light 
liquid pumps there is no performance level specified, therefore it was 
assumed that the leak occurrence rate was equal to 50 percent of the 
initial leak frequency. Subsequent leak frequencies for the revised EPA 
analysis were estimated to be 0.25 percent for valves, 3.44 percent for 
pumps, and 0.25 percent for connectors.
    Emission reductions for the program were estimated to be the 
difference between the uncontrolled emission rate, as calculated using 
the mass emission rate, in kg/hr-source, calculated from the Average 
Leak Rate (ALR) equations and initial leak data, and the controlled 
emission rate, calculated using the ALR equations and assumed 
subsequent leak frequencies. The controlled emission rate was based on 
one-half of the occurrence rate. This assumption was necessary to 
account for the average leak frequency over the entire monitoring 
cycle.
    The EPA, in the revised analysis, also addressed concerns of the 
commenters related to specific cost items. In general, capital and 
annualized costs for monitoring instruments, data management systems, 
and actual monitoring are not unreasonable and fall within the costs 
quoted by vendors and LDAR contract services, based on recent inquiries 
by EPA. Therefore, EPA did not revise significantly any cost items used 
in the model facility analysis.
    Based on this revised analysis, the Agency found that the cost 
effectiveness of the CAR LDAR program was approximately $1000/Mg HAP 
for a model pharmaceutical facility.
    After consideration of the above comments, EPA revised the proposed 
leak detection and repair provisions to be consistent with the Agency's 
recent efforts toward consolidation of equipment leak requirements for 
air regulations, the increased focus on processes with leaking 
components, and a general lessening of monitoring and recordkeeping and 
reporting requirements for processes with nonleaking components. Most 
of the changes to the proposed rule involve the requirements for valves 
and connectors in gas/vapor service and in light liquid service. These 
changes include the addition of 2 year monitoring (instead of once 
every four quarters) for those processes with less than 0.25 percent 
leaking valves; extending the monitoring period for connectors with low 
leak rates; provisions for valve subgrouping; deletion of the quality 
improvement program implementation requirement and the credit for 
valves removed; and revisions to the calculations for determining the 
percentage of leaking valves. The Agency believes that the equipment 
leak requirements included in today's final rule greatly reduce the 
administrative burden associated with LDAR recordkeeping and reporting, 
and at the same time, result in a significant reduction in emissions.

F. Pollution Prevention Alternative

    Many comments were received on the proposed pollution prevention 
alternative, primarily relating to the proposed restrictions to the use 
of this alternative and the lack of specific recordkeeping and 
reporting requirements. The following sections summarize the 
commenters' concerns regarding the proposed pollution prevention 
alternative, EPA's response to these concerns, and subsequent changes 
made in today's final rule.
1. Restrictions on the Pollution Prevention (P2) Alternative
    At proposal, processes emitting HAP that are generated in the 
process were perceived by commenters as being prohibited from using the 
pollution prevention alternative. Many commenters stated that processes 
that generate HAP should be allowed to use the P2 alternative as long 
as these quantities were included in the analysis. These commenters 
also recommended that the rule provide a de minimis HAP generation 
cutoff below which facilities could use the P2 alternative. The EPA 
agrees with the commenters that PMPU's that generate HAP emissions 
should be eligible for the P2 standard, provided the HAP emissions 
generated by the PMPU are controlled to the required levels. Therefore, 
today's final rule clarifies that processes that generate HAP can use 
the P2 alternative, provided that the HAP emissions generated in the 
PMPU are controlled to the required levels for storage tanks, process 
vents, wastewater and equipment leaks in Secs. 63.1253 through 63.1256 
of today's final, and the remaining requirements of the P2 alternative 
are met. Because the final rule requires sources to account for HAP 
generated in the process, a de minimis HAP generation cutoff is not 
needed.
    No increase in the production-indexed VOC consumption factor was 
allowed as the result of compliance with the P2 alternative at 
proposal. One commenter stated that the stipulation in the P2 
alternative that does not allow for an increase in the VOC consumption 
factor as a result of a decrease in use of HAP is unfair. According to 
the commenter, this restriction will eliminate many solvent replacement 
projects. The example that the commenter used was a 100 percent 
reduction in the use of methylene chloride (a non-VOC HAP) by replacing 
this solvent with a water-based solvent that contains trace amounts of 
some VOC. This trace amount of VOC would result in an increase in the 
VOC consumption factor. The commenter further explained that HAP 
solvents generally tend to have more aggressive solvent properties than 
non-HAP, and thus, when replacing a HAP solvent with a non-HAP solvent, 
the result is generally lower yields, more extensive processing, or 
higher quantities of solvent used. The commenter suggested that an 
upper limit could be set on the increase in VOC consumption, and gave a 
``conservative'' limit of two times the baseline production-indexed VOC 
consumption factor.
    In developing the pollution prevention alternative, EPA's intention 
was to recognize those processes that have reduced or will reduce the 
amount of HAP solvents used in the manufacture of pharmaceutical 
products as viable alternatives to add-on controls. By preventing 
affected sources from increasing the production-indexed VOC consumption 
factor, EPA intended to prevent solvent substitutions that merely 
swapped HAP for VOC. After reviewing the proposed pollution prevention 
standards in light of commenters concerns, EPA realized that the 
proposed standards gave an unfair advantage to affected sources that 
use VOC-HAP solvents as opposed to non-VOC HAP solvents. As proposed, 
the rule did not allow affected sources using non-VOC HAP solvents to 
switch to

[[Page 50302]]

low-VOC solvents and still qualify under the pollution prevention 
alternative because of the automatic increase in the production-indexed 
VOC consumption factor. However, affected sources that use VOC-HAP 
solvents could switch to low-VOC solvents as long as the production-
indexed VOC consumption factor did not increase. The EPA's intention in 
the final rule is that pollution prevention be accomplished through 
reductions in solvent usage as opposed to solvent substitution. 
However, the EPA realized that the proposed rule gave an unfair 
advantage to sources using VOC-HAP solvents as opposed to non-HAP 
solvents because the rule did not allow affected sources using non-VOC 
HAP solvents to switch to VOC solvents and still qualify under the 
pollution prevention alternative. After consideration of this concern, 
EPA changed the final rule to require an equivalent reduction in the 
production-indexed VOC consumption factor, if the reduction in the 
production-indexed HAP consumption factor is achieved by reducing a HAP 
that is also a VOC. If the reduction in the production-indexed HAP 
consumption factor is achieved by reducing HAP that is not VOC, the 
consumption-indexed VOC factor may not be increased. In making these 
changes to the final rule, EPA essentially eliminated the possibility 
of receiving credit, through the pollution prevention alternative, for 
substituting VOC for HAP.
    For example, a given PMPU has established its baseline production-
indexed consumption factors of 10 kg/kg HAP and 20 kg/kg VOC. The 10 
kg/kg HAP factor is made up of 4 kg/kg methanol and 6 kg/kg methylene 
chloride. The 20 kg/kg VOC factor is made up of 16 kg/kg ethanol and 4 
kg/kg methanol. In order to comply with the P2 alternative, the owner/
operator would be required to reduce their 10 kg/kg HAP factor to 2.5 
kg/kg. This could be accomplished in a number of ways. Even if all the 
methanol were eliminated, a reduction of 3.5 kg/kg methylene chloride 
would still be required to yield 2.5 kg/kg. In this case, the 
production-indexed VOC consumption factor would also be decreased by 
the 4 kg/kg MeOH to 16 kg/kg VOC; however, no additional reductions of 
the ethanol would be required.
    Today's final rule also changes the time period over which the 
baseline production-indexed HAP and VOC consumption factors are 
determined. At proposal, baseline production indexed consumption 
factors were determined based on the average values for the first full 
year of operation (or the first year for which data are available). The 
final rule requires that the baseline production-indexed HAP and VOC 
consumption factors be determined based on consumption and production 
values that are averaged over the time period from startup of the 
process until the present time (assuming the process has been in 
operation at least 1 full year), or the first 3 years of operation, 
whichever is the lesser time period. The changes to the baseline 
averaging period were made to ensure the baseline production indexed 
HAP consumption factor reflected normal production.
    Another restriction on the pollution prevention alternative that 
many commenters wanted removed was the exclusion of control devices 
that recycle material back to the process. A number of commenters 
stated that the proposed restrictions on the P2 alternative would 
exclude multiproduct (nondedicated) processes due to strict FDA and 
quality control restrictions on cross-contamination, which oppose 
attempts to reduce the amount of solvent consumed per kilogram of 
product. For this reason, the commenters suggested that the P2 
alternative be modified to give multiple-product facilities greater 
opportunity to make use of this alternative. The specific modification 
suggested by the commenters includes allowing solvent that is 
``returned to the economy'' to be considered as an alternative for 
multiproduct processes. The commenters noted that, for implementation 
purposes, the interested party (first user of the solvent) would need 
to demonstrate that the required fraction of solvent was transferred to 
another (second) user as a raw material, to be used as is, so that the 
second user will purchase that much less solvent. Under this approach, 
the consumption of HAP would be equivalent to the amount purchased 
minus the amount sold. Similarly, two commenters suggested that the P2 
alternative should be revised to allow credit for in-process recycling 
in the calculation of HAP reduction from a process. Although EPA 
recognizes that multiple-product facilities may not be able to take 
advantage of the pollution prevention alternative, the type of program 
whereby one entity certifies the nature and amount of the recovered 
solvent usage by another entity would be difficult and burdensome to 
implement, and would require tracking and verifying the usage of the 
recovered solvent at the second entity. Also, when the recovered 
solvent is sold to the second entity, the first entity does not achieve 
any real emission reduction (i.e., reduction in solvent usage), but 
instead, takes credit for the assumed emission reduction that would 
occur at the second entity. Also, the second entity may not be a 
pharmaceutical manufacturing facility which would result in emission 
reductions being moved across source categories. For these reasons, the 
final rule does not allow credit for sale of recovered solvents in the 
P2 standard. Also, EPA disagrees with the commenters that suggest 
credits be given for in-process recycling because giving a source 
``credit'' for in-process recycling would result in ``double-counting'' 
of the emission reduction. By recycling solvents, the owner or operator 
already has reduced the amount of solvent entering the process (i.e., 
the more that is recycled, the less that is purchased), so further 
credits due to recycling are not necessary. For the reasons given 
above, the restrictions on solvent recycling in the proposed rule 
remain unchanged in today's final rule.
2. P2 Demonstration Summary
    The proposed rule in Sec. 63.1255(a)(4) would have required sources 
that comply with the P2 alternative to maintain records of rolling 
average values of kg HAP/kg production and kg VOC/kg production. The 
proposed rule also specified how production-indexed HAP and VOC 
consumption factors should be calculated (i.e., by dividing annual 
consumption of total HAP or VOC by the annual production rate, per 
process) but did not require the owner or operator to explain how the 
reductions in production-indexed HAP consumption factors are achieved. 
Several commenters stated that EPA should develop data requirements 
necessary to substantiate compliance with the pollution prevention 
alternative. Two commenters suggested that the final rule require 
facilities to submit a ``P2 Demonstration Summary'' that briefly 
describes the pollution prevention methods that were used to achieve 
the reduction in HAP consumption. The commenters stated that 
information on the facility's P2 activities was necessary to verify 
that (1) the HAP consumption data are directly related, on a per 
process basis, to each process that is complying with the P2 
alternative; and (2) the reduction in HAP consumption was achieved via 
pollution prevention methods that meet the Agency's definition of 
pollution prevention. These commenters also noted that, in order to 
provide adequate incentive for facilities to choose the pollution 
prevention alternative, the EPA should ensure that data requirements 
are reasonable and protect confidential chemical formulation data.

[[Page 50303]]

In response to the above comments, today's final rule requires owners 
and operators seeking to comply with the P2 alter native to submit a P2 
Demonstration Summary that describes how the P2 alternative will be 
applied at their facilities. The P2 Demonstration Summary must be 
included in the facility's Precompliance Report, which is submitted 6 
months prior to the compliance date. The minimum requirements of the P2 
Demonstration Summary are listed in Sec. 63.1257(f) of today's final 
rule. These data requirements include descriptions of how each facility 
measures and records HAP consumption and pharmaceutical product 
production on a daily, monthly, and annual basis, and appropriate 
documentation such as operator log sheets, copies of daily, monthly, 
and annual inventories of materials and products, shipment and purchase 
records, tank-specific charts for converting tank-level measurements to 
volume (e.g., gallons) of HAP or product, and temperature/density 
charts for converting tank volume measurements into weight 
measurements. Also, if a facility complying with the P2 standard uses 
the same HAP in more than one process, the owner or operator will be 
required to modify existing methods of tracking HAP consumption at the 
plant, if necessary, to ensure that HAP consumption can be measured for 
each PMPU, as opposed to facility-wide.

G. Alternative Standard

    Commenters requested that EPA consider an alternative standard for 
facilities that treat HAP emissions with add-on control devices. 
Industry commenters stated that an alternative standard would be 
especially useful for facilities that use a common control device to 
treat aggregated emis sion streams. The commenters further stated the 
use of common dedicated control systems should be encouraged rather 
than discouraged for the following reasons: (1) the use of common 
controls will ultimately result in a greater emission reduction because 
processes that are not required to reduce emissions under the rule 
would be controlled as well; (2) the use of common controls may 
facilitate the streamlining of monitoring, performance testing, and 
recordkeeping requirements and as a result reduce the resource burdens 
on both industry and the enforcement agencies; (3) the use of common 
controls may make it easier to assure and assess compliance; and (4) 
common controls may ultimately be more energy-efficient and result in 
lower emissions of secondary pollutants since fewer control devices 
will be employed.
    The Agency agrees with the commenters and decided for the above 
reasons to include an alternative standard for storage tanks and 
process vents that are equipped with add-on control devices in 
Secs. 63.1253(d) and 63.1254(c), respectively. The Agency also agrees 
with the commenters' belief that there will be a number of facilities 
and State regulators that will benefit from a regulatory alternative 
that encourages aggregating and treating emissions with a state-of-the-
art common control device. The alternative standard included in the 
final rule can be applied to individual process vents or storage tanks 
that have emissions that are controlled with add-on control devices or 
to storage tanks and/or process vents that are manifolded together 
prior to treatment in an end-of-line control device (or series of 
devices). The control device (or last control device in a series) must 
achieve an outlet, undiluted TOC concentration of 20 ppmv or less, as 
methane, or calibrated based on the predominant HAP. The control device 
must also achieve an outlet concentration of 20 ppmv or less hydrogen 
halides and halogens. The EPA considers this level of emissions the 
practical level of control for the technologies on which the standard 
is based. The requirement to correct for 3% O2 if supplemental 
combustion air is used is currently under review. This requirement may 
be revised at a later time.
    To simplify applicability of the alternative, all process vent and 
storage tank emissions that are manifolded to a common control device 
are considered as one regulated entity under the alternative standard. 
Nonmanifolded vents are regulated under the rule as otherwise specified 
without taking credit for the manifolded portion of the process.

H. Testing and Compliance Demonstrations

1. Worst-Case Conditions for Testing
    Extensive comments were received on the provisions for absolute or 
hypothetical worst-case testing contained in the proposed rule. Many 
commenters stated that the provisions are not workable, especially in 
batch facilities where multiple streams are routed to common control 
devices. In these situations, owners and operators might be required to 
cease production in order to simulate a hypothetical worst-case test 
for a given device, or would have to artificially affect production in 
order to align emission events for testing that would meet absolute 
worst-case conditions. Commenters emphasized that, in both situations, 
there are safety concerns associated with generating such conditions, 
as well as practical concerns.
    One safety concern raised by the commenters related to both 
absolute and hypothetical worst-case testing is that the manifold 
systems designed to carry emission streams to control devices may not 
be sized to handle the absolute worst-case situation, which could lead 
to potentially explosive situations during absolute and hypothetical 
worst-case testing. Many commenters stated that sources often design 
and install manifold systems at a lower capacity than that of the 
control device itself to prevent such explosion potential.
    The most common practical concern expressed was that the prediction 
of when worst-case conditions would be occurring would be very 
difficult, although many commenters stated that calculating the 
potential maximum inlet loading scenario for a control device used to 
control emissions from multiple batch processing vessels would be a 
difficult, but manageable, task. Many commenters suggested that 
fluctuations related to processing, including sudden changes in 
temperatures or operator, could shift the timing of emission events and 
render any predictions about the timing of specific events invalid. The 
commenters believe that, for devices controlling multiple streams from 
moderately complex facilities, absolute worst-case test conditions 
might never occur within the life of the facility, nor could they 
reasonably be predicted. Additionally, one commenter stated that an 
owner or operator might encounter difficulty in proving to a compliance 
inspector that the conditions of a test were, indeed, run at absolute 
worst case.
    A practical concern with hypothetical worst case conditions raised 
by the commenters is that testing cannot be performed while an actual 
batch is being produced. Based on the commenters' past experiences, 
testing in some cases could result in a process shutdown for 2 weeks, 
resulting in serious production losses.
    One commenter also stated that representative worst case will also 
result in timing uncertainties similar to those of the absolute worst-
case situation, especially when the device is controlling a single 
process with numerous emission episodes.
    For normal testing conditions, commenters believe that the 
restriction to operate within conditions that existed during the test 
should be dropped. They stated that, because the proposed

[[Page 50304]]

standards include an annual compliance period, the commenters argued 
that the control device will constantly see variably challenging 
conditions and therefore, should be allowed to operate under conditions 
that are outside the range of conditions encountered during testing. In 
order to alleviate the EPA's concerns that a test under normal 
conditions may not indicate a control device's performance under more 
challenging conditions, one commenter suggested that an additional 
requirement to provide a design evaluation under more challenging 
conditions be added. Many commenters also suggested that representative 
worst case should be revised to include all control devices, and should 
not be restricted to ``the level for which it was designed.'' 
Additionally, one commenter believes that EPA did not mean to impose 
this limit on representative testing conditions and would like EPA to 
make the appropriate language changes to reflect their intent. Lastly, 
several commenters expressed approval of testing under worst-case 
conditions, but would like the conditions to be more clearly defined.
    The Agency's intent in requiring testing under worst case 
conditions is to document the reduction efficiency of the control 
device under its most challenging conditions. Subsequent to the initial 
compliance test, continuous monitoring of operating parameters 
established during the initial test is a reasonable measure of 
continuous compliance with the efficiency requirement under all 
conditions. Presumably, the control device should function as well or 
better under conditions that are not as challenging.
    Many of the comments regarding worst-case testing conditions are 
related to the restrictive language defining the worst case challenge 
and the difficulty associated with developing a time-dependent 
emissions profile to identify the appropriate test period. In an effort 
to provide more flexibility to owners and operators regarding the 
identification of the proper testing conditions, EPA has redefined the 
worst case ``challenge'' to include challenging conditions that are not 
based on high HAP load. These conditions include cases where 
efficiencies are dependent on other characteristics of emission 
streams, including the characteristics of components and the operating 
principles of the devices. For example, in situations in which non-HAP 
VOC's are present, where the efficiency of a device is most challenged 
by dilute steam characteristics or where specific characteristics of 
the compounds create limitations on control efficiency. In sizing and 
estimating the regeneration requirement for a carbon adsorber, for 
example, all material in the emission stream entering the unit must be 
considered in estimating bed capacity. Likewise, a limiting factor in 
scrubber efficiency is the solubility or reactivity of components in 
the scrubbing liquor. These considerations must be made at the time of 
evaluation of the device for compliance with the rule.
    For worst-case challenges that are based on loading of HAP, EPA has 
also expanded the language describing the development of the emission 
profile. The emissions profile can be developed based on the actual 
processing conditions at the facility, as proposed, in which all 
emission events that can contribute to the control device are 
identified and considered to determine the highest hourly HAP load from 
all events that can occur at the same time. However, in the final rule, 
other options for the emissions profile have been developed that 
consider the facility's limitations based on equipment or conveyance 
and capture systems. Owners and operators can develop emission profiles 
based on equipment, in which the highest hourly HAP-producing emission 
streams that possibly could enter the control device, considering the 
facility's available equipment and HAP materials, are identified as 
appropriate testing conditions. Also, owners and operators have the 
option to develop emission profiles based on limitations of the control 
device or conveyance system. For example, many manifolds are limited in 
flows and concentration limits by fans and LEL monitors. Conducting 
performance tests based on conditions approaching these limits is also 
an option provided in the rule.
    The expanded language on emission profiles eliminates the need for 
allowing owners and operators to test at conditions that are less than 
the worst-case challenge. Therefore, language referring to testing 
under ``representative'' and ``normal'' conditions was deleted from the 
batch testing provisions. Additionally, the added flexibility 
associated describing worst case may alleviate commenter's concerns 
regarding loss of production time.
2. Expedited Test Methods
    Many commenters stated that the test methods referenced in the 
proposal under Sec. 63.1253(b) (1) through (6) will require 
modification, because the methods were developed for continuous 
processes. Based on the commenters' past experience, obtaining approval 
for modifications to test methods often takes 6 to 12 months. 
Therefore, the industry commenters would like for EPA to consider 
adding explicit language in the rule allowing for the use of 
alternative test methods and providing some mechanism for expedited 
approval.
    Specific suggestions from the above commenters for expediting 
approval were to eliminate EPA's validation Method 301 in favor of a 
less burdensome method and to explicitly state that approval of minor 
modifications do not require Method 301 validation, or that approval of 
alternative test methods should not trigger the need for a title V 
permit revision.
    In response to the above comments, the Agency believes that the 
provisions in the final rule that require a site-specific test plan be 
submitted prior to any testing suffice in providing a mechanism for the 
presentation of, and approval of, proposed modifications to EPA test 
methods. In general, Method 301 should be used as a validation method 
for completely new and different testing procedures and instruments 
that have not previously been reviewed by EPA. It is not the Agency's 
intent to require the use of Method 301 for minor modifications to test 
methods such as the relocation of sampling probes.
3. Use of Method 25A
    One commenter stated that Method 25A should be used only after an 
accurate response factor has been determined. The final rule specifies 
the following test methods:
    1. Method 18 for control efficiency in all situations.
    2. Method 25 for control efficiency determination in combustion 
devices.
    3. Method 25A for the 20 ppmv outlet TOC concentration standard.
    4. Method 25A in control efficiency determinations in the 
situations described in the introductory paragraphs of Part 60, 
Appendix A, Method 25 (when direct measurement by FID is appropriate).
    The importance of calibrating a FID reading obtained using Method 
25A with respect to a certain compound (adjustment by response factor) 
depends on how the Method will be used to demonstrate compliance with 
the standard. In general, the EPA believes that an accurate response 
factor is necessary in cases where Method 25A is used to demonstrate 
control efficiency across a device where the composition of the stream 
may change, or in situations where multiple components, including non-
HAP VOC's, are present. Because the relative proportion of

[[Page 50305]]

organic compounds may change across the control device, appropriate 
response factors are needed to accurately quantify TOC at the inlet and 
outlet of a control device. In addition, the final rule allows owners 
and operators the opportunity to demonstrate compliance at the outlet 
of a control device by measuring 20 ppmv TOC or less. The EPA has 
allowed owners and operators to calibrate the FID using methane or the 
predominant HAP expected in the emission stream. The use of methane as 
a calibration gas for the 20 ppmv TOC alternative standard is based on 
the response factor of methane because it is similar to response 
factors of HAP that are predominant in this industry, such as methylene 
chloride and methanol. The EPA intends with this requirement to 
minimize the burden of recalibration for various HAP constituents that 
may actually change over a given period of time.
4. Emission Profiles
    Many commenters requested clarification of the methodology for 
developing an emissions profile, which was contained in 
Sec. 63.1253(b)(iii) of the proposed rule. The commenters stated that 
the definition of emissions profile implies that sources must prepare a 
graph of HAP emissions versus time. However, because EPA included the 
language ``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 average hourly block 
average'', the commenters thought that EPA's intent was not to profile 
emissions versus time, but rather to simply list each batch episode and 
the average hourly HAP emissions loading from each episode. 
Additionally, some commenters stated that the emission profile method 
seemed very complicated, and that personnel with operating experience 
can quickly determine the worst-case conditions for a control device 
without producing the extensive information required by the emissions 
profile. One commenter suggested changing the language of 
Sec. 63.1253(b)(7)(iii)(A) by eliminating the phase ``must include,'' 
so that sources can have the option of discussing an alternative means 
of determining appropriate test conditions with the permitting 
authority.
    The Agency's intent, when requiring the development of an emissions 
profile, is to determine the maximum HAP loading to a control device 
over time. Therefore, the rule requires that the emissions to the 
device be evaluated by plotting HAP emissions versus time. The EPA has 
not, in the final rule, changed the requirements for developing the 
emissions profile, although EPA did clarify the exact language in the 
final rule to address the commenter's concerns about the clarity of the 
requirement. Additionally, two other methods for developing the 
emission profile were provided in the final rule.

I. Equations

1. Use of Equations in 1978 CTG
    As part of the procedure to demonstrate compliance with the 
emission reduction standard for process vents, the final rule requires 
the owner or operator to determine uncontrolled emissions from each 
vent. Equations to calculate emissions from certain unit operations are 
provided in the rule. Numerous commenters requested that the rule also 
allow the use of similar equations for the same unit operations that 
are presented in the 1978 CTG. The commenters stated that although the 
two procedures give different results, they are based on the same 
fundamental principles and neither gives better results. The commenters 
provided the following additional reasons for allowing use of the 
equations from the 1978 CTG: (1) the MACT floor was based on data from 
the industry, which were estimated using the procedures in the 1978 
CTG, (2) sources are already using the procedures in the 1978 CTG to 
comply with other regulatory programs and would incur significant costs 
to invest in a program and data systems to develop and maintain a 
second method for estimating emissions, (3) maintaining two sets of 
emission estimates would make State review and compliance efforts 
complex and confusing, possibly leading to compliance actions for 
perceived violations of one estimate but not the other, and (4) the 
emission estimation equations in the rule are based on the 1994 ACT, 
which has not undergone public review and comment.
    The EPA reevaluated the procedures for calculating uncontrolled 
emissions and concluded that except for two situations, the equations 
in both the 1978 CTG and the 1994 ACT documents give acceptable 
estimates of emissions for the purposes of this rule. Therefore, both 
sets of equations, except as noted below, are included in the final 
rule for existing sources. The two situations for which emission 
estimation procedures in the 1978 CTG are not acceptable for this rule 
are: (1) purging with streams that have high flow rates and (2) heating 
when the final temperature is higher than 10 K below the boiling point. 
The EPA believes this change mitigates the commenters concerns because 
the two situations where the 1978 CTG procedures are not allowed affect 
a small number of streams. Owners and operators will have to redo 
calculations for existing processes under these two conditions. In 
addition, the owner or operator will have to calculate uncontrolled 
emissions for those events that the owners/operators have only 
controlled emission estimates. This is because the 1978 CTG uses 
condenser temperature instead of vessel temperature. Details about the 
equations for purging and heating are provided in sections VI.I.2.b and 
VI.I.3.
2. Procedures to Estimate Emissions from Purging
    a. Equation. The equation for purging was changed in the final rule 
because the term that accounts for the increase in flow rate due to the 
volatilization of HAP was inadvertently left out of the equation in the 
proposed rule (i.e., the purge flow rate needs to be multiplied by the 
ratio of the total pressure to the partial pressure of noncondensables 
at saturation). The revised equation is identical to the equation in 
the 1994 ACT and gives the same results as the equation in the 1978 CTG 
as long as the total pressure is equal to 760 mmHg.
    b. Saturation level for large purge streams. The rule requires an 
owner or operator to assume a purge stream greater than 100 scfm is 25 
percent saturated. One commenter believes the assumption that the vapor 
phase is 25 percent saturated rather than 100 percent saturated is 
merely a different assumption and is not based on better information. 
The commenter also stated that assuming streams are 100 percent 
saturated is more conservative because it will overestimate emissions, 
whereas the 25 percent assumption will sometimes overestimate and 
sometimes underestimate emissions.
    The assumptions that purge streams with flow rates less than or 
equal to 100 scfm are 100 percent saturated, and that purge streams 
with flow rates greater than 100 scfm are 25 percent saturated, are 
based on modeling analyses that are described in the 1994 ACT. In the 
1994 ACT, the mass transfer (of toluene) from the liquid to the purge 
stream was estimated using various correlations and a range of design 
and operating parameters. The correlations showed the purge streams, 
especially purge streams with high flow rates, were well below 
saturation for all but the most agitated vessels or vessels with very 
shallow head space. Assuming these large streams are completely 
saturated would result in significantly overestimated uncontrolled 
emissions.

[[Page 50306]]

    Overestimating uncontrolled emissions leads to at least two 
problems. First, for a condenser, overestimating uncontrolled emissions 
means the control efficiency of the condenser will be overstated (and 
the condenser will operate at a higher temperature than is actually 
needed to meet the standard). A second problem with overestimating the 
uncontrolled emissions is that even if the control efficiency is being 
met (say with an incinerator), the quantity of emissions reductions 
would also be overestimated, which, if this stream were used in 
emissions averaging, would result in overestimation of credits. To 
mitigate these problems, EPA reviewed the results of the modeling 
analyses and selected values that while still conservative greatly 
reduce the potential amount of overestimation. The correlations showed 
that under all types of conditions, the degree of saturation declines 
rapidly with increases in purge flow rate up to about 100 scfm, and 
then nearly levels off; the ``knee'' of the curve was at about 100 scfm 
for every scenario. For all modeled scenarios, purge flow rates greater 
than 100 scfm were always less than 25 percent of saturation. Based on 
these results, the EPA believes that assuming purge streams with flow 
rates greater than 100 scfm are 25 percent saturated rather than 100 
percent saturated results in a better estimate of emissions, more 
accurate operating parameters, and reasonable credits for emissions 
averaging. Thus, the requirement to assume purge streams with flow 
rates greater than 100 scfm are 25 percent saturated was retained in 
the final rule; but an owner or operator also may conduct an 
engineering assessment to show that another value is more appropriate.
3. Procedures to Estimate Emissions from Heating
    a. Heatup temperature within 50 K of boiling. When the contents of 
a vessel are heated to a temperature within 50 K of boiling, the 
proposed rule would require the owner or operator to calculate 
emissions in increments. One increment covered the range from the 
initial vessel temperature to the temperature 50 K below the boiling 
point. The procedure then required estimates for each 5 K temperature 
range up to the final heatup temperature. One commenter believes 
calculating over 5 K increments is overly conservative. Other 
commenters believe the approach is an error because it differs from the 
approach in the 1994 ACT.
    As noted in section VI.I.1, EPA is changing the rule to include the 
equations from the 1978 CTG and the 1994 ACT as well as the approach in 
the proposed rule for most heatup conditions at existing sources. In 
response to industry concerns, the EPA is also reducing the temperature 
cutoff from 50 to 10 K below the boiling point. The concept of a cap is 
retained because the procedures in the 1978 CTG and the 1994 ACT can 
greatly overestimate emissions when the final heatup temperature is 
close to the boiling point. The equation in the 1978 CTG estimates 
emissions assuming equilibrium at the temperature of a receiver (i.e., 
the equation uses a ratio of the condensables partial pressure to the 
noncondensables partial pressure at equilibrium). This procedure does 
not specify what equilibrium conditions should be used in the absence 
of a condenser. If the equilibrium partial pressures at the final 
heatup temperature are used, the equation overestimates emissions. The 
overestimate is most significant when the final heatup temperature is 
close to the boiling point because the partial pressures ratio 
(condensables to noncondensables) increases exponentially with 
increasing temperature, and goes to infinity as the temperature 
approaches the boiling point. Using the average of the ratios at the 
initial and final temperatures, as is done in the 1994 ACT, also can 
overestimate emissions. The EPA believes calculating emissions over the 
5 K increments when the final heatup temperature is above the 
temperature 10 K below the boiling point is a reasonable compromise 
between the accuracy of the estimate and the effort needed to perform 
the calculation.
    b. Emissions From Process Condenser. Under the proposed rule, if 
the contents of a vessel are heated to the boiling point and the vessel 
operates with a process condenser, the emissions would be calculated 
using both the heatup and displacement equations. One commenter noted 
that this procedure results in negative emissions. The EPA reevaluated 
this equation and determined that this result occurs only if the 
process condenser operates at a temperature lower than the initial 
temperature of the vessel. To correct this problem, the final rule 
states that either the heatup procedure in the 1978 CTG or a variation 
of this procedure is to be used. The variation allows the owner or 
operator to use a vapor-liquid equilibrium relationship other than 
Raoult's law and to use the actual system pressure rather than assuming 
the system is at atmospheric pressure. Both procedures are also 
applicable when the condenser temperature is higher than the initial 
temperature of the vessel.
4. Vapor-Liquid Equilibrium Relationships for Multicomponent Systems
    To estimate emissions, the rule specifies that owners and operators 
assume one of four vapor-liquid equilibrium (VLE) relationships apply, 
depending on the system conditions. These relationships are: (1) 
Raoult's law, (2) Henry's law, (3) a VLE relationship based on the use 
of activity coefficients (obtained experimentally or from models) to 
correct for nonideality in the liquid phase, and (4) the assumption 
that components of the system behave independently so that the sum of 
all HAP vapor pressures is equal to the total HAP partial pressure. 
Once the applicable VLE relationship is established, the HAP partial 
pressure(s) can be determined and used in the applicable equation to 
estimate the HAP emissions.
    Two commenters expressed concern about some of the VLE 
relationships that the rule requires for estimating emissions from 
multicomponent systems. The commenters concur with EPA that Raoult's 
law is appropriate for miscible systems. The commenters also 
acknowledged that use of Henry's law is generally more accurate that 
Raoult's law in predicting vapor mole fraction for mixtures below the 
solubility limit, but they stated that this approach is excessively 
difficult and unworkable because Henry's law constants are not 
available for many of the solvents and reagents used in the 
pharmaceuticals industry. Therefore, the commenters would prefer to use 
Raoult's law for these mixtures. For multicomponent systems in which 
the compounds are not miscible or are only partially miscible, the 
commenters opposed the use of equilibrium relationships based on 
activity coefficients because developing activity coefficients is 
burdensome. As an alternative, the commenters recommended using an 
approach in which each liquid phase is treated independently, and 
emissions from each phase are calculated separately.
    The final rule clarifies EPA's intent regarding the use of vapor-
liquid equilibrium relationships. If the components are miscible in one 
another, Raoult's law may be used when it is applicable. However, if a 
miscible solution is not well characterized by Raoult's law, activity 
coefficients must be used. For dilute aqueous mixtures, Henry's law 
must be used. The EPA rejects the commenter's argument to use

[[Page 50307]]

Raoult's law due to the lack of Henry's law constants; Table I of 
appendix C in 40 CFR 63 contains Henry's law constants at 25 deg.C and 
100 deg.C for 125 of the most common organic HAP compounds. For HAP 
compounds that are not on the list, the owner or operator must estimate 
the Henry's law constant. For systems with multiple liquid phases, the 
owner or operator may either use activity coefficients or, as suggested 
by the commenter, assume the components behave independently and assume 
the HAP vapor pressures and partial pressures are equal.
5. Emission Estimation Equations Versus Engineering Assessments
    The rule lists two conditions under which an owner or operator may 
conduct an engineering assessment to show that equations in the rule 
are not appropriate: (1) if available test data and the results of 
calculations using an equation differ by more than 20 percent and (2) 
if the owner or operator can demonstrate through any other means that 
the emission estimation equations are not appropriate for a given batch 
emissions episode. Several commenters stated that both conditions 
should be deleted from the rule. The commenters rationale for deleting 
the conditions shows the language in the proposed rule did not convey 
EPA's intent. As a result, the conditions are rewritten in the final 
rule for clarity, and additional clarification is provided in the 
following paragraphs of today's notice.
    Batch emission episodes may be due to a unit operation that is 
described by an equation in the rule or to a unit operation that is not 
described by an equation in the rule. Estimating emissions using the 
applicable equation is always the standard approach for emissions 
episodes that are covered by an equation. However, an owner or operator 
also always has the opportunity to conduct an engineering assessment to 
demonstrate and get approval to use another emission estimation 
technique. The intent of the first condition is to indicate that an 
owner or operator could include such a discrepancy between test data 
and calculations in an engineering assessment and it would be 
considered evidence that the equation is not appropriate (provided, of 
course, that the permitting authority agrees that the test data were 
obtained under ``representative conditions''). The purpose of the 
second condition is to indicate that other information may also be used 
in the design evaluation as evidence that an equation is not 
appropriate. Again, the permitting authority would have to approve the 
use of any proposed alternative to the equation.
    The conditions have nothing to do with estimating emissions for 
batch emissions episodes from unit operations that are not described by 
equations in the rule. For such emissions episodes, an owner or 
operator would be required to conduct an engineering assessment to show 
how emissions will be estimated.
6. Calculation of Controlled Emissions
    Two commenters stated that the rule should allow the use of 
techniques in the 1978 CTG to calculate controlled emissions from a 
condenser. The commenters stated that the procedures in the proposed 
rule cannot be used because they specify the use of system temperature, 
whereas the correct technique, which is used in the 1978 CTG, is to use 
the exit gas temperature from the condenser. One commenter also stated 
that even when the equations in the rule and the 1978 CTG are 
identical, ``implementation differences'' cause the controlled 
emissions estimates to differ. To address the commenters' concerns, the 
final rule specifies both the applicable equation and any changes to 
the temperature or volume that are needed for calculating controlled 
emissions.

J. Monitoring Requirements

    Many commenters objected to the use of monitoring parameters for 
the determination of a source's compliance status on a continuous 
basis. Their central issue, for many emission streams controlled in 
this industry (e.g., batch, nondedicated, possibly manifolded together 
and routed to common control), is that an exceedance of a parameter 
level, as measured on 15-minute intervals and averaged over a 24-hour 
basis, may not necessarily constitute a violation of the 93 percent 
control requirement for the process for the following reasons:
    1. If the parameter is conservative, the device will operate above 
the required efficiency;
    2. The loading on the control device may be less than the assumed 
loading used to set the parameter, so the device provides adequate 
control even though the parameter has not been attained;
    3. The actual compounds in the emission streams may be easier to 
treat than those used to set the parameter; and
    4. The excursion may occur when there are little or no HAP 
emissions from the process routed to the device.
    The EPA had solicited comment on this issue, and at that time, had 
questioned why the industry couldn't set multiple parametric levels for 
control devices to account for different operating scenarios. The 
commenters countered that, especially in the case of manifolded, end-
of-line devices, it is not possible to predict with precision what 
conditions will exist at any point in time. Rather than establishing, 
up-front, a complex ``grid'' of parameters that will serve all 
potential combinations of operating scenarios, they would want to set 
conservative parametric levels as a screening mechanism for determining 
whether or not emission limits might have been exceeded, with an option 
to evaluate actual parameter excursions on a case-by-case basis after 
exceedances had occurred to determine whether an emission limit was 
actually exceeded.
    The commenters recommended that the rule provide that a parameter 
exceedance must be reported to the permitting authority, with the 
opportunity to rebut the presumption that the emission limit(s) have 
been exceeded. Other commenters suggested that sources be treated in a 
manner consistent with the Compliance Assurance Monitoring (CAM) rule, 
which provides only that an excursion of a monitored parameter is an 
indication that an emission standard may have been exceeded, but makes 
no automatic finding of a violation of that emission standard.
    In general, EPA recognizes two basic approaches to assuring that 
control devices used by the owner or operator to achieve compliance are 
properly operated and maintained so that the owner or operator 
continues to achieve compliance with applicable requirements. One 
method is to establish monitoring as a method for directly determining 
continuous compliance with the applicable requirements. The Agency has 
adopted this approach in part 63 standards, and is committed to 
following this approach whenever appropriate in future rulemakings. 
Another approach is to establish monitoring for the purposes of 
documenting continued operation of the control devices that are 
designed to provide a reasonable assurance of compliance, indicating 
excursion from these ranges, and correcting problems creating 
excursions. This second approach is outlined in the CAM rule, which 
applies to sources that are not currently subject to part 63 standards.
    When determining appropriate monitoring options, EPA considers the 
availability and feasibility of the following monitoring strategies in 
a ``top-down'' fashion: (1) CEMS for the actual HAP emitted, (2) CEMS 
for HAP surrogates, (3) monitoring operating parameters, and (4) work 
practice standards. In evaluating the use of

[[Page 50308]]

CEMS in this standard, monitoring of individual HAP species was not 
found to be reasonable or technically feasible for many streams. 
However, in the case of continuous monitoring of surrogates, continuous 
TOC monitoring is considered a more viable monitoring option and is 
provided for some instances in the rule. (See discussion on alternative 
standard and on monitoring for carbon bed systems.) Monitoring of 
control device operating parameters is considered appropriate for many 
other emission sources, and therefore, most of the other monitoring 
options provided in the final rule are based on parametric monitoring.
    The EPA has considered the commenters' argument that an exceedance 
of a monitoring parameter is not necessarily an exceedance of an 
emission limit, especially as described in the generic situations 
provided above. In the first three situations, EPA believes that as 
long as the source is given the flexibility to select operating 
parameters, including the option retained from the proposed rule to 
allow the owner or operator to set multiple parameter levels for 
different operating conditions, then the burden is on the source to 
remain within the parameter or parameter(s).
    To address the potential disparity between parameter limit 
exceedances and emission limit exceedances, the final rule contains two 
different types of continuous compliance violations. Where a source is 
using a CEMS to monitor compliance with the 20 ppmv alternative 
standard, an exceedance is defined as a violation of the emission 
limit. Similarly, because the exit gas temperature of a condenser is so 
closely correlated with emissions, a condenser temperature exceedance 
is considered a violation of the emission limit. Exceedances of other 
types of parameter limits are defined as violations of an operating 
limit, rather than violations of the emission limit.
    In response to industry's preference to evaluate parameter levels 
after an exceedance of a conservative parameter level to determine 
whether an emission limit was exceeded (thereby eliminating the need 
for a complex grid of preset parameter levels), EPA believes that the 
establishment of compliance levels prior to operation of the device or 
process is imperative; otherwise, the constant opportunity for 
rebutting a violation of the standard would render the standard 
unenforceable. While EPA is sensitive to industry's need to minimize 
its compliance burden, EPA believes that the burden placed on State 
agencies to consider the amount of information that the rebuttable 
presumption option would encourage is not reasonable.
    In response to the fourth generic situation described by industry, 
EPA has provided in the final rule, clarification of situations (no 
flow) when exceedances of preset parameters would not constitute a 
violation of the standard.
    For reasons described above, EPA rejects the assertion that the 
parametric levels should not be used as a direct indicator of 
compliance. The EPA believes that conditions in the proposed rule which 
have been retained in the final rule including options for setting 
parameters, coupled with clarifying the averaging times for compliance 
determinations and establishing valid data criteria for monitored 
parameters should address concerns of commenters, while retaining the 
enforceability of the standard. The final rule provides options for 
presetting multiple parameter levels to account for variation in batch 
emission stream characteristics within emission sources (as proposed), 
and to account for variability in combined stream characteristics in 
manifolds.
    The final rule provides owners and operators with the option of 
setting averaging times based on either a ``block'' of time suitable 
for the expected variations of emission stream characteristics from a 
batch process (determined by the owner or operator, with some 
restrictions), or a 24-hour basis (as proposed).
    The final rule also provides owners and operators with an 
opportunity to verify compliance based on a review of operating logs 
during periods of exceedances. Exceedances will not constitute 
violations of subpart GGG during periods when a parameter has been set 
based on worst-case conditions, or other conditions that were not 
representative of the conditions in the device during the exceedance, 
if the owner or operator has predetermined other levels that ensure 
compliance with the standards for these representative periods. If 
predetermined levels were established, the owner or operator can also 
determine compliance for discrete streams in manifolds by referencing 
to these limits.
    Additionally, monitored data obtained during periods in which no 
flow to the control device occur should not be considered valid; during 
such periods, the final rule allows for the exclusion of such data from 
the daily or block averages. The use of a flowmeter to identify and 
exclude such periods from compliance average is therefore required in 
the final rule, if they cannot otherwise be predicted.

K. Recordkeeping and Reporting Requirements

    Issues related to the amount and type(s) of recordkeeping and 
reporting requirements that were included in the proposed rule were 
raised by commenters representing both industry and enforcement 
agencies. The pharmaceutical manufacturing industry involves a wide 
variety of processes, products, and resulting emissions. In order to 
demonstrate compliance with the necessary MACT requirements, detailed 
records are needed to have a reliable, documented record of how the 
source complied with the regulation. The EPA has made a concerted 
effort to reduce the recordkeeping requirements of the final 
pharmaceutical rule. The EPA recognizes that unnecessary recordkeeping 
and reporting requirements would burden both the affected source and 
EPA/State enforcement agencies and will continue to review requirements 
to identify and implement other possible streamlining measures.
    The EPA has reviewed the recordkeeping and reporting requirements 
required by the proposed rule and has eliminated those areas where 
duplicative and inapplicable requirements were proposed. Most of these 
changes involved areas where the referenced General Provision 
requirements were not directly applicable to this industry. 
Clarifications and/or additional language have been added to tailor the 
recordkeeping and reporting requirements to the relevant data needs 
from pharmaceutical manufacturing operations. Table 1 in today's final 
regulation was modified to include a summary column describing the 
relevant information in each part of the General Provisions, and more 
information was added to better relate the requirements of the final 
rule and those in the General Provisions.
    Comments on precompliance reporting were varied depending on the 
commenter's perspective and experience. Some commenters viewed the 
precompliance reporting requirements as burdensome and restrictive. One 
commenter stated that submittal dates for reports and notifications due 
prior to the compliance date are much too early, unnecessary, and can 
be counterproductive. Two commenters stated that the Precompliance 
Report should be due only 3 months prior to the compliance date. Other 
commenters argued that the ``early'' due date for the Precompliance 
Report is valuable because it provides a practical means of

[[Page 50309]]

ensuring that a source is aware of the upcoming deadline. One of the 
commenters also stated that the description of test conditions and 
limits of operation for control devices tested under normal conditions 
and the corresponding monitoring parameter values should be submitted 
as part of the Pretest Notification Report rather than with the 
Precompliance Report. In response, the Agency revised the submittal 
dates for the precompliance report and the emissions averaging 
implementation plan to 6 months prior to the compliance date. The 
Agency believes the final submittal dates and data requirements for the 
precompliance report are adequate to provide the enforcement agencies 
with sufficient time to review the information.
    Some commenters also suggested that the use of alternative 
parameters be included in the precompliance report and that periodic 
testing be done to correlate actual emission rates to alternative 
parameters. The EPA response to this issue is addressed in section VI.L 
of this preamble.
    One commenter suggested that sources be required to establish an 
effective environmental management system to eliminate much of the 
paperwork burden associated with the proposed recordkeeping and 
reporting requirements. The Agency believes an effective environmental 
management system can be used to comply with all the requirements of 
the final rule provided the system is based on meeting the MACT 
requirements in the final rule. Sources are free to submit an 
alternative compliance plan to the appropriate agency to review/approve 
in lieu of any or all recordkeeping or reporting requirements.
    Commenters also raised issues related to data availability stating 
that the proposed requirements were unreasonable, impracticable, and 
more stringent than those for other industries. The Agency does not 
agree with these comments.

L. Permitting and Compliance Options/Change Management Strategy

1. Proposal Comments Received
    In the April 1997 proposal, the EPA solicited comment on the 
interaction of this standard with the title V operating permits 
program, implemented at 40 CFR part 70. In addition, the Agency 
requested comment on an approach which would incorporate by reference 
the Notification of Compliance Status Report (NOCSR) into a 
pharmaceutical manufacturing facility's title V permit. The EPA also 
solicited comment on the types of operational changes that would 
trigger revision of the operating permit under title V. However, in 
soliciting comment on these issues, the Agency did not propose to 
revise part 70 through the establishment or implementation of subpart 
GGG.
    Commenters to the proposed subpart GGG raised several issues with 
respect to process changes at pharmaceutical facilities, which they 
claimed would result in a potentially unmanageable title V permit 
administrative process. The pharmaceutical industry produces a wide 
range of existing and new and/or improved products primarily through 
the use of nondedicated equipment operated in a batch production mode. 
Commenters were fearful that frequent changes in the use of existing 
equipment as well as the additions of new equipment at pharmaceutical 
facilities would require frequent revisions to the operating permits 
for these facilities. These commenters predicted that such permit 
revisions would result in delays in implementing process changes and 
cause significant new administrative burdens on the facility and 
permitting authority.
    The preamble to the proposed rule described the NOCSR as the 
compliance ``blueprint'' for implementation of the standard, containing 
``[a]ll information regarding documentation of the facility's 
compliance status with regard to the standard. . . .'' This information 
would include ``process descriptions, emissions estimates from those 
processes, control device performance documentation, and continuous 
compliance demonstration strategies, including monitoring.'' The EPA 
solicited comment on whether the NOCSR could be initially incorporated 
by reference into the title V permit and whether the permit could be 
revised as necessary through quarterly update reports. The proposal 
posited that only changes requiring site-specific approval (such as the 
use of a monitoring parameter that was not identified in the standard) 
would trigger some significant review action under title V. The Agency 
expressed the view that this approach would allow enough flexibility 
for sources to make operational changes as necessary as well as changes 
to operating and compliance procedures without additional approval, if 
the changes were straightforward, and would assure that the compliance 
plan for the facility would always be reasonably current.
    Most commenters did not support an ongoing implementation strategy 
based on permit revision for operational changes, even if it could be 
streamlined. Several industry commenters strongly reiterated concerns 
about the potentially huge administrative problems associated with 
implementing subpart GGG within title V permits.
    In particular, PHRMA recommended an approach under which facilities 
that have been issued a title V permit before subpart GGG is finalized 
would be required to apply for a minor permit modification (MPM) by the 
due date for the NOCSR. The suggested MPM application would include: 
(1) a list of applicable subpart GGG requirements that should be 
included in the permit itself (including a ``menu'' of applicable 
process vent, tank, and wastewater standards); (2) a requirement for 
the facility to submit a compliance plan that outlines the regulated 
entities within the affected source (such list should include the 
identification of regulated processes, process vents, tanks, and 
wastewater PODs; a determination as to which substantive standard 
applies to each; and a list of corresponding testing, monitoring, 
record keeping, and reporting requirements); (3) a requirement for the 
facility to update the plan when a compliance requirement changes; (4) 
a requirement to submit the plan to the permitting authority every 6 
months; and (5) a requirement to operate in accordance with the plan. 
For facilities that have not been issued a title V permit until after 
subpart GGG is finalized, a facility's initial permit would be issued 
to include these five items. Facilities that trigger new source MACT 
would be required to apply for a significant permit modification (SPM) 
prior to implementing the triggering change. Under this approach, PHRMA 
believes that a source could make most changes at the affected facility 
without triggering a title V permit revision, provided the compliance 
plan was updated to indicate the new regulated entities and/or new 
requirements that would result from the change, thus avoiding delay 
while ensuring that the part 70 requirements are satisfied through 
timely recording of the requirements applicable to the source.
    Title V requires operating permits to assure compliance with all 
applicable requirements at a source, including a section 112 standard 
such as subpart GGG. An existing source subject to subpart GGG must 
include in its operating permit by the time of the standard's 
compliance date--the latest date by which most provisions of the 
standard would become applicable requirements at existing affected 
sources-sufficient permit terms and conditions to assure compliance 
with the standard. If a source's initial title V permit does not 
include terms to assure compliance with subpart GGG by the

[[Page 50310]]

compliance date, the permit must be revised to incorporate the standard 
not later than 18 months after the standard's promulgation. See CAA 
section 502(b)(9). This will ensure that subpart GGG is reflected in 
title V permits for pharmaceutical facilities by the time of the 
compliance date and as required by statute, since the compliance date 
for subpart GGG is up to 36 months after the standard's promulgation 
(see section 63.1250(f)(1). Consistent with section 502(b)(6) of the 
Act, however, if the standard is promulgated when fewer than 3 years 
remain on a major source's permit term, a permitting authority's 
program may reflect the option not to require revisions to the permit 
to incorporate the standard. The Act permits State programs to require 
revisions to the permit to incorporate the standard in such instances, 
however, so any sources with fewer than 3 years remaining on their 
permits upon the promulgation of today's action, should consult their 
State permitting program regulations to determine whether revision to 
their permits is necessary to incorporate subpart GGG.
    The EPA does not believe that PHRMA's recommended permitting 
approach would ensure that operating permits for pharmaceutical 
facilities assure compliance with subpart GGG by the standard's 
compliance date and subsequently during the permit term. PHRMA 
recommends including basic permit content information--such as the 
identification of regulated emissions units and activities, and their 
associated compliance requirements--in an off-permit compliance plan, 
when such information is appropriately required in the permit. The 
proposal addressed this point by soliciting comment on the 
incorporation by reference into the facility's permit of the NOCSR. The 
EPA believes that it is possible to provide the flexibility sought by 
pharmaceutical manufacturers while maintaining Congress' intent that 
the title V permit contain all of the applicable Federal requirements. 
However, neither the proposal nor today's final rule purports to revise 
part 70 to accomplish this transfer of permit content from the permit 
to an off-permit compliance plan, and EPA does not believe that a MACT 
standard such as this is the appropriate vehicle to accomplish 
revisions to part 70. A separate rulemaking is currently underway to 
revise part 70, and features of today's approach may be adopted in that 
rulemaking.
    Moreover, for facilities that have been issued a title V permit 
before the MACT is promulgated, PHRMA's recommended approach would not 
meet the requirement that these permits assure compliance with subpart 
GGG by the standard's compliance date. In addition, the approach would 
not satisfy section 502(b)(9)'s requirement that such permits be 
revised not later than 18 months after the promulgation of subpart GGG. 
PHRMA recommended that facilities that have been issued a title V 
permit before the MACT is promulgated be required only to apply for a 
MPM by the due date for the NOCSR. The due date for the NOCSR under 
subpart GGG can fall as late as 150 days after the compliance date, see 
section 63.1260(f), and the compliance date for existing sources is 
within 3 years after the promulgation date of the standard, see section 
63.1250(f)(1). Finally, under section 70.7(e)(2)(iv), a permitting 
authority may have up to 90 days following receipt of a MPM application 
to issue an actual MPM reflecting subpart GGG.
    Therefore, PHRMA's recommended approach would allow existing 
sources with title V permits to delay revisions to their permits to 
incorporate subpart GGG as long as 44 months--36 months plus 5 months 
plus 3 months--after promulgation of the standard, when section 
502(b)(9) requires such revisions to be accomplished not later than 18 
months after promulgation of the standard. In addition, of course, 
PHRMA's approach would not ensure that existing sources subject to 
subpart GGG have permits that assure compliance with the standard by 
the time of the standard's compliance date. For these reasons, EPA 
declines to adopt PHRMA's recommended approach in its entirety. 
However, as stated above, EPA believes the Agency can meet the 
industry's needs while complying with statutory obligations and 
Congressional intent.
    The EPA agrees that some types of pharmaceutical operational 
changes may be subject to frequent title V revisions. As a result, the 
EPA met with industry representatives to clarify industry comments 
received on the proposal. In response, EPA developed a recommended 
approach for managing changes involving reconfigurations of existing 
equipment and the additions of certain new equipment subject to the 
pharmaceutical MACT through title V permits. This change management 
strategy in general adopts aspects of both the EPA proposal (e.g., to 
incorporate the NOCSR into the title V permit) and of industry 
suggestions for managing change made subsequent to the NOCSR.
2. Description of Recommended Approach
    a. General strategy for change management. This notice presents an 
interpretation of the current regulations at 40 CFR part 70, for 
purposes of an experimental permitting approach under which title V 
operating permits may be designed to implement subpart GGG and provide 
operational flexibility without frequent permit revision. This approach 
represents EPA's current views on these issues and, while it may 
include various statements that permitting authorities or sources may 
take certain actions, these statements are made pursuant to EPA's 
preliminary interpretations and, thus, are not binding on any party as 
a matter of law. Only if EPA makes its interpretations final through 
rulemaking will they be binding as a matter of law. This means that 
States are not required to follow this approach in implementing subpart 
GGG through their operating permit programs, and EPA will fully and 
fairly consider all comments and petitions calling upon the Agency to 
object to permits that rely upon the change management strategy.
    Nonetheless, the Agency encourages States to use the flexibility 
described in this preamble wherever they believe that the change 
management strategy will assure compliance with subpart GGG, while 
implementing the MACT standard in an efficient, streamlined fashion. 
The EPA intends to use this strategy where requested by a 
pharmaceutical facility and where the Agency would to be the permitting 
authority of jurisdiction under 40 CFR part 71.
    It should also be noted that the described change management 
strategy is only tailored toward meeting the requirements of subpart 
GGG. Additional strategies are likely to be needed to address the 
consequences of a particular change relative to other relevant 
applicable requirements [e.g., minor or major new source review (NSR)], 
particularly when the change would cause an increase in the type or 
amount of air pollutants released.
    Under EPA's interpretation, the Agency envisions that all title V 
permits implementing the pharmaceutical MACT will contain two principal 
structures: the incorporated pharmaceutical MACT standard and a 
detailed description of the array of process equipment, control 
devices, and initial operating conditions at the subject facility. In 
addition, the title V permit may contain a third structure implementing 
the change management strategy through prior approval of

[[Page 50311]]

reasonably anticipated alternative operating scenarios [see section 
70.6(a)(9)].
    First, as it must under title V and part 70, the title V permit 
will contain permit terms and conditions that incorporate subpart GGG. 
These permit terms will include the requirements of the MACT rule 
applicable to PMPUs and other equipment that comprise pharmaceutical 
manufacturing operations, including all requirements for identifying 
affected emissions sources and applicable emission standards, 
calculating emissions, demonstrating compliance (e.g. requirements for 
the operation of control devices), and for testing, monitoring, record 
keeping and reporting.
    The second permit structure, from the NOCSR submitted by the source 
owner, shows current operations and how the source is complying at that 
time with all the relevant requirements of subpart GGG (which were 
incorporated as the first permit feature). Named and described in the 
permit are the specific processes in operation at the time of the NOCSR 
and all those that will be run during the term of the permit; the PMPUs 
and other regulated emissions equipment and activities associated with 
the pharmaceutical manufacturing operations; the linkages between 
identified emissions points and control devices used for compliance 
with the standard; and the linkages between the identified emissions 
points and their associated compliance obligations under subpart GGG. 
The calculations demonstrating compliance must be submitted by the 
source in support of these linkages.
    The third permit structure addresses the management of frequent 
changes at pharmaceutical facilities subject to subpart GGG. This 
structure generally will allow permit revisions at pharmaceutical 
facilities to be avoided without sacrificing compliance assurance, in 
instances where reasonably anticipated alternative operating scenarios 
can be established in title V permits and supported with detailed 
operating logs (onsite records). If a source owner or operator can 
reasonably anticipate the type of changes and operating scenarios 
relative to the current operations defined by the NOCSR (i.e. the 
baseline operating scenario) that will use the equipment identified in 
the permit and will occur over the life of a title V permit, part 70 
provides for the permitting of such changes through alternative 
operating scenarios. However, because equipment configurations at 
pharmaceutical facilities can change frequently (and without complete 
predictability) in response to product changeovers, new drug 
introductions, and process improvements, the allowed operating 
scenarios need to be constructed in the title V permit in a ``menu'' 
format.
    Under the permit menu for subpart GGG, a pharmaceutical source will 
be able to vary its array of processes and control devices from the 
permitted baseline scenario without need for permit revision, provided 
that these ways have been preapproved as alternative operating 
scenarios. This could include shifting process equipment, adding 
replacement process equipment, eliminating equipment within the same 
process, or changing the type or amount of solvent in order to improve 
existing processes or to add new processes. These changes, however, 
must not exceed the capacity of the control and process equipment as 
set out in the permit, and must always comply with the permit and all 
applicable requirements. The Agency again notes that such changes 
occurring under the change management strategy are preapproved for 
subpart GGG purposes only and other actions and/or strategies are 
necessary where other applicable requirements are implicated by such 
changes.
    The change management strategy also addresses the addition of new 
condensers and of new process equipment subject to subpart GGG. 
Condensers are the only new control devices currently that may be 
advance approved and only in limited circumstances (see section 
VI.L.2.b. Additional Considerations). Bringing new process equipment 
into service may be accomplished in two situations as a reasonably 
anticipated alternative operating scenario for purposes of subpart GGG, 
provided that the new equipment is preapproved in the permit and 
otherwise meets the requirements below.
    The first situation involves the like-kind replacement of permitted 
process equipment which is functionally equivalent to and provides no 
greater production capacity than the equipment being retired. The 
replacement transaction, and identification of the new process 
equipment, must be recorded in the OSIL along with other information 
necessary to reflect the changed operating scenario. Because the new 
process equipment is replacing the retired equipment that was 
specifically identified in the permit, the new process equipment need 
not be specifically identified in the initial permit in order to be 
preapproved. The preapproval approach does not allow the substitution 
of new process equipment for permitted equipment that will remain in 
service elsewhere at the source.
    The second situation involves the addition of process equipment 
which already exists on-site but is not in current service. In order to 
be approved for purposes of subpart GGG, this equipment must be 
specifically identified in the permit in terms of its type and 
capacity. The Agency notes that the authority to preapprove such 
process equipment in the permit is limited to equipment for which the 
owner or operator holds a reasonable expectation that the equipment 
will be called into service over the 5-year life of the title V permit. 
Because this category of equipment already exists at the facility, and 
will be specifically identified in the permit with its capacity and 
type listed for review by the permitting authority, EPA, and public, 
the Agency believes such equipment may not only replace permitted, 
retired equipment, but may also augment permitted equipment in service 
and thereby increase production capacity at the source.
    In both of these situations, the additions of such equipment must 
meet all provisions of the permit governing their operation, including 
the requirement to stay within the approved capacity of the control 
device to which their emissions are routed. Other situations involving 
process equipment may not be preapproved and are subject to the notice 
procedures of section 70.4(b) or the permit revision procedures of 
section 70.7. Options under the current regulations are, however, 
expected to change (see section VI.L.3. Legal Considerations for 
discussion of anticipated treatment of subpart GGG requirements 
attaching to new emissions units under the upcoming part 70 revisions).
    At the time a source wishes to undertake a change that could 
trigger different obligations under subpart GGG or its permit, the 
source will evaluate first whether the change is within the scope of an 
approved alternative operating scenario in the permit. If so, the 
source will select the appropriate compliance options from the 
alternatives approved in the permit and implement the change consistent 
with the terms of the permit governing such selection. The source would 
not be required by the permit to route emissions from specific process 
equipment only to the specific control devices that were linked to them 
in the initial detailed compliance baseline. Instead, the menu of 
alternative operating scenarios, described below, in conjunction with 
features of subpart

[[Page 50312]]

GGG will allow a source to shift to the compliance obligations 
governing the change and, where applicable, to select among the control 
devices at the facility that the permitting authority has approved as 
capable of achieving compliance.
    The menu of alternative operating scenarios is a combination of the 
first permit structure discussed above (i.e., the requirements of 
subpart GGG) and some additional features. In particular, the menu 
consists of: (1) a description of the emissions sources (e.g., process 
vents, wastewater points of determination, storage tanks, and other 
regulated equipment components) subject to the pharmaceutical MACT; (2) 
the specific emission standard or standards that potentially apply to 
each source; (3) all control devices that have been approved by the 
permitting authority through performance tests or engineering analyses 
(as provided by subpart GGG) to comply with those standards; (4) the 
parameters to be monitored and data to be recorded specified for each 
control device, each process or equipment, as appropriate, as well as 
the monitored parameter values that indicate compliance (i.e., 
parameter trigger levels); and (5) the testing, record keeping and 
reporting provisions that are relevant to each type of process or 
emissions source.
    Whether a change can be accommodated within a preapproved 
alternative operating scenario from the menu depends on certain 
boundary conditions governing such use. These boundaries primarily 
depend upon: (1) the performance capabilities and any capacity 
limitations on control devices as approved in the permit for 
compliance; 1 (2) whether subpart GGG's provisions governing 
that change are limited to replicable operating procedures (ROPs) for 
determining emissions and applicable emissions limits; (3) whether 
changed emissions fall within the performance limits of (1) above; and 
(4) whether the approved monitoring approach remains applicable. The 
ROPs must be capable of yielding the identical compliance assessment 
whether applied by the source, permitting authority, EPA or member of 
the public. That is, the results from using these procedures are the 
same regardless of who uses it and when. The ROPs must be 
scientifically credible and be based solely on nondiscretionary steps 
and on objective data (where data are required). These ROPs are 
contained either in the standard itself or established during the title 
V permitting process. Where the applicable subpart GGG requirement is 
not already such a procedure, but one that can be established during 
the permit process (see later discussion as to which require ments are 
eligible), then the source would propose it and the permitting 
authority would specifically need to approve it, including any limits 
on its use, during a title V permit process that is subject to EPA and 
public review.
---------------------------------------------------------------------------

    \1\ Note that these limitations must include restrictions on the 
amount of HAPs and, where relevant, the type of HAPs which can be 
routed to the device. It may be necessary to include other 
restrictions, e.g., total organic compounds that define the capacity 
and the performance of the control device.
---------------------------------------------------------------------------

    Where a permit would contain the change management structure, the 
source's on-site documentation, as required by subpart GGG (section 
63.1259(b)(9)), will include an up-to-date operating log for 
alternative operating scenarios, [also required by section 
70.6(a)(9)(i)]. The on-site implementation log (OSIL) must record 
sufficient information to show the compliance obligations of each 
specific operating scenario in advance of its operation. Accordingly, 
the OSIL must include for each process: (1) a description of the 
process and the type of process equipment used; (2) an identification 
of related process vents and their associated emissions episodes and 
durations, wastewater PODs, and tanks; (3) the applicable control 
requirements of this subpart, including the level of required control; 
(4) the control or treatment devices used, as applicable, including a 
description of operating and/or testing conditions for any associated 
control device; (5) the process vents, wastewater PODs, and tanks 
(including those from other processes) that are simultaneously routed 
to the control or treatment device(s); (6) the applicable monitoring 
requirements of this subpart and any parametric level that assures 
compliance for all emissions routed to the control or treatment device; 
(7) calculations and engineering analyses required to demonstrate 
compliance; and (8) a verification that the operating conditions for 
any associated control or treatment device have not been exceeded and 
that any required calculations and engineering analyses have been 
performed.
    The OSIL, in conjunction with and the information contained in the 
permit, monitoring records, and any other available information and 
belief formed after reasonable inquiry, will provide the basis for 
making annual compliance certifications under section 70.5(d). 
Moreover, this information will allow an enforcement authority to 
verify when processes were being operated, to identify which emissions 
points from each process were controlled and how, and to determine 
whether the control devices were operated at performance levels that 
assured compliance with subpart GGG. The permit would require the 
source to submit a quarterly report of the new operating scenarios 
contained in to the OSIL to the permitting authority and to certify to 
its truth, accuracy and completeness pursuant to section 70.5(d). For 
reporting purposes, a change to any of the elements defining an 
operating scenario (see above) which have not previously been reported, 
except for element (5) above, shall constitute a new operating 
scenario. The permit shall also require that monitoring data, including 
that relevant to the identified parameter trigger levels, be submitted 
semiannually (except that deviations must be reported promptly). The 
source or the permitting authorities would then make compliance 
information and the OSIL reports available to EPA or members of the 
public upon request, consistent with confidential business information 
protections.
    In establishing alternative operating scenarios in a title V 
permit, the source would propose performance levels and operating 
limits for control devices to be used for compliance. Except for 
condensers (see section VI.L.2.b. Additional Considerations), sources 
would then demonstrate compliance using control devices operated to 
accommodate the range of anticipated emissions episodes [i.e., a worst-
case scenario(s) as provided in section 63.1257(b)(8)(i)]. The source 
must provide to the permitting authority in the NOCSR control device 
testing information and results (or other prescribed documentation), 
and monitoring provisions with parameters to be monitored to show 
compliance with the rule. Establishing monitoring parameter levels 
correlated to the required emissions reduction (i.e., trigger levels 
for compliance) assures compliance for anticipated worst-case 
emissions. This provides a source with considerable flexibility since 
most, if not all, changes to the source are likely to fall within the 
permitted worst-case emissions boundary and would not trigger a permit 
revision.
    In some situations, the source may wish to establish multiple 
trigger levels for the same monitored parameter within the normal 
operating range of an existing control device, each of which would 
assure compliance for different specifically defined emissions 
profiles. Thus, within the constraints of a control device's capacity, 
the title V permit may establish more than one enforceable

[[Page 50313]]

trigger level for an operating parameter to accommodate most common 
kinds of anticipated operations without the need for a permit revision. 
A ROP in the permit must be used to calculate the emissions profile of 
any proposed change and match the new emissions profile to the 
appropriate operating parameter trigger level that assures compliance 
with subpart GGG. For example, in a system with three separate trigger 
levels for the same parameter, which have been predetermined in the 
permit, assume that the projected emissions associated with a 
particular change would require the level of control corresponding to 
the second trigger level. As a result, the calculated emissions would 
exceed the emissions profile associated with the first cutoff (and its 
lower level of control), would correspond to the emissions profile 
covered by the second and meet its required parameter trigger level, 
and would not meet the emissions profile characteristics and not 
require the greater control associated with the third trigger level.
    For sources employing the change management strategy, the permit 
shall provide that a violation of the ROPs, a violation of other 
conditions implementing the change management strategy, or a violation 
of the monitored parameter trigger levels (as applicable and recorded 
in the OSIL) would be a violation of the permit and of the control 
device trigger operating limit, and a violation of the emissions limit 
where specifically provided for by the standard (e.g., an exceedance of 
the outlet gas temperature for a condenser). The EPA notes that neither 
the change management strategy nor the OSIL can alter any obligations 
that the source has to comply with either the permit or the MACT 
standard itself. While permitting authorities may extend the permit 
shield in section 70.6(f) to the permit terms and conditions of each 
alternative operating scenario contained in the permit, assuming the 
State program has a permit shield provision, this permit shield may not 
be applied to the specific compliance-related changes which are only 
recorded by the source in its OSIL (see section VI.L.3. Legal 
Considerations). Like CAA section 502(b)(10) changes, most 
administrative permit amendments, and MPMs which do not undergo prior 
public review [see sections 70.4(b)(12)(i)(B), 70.7(d)(4) and 
70.7(e)(2)(vi)], the part 70 permit shield may not extend to an OSIL or 
source determinations made pursuant to the change management approach 
that have failed to undergo prior EPA and public review. The source's 
compliance with those parameter levels recorded in the OSIL will not 
shield the source against challenges to the source's compliance with 
subpart GGG.
    To illustrate the change management permitting strategy, suppose a 
pharmaceutical source undertakes a process improvement project that 
replaces two steps in an existing pharmaceutical process with one new 
step. This project results in the elimination of two existing process 
vents from the process and the addition of a new vent. No new equipment 
is involved. Further, suppose that subpart GGG requires the existing 
process and the proposed process change to meet the 93 percent 
reduction requirement for process vents, and the source opts to meet 
that limit by ducting all vents from the process to an existing thermal 
oxidizer. As a first step, the source owner/operator must determine 
whether and to what extent the previously established baseline 
emissions profile for the process will change. To do this, the owner/
operator will calculate the uncontrolled emissions from the new vent 
using the equations provided in the MACT rule (and incorporated into 
the permit). The new process step involves the following emissions-
related activities: vapor displacement (Equation 8 in section 
63.1257(d)(2)(i)(A) of the rule), heating (Equations 10-17), and 
depressurization (Equations 18-29). In calculating emissions, the 
owner/operator must supply the physical characteristics from the 
process batch production procedures as inputs to the required 
equations. This description is the material used and the procedures 
followed exactly by the source to perform the process each time the 
specific product is produced. The process batch description includes 
details such as: the amount and type of raw materials to be used in 
each batch, the mixing and heating cycle durations, the final 
temperature of the heated ingredients, reflux rates, and the 
temperature of the reflux condenser.
    Once the emissions from the new process step are calculated, the 
owner/operator adds these emissions to the previously documented 
emissions from the process and subtracts the emissions from the two 
process steps that were eliminated to determine the total emissions to 
be routed to the thermal oxidizer. A revised emissions profile for the 
process is now established. Next, the owner/operator must evaluate 
whether the thermal oxidizer still assures compliance with the 93 
percent reduction requirement. Under the source's title V permit, the 
owner/operator will have calculated and documented (and the permitting 
authority would have approved) the worst-case emissions profile that 
could be accommodated by the thermal oxidizer. The owner/operator 
compares the emissions profile in the worst-case analysis with the 
improved process emissions. If the worst-case emissions profile will 
not be exceeded, the changed process will comply with the standard, and 
the existing title V permit does not have to be revised (unless 
required to assure compliance with applicable requirements other than 
those of subpart GGG). If a new worst-case scenario would be created by 
the change, a permit revision must be undertaken to determine whether 
the change can be made. In order to support the permit revision, the 
owner/operator will have to perform additional analysis or testing, as 
required by the MACT rule and/or the permitting authority, to show that 
the oxidizer has sufficient capacity to control the new scenario to 
meet subpart GGG. This may require a corresponding revision to the 
monitored parameter compliance trigger level in the permit as well.
    As stated earlier, the owner/operator is required by the MACT rule 
to keep records of all calculations performed to support the process 
improvement change. Thus, the on-site records include results of 
calculations to determine emissions from the new process step and total 
emissions from the improved process, and the comparison of emissions 
from the improved process with the previously established worst-case 
emissions analysis. If the change can be made without permit revision, 
the owner/operator also is required to maintain records in the OSIL 
showing when the change was made and how the new vent is controlled. In 
addition, the permit must require that the source operate consistently 
with the calculations made for the operating scenario described in the 
OSIL. Such consistency, however, does not protect a source from 
violations of the standard, where the calculations are in error or 
otherwise fail to assure compliance with subpart GGG.
    In the example presented above, the new process involves emissions-
related activities that are covered by the ROPs contained in subpart 
GGG. However, some activities may not fall under operations for which 
equations have been provided in the standard. In many such cases, the 
change management strategy allows the source to submit for approval its 
proposed methodology for quantifying these emissions. Under this 
approach, the permitting authority would have the opportunity to 
evaluate the proposed methodology and, if

[[Page 50314]]

judged replicable, by the permitting authority--with EPA and public 
review, establish this methodology in the title V permit. The ROPs 
could be established in the permit only through the permit issuance, 
permit renewal, or significant permit modification process. Where they 
are approved and upon their incorporation into the permit, the source 
must then use these procedures, as applicable, to determine if 
subsequent changes qualify for advance approval without need for permit 
revision under the change management strategy. The EPA intends to issue 
additional guidance to inform the development, review, and approval of 
such ROPs during the permitting process.
    For example, the MACT rule does not give exact procedures or 
formulae for calculating wastewater characteristics needed to determine 
control requirements. Instead, the rule states that HAP concentrations 
in wastewater are to be determined based on testing, knowledge of the 
wastewater stream (using a mass balance approach or one relying on 
published water solubility data), or bench-scale or pilot-scale testing 
(see section 63.1257(e)(1)). To explain the development of ROPs to 
address this requirement, a more specific situation must be described. 
Suppose that the process improvement project above includes an 
extraction that was not previously part of the process, resulting in a 
new wastewater stream which the owner/ operator wishes to treat using 
an existing steam stripper. In order to create the necessary ROP for 
determining the wastewater characteristics of streams, the owner/
operator must first establish a methodology to determine this for the 
baseline scenario. During the initial compliance demonstration/
permitting process, the owner/operator in this example would do so by 
proposing to determine the concentration of a partially soluble HAP in 
the aqueous phase of an extraction when a single organic compound is 
present by assuming that the concentration will be at the maximum 
possible value based on the solubility value found in standard 
reference texts. This procedure, along with the batch description and 
the number of batches to be produced each year, provides a ROP for 
determining the characteristics of the extraction step wastewater 
stream (i.e., HAP concentration and annual HAP load). After approval by 
the permitting authority, the ROP can be used for new or modified 
extraction wastewater streams to characterize the stream and to 
determine whether the stream is subject to treatment under the MACT 
standard per Sec. 63.1256(a)(1)(i). [Note that this ROP would apply 
only when a single organic compound is present. A separate ROP would 
have to be developed and applied in other cases.]
    In addition to this procedure, the owner/operator must also 
establish a replicable procedure to compare the wastewater 
characteristics associated with a change to the worst-case capabilities 
of the treatment unit. Accordingly, the appropriate operating parameter 
and the trigger level necessary to assure compliance with the standard 
must be established in the permit. The owner/operator may wish to 
establish more than one such trigger level to allow steam stripper 
operating parameters to be varied according to the ability of the 
treatment unit to treat different streams being routed to it. In this 
example, assume that an existing process at the facility uses methyl 
ethyl ketone (MEK) and generates an affected wastewater stream with 
125,000 ppm MEK (based on the published solubility of MEK in water). 
Published data show that the Henry's Law Constant for MEK is 4.36  x  
10-5 atm/gmole/m3. Assume further that the 
initial steam stripper compliance demonstration for MEK removal 
indicated that a liquid/vapor (L/V) ratio of 12.7 and an average steam 
feed of 2,900 pounds per hour (not to fall below an instantaneous 
minimum of 2,300 pounds per hour) are required to achieve compliance.
    Next, assume that a second existing process at the facility uses 
N,N-Dimethylanaline (DMA) and generates an affected wastewater stream 
with 16,000 ppm (based on the published water solubility for DMA). 
Published data show that the Henry's Law Constant for DMA is 1.75  x  
10-5 atm/ gmole/m3. Assume further that the 
initial steam stripper compliance demonstration for DMA removal 
indicated that an L/V ratio of 10.0 and an average steam feed of 3,100 
pounds per hour (not to fall below an instantaneous minimum of 2,400 
pounds per hour) are required to achieve compliance.
    The Henry's Law Constant is a measure of the partition of a 
compound between air and water (i.e., the ``strippability'' of the 
compound). Thus, based on the compliance demonstration results above, 
the owner/operator could propose, and the permitting authority approve, 
the conditions below for inclusion in the title V operating permit to 
assure compliance with subpart GGG for new and modified wastewater 
streams routed to the steam stripper. Note that these conditions would 
apply only to partially soluble HAPs with Henry's Law Constants equal 
to or greater than that of DMA. Other provisions would have to be made 
for soluble HAPs and for partially soluble HAPs with lower Henry's Law 
Constants, or the source would have to undertake a permit revision to 
address new streams containing HAPs of these types.
    1. When the steam stripping unit is receiving wastewater containing 
one or more partially soluble HAP (and no soluble HAPs) and the lowest 
Henry's Law Constant for any of the HAPs is greater than or equal to 
1.75  x  10-5 atm/ gmole/m3 but less than 4.36 
x  10-5 atm/gmole/m3, the stripper will maintain 
a maximum L/V ratio of 10.0 and an average steam feed of 3,100 pounds 
per hour (not to fall below an instantaneous minimum of 2,400 pounds 
per hour).
    2. When the steam stripping unit is receiving wastewater containing 
one or more partially soluble HAP (and no soluble HAPs) and the lowest 
Henry's Law Constant for any of the HAPs is greater than or equal to 
4.36  x  10-5 atm/ gmole/m3, the stripper will 
maintain a maximum L/V ratio of 12.7 and an average steam feed of 2,900 
pounds per hour (not to fall below an instantaneous minimum 2,300 
pounds per hour).
    To illustrate the change management strategy for the wastewater 
requirements, assume in this example that a new extraction step will 
use methylene chloride which is listed as a partially soluble HAP in 
Table 2 of subpart GGG. Using the operating procedure already approved 
in the title V permit, the owner/operator determines that the new 
extraction step will generate a wastewater stream with 20,000 ppm 
methylene chloride (based on the published solubility of methylene 
chloride in water) and an annual load of more than 1 Megagram per year 
(based on the process ``recipe'' and maximum possible production rate 
or as limited by permit conditions). Thus, the new wastewater stream is 
subject to treatment under the MACT standard pursuant to section 
63.1256(a)(1)(i)(A). Published data show that the Henry's Law Constant 
for methylene chloride is 2.68 x 10-3 atm/gmole/
m3. Since the Henry's Law Constant is greater than 4.36 x 
10-5 atm/gmole/m3, this stream can be discharged 
to the existing steam stripper provided the stripper is operated within 
the operating parameter trigger level established in the permit [i.e., 
maintaining a maximum L/V ratio of 12.7 and an average steam feed of 
2,900 pounds per hour (not to fall below an instantaneous minimum of 
2,300 pounds per hour)].

[[Page 50315]]

    Based on this analysis, the new extraction step can be controlled 
by the steam stripper to assure compliance with the MACT standard and 
the change can be instituted without a permit revision. The owner/
operator shall maintain in the on-site log records of all the 
procedures used (including the characterization of the new wastewater 
stream, the determination that the stream is subject to treatment under 
subpart GGG, and the comparison with the stripper's two-level Henry's 
Law Constant cutoffs) and the process and treatment unit parameters 
needed to verify ongoing compliance (including when the process change 
was instituted, when the modified process is in operation, how the 
wastewater stream is controlled, and the L/V ratio and average steam 
feed rate for the stripper). Moreover, the permit shall require the 
recordation in the log of additional applicability and compliance 
information, as necessary to assure compliance with subpart GGG.
    b. Additional considerations. Additional options are available to 
permitting authorities designing flexible title V permits to 
accommodate, without permit revision, emissions changes controlled by a 
condenser. Instead of requiring that all changes affecting emissions 
must meet the MACT standard under constant operation of an existing 
condenser at worst-case conditions, a permitting authority may issue 
permits where the condenser may be operated at different temperatures 
correlated to actual emissions profiles. Permits (through their terms 
which incorporate subpart GGG) will already contain the replicable 
means to calculate emissions profiles for process changes and the 
condenser exit temperatures required to control them. The Agency may 
explore development of similar approaches for other control devices, 
but recognizes that any such approaches before being incorporated into 
the permit would have to: (1) be calibrated in the field for a 
particular site; (2) meet rigorous tests to demonstrate scientific 
credibility, replicability, and practical usage; (3) ultimately assure 
compliance with subpart GGG and all other relevant applicable 
requirements; and (4) be evaluated by EPA to determine whether such an 
approach is possible for other control devices.
    New control devices are, in general, not preapproved and their 
operational limits must be the subject of a permit revision which 
incorporates this information into the title V permit. The Agency, 
based on its ongoing efforts to assure compliance, has found that the 
proposed new control devices must be subject to a prior site-specific 
evaluation by a reviewing authority in order to assure that the control 
device is adequately sized and that reasonable assumptions were used 
related to its performance. This general limitation is not related to 
change management except where the addition of new productive capacity 
(e.g., a new process using new process equipment) would require control 
capacity beyond that previously approved in the permit. Currently, the 
only exception to this limitation under the change management strategy 
involves the preapproval of certain new condensers. Here the permitting 
authority may advance approve new condensers but only to the extent 
that they are like-kind replacements for those currently approved in 
the permit or are specifically identified from an inventory of 
preapproved, existing (but not currently in-service) devices at the 
facility.
    With respect to Leak Detection and Repair (LDAR) work practice 
standards under subpart GGG, changing to a new process or modifying an 
existing one would not affect the content of the title V permit. These 
LDAR requirements apply broadly across a site as a work practice 
standard to the fugitive emissions of many types of equipment 
components at a facility. This equipment typically includes pumps, 
pressure relief devices, valves, and connectors, which typically number 
in the thousands at pharmaceutical facilities. The individual 
components subject to the LDAR requirements do not need to be 
specifically listed in a facility's title V permit.2
---------------------------------------------------------------------------

    \2\ The rule's LDAR provisions apply to significant numbers of 
emissions units, and typically do not involve different emissions 
control levels for equipment components subject to LDAR 
requirements. The LDAR requirements typically are written as a set 
of work practice standards that either apply to a piece of equipment 
or do not apply. To ensure that an affected source properly 
identifies those pieces of equipment subject to the LDAR 
requirements under subpart GGG, the regulation is including a 
requirement to maintain a separate list of affected equipment 
components within the LDAR recordkeeping provisions. For these 
reasons, and because the LDAR requirements apply to so many 
equipment components at pharmaceutical facilities, the Agency 
believes it is appropriate not to require the individual components 
to be specifically listed in the title V permit for these 
facilities.
---------------------------------------------------------------------------

    Instead, the title V permit shall contain a general identification 
in the title V permit of the equipment covered and the associated 
compliance obligations that will suffice to assure compliance with the 
LDAR requirements. Accordingly, a separate up-to-date list of affected 
equipment components must be maintained as required by the extensive 
LDAR record keeping provisions. Given that no specific list of 
components is required in the permit, and the permit shall 
comprehensively cover the equipment component types subject to LDAR 
requirements, the content of the permit will be unaffected by changes 
to such components that occur in the course of introducing a new 
process or modifying an existing one.
    Finally, the promulgated rule features alternative standards for 
any process vent and storage tank emissions sources that are ducted to 
control devices. These alternative standards require achieving a 
specific total organic carbon (TOC) concentration of 20 ppmv and a 
concentration of hydrogen halides and halogens of 20 ppmv from the 
outlet of control devices. Sources using these alternative compliance 
options are likely to reduce significantly (particularly where a single 
control device services multiple processes using nondedicated 
equipment) the required record keeping and reporting and to simplify 
the change management strategy. For example, a source could specify 
processes (which do not emit hydrogen halides or halogens), each of 
which vents to a carbon adsorption bed documented to achieve 20 ppmv 
TOC. In this case, several of the permit elements implementing the 
previously described change management strategy could be eliminated 
(e.g., provisions related to the menu of compliance options and 
suitable control devices, and the monitoring of parameter values), and 
much of the record keeping could be reduced to tracking which processes 
are routed to the common control device and monitoring TOC outlet 
concentrations to show compliance with the 20 ppmv standard. However, 
other monitoring and record keeping requirements (e.g., flow rate 
maximum through the control equipment) may be needed in the permit to 
address periodic monitoring or compliance assurance monitoring and non-
MACT applicable requirements (e.g., minor NSR) which limit the total 
atmospheric loading from the source.
3. Legal Considerations
    The management of change strategies set forth in this preamble 
represent the Agency's effort to devise an innovative approach to deal 
with the frequent process changes that take place at pharmaceutical 
manufacturing facilities without the need for equally frequent 
revisions to their permits. The strategies rely upon a number of 
factors (see section VI.L.4. Supporting Rationale for Recommended 
Strategy) that, while perhaps not unique in this industry and

[[Page 50316]]

in subpart GGG, are specific to it, and the Agency is uncertain whether 
and to what extent they may have application in other contexts. These 
factors underlie the Agency's present belief that the change management 
strategy in its practical application will assure compliance with 
subpart GGG through title V permits, and satisfy the objectives of part 
70 and title V of the Act.
    This approach is frankly an experimental one. Although EPA believes 
that the legal interpretations upon which the Agency is relying are 
consistent with the Clean Air Act and existing regulations, some 
aspects of this approach strike out in new and untried directions. In 
effect, EPA is conducting a pilot program to demonstrate whether 
permits that allow changes under subpart GGG can be made: (1) without 
permit revision or 7-day advance notification under section 502(b)(10); 
(2) based on the source's application of clear, simple definitions and 
ROPs; and (3) while contemporaneously being recorded in detailed 
operating logs. The EPA will therefore be testing its belief that such 
an approach will be practicably enforceable, will assure compliance 
with the standard-obtaining the emissions reductions required by the 
standard, and will satisfy the objectives of title V of the Act.
    The 40 CFR parts 70 and 71 provide for the establishment in title V 
operating permits of terms and conditions for reasonably anticipated 
operating scenarios at a source.3 A source may then 
preapprove alternative operating scenarios in its permit and switch 
among these scenarios in response to operational demands, without 
obtaining a permit revision to account for the previously approved new 
operating scenarios and their different applicable requirements. All 
title V permits, including those implementing alternative scenarios, 
must contain terms and conditions sufficient to assure that each 
operating scenario will comply with all applicable requirements and 
will meet the requirements of part 70. Pursuant to section 70.6(a)(9), 
the source must identify such scenarios in its permit application and 
the permitting authority must approve the scenarios for inclusion in 
the permit. The permit terms and conditions necessary to implement the 
alternative operating scenarios must also require the source to record 
contemporaneously in an on-site log the scenario under which it is 
operating, upon changing from one scenario to another. The 
contemporaneous record of the present operating scenario that the 
source maintains on-site serves to document for important inspection 
and enforcement purposes that the source is in compliance with the 
source's permit terms and conditions.
---------------------------------------------------------------------------

    \3\ Because part 71 addresses alternative operating scenarios in 
the same fashion as part 70, the Agency believes that part 71 is 
equally amenable to the management of change approach described in 
this section. For ease of discussion, this section will refer to the 
relevant provisions of part 70 in discussing the management of 
change approach. The EPA intends, however, that the part 70 
discussions in this section should have equal force and application 
to the corresponding provisions of part 71.
---------------------------------------------------------------------------

    The determination of when alternative scenarios are ``reasonably 
anticipated'' and would meet the requirements of section 70.6(a)(9) is 
not amenable to a rigid legal formula that can dictate through general 
guidance what types of permit terms and conditions will ensure that a 
source's future operations comply with these requirements. Instead, 
there must be legal and practical considerations that inform this 
determination within EPA's reasonably broad discretion to do so. The 
Agency has identified certain preliminary legal boundary considerations 
and conditions for implementing reasonably anticipated operating 
scenarios to meet subpart GGG, pending further experience with pilot 
projects and permits and further guidance or rulemaking on the subject.
    The structure and nature of title V permitting will determine how 
permit terms and conditions may be developed to reasonably anticipate 
alternative operating scenarios. The part 70 regulations govern the 
content requirements for permit applications and permits in section 
70.5 and 70.6, respectively, and these sections will govern how 
reasonably anticipated alternative operating scenarios must be 
addressed in permit applications and permits as well. For example, all 
part 70 permit applications must contain information ``for each 
emissions unit at a part 70 source,'' which includes a description of 
the source's processes and products for each alternate scenario 
identified by the source [sections 70.5(c) and (c)(2)]. Section 
70.6(a)(9) in turn makes clear that a source must identify in its 
application each reasonably anticipated operating scenario for which it 
intends to include permit terms and conditions.
    Along the same lines, section 70.6 requires that all part 70 
permits include emissions limitations and standards, monitoring, record 
keeping, reporting, compliance and other requirements to assure 
compliance with all applicable requirements. Section 70.6(a)(9) again 
makes clear that the permit terms and conditions governing alternative 
scenarios must meet these requirements. Applicable requirements 
generally fix a source's compliance obligations on an emissions unit or 
activity, control equipment, process, or combination thereof. 
Permitting alternative scenarios requires the ability to reasonably 
anticipate future emissions units, future operational details, and the 
compliance obligations under each applicable requirement associated 
with each operational state, as necessary to assure compliance with 
each applicable requirement.
    The permit terms and conditions governing each alternative 
operating scenario must assure compliance with all part 70 and 
applicable requirements at all times. This means that the permit terms 
and conditions must assure compliance with all relevant requirements at 
the time of initial permit issuance and at the time that changes to 
alternative operating scenarios are undertaken in the future. Upon a 
source's change from one operating scenario to another, the terms and 
conditions of the permit must continue to fully and accurately reflect 
the source's compliance obligations under all requirements applicable 
to the change. If a source changes to an operating scenario that was 
not provided for in its permit, or if a change undertaken by a source 
triggers compliance obligations that are not fully and accurately 
reflected in the permit, then the source would be subject to the permit 
revision, permit reopening, or section 70.4(b) notification provisions, 
as applicable, under the part 70 regulations prior to making the 
change.
    The permitting of established operating scenarios at a part 70 
source that are fully known, identified and expected is 
straightforward. Such situations are accounted for in part 70 permits 
through terms and conditions that specify the emissions units and 
activities, provide required citations to applicable requirements, and 
supply the additional range of permit provisions required in a complete 
title V permit. Reflecting current equipment and activities, existing 
operating configurations, and presently applicable regulatory 
requirements, these operating scenarios present no difficulty to 
incorporating into an operating permit sufficient terms to meet the 
permit content requirements of part 70.
    The preapproval and permitting of reasonably anticipated 
alternative operating scenarios is somewhat different in that their 
associated emissions units and activities, operational configurations, 
and applicable requirements may not be known with the same specificity 
as

[[Page 50317]]

previously established operating scenarios. Nonetheless, in order to be 
included in the permit as alternative operating scenarios, the source 
must provide sufficient specificity for those scenarios to allow the 
permitting authority to determine the applicable requirement(s) and 
establish permit terms and conditions assuring compliance with those 
applicable requirements and the requirements of part 70. The EPA 
believes that it is a reasonable interpretation of section 70.6(a)(9) 
to require only that permit terms and conditions reasonably anticipate 
the emissions units and activities, operational configurations, 
compliance obligations, and other relevant information associated with 
each alternative operating scenario, so long as the permit terms and 
conditions assure compliance with relevant applicable requirements at 
all times. Conversely, there may be new or different requirements that 
attach to an operating scenario at the time that the source changes to 
that scenario, or other material differences from the permitted 
operating scenario may have arisen, such that the change and its 
regulatory requirements are not covered by the permit. If the permit 
does not reflect those requirements because they were not previously 
established, then the source, as provided for under the part 70 
regulation, must account for all requirements applicable to that 
operating scenario, whether through a permit revision or advance 
notification or in response to a permit reopening.
    The permit terms needed to approve alternative operating scenarios 
to assure compliance with all applicable requirements and to be 
reasonably anticipated may, in general, be expected to vary by source 
category, the different types of emissions units and operating 
scenarios present at sources, and the inherent uncertainty of 
predicting future operating conditions and market demands. In 
particular, the authorizing permit limits might vary based on several 
factors which primarily include, but are not necessarily limited to: 
the types and specific terms of the applicable requirement(s); the 
complexity of the facility; whether the type or quantity of emissions 
will change widely; whether different pollution control devices will be 
needed; the ability of the permitting authority to develop practicably 
enforceable permit terms for alternative scenarios and to define the 
limitations of the control and monitoring approaches; the potential for 
future technology advances (where such advances are linked to the 
nature of the applicable requirements); and the presence of discretion 
in determining the applicability and/or the compliance status of the 
change. These factors are not always present, are often interdependent, 
and can range widely in their ability to affect whether compliance with 
the applicable requirements can be assured and whether operating 
scenarios can be reasonably anticipated.
    Because permit terms and conditions for reasonably anticipated 
operating scenarios implementing subpart GGG will be based in part upon 
ROPs that are designed to yield site-specific compliance details at the 
time of a change, EPA believes these procedures must be capable of 
yielding the identical compliance details, such as compliance triggers 
for monitored control device parameters, whether applied by the source, 
permitting authority, EPA or member of the public. Thus, the permit 
terms and conditions which incorporate such procedures will produce 
predictable and certain compliance results at the time of a change.
    The EPA is testing this approach to determine in practice the 
appropriateness of allowing pharmaceutical facilities to determine the 
specific compliance obligation(s) under subpart GGG that apply to a 
particular process change through reliance on the standard's ROPs and 
ROPs that gained earlier approval through the permitting process. The 
form of the ROPs in subpart GGG and the nature of pharmaceutical 
manufacturing operations, in conjunction with the other safeguards and 
features of the change management strategy, are central to the Agency's 
willingness to conduct this pilot strategy here.
    A source's compliance with permit terms and conditions for 
reasonably anticipated operating scenarios based upon properly 
implementing ROPs derived from subpart GGG will be ``deemed'' 
compliance with the applicable requirement for section 70.6(f)'s permit 
shield only to the extent that the source applies the procedures 
correctly. While permitting authorities may extend the permit shield to 
the permit terms and conditions of each alternate operating scenario 
implementing subpart GGG, assuming the State program has a permit 
shield provision and assuming it is applied in the permit consistent 
with section 70.6(f), part 70's permit shield may not extend to on-site 
implementation logs required by section 70.6(a)(9)(i). Like section 
502(b)(10) changes, most administrative permit amendments, and MPMs 
that do not undergo prior public review [see sections 
70.4(b)(12)(i)(B), 70.7(d)(4) and 70.7(e)(2)(vi)], the part 70 permit 
shield may not extend to an implementation log that has failed to 
undergo prior public review. Nor may the shield extend to the outcomes 
of ROP equations, applicability or nonapplicability determinations, or 
other compliance determinations recorded only in the OSIL. While a 
source will be required to use the implementation log to follow 
compliance triggers that implement the permit and one or more 
applicable requirements, the permit shield is not available to deem the 
source's compliance with those compliance triggers to be compliance 
with the permit or the applicable requirement.
    In addition to permitting authority review, part 70 permits are 
subject to public and EPA review to ensure that the permit terms and 
conditions assure compliance with all applicable requirements and the 
requirements of part 70. An essential consideration in determining 
whether permit terms and conditions reasonably anticipate operating 
scenarios is whether the permit provides sufficient information and 
opportunity for the public and EPA to determine and comment in a 
meaningful fashion whether the terms and conditions of reasonably 
anticipated operating scenarios meet, and will continue to meet, all 
applicable requirements (including those of subpart GGG) and part 70 
requirements.
    Permit terms and conditions reflecting alternative operating 
scenarios, like all part 70 permit terms and conditions, are subject to 
the possibility of EPA objection and public petition under section 
505(b) of the Act. In addition, operating permits are subject to the 
possibility of reopening by permitting authorities or EPA under 
sections 502(b)(5) and 505(e) of the Act. Permit terms and conditions 
of alternative operating scenarios that fail to reasonably anticipate 
future operating scenarios, emissions units and activities, and their 
associated compliance obligations may be subject to EPA objection, 
public petition, or reopening for cause. Failure by permitting 
authorities to submit information necessary for the public and EPA to 
review proposed permits adequately constitutes grounds for an EPA 
objection under section 70.8(c)(3)(ii), but information necessary for 
the review of alternative operating scenarios should be guided by the 
principle that permit terms and conditions must reasonably, but not 
perfectly, anticipate alternative operating scenarios. (Note, however, 
that the permit and any alternative

[[Page 50318]]

operating scenarios must fully and accurately govern changes that a 
source believes to be pre-approved at the time of the change, or else 
the part 70 permit revision, permit reopening, or 502(b)(10) 
notification provisions, as applicable, must be followed prior to 
making the change.)
    Section 70.6(a)(9) affords permitting authorities the latitude to 
impose permit terms and conditions to assure that alternative operating 
scenarios meet all applicable requirements and the requirements of part 
70. Such terms and conditions may go beyond compliance obligations 
strictly incorporated from applicable requirements being implemented 
pursuant to the alternative scenario. For example, in order to assure 
compliance with an applicable requirement or part 70, a permitting 
authority may determine that it is necessary to impose additional 
safeguards for alternative scenarios, such as requiring new emissions 
units or emissions units operating under different scenarios to be 
routed to a common, existing control device with preapproved capacities 
and operating parameter limitations. A permit might also require 
additional monitoring, record keeping, or reporting, or require that 
the source undertake a permit revision should future changes deviate 
materially from the reasonably anticipated scenarios in a manner that 
jeopardizes the permit's ability to meet all part 70 and applicable 
requirements. Finally, the permitting authority may require additional 
details and compliance information in the source's on-site log to 
ensure that the record of the source's current operating scenario, in 
conjunction with the permit terms and conditions, assures compliance 
with all requirements in a manner that serves important compliance, 
inspection, and enforcement purposes. If the permitting authority 
determines that these additional safeguards are necessary for an 
alternative operating scenario to assure compliance with one or more 
applicable requirements, the permitting authority need not approve the 
alternative scenario in the permit without such measures.
    The preceding legal considerations apply in general to alternative 
operating scenarios implementing subpart GGG. It is also important to 
distinguish further among categories of alternative operating 
scenarios, on the basis of whether new versus existing process 
equipment or control devices are involved, and on the basis of the 
specificity of the equipment identification, operational 
configurations, and linkages to applicable requirements in the permit. 
Of the three categories of alternative operating scenarios described 
below, the Agency is prepared to test the appropriateness of the second 
and third approaches under section 70.6(a)(9) for purposes of 
implementing subpart GGG.
    First, there are alternative operating scenarios for existing 
emissions units and activities at a part 70 source, covering 
specifically identified operational states or configurations for 
specified emissions units. In its simplest form, this category is 
exemplified by an emissions unit such as a fossil fuel-fired boiler 
that has two fuel burning options, which are each subject to a 
different applicable requirement with different monitoring obligations. 
The task of reasonably anticipating the terms and conditions of an 
alternative operating scenario such as this is furthered by the 
relative ease of specifying the emissions unit and its activities, 
operational configurations and conditions, and associated applicable 
requirements. A source's past operating experience as well as future 
operational certainty, founded upon existing emissions units and 
activities, will make permitting of such alternative scenarios more 
like the task of permitting a source's current operating scenario.
    The second category of alternative operating scenario, being tested 
to implement subpart GGG, covers the combination and reconfiguration of 
existing emissions units and control devices in alternative operational 
states and configurations that are not specifically identified in the 
permit. As described in greater detail in section VI.L.2.a General 
Strategy for Change Management, a permit menu of alternative operating 
scenarios may be constructed to govern only the subpart GGG compliance 
obligations of process equipment and control devices specifically 
identified in the permit. If a change to an alternative operating 
scenario preapproved in a permit menu involves only the reconfiguration 
of existing, permitted emissions units or control devices, and the 
change remains within the capacity of an approved control device to 
which it is routed; if subpart GGG's provisions governing that change 
are limited to ROPs; and if the other criteria of the change management 
strategy are satisfied (including the contemporaneous recordation of 
compliance information in the OSIL), then EPA is willing to test 
whether such an approach will assure compliance with subpart GGG 
through title V permitting. While this approach will not specify future 
applicability determinations and establish the specific compliance 
obligations of particular process configurations to the same degree as 
the first category of alternative operating scenarios, EPA anticipates 
that the approach will nonetheless assure compliance with subpart GGG 
and otherwise meet the requirements of part 70.
    The third category of alternative operating scenario, again tested 
in this pilot permitting approach to subpart GGG, covers new emissions 
units and condensers that are not in service at the time the operating 
scenario is established in the permit, but that may be preapproved 
(with respect to subpart GGG requirements) in two circumstances only. 
First, the permit may preapprove future like-kind emissions units or 
condensers that will replace retired emissions units or condensers 
without increasing permitted capacity. Second, the permit may 
preapprove specifically identified, on-site surplus processing 
equipment that may replace retired equipment or augment in-service 
equipment by increasing production capacity. The Agency believes that 
it is a viable interpretation of the existing section 70.6(a)(9) to 
allow alternative operating scenarios implementing today's standard to 
include permit terms and conditions approving in advance these 
categories and usages of new emissions units and condensers that will 
be subject to subpart GGG, if they meet the criteria discussed earlier 
in section L.2.a.
    The EPA, in August 1994, proposed to allow use of the concept of 
alternative operating scenarios under section 70.6(a)(9) to provide 
advance approval to construct and operate new or modified units subject 
to NSR and section 112(g) (referred to as ``advance NSR''). (59 FR 
44460, 44472, Aug. 29, 1994). Under this proposal, advance NSR would 
have allowed permitting authorities to establish the applicable NSR or 
section 112(g) requirements before a reasonably anticipated project or 
class of projects was constructed or modified, and then include that 
project's requirements in the part 70 permit for the facility. As a 
result, the project would be ``preapproved'' by the permitting 
authority, without the need for a later part 70 permit revision since 
the part 70 permit would already contain the relevant construction and 
operation requirements for the project.
    In August 1995, EPA further clarified its advance NSR proposal by 
proposing to add a definition of advance NSR to section 70.2, and by 
explaining that, in EPA's view, a change subject to an advance approval 
scenario would not be a change under section 502(b)(10) of the Act (60 
FR 45530, 45544-45, Aug. 31, 1995). Rather, it would constitute a

[[Page 50319]]

switch to an alternative operating scenario under section 70.6(a)(9). 
As the 1995 preamble noted, this interpretation would have two 
advantages. First, it would allow the use of advance NSR for title I 
modifications, and avoid the limitation that changes made under section 
502(b)(10) cannot be title I modifications. Second, and more important, 
the 7-day advance notification under section 502(b)(10) which attaches 
to each change made under that section would not apply to changes under 
the advance NSR approval. Consequently, where the State operating 
permit program allows for advance approval, and the permitting 
authority approves an alternative scenario containing advance approval, 
the part 70 permit could allow a source to make the approved change 
without an advance notice or a part 70 permit revision.
    Although the Agency has not finalized revisions to the part 70 
regulations to adopt the proposed amendments to sections 70.2 and 
70.6(a)(9) discussed above, the Agency is prepared to interpret the 
existing part 70 regulations for purposes of the change management 
strategy for subpart GGG approach to enable alternative operating 
scenarios to encompass advance approvals in the limited manner 
described in this notice. In other words, for purposes of the approach 
described in this section, EPA believes that it is a reasonable 
interpretation of existing section 70.6(a)(9) to cover the advance 
approval of the categories of new process equipment and condensers 
described in this notice, within the scope of alternative operating 
scenarios that may be included in part 70 permits. The concept of 
``reasonably anticipated operating scenarios'' is expansive enough to 
encompass not only existing equipment that may operate under a 
different operating scenario reasonably anticipated to occur, but also 
to encompass new equipment that replaces permitted equipment (without 
increasing permitted capacity), and new surplus equipment that is on-
site and specifically identified and pre-approved in the permit.
    The Agency is prepared to advance these interpretations under the 
current regulations prior to any final action on the part 70 revisions 
that might adopt the proposed amendments, for purposes of implementing 
subpart GGG through the pilot approach for the change management 
strategy described herein. This interpretation may not be relied upon 
for purposes of implementing applicable requirements other than subpart 
GGG through title V permits. The EPA may extend this interpretation to 
other applicable requirements, however, in the context of an individual 
permitting pilot project in order to facilitate the development and 
evaluation of the change management strategy, along with other flexible 
permitting opportunities, for the pharmaceutical industry. The policies 
set forth in this section are intended solely as guidance for purposes 
of implementing subpart GGG, do not represent final Agency action, and 
cannot be relied upon to create any rights enforceable by any party.
    Other changes that a pharmaceutical facility undertakes that 
implicate subpart GGG requirements and that are not preapproved in the 
permit through the change management strategy or ordinary alternative 
operating scenarios, must be accounted for through part 70's permit 
revision or section 70.4(b)(12) or (b)(14) notice procedures, as 
appropriate. Such changes would include, but are not necessarily 
limited to: changes among permitted, in-service equipment involving 
subpart GGG's provisions governing the change that are not limited to 
ROPs; changes that would exceed the performance capabilities or 
capacity limitations of approved control devices; changes involving the 
addition of new emissions units or control devices (including any 
control device other than condensers) that have not been approved 
pursuant to the categories discussed in section L.2.a; and other 
changes that are not otherwise preapproved in the permit. Finally, of 
course, changes that implicate applicable requirements other than or in 
addition to subpart GGG must be addressed in the manner required by the 
part 70 regulations.
    In the proposed revisions to part 70 in August 1995, 60 FR 45530, 
EPA proposed an expeditious permit revision process for the 
incorporation of requirements that would not need source-specific 
tailoring. The process was referred to as ``notice-and-go,'' since the 
source could operate the change as soon as it submitted a notice to the 
permitting authority, and would not need to wait for review or approval 
of the change by the permitting authority. The EPA further elaborated 
on the concept in a Federal Register notice announcing the availability 
of its May 14, 1997 draft final revisions to part 70, published on June 
3, 1997, 62 FR 30289, where the process was called ``notice-only.''
    As currently envisioned, the process would be available for changes 
that are: (1) subject to requirements taken directly from the 
applicable requirement; (2) where there is no creation of any source-
specific requirements; and (3) the permitting authority allows the 
change to take place without the need for its review or approval. For 
example, incorporation into the permit of a compliance option specified 
in a MACT standard would be eligible for notice-only procedures, but 
the establishment of source-specific parameter ranges for monitoring 
the performance of a control device would not be eligible. The 
installation of a degreasing unit subject to the halogenated solvent 
cleaning MACT standard under subpart T of Part 63 would also be 
eligible, if the facility elects to meet the standard through one or 
more of the compliance options specified in the MACT standard. This 
change would be eligible for the notice-only process because the permit 
terms that apply to the change would be taken straight from the 
underlying requirement, and there would be no need to add monitoring 
requirements.
    In the May 1997 draft, EPA would have required the source to 
certify compliance in the notice with all applicable requirements that 
apply to the change (in the case of subpart GGG, for example, a new 
unit being added). This certification requirement helps offset the lack 
of review by the permit authority prior to operation of the change, 
since a source making a false certification would be subject to 
penalties, or to criminal fines in the case of a knowing violation. 
There would also be no permit shield available for ``notice-only'' 
changes, so if a source failed to identify one or more requirements 
that apply to a new unit, the requirements are nonetheless applicable, 
and the source would be liable for any violations of applicable 
requirements to which the change is subject.
    The Agency anticipates that the notice-only category of the third 
tier of the part 70 revisions, if adopted as presently conceived, would 
accommodate the application of subpart GGG requirements to new process 
equipment and control devices through part 70 permit revisions. Part 70 
permits implementing subpart GGG through the management of change 
approach described in today's notice likely will have established 
source-specific requirements for existing control devices in the 
initial permit. The purpose of the notice-only procedures would be to 
revise the permit so as to identify new process equipment or control 
devices being added at the source, and to match up relevant permit 
requirements that apply to the new units. As noted at the outset of 
this section, however, it still may be

[[Page 50320]]

necessary to address the consequences of a particular change relative 
to other relevant applicable requirements that may attach to that 
change. Thus, changes must be evaluated under the part 70 permit 
revisions to determine what level of permit revision might be required 
to address other regulatory consequences of the change.
4. Supporting Rationale for Recommended Strategy
    a. Overview. The EPA has initiated this pilot permitting strategy 
for subpart GGG based upon a preliminary view that the recommended 
approach will satisfy section 70.6(a)(9)'s expectations for 
``reasonably anticipated'' alternative operating scenarios, and comport 
with title V's mandate that operating permits assure compliance with 
applicable requirements. In general, the Agency believes the change 
management strategy meets these criteria by relying upon the basic 
design and provisions of subpart GGG; the additional requirements under 
the policy for permits to contain terms that assure the proper 
identification and compliance of all alternative operating scenarios 
covered by the strategy; and the title V permit issuance, significant 
permit modification, or renewal processes, along with quarterly 
reporting to permitting authorities, to afford meaningful opportunities 
for the permitting authority, EPA, and the public to review the 
strategy proposed by a source, and oversee its implementation, for a 
particular location.
    Notwithstanding these provisions and protections, the Agency is 
recommending that permitting authorities use the change management 
strategy only on a trial basis, and only with respect to subpart GGG. 
The EPA notes that the need to match that changes in emissions 
correctly to their applicable subpart GGG requirements is central to 
the purpose of section 70.6(a)(9). As a critical first step, certain 
key definitions (e.g., process vent, process) and other rule provisions 
must be interpreted by EPA or the permitting authority in the permit 
process before applying the relevant ROPs. The ROPs then objectively 
size and sort emissions changes relative to their subpart GGG 
obligations and assure compliance in part by routing the new emissions, 
as appropriate, to a control device with sufficient capacity. Use of 
these definitions and regulatory provisions could be open to 
interpretive disputes and misapplication of the standard. However, due 
to several factors (including the homogeneity of process equipment in 
the industry, the high accuracy with which emissions resulting from 
changes can be characterized, the existence of ROPs for determining 
emissions and the effects of emissions controls, and the validation of 
a source's use of the relevant definitions, regulatory provisions, and 
ROPs during the title V permit process), EPA believes that there is a 
sufficiently low probability that sources will make errors in applying 
these definitions and provisions during the implementation of the 
change management strategy. Accordingly, the Agency will determine on 
the basis of empirical results whether this strategy needs additional 
protections, whether it is an appropriate approach to permitting, and/
or whether and on what basis it can be made available to a broader 
range of sources and standards.
    b. Detailed Rationale. Subpart GGG is a process-based standard 
which has been carefully designed to provide the framework needed by 
the change management strategy to establish the preapproved family of 
alternative operating scenarios for reconfiguration of existing process 
equipment and to define the compliance obligations of operating 
scenarios involving the addition of certain new process equipment. This 
framework is defined primarily from three types of features found in 
subpart GGG. In total, these three features establish a means for 
demonstrating continuous compliance that must be repeatedly applied for 
process and operational changes at the source.
    The first feature is comprised of requirements relating to the use 
of equations to estimate emissions from various pharmaceutical 
operations. These equations provide the ability to characterize a 
process or operational change's effect on emissions in a replicable and 
accurate fashion. The equations incorporate proven chemical and 
physical principles such as the Ideal Gas Law and Raoult's Law, and 
have previously been approved by the Agency (most recently in MACT 
standards for the Polymers and Resins Industry, subparts U and JJJ of 
40 CFR part 63). Upon their incorporation into the permit and approval 
by the permitting authority, a source must use these equations to 
determine applicability of the standard and to demonstrate initial 
compliance with it. Subsequently, the source must use the equations to 
determine the emissions from changes in operations together with those 
from ongoing operations. Anyone using the level of emissions predicted 
from these equations would then determine in exactly the same objective 
fashion how to maintain compliance with subpart GGG while manufacturing 
different intermediate or final products.
    The second feature providing flexibility is the requirement that 
control devices be designed to accommodate reasonable worst-case 
operating scenarios without need for revised operating parameters or 
operating conditions. This means that most changes that affect 
emissions can be handled by the devices. In all cases, compliance 
assurance is achieved by virtue of the requirement to compare the 
emissions profile associated with the change with the worst-case 
operation approved for the relevant control device(s) and to require a 
permit revision where the changed operation would present a need for 
greater control.
    The third feature of the rule that facilitates operating changes is 
the record keeping requirements. In the OSIL, as described earlier (see 
section VI.L.2.a. General Strategy for Change Management) sources must 
keep a precise log of the operation of batches, the occurrence of any 
process or operational changes and associated changes in emissions, the 
requirements of subpart GGG contemporaneously applicable to each 
process under its new operational state, and the controls used to 
comply with these requirements. The information required by the permit, 
together with on-site records and the required calculations for the 
sizing of emissions sources and the sorting of changes relative to 
their subpart GGG requirements allows an inspector to determine 
initially and for any subsequent time period which activities from a 
listed process require control and the level of control that is 
required for each.
    The rule enables the company's basic framework for the change 
management strategy to be incorporated into the title V permit. In 
addition, other permit terms are needed to assure that an appropriately 
useful scope of alternative scenarios can be reasonably anticipated and 
preapproved to meet section 70.6(a)(9) and that the compliance 
obligations of certain new process equipment (i.e., like-kind 
replacements and on-site surplus equipment identified in the permit) 
can be defined. The first of these terms applies to operations that are 
not covered by ROPs as taken directly from the requirements in subpart 
GGG. Previous discussions of ROPs have alluded to two types, those that 
are included in detail in subpart GGG and those that are established in 
the title V permitting process to meet subpart GGG. The latter category 
is necessary because of the compliance flexibility that subpart GGG 
contains.

[[Page 50321]]

    For the methodology that the source proposes to receive the status 
of a permit-required ROP for purposes of the change management 
strategy, the permitting authority must determine that the methodology 
is scientifically credible and is objectively replicable. The bottom 
line is that the ROP must be a procedure based solely on 
nondiscretionary steps and on objective data (where data are required) 
to accomplish these steps. Accordingly, the results from using these 
procedures are the same regardless of who uses them and when. Where the 
permitting authority preapproves ROPs, the permit shall require the 
source to use them over the defined range of similar operations 
(unless, of course, the source wishes to obtain approval of a different 
method under the permit revision process). The EPA would like to stress 
that the ROPs are only an important part of the compliance process 
established by following the standard and are not an alternative 
standard, monitoring, or test method.
    Section 504 (a) of the Act provides the legal basis for 
establishing ROPs during the permit process. This section requires that 
title V permits contain emissions limits/ standards and other terms as 
needed to assure compliance with applicable requirements. In its White 
Paper Number Two issued in March 1996, EPA stated that title V permits 
pursuant to section 504(a) may contain terms which are not necessarily 
the terms of a particular applicable requirement, provided that such 
terms assure compliance with this requirement. (see section II.A.2.d. 
and II.A.5.) The Agency believes that this same authority also supports 
development of a methodology as a ROP during the title V permit 
process, provided that its development is consistent with the 
provisions of the applicable requirement, following the methodology 
would provide the same degree of compliance assurance as would 
following the applicable requirement directly, and sufficient 
procedural safeguards are followed in its establishment.
    Subpart GGG is consistent with establishing such methodologies. For 
example, it empowers the permitting authority to review and approve, as 
appropriate, a source's proposed emissions estimating procedures for 
operations not covered by the standard's equations. In addition, as 
part of the initial compliance determination process laid out in 
subpart GGG, the source is required to provide the specifics of its 
calculations and engineering analysis procedures to the permitting 
authority as a matter of course. Subject to certain boundary conditions 
on its applicability and use, the specific source proposal can often be 
extended into a methodology to address future qualifying changes.
    The EPA is testing whether reliance on this approach also provides 
equivalent compliance assurance to that provided from a case-by-case 
review implemented for the same change by the permitting authority. In 
the absence of the change management strategy, the permitting authority 
would evaluate the procedures used by the source each time a change was 
to be made. Thus, the permitting authority would be called upon to make 
the same judgements in either case; only the timing and frequency of 
the review and approval process would change. In the context of the 
strategy, the permitting authority and the source simply agree ahead of 
time on the replicable procedures that are to be used for a range of 
changes.
    Finally, by requiring that the approval to take place during permit 
issuance, permit renewal, or significant permit modification, the 
change management strategy ensures that adequate oversight by the 
public and EPA occurs. This determination and approval by the 
permitting authority must take place during a process in which EPA and 
the public are afforded the opportunity to review and comment on the 
methodology and upon its initial use. The EPA requires that the 
streamlining process contained in its White Paper Number Two issued 
March 1996 be used to accomplish this review (including the submittal 
of the demonstration to EPA while a complete application containing the 
demonstration is otherwise submitted to the permitting authority). 
Application of the methodology and its outcomes must also be reflected 
in the OSIL. Verification of its use as well as the supporting 
calculations and analyses will be included (consistent with 
confidential business information protections) as part of the quarterly 
OSIL report describing changes since the last report. This report shall 
be submitted to the permitting authority on a quarterly basis and be 
made available to the public and EPA.
    It should be noted that subpart GGG, while not specifying enough 
details to make some procedures replicable, typically does include 
guidance on what will be required. For example, the standard allows 
sources to demonstrate compliance for small control devices using a 
design evaluation and specifies for each type of control device the 
factors that must be included in this evaluation. This guidance 
facilitates the permitting authority's review of the design evaluation 
that the source subsequently submits. Thus, in many cases, the standard 
provides the target for the design of a ROP, but leaves the details to 
be proposed by the source and approved by the permitting authority.
    While the mentioned ROPs should enable the vast majority of 
expected changes to be preapproved in the title V permit with respect 
to compliance with the MACT standard, some exceptions do exist. Changes 
governed by MACT provisions which are affected by any meaningful 
subjective judgments cannot be preapproved. This would include all 
procedures which are not replicable as contained in subpart GGG and are 
not otherwise approved during the permit issuance or revision process 
to be ROPs. In addition, certain requirements apply in a very event-
specific fashion and cannot be preapproved without a precise advance 
understanding of a particular change. The EPA has already identified 
some requirements and procedures in the final MACT rule that cannot be 
relied upon or developed as ROPs, and thus may not be employed under 
the change management strategy.
    For example, for any process unit complying with the pollution 
prevention alternative standard, an owner/operator must establish 
baseline production-indexed HAP consumption factors from which to apply 
the 75 percent consumption reduction requirement. Such baseline factors 
are determined from historical information, and the acceptability of 
the value depends on which historical years are selected to represent 
the baseline and on the methods used for the involved material balance 
around the process unit. It is highly probable that each baseline 
consumption factor demonstration will encompass unique, process-
specific information and methodologies that significantly affect the 
final value of the factor. With that in mind, the Agency feels that 
generic preapproval is not possible for changes whereby existing 
process units switch from complying with individual emission standards 
on emissions sources (such as a 93 percent reduction requirement for 
process vents) to complying with the pollution prevention alternative 
standard. It is appropriate that the permit revision process be used 
for making such changes.
    An additional category not eligible for conversion to ROPs consists 
of determinations or approvals which have not been delegated to the 
permitting authority and must be submitted to EPA for approval. For 
example, the Administrator must review and approve, as appropriate, any 
source

[[Page 50322]]

proposal for an alternative emissions limit or test method. Such 
reviews cannot therefore be addressed in advance by a ROP defined by 
the permitting authority.
    The Agency has preliminarily reviewed the requirements of subpart 
GGG in the context of defining which of them contain: (1) ROPs as 
written; (2) requirements that can be established during the permit 
process as a ROP; and (3) requirements which are ineligible for 
developing such procedures. Tables 3, 4, and 5 follow which describe 
this initial categorization. The EPA expects to address this subject 
more in its implementation guidance for subpart GGG.

                       Table 3.--Procedures That Are Replicable as Written in Subpart GGG                       
----------------------------------------------------------------------------------------------------------------
                  Procedure                                         40 CFR part 63 citation                     
----------------------------------------------------------------------------------------------------------------
Calculating uncontrolled emissions from        63.1257(d)(2)(i)(A) through (H).                                 
 process vents--equations for eight types of                                                                    
 operations.                                                                                                    
Calculating controlled emissions from process  63.1257(d)(3)(i)(B) (1) through (8).                             
 vents discharged through a condenser--                                                                         
 equations for eight types of operations.                                                                       
Equations for determining whether an existing  63.1254(a)(3)(i).                                                
 vent is subject to 98% control.                                                                                
EPA performance test methods and calculations  63.1257(a)(2), (a)(3), (b)(1) through (8), and (b)(10)(i) through
                                                (iii).                                                          
----------------------------------------------------------------------------------------------------------------


 Table 4.--Potentially Replicable Operating Procedures That Can Be Established Through Permitting Where Approved
                      by Permitting Authority, and Subject to Review by EPA and the Public                      
----------------------------------------------------------------------------------------------------------------
                  Procedure                                         40 CFR part 63 citation                     
----------------------------------------------------------------------------------------------------------------
Evaluation of an air pollution control device  63.1257(b)(8)(ii).                                               
 capability for new scenario (not subject to                                                                    
 testing).                                                                                                      
Establishing the emissions profile for inlet   63.1257(a)(i).                                                   
 to control device.                                                                                             
Determining uncontrolled process vent          63.1257(d)(2)(ii).                                               
 emissions from an operation not covered by                                                                     
 the eight equations in subpart GGG.                                                                            
Determining whether a new/modified process     None.                                                            
 vent is within the worst-case emissions                                                                        
 approved for a control device.                                                                                 
Determining annual HAP load in a wastewater    63.1257(e)(1)(iii).                                              
 stream.                                                                                                        
Determining annual average HAP concentration   63.1257(e)(1)(ii).                                               
 in a wastewater stream.                                                                                        
Identification of wastewater streams that      63.1256(a)(1).                                                   
 require control.                                                                                               
Evaluation of wastewater treatment unit        63.1257(e)(2)(ii).                                               
 capability for new scenario.                                                                                   
Demonstrating that wastewater tank emissions   63.1256(b)(1).                                                   
 are increased no more than 5 percent by                                                                        
 heating, treating with an exothermic                                                                           
 reaction, or sparging.                                                                                         
Determining storage tank design capacity.....  63.1253(a) (1) and (2).                                          
Maximum true vapor pressure for determining    63.1251.                                                         
 storage tank applicability.                                                                                    
Methodology for determining individual HAP     63.1257(d)(2)(i).                                                
 partial pressures in nonstandard situations.                                                                   
Emissions averaging compliance alternative...  63.1252(d).                                                      
Pollution prevention compliance alternative..  63.1252(e).                                                      
Demonstrating that an equation in the rule is  63.1257(d)(2)(ii).                                               
 not appropriate in a specific case for an                                                                      
 operation covered by one of the eight                                                                          
 equations.                                                                                                     
Demonstrating alternative test methods or      63.1261.                                                         
 emissions limits (or any other                                                                                 
 determinations which the Administrator has                                                                     
 not delegated).                                                                                                
----------------------------------------------------------------------------------------------------------------

    The recommended approach for permits also assures that alternative 
operating scenarios are reasonably anticipated for the reconfigurations 
of permit-listed equipment by requiring the initial detailed linkages 
among processes, vents, PODs, tanks, control obligations, and eligible 
controls contained in the NOCSR to be incorporated into the permit. 
This incorporation of the baseline operation serves to define an 
important benchmark from which to anticipate similar, but different 
future operating scenarios using the same equipment.
    The Agency believes that the more general description of equipment 
within each particular alternative operating scenario in the menu may 
be appropriate under the particular design of the pharmaceutical MACT 
standard. That is, a description of process equipment in less detail 
can be justified here where the determination of process emissions is 
clear and a highly effective control approach is used, which is also 
versatile and effective enough to accommodate a wide range of inlet 
loadings (and the range is documented and specified on permits). Thus, 
a conservative approach to emissions reduction (e.g., most devices 
would operate as if the worst-case scenario were occurring), coupled 
with a replicable, objective basis (i.e., a required ROP for emissions 
calculation) to assure that each new change in operation is no more 
demanding on the control device than the previously established worst 
case, inherently allows more flexibility under which to ``anticipate'' 
a family of alternative operating scenarios.
    One potential weakness of the change management strategy is that, 
before the mentioned ROPs can be relied upon to establish compliance 
obligations and to assure compliance with them, the strategy depends on 
the correct application of certain key definitions (e.g., process vent, 
process) and other regulatory provisions when a change in emissions 
occurs. Although EPA has carefully designed these definitions to be 
clear in their meaning, interpretive disputes could still conceivably 
arise. The Agency believes for several reasons, however, that there is 
an extremely low probability for such disputes to occur and that the 
change management strategy should assure compliance with subpart GGG.
    First, the industry, in its basic operations and how subpart GGG 
definitions will apply to them, is relatively well known. While this 
assertion may appear to run counter to previous statements regarding 
the constantly changing processes and equipment configurations that 
characterize much of the industry, in actuality, the process steps that 
make up

[[Page 50323]]

the wide range of processes in the industry are confined to a 
relatively limited number of different chemical engineering unit 
operations. Thus, while the number of process steps, their order, and 
the specific conditions of each (e.g., temperature, solvents, etc.) may 
vary widely from process to process, the individual steps are basic, 
standard unit operations. The chemical engineering principles that 
govern these unit operations (and their air and wastewater emissions) 
are well understood. In addition, the FDA independently requires 
processes to be well defined which limits further any variations in 
definitional interpretations.
    In addition to the significant protections that these inherent 
safeguards and the OSIL provide, the probability of misinterpreting the 
use of a particular definition is further reduced during the permit 
action that establishes the change management strategy. As mentioned, 
the initial linkages among processes, vents, PODs, tanks, control 
obligations, and eligible controls contained in the NOCSR would be 
incorporated into the title V permit to establish the baseline scenario 
from which to envision future changes. This incorporation also serves 
to demonstrate an appropriate working knowledge with the key 
definitions governing the applicability of subpart GGG. More 
importantly, the permitting authority must specifically approve the 
source's use of these definitions and this approval is subject to 
review by EPA and the public. The result will be that the source and 
the permitting authority will have a well validated common 
understanding of how these definitions work and how to apply them to 
future changes.
    The recommended approach also fulfills the need to provide adequate 
review opportunities. In the permit issuance process, the permitting 
authority, EPA, and the public all have an opportunity to review how 
the current source operations would comply with the standard and how 
the proposed permit conditions establish alternative operating 
scenarios to manage changes occurring with respect to this compliance 
baseline. In particular, these groups will have the opportunity to 
review the operating boundaries to assure equal or greater 
controllability of other emissions profiles and to determine any 
further need to add specific operational constraints to safeguard 
against overloading the particular control device(s), for example, or 
additional permit terms or descriptions in order to assure compliance 
with the standard. The alternative operating scenarios as described in 
the permit must reasonably anticipate reconfigurations of existing 
emissions units and activities and the additions of certain other 
preapproved equipment and must contain the associated compliance 
obligations for these changes under subpart GGG, in order to afford 
permitting authorities, EPA and the public meaningful opportunity to 
ensure that the permit's alternative scenarios assure compliance with 
the MACT standard. To provide an ongoing opportunity to understand 
which alternative operating scenarios have been operated by the source 
and the specific corresponding compliance obligations that apply, the 
permit shall require quarterly transmission of the OSIL changes to the 
permitting authority, which shall make copies available to the public 
and EPA upon request.
    The Agency is considering whether and to what extent the change 
management strategy for implementing subpart GGG might also be 
appropriate for other sources and applicable requirements. 
Preliminarily, EPA believes that the recommended permitting approach 
for subpart GGG will be essentially limited to the pharmaceutical and 
other similar batch chemical industries but it could be extended to 
industries subject to other emission standards to the extent that EPA 
believes the same level of compliance assurance associated with the 
change management strategy described for subpart GGG would be achieved. 
The EPA expects to evaluate other situations individually, using the 
mentioned factors and other considerations as appropriate. Affected 
parties are encouraged to comment on the adequacy of other EPA 
rulemakings (including those for other MACT standards), to address 
issues related to the change management strategy where similar needs 
for operational flexibility potentially exist. Certainly, the same 
legal constraints together with several situation specific factors 
(such as those involving the replicability of operating procedures 
contained in, or derived from, the applicable requirements, the 
potential for misapplication of the standard, the expectation for 
detailed descriptions and emissions reduction from the applicable 
requirement itself for subject equipment, and the ability of the 
control and monitoring approaches to accommodate changes) would again 
be relevant to defining whether a strategy for such applicable 
requirements based on alternative operating scenarios is possible under 
section 70.6(a)(9).
    The EPA believes that the change management strategy should 
presumptively be limited to the pharmaceutical MACT, since other 
standards do not initially appear to produce equivalent opportunities 
to create alternative operating scenarios under such a strategy. The 
most limiting element is the ability to predict accurately, using 
relatively simple, repeatable procedures, the effect a particular 
change has on emissions and compliance obligations. In the 
pharmaceutical industry, it is possible to do so in an extremely 
accurate fashion since HAP emissions nearly exclusively result from 
nonreactant solvent use. It may be more difficult, for example, to 
predict the effect of process changes in chemical manufacturing 
industries other than pharmaceutical manufacturing. Changes in these 
industries often involve complex reaction theory and reaction kinetics 
and other factors, which must be applied individually to the specific 
situation at hand to determine how HAP emissions will change. For most 
changes, it would be difficult to distill these chemical dynamics into 
an equation that would predict emissions variations for a source's 
process changes accurately. Without an accurate ROP, the applicable 
permit revision process would be necessary to reevaluate compliance 
under the change.
    As previously mentioned, the Agency's decision whether to extend 
the availability of a change management strategy similar to that for 
subpart GGG to other standards will also depend on the empirical 
results achieved from implementing subpart GGG through such a strategy. 
In particular, EPA expects to learn whether and how frequently 
interpretive disputes result from using the blend of definitions and 
approved ROPs relied upon to carry out the change management strategy 
and how to develop permit terms that establish and implement ROPs.
    Finally, the Agency supports the testing of the recommended subpart 
GGG strategy since it is consistent with the Agency's program 
objectives to reinvent regulations, to eliminate delays and paperwork 
burdens, and to implement more efficiently the title V program. The 
development of the recommended approach benefited to a significant 
extent through the activities of a permitting pilot project which EPA 
initiated with the Environmental Quality Board of Puerto Rico and Merck 
Corporation. Considering the implementation of subpart GGG through 
title V permits in the context of this project has been extremely 
valuable in defining the type and frequency of

[[Page 50324]]

anticipated operational changes and evaluating the appropriate permit 
content to assure compliance for these changes. The Agency is grateful 
to the participants in this Reinvention project and expects that its 
final results (in the form of more detailed guidance and/or model 
permit conditions) will be useful to others seeking to implement 
subpart GGG.

VII. Technical Amendment to 40 CFR Part 9

    In compliance with the Paperwork Reduction Act (PRA), this 
technical correction amends the table that lists the Office of 
Management and Budget (OMB) control numbers issued under the RPA for 
this final rule.
    The EPA is today amending the table in 40 CFR part 9 (Section 9.1) 
of currently approved information collection request (ICR) control 
numbers issued by OMB for various regulation. The affected regulations 
are codified at 40 CFR part 63 subpart GGG, sections 63.1259 and 
63.1260 (recordkeeping and reporting requirements, respectively). The 
OMB control (tracking) number for this final rule is 2060-0358. The EPA 
will continue to present OMB control numbers in a consolidated table 
format to be codified in 40 CFR part 9 of the Agency's regulations, and 
in each CFR volume containing EPA regulations. The table lists the 
section numbers with reporting and recordkeeping requirements, and the 
current OMB control numbers. The listing of the OMB control numbers and 
their subsequent codification in the CFR satisfy the requirements of 
the Paperwork Reduction Act (44 U.S.C. 3501 et seq.) and OMB's 
implementing regulations at 5 CFR part 1320.
    This ICR was previously subject to public notice and comment prior 
to OMB approval. As a result, EPA finds that there is ``good cause'' 
under section 553(b)(B) of the Administrative Procedure Act (5 U.S.C. 
553(b)(B)) to amend this table without prior notice and comment. Due to 
the technical nature of the table, further notice and comment would be 
necessary.

VIII. Administrative Requirements

A. 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)]).

B. 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.

C. 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 through out the 
development of this final regulation. Comments from the partnership 
members were carefully considered. In addition, all States were 
encouraged to comment on the proposed rule during the public comment 
period, and the EPA fully considered all the comments submitted by 
States in this final rulemaking.

D. Paperwork Reduction Act

    The Office of Management and Budget (OMB) has approved the 
information collection requirements contained in this rule under the 
provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq and 
has assigned OMB control No. 2060-0358. An information collection 
request (ICR) document has been prepared by EPA (ICR No. 1781.01), and 
a copy may be obtained from Sandy Farmer, Regulatory Information 
Division, U.S. Environmental Protection Agency (Mail Code 2137), 401 M 
Street SW., Washington, DC 20460, or by calling 202-260-2740.
    The EPA is required under section 112(d) of the Clean Air Act to 
regulate emissions of HAPs listed in section 112(b). The requested 
information is needed as part of the overall compliance and enforcement 
program. The ICR requires that pharmaceuticals production facilities 
retain records of control device monitoring or HAP emissions 
calculations records at facilities for a period of 5 years, which is 
consistent with the General Provisions to 40 CFR part 63 and the permit 
requirements under 40 CFR part 70. All sources subject to this rule 
will be required to obtain operating permits either through the State-
approved permitting program or, if one does not exist, in accordance 
with the provisions of 40 CFR part 71, when promulgated.
    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. It 
is also estimated that there are approximately 100 facilities that are 
likely respondents. These estimates include time for reviewing 
instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
or disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; develop, acquire, 
install, and utilize technology and systems for the purposes of 
collecting, validating, and verifying information, processing and 
maintaining information, and disclosing and providing information; 
adjust the existing ways to comply with any previously applicable 
instructions and requirements; train personnel to be able to respond to 
a collection of

[[Page 50325]]

information; search data sources; complete and review the collection of 
information; and transmit or otherwise disclose the information.
    An Agency may not conduct or sponsor, and a person is not required 
to respond to a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations are listed in 40 CFR part 9 and 48 CFR Chapter 15. The EPA 
is amending Table 9.1 in 40 CFR part 9 of currently approved ICR 
control numbers issued by OMB for various regulations to list the 
information requirements contained in this final rule.

E. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) provides that, whenever an 
agency promulgates a final rule under 5 U.S.C. 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), the 
Agency certifies 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 pharmaceutical producing firms are 
small entities--not a substantial number of entities. Of these 16 
firms, only 4 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. That evaluation is available in the 
administrative record for today's action.

F. Unfunded Mandates

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub. 
L. 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 inter- governmental mandates, and informing, educating, and 
advising small governments on compliance with the regulatory 
requirements.
    The EPA has determined that the final 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.

G. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. The EPA will submit a report containing this rule and 
other required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comproller General of the United States prior 
to publication of the rule in the Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

H. National Technology Transfer and Advancement Act (NTTAA)

    Under section 12(d) of the National Technology Transfer and 
Advancement Act (``NTTAA)''), the Agency is required to use voluntary 
consensus standards in its regulatory activities unless to do so would 
be inconsistent with applicable law or otherwise impractical. Voluntary 
consensus standards are technical standards (e.g., materials 
specifications, test methods, sampling procedures, business practices, 
etc.) that are developed or adopted by voluntary consensus standards 
bodies. Where available and potentially applicable voluntary consensus 
standards are not used by EPA, the Act requires the Agency to provide 
Congress, through the Office of Management and Budget, an explanation 
of the reasons for not using such standards.
    The Agency does not believe that this Notice addresses any 
technical standards subject to the NTTAA.

I. Executive Order 13045

    The Executive Order 13045 applies to any rule that EPA determines 
(1) ``economically significant'' as defined under Executive Order 
12866, and (2) the environmental health or safety risk addressed by the 
rule has a disproportionate effect on children. If the regulatory 
action meets both criteria, the Agency must evaluate the environmental 
health or safety effects of the planned rule on children; and National 
Emission Standards for Hazardous Air Pollutants Pharmaceuticals 
Production--explain why the planned regulation is preferable to other 
potentially effective and reasonably feasible alternatives considered 
by the Agency.
    This final rule is not subject to Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997), because it does not involve 
decisions on environmental health risks or safety risks that may 
disproportionately affect children.

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

[[Page 50326]]

40 CFR Part 63

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

    Dated: July 30, 1998.
Carol M. Browner,
Administrator.

    For the reasons set out in the preamble, parts 9 and 63 of title 
40, chapter I, of the Code of Federal Regulations is amended as 
follows:

PART 9--[AMENDED]

    1. The authority citation for part 9 continues to read as follows:

    Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 
300j-3, 300j-4, 300j-9 1857 et seq., 6901-6992k, 7401-7671g, 7542, 
9601-9657, 11023, 11048.

    2. Section 9.1 is amended by adding in numerical order a new entry 
to the table under the indicated heading to read as follows:


Sec. 9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                             OMB control
                      40 CFR citation                            No.    
------------------------------------------------------------------------
                                                                        
               *         *         *         *         *                
  National Emission Standards for Hazardous Air Pollutants for Source   
Categories.\3\                                                          
                                                                        
                                                                        
                *         *         *         *         *               
63.1259-63.1260............................................    2060-0314
                                                                        
               *         *         *         *         *                
------------------------------------------------------------------------
\3\ The ICR's referenced in this section of the table encompass the     
  applicable general provisions contained in the 40 CFR part 63, subpart
  A, which are not independent information collection requirements.     

* * * * *

PART 63--[AMENDED]

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

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

    4. Section 63.14 is amended by adding paragraphs (b)(19) and (c)(3) 
to read as follows:


Sec. 63.14  Incorporations by reference.

* * * * *
    (b) * * *
    (19) ASTM D2879-97, Standard Test Method for Vapor Pressure-
Temperature Relationship and Initial Decomposition Temperature of 
Liquids by Isoteniscope, IBR approved for Sec. 63.1251 of subpart GGG 
of this part.
    (c) * * *
    (3) API Manual of Petroleum Measurement Specifications (MPMS) 
Chapter 19.2, Evaporative Loss From Floating-Roof Tanks (formerly API 
Publications 2517 and 2519), First Edition, April 1997, IBR approved 
for Sec. 63.1251 of subpart GGG of this part.
* * * * *
    5. Part 63 is amended by adding a new subpart GGG to read as 
follows:

Subpart GGG--National Emission Standards for Pharmaceuticals 
Production

Sec.
63.1250  Applicability.
63.1251  Definitions.
63.1252  Standards: General.
63.1253  Standards: Storage tanks.
63.1254  Standards: Process vents.
63.1255  Standards: Equipment leaks.
63.1256  Standards: Wastewater.
63.1257  Test methods and compliance procedures.
63.1258  Monitoring requirements.
63.1259  Recordkeeping requirements.
63.1260  Reporting requirements.
63.1261  Delegation of authority.

Table 1 to Subpart GGG--General Provisions Applicability to Subpart GGG

Table 2 to Subpart GGG--Partially Soluble HAP

Table 3 to Subpart GGG--Soluble HAP

Table 4 to Subpart GGG--Monitoring Requirements for Control Devices

Table 5 to Subpart GGG--Control Requirements for Items of Equipment 
That Meet the Criteria of Sec. 63.1252(f)

Table 6 to Subpart GGG--Wastewater--Compliance Options for Wastewater 
Tanks

Table 7 to Subpart GGG--Wastewater--Inspection and Monitoring 
Requirements for Waste Management Units

Table 8 to Subpart GGG--Fraction Measured (Fm) for HAP 
Compounds in Wastewater Streams

Table 9 to Subpart GGG--Default Biorates for List 1 Compounds


Sec. 63.1250  Applicability.

    (a) Definition of affected source. The affected source subject to 
this subpart is the pharmaceutical manufacturing operation, as defined 
in Sec. 63.1251. Except as specified in paragraph (d) of this section, 
the provisions of this subpart apply to pharmaceutical manufacturing 
operations that meet the criteria specified in paragraphs (a)(1) 
through (a)(3) of this section as follows:
    (1) Manufacture a pharmaceutical product, as defined in 
Sec. 63.1251;
    (2) Are located at a plant site that is a major source as defined 
in section 112(a) of the Act; and
    (3) Process, use, or produce HAP.
    (b) New source applicability. A new affected source subject to this 
subpart and to which the requirements for new sources apply is: an 
affected source for which construction or reconstruction commenced 
after April 2, 1997 and the standard was applicable at the time of 
construction or reconstruction; or a pharmaceutical manufacturing 
process unit (PMPU), dedicated to manufacturing a single product, that 
has the potential to emit 10 tons per year of any one HAP or 25 tons 
per year of combined HAP, for which construction commenced after April 
2, 1997.
    (c) General Provisions. Table 1 of this subpart specifies the 
provisions of subpart A of this part that apply to an owner or operator 
of an affected source subject to this subpart, and clarifies specific 
provisions in subpart A of this part as necessary for this subpart.
    (d) Processes exempted from the affected source. The provisions of 
this subpart do not apply to research and development facilities.
    (e) Storage tank ownership determination. The owner or operator 
shall follow the procedures specified in paragraphs (e)(1) through 
(e)(5) of this section to determine to which PMPU a storage tank shall 
belong.
    (1) If a storage tank is dedicated to a single PMPU, the storage 
tank shall belong to that PMPU.
    (2) If a storage tank is shared among PMPU's, then the storage tank 
shall belong to that PMPU located on the same plant site as the storage 
tank that has the greatest annual volume input into or output from the 
storage tank (i.e., said PMPU has the predominant use of the storage 
tank).
    (3) If predominant use cannot be determined for a storage tank that 
is shared among PMPU's and if one of those PMPU's is subject to this 
subpart, the storage tank shall belong to said PMPU.
    (4) If the predominant use of a storage tank varies from year to 
year, then predominant use shall be determined based on the utilization 
that occurred during the year preceding September 21, 1998 for existing 
affected sources. For new affected sources, predominant use will be 
based on the first year after initial startup. The determination of 
predominant use shall be reported in the Notification of Compliance 
Status required by Sec. 63.1260(f). If the predominant use changes, the 
redetermination of predominant use

[[Page 50327]]

shall be reported in the next Periodic Report.
    (5) If the storage tank begins receiving material from (or sending 
material to) another PMPU; or ceases to receive material from (or send 
material to) a PMPU; or if the applicability of this subpart to a 
storage tank has been determined according to the provisions of 
paragraphs (e)(1) through (4) of this section and there is a 
significant change in the use of the storage tank that could reasonably 
change the predominant use, the owner or operator shall reevaluate the 
applicability of this subpart to the storage tank, and report such 
changes to EPA in the next Periodic report.
    (f) Compliance dates. 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 September 21, 
1998.
    (2) An owner or operator of a new or reconstructed affected source 
must comply with the provisions of this subpart on September 21, 1998 
or upon startup, whichever is later.
    (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 September 21, 1998 shall 
not be required to comply with such promulgated standard until 3 years 
after September 21, 1998 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 September 21, 1998.
    (4) Pursuant to section 112(i)(3)(B) of the Act, an owner or 
operator may request an extension allowing the existing source up to 1 
additional year to comply with section 112(d) standards.
    (i) For purposes of this subpart, a request for an extension shall 
be submitted no later than 120 days prior to the compliance dates 
specified in paragraphs (f)(1) through (3) of this section, except as 
provided in paragraph (f)(4)(ii) of this section. The dates specified 
in Sec. 63.6(i) for submittal of requests for extensions shall not 
apply to sources subject to this subpart.
    (ii) An owner or operator may submit a compliance extension request 
after the date specified in paragraph (f)(4)(i) of this section 
provided the need for the compliance extension arose after that date 
and before the otherwise applicable compliance date, and the need arose 
due to circumstances beyond reasonable control of the owner or 
operator. This request shall include the data described in 
Sec. 63.6(i)(6)(i)(A), (B), (C), and (D).
    (g) Applicability of this subpart except during periods of startup, 
shutdown, and malfunction. (1) Each provision set forth in this subpart 
shall apply at all times except that emission limitations shall not 
apply during periods of: startup; shutdown; and malfunction, if the 
startup, shutdown, and malfunction precludes the ability of a 
particular emission point of an affected source to comply with one or 
more specific emission limitations to which it is subject and the owner 
or operator follows the provisions for periods of startup, shutdown, 
and malfunction, as specified in Secs. 63.1259(a)(3) and 63.1260(i). 
Startup, shutdown, and malfunction are defined in Sec. 63.1251.
    (2) The provisions set forth in Sec. 63.1255 of this subpart shall 
apply at all times except during periods of nonoperation of the PMPU 
(or specific portion thereof) in which the lines are drained and 
depressurized resulting in the cessation of the emissions to which 
Sec. 63.1255 of this subpart applies.
    (3) The owner or operator shall not shut down items of equipment 
that are required or utilized for compliance with the emissions 
limitations of this subpart during times when emissions (or, where 
applicable, wastewater streams or residuals) are being routed to such 
items of equipment, if the shutdown would contravene emissions 
limitations of this subpart applicable to such items of equipment. This 
paragraph does not apply if the item of equipment is malfunctioning, or 
if the owner or operator must shut down the equipment to avoid damage 
due to a malfunction of the PMPU or portion thereof.
    (4) During startups, shutdowns, and malfunctions when the emissions 
limitations of this subpart do not apply pursuant to paragraphs (g)(1) 
through (3) of this section, the owner or operator shall implement, to 
the extent reasonably available, measures to prevent or minimize excess 
emissions to the extent practical. For purposes of this paragraph, 
``excess emissions'' means emissions in excess of those that would have 
occurred if there were no startup, shutdown, or malfunction and the 
owner or operator complied with the relevant provisions of this 
subpart. The measures to be taken shall be identified in the applicable 
startup, shutdown, and malfunction plan, and may include, but are not 
limited to, air pollution control technologies, work practices, 
pollution prevention, monitoring, and/or changes in the manner of 
operation of the source. Back-up control devices are not required, but 
may be used if available.
    (h) Consistency with other regulations. (1) Consistency with other 
MACT standards. After the compliance dates specified in this section, 
an affected source subject to the provisions of this subpart that is 
also subject to the provisions of any other subpart of 40 CFR part 63 
may elect, to the extent the subparts are consistent, which subpart 
under which to maintain records and report to EPA. The affected source 
shall identify in the Notification of Compliance Status report required 
by Sec. 63.1260(f) under which authority such records will be 
maintained.
    (2) Consistency with 40 CFR parts 264 and 265, subparts AA, BB, 
and/or CC. After the compliance dates specified in this section, if any 
affected source subject to this subpart is also subject to monitoring, 
recordkeeping, and reporting requirements in 40 CFR part 264, subpart 
AA, BB, or CC, or is subject to monitoring and recordkeeping 
requirements in 40 CFR part 265, subpart AA, BB, or CC and the owner or 
operator complies with the periodic reporting requirements under 40 CFR 
part 264, subpart AA, BB, or CC that would apply to the device if the 
facility had final-permitted status, the owner or operator may elect to 
comply either with the monitoring, recordkeeping, and reporting 
requirements of this subpart, or with the monitoring, recordkeeping, 
and reporting requirements in 40 CFR parts 264 and/or 265, as described 
in this paragraph, which shall constitute compliance with the 
monitoring, record keeping, and reporting requirements of this subpart. 
If the owner or operator elects to comply with the monitoring, 
recordkeeping, and reporting requirements in 40 CFR parts 264 and/or 
265, the owner or operator shall report all information required by 
Sec. 63.1260(g). The owner or operator shall identify in the 
Notification of Compliance Status required by Sec. 63.1260(f) the 
monitoring, recordkeeping, and reporting authority under which the 
owner or operator will comply.
    (3) Consistency with 40 CFR 60.112b. After the compliance dates 
specified in this section, a storage tank controlled with a floating 
roof and in compliance with the provisions of 40 CFR 60.112b, subpart 
Kb, constitutes compliance with the provisions of this subpart GGG. A 
storage tank with a fixed roof, closed vent system, and control device 
in compliance with the provisions of 40 CFR 60.112b, subpart Kb must 
comply with the monitoring, recordkeeping, and reporting provisions of 
this subpart GGG. The owner or operator shall identify in the 
Notification of Compliance Status report required by

[[Page 50328]]

Sec. 63.1260(f) which tanks are in compliance with subpart Kb.
    (4) Consistency with subpart I of this part. After the compliance 
dates specified in this section, for equipment at an affected source 
subject to this subpart that is also subject to subpart I of this part, 
an owner or operator may elect to comply with either the provisions of 
this subpart GGG or the provisions of subpart I of this part. The owner 
or operator shall identify in the Notification of Compliance Status 
report required by Sec. 63.1260(f) the provisions with which the owner 
elects to comply.
    (5) Consistency with other regulations for wastewater. After the 
compliance dates specified in this section, the owner or operator of an 
affected wastewater that is also subject to provisions in 40 CFR parts 
260 through 272 shall comply with the more stringent control 
requirements (e.g., waste management units, numerical treatment 
standards, etc.) and the more stringent testing, monitoring, recording, 
and recordkeeping requirements that overlap between the provisions of 
this subpart and the provisions of 40 CFR parts 260 through 272. The 
owner or operator shall keep a record of the information used to 
determine which requirements were the most stringent and shall submit 
this information if requested by the Administrator.
    (i) For the purposes of establishing whether a person is in 
violation of this subpart, nothing in this subpart shall preclude the 
use of any credible evidence or information relevant to whether a 
source would have been in compliance with applicable requirements.


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 this subpart.
    Active ingredient means any component that is intended to furnish 
pharmacological activity or other direct effect in the diagnosis, cure, 
mitigation, treatment, or prevention of disease, or to affect the 
structure or any function of the body of man or other animals. The term 
includes those components that may undergo chemical change in the 
manufacture of the pharmaceutical product and be present in the 
pharmaceutical product in a modified form intended to furnish the 
specified activity or effect.
    Actual HAP emissions means the HAP emitted to the atmosphere from 
either uncontrolled or controlled emission points.
    Air pollution control device or 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. The equipment may consist of an individual device or a series 
of devices. Examples include, but are not limited to, incinerators, 
carbon adsorption units, condensers, flares, boilers, process heaters, 
and gas absorbers. Process condensers are not considered air pollution 
control devices or control devices.
    Annual average concentration, as used in the wastewater provisions, 
means the annual average concentration as determined according to the 
procedures specified in Sec. 63.1257(e)(1).
    Automated monitoring and recording system means any means of 
measuring values of monitored parameters and creating a hard copy or 
computer record of the measured values that does not require manual 
reading of monitoring instruments and manual transcription of data 
values. Automated monitoring and recording systems include, but are not 
limited to, computerized systems and strip charts.
    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.
    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.
    Block means a time period that comprises a single batch.
    Cleaning operation means routine rinsing, washing, or boil-off of 
equipment in batch operations between batches.
    Closed biological treatment process means a tank or surface 
impoundment where biological treatment occurs and air emissions from 
the treatment process are routed to either a control device by means of 
a closed-vent system or by means of hard-piping. The tank or surface 
impoundment has a fixed roof, as defined in this section, or a floating 
flexible membrane cover that meets the requirements specified in 
Sec. 63.1256(c).
    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.
    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.
    Combustion device means an individual unit of equipment, such as a 
flare, incinerator, process heater, or boiler, used for the combustion 
of HAP vapors.
    Component means any ingredient for use in the manufacture of a drug 
product, including those that may not appear in such drug product.
    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. 63.1255(b)(1)(vii) and Sec. 63.1255(f)(3).
    Construction means the onsite fabrication, erection, or 
installation of an affected source or a PMPU.
    Consumption means the quantity of HAP entering a process that is 
not used as reactant (makeup). If the same HAP component is generated 
in the process

[[Page 50329]]

as well as added as makeup, consumption shall include the quantity 
generated in the process, as calculated assuming 100 theoretical 
conversion. 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 
m3 in which a material is stored, transported, treated, or 
otherwise handled. Examples of containers are drums, 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 recorder means a data recording device that either 
records an instantaneous data value at least once every 15 minutes or 
records 15-minute or more frequent block average values.
    Continuous seal means a seal that forms a continuous closure that 
completely covers the space between the wall of the storage tank and 
the edge of the floating roof. A continuous seal may be a vapor-
mounted, liquid-mounted, or metallic shoe seal.
    Control device, for purposes of this Sec. 63.1255, 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.
    Controlled HAP emissions means the quantity of HAP discharged to 
the atmosphere from an air pollution control device.
    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 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 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.
    Dedicated PMPU means a PMPU that is composed of equipment that is 
used to manufacture the same product for a continuous period of 6 
months or greater. The PMPU includes any shared storage tank(s) that 
are determined to belong to the PMPU according to the procedures in 
Sec. 63.1250(e).
    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.
    Enhanced biological treatment system or enhanced biological 
treatment process means an aerated, thoroughly mixed treatment unit(s) 
that contains biomass suspended in water followed by a clarifier that 
removes biomass from the treated water and recycles recovered biomass 
to the aeration unit. The mixed liquor volatile suspended solids 
(biomass) is greater than 1 kilogram per cubic meter throughout each 
aeration unit. The biomass is suspended and aerated in the water of the 
aeration unit(s) by either submerged air flow or mechanical agitation. 
A thoroughly mixed treatment unit is a unit that is designed and 
operated to approach or achieve uniform biomass distribution and 
organic compound concentration throughout the aeration unit by quickly 
dispersing the recycled biomass and the wastewater entering the unit.
    Equipment, for purposes of Sec. 63.1255, means each pump, 
compressor, agitator, pressure relief device, sampling connection 
system, open-ended valve or line, valve, connector, and instrumentation 
system in organic hazardous air pollutant service; and any control 
devices or closed-vent systems required by this subpart.
    Excipient means any substance other than the active drug or product 
which have been appropriately evaluated for safety and are included in 
a drug delivery system to either aid the processing of the drug 
delivery system during its manufacture; protect, support or enhance 
stability, bioavailability, or patient acceptability; assist in product 
identification; or enhance any other attribute of the overall safety 
and effectiveness of the drug delivery system during storage or use.
    External floating roof means a pontoon-type or double-deck type 
cover that rests on the liquid surface in a storage tank or waste 
management unit with no fixed roof.
    Fill or filling means the introduction of material into a storage 
tank or the introduction of a wastewater stream or residual into a 
waste management unit, but not necessarily to complete capacity.
    First attempt at repair means to take action for the purpose of 
stopping or reducing leakage of organic material to the atmosphere.
    Fixed roof means a cover that is mounted on a waste management unit 
or storage tank 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 tank wall.
    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.
    Formulation means the process of mixing, blending, or diluting one 
or more active or inert ingredients with one or more active or inert 
ingredients, without an intended chemical reaction, to obtain a 
pharmaceutical dosage form. Formulation operations include mixing, 
compounding, blending, and tablet coating.
    Group of processes means all of the equipment associated with 
processes in a building, processing area, or facility-wide. For a 
dedicated process, a group of processes may consist of a single 
process.
    Halogen atoms mean atoms of chlorine or fluorine.
    Halogenated compounds means organic HAP compounds that contain 
halogen atoms.
    Halogenated vent stream or Halogenated stream means a process, 
storage tank, or waste management unit vent determined to have a 
concentration of halogenated compounds of greater than 20 ppmv, as 
determined through process knowledge, test results using Method 18 of 
40 CFR part 60, appendix A, or test results using any other test method 
that has been validated according to the procedures in Method 301 of 
appendix A of this part.
    Hard-piping means piping or tubing that is manufactured and 
properly installed using good engineering judgment and standards, such 
as ANSI B31-3.
    Hydrogen halides and halogens means hydrogen chloride (HCl), 
chlorine (Cl2), and hydrogen fluoride (HF).
    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

[[Page 50330]]

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.
    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; and 
associated sewer lines, 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.
    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 
start ups (as defined in this section) of processes following 
malfunctions or process shutdowns.
    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 tank or waste management unit that has a permanently affixed 
roof.
    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.
    Junction box means a manhole or access point to a wastewater sewer 
system line or a lift station.
    Large control device means a control device that controls process 
vents with total emissions of greater than or equal to 10 tons of HAP 
per year, before control.
    Liquid-mounted seal means a foam- or liquid-filled seal mounted in 
contact with the liquid between the wall of the storage tank or waste 
management unit and the floating roof. The seal is mounted continuously 
around the tank or unit.
    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.
    Malfunction means any sudden, infrequent, and not reasonably 
preventable failure of air pollution control equipment, emissions 
monitoring equipment, process equipment, or a process to operate in a 
normal or usual manner. Failures that are caused all or in part by poor 
maintenance or careless operation are not malfunctions.
    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 Chapter 19.2 of the 
American Petroleum Institute's Manual of Petroleum Measurement 
Standards, Evaporative Loss From Floating-Roof Tanks (incorporated by 
reference as specified in Sec. 63.14); or
    (2) As obtained from standard reference texts; or
    (3) As determined by the American Society for Testing and Materials 
Method D2879-97, Test Method for Vapor Pressure-Temperature 
Relationship and Initial Decomposition Temperature of Liquids by 
Isoteniscope (incorporated by reference as specified in Sec. 63.14); or
    (4) Any other method approved by the Administrator.
    Metallic shoe seal or mechanical shoe seal means metal sheets that 
are held vertically against the wall of the storage tank by springs, 
weighted levers, or other mechanisms and 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.
    Nondedicated formulation operations means equipment used to 
formulate numerous products.
    Nondedicated recovery device(s) means a recovery device that 
receives material from more than one PMPU.
    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 biological treatment process means a biological treatment 
process that is not a closed biological treatment process as defined in 
this section.
    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.
    Operating scenario for the purposes of reporting and recordkeeping, 
means any specific operation of a PMPU and includes for each process:
    (1) A description of the process and the type of process equipment 
used;
    (2) An identification of related process vents and their associated 
emissions episodes and durations, wastewater PODs, and storage tanks;
    (3) The applicable control requirements of this subpart, including 
the level of required control;
    (4) The control or treatment devices used, as applicable, including 
a

[[Page 50331]]

description of operating and/or testing conditions for any associated 
control device;
    (5) The process vents, wastewater PODs, and storage tanks 
(including those from other processes) that are simultaneously routed 
to the control or treatment device(s);
    (6) The applicable monitoring requirements of this subpart and any 
parametric level that assures compliance for all emissions routed to 
the control or treatment device;
    (7) Calculations and engineering analyses required to demonstrate 
compliance; and
    (8) A verification that the operating conditions for any associated 
control or treatment device have not been exceeded and that any 
required calculations and engineering analyses have been performed. For 
reporting purposes, a change to any of these elements not previously 
reported, except for paragraph (5) of this definition, shall constitute 
a new operating scenario.
    Partially soluble HAP means a HAP listed in Table 2 of this 
subpart.
    Pharmaceutical manufacturing operations means the facility-wide 
collection of PMPU's and any other equipment such as heat exchanger 
systems, or cooling towers that are not associated with an individual 
PMPU, but that are located at a facility for the purpose of 
manufacturing pharmaceutical products and are under common control.
    Pharmaceutical manufacturing process unit (PMPU) means the process, 
as defined in this subpart, and any associated storage tanks, equipment 
identified in Sec. 63.1252(f), and 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 product means:
    (1) Any material described by the standard industrial 
classification (SIC) code 2833 or 2834;
    (2) Any material whose manufacturing process is described by north 
american industrial classification system (NAICS) code 325411 or 
325412;
    (3) A finished dosage form of a drug, for example, a tablet, 
capsule, solution, etc., that contains an active ingredient generally, 
but not necessarily, in association with inactive ingredients; or
    (4) Any component whose intended primary use is to furnish 
pharmacological activity or other direct effect in the diagnosis, cure, 
mitigation, treatment, or prevention of disease, or to affect the 
structure or any function of the body of man or other animals (the term 
does not include excipients, but includes drug components such as raw 
starting materials or precursors that undergo chemical change or 
processing before they become active ingredients).
    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.
    Point of determination (POD) means the point where a wastewater 
stream exits the process, storage tank, or last recovery device. If 
soluble and/or partially soluble HAP compounds are not recovered from 
water before discharge, the discharge point from the process equipment 
or storage tank is a POD. If water streams are routed to a recovery 
device, the discharge from the recovery device is a POD. There can be 
more than 1 POD per process or PMPU.
    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.
    Primary use means the single largest use of a material.
    Process means all equipment which collectively function to produce 
a pharmaceutical product. A process may consist of one or more unit 
operations. For the purposes 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 pharmaceutical product. Cleaning operations conducted are 
considered part of the process. The holding of the pharmaceutical 
product in tanks or other holding equipment for more than 30 
consecutive days, or transfer of the pharmaceutical product to 
containers for shipment, marks the end of a process, and the tanks are 
considered part of the PMPU that produced the stored material. When 
material from one unit operation is used as the feedstock for the 
production of two or more different pharmaceutical products, the unit 
operation is considered the endpoint of the process that produced the 
material, and the unit operations into which the material is routed 
mark the beginning of the other processes. Nondedicated recovery 
devices located within a contiguous area within the affected source are 
considered single processes. Nondedicated formulation operations 
occurring within a contiguous area are considered a single process that 
is used to formulate numerous materials and/or products. Quality 
Assurance and Quality Control laboratories are not considered part of 
any process.
    Process condenser means a condenser whose primary purpose is to 
recover material as an integral part of a process. The condenser must 
support a vapor-to-liquid phase change for periods of source equipment 
operation that are at or above the boiling or bubble point of 
substance(s) at the liquid surface. Examples of process condensers 
include distillation condensers, reflux condensers, and condensers used 
in stripping or flashing operations. In a series of condensers, all 
condensers up to and including the first condenser with an exit gas 
temperature below the boiling or bubble point of the substance(s) at 
the liquid surface are considered to be process condensers. All 
condensers in line prior to a vacuum source are included in this 
definition.
    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 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.
    Process tank means a tank that is used to collect material 
discharged from a feedstock storage tank or unit operation

[[Page 50332]]

within the process and transfer this material to another unit operation 
within the process or to 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 or vents from 
multiple unit operations within a process that are manifolded together 
into a common header, 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. Emission streams 
that are undiluted and uncontrolled containing less than 50 ppmv HAP, 
as determined through process knowledge that no HAP are present in the 
emission stream or using an engineering assessment as discussed in 
Sec. 63.1257(d)(2)(ii), test data using Methods 18 of 40 CFR part 60, 
appendix A, or any other test method that has been validated according 
to the procedures in Method 301 of appendix A of this part, are not 
considered process vents. Process vents do not include vents on storage 
tanks regulated under Sec. 63.1253, vents on wastewater emission 
sources regulated under Sec. 63.1256, or pieces of equipment regulated 
under Sec. 63.1255.
    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. 
Sec. 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(o).
    Reactor means a device or vessel in which one or more chemicals or 
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, as used in the wastewater provisions, 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. Examples of equipment 
that may be recovery devices include organic removal devices such as 
decanters, strippers, or thin-film evaporation units. To be a recovery 
device, a decanter and any other equipment based on the operating 
principle of gravity separation must receive only two-phase liquid 
streams.
    Repaired means that equipment is adjusted, or otherwise altered, to 
eliminate a leak as defined in the applicable sections of Sec. 63.1255.
    Research and development facility means any stationary source whose 
primary purpose is to conduct research and development into new 
processes and products, where such source is operated under the close 
supervision of technically trained personnel, and is not engaged in the 
manufacture of products for commercial sale in commerce, 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 waste 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.
    Safety device means a closure device such as a pressure relief 
valve, frangible disc, fusible plug, or any other type of device which 
functions exclusively to prevent physical damage or permanent 
deformation to a unit or its air emission control equipment by venting 
gases or vapors directly to the atmosphere during unsafe conditions 
resulting from an unplanned, accidental, or emergency event. For the 
purposes of this subpart, a safety device is not used for routine 
venting of gases or vapors from the vapor headspace underneath a cover 
such as during filling of the unit or to adjust the pressure in this 
vapor headspace in response to normal daily diurnal ambient temperature 
fluctuations. A safety device is designed to remain in a closed 
position during normal operations and open only when the internal 
pressure, or another relevant parameter, exceeds the device threshold 
setting applicable to the air emission control equipment as determined 
by the owner or operator based on manufacturer recommendations, 
applicable regulations, fire protection and prevention codes, standard 
engineering codes and practices, or other requirements for the safe 
handling of flammable, combustible, explosive, reactive, or hazardous 
materials.
    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.
    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.
    Shutdown means the cessation of operation of a PMPU or an 
individual piece of equipment required or used to comply with this part 
or for emptying and degassing storage tanks. Shutdown occurs for 
purposes including but not limited to: periodic maintenance, 
replacement of equipment, or repair. Shutdown does not apply to routine 
batch operations or the rinsing or washing of equipment in batch 
operations between batches.
    Single-seal system means a floating roof having one continuous seal 
that completely covers the space between the wall of the storage tank 
and the edge of the floating roof. This seal may be a vapor-mounted, 
liquid-mounted, or metallic shoe seal.
    Small control device means a control device that controls process 
vents with total emissions of less than 10 tons of HAP per year, before 
control.
    Soluble HAP means a HAP listed in Table 3 of this subpart.
    Startup means the first time a new or reconstructed source begins 
production, or, for new equipment added, including equipment used to 
comply with this subpart, the first time the equipment is put into 
operation, or for the introduction of a new product/process, the first 
time the product or process is run in equipment. As used in 
Sec. 63.1255, startup means the setting in operation of

[[Page 50333]]

a piece of equipment or a control device that is subject to this 
subpart.
    Storage tank means a tank or other vessel that is used to store 
organic liquids that contain one or more HAP as feedstocks or products 
of a PMPU. 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.
    Total organic compounds (TOC) means those compounds measured 
according to the procedures of Method 18 or Method 25A, 40 CFR part 60, 
appendix A.
    Treatment process means a specific technique that removes or 
destroys the organics in a wastewater or residual stream such as a 
steam 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. 63.1256. 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 process (or process condenser, if any), 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 tank 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 (VOC) means those materials defined in 
40 CFR 51.100.
    Waste management unit means the equipment, structure(s),and or 
devices used to convey, store, treat, or dispose 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 
wastewater 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 means any portion of an individual wastewater stream or 
any aggregation of wastewater streams.
    Wastewater stream means water that is discarded from a PMPU through 
a single POD, that contains an annual average concentration of 
partially soluble and/or soluble HAP compounds of at least 5 parts per 
million by weight and a load of at least 0.05 kg/yr, and that is not 
exempted by the provisions of Sec. 63.1256(a)(3). For the purposes of 
this subpart, noncontact cooling water is not considered a wastewater 
stream. Wastewater streams are generated by both process operations and 
maintenance activities.
    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: General.

    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(f). Compliance with the emission limits may be 
demonstrated initially through the provisions of Sec. 63.1257 (Test 
methods and compliance procedures) and continuously through the 
provisions of Sec. 63.1258 (Monitoring requirements).
    (a) Opening of a safety device. Opening of a safety device, as 
defined in Sec. 63.1251, is allowed at any time conditions require it 
to do so to avoid unsafe conditions.
    (b) Closed-vent systems. The owner or operator of a closed-vent 
system that contains bypass lines that could divert a vent stream away 
from a control device used to comply with the requirements in 
Secs. 63.1253, 63.1254, and 63.1256 shall comply with the requirements 
of Table 4 to this subpart and paragraph (b)(1) or (2) of this section. 
Equipment such as low leg drains, high point bleeds, analyzer vents, 
open-ended valves or lines, rupture disks and pressure relief valves 
needed for safety purposes are not subject to this paragraph.
    (1) Install, calibrate, maintain, and operate a flow indicator that 
determines whether vent stream flow is present at least once every 15 
minutes. Records shall be maintained as specified in 
Sec. 63.1259(i)(6)(i). The flow indicator shall be installed at the 
entrance to any bypass line that could divert the vent stream away from 
the control device to the atmosphere; or
    (2) Secure the bypass line valve in the closed position with a car 
seal or lock and key type configuration. A visual inspection of the 
seal or closure mechanism shall be performed at least once every month 
to ensure that the valve is maintained in the closed position and the 
vent stream is not diverted through the bypass line. Records shall be 
maintained as specified in Sec. 63.1259(i)(6)(ii).
    (c) Heat exchange systems. Except as provided in paragraph (c)(2) 
of this section, owners and operators of affected sources shall comply 
with the requirements in paragraph (c)(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

[[Page 50334]]

Sec. 63.104, except that the monitoring frequency shall be no less than 
quarterly.
    (2) For identifying leaking equipment, the owner or operator of 
heat exchange systems on equipment which meet current good 
manufacturing practice (CGMP) requirements of 21 CFR part 211 may elect 
to use the physical integrity of the reactor as the surrogate indicator 
of heat exchange system leaks around the reactor.
    (d) Emissions averaging provisions. Except as specified in 
paragraphs (d)(1) through (5) of this section, owners or operators of 
storage tanks or processes subject to the provisions of Secs. 63.1253 
and 63.1254 may choose to comply by using emissions averaging 
requirements specified in Sec. 63.1257(g) or (h) for any storage tank 
or process.
    (1) A State may prohibit averaging of HAP emissions and require the 
owner or operator of an existing source to comply with the provisions 
in Secs. 63.1253 and 63.1254.
    (2) Only emission sources subject to the requirements of 
Sec. 63.1253(b)(1) and (c)(1) or Sec. 63.1254(a)(2), (a)(3)(ii)(A) or 
(a)(3)(iii) may 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. 63.1257(g) 
and (h).
    (5) Emission points controlled to comply with a State or Federal 
rule other than this subpart may not be included in an emission 
averaging group, 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 subject to Sec. 63.1254(a)(2)(i), 20 
storage tanks subject to Sec. 63.1253(b)(1), and 20 storage tanks 
subject to Sec. 63.1253(c)(1)(i) at an affected source may be included 
in an emissions averaging group.
    (7) Compliance with the emissions standards in Sec. 63.1253 shall 
be satisfied when the annual percent reduction efficiency is greater 
than or equal to 90 percent for those tanks meeting the requirements of 
Sec. 63.1253(a)(1) and 95 percent for those tanks meeting the 
requirements of Sec. 63.1253(a)(2), as demonstrated using the test 
methods and compliance procedures specified in Sec. 63.1257(g).
    (8) Compliance with the emissions standards in Sec. 63.1254(a)(2) 
shall be satisfied when the annual percent reduction efficiency is 
greater than or equal to 93 percent, as demonstrated using the test 
methods and compliance procedures specified in Sec. 63.1257(h).
    (e) Pollution prevention alternative. Except as provided in 
paragraph (e)(1) of this section, owners and operators may choose to 
meet the pollution prevention alternative requirement specified in 
either paragraph (e)(2) or (3) of this section for any PMPU, in lieu of 
the requirements specified in Secs. 63.1253, 63.1254, 63.1255, and 
63.1256. Compliance with paragraphs (e)(2) and (3) of this section 
shall be demonstrated through the procedures in Sec. 63.1257(f).
    (1) The HAP that are generated in the PMPU that are not part of the 
production-indexed consumption factor must be controlled according to 
the requirements of Secs. 63.1253, 63.1254, 63.1255, and 63.1256. The 
HAP that are generated as a result of combustion control of emissions 
must be controlled according to the requirements of paragraph (g) of 
this section.
    (2) The production-indexed HAP consumption factor (kg HAP consumed/
kg produced) shall be reduced by at least 75 percent from a 3 year 
average baseline established no earlier than the 1987 calendar year, or 
for the time period from startup of the process until the present in 
which the PMPU was operational and data are available, whichever is the 
lesser time period. If a time period less than 3 years is used to set 
the baseline, the data must represent at least 1 year's worth of data. 
For any reduction in the HAP factor achieved by reducing a HAP that is 
also a VOC, an equivalent reduction in the VOC factor is also required. 
For any reduction in the HAP factor that is achieved by reducing a HAP 
that is not a VOC, the VOC factor may not be increased.
    (3) Both requirements specified in paragraphs (e)(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 at least 50 percent from a 3-year 
average baseline established no earlier than the 1987 calendar year, or 
for the time period from startup of the process until the present in 
which the PMPU was operational and data are available, whichever is 
less. If a time period less than 3 years is used to set the baseline, 
the data must represent at least 1 year's worth of data. For any 
reduction in the HAP factor achieved by reducing a HAP that is also a 
VOC, an equivalent reduction in the VOC factor is also required. For 
any reduction in the HAP factor that is achieved by reducing a HAP that 
is not a VOC, the VOC factor may not be increased.
    (ii) The total PMPU HAP emissions shall be reduced by an amount, in 
kg/yr, that, when divided by the annual production rate, in kg/yr, and 
added to the reduction of the production-indexed HAP consumption 
factor, in kg/kg, yields a value of at least 75 percent of the average 
baseline HAP production-indexed consumption factor established 
according to paragraph (e)(3)(i) of this section according to the 
equation provided in Sec. 63.1257(f)(2)(ii)(A). The total PMPU VOC 
emissions shall be reduced by an amount calculated according to the 
equation provided in Sec. 63.1257(f)(2)(ii)(B). The annual reduction in 
HAP and VOC 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) 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 PMPU.
    (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 PMPU.
    (f) Control requirements for certain liquid streams in open systems 
within a PMPU. (1) The owner or operator shall comply with the 
provisions of Table 5 of this subpart, for each item of equipment 
meeting all the criteria specified in paragraphs (f)(2) through (4) and 
either paragraph (f)(5)(i) or (ii) of this section.
    (2) The item of equipment is of a type identified in Table 5 of 
this subpart;
    (3) The item of equipment is part of a PMPU, as defined in 
Sec. 63.1251;
    (4) The item of equipment is controlled less stringently than in 
Table

[[Page 50335]]

5 of this subpart and the item of equipment is not otherwise exempt 
from controls by the provisions of this subpart or subpart A of this 
part; and
    (5) The item of equipment:
    (i) Is a drain, drain hub, manhole, lift station, trench, pipe, or 
oil/water separator that conveys water with an annual average 
concentration greater than or equal to 1,300 parts per million by 
weight (ppmw) of partially soluble HAP compounds; or an annual average 
concentration greater than or equal to 5,200 ppmw of partially soluble 
and/or soluble HAP compounds. The annual average concentration shall be 
determined according to the procedures in Sec. 63.1257(e)(1)(ii).
    (ii) Is a tank that receives one or more streams that contain water 
with an annual average concentration greater than or equal to 1,300 
ppmw of partially soluble HAP compounds, or greater than or equal to 
5,200 ppmw of total partially soluble and/or soluble HAP compounds. The 
owner or operator of the source shall determine the average 
concentration of the stream at the inlet to the tank and according to 
the procedures in Sec. 63.1257(e)(1)(ii).
    (g) Control requirements for halogenated vent streams that are 
controlled by combustion devices. If a combustion device is used to 
comply with the provisions of Secs. 63.1253 (storage tanks), 63.1254 
(process vents), 63.1256(h) (wastewater vent streams) for a halogenated 
vent stream, then the vent stream shall be ducted to a halogen 
reduction device such as, but not limited to, a scrubber, before it is 
discharged to the atmosphere. The halogen reduction device must reduce 
emissions by the amounts specified in either paragraph (g)(1) or (2) of 
this section.
    (1) A halogen reduction device after the combustion control device 
must reduce overall emissions of hydrogen halides and halogens, as 
defined in Sec. 63.1251, by 95 percent or to a concentration less than 
or equal to 20 ppmv.
    (2) A halogen reduction device located before the combustion 
control device must reduce the halogen atom content of the vent stream 
to a concentration less than or equal to 20 ppmv.


Sec. 63.1253  Standards: Storage tanks.

    (a) Except as provided in paragraphs (d) and (e) of this section, 
the owner or operator of a storage tank meeting the criteria of 
paragraph (a)(1) of this section is subject to the requirements of 
paragraph (b) of this section. Except as provided in paragraphs (d) and 
(e) of this section, the owner or operator of a storage tank meeting 
the criteria of paragraph (a)(2) of this section is subject to the 
requirements of paragraph (c) of this section. Compliance with the 
provisions of paragraphs (b) and (c) of this section is demonstrated 
using the initial compliance procedures in Sec. 63.1257(c) and the 
monitoring requirements in Sec. 63.1258.
    (1) A storage tank with a design capacity greater than or equal to 
38 m3 (10,000 gallons [gal]) but less than 75 m3 
(20,000 gal), 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).
    (2) A storage tank with a design capacity greater than or equal to 
75 m3 (20,000 gal) 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).
    (b) 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 meeting the 
conditions of Sec. 63.1252(b) with a control device that meets any of 
the following conditions:
    (1) Reduces inlet emissions of total HAP by 90 percent by weight or 
greater;
    (2) Is an enclosed combustion device that provides a minimum 
residence time of 0.5 seconds at a minimum temperature of 760 deg. C;
    (3) Is a flare that meets the requirements of Sec. 63.11(b); or
    (4) Is a control device specified in Sec. 63.1257(a)(4).
    (c) 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 meeting the 
conditions of Sec. 63.1252(b) with a control device that meets any of 
the following conditions:
    (1) Reduces inlet emissions of total HAP as specified in paragraph 
(c)(1) (i) or (ii) of this section:
    (i) By 95 percent by weight or greater; or (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 by weight but less 
than 95 percent by weight, then the control device is required to be 
operated to reduce inlet emissions of total HAP by 90 percent or 
greater.
    (2) Is an enclosed combustion device that provides a minimum 
residence time of 0.5 seconds at a minimum temperature of 760 deg. C;
    (3) Is a flare that meets the requirements of Sec. 63.11(b); or
    (4) Is a control device specified in Sec. 63.1257(a)(4).
    (d) As an alternative standard, the owner or operator of an 
existing or new affected source may comply with the storage tank 
standards by routing storage tank vents to a control device achieving 
an outlet TOC concentration, as calibrated on methane or the 
predominant HAP, of 20 ppmv or less, and an outlet concentration of 
hydrogen halides and halogens of 20 ppmv or less. Compliance with the 
outlet concentrations shall be determined by the initial compliance 
procedures of Sec. 63.1257(c)(4) and the continuous emission monitoring 
requirements of Sec. 63.1258(b)(5).
    (e) Planned routine maintenance. The specifications and 
requirements in paragraphs (b) through (d) of this section for control 
devices do not apply during periods of planned routine maintenance. 
Periods of planned routine maintenance of the control devices, during 
which the control device does not meet the specifications of paragraphs 
(b) through (d) of this section, as applicable, shall not exceed 240 
hours per year.


Sec. 63.1254  Standards: Process vents.

    (a) Existing sources. Except as provided in paragraph (c) of this 
section, the owner or operator of an existing affected source must 
control the collection of all gas streams originating from processes 
subject to this standard so as to comply with the requirements in 
paragraph (a)(1) or the requirements of paragraphs (a)(2) and (a)(3) of 
this section. If any vent within a process meets the criteria of 
paragraph (a)(3)(i) of this section, the owner or operator must comply 
with the provisions in paragraphs (a)(2) and (a)(3) for that process. 
The requirements of paragraphs (a) (1) and (2) of this section apply to 
all process vents within a process, as a group, and do not apply to 
individual vents. An owner or operator may switch from compliance with 
paragraph (a)(1) of this section to compliance with paragraphs (a) (2) 
and (3) of this section only after at least 1 year of operation in 
compliance with paragraph (a)(1) of this section. An owner or operator 
may switch from compliance with paragraphs (a) (2) and (3) of this 
section to compliance with paragraph (a)(1) of this section at any 
time. Notification of such a change in the compliance method shall be 
reported according to the procedures in Sec. 63.1260(h) of this 
subpart. Compliance with the required

[[Page 50336]]

emission limits or reductions in paragraphs (a) (1) through (3) of this 
section may be demonstrated using the initial compliance procedures 
described in Sec. 63.1257(d) and the monitoring requirements described 
in Sec. 63.1258.
    (1) Except for processes with a vent that meets the conditions in 
paragraph (a)(3)(i) of this section, actual HAP emissions shall not 
exceed 900 kilograms (kg) per year [2,000 pounds per year] from the sum 
of all process vents within a process.
    (i) Except as provided in paragraph (a)(1)(ii) of this section, the 
owner or operator is limited to 7 processes in any 365-day period that 
can be selected to comply with paragraph (a)(1) of this section.
    (ii) The owner or operator may exclude processes with less than 100 
lb/yr HAP, on an uncontrolled basis, from the 7-process limit described 
in paragraph (a)(1)(i) of this section.
    (2) Uncontrolled HAP emissions from the sum of all process vents 
within a process that do not meet the conditions in paragraph (a)(3)(i) 
of this section or are not controlled according to any of the 
requirements of paragraphs (a)(2)(i), (a)(2)(ii), (a)(2)(iii), or (c) 
of this section shall be reduced by 93 percent or greater by weight.
    (i) To outlet concentrations less than or equal to 20 ppmv as TOC 
and less than or equal to 20 ppmv as hydrogen halides and halogens;
    (ii) By a flare that meets the requirements of Sec. 63.11(b); or 
(iii) By a control device specified in Sec. 63.1257(a)(4).
    (3) Except as provided in paragraph (a)(3)(iii) of this section, 
uncontrolled HAP emissions from each process vent that meets the 
conditions in paragraph (a)(3)(i) of this section shall be reduced as 
specified in paragraph (a)(3)(ii) of this section.
    (i) Uncontrolled HAP emissions from a process vent shall be reduced 
as specified in paragraph (a)(3)(ii) if the vent meets either of the 
criteria described in paragraph (a)(3)(i) (A) or (B) of this section:
    (A) The flow-weighted average flowrate calculated using Equation 1 
of this subpart is less than or equal to the flowrate calculated using 
Equation 2 of this subpart.
[GRAPHIC] [TIFF OMITTED] TR21SE98.000

[GRAPHIC] [TIFF OMITTED] TR21SE98.001

Where:

FRa = flow-weighted average flowrate for the vent, scfm
Di = duration of each emission event, min
FRi = flowrate of each emission event, scfm
n = number of emission events
FR = flowrate, scfm
HL = annual uncontrolled HAP emissions, lb/yr, as defined in 
Sec. 63.1251

    (B) As an alternative to the criteria described in paragraph 
(a)(3)(i)(A) of this section, uncontrolled HAP emissions from a process 
vent shall be reduced or controlled as specified in paragraph 
(a)(3)(ii) of this section if the process vent meets the criteria 
specified in paragraphs (a)(3)(i)(B)(1) and (2) of this section or the 
criteria specified in paragraphs (a)(3)(i)(B)(1) and (3) of this 
section.
    (1) Uncontrolled HAP emissions from the process vent exceed 25 tons 
per year.
    (2) The flow-weighted average flowrate for the vent, as calculated 
in Equation 1 of this section, is less than or equal to 100 scfm.
    (3) The flow weighted average is greater than 100 scfm and less 
than or equal to the flowrate calculated using Equation 2 of this 
section.
    (ii) Uncontrolled HAP emissions shall be reduced:
    (A) By 98 percent by weight or greater; or
    (B) To outlet concentrations less than or equal to 20 ppmv as TOC 
and less than or equal to 20 ppmv as hydrogen halides and halogens; or
    (C) By a flare that meets the requirements of Sec. 63.11(b); or
    (D) By a control device specified in Sec. 63.1257(a)(4).
    (iii) If the owner or operator can demonstrate that a control 
device, installed on a process vent that meets the conditions of 
paragraph (a)(3)(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 by weight, but less than 98 percent by 
weight, then the control device is required to be operated to reduce 
inlet emissions of total HAP by 93 percent by weight or greater.
    (b) New sources. Uncontrolled HAP emissions from the sum of all 
process vents within a process at a new affected source that are not 
controlled according to any of the requirements of paragraphs (b)(1), 
(2), or (3) of this section or paragraph (c) of this section shall be 
reduced by 98 percent or greater by weight if the uncontrolled HAP 
emissions from the sum of all process vents within a process is greater 
than 180 kg/yr (400 lb/yr). Compliance with the required emission limit 
or reduction is demonstrated using the initial compliance procedures in 
Sec. 63.1257(d) and the monitoring requirements described in 
Sec. 63.1258.
    (1) To outlet concentrations less than or equal to 20 ppmv as TOC 
and less than or equal to 20 ppmv as hydrogen halides and halogens;
    (2) By a flare that meets the requirements of Sec. 63.11(b); or
    (3) By a control device specified in Sec. 63.1257(a)(4).
    (c) As an alternative standard, the owner or operator of an 
existing or new affected source may comply with the process vent 
standards by routing all vents from a process to a control device 
achieving an outlet TOC concentration, as calibrated on methane or the 
predominant HAP, of 20 ppmv or less, and an outlet concentration of 
hydrogen halides and halogens of 20 ppmv or less. Any process vents 
within a process that are not routed to this control device must be 
controlled in accordance with the provisions of paragraphs 
(a)(2),(a)(3), and (b) of this section, as applicable. Compliance with 
the outlet concentrations shall be determined by the initial compliance 
procedures described in Sec. 63.1257(d)(1)(iv) and the continuous 
emission monitoring requirements described in Sec. 63.1258(b)(5).


Sec. 63.1255  Standards: Equipment leaks.

    (a) General Equipment Leak Requirements. (1) The provisions of this 
section 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.
    (2) Consistency with other regulations. After the compliance date 
for a process, equipment subject to both this section and either of the 
following will be required to comply only with the provisions of this 
subpart:
    (i) 40 CFR part 60.
    (ii) 40 CFR part 61.
    (3) [Reserved]
    (4) The provisions in Sec. 63.1(a)(3) of subpart A of this part do 
not alter the provisions in paragraph (a)(2) of this section.
    (5) Lines and equipment not containing process fluids are not 
subject

[[Page 50337]]

to the provisions of this section. 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.
    (6) The provisions of this section 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.
    (7) Each piece of equipment to which this section applies shall be 
identified such that it can be distinguished readily from equipment 
that is not subject to this section. 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.
    (8) Equipment that is in vacuum service is excluded from the 
requirements of this section.
    (9) 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 section if it is identified as required in 
paragraph (g)(9) of this section.
    (10) When each leak is detected by visual, audible, or olfactory 
means, or by monitoring as described in Sec. 63.180(b) or (c), the 
following requirements apply:
    (i) A weatherproof and readily visible identification, marked with 
the equipment identification number, shall be attached to the leaking 
equipment.
    (ii) 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 paragraph (e)(7)(iii) of this section and Sec. 63.174(e), 
and no leak has been detected during the follow-up monitoring.
    (iii) 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.
    (b) References. (1) The owner or operator of a source subject to 
this section shall comply with the following sections of subpart H, 
except for Sec. 63.160, Sec. 63.161, Sec. 63.162, Sec. 63.163, 
Sec. 63.167, Sec. 63.168, Sec. 63.170, Sec. 63.171, Sec. 63.172, 
Sec. 63.173, Sec. 63.181, and Sec. 63.182 of this subpart. In place of 
Sec. 63.160 and Sec. 63.162, the owner or operator shall comply with 
paragraph (a) of this section; in place of Sec. 63.161, the owner or 
operator shall comply with Sec. 63.1251 of this subpart; in place of 
Sec. 63.163 and Sec. 63.173, the owner or operator shall comply with 
paragraph (c) of this section; in place of Sec. 63.167, the owner or 
operator shall comply with paragraph (d) of this section; in place of 
Sec. 63.168, the owner or operator shall comply with paragraph (e) of 
this section; in place of Sec. 63.170, the owner or operator shall 
comply with Sec. 63.1254 of this subpart; in place of Sec. 63.171, the 
owner or operator shall comply with paragraph (b)(1)(v) of this 
section; in place of Sec. 63.172, the owner or operator shall comply 
with paragraph (b)(1)(vi) of this section; in place of Sec. 63.181, the 
owner or operator shall comply with paragraph (g) of this section; in 
place of Sec. 63.182, the owner or operator shall comply with paragraph 
(h) of this section. The term ``process unit'' as used in subpart H 
shall be considered to be defined the same as ``group of processes'' 
for sources subject to this subpart GGG.
    (i) Section 63.164, Compressors;
    (ii) Section 63.165, Pressure relief devices in gas/vapor service;
    (iii) Section 63.166, Sampling connection systems;
    (iv) Section 63.169, Pumps, valves, connectors, and agitators in 
heavy liquid service; instrumentation systems; and pressure relief 
devices in liquid service;
    (v) Section 63.171, Delay of repair, shall apply except 
Sec. 63.171(a) shall not apply. Instead, delay of repair of equipment 
for which leaks have been detected is allowed if one of the following 
conditions exist:
    (A) The repair is technically infeasible without a process 
shutdown. Repair of this equipment shall occur by the end of the next 
scheduled process shutdown.
    (B) 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.
    (vi) Section 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 section only, except
    (A) Sections 63.172(k) and (l) shall not apply. In place of 
Sec. 63.172(k) and (l), the owner or operator shall comply with 
paragraph (f) of this section.
    (B) 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.
    (vii) Section 63.174, Connectors, except:
    (A) Sections 63.174(f) and (g) shall not apply. In place of 
Sec. 63.174(f) and (g), the owner or operator shall comply with 
paragraph (f) of this section.
    (B) Days that the connectors are not in organic HAP service shall 
not be considered part of the 3 month period in Sec. 63.174(e).
    (C) Section 63.174(b)(3)(ii) shall not apply. Instead, if the 
percent leaking connectors in the process unit was less than 0.5 
percent, but equal to or greater than 0.25 percent, during the last 
required monitoring period, monitoring shall be performed once every 4 
years. An owner or operator may comply with the requirements of this 
paragraph by monitoring at least 40 percent of the connectors in the 
first 2 years and the remainder of the connectors within the next 2 
years. The percent leaking connectors will be calculated for the total 
of all monitoring performed during the 4 year period.
    (D) Section 63.174(b)(3)(iv) shall not apply. Instead, the owner or 
operator shall increase the monitoring frequency to once every 2 years 
for the next monitoring period if leaking connectors comprise at least 
0.5 percent but less than 1.0 percent of the connectors monitored 
within the 4 years specified in paragraph (b)(1)(vii)(C) of this 
section or the first 4 years specified in Sec. 63.174(b)(3)(iii). At 
the end of that 2 year monitoring period, the owner or operator shall 
monitor once per year while the percent leaking connectors is greater 
than or equal to 0.5 percent; if the percent leaking connectors is less 
than 0.5 percent, the owner or operator may return to monitoring once 
every 4 years or may monitor in accordance with Sec. 63.174(b)(3)(iii), 
if appropriate.
    (E) Section 63.174(b)(3)(v) shall not apply. Instead, if an owner 
or operator complying with the requirements of paragraph (b)(1)(vii)(C) 
and (D) of this section or Sec. 63.174 (b)(3)(iii) for a group of 
processes determines that 1 percent or greater of the connectors are 
leaking, the owner or operator shall increase the monitoring frequency 
to one time per year. The owner or operator may again elect to use the 
provisions of paragraphs (b)(1)(vii)(C) or (D) of this section after a 
monitoring period in which less than

[[Page 50338]]

0.5 percent of the connectors are determined to be leaking.
    (F) Section 63.174(b)(3)(iii) shall not apply. Instead, monitoring 
shall be required once every 8 years, if the percent leaking connectors 
in the process unit was less than 0.25 percent during the last required 
monitoring period. An owner or operator shall monitor at least 50 
percent of the connectors in the first 4 years and the remainder of the 
connectors within the next 4 years. If the percent leaking connectors 
in the first 4 years is equal to or greater than 0.35 percent, the 
monitoring program shall revert at that time to the appropriate 
monitoring frequency specified in paragraphs (b)(1)(vii)(C), (D), or 
(E) of this section.
    (viii) Section 63.177, Alternative means of emission limitation: 
General;
    (ix) Section 63.178, Alternative means of emission limitation: 
Batch processes, except that Sec. 63.178(b), requirements for pressure 
testing, shall apply to all processes, not just batch processes;
    (x) Section 63.179, Alternative means of emission limitation: 
Enclosed-vented process units;
    (xi) Section 63.180, Test methods and procedures, except 
Sec. 63.180(b)(4)(ii)(A) through (C) shall not apply. Instead 
calibration gases shall be a mixture of methane and air at a 
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 section 
63.180(b)(4)(iii).
    (2) [Reserved]
    (c) Standards for Pumps in Light Liquid Service and Agitators in 
Gas/Vapor Service and in Light Liquid Service. (1) 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.
    (2)(i) Monitoring. 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 subpart H, except as provided in Sec. 63.177 of 
subpart H, paragraph (f) of this section, and paragraphs (c)(5) through 
(c)(9) of this section.
    (ii) Leak definition. The instrument reading, as determined by the 
method as specified in Sec. 63.180(b), that defines a leak is:
    (A) For agitators, an instrument reading of 10,000 parts per 
million or greater.
    (B) For pumps, an instrument reading of 2,000 parts per million or 
greater.
    (iii) Visual Inspections. 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.
    (3) Repair provisions. (i) 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 (b)(1)(v) of this 
section.
    (ii) 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:
    (A) Tightening of packing gland nuts.
    (B) Ensuring that the seal flush is operating at design pressure 
and temperature.
    (4) Calculation of percent leakers. (i) The owner or operator shall 
decide no later than the end of the first monitoring period what groups 
of processes will be developed. Once the owner or operator has decided, 
all subsequent percent calculations shall be made on the same basis.
    (ii) If, calculated on a 1 year rolling average, the greater of 
either 10 percent or three of the pumps in a group of processes leak, 
the owner or operator shall monitor each pump once per month.
    (iii) The number of pumps in a group of processes 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.
    (iv) Percent leaking pumps shall be determined by the following 
Equation 3:

%PL = [(PL--PS)/(PT--
PS)]  x  100 (Eq. 3)

Where:
%PL = percent leaking pumps
PL = number of pumps found leaking as determined through 
quarterly monitoring as required in paragraphs (c)(2)(i) and (c)(2)(ii) 
of this section.
PT = total pumps in organic HAP service, including those 
meeting the criteria in paragraphs (c)(5) and (c)(6) of this section
PS = number of pumps in a continuous process leaking within 1 quarter 
of startup during the current monitoring period

    (5) Exemptions. Each pump or agitator equipped with a dual 
mechanical seal system that includes a barrier fluid system is exempt 
from the requirements of paragraphs (c)(1) through (c)(4)(iii) of this 
section, provided the following requirements are met:
    (i) Each dual mechanical seal system is:
    (A) Operated with the barrier fluid at a pressure that is at all 
times greater than the pump/agitator stuffing box pressure; or
    (B) 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 paragraph (b)(1)(vi) of this section; or
    (C) Equipped with a closed-loop system that purges the barrier 
fluid into a process stream.
    (ii) The barrier fluid is not in light liquid service.
    (iii) Each barrier fluid system is equipped with a sensor that will 
detect failure of the seal system, the barrier fluid system, or both.
    (iv) Each pump/agitator is checked by visual inspection each 
calendar week for indications of liquids dripping from the pump/
agitator seal.
    (A) 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.
    (B) 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.
    (v) Each sensor as described in paragraph (c)(5)(iii) 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.
    (vi)(A) 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 indicate failure 
of the seal system, the barrier fluid system, or both.
    (B) If indications of liquids dripping from the pump/agitator seal 
exceed the criteria established in paragraph (c)(5)(vi)(A) of this 
section, or if, based on the criteria established in paragraph 
(c)(5)(vi)(A) of this section, the sensor indicates failure of the seal 
system, the barrier fluid system, or both, a leak is detected.
    (C) 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 (b)(1)(v) of this section.
    (D) A first attempt at repair shall be made no later than 5 
calendar days after each leak is detected.
    (6) Any pump/agitator that is designed with no externally actuated

[[Page 50339]]

shaft penetrating the pump/agitator housing is exempt from the 
requirements of paragraphs (c)(1) through (c)(4) of this section, 
except for the requirements of paragraph (c)(2)(iii) and, for pumps, 
paragraph (c)(4)(iv).
    (7) 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 paragraph (b)(1)(vi) of this section is exempt from the requirements 
of paragraphs (c)(2) through (c)(5) of this section.
    (8) Any pump/agitator that is located within the boundary of an 
unmanned plant site is exempt from the weekly visual inspection 
requirement of paragraphs (c)(2)(iii) and (c)(5)(iv) of this section, 
and the daily requirements of paragraph (c)(5)(v) of this section, 
provided that each pump/agitator is visually inspected as often as 
practicable and at least monthly.
    (9) If more than 90 percent of the pumps in a group of processes 
meet the criteria in either paragraph (c)(5) or (c)(6) of this section, 
the process is exempt from the requirements of paragraph (c)(4) of this 
section.
    (d) Standards: Open-Ended Valves or Lines. (1)(i) 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 paragraphs (d)(4) 
through (6) of this section.
    (ii) 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.
    (2) 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.
    (3) 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 
(d)(1) of this section at all other times.
    (4) 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 (d)(1) through 
(d)(3) of this section.
    (5) Open-ended valves or lines containing materials which would 
autocatalytically polymerize are exempt from the requirements of 
paragraphs (d)(1) through (d)(3) of this section.
    (6) Open-ended valves or lines containing materials which could 
cause an explosion, serious overpressure, or other safety hazard if 
capped or equipped with a double block and bleed system as specified in 
paragraphs (d)(1) through (d)(3) of this section are exempt from the 
requirements of paragraphs (d)(1) through (d)(3) of this section.
    (e) Standards: Valves in Gas/Vapor Service and in Light Liquid 
Service. (1) The provisions of this section apply to valves that are 
either in gas organic HAP service or in light liquid organic HAP 
service.
    (2) For existing and new affected sources, all valves subject to 
this section shall be monitored, except as provided in paragraph (f) of 
this section and in Sec. 63.177, by no later than 1 year after the 
compliance date.
    (3) Monitoring. The owner or operator of a source subject to this 
section shall monitor all valves, except as provided in paragraph (f) 
of this section and in Sec. 63.177, at the intervals specified in 
paragraph (e)(4) of this section and shall comply with all other 
provisions of this section, except as provided in paragraph (b)(1)(v) 
of this section, Sec. 63.178, and Sec. 63.179.
    (i) The valves shall be monitored to detect leaks by the method 
specified in Sec. 63.180(b).
    (ii) An instrument reading of 500 parts per million or greater 
defines a leak.
    (4) Subsequent monitoring frequencies. After conducting the initial 
survey required in paragraph (e)(2) of this section, the owner or 
operator shall monitor valves for leaks at the intervals specified 
below:
    (i) For a group of processes with 2 percent or greater leaking 
valves, calculated according to paragraph (e)(6) of this section, the 
owner or operator shall monitor each valve once per month, except as 
specified in paragraph (e)(9) of this section.
    (ii) For a group of processes with less than 2 percent leaking 
valves, the owner or operator shall monitor each valve once each 
quarter, except as provided in paragraphs (e)(4)(iii) through (e)(4)(v) 
of this section.
    (iii) For a group of processes with less than 1 percent leaking 
valves, the owner or operator may elect to monitor each valve once 
every 2 quarters.
    (iv) For a group of processes with less than 0.5 percent leaking 
valves, the owner or operator may elect to monitor each valve once 
every 4 quarters.
    (v) For a group of processes with less than 0.25 percent leaking 
valves, the owner or operator may elect to monitor each valve once 
every 2 years.
    (5) Calculation of percent leakers. For a group of processes to 
which this subpart applies, an owner or operator may choose to 
subdivide the valves in the applicable group of processes and apply the 
provisions of paragraph (e)(4) of this section to each subgroup. If the 
owner or operator elects to subdivide the valves in the applicable 
group of processes, then the provisions of paragraphs (e)(5)(i) through 
(e)(5)(viii) of this section apply.
    (i) The overall performance of total valves in the applicable group 
of processes must be less than 2 percent leaking valves, as detected 
according to paragraphs (e)(3) (i) and (ii) of this section and as 
calculated according to paragraphs (e)(6) (ii) and (iii) of this 
section.
    (ii) The initial assignment or subsequent reassignment of valves to 
subgroups shall be governed by the provisions of paragraphs (e)(5)(ii) 
(A) through (C) of this section.
    (A) The owner or operator shall determine which valves are assigned 
to each subgroup. Valves with less than 1 year of monitoring data or 
valves not monitored within the last 12 months must be placed initially 
into the most frequently monitored subgroup until at least 1 year of 
monitoring data has been obtained.
    (B) Any valve or group of valves can be reassigned from a less 
frequently monitored subgroup to a more frequently monitored subgroup 
provided that the valves to be reassigned were monitored during the 
most recent monitoring period for the less frequently monitored 
subgroup. The monitoring results must be included with the less 
frequently monitored subgroup's monitoring event and associated next 
percent leaking valves calculation for that group.
    (C) Any valve or group of valves can be reassigned from a more 
frequently monitored subgroup to a less frequently monitored subgroup 
provided that the valves to be reassigned have not leaked for the 
period of the less frequently monitored subgroup (e.g., for the last 12 
months, if the valve or group of valves is to be reassigned to a 
subgroup being monitored annually). Nonrepairable valves may not be 
reassigned to a less frequently monitored subgroup.
    (iii) The owner or operator shall determine every 6 months if the 
overall performance of total valves in the applicable group of 
processes is less than 2 percent leaking valves and so indicate the 
performance in the next periodic report. If the overall performance of 
total valves in the

[[Page 50340]]

applicable group of processes is 2 percent leaking valves or greater, 
the owner or operator shall revert to the program required in 
paragraphs (e)(2) through (e)(4) of this section. The overall 
performance of total valves in the applicable group of processes shall 
be calculated as a weighted average of the percent leaking valves of 
each subgroup according to the following Equation 4:
[GRAPHIC] [TIFF OMITTED] TR21SE98.002

where:

%VLO = overall performance of total valves in the applicable 
process or group of processes
%VLi = percent leaking valves in subgroup I, most recent 
value calculated according to the procedures in paragraphs (e)(6) (ii) 
and (iii) of this section
Vi = number of valves in subgroup I
n = number of subgroups

    (iv) Records. In addition to records required by paragraph (g) of 
this section, the owner or operator shall maintain records specified in 
paragraphs (e)(5)(iv)(A) through (D) of this section.
    (A) Which valves are assigned to each subgroup,
    (B) Monitoring results and calculations made for each subgroup for 
each monitoring period,
    (C) Which valves are reassigned and when they were reassigned, and
    (D) The results of the semiannual overall performance calculation 
required in paragraph (e)(5)(iii) of this section.
    (v) The owner or operator shall notify the Administrator no later 
than 30 days prior to the beginning of the next monitoring period of 
the decision to subgroup valves. The notification shall identify the 
participating processes and the valves assigned to each subgroup.
    (vi) Semiannual reports. In addition to the information required by 
paragraph (h)(3) of this section, the owner or operator shall submit in 
the periodic reports the information specified in paragraphs 
(e)(5)(vi)(A) and (B) of this section.
    (A) Valve reassignments occurring during the reporting period, and
    (B) Results of the semiannual overall performance calculation 
required by paragraph (e)(5)(iii) of this section.
    (vii) To determine the monitoring frequency for each subgroup, the 
calculation procedures of paragraph (e)(6)(iii) of this section shall 
be used.
    (viii) Except for the overall performance calculations required by 
paragraphs (e)(5)(i) and (e)(5)(iii) of this section, each subgroup 
shall be treated as if it were a process for the purposes of applying 
the provisions of this section.
    (6)(i) The owner or operator shall decide no later than the 
implementation date of this subpart or upon revision of an operating 
permit how to group the processes. Once the owner or operator has 
decided, all subsequent percentage calculations shall be made on the 
same basis.
    (ii) Percent leaking valves for each group of processes or subgroup 
shall be determined by the following Equation 5:

%VL = [VL/VT]  x  100    (Eq. 5)

Where:

%VL = percent leaking valves
VL = number of valves found leaking excluding nonrepairables 
as provided in paragraph (e)(6)(iv)(A) of this section
VT = total valves monitored, in a monitoring period 
excluding valves monitored as required by (e)(7)(iii) of this section

    (iii) When determining monitoring frequency for each group of 
processes or subgroup subject to monthly, quarterly, or semiannual 
monitoring frequencies, the percent leaking valves shall be the 
arithmetic average of the percent leaking valves from the last two 
monitoring periods. When determining monitoring frequency for each 
group of processes or subgroup subject to annual or biennial (once 
every 2 years) monitoring frequencies, the percent leaking valves shall 
be the arithmetic average of the percent leaking valves from the last 
three monitoring periods.
    (iv)(A) 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 comply with paragraph 
(e)(6)(iv)(B) 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.
    (B) 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.
    (7) Repair provisions. (i) 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 paragraph (b)(1)(v) 
of this section.
    (ii) A first attempt at repair shall be made no later than 5 
calendar days after each leak is detected.
    (iii) 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 is not in organic HAP service shall not be considered part of 
this 3 month period.
    (8) First attempts at repair include, but are not limited to, the 
following practices where practicable:
    (i) Tightening of bonnet bolts,
    (ii) Replacement of bonnet bolts,
    (iii) Tightening of packing gland nuts, and
    (iv) Injection of lubricant into lubricated packing.
    (9) 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 specified in paragraph (e)(4)(i) 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 (e)(4)(iii) or (e)(4)(iv) of this section.
    (f) Unsafe to Monitor, Difficult to Monitor, and Inaccessible 
Equipment. (1) Equipment that is designated as unsafe to monitor, 
difficult to monitor, or inaccessible is exempt from the monitoring 
requirements specified in paragraphs (f)(1)(i) through (iv) of this 
section provided the owner or operator meets the requirements specified 
in paragraph (f)(2), (f)(3), or (f)(4) of this section, as applicable. 
Ceramic or ceramic-lined connectors are subject to the same 
requirements as inaccessible connectors.
    (i) For pumps and agitators, paragraphs (c)(2), (c)(3), and (c)(4) 
of this section do not apply.
    (ii) For valves, paragraphs (e)(2) through (e)(7) of this section 
do not apply.
    (iii) For closed-vent systems, Sec. 63.172(f)(1) and (2), and (g) 
do not apply.
    (iv) For connectors, Sec. 63.174(b) through (e) do not apply.
    (2) Equipment that is unsafe to monitor. (i) Equipment may be 
designated as unsafe to monitor if the owner or operator determines 
that monitoring personnel would be exposed to an immediate danger as a 
consequence of complying with the monitoring requirements in paragraphs 
(f)(1)(i) through (iv) of this section.

[[Page 50341]]

    (ii) The owner or operator of equipment that is designated as 
unsafe-to-monitor must have 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.
    (3) Equipment that is difficult to monitor. (i) Equipment may be 
designated as difficult to monitor if the owner or operator 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;
    (ii) At an existing source, any equipment within a group of 
processes that meets the criteria of paragraph (f)(3)(i) of this 
section may be designated as difficult to monitor. At a new affected 
source, an owner or operator may designate no more than 3 percent of 
each type of equipment as difficult to monitor.
    (iii) The owner or operator of equipment designated as difficult to 
monitor must follow a written plan that requires monitoring of the 
equipment at least once per calendar year.
    (4) Inaccessible equipment and ceramic or ceramic-lined connectors. 
(i) A connector, agitator, or valve may be designated as inaccessible 
if it is:
    (A) Buried;
    (B) Insulated in a manner that prevents access to the equipment by 
a monitor probe;
    (C) Obstructed by equipment or piping that prevents access to the 
equipment by a monitor probe;
    (D) 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; or
    (E) 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.
    (ii) At an existing source, any connector, agitator, or valve that 
meets the criteria of paragraph (f)(4)(i) of this section may be 
designated as inaccessible. At a new affected source, an owner or 
operator may designate no more than 3 percent of each type of equipment 
as inaccessible.
    (iii) If any inaccessible equipment or ceramic or ceramic-lined 
connector 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 paragraph (g) of this section.
    (g) Recordkeeping Requirements. (1) An owner or operator of more 
than one group of processes subject to the provisions of this section 
may comply with the recordkeeping requirements for the groups of 
processes in one recordkeeping system if the system identifies with 
each record the program being implemented (e.g., quarterly monitoring) 
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.
    (2) General recordkeeping. Except as provided in paragraph (e) of 
this section and in paragraph (a)(9) of this section, the following 
information pertaining to all equipment subject to the requirements in 
this section shall be recorded:
    (i)(A) A list of identification numbers for equipment (except 
connectors that are not subject to paragraph (f) of this section and 
instrumentation systems) subject to the requirements of this section. 
Connectors, except those subject to paragraph (f) of this section, need 
not be individually identified if all connectors in a designated area 
or length of pipe subject to the provisions of this section are 
identified as a group, and the number of subject connectors is 
indicated. The list for each type of equipment shall be completed 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.
    (B) A schedule for monitoring connectors subject to the provisions 
of Sec. 63.174(a) and valves subject to the provisions of paragraph 
(e)(4) of this section.
    (C) Physical tagging of the equipment to indicate that it is in 
organic HAP service is not required. Equipment subject to the 
provisions of this section may be identified on a plant site plan, in 
log entries, or by other appropriate methods.
    (ii)(A) 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 paragraph (c)(7) of this section, 
Sec. 63.164(h), or Sec. 63.165(c).
    (B) 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).
    (iii)(A) A list of identification numbers for pressure relief 
devices subject to the provisions in Sec. 63.165(a).
    (B) A list of identification numbers for pressure relief devices 
equipped with rupture disks, under the provisions of Sec. 63.165(d).
    (iv) Identification of instrumentation systems subject to the 
provisions of this section. Individual components in an instrumentation 
system need not be identified.
    (v) 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. 63.1260(i), for the source or may be part of a 
separate document that is maintained at the plant site. Reasons for 
delay of repair may be documented by citing the relevant sections of 
the written procedure.
    (vi) The following information shall be recorded for each dual 
mechanical seal system:
    (A) Design criteria required by paragraph (c)(5)(vi)(A) of this 
section and Sec. 63.164(e)(2), and an explanation of the design 
criteria; and
    (B) Any changes to these criteria and the reasons for the changes.
    (vii) A list of equipment designated as unsafe to monitor, 
difficult to monitor, or inaccessible under paragraphs (f) or 
(b)(1)(v)(B) of this section and a copy of the plan for monitoring or 
inspecting this equipment.
    (viii) 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.
    (ix) 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 
each monitoring survey for the type of equipment monitored.
    (3) Records of visual inspections. For visual inspections of 
equipment subject to the provisions of paragraphs (c)(2)(iii) and 
(c)(5)(iv)(A) of this section, the

[[Page 50342]]

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 (g)(4) of this section for leaking 
equipment identified in this inspection, except as provided in 
paragraph (g)(5) of this section. These records shall be retained for 2 
years.
    (4) Monitoring records. When each leak is detected as specified in 
paragraph (c) of this section and Sec. 63.164; paragraph (e) of this 
section and Sec. 63.169; and Secs. 63.172 and 63.174 of subpart H, the 
following information shall be recorded and kept for 2 years onsite and 
3 years offsite (5 years total):
    (i) The instrument and the equipment identification number and the 
operator name, initials, or identification number.
    (ii) The date the leak was detected and the date of the first 
attempt to repair the leak.
    (iii) The date of successful repair of the leak.
    (iv) If postrepair monitoring is required, the maximum instrument 
reading measured by Method 21 of 40 CFR part 60, appendix A after the 
leak is successfully repaired or determined to be nonrepairable.
    (v) ``Repair delayed'' and the reason for the delay if a leak is 
not repaired within 15 calendar days after discovery of the leak.
    (A) 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.
    (B) 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.
    (vi) If repairs were delayed, dates of process shutdowns that occur 
while the equipment is unrepaired.
    (vii)(A) 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).
    (B) 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.
    (viii) 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.
    (ix) Copies of the periodic reports as specified in paragraph 
(h)(3) of this section, if records are not maintained on a computerized 
data base capable of generating summary reports from the records.
    (5) Records of pressure tests. The owner or operator who elects to 
pressure test a process equipment train and supply lines between 
storage and processing areas to demonstrate compliance with this 
section is exempt from the requirements of paragraphs (g)(2), (g)(3), 
(g)(4), and (g)(6) of this section. Instead, the owner or operator 
shall maintain records of the following information:
    (i) The identification of each product, or product code, produced 
during the calendar year. It is not necessary to identify individual 
items of equipment in the process equipment train.
    (ii) Records demonstrating the proportion of the time during the 
calendar year the equipment is in use in the 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).
    (iii) Physical tagging of the equipment to identify that it is in 
organic HAP service and subject to the provisions of this section is 
not required. Equipment in a process subject to the provisions of this 
appendix may be identified on a plant site plan, in log entries, or by 
other appropriate methods.
    (iv) The dates of each pressure test required in Sec. 63.178(b), 
the test pressure, and the pressure drop observed during the test.
    (v) Records of any visible, audible, or olfactory evidence of fluid 
loss.
    (vi) When a process equipment train does not pass two consecutive 
pressure tests, the following information shall be recorded in a log 
and kept for 2 years:
    (A) The date of each pressure test and the date of each leak repair 
attempt.
    (B) Repair methods applied in each attempt to repair the leak.
    (C) The reason for the delay of repair.
    (D) The expected date for delivery of the replacement equipment and 
the actual date of delivery of the replacement equipment.
    (E) The date of successful repair.
    (6) Records of compressor compliance tests. 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:
    (i) The background level measured during each compliance test.
    (ii) The maximum instrument reading measured at each piece of 
equipment during each compliance test.
    (7) Records for closed-vent systems. The owner or operator shall 
maintain records of the information specified in paragraphs (g)(7)(i) 
through (g)(7)(iii) of this section for closed-vent systems and control 
devices subject to the provisions of paragraph (b)(1)(vi) of this 
section. The records specified in paragraph (g)(7)(i) of this section 
shall be retained for the life of the equipment. The records specified 
in paragraphs (g)(7)(ii) and (g)(7)(iii) of this section shall be 
retained for 2 years.
    (i) The design specifications and performance demonstrations 
specified in paragraphs (g)(7)(i)(A) through (g)(7)(i)(D) of this 
section.
    (A) Detailed schematics, design specifications of the control 
device, and piping and instrumentation diagrams.
    (B) The dates and descriptions of any changes in the design 
specifications.
    (C) The flare design (i.e., steam assisted, air assisted, or 
nonassisted) and the results of the compliance demonstration required 
by Sec. 63.11(b).
    (D) A description of the parameter or parameters monitored, as 
required in paragraph (b)(1)(vi) of this section, 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.
    (ii) Records of operation of closed-vent systems and control 
devices.
    (A) Dates and durations when the closed-vent systems and control 
devices required in paragraph (c) of this section 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.
    (B) Dates and durations during which the monitoring system or 
monitoring device is inoperative.
    (C) Dates and durations of startups and shutdowns of control 
devices required in paragraph (c)(7) of this section and Secs. 63.164 
through 63.166.
    (iii) Records of inspections of closed-vent systems subject to the 
provisions of Sec. 63.172.

[[Page 50343]]

    (A) 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.
    (B) For each inspection conducted in accordance with the provisions 
of Sec. 63.172(f)(1) or (f)(2) during which leaks were detected, the 
information specified in paragraph (g)(4) of this section shall be 
recorded.
    (8) Records for components in heavy liquid service. 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.
    (9) Records of exempt components. 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 section.
    (10) Records of alternative means of compliance determination. 
Owners and operators choosing to comply with the requirements of 
Sec. 63.179 shall maintain the following records:
    (i) Identification of the process(es) and the organic HAP they 
handle.
    (ii) A schematic of the process, enclosure, and closed-vent system.
    (iii) 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.
    (h) Reporting Requirements.
    (1) Each owner or operator of a source subject to this section 
shall submit the reports listed in paragraphs (h)(1)(i) through (ii) of 
this section.
    (i) A Notification of Compliance Status Report described in 
paragraph (h)(2) of this section,
    (ii) Periodic Reports described in paragraph (h)(3) of this 
section, and
    (2) Notification of compliance report. Each owner or operator of a 
source subject to this section shall submit the information specified 
in paragraphs (h)(2)(i) through (iii) of this section in the 
Notification of Compliance Status Report described in Sec. 63.1260(f).
    (i) The notification shall provide the information listed in 
paragraphs (h)(2)(i)(A) through (C) of this section for each process 
subject to the requirements of paragraphs (b) through (g) of this 
section.
    (A) Process group identification.
    (B) Approximate number of each equipment type (e.g., valves, pumps) 
in organic HAP service, excluding equipment in vacuum service.
    (C) Method of compliance with the standard (for example, ``monthly 
leak detection and repair'' or ``equipped with dual mechanical 
seals'').
    (ii) The notification shall provide the information listed in 
paragraphs (h)(2)(ii)(A) and (B) of this section for each process 
subject to the requirements of paragraph (b)(1)(ix) of this section and 
Sec. 63.178(b).
    (A) Products or product codes subject to the provisions of this 
section, and
    (B) Planned schedule for pressure testing when equipment is 
configured for production of products subject to the provisions of this 
section.
    (iii) The notification shall provide the information listed in 
paragraphs (h)(2)(iii)(A) and (B) of this section for each process 
subject to the requirements in Sec. 63.179.
    (A) Process identification.
    (B) 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 paragraph (b)(1)(vi) of this section.
    (iv) Any change in the information submitted under paragraph (h) of 
this section 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 Report described in this paragraph 
(h)(2) of this section.
    (3) Periodic reports. The owner or operator of a source subject to 
this section shall submit Periodic Reports.
    (i) A report containing the information in paragraphs (h)(3)(ii), 
(h)(3)(iii), and (h)(3)(iv) of this section shall be submitted 
semiannually starting 6 months after the Notification of Compliance 
Status Report, as required in paragraph (h)(2) 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.
    (ii) For equipment complying with the provisions of paragraphs (b) 
through (g) of this section, the summary information listed in 
paragraphs (h)(3)(ii)(A) through (L) of this section for each 
monitoring period during the 6-month period.
    (A) The number of valves for which leaks were detected as described 
in paragraph (e)(3) of this section, the percent leakers, and the total 
number of valves monitored;
    (B) The number of valves for which leaks were not repaired as 
required in paragraph (e)(7) of this section, identifying the number of 
those that are determined nonrepairable;
    (C) The number of pumps and agitators for which leaks were detected 
as described in paragraph (c)(2) of this section, the percent leakers, 
and the total number of pumps and agitators monitored;
    (D) The number of pumps and agitators for which leaks were not 
repaired as required in paragraph (c)(3) of this section;
    (E) The number of compressors for which leaks were detected as 
described in Sec. 63.164(f);
    (F) The number of compressors for which leaks were not repaired as 
required in Sec. 63.164(g);
    (G) 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;
    (H) 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;
    (I) The facts that explain any delay of repairs and, where 
appropriate, why a process shutdown was technically infeasible.
    (J) 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.
    (K) If applicable, the initiation of a monthly monitoring program 
under either paragraph (c)(4)(ii) or paragraph (e)(4)(i) of this 
section.
    (L) If applicable, notification of a change in connector monitoring 
alternatives as described in Sec. 63.174(c)(1).
    (iii) For owners or operators electing to meet the requirements of 
Sec. 63.178(b), the report shall include the information listed in 
paragraphs (h)(3)(iii)(A) through (E) of this paragraph for each 
process.
    (A) Product process equipment train identification;
    (B) The number of pressure tests conducted;
    (C) The number of pressure tests where the equipment train failed 
either the retest or two consecutive pressure tests;
    (D) The facts that explain any delay of repairs; and
    (E) The results of all monitoring to determine compliance with 
Sec. 63.172(f) of subpart H.
    (iv) Any revisions to items reported in earlier Notification of 
Compliance

[[Page 50344]]

Status Report, if the method of compliance has changed since the last 
report or any other changes to the information reported has occurred.


Sec. 63.1256  Standards: Wastewater.

    (a) General. Each owner or operator of any affected source 
(existing or new) shall comply with the general wastewater requirements 
in paragraphs (a)(1) and (2) of this section.
    (1) Identify wastewater that requires control. For each POD, the 
owner or operator shall comply with the requirements in either 
paragraph (a)(1)(i), or (ii) of this section to determine whether a 
wastewater stream is an affected wastewater stream that requires 
control for soluble and/or partially soluble HAP compounds or to 
designate the wastewater stream as an affected wastewater stream, 
respectively. The owner or operator may use a combination of the 
approaches in paragraphs (a)(1)(i) and (ii) of this section for 
different affected wastewater generated at the source. The owner or 
operator shall also comply with the requirements for multiphase 
discharges in paragraph (a)(4) of this section. Wastewater identified 
in paragraph (a)(3) of this section is exempt from the provisions of 
this subpart.
    (i) Determine characteristics of a wastewater stream. At new and 
existing sources, a wastewater stream is an affected wastewater stream 
if the annual average concentration and annual load exceed any of the 
criteria specified in paragraph (a)(1)(i)(A) through (C) of this 
section. At new sources, a wastewater stream is subject to additional 
control requirements if the annual average concentration and annual 
load exceed the criteria specified in paragraphs (a)(1)(i)(D) of this 
section. The owner or operator shall comply with the provisions of 
Sec. 63.1257(e)(1) to determine the annual average concentrations and 
annual load of partially soluble and soluble HAP compounds.
    (A) The wastewater stream contains partially soluble HAP compounds 
at an annual average concentration greater than 1,300 ppmw, and the 
total soluble and partially soluble HAP load in all wastewater from the 
PMPU exceeds 1 Mg/yr.
    (B) The wastewater stream contains partially soluble and/or soluble 
HAP compounds at an annual average concentration of 5,200 ppmw, and the 
total soluble and partially soluble HAP load in all wastewater from the 
PMPU exceeds 1 Mg/yr.
    (C) The wastewater stream contains partially soluble and/or soluble 
HAP at an annual average concentration of greater than 10,000 ppmw, and 
the total partially soluble and/or soluble HAP load in all wastewater 
from the affected source is greater than 1 Mg/yr.
    (D) The wastewater stream contains soluble HAP compounds at an 
annual average concentration greater than 110,000 ppmw, and the total 
soluble and partially soluble HAP load in all wastewater from the PMPU 
exceeds 1 Mg/yr.
    (ii) Designate wastewater as affected wastewater. For existing 
sources, the owner or operator may elect to designate wastewater 
streams as meeting the criteria of either paragraphs (a)(1)(i)(A),(B), 
or (C) of this section. For new sources, the owner or operator may 
elect to designate wastewater streams meeting the criterion in 
paragraph (a)(1)(i)(D) or for wastewater known to contain no soluble 
HAP, as meeting the criterion in paragraph (a)(1)(i)(A) of this 
section. For designated wastewater the procedures specified in 
paragraphs (a)(1)(ii)(A) and (B) of this section shall be followed, 
except as specified in paragraphs (g)(8)(i), (g)(9)(i), and (g)(10) of 
this section. The owner or operator is not required to determine the 
annual average concentration or load for each designated wastewater 
stream for the purposes of this section.
    (A) From the POD for the wastewater stream that is designated as an 
affected wastewater stream to the location where the owner or operator 
elects to designate such wastewater stream as an affected wastewater 
stream, the owner or operator shall comply with all applicable emission 
suppression requirements specified in paragraphs (b) through (f) of 
this section.
    (B) From the location where the owner or operator designates a 
wastewater stream as an affected wastewater stream, such wastewater 
stream shall be managed in accordance with all applicable emission 
suppression requirements specified in paragraphs (b) through (f) of 
this section and with the treatment requirements in paragraph (g) of 
this section.
    (iii) Scrubber Effluent. Effluent from a water scrubber that has 
been used to control Table 2 HAP-containing vent streams that are 
controlled in order to meet the process vent requirements in 
Sec. 63.1254 of this subpart is considered an affected wastewater 
stream.
    (2) Requirements for affected wastewater. (i) An owner or operator 
of a facility shall comply with the applicable requirements for 
wastewater tanks, surface impoundments, containers, individual drain 
systems, and oil/water separators as specified in paragraphs (b) 
through (f) of this section, except as provided in paragraph (g)(3) of 
this section.
    (ii) Comply with the applicable requirements for control of soluble 
and partially soluble compounds as specified in paragraph (g) of this 
section. Alternatively, the owner or operator may elect to comply with 
the treatment provisions specified in paragraph (a)(5) of this section.
    (iii) Comply with the applicable monitoring and inspection 
requirements specified in Sec. 63.1258.
    (iv) Comply with the applicable recordkeeping and reporting 
requirements specified in Secs. 63.1259 and 63.1260.
    (3) Exempt wastewater. 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.
    (4) Requirements for multiphase discharges. The owner or operator 
shall not discharge a separate phase that can be isolated through 
gravity separation from the aqueous phase to a waste management or 
treatment unit, unless the stream is discharged to a treatment unit in 
compliance with paragraph (g)(13) of this section.
    (5) Offsite treatment or onsite treatment not owned or operated by 
the source. The owner or operator may elect to transfer affected 
wastewater streams that contain less than 50 ppmw of partially soluble 
HAP or a residual removed from such affected wastewater to an onsite 
treatment operation not owned or operated by the owner or operator of 
the source generating the wastewater or residual, or to an offsite 
treatment operation, provided that the waste management units up to the 
activated sludge unit are covered or the owner or operator demonstrates 
that less than 5 percent of the total soluble HAP is emitted from the 
these units.
    (i) The owner or operator transferring the wastewater or residual 
shall:
    (A) Comply with the provisions specified in paragraphs (b) through 
(f) of this section for each waste management unit that receives or 
manages affected wastewater or a residual removed from affected 
wastewater prior to shipment or transport.
    (B) Include a notice with each shipment or transport of affected 
wastewater or residual removed from affected wastewater. The notice 
shall state that the affected wastewater or residual contains organic 
HAP that are to be treated in accordance with the

[[Page 50345]]

provisions of this subpart. When the transport is continuous or ongoing 
(for example, discharge to a publicly-owned treatment works), the 
notice shall be submitted to the treatment operator initially and 
whenever there is a change in the required treatment. The owner or 
operator shall keep a record of the notice in accordance with 
Sec. 63.1259(g).
    (ii) The owner or operator may not transfer the affected wastewater 
or residual unless the transferee has submitted to the EPA a written 
certification that the transferee will manage and treat any affected 
wastewater or residual removed from affected wastewater received from a 
source subject to the requirements of this subpart in accordance with 
the requirements of either:
    (A) Paragraphs (b) through (i) of this section; or
    (B) Subpart D of this part if alternative emission limitations have 
been granted the transferor in accordance with those provisions; or
    (C) Section 63.6(g).
    (iii) The certifying entity may revoke the written certification by 
sending a written statement to the EPA and the owner or operator giving 
at least 90 days notice that the certifying entity is rescinding 
acceptance of responsibility for compliance with the regulatory 
provisions listed in this paragraph. Upon expiration of the notice 
period, the owner or operator may not transfer the wastewater stream or 
residual to the treatment operation.
    (iv) By providing this written certification to the EPA, the 
certifying entity accepts responsibility for compliance with the 
regulatory provisions listed in paragraph (a)(5)(ii) of this section 
with respect to any shipment of wastewater or residual covered by the 
written certification. Failure to abide by any of those provisions with 
respect to such shipments may result in enforcement action by the EPA 
against the certifying entity in accordance with the enforcement 
provisions applicable to violations of these provisions by owners or 
operators of sources.
    (v) Written certifications and revocation statements, to the EPA 
from the transferees of wastewater or residuals shall be signed by the 
responsible official of the certifying entity, provide the name and 
address of the certifying entity, and be sent to the appropriate EPA 
Regional Office at the addresses listed in Sec. 63.13. Such written 
certifications are not transferable by the treater.
    (b) Wastewater tanks. For each wastewater tank that receives, 
manages, or treats affected wastewater or a residual removed from 
affected wastewater, the owner or operator shall comply with the 
requirements of either paragraph (b)(1) or (2) of this section as 
specified in Table 6 of this subpart.
    (1) The owner or operator shall operate and maintain a fixed roof 
except when the contents of the wastewater tank are heated, treated by 
means of an exothermic reaction, or sparged, during which time the 
owner or operator shall comply with the requirements specified in 
paragraph (b)(2) of this section. For the purposes of this paragraph, 
the requirements of paragraph (b)(2) of this section are satisfied by 
operating and maintaining a fixed roof if the owner or operator 
demonstrates that the total soluble and partially soluble HAP emissions 
from the wastewater tank are no more than 5 percent higher than the 
emissions would be if the contents of the wastewater tank were not 
heated, treated by an exothermic reaction, or sparged.
    (2) The owner or operator shall comply with the requirements in 
paragraphs (b)(3) through (9) of this section and shall operate and 
maintain one of the emission control techniques listed in paragraphs 
(b)(2)(i) through (iii) of this section.
    (i) A fixed roof and a closed-vent system that routes the organic 
HAP vapors vented from the wastewater tank to a control device; or
    (ii) A fixed roof and an internal floating roof that meets the 
requirements specified in Sec. 63.119(b), with the differences noted in 
Sec. 63.1257(c)(3)(i) through (iii) for the purposes of this subpart; 
or
    (iii) An external floating roof that meets the requirements 
specified in Secs. 63.119(c), 63.120(b)(5), and 63.120(b)(6), with the 
differences noted in Sec. 63.1257(c)(3)(i) through (v) for the purposes 
of this subpart.
    (3) If the owner or operator elects to comply with the requirements 
of paragraph (b)(2)(i) of this section, the fixed roof shall meet the 
requirements of paragraph (b)(3)(i) of this section, the control device 
shall meet the requirements of paragraph (b)(3)(ii) of this section, 
and the closed-vent system shall meet the requirements of paragraph 
(b)(3)(iii) of this section.
    (i) The fixed roof shall meet the following requirements:
    (A) Except as provided in paragraph (b)(3)(iv) of this section, the 
fixed roof and all openings (e.g., access hatches, sampling ports, and 
gauge wells) shall be maintained in accordance with the requirements 
specified in Sec. 63.1258(h).
    (B) Each opening shall be maintained in a closed position (e.g., 
covered by a lid) at all times that the wastewater tank contains 
affected wastewater or residual removed from affected wastewater except 
when it is necessary to use the opening for wastewater sampling, 
removal, or for equipment inspection, maintenance, or repair.
    (ii) The control device shall be designed, operated, and inspected 
in accordance with the requirements of paragraph (h) of this section.
    (iii) Except as provided in paragraph (b)(3)(iv) of this section, 
the closed-vent system shall be inspected in accordance with the 
requirements of Sec. 63.1258(h).
    (iv) For any fixed roof tank and closed-vent system that is 
operated and maintained under negative pressure, the owner or operator 
is not required to comply with the requirements specified in 
Sec. 63.1258(h).
    (4) If the owner or operator elects to comply with the requirements 
of paragraph (b)(2)(ii) of this section, the floating roof shall be 
inspected according to the procedures specified in Sec. 63.120(a)(2) 
and (3), with the differences noted in Sec. 63.1257(c)(3)(iv) for the 
purposes of this subpart.
    (5) Except as provided in paragraph (b)(6) of this section, if the 
owner or operator elects to comply with the requirements of paragraph 
(b)(2)(iii) of this section, seal gaps shall be measured according to 
the procedures specified in Sec. 63.120(b)(2)(i) through (b)(4) and the 
wastewater tank shall be inspected to determine compliance with 
Sec. 63.120(b)(5) and (6) according to the schedule specified in 
Sec. 63.120(b)(1)(i) through (iii).
    (6) If the owner or operator determines that it is unsafe to 
perform the seal gap measurements specified in Sec. 63.120(b)(2)(i) 
through (b)(4) or to inspect the wastewater tank to determine 
compliance with Sec. 63.120(b)(5) and (6) because the floating roof 
appears to be structurally unsound and poses an imminent or potential 
danger to inspecting personnel, the owner or operator shall comply with 
the requirements in either paragraph (b)(6)(i) or (ii) of this section.
    (ii) The owner or operator shall empty and remove the wastewater 
tank from service within 45 calendar days of determining that the roof 
is unsafe. If the wastewater tank cannot be emptied within 45 calendar 
days, the owner or operator may utilize up to two extensions of up to 
30 additional calendar days each. Documentation of a decision to 
utilize an extension shall include an explanation of why it was unsafe 
to perform the inspection or seal gap measurement, shall document that 
alternate storage capacity is unavailable, and shall specify a schedule 
of actions that will ensure that the wastewater

[[Page 50346]]

tank will be emptied as soon as possible.
    (7) Except as provided in paragraph (b)(6) of this section, each 
wastewater tank shall be inspected initially, and semiannually 
thereafter, for improper work practices in accordance with 
Sec. 63.1258(g). For wastewater tanks, improper work practice includes, 
but is not limited to, leaving open any access door or other opening 
when such door or opening is not in use.
    (8) Except as provided in paragraph (b)(6) of this section, each 
wastewater tank shall be inspected for control equipment failures as 
defined in paragraph (b)(8)(i) of this section according to the 
schedule in paragraphs (b)(8)(ii) and (iii) of this section in 
accordance with Sec. 63.1258(g).
    (i) Control equipment failures for wastewater tanks include, but 
are not limited to, the conditions specified in paragraphs (b)(8)(i)(A) 
through (I) of this section.
    (A) The floating roof is not resting on either the surface of the 
liquid or on the leg supports.
    (B) There is stored liquid on the floating roof.
    (C) A rim seal is detached from the floating roof.
    (D) There are holes, tears, cracks or gaps in the rim seal or seal 
fabric of the floating roof.
    (E) There are visible gaps between the seal of an internal floating 
roof and the wall of the wastewater tank.
    (F) There are gaps between the metallic shoe seal or the liquid 
mounted primary seal of an external floating roof and the wall of the 
wastewater tank that exceed 212 square centimeters per meter of tank 
diameter or the width of any portion of any gap between the primary 
seal and the tank wall exceeds 3.81 centimeters.
    (G) There are gaps between the secondary seal of an external 
floating roof and the wall of the wastewater tank that exceed 21.2 
square centimeters per meter of tank diameter or the width of any 
portion of any gap between the secondary seal and the tank wall exceeds 
1.27 centimeters.
    (H) Where a metallic shoe seal is used on an external floating 
roof, one end of the metallic shoe does not extend into the stored 
liquid or one end of the metallic shoe does not extend a minimum 
vertical distance of 61 centimeters above the surface of the stored 
liquid.
    (I) A gasket, joint, lid, cover, or door has a crack or gap, or is 
broken.
    (ii) The owner or operator shall inspect for the control equipment 
failures in paragraphs (b)(8)(i)(A) through (H) according to the 
schedule specified in paragraphs (b)(4) and (5) of this section.
    (iii) The owner or operator shall inspect for the control equipment 
failures in paragraph (b)(8)(i)(I) of this section initially, and 
semiannually thereafter.
    (9) Except as provided in paragraph (i) of this section, when an 
improper work practice or a control equipment failure is identified, 
first efforts at repair shall be made no later than 5 calendar days 
after identification and repair shall be completed within 45 calendar 
days after identification. If a failure that is detected during 
inspections required by this section cannot be repaired within 45 
calendar days and if the tank cannot be emptied within 45 calendar 
days, the owner or operator may utilize up to two extensions of up to 
30 additional calendar days each. Documentation of a decision to 
utilize an extension shall include a description of the failure, shall 
document that alternate storage capacity is unavailable, and shall 
specify a schedule of actions that will ensure that the control 
equipment will be repaired or the tank will be emptied as soon as 
practical.
    (c) Surface impoundments. For each surface impoundment that 
receives, manages, or treats affected wastewater or a residual removed 
from affected wastewater, the owner or operator shall comply with the 
requirements of paragraphs (c)(1), (2), and (3) of this section.
    (1) The owner or operator shall operate and maintain on each 
surface impoundment either a cover (e.g., air-supported structure or 
rigid cover) and a closed-vent system that routes the organic hazardous 
air pollutants vapors vented from the surface impoundment to a control 
device in accordance with paragraphs (c)(1)(i), (iii), (iv), and (v) of 
this section, or a floating flexible membrane cover as specified in 
paragraph (c)(1)(ii) of this section.
    (i) The cover and all openings shall meet the following 
requirements:
    (A) Except as provided in paragraph (c)(1)(iv) of this section, the 
cover and all openings (e.g., access hatches, sampling ports, and gauge 
wells) shall be maintained in accordance with the requirements 
specified in Sec. 63.1258(h).
    (B) Each opening shall be maintained in a closed position (e.g., 
covered by a lid) at all times that affected wastewater or residual 
removed from affected wastewater is in the surface impoundment except 
when it is necessary to use the opening for sampling, removal, or for 
equipment inspection, maintenance, or repair.
    (C) The cover shall be used at all times that affected wastewater 
or residual removed from affected wastewater is in the surface 
impoundment except during removal of treatment residuals in accordance 
with 40 CFR 268.4 or closure of the surface impoundment in accordance 
with 40 CFR 264.228.
    (ii) Floating flexible membrane covers shall meet the requirements 
specified in paragraphs (c)(1)(ii)(A) through (F) of this section.
    (A) The floating flexible cover shall be designed to float on the 
liquid surface during normal operations, and to form a continuous 
barrier over the entire surface area of the liquid.
    (B) The cover shall be fabricated from a synthetic membrane 
material that is either:
    (1) High density polyethylene (HDPE) with a thickness no less than 
2.5 millimeters (100 mils); or
    (2) A material or a composite of different materials determined to 
have both organic permeability properties that are equivalent to those 
of the material listed in paragraph (c)(1)(ii)(B)(1) of this section, 
and chemical and physical properties that maintain the material 
integrity for the intended service life of the material.
    (C) The cover shall be installed in a manner such that there are no 
visible cracks, holes, gaps, or other open spaces between cover section 
seams or between the interface of the cover edge and its foundation 
mountings.
    (D) Except as provided for in paragraph (c)(1)(ii)(E) of this 
section, each opening in the floating membrane cover shall be equipped 
with a closure device designed to operate such that when the closure 
device is secured in the closed position there are no visible cracks, 
holes, gaps, or other open spaces in the closure device or between the 
perimeter of the cover opening and the closure device.
    (E) The floating membrane cover may be equipped with one or more 
emergency cover drains for removal of stormwater. Each emergency cover 
drain shall be equipped with a slotted membrane fabric cover that 
covers at least 90 percent of the area of the opening or a flexible 
fabric sleeve seal.
    (F) The closure devices shall be made of suitable materials that 
will minimize exposure of organic HAP to the atmosphere, to the extent 
practical, and will maintain the integrity of the equipment throughout 
its intended service life. Factors to be considered in designing the 
closure devices shall include: the effects of any contact with the 
liquid and its vapor managed in the surface impoundment; the effects of 
outdoor exposure to wind, moisture, and sunlight; and the operating

[[Page 50347]]

practices used for the surface impoundment on which the floating 
membrane cover is installed.
    (G) Whenever affected wastewater or residual from affected 
wastewater is in the surface impoundment, the floating membrane cover 
shall float on the liquid and each closure device shall be secured in 
the closed position. Opening of closure devices or removal of the cover 
is allowed to provide access to the surface impoundment for performing 
routine inspection, maintenance, or other activities needed for normal 
operations and/or to remove accumulated sludge or other residues from 
the bottom of surface impoundment. Openings shall be maintained in 
accordance with Sec. 63.1258(h).
    (iii) The control device shall be designed, operated, and inspected 
in accordance with paragraph (h) of this section.
    (iv) Except as provided in paragraph (c)(1)(v) of this section, the 
closed-vent system shall be inspected in accordance with 
Sec. 63.1258(h).
    (v) For any cover and closed-vent system that is operated and 
maintained under negative pressure, the owner or operator is not 
required to comply with the requirements specified in Sec. 63.1258(h).
    (2) Each surface impoundment shall be inspected initially, and 
semiannually thereafter, for improper work practices and control 
equipment failures in accordance with Sec. 63.1258(g).
    (i) For surface impoundments, improper work practice includes, but 
is not limited to, leaving open any access hatch or other opening when 
such hatch or opening is not in use.
    (ii) For surface impoundments, control equipment failure includes, 
but is not limited to, any time a joint, lid, cover, or door has a 
crack or gap, or is broken.
    (3) Except as provided in paragraph (i) of this section, when an 
improper work practice or a control equipment failure is identified, 
first efforts at repair shall be made no later than 5 calendar days 
after identification and repair shall be completed within 45 calendar 
days after identification.
    (d) Containers. For each container that receives, manages, or 
treats affected wastewater or a residual removed from affected 
wastewater, the owner or operator shall comply with the requirements of 
paragraphs (d)(1) through (5) of this section.
    (1) The owner or operator shall operate and maintain a cover on 
each container used to handle, transfer, or store affected wastewater 
or a residual removed from affected wastewater in accordance with the 
following requirements:
    (i) Except as provided in paragraph (d)(3)(iv) of this section, if 
the capacity of the container is greater than 0.42 m3, the 
cover and all openings (e.g., bungs, hatches, sampling ports, and 
pressure relief devices) shall be maintained in accordance with the 
requirements specified in Sec. 63.1258(h).
    (ii) If the capacity of the container is less than or equal to 0.42 
m3, the owner or operator shall comply with either paragraph 
(d)(1)(ii)(A) or (B) of this section.
    (A) The container must meet existing Department of Transportation 
specifications and testing requirements under 49 CFR part 178; or
    (B) Except as provided in paragraph (d)(3)(iv) of this section, the 
cover and all openings shall be maintained without leaks as specified 
in Sec. 63.1258(h).
    (iii) The cover and all openings shall be maintained in a closed 
position (e.g., covered by a lid) at all times that affected wastewater 
or a residual removed from affected wastewater is in the container 
except when it is necessary to use the opening for filling, removal, 
inspection, sampling, or pressure relief events related to safety 
considerations.
    (2) For containers with a capacity greater than or equal to 0.42 
m3, either a submerged fill pipe shall be used when a 
container is being filled by pumping with affected wastewater or a 
residual removed from affected wastewater or the container shall be 
located within an enclosure with a closed-vent system that routes the 
organic HAP vapors vented from the container to a control device.
    (i) The submerged fill pipe outlet shall extend to no more than 6 
inches or within two fill pipe diameters of the bottom of the container 
while the container is being filled.
    (ii) The cover shall remain in place and all openings shall be 
maintained in a closed position except for those openings required for 
the submerged fill pipe and for venting of the container to prevent 
physical damage or permanent deformation of the container or cover.
    (3) During treatment of affected wastewater or a residual removed 
from affected wastewater, including aeration, thermal or other 
treatment, in a container, whenever it is necessary for the container 
to be open, the container shall be located within an enclosure with a 
closed-vent system that routes the organic HAP vapors vented from the 
container to a control device.
    (i) Except as provided in paragraph (d)(3)(iv) of this section, the 
enclosure and all openings (e.g., doors, hatches) shall be maintained 
in accordance with the requirements specified in Sec. 63.1258(h).
    (ii) The control device shall be designed, operated, and inspected 
in accordance with paragraph (h) of this section.
    (iii) Except as provided in paragraph (d)(3)(iv) of this section, 
the closed-vent system shall be inspected in accordance with 
Sec. 63.1258(h).
    (iv) For any enclosure and closed-vent system that is operated and 
maintained under negative pressure, the owner or operator is not 
required to comply with the requirements specified in Sec. 63.1258(h).
    (4) Each container shall be inspected initially, and semiannually 
thereafter, for improper work practices and control equipment failures 
in accordance with Sec. 63.1258(g).
    (i) For containers, improper work practice includes, but is not 
limited to, leaving open any access hatch or other opening when such 
hatch or opening is not in use.
    (ii) For containers, control equipment failure includes, but is not 
limited to, any time a cover or door has a gap or crack, or is broken.
    (5) Except as provided in paragraph (i) of this section, when an 
improper work practice or a control equipment failure is identified, 
first efforts at repair shall be made no later than 5 calendar days 
after identification and repair shall be completed within 15 calendar 
days after identification.
    (e) Individual drain systems. For each individual drain system that 
receives or manages affected wastewater or a residual removed from 
affected wastewater, the owner or operator shall comply with the 
requirements of paragraphs (e) (1), (2), and (3) or with paragraphs (e) 
(4), (5), and (6) of this section.
    (1) If the owner or operator elects to comply with this paragraph, 
the owner or operator shall operate and maintain on each opening in the 
individual drain system a cover and if vented, route the vapors to a 
process or through a closed-vent system to a control device. The owner 
or operator shall comply with the requirements of paragraphs (e)(1) (i) 
through (v) of this section.
    (i) The cover and all openings shall meet the following 
requirements:
    (A) Except as provided in paragraph (e)(1)(iv) of this section, the 
cover and all openings (e.g., access hatches, sampling ports) shall be 
maintained in accordance with the requirements specified in 
Sec. 63.1258(h).
    (B) The cover and all openings shall be maintained in a closed 
position at all

[[Page 50348]]

times that affected wastewater or a residual removed from affected 
wastewater is in the drain system except when it is necessary to use 
the opening for sampling or removal, or for equipment inspection, 
maintenance, or repair.
    (ii) The control device shall be designed, operated, and inspected 
in accordance with paragraph (h) of this section.
    (iii) Except as provided in paragraph (e)(1)(iv) of this section, 
the closed-vent system shall be inspected in accordance with 
Sec. 63.1258(h).
    (iv) For any cover and closed-vent system that is operated and 
maintained under negative pressure, the owner or operator is not 
required to comply with the requirements specified in Sec. 63.1258(h).
    (v) The individual drain system shall be designed and operated to 
segregate the vapors within the system from other drain systems and the 
atmosphere.
    (2) Each individual drain system shall be inspected initially, and 
semiannually thereafter, for improper work practices and control 
equipment failures, in accordance with Sec. 63.1258(g).
    (i) For individual drain systems, improper work practice includes, 
but is not limited to, leaving open any access hatch or other opening 
when such hatch or opening is not in use for sampling or removal, or 
for equipment inspection, maintenance, or repair.
    (ii) For individual drain systems, control equipment failure 
includes, but is not limited to, any time a joint, lid, cover, or door 
has a gap or crack, or is broken.
    (3) Except as provided in paragraph (i) of this section, when an 
improper work practice or a control equipment failure is identified, 
first efforts at repair shall be made no later than 5 calendar days 
after identification and repair shall be completed within 15 calendar 
days after identification.
    (4) If the owner or operator elects to comply with this paragraph, 
the owner or operator shall comply with the requirements in paragraphs 
(e)(4) (i) through (iii) of this section:
    (i) Each drain shall be equipped with water seal controls or a 
tightly fitting cap or plug. The owner or operator shall comply with 
paragraphs (e)(4)(i)(A) and (B) of this section.
    (A) For each drain equipped with a water seal, the owner or 
operator shall ensure that the water seal is maintained. For example, a 
flow-monitoring device indicating positive flow from a main to a branch 
water line supplying a trap or water being continuously dripped into 
the trap by a hose could be used to verify flow of water to the trap. 
Visual observation is also an acceptable alternative.
    (B) If a water seal is used on a drain receiving affected 
wastewater, the owner or operator shall either extend the pipe 
discharging the wastewater below the liquid surface in the water seal 
of the receiving drain, or install a flexible shield (or other 
enclosure which restricts wind motion across the open area between the 
pipe and the drain) that encloses the space between the pipe 
discharging the wastewater to the drain receiving the wastewater. 
(Water seals which are used on hubs receiving wastewater that is not 
subject to the provisions of this subpart for the purpose of 
eliminating cross ventilation to drains carrying affected wastewater 
are not required to have a flexible cap or extended subsurface 
discharging pipe.)
    (ii) Each junction box shall be equipped with a tightly fitting 
solid cover (i.e., no visible gaps, cracks, or holes) which shall be 
kept in place at all times except during inspection and maintenance. If 
the junction box is vented, the owner or operator shall comply with the 
requirements in paragraph (e)(4)(ii) (A) or (B) of this section.
    (A) The junction box shall be vented to a process or through a 
closed-vent system to a control device. The closed-vent system shall be 
inspected in accordance with the requirements of Sec. 63.1258(h) and 
the control device shall be designed, operated, and inspected in 
accordance with the requirements of paragraph (h) of this section.
    (B) If the junction box is filled and emptied by gravity flow 
(i.e., there is no pump) or is operated with no more than slight 
fluctuations in the liquid level, the owner or operator may vent the 
junction box to the atmosphere provided that the junction box complies 
with the requirements in paragraphs (e)(4)(ii)(B) (1) and (2) of this 
section.
    (1) The vent pipe shall be at least 90 centimeters in length and no 
greater than 10.2 centimeters in nominal inside diameter.
    (2) Water seals shall be installed and maintained at the wastewater 
entrance(s) to or exit from the junction box restricting ventilation in 
the individual drain system and between components in the individual 
drain system. The owner or operator shall demonstrate (e.g., by visual 
inspection or smoke test) upon request by the Administrator that the 
junction box water seal is properly designed and restricts ventilation.
    (iii) Each sewer line shall not be open to the atmosphere and shall 
be covered or enclosed in a manner so as to have no visible gaps or 
cracks in joints, seals, or other emission interfaces. (Note: This 
provision applies to sewers located inside and outside of buildings.)
    (5) Equipment used to comply with paragraphs (e)(4) (i), (ii), or 
(iii) of this section shall be inspected as follows:
    (i) Each drain using a tightly fitting cap or plug shall be 
visually inspected initially, and semiannually thereafter, to ensure 
caps or plugs are in place and that there are no gaps, cracks, or other 
holes in the cap or plug.
    (ii) Each junction box shall be visually inspected initially, and 
semiannually thereafter, to ensure that there are no gaps, cracks, or 
other holes in the cover.
    (iii) The unburied portion of each sewer line shall be visually 
inspected initially, and semiannually thereafter, for indication of 
cracks or gaps that could result in air emissions.
    (6) Except as provided in paragraph (i) of this section, when a 
gap, hole, or crack is identified in a joint or cover, first efforts at 
repair shall be made no later than 5 calendar days after 
identification, and repair shall be completed within 15 calendar days 
after identification.
    (f) Oil-water separators. For each oil-water separator that 
receives, manages, or treats affected wastewater or a residual removed 
from affected wastewater, the owner or operator shall comply with the 
requirements of paragraphs (f)(1) through (6) of this section.
    (1) The owner or operator shall maintain one of the following:
    (i) A fixed roof and a closed-vent system that routes the organic 
HAP vapors vented from the oil-water separator to a control device. The 
fixed roof, closed-vent system, and control device shall meet the 
requirements specified in paragraph (f)(2) of this section;
    (ii) A floating roof that meets the requirements in 40 CFR 60.693-
2(a)(1)(i), (a)(1)(ii), (a)(2), (a)(3), and (a)(4). For portions of the 
oil-water separator where it is infeasible to construct and operate a 
floating roof, such as over the weir mechanism, the owner or operator 
shall operate and maintain a fixed roof, closed-vent system, and 
control device that meet the requirements specified in paragraph (f)(2) 
of this section.
    (2) A fixed roof shall meet the requirements of paragraph (f)(2)(i) 
of this section, a control device shall meet the requirements of 
paragraph (f)(2)(ii) of this section, and a closed-vent system shall 
meet the requirements of (f)(2)(iii) of this section.
    (i) The fixed roof shall meet the following requirements:

[[Page 50349]]

    (A) Except as provided in (f)(2)(iv) of this section, the fixed 
roof and all openings (e.g., access hatches, sampling ports, and gauge 
wells) shall be maintained in accordance with the requirements 
specified in Sec. 63.1258(h).
    (B) Each opening shall be maintained in a closed, sealed position 
(e.g., covered by a lid that is gasketed and latched) at all times that 
the oil-water separator contains affected wastewater or a residual 
removed from affected wastewater except when it is necessary to use the 
opening for sampling or removal, or for equipment inspection, 
maintenance, or repair.
    (ii) The control device shall be designed, operated, and inspected 
in accordance with the requirements of paragraph (h) of this section.
    (iii) Except as provided in paragraph (f)(2)(iv) of this section, 
the closed-vent system shall be inspected in accordance with the 
requirements of Sec. 63.1258(h).
    (iv) For any fixed-roof and closed-vent system that is operated and 
maintained under negative pressure, the owner or operator is not 
required to comply with the requirements of Sec. 63.1258(h).
    (3) If the owner or operator elects to comply with the requirements 
of paragraph (f)(1)(ii) of this section, seal gaps shall be measured 
according to the procedures specified in 40 CFR part 60, subpart QQQ 
Sec. 60.696(d)(1) and the schedule specified in paragraphs (f)(3)(i) 
and (ii) of this section.
    (i) Measurement of primary seal gaps shall be performed within 60 
calendar days after installation of the floating roof and introduction 
of affected wastewater or a residual removed from affected wastewater 
and once every 5 years thereafter.
    (ii) Measurement of secondary seal gaps shall be performed within 
60 calendar days after installation of the floating roof and 
introduction of affected wastewater or a residual removed from affected 
wastewater and once every year thereafter.
    (4) Each oil-water separator shall be inspected initially, and 
semiannually thereafter, for improper work practices in accordance with 
Sec. 63.1258(g). For oil-water separators, improper work practice 
includes, but is not limited to, leaving open or ungasketed any access 
door or other opening when such door or opening is not in use.
    (5) Each oil-water separator shall be inspected for control 
equipment failures as defined in paragraph (f)(5)(i) of this section 
according to the schedule specified in paragraphs (f)(5)(ii) and (iii) 
of this section.
    (i) For oil-water separators, control equipment failure includes, 
but is not limited to, the conditions specified in paragraphs 
(f)(5)(i)(A) through (G) of this section.
    (A) The floating roof is not resting on either the surface of the 
liquid or on the leg supports.
    (B) There is stored liquid on the floating roof.
    (C) A rim seal is detached from the floating roof.
    (D) There are holes, tears, or other open spaces in the rim seal or 
seal fabric of the floating roof.
    (E) There are gaps between the primary seal and the separator wall 
that exceed 67 square centimeters per meter of separator wall perimeter 
or the width of any portion of any gap between the primary seal and the 
separator wall exceeds 3.8 centimeters.
    (F) There are gaps between the secondary seal and the separator 
wall that exceed 6.7 square centimeters per meter of separator wall 
perimeter or the width of any portion of any gap between the secondary 
seal and the separator wall exceeds 1.3 centimeters.
    (G) A gasket, joint, lid, cover, or door has a gap or crack, or is 
broken.
    (ii) The owner or operator shall inspect for the control equipment 
failures in paragraphs (f)(5)(i)(A) through (F) according to the 
schedule specified in paragraph (f)(3) of this section.
    (iii) The owner or operator shall inspect for control equipment 
failures in paragraph (f)(5)(i)(G) of this section initially, and 
semiannually thereafter.
    (6) Except as provided in paragraph (i) of this section, when an 
improper work practice or a control equipment failure is identified, 
first efforts at repair shall be made no later than 5 calendar days 
after identification and repair shall be completed within 45 calendar 
days after identification.
    (g) Performance standards for treatment processes managing 
wastewater and/or residuals removed from wastewater. This section 
specifies the performance standards for treating affected wastewater. 
The owner or operator shall comply with the requirements as specified 
in paragraphs (g)(1) through (6) of this section. Where multiple 
compliance options are provided, the options may be used in combination 
for different wastewater and/or for different compounds (e.g., soluble 
versus partially soluble compounds) in the same wastewater, except 
where otherwise provided in this section. Once affected wastewater or a 
residual removed from affected wastewater has been treated in 
accordance with this subpart, it is no longer subject to the 
requirements of this subpart.
    (1) Existing source. For a wastewater stream at an existing source 
that exceeds or is designated to exceed the concentration and load 
criteria in paragraph (a)(1)(i)(A) of this section, the owner or 
operator shall comply with a control option in paragraph (g)(8) of this 
section. For a wastewater stream at an existing source that exceeds the 
concentration and load criteria in either paragraph (a)(1)(i)(B) or (C) 
of this section, the owner or operator shall comply with a control 
option in paragraph (g)(8) of this section and a control option in 
paragraph (g)(9) of this section. As an alternative to the control 
options in paragraphs (g)(8) and (g)(9) of this section, the owner or 
operator may comply with a control option in either paragraph (g)(10), 
(11) or (13) of this section, as applicable.
    (2) New source. For a wastewater stream at a new source that 
exceeds or is designated to exceed the concentration and load criteria 
in paragraph (a)(1)(i)(A) of this section, the owner or operator shall 
comply with a control option in paragraph (g)(8) of this section. For 
wastewater at a new source that exceeds the concentration and load 
criteria in either paragraph (a)(1)(i)(B) or (C) of this section, but 
does not exceed the criteria in paragraph (a)(1)(i)(D) of this section, 
the owner or operator shall comply with a control option in paragraph 
(g)(8) of this section and a control option in paragraph (g)(9) of this 
section. As an alternative to the control options in paragraphs (g)(8) 
and/or (9) of this section, the owner or operator may comply with a 
control option in either paragraph (g)(10), (11), or (13) of this 
section, as applicable. For a wastewater stream at a new source that 
exceeds or is designated to exceed the concentration and load criteria 
in paragraph (a)(1)(i)(D) of this section, the owner or operator shall 
comply with a control option in paragraph (g)(12) or (13) of this 
section.
    (3) Biological treatment processes. Biological treatment processes 
in compliance with this section may be either open or closed biological 
treatment processes as defined in Sec. 63.1251. An open biological 
treatment process in compliance with this section need not be covered 
and vented to a control device. An open or a closed biological 
treatment process in compliance with this section and using 
Sec. 63.1257(e)(2)(iii)(E) or (F) to demonstrate compliance is not 
subject to the requirements of paragraphs (b) and (c) of this section. 
A closed biological treatment process in compliance with this section 
and using Sec. 63.1257(e)(2)(iii)(G) to demonstrate compliance shall 
comply with the

[[Page 50350]]

requirements of paragraphs (b) and (c) of this section. Waste 
management units upstream of an open or closed biological treatment 
process shall meet the requirements of paragraphs (b) through (f) of 
this section, as applicable.
    (4) Performance tests and design evaluations. If the Resource 
Conservation and Recovery Act (RCRA) option [paragraph (g)(13) of this 
section] or the enhanced biological treatment process for soluble HAP 
compounds option [paragraph (g)(10) of this section] is selected to 
comply with this section, neither a design evaluation nor a performance 
test is required. For any other nonbiological treatment process, and 
for closed biological treatment processes as defined in Sec. 63.1251, 
the owner or operator shall conduct either a design evaluation as 
specified in Sec. 63.1257(e)(2)(ii) or performance test as specified in 
Sec. 63.1257(e)(2)(iii). For each open biological treatment process as 
defined in Sec. 63.1251, the owner or operator shall conduct a 
performance test as specified in Sec. 63.1257(e)(2)(iii)(E) or (F).
    (5) Control device requirements. When gases are vented from the 
treatment process, the owner or operator shall comply with the 
applicable control device requirements specified in paragraph (h) of 
this section and Sec. 63.1257(e)(3), and the applicable leak inspection 
provisions specified in Sec. 63.1258(h). This requirement is in 
addition to the requirements for treatment systems specified in 
paragraphs (g)(8) through (14) of this section. This requirement does 
not apply to any open biological treatment process that meets the mass 
removal requirements.
    (6) Residuals: general. When residuals result from treating 
affected wastewater, the owner or operator shall comply with the 
requirements for residuals specified in paragraph (g)(14) of this 
section.
    (7) Treatment using a series of treatment processes. In all cases 
where the wastewater provisions in this subpart allow or require the 
use of a treatment process or control device to comply with emissions 
limitations, the owner or operator may use multiple treatment processes 
or control devices, respectively. For combinations of treatment 
processes where the wastewater stream is conveyed by hard-piping, the 
owner or operator shall comply with either the requirements of 
paragraph (g)(7)(i) or (ii) of this section. For combinations of 
treatment processes where the wastewater stream is not conveyed by 
hard-piping, the owner or operator shall comply with the requirements 
of paragraph (g)(7)(ii) of this section. For combinations of control 
devices, the owner or operator shall comply with the requirements of 
paragraph (g)(7)(i) of this section.
    (i) Compliance across the combination of all treatment units or 
control devices in series. (A) For combinations of treatment processes, 
the wastewater stream shall be conveyed by hard-piping between the 
treatment processes. For combinations of control devices, the vented 
gas stream shall be conveyed by hard-piping between the control 
devices.
    (B) For combinations of treatment processes, each treatment process 
shall meet the applicable requirements of paragraphs (b) through (f) of 
this section, except as provided in paragraph (g)(3) of this section.
    (C) The owner or operator shall identify, and keep a record of, the 
combination of treatment processes or of control devices, including 
identification of the first and last treatment process or control 
device. The owner or operator shall include this information as part of 
the treatment process description reported in the Notification of 
Compliance Status.
    (D) The performance test or design evaluation shall determine 
compliance across the combination of treatment processes or control 
devices. If a performance test is conducted, the ``inlet'' shall be the 
point at which the wastewater stream or residual enters the first 
treatment process, or the vented gas stream enters the first control 
device. The ``outlet'' shall be the point at which the treated 
wastewater stream exits the last treatment process, or the vented gas 
stream exits the last control device.
    (ii) Compliance across individual units. (A) For combinations of 
treatment processes, each treatment process shall meet the applicable 
requirements of paragraphs (b) through (f) of this section except as 
provided in paragraph (g)(3) of this section.
    (B) The owner or operator shall identify, and keep a record of, the 
combination of treatment processes, including identification of the 
first and last treatment process. The owner or operator shall include 
this information as part of the treatment process description reported 
in the Notification of Compliance Status report.
    (C) The owner or operator shall determine the mass removed or 
destroyed by each treatment process. The performance test or design 
evaluation shall determine compliance for the combination of treatment 
processes by adding together the mass removed or destroyed by each 
treatment process and determine the overall control efficiency of the 
treatment system.
    (8) Control options: Wastewater containing partially soluble HAP 
compounds. The owner or operator shall comply with either paragraph 
(g)(8)(i) or (ii) of this section for the control of partially soluble 
HAP compounds at new or existing sources.
    (i) 50 ppmw concentration option. The owner or operator shall 
comply with paragraphs (g)(8)(i)(A) and (B) of this section.
    (A) Reduce, by removal or destruction, the concentration of total 
partially soluble HAP compounds to a level less than 50 ppmw as 
determined by the procedures specified in Sec. 63.1257(e)(2)(iii)(B).
    (B) This option shall not be used when the treatment process is a 
biological treatment process. This option shall not be used when the 
wastewater is designated as an affected wastewater as specified in 
paragraph (a)(1)(ii) of this section. Dilution shall not be used to 
achieve compliance with this option.
    (ii) Percent mass removal/destruction option. The owner or operator 
shall reduce, by removal or destruction, the mass of total partially 
soluble HAP compounds by 99 percent or more. The removal destruction 
efficiency shall be determined by the procedures specified in 
Sec. 63.1257(e)(2)(iii)(C), for noncombustion, nonbiological treatment 
processes; Sec. 63.1257(e)(2)(iii)(D), for combustion processes; and 
Sec. 63.1257(e)(2)(iii)(F) or (G) for biological treatment processes.
    (9) Control options: Wastewater containing soluble HAP compounds. 
The owner or operator shall comply with either paragraph (g)(9)(i) or 
(ii) of this section for the control of soluble HAP compounds at new or 
existing sources.
    (i) 520 ppmw concentration option. The owner or operator shall 
comply with paragraphs (g)(9)(i)(A) and (B) of this section.
    (A) Reduce, by removal or destruction, the concentration of total 
soluble HAP compounds to a level less than 520 ppmw as determined in 
the procedures specified in Sec. 63.1257(e)(2)(iii)(B).
    (B) This option shall not be used when the treatment process is a 
biological treatment process. This option shall not be used when the 
wastewater is designated as an affected wastewater as specified in 
paragraph (a)(1)(ii) of this section. Dilution shall not be used to 
achieve compliance with this option.
    (ii) Percent mass removal/destruction option. The owner or operator 
shall reduce, by removal or destruction, the mass of total soluble HAP 
by 90 percent

[[Page 50351]]

or more. The removal/destruction efficiency shall be determined by the 
procedures in Sec. 63.1257(e)(2)(iii)(C), for noncombustion, 
nonbiological treatment processes; Sec. 63.1257(e)(2)(iii)(D), for 
combustion processes; and Sec. 63.1257(e)(2)(iii)(F) or (G) for 
biological treatment processes.
    (10) Control option: Enhanced biotreatment for wastewater 
containing soluble HAP. The owner or operator may elect to treat 
affected wastewater streams containing soluble HAP and less than 50 
ppmw partially soluble HAP in an enhanced biological treatment system, 
as defined in Sec. 63.1251. This option shall not be used when the 
wastewater is designated as an affected wastewater as specified in 
paragraph (a)(1)(ii) of this section. These treatment processes are 
exempt from the design evaluation or performance tests requirements 
specified in paragraph (g)(4) of this section.
    (11) 95-percent mass reduction option, for biological treatment 
processes. The owner or operator of a new or existing source using 
biological treatment for any affected wastewater shall reduce the mass 
of total soluble and partially soluble HAP sent to that biological 
treatment unit by at least 95 percent. All wastewater as defined in 
Sec. 63.1251 entering such a biological treatment unit from PMPU's 
subject to this subpart shall be included in the demonstration of the 
95-percent mass removal. The owner or operator shall comply with 
paragraphs (g)(11)(i) through (iv) of this section.
    (i) Except as provided in paragraph (g)(11)(iv) of this section, 
the owner or operator shall ensure that all wastewater from PMPU's 
subject to this subpart entering a biological treatment unit are 
treated to destroy at least 95-percent total mass of all soluble and 
partially soluble HAP compounds.
    (ii) For open biological treatment processes, compliance shall be 
determined using the procedures specified in 
Sec. 63.1257(e)(2)(iii)(E). For closed aerobic biological treatment 
processes compliance shall be determined using the procedures specified 
in Sec. 63.1257(e)(2)(iii)(E) or (G). For closed anaerobic biological 
treatment processes compliance shall be determined using the procedures 
specified in Sec. 63.1257(e)(2)(iii)(G).
    (iii) For each treatment process or waste management unit that 
receives, manages, or treats wastewater subject to this paragraph, from 
the POD to the biological treatment unit, the owner or operator shall 
comply with paragraphs (b) through (f) of this section for control of 
air emissions. When complying with this paragraph, the term affected 
wastewater in paragraphs (b) through (f) of this section shall mean all 
wastewater from PMPU's, not just affected wastewater.
    (iv) If wastewater is in compliance with the requirements in 
paragraph (g)(8), (9), or (12) of this section before entering the 
biological treatment unit, the hazardous air pollutants mass of that 
wastewater is not required to be included in the total mass flow rate 
entering the biological treatment unit for the purpose of demonstrating 
compliance.
    (12) Percent mass removal/destruction option for soluble HAP 
compounds at new sources. The owner or operator of a new source shall 
reduce, by removal or destruction, the mass flow rate of total soluble 
HAP from affected wastewater by 99 percent or more. The removal/
destruction efficiency shall be determined by the procedures in 
Sec. 63.1257(e)(2)(iii)(C), for noncombustion, nonbiological treatment 
processes; Sec. 63.1257(e)(2)(iii)(D), for combustion processes; and 
Sec. 63.1257(e)(2)(iii)(F) or (G) for biological treatment processes.
    (13) Treatment in a RCRA unit option. The owner or operator shall 
treat the affected wastewater or residual in a unit identified in, and 
complying with, paragraph (g)(13)(i), (ii), or (iii) of this section. 
These units are exempt from the design evaluation or performance tests 
requirements specified in paragraph (g)(4) of this section and 
Sec. 63.1257(e)(2), and from the monitoring requirements specified in 
paragraph (a)(2)(iii) of this section, as well as recordkeeping and 
reporting requirements associated with monitoring and performance 
tests.
    (i) The wastewater or residual is discharged to a hazardous waste 
incinerator for which the owner or operator has been issued a final 
permit under 40 CFR part 270 and complies with the requirements of 40 
CFR part 264, subpart O, or has certified compliance with the interim 
status requirements of 40 CFR part 265, subpart O;
    (ii) The wastewater or residual is discharged to a process heater 
or boiler 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.
    (iii) The wastewater or residual is discharged to an underground 
injection well for which the owner or operator has been issued a final 
permit under 40 CFR part 270 or 40 CFR part 144 and complies with the 
requirements of 40 CFR part 122. The owner or operator shall comply 
with all applicable requirements of this subpart prior to the point 
where the wastewater enters the underground portion of the injection 
well.
    (14) Residuals. For each residual removed from affected wastewater, 
the owner or operator shall control for air emissions by complying with 
paragraphs (b) through (f) of this section and by complying with one of 
the provisions in paragraphs (g)(14)(i) through (iv) of this section.
    (i) Recycle the residual to a production process or sell the 
residual for the purpose of recycling. Once a residual is returned to a 
production process, the residual is no longer subject to this section.
    (ii) Return the residual to the treatment process.
    (iii) Treat the residual to destroy the total combined mass flow 
rate of soluble and/or partially soluble HAP compounds by 99 percent or 
more, as determined by the procedures specified in 
Sec. 63.1257(e)(2)(iii)(C) or (D).
    (iv) Comply with the requirements for RCRA treatment options 
specified in paragraph (g)(13) of this section.
    (h) Control devices. For each control device or combination of 
control devices used to comply with the provisions in paragraphs (b) 
through (f) and (g)(5) of this section, the owner or operator shall 
operate and maintain the control device or combination of control 
devices in accordance with the requirements of paragraphs (h) (1) 
through (4) of this section.
    (1) Whenever organic HAP emissions are vented to a control device 
which is used to comply with the provisions of this subpart, such 
control device shall be operating.
    (2) The control device shall be designed and operated in accordance 
with paragraph (h)(2) (i), (ii), (iii), (iv), or (v) of this section, 
as demonstrated by the provisions in Sec. 63.1257(e)(3).
    (i) An enclosed combustion device (including but not limited to a 
vapor incinerator, boiler, or process heater) shall meet the conditions 
in paragraph (h)(2)(i) (A), (B), or (C) of this section, alone or in 
combination with other control devices. If a boiler or process heater 
is used as the control device, then the vent stream shall be introduced 
into the flame zone of the boiler or process heater.
    (A) Reduce the organic HAP emissions vented to the control device 
by 95 percent by weight or greater;
    (B) Achieve an outlet TOC concentration of 20 ppmv on a dry basis 
corrected to 3 percent oxygen. The

[[Page 50352]]

owner or operator shall use either Method 18 of 40 CFR part 60, 
appendix A, or any other method or data that has been validated 
according to the applicable procedures in Method 301 of appendix A of 
this part; or
    (C) Provide a minimum residence time of 0.5 seconds at a minimum 
temperature of 760 deg.C.
    (ii) A vapor recovery system (including but not limited to a carbon 
adsorption system or condenser), alone or in combination with other 
control devices, shall reduce the organic HAP emissions vented to the 
control device by 95 percent by weight or greater or achieve an outlet 
TOC concentration of 20 ppmv. The 20 ppmv performance standard is not 
applicable to compliance with the provisions of paragraphs (c) or (d) 
of this section.
    (iii) A flare shall comply with the requirements of Sec. 63.11(b).
    (iv) A scrubber, alone or in combination with other control 
devices, shall reduce the organic HAP emissions in such a manner that 
95 weight-percent is either removed, or destroyed by chemical reaction 
with the scrubbing liquid, or achieve an outlet TOC concentration of 20 
ppmv. The 20 ppmv performance standard is not applicable to compliance 
with the provisions of paragraphs (c) or (d) of this section.
    (v) Any other control device used shall, alone or in combination 
with other control devices, reduce the organic HAP emissions vented to 
the control device by 95 percent by weight or greater or achieve an 
outlet TOC concentration of 20 ppmv. The 20 ppmv performance standard 
is not applicable to compliance with the provisions of paragraphs (c) 
or (d) of this section.
    (3) If the control device is a combustion device, the owner or 
operator shall comply with the requirements in Sec. 63.1252(g) to 
control halogenated vent streams.
    (4) Except as provided in paragraph (i) of this section, if gaps, 
cracks, tears, or holes are observed in ductwork, piping, or 
connections to covers and control devices during an inspection, a first 
effort to repair shall be made as soon as practical but no later than 5 
calendar days after identification. Repair shall be completed no later 
than 15 calendar days after identification or discovery of the defect.
    (i) Delay of repair. Delay of repair of equipment for which a 
control equipment failure or a gap, crack, tear, or hole has been 
identified, is allowed if the repair is technically infeasible without 
a shutdown, as defined in Sec. 63.1251, or if the owner or operator 
determines that emissions of purged material from immediate repair 
would be greater than the emissions likely to result from delay of 
repair. Repair of this equipment shall occur by the end of the next 
shutdown.
    (1) Delay of repair of equipment for which a control equipment 
failure or a gap, crack, tear, or hole has been identified, is allowed 
if the equipment is emptied or is no longer used to treat or manage 
affected wastewater or residuals removed from affected wastewater.
    (2) Delay of repair of equipment for which a control equipment 
failure or a gap, crack, tear, or hole has been identified is also 
allowed if additional time is necessary due to the unavailability of 
parts beyond the control of the owner or operator. Repair shall be 
completed as soon as practical. The owner or operator who uses this 
provision shall comply with the requirements of Sec. 63.1259(h) to 
document the reasons that the delay of repair was necessary.


Sec. 63.1257   Test methods and compliance procedures.

    (a) General. Except as specified in paragraph (a)(5) of this 
section, the procedures specified in paragraphs (c), (d), (e), and (f) 
of this section are required to demonstrate initial compliance with 
Secs. 63.1253, 63.1254, 63.1256, and 63.1252(e), respectively. The 
provisions in paragraphs (a) (2) through (3) apply to performance tests 
that are specified in paragraphs (c), (d), and (e) of this section. The 
provisions in paragraph (a)(5) of this section are used to demonstrate 
initial compliance with the alternative standards specified in 
Secs. 63.1253(d) and 63.1254(c). The provisions in paragraph (a)(6) of 
this section are used to comply with the outlet concentration 
requirements specified in Secs. 63.1253(c), 63.1254 (a)(2)(i) and 
(a)(3)(ii)(B), 63.1254(b)(i) and 63.1256(h)(2).
    (1) Design evaluation. To demonstrate that a control device meets 
the required control efficiency, a design evaluation must address the 
composition and organic HAP concentration of the vent stream entering 
the control device. A design evaluation also must address other vent 
stream characteristics and control device operating parameters as 
specified in any one of paragraphs (a)(1) (i) through (vi) of this 
section, depending on the type of control device that is used. If the 
vent stream is not the only inlet to the control device, the efficiency 
demonstration also must consider all other vapors, gases, and liquids, 
other than fuels, received by the control device.
    (i) For an enclosed combustion device used to comply with the 
provisions of 63.1253 (b)(2) or (c)(2), or 63.1256(h)(2)(i)(C) with a 
minimum residence time of 0.5 seconds and a minimum temperature of 
760 deg.C, the design evaluation must document that these conditions 
exist.
    (ii) For a combustion control device that does not satisfy the 
criteria in paragraph (a)(1)(i) of this section, the design evaluation 
must document control efficiency and address the following 
characteristics, depending on the type of control device:
    (A) For a thermal vapor incinerator, the design evaluation must 
consider the autoignition temperature of the organic HAP, must consider 
the vent stream flow rate, and must establish the design minimum and 
average temperature in the combustion zone and the combustion zone 
residence time.
    (B) For a catalytic vapor incinerator, the design evaluation shall 
consider the vent stream flow rate and shall establish the design 
minimum and average temperatures across the catalyst bed inlet and 
outlet.
    (C) For a boiler or process heater, the design evaluation shall 
consider the vent stream flow rate; shall establish the design minimum 
and average flame zone temperatures and combustion zone residence time; 
and shall describe the method and location where the vent stream is 
introduced into the flame zone.
    (iii) For a condenser, the design evaluation shall consider the 
vent stream flow rate, relative humidity, and temperature and shall 
establish the design outlet organic HAP compound concentration level, 
design average temperature of the condenser exhaust vent stream, and 
the design average temperatures of the coolant fluid at the condenser 
inlet and outlet. The temperature of the gas stream exiting the 
condenser must be measured and used to establish the outlet organic HAP 
concentration.
    (iv) For a carbon adsorption system that regenerates the carbon bed 
directly onsite in the control device such as a fixed-bed adsorber, the 
design evaluation shall consider the vent stream flow rate, relative 
humidity, and temperature and shall establish the design exhaust vent 
stream organic compound concentration level, adsorption cycle time, 
number and capacity of carbon beds, type and working capacity of 
activated carbon used for carbon beds, design total regeneration stream 
mass or volumetric flow over the period of each complete carbon bed 
regeneration cycle, design carbon bed temperature after regeneration, 
design carbon bed regeneration time, and design service

[[Page 50353]]

life of carbon. For vacuum desorption, the pressure drop shall be 
included.
    (v) For a carbon adsorption system that does not regenerate the 
carbon bed directly onsite in the control device such as a carbon 
canister, the design evaluation shall consider the vent stream mass or 
volumetric flow rate, relative humidity, and temperature and shall 
establish the design exhaust vent stream organic compound concentration 
level, capacity of carbon bed, type and working capacity of activated 
carbon used for carbon bed, and design carbon replacement interval 
based on the total carbon working capacity of the control device and 
source operating schedule.
    (vi) For a scrubber, the design evaluation shall consider the vent 
stream composition; constituent concentrations; liquid-to-vapor ratio; 
scrubbing liquid flow rate and concentration; temperature; and the 
reaction kinetics of the constituents with the scrubbing liquid. The 
design evaluation shall establish the design exhaust vent stream 
organic compound concentration level and will include the additional 
information in paragraphs (a)(1)(vi)(A) and (B) of this section for 
trays and a packed column scrubber.
    (A) Type and total number of theoretical and actual trays;
    (B) Type and total surface area of packing for entire column, and 
for individual packed sections if column contains more than one packed 
section.
    (2) Calculation of TOC or total organic HAP concentration. The TOC 
concentration or total organic HAP concentration is the sum of the 
concentrations of the individual components. If compliance is being 
determined based on TOC, the owner or operator shall compute TOC for 
each run using Equation 6 of this subpart. If compliance with the 
wastewater provisions is being determined based on total organic HAP, 
the owner or operator shall compute total organic HAP using Equation 6 
of this subpart, except that only the organic HAP compounds shall be 
summed; when determining compliance with paragraph (e)(3)(i) of this 
section, only the soluble and partially soluble HAP compounds shall be 
summed.
[GRAPHIC] [TIFF OMITTED] TR21SE98.003

where:
    CGT=total concentration of TOC in vented gas stream, 
average of samples, dry basis, ppmv
CGSi,j=concentration of sample components in vented gas 
stream for sample j, dry basis, ppmv
i=identifier for a compound
n=number of components in the sample
j=identifier for a sample
m=number of samples in the sample run

    (3) Percent oxygen correction for combustion control devices. If 
the control device is a combustion device, the TOC or total organic HAP 
concentrations must be corrected to 3 percent oxygen. The integrated 
sampling and analysis procedures of Method 3B of 40 CFR part 60, 
appendix A shall be used to determine the actual oxygen concentration 
(%02d). The samples shall be taken during the same time that 
the TOC or total organic HAP samples are taken. The concentration 
corrected to 3 percent oxygen (Cd) shall be computed using 
Equation 7 of this subpart:
[GRAPHIC] [TIFF OMITTED] TR21SE98.004

where:

Cc = concentration of TOC or total organic HAP corrected to 
3 percent oxygen, dry basis, ppmv
Cm = total concentration of TOC in vented gas stream, 
average of samples, dry basis, ppmv
%02d = concentration of oxygen measured in vented gas 
stream, dry basis, percent by volume

    (4) Exemptions from compliance demonstrations. An owner or operator 
using any control device specified in paragraphs (a)(4)(i) through (iv) 
of this section is exempt from the initial compliance provisions in 
paragraphs (c), (d), and (e) of this section.
    (i) A boiler or process heater with a design heat input capacity of 
44 megawatts or greater.
    (ii) A boiler or process heater into which the emission stream is 
introduced with 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.
    (iv) A hazardous waste incinerator for which the owner or operator 
has been issued a final permit under 40 CFR part 270 and complies with 
the requirements of 40 CFR part 264, subpart O, or has certified 
compliance with the interim status requirements of 40 CFR part 265, 
subpart O.
    (5) Initial compliance with alternative standard. Initial 
compliance with the alternative standards in Secs. 63.1253(d) and 
63.1254(c) is demonstrated when the outlet TOC concentration is 20 ppmv 
or less, and the outlet hydrogen halide and halogen concentration is 20 
ppmv or less. To demonstrate initial compliance, the owner or operator 
shall be in compliance with the monitoring provisions in 
Sec. 63.1258(b)(5) on the initial compliance date. The owner or 
operator shall use Method 18 to determine the predominant organic HAP 
in the emission stream if the TOC monitor is calibrated on the 
predominant HAP.
    (6) Initial compliance with the 20 ppmv outlet limit. Initial 
compliance with the 20 ppmv TOC and hydrogen halide and halogen 
concentration is demonstrated when the outlet TOC concentration is 20 
ppmv or less, and the outlet hydrogen halide and halogen concentration 
is 20 ppmv or less. To demonstrate initial compliance, the operator 
shall use test methods described in paragraph (b) of this section. The 
owner or operator shall comply with the monitoring provisions in 
Sec. 63.1258(b)(1) through (5) of this subpart on the initial 
compliance date.
    (b) Test methods. When testing is conducted to measure emissions 
from an affected source, the test methods specified in paragraphs 
(b)(1) through (10) 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) [Reserved]
    (6) Concentration measurements shall be adjusted to negate the 
dilution effects of introducing nonaffected gaseous streams into the 
vent streams prior to control or measurement. The following methods are 
specified for concentration measurements:
    (i) Method 18 may be used to determine HAP concentration in any 
control device efficiency determination.
    (ii) Method 25 of appendix A of part 60 may be used to determine 
total gaseous nonmethane organic concentration for control efficiency 
determinations in combustion devices.
    (iii) Method 26 of appendix A of part 60 shall be used to determine 
hydrogen chloride concentrations in control device efficiency 
determinations or in the 20 ppmv outlet hydrogen halide concentration 
standard.
    (iv) Method 25A of appendix A of part 60 may be used to determine 
the HAP or TOC concentration for control device

[[Page 50354]]

efficiency determinations under the conditions specified in Method 25 
of appendix A for direct measurement of an effluent with a flame 
ionization detector, or in demonstrating compliance with the 20 ppmv 
TOC outlet standard. If Method 25A is used to determine the 
concentration of TOC for the 20 ppmv standard, the instrument shall be 
calibrated on methane or the predominant HAP. If calibrating on the 
predominant HAP, the use of Method 25A shall comply with paragraphs 
(b)(6)(iv)(A) through (C) of this section.
    (A) The organic HAP used as the calibration gas for Method 25A, 40 
CFR part 60, appendix A, shall be the single organic HAP representing 
the largest percent by volume.
    (B) The use of Method 25A, 40 CFR part 60, appendix A, is 
acceptable if the response from the high level calibration gas is at 
least 20 times the standard deviation of the response from the zero 
calibration gas when the instrument is zeroed on the most sensitive 
scale.
    (C) The span value of the analyzer must be less than 100 ppmv.
    (7) Testing conditions for continuous processes. Testing of 
emissions 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.
    (8) Testing and compliance determination conditions for batch 
processes. Testing of emissions on equipment where the flow of gaseous 
emissions is intermittent (batch operations) shall be conducted as 
specified in paragraphs (b)(8)(i) through (iii) of this section.
    (i) Except as provided in paragraph (b)(9) of this section for 
condensers, testing shall be conducted at absolute worst-case 
conditions or hypothetical worst-case conditions. 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 shall be adjusted proportionally to reflect 
variations in flow rate. The absolute worst-case or hypothetical worst-
case conditions shall be characterized by the criteria presented in 
paragraphs (b)(8)(i)(A) and (B)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) and Sec. 63.1260(l). 
The test plan shall include the emission profile described in paragraph 
(b)(8)(ii) of this section.
    (A) Absolute worst-case conditions are defined by the criteria 
presented in paragraph (b)(8)(i)(A)(1) or (2) of this section if the 
maximum load is the most challenging condition for the control device. 
Otherwise, absolute worst-case conditions are defined by the conditions 
in paragraph (b)(8)(i)(A)(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)(8)(ii)(A) 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)(8)(ii)(A) of this section shall be used to 
identify the 1-hour period of maximum HAP loading.
    (3) The period of time when the HAP loading or stream composition 
(including non-HAP) is most challenging for the control device. These 
conditions include, but are not limited to the following:
    (i) Periods when the stream contains the highest combined VOC and 
HAP load, in lb/hr, described by the emission profiles in (b)(8)(ii);
    (ii) Periods when the streams contain HAP constituents that 
approach limits of solubility for scrubbing media;
    (iii) Periods when the streams contain HAP constituents that 
approach limits of adsorptivity for carbon adsorption systems.
    (B) Hypothetical worst-case conditions are simulated test 
conditions that, at a minimum, contain the highest hourly HAP load of 
emissions that would be predicted to be vented to the control device 
from the emissions profile described in paragraph (b)(8)(ii)(B) or (C) 
of this section.
    (ii) Emissions profile. 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 that describes the 
characteristics of the vent stream at the inlet to the control device 
under worst case conditions. The emission profile shall be developed 
based on any one of the procedures described in (b)(8)(ii)(A) through 
(C) of this section, as required by paragraph (b)(8)(i).
    (A) Emission profile by process. The emission profile must consider 
all emission episodes that could contribute to the vent stack for a 
period of time that is sufficient to include all processes venting to 
the stack and shall consider production scheduling. The profile shall 
describe the HAP load to the device that equals the highest sum of 
emissions from the episodes that can vent to the control device in any 
given hour. Emissions per episode shall be calculated using the 
procedures specified in paragraph (d)(2) of this section. Emissions per 
episode shall be divided by the duration of the episode only if the 
duration of the episode is longer than 1 hour.
    (B) Emission profile by equipment. The emission profile must 
consist of emissions that meet or exceed the highest emissions, in lb/
hr, that would be expected under actual processing conditions. The 
profile shall describe equipment configurations used to generate the 
emission events, volatility of materials processed in the equipment, 
and the rationale used to identify and characterize the emission 
events. The emissions may be based on using a compound more volatile 
than compounds actually used in the process(es), and the emissions may 
be generated from all equipment in the process(es) or only selected 
equipment.
    (C) Emission profile by capture and control device limitation. The 
emission profile shall consider the capture and control system 
limitations and the highest emissions, in lb/hr, that can be routed to 
the control device, based on maximum flowrate and concentrations 
possible because of limitations on conveyance and control equipment 
(e.g., fans, LEL alarms and safety bypasses).
    (iii) Three runs, at a minimum of 1 hour each and a maximum of 8 
hours each, are required for performance testing. Each run must occur 
over the same worst-case conditions, as defined in paragraph (b)(8)(i) 
of this section.

[[Page 50355]]

    (9) Testing requirements for condensers. For emission streams 
controlled using condensers, continuous direct measurement of condenser 
outlet gas temperature to be used in determining concentrations per the 
design evaluation described in Sec. 63.1257(a)(1)(iii) is required.
    (10) Wastewater testing. Wastewater analysis shall be conducted in 
accordance with paragraph (b)(10)(i), (ii), (iii), or (iv) of this 
section.
    (i) Method 305. Use procedures specified in Method 305 of 40 CFR 
part 63, appendix A and comply with requirements specified in paragraph 
(b)(10)(v) of this section.
    (ii) Method 624, 625, 1624, 1625, or 8270. Use procedures specified 
in Method 624, 625, 1624, 1625, or 8270 of 40 CFR part 136, appendix A 
and comply with requirements in paragraph (b)(10)(v) of this section.
    (iii) Other EPA Methods. Use procedures specified in the method, 
validate the method using the procedures in paragraph (b)(10)(iii)(A) 
or (B) of this section, and comply with the procedures in paragraph 
(b)(10)(v) of this section.
    (A) Validate the method according to section 5.1 or 5.3 of Method 
301 of 40 CFR part 63, appendix A.
    (B) Follow the procedure as specified in ``Alternative Validation 
Procedure for EPA Waste Methods'' 40 CFR part 63, appendix D.
    (iv) Methods other than an EPA method. Use procedures specified in 
the method, validate the method using the procedures in paragraph 
(b)(10)(iii)(A) of this section, and comply with the requirements in 
paragraph (b)(10)(v) of this section.
    (v) Sampling plan. The owner or operator shall prepare a sampling 
plan. Wastewater samples shall be collected using sampling procedures 
which minimize loss of organic compounds during sample collection and 
analysis and maintain sample integrity. The sample plan shall include 
procedures for determining recovery efficiency of the relevant 
partially soluble and soluble HAP compounds. An example of an 
acceptable sampling plan would be one that incorporates similar 
sampling and sample handling requirements to those of Method 25D of 40 
CFR part 60, appendix A. The sampling plan shall be maintained at the 
facility.
    (c) Initial compliance with storage tank provisions. The owner or 
operator of an affected storage tank shall demonstrate initial 
compliance with Sec. 63.1253(b) or (c), as applicable, by fulfilling 
the requirements of paragraph (c)(1),or (c)(2), or (c)(3) of this 
section.
    (1) Performance test. If this option is chosen to demonstrate 
initial compliance with the percent reduction requirement of 
Sec. 63.1253(b)(1) or (c)(1)(i), the efficiency of the control device 
shall be calculated using performance test data as specified in 
paragraphs (c)(1)(i) through (iii) of this section. Initial compliance 
with the outlet concentration requirement of Sec. 63.1253(b)(2) or 
(c)(1)(ii) is demonstrated by fulfilling the requirements of paragraph 
(a)(6) of this section.
    (i) Equations 8 and 9 of this subpart shall be used to calculate 
the mass rate of total HAP reasonably expected maximum filling rate at 
the inlet and outlet of the control device for standard conditions of 
20 deg.C: where:
[GRAPHIC] [TIFF OMITTED] TR21SE98.005

[GRAPHIC] [TIFF OMITTED] TR21SE98.006

where:

Cij, Coj = concentration of sample component j of 
the gas stream at the inlet and outlet of the control device, 
respectively, dry basis, ppmv
Ei, Eo = mass rate of total HAP at the inlet and 
outlet of the control device, respectively, dry basis, kg/hr
Mij, Moj = molecular weight of sample component j 
of the gas stream at the inlet and outlet of the control device, 
respectively, gram/gram-mole
Qi, Qo = flow rate of gas stream at the inlet and 
outlet of the control device, respectively, dry standard cubic meter 
per minute
K2 = constant, 2.494  x  10-6 (parts per million) 
-1 (gram-mole per standard cubic meter) (kilogram/gram) 
(minute/hour), where standard temperature is 20 deg.C
n = number of sample components in the gas stream

    (ii) The percent reduction in total HAP shall be calculated using 
Equation 10 of this subpart:
[GRAPHIC] [TIFF OMITTED] TR21SE98.007

where:

R = control efficiency of control device, percent
Ei = 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
Eo = 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. 63.1253 (storage tank 
provisions) is also used to comply with Sec. 63.1254 (process vent 
provisions), and compliance with Sec. 63.1254 has been demonstrated in 
accordance with paragraph (d) of this section.
    (2) Design evaluation. If this option is chosen to demonstrate 
initial compliance with the percent reduction requirement of 
Sec. 63.1253(b) or (c), a design evaluation shall be prepared in 
accordance with the provisions in paragraph (a)(1) of this section. The 
design evaluation shall include documentation demonstrating that the 
control device being used achieves the required control efficiency 
during reasonably expected maximum filling rate.
    (3) Floating roof. If the owner or operator of an affected source 
chooses to comply with the provisions of Sec. 63.1253(b) or (c) by 
installing a floating roof, the owner or operator shall comply with the 
procedures described in Secs. 63.119(b), (c), (d), and 63.120(a), (b), 
and (c), with the differences noted in paragraphs (c)(3)(i) through (v) 
of this section for the purposes of this subpart.
    (i) When the term ``storage vessel'' is used in Secs. 63.119 and 
63.120, the definition of ``storage tank'' in Sec. 63.1251 shall apply 
for the purposes of this subpart.
    (ii) When December 31, 1992 is referred to in Sec. 63.119, April 2, 
1997 shall apply instead for the purposes of this subpart.
    (iii) When April 22, 1994 is referred to in Sec. 63.119, September 
21, 1998 shall apply instead for the purposes of this subpart.
    (iv) When the phrase ``the compliance date specified in Sec. 63.100 
of subpart F of this part'' is referred to in Sec. 63.120, the phrase 
``the compliance date specified in Sec. 63.1250'' shall apply for the 
purposes of this subpart.
    (v) When the phrase ``the maximum true vapor pressure of the total 
organic HAP's in the stored liquid falls below the values defining 
Group 1 storage vessels specified in table 5 or table 6 of this 
subpart'' is referred to in Sec. 63.120(b)(1)(iv), the phrase ``the 
maximum true vapor pressure of the total organic HAP in the stored 
liquid

[[Page 50356]]

falls below 13.1 kPa (1.9 psia)'' shall apply for the purposes of this 
subpart.
    (4) Initial compliance with alternative standard. Initial 
compliance with Sec. 63.1253(d) is demonstrated by fulfilling the 
requirements of paragraph (a)(5) of this section.
    (5) Planned maintenance. The owner or operator shall demonstrate 
compliance with the requirements of Sec. 63.1253(e) by including the 
periods of planned routine maintenance specified by date and time in 
each Periodic Report required by Sec. 63.1260.
    (d) Initial compliance with process vent provisions. An owner or 
operator of an affected source complying with the process vent 
standards in Sec. 63.1254 shall demonstrate compliance using the 
procedures described in paragraphs (d)(1) through (4) of this section.
    (1) Except as provided in paragraph (a)(4) of this section, initial 
compliance with the process vent standards in Sec. 63.1254 shall be 
demonstrated using the procedures specified in paragraphs (d)(1)(i) 
through (iv), as applicable.
    (i) Initial compliance with Sec. 63.1254(a)(1)(i) is demonstrated 
when the actual emissions of HAP from the sum of all process vents 
within a process that do not meet the criteria specified in 
Sec. 63.1254(a)(3) is less than or equal to 2,000 lb/yr. Initial 
compliance with Sec. 63.1254(a)(1)(ii) is demonstrated when the 
uncontrolled emissions of HAP from the sum of all process vents within 
a process is less than or equal to 100 lb/yr. Uncontrolled HAP 
emissions and controlled HAP emissions shall be determined using the 
procedures described in paragraphs (d)(2) and (3) of this section.
    (ii) Initial compliance with the percent reduction requirements in 
Secs. 63.1254(a)(2), (a)(3), and (b) is demonstrated by:
    (A) Determining controlled HAP emissions using the procedures 
described in paragraph (d)(3) of this section and uncontrolled HAP 
emissions determined using the procedures described in paragraph (d)(2) 
of this section and demonstrating that the reductions required by 
Secs. 63.1254(a)(2), (a)(3), and (b) are met; or
    (B) Controlling the process vents using a device meeting the 
criteria specified in paragraph (a)(4) of this section.
    (iii) Initial compliance with the outlet concentration requirements 
in Sec. 63.1254(a)(2)(ii) and (3) is demonstrated when the outlet TOC 
concentration is 20 ppmv or less and the outlet hydrogen halide and 
halogen concentration is 20 ppmv or less. The owner or operator shall 
demonstrate compliance by fulfilling the requirements in paragraph 
(a)(6) of this section.
    (iv) Initial compliance with Sec. 63.1254(c) is demonstrated by 
fulfilling the requirements of paragraph (a)(5) of this section.
    (2) Uncontrolled emissions. An owner or operator of an affected 
source complying with the emission limitation required by 
Sec. 63.1254(a)(1), or emissions reductions specified in 
Sec. 63.1254(a)(2), (a)(3), or (b), for each process vent within a 
process, shall calculate uncontrolled emissions from all equipment in 
the process according to the procedures described in paragraph 
(d)(2)(i) or (ii) of this section, as appropriate.
    (i) Emission estimation procedures. 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 (H) of this section. Except where variations are 
noted, 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) Vapor displacement. Emissions from vapor displacement due to 
transfer of material shall be calculated using Equation 11 of this 
subpart. The individual HAP partial pressures may be calculated using 
Raoult's law.
[GRAPHIC] [TIFF OMITTED] TR21SE98.008

where:

E = mass of HAP emitted
V = volume of gas displaced from the vessel
R = ideal gas law constant
T = temperature of the vessel vapor space; absolute
Pi = partial pressure of the individual HAP
MWi = molecular weight of the individual HAP
n = number of HAP compounds in the emission stream i = identifier for a 
HAP compound

    (B) Purging. Emissions from purging shall be calculated using 
Equation 12 of this subpart. The partial pressures of individual 
condensable compounds may be calculated using Raoult's law, the 
pressure of the vessel vapor space may be set equal to 760 mmHg, and 
the partial pressure of HAP shall be assumed to be 25 percent of the 
saturated value if the purge flow rate is greater than 100 standard 
cubic feet per minute (scfm).
[GRAPHIC] [TIFF OMITTED] TR21SE98.009


Where:
E = mass of HAP emitted
V = purge flow rate at the temperature and pressure of the vessel vapor 
space
R = ideal gas law constant
T = temperature of the vessel vapor space; absolute
Pi = partial pressure of the individual HAP
Pj = partial pressure of individual condensable VOC 
compounds (including HAP)
PT = pressure of the vessel vapor space
MWi = molecular weight of the individual HAP
t = time of purge
n = number of HAP compounds in the emission stream
i = identifier for a HAP compound
j = identifier for a condensable compound
m = number of condensable compounds (including HAP) in the emission 
stream


[[Page 50357]]


    (C) Heating. Emissions caused by the heating of a vessel to a 
temperature equal to or lower than 10 K below the boiling point shall 
be calculated using the procedures in either paragraph (d)(2)(i)(C)(1) 
or (3) of this section. Emissions caused by heating a vessel to a 
temperature that is higher than 10 K below the boiling point and less 
than the boiling point, must be calculated using the procedures in 
either paragraph (d)(2)(i)(C) (2) or (3) of this section. If the 
contents of a vessel are heated to the boiling point, emissions must be 
calculated using the procedures in paragraph (d)(2)(i)(C)(4) of this 
section.
    (1) This paragraph describes procedures to calculate emissions if 
the final temperature to which the vessel contents are heated is 10 K 
below the boiling point of the HAP in the vessel, or lower. The owner 
or operator shall calculate the mass of HAP emitted per episode using 
either Equation 13 or 14 of this subpart. The moles of noncondensable 
gas displaced are calculated using Equation 15 of this subpart. The 
initial and final pressure of the noncondensable gas in the vessel 
shall be calculated using Equation 16 of this subpart. The average 
molecular weight of HAP in the displaced gas shall be calculated using 
Equation 17 of this subpart.
[GRAPHIC] [TIFF OMITTED] TR21SE98.010

[GRAPHIC] [TIFF OMITTED] TR21SE98.011

[GRAPHIC] [TIFF OMITTED] TR21SE98.012

[GRAPHIC] [TIFF OMITTED] TR21SE98.013

[GRAPHIC] [TIFF OMITTED] TR21SE98.014

Where:

E = mass of HAP vapor displaced from the vessel being heated
xi = mole fraction of each HAP in the liquid phase
xj = mole fraction of each condensable VOC (including HAP) 
in the liquid phase
(Pi*) = vapor pressure of each HAP in the vessel headspace 
at any temperature between the initial and final heatup temperatures, 
mmHg
(Pj*) = vapor pressure of each condensable VOC (including 
HAP) in the vessel headspace at any temperature between the initial and 
final heatup temperatures, mmHg
760 = atmospheric pressure, mmHg
MWHAP = the average molecular weight of HAP present in the 
displaced gas
 = number of moles of noncondensable gas displaced
V = volume of free space in the vessel
R = ideal gas law constant
T1 = initial temperature of vessel contents, absolute
T2 = final temperature of vessel contents, absolute
Pan = partial pressure of noncondensable gas in the vessel 
headspace at initial (n=1) and final (n=2) temperature
Patm = atmospheric pressure (when  is 
used in Equation 13 of this subpart, Patm may be set equal 
to 760 mmHg for any vessel)
(Pj)Tn = partial pressure of each condensable 
compound (including HAP) in the vessel headspace at the initial 
temperature (n=1) and final (n=2) temperature
m = number of condensable compounds (including HAP) in the displaced 
vapor
j = identifier for a condensable compound
(Pi)Tn = partial pressure of each HAP in the 
vessel headspace at initial (T1) and final (T2) 
temperature; [for use in Equation 13, replace 
(Pi)T1+(Pi)T2 with 
Pi at the temperature used to calculate vapor pressure of 
HAP in Equation 13]
MWi = molecular weight of each HAP
n = number of HAP compounds in the emission stream
i = identifier for a HAP compound

    (2) If the vessel contents are heated to a temperature that is 
higher than 10 K below the boiling point and less than the boiling 
point, emissions must be calculated using the procedures in

[[Page 50358]]

paragraph (d)(2)(i)(C)(2)(i), or (ii), or (iii) of this section.
    (i) Use Equation 13 of this subpart. In Equation 13 of this 
subpart, the HAP vapor pressures must be determined at the temperature 
10 K below the boiling point. In the calculation of  
for Equation 13 of this subpart, T2 must be the temperature 
10 K below the boiling point, and Pa2 must be determined at 
the temperature 10 K below the boiling point. In the calculation of 
MWHAP, the HAP partial pressures must be determined at the 
temperature 10 K below the boiling point.
    (ii) Use Equation 14 of this subpart. In Equation 14 of this 
subpart, the HAP partial pressures must be deter mined at the 
temperature 10 K below the boiling point. In the calculation of 
 for Equation 14 of this subpart, T2 must 
be the temperature 10 K below the boiling point, and Pa2 
must be determined at the temperature 10 K below the boiling point. In 
the calculation of MWHAP, the HAP partial pressures must be 
determined at the temperature 10 K below the boiling point.
    (iii) Use Equation 14 of this subpart over specific temperature 
increments. If the initial temperature is lower than 10 K below the 
boiling point, emissions must be calculated as the sum over two 
increments; one increment is from the initial temperature to 10 K below 
the boiling point, and the second is from 10 K below the boiling point 
to the lower of either the final temperature or the temperature 5 K 
below the boiling point. If the initial temperature is higher than 10 K 
below the boiling point, emissions are calculated over one increment 
from the initial temperature to the lower of either the final 
temperature or the temperature 5 K below the boiling point.
    (3)(i) Emissions caused by heating a vessel are calculated using 
Equation 18 of this subpart.
[GRAPHIC] [TIFF OMITTED] TR21SE98.015

Where:

E = mass of HAP vapor displaced from the vessel being heated
Navg = average gas space molar volume during the heating 
process
PT= total pressure in the vessel
Pi,1 = partial pressure of the individual HAP compounds at 
T1
Pi,2 = partial pressure of the individual HAP compounds at 
T2
MWHAP = average molecular weight of the HAP compounds
ni,1 = number of moles of condensable in the vessel 
headspace at T1
ni,2 = number of moles of condensable in the vessel 
headspace at T2
n = number of HAP compounds in the emission stream

    (ii) The average gas space molar volume during the heating process 
is calculated using Equation 19 of this subpart.
[GRAPHIC] [TIFF OMITTED] TR21SE98.016

Where:

Navg = average gas space molar volume during the heating 
process
V = volume of free space in vessel
PT = total pressure in the vessel
R = ideal gas law constant
T1 = initial temperature of the vessel
T2 = final temperature of the vessel

    (iii) The difference in the number of moles of condensable in the 
vessel headspace between the initial and final temperatures is 
calculated using Equation 20 of this subpart.
[GRAPHIC] [TIFF OMITTED] TR21SE98.017

Where:

V = volume of free space in vessel
R = ideal gas law constant
T1 = initial temperature in the vessel
T2 = final temperature in the vessel
Pi,1 = partial pressure of the individual HAP compounds at 
T1
Pi,2 = partial pressure of the individual HAP compounds at 
T2
n = number of HAP compounds in the emission stream

    (4) If the vessel contents are heated to the boiling point, 
emissions must be calculated using the procedure in paragraphs 
(d)(2)(i)(c)(4)(i) and (ii) of this section.
    (i) Use either of the procedures in paragraph (d)(3)(i)(B)(3) of 
this section to calculate the emissions from heating to the boiling 
point (note that Pa2=0 in the calculation of 
); and
    (ii) While boiling, the vessel must be operated with a properly 
operated process condenser. An initial demonstration that a process 
condenser is properly operated is required for vessels that operate 
process condensers without secondary condensers that are air pollution 
control devices. The owner or operator must either measure the 
condenser exhaust gas temperature and show it is less than the boiling 
point of the substance(s) in the vessel, or perform a material balance 
around the vessel and condenser to show that at least 99 percent of the 
material vaporized while boiling is condensed. Uncontrolled emissions 
are assumed to be zero under these conditions. The initial 
demonstration shall be conducted for all appropriate operating 
scenarios and documented in the Notification of Compliance report 
described in Sec. 63.1260(f).

[[Page 50359]]

    (D) Depressurization. Emissions from depressurization shall be 
calculated using the procedures in either paragraphs (d)(2)(i)(D)(1) 
through (4), paragraphs (d)(2)(i)(D)(5) through (9), or paragraph 
(d)(2)(i)(D)(10) of this section.
    (1) Equations 21 and 22 of this subpart are used to calculate the 
initial and final volumes of noncondensable gas present in the vessel, 
adjusted to atmospheric pressure. The HAP partial pressures may be 
calculated using Raoult's law.
[GRAPHIC] [TIFF OMITTED] TR21SE98.018

[GRAPHIC] [TIFF OMITTED] TR21SE98.019

Where:

Vnc1 = initial volume of noncondensable gas in the vessel
Vnc2 = final volume of noncondensable gas in the vessel
V = free volume in the vessel being depressurized
Pnc1 = initial partial pressure of the noncondensable gas, 
as calculated using Equation 23 of this subpart, mmHg
Pnc2 = final partial pressure of the noncondensable gas, as 
calculated using Equation 24 of this subpart, mmHg
760 = atmospheric pressure, mmHg

    (2) The initial and final partial pressures of the noncondensable 
gas in the vessel are determined using Equations 23 and 24 of this 
subpart: 
[GRAPHIC] [TIFF OMITTED] TR21SE98.020

 [GRAPHIC] [TIFF OMITTED] TR21SE98.021

Where:
Pnc1 = initial partial pressure of the noncondensable gas
Pnc2 = final partial pressure of the noncondensable gas
P1 = initial vessel pressure
P2 = final vessel pressure
Pj* = vapor pressure of each condensable (including HAP) in 
the emission stream
xj = mole fraction of each condensable (including HAP) in 
the emission stream
m = number of condensable compounds (including HAP) in the emission 
stream
j = identifier for a condensable compound

(3) The average ratio of moles of noncondensable to moles of HAP is 
calculated using Equation 25 of this subpart: 
[GRAPHIC] [TIFF OMITTED] TR21SE98.022

Where:

nR = average ratio of moles of noncondensable to moles of 
HAP
Pnc1 = initial partial pressure of the noncondensable gas, 
as calculated using Equation 23 of this subpart
Pnc2 = final partial pressure of the noncondensable gas, as 
calculated using Equation 24 of this subpart
Pi* = vapor pressure of each individual HAP
xi = mole fraction of each individual HAP in the liquid 
phase
n = number of HAP compounds
i = identifier for a HAP compound

    (4) The mass of HAP emitted shall be calculated using Equation 26 
of this subpart: 
[GRAPHIC] [TIFF OMITTED] TR21SE98.023

Where:

E = mass of HAP emitted
Vnc1 = initial volume of noncondensable gas in the vessel, 
as calculated using Equation 21 of this subpart
Vnc2 = final volume of noncondensable gas in the vessel, as 
calculated using Equation 22 of this subpart nR = average 
ratio of moles of noncondensable to moles of HAP, as calculated using 
Equation 25 of this subpart
Patm = atmospheric pressure, standard
R = ideal gas law constant
T = temperature of the vessel, absolute
MWHAP = average molecular weight of the HAP, as calculated 
using Equation 17 of this subpart

    (5) The moles of HAP vapor initially in the vessel are calculated 
using the ideal gas law using Equation 27 of this subpart: 
[GRAPHIC] [TIFF OMITTED] TR21SE98.024

Where:

YHAP = mole fraction of HAP (the sum of the individual HAP 
fractions, Yi)
V = free volume in the vessel being depressurized
P1 = initial vessel pressure
R = ideal gas law constant
T = vessel temperature, absolute

    (6) The initial and final moles of noncondensable gas present in 
the vessel are calculated using Equations 28 and 29 of this subpart: 
[GRAPHIC] [TIFF OMITTED] TR21SE98.025

 [GRAPHIC] [TIFF OMITTED] TR21SE98.026

Where:

n1 = initial number of moles of noncondensable gas in the 
vessel
n2 = final number of moles of noncondensable gas in the 
vessel

[[Page 50360]]

V = free volume in the vessel being depressurized
Pnc1 = initial partial pressure of the noncondensable gas, 
as calculated using Equation 23 of this subpart
Pnc2 = final partial pressure of the noncondensable gas, as 
calculated using Equation 24 of this subpart
R = ideal gas law constant
T = temperature, absolute

    (7) The initial and final partial pressures of the noncondensable 
gas in the vessel are determined using Equations 23 and 24 of this 
subpart.
    (8) 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, using Equation 30 
of this subpart: 
where:
[GRAPHIC] [TIFF OMITTED] TR21SE98.027

nHAP = moles of HAP emitted
n1 = initial number of moles of noncondensable gas in the 
vessel, as calculated using Equation 28 of this subpart
n2 = final number of moles of noncondensable gas in the 
vessel, as calculated using Equation 29 of this subpart

    (9) The mass of HAP emitted can be calculated using Equation 31 of 
this subpart:

E =NHAP * MWHAP    (Eq. 31)

where:
E = mass of HAP emitted
nHAP = moles of HAP emitted, as calculated using Equation 30 
of this subpart
MWHAP = average molecular weight of the HAP as calculated 
using Equation 17 of this subpart

    (10) Emissions from depressurization may be calculated using 
Equation 32 of this subpart:
[GRAPHIC] [TIFF OMITTED] TR21SE98.028

where:

V = free volume in vessel being depressurized
R = ideal gas law constant
T = temperature of the vessel, absolute
P1 = initial pressure in the vessel
P2 = final pressure in the vessel
Pi = partial pressure of the individual HAP compounds
    MWi = molecular weight of the individual HAP compounds
n = number of HAP compounds in the emission stream
i = identifier for a HAP compound

    (E) Vacuum systems. Emissions from vacuum systems may be calculated 
using Equation 33 of this subpart if the air leakage rate is known or 
can be approximated.
[GRAPHIC] [TIFF OMITTED] TR21SE98.029

where:

E = mass of HAP emitted
Psystem = absolute pressure of receiving vessel or ejector 
outlet conditions, if there is no receiver
Pi* = vapor pressure of the HAP at the receiver temperature 
or the ejector outlet conditions
La = total air leak rate in the system, mass/time
MWnc = molecular weight of noncondensable gas
t = time of vacuum operation
MWHAP = average molecular weight of HAP in the emission 
stream, as calculated using Equation 17 of this subpart, with HAP 
partial pressures calculated at the temperature of the receiver or 
ejector outlet, as appropriate

    (F) Gas evolution. Emissions from gas evolution shall be calculated 
using Equation 12 of this subpart with V calculated using Equation 34 
of this subpart:
[GRAPHIC] [TIFF OMITTED] TR21SE98.030

Where:

V = volumetric flow rate of gas evolution
Wg = mass flow rate of gas evolution
R = ideal gas law constant
T = temperature at the exit, absolute
PT = vessel pressure
MWg = molecular weight of the evolved gas


[[Page 50361]]


    (G) Air drying. Emissions from air drying shall be calculated using 
Equation 35 of this subpart:
[GRAPHIC] [TIFF OMITTED] TR21SE98.031

Where:

E = mass of HAP emitted
B = mass of dry solids
PS1 = HAP in material entering dryer, weight percent
PS2 = HAP in material exiting dryer, weight percent

    (H) Empty vessel purging. Emissions from empty vessel purging shall 
be calculated using Equation (36) of this subpart (Note: The term -Ft/v 
can be assumed to be 1):
[GRAPHIC] [TIFF OMITTED] TR21SE98.032

Where:

V = volume of empty vessel
R = ideal gas law constant
T = temperature of the vessel vapor space; absolute
Pi = partial pressure of the individual HAP at the beginning 
of the purge
(MWi) = molecular weight of the individual HAP
F = flowrate of the purge gas
t = duration of the purge
n = number of HAP compounds in the emission stream
i = identifier for a HAP compound

    (ii) Engineering assessments. The owner or operator shall conduct 
an engineering assessment to calculate uncontrolled HAP emissions for 
each emission episode that is not due to vapor displacement, purging, 
heating, depressurization, vacuum operations, gas evolution, or air 
drying. For emission episodes caused by any of these types of 
activities, the owner or operator also may calculate uncontrolled HAP 
emissions based on an engineering assessment if the owner or operator 
can demonstrate to the Administrator that the methods in paragraph 
(d)(2)(i) of this section are not appropriate. One criterion the owner 
or operator could use to demonstrate that the methods in paragraph 
(d)(2)(i) of this section are not appropriate is if previous test data 
are available that show a greater than 20 percent discrepancy between 
the test value and the estimated value. An engineering assessment 
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 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. 63.1260(e). Data 
or other information supporting a finding that the emissions estimation 
equations are inappropriate shall be reported in the Precompliance 
report.
    (3) Controlled emissions. An owner or operator shall determine 
controlled emissions using the procedures in either paragraph (d)(3)(i) 
or (ii) of this section. For condensers, controlled emissions shall be 
calculated using the emission estimation equations described in 
paragraph (d)(3)(i)(B) of this section.
    (i) Small control devices. Except for condensers, controlled 
emissions for each process vent that is controlled using a small 
control device shall be determined by using the design evaluation 
described in paragraph (d)(3)(i)(A) of this section, or conducting a 
performance test in accordance with paragraph (d)(3)(ii) of this 
section. Whenever a small control device becomes a large control 
device, the owner or operator must comply with the provisions in 
paragraph (d)(3)(ii) of this section and submit the test report in the 
next Periodic report.
    (A) Design evaluation. The design evaluation shall include 
documentation demonstrating that the control device being used achieves 
the required control efficiency under worst-case conditions, as 
determined from the emission profile described in 
Sec. 63.1257(b)(8)(ii). The control efficiency determined from this 
design evaluation shall be applied to uncontrolled emissions to 
estimate controlled emissions. The documentation must be conducted in 
accordance with the provisions in paragraph (a)(1) of this section. The 
design evaluation shall also include the value(s) and basis for the 
parameter(s) monitored under Sec. 63.1258.
    (B) Emission estimation equations. An owner or operator using a 
condenser as a control device shall determine controlled emissions 
using exhaust gas temperature measurements and calculations for each 
batch emission episode within each unit operation according to the 
engineering methodology in paragraphs (d)(3)(i)(B)(1) through (8) of 
this section. Individual HAP partial pressures shall be calculated as 
specified in paragraph (d)(2)(i) of this section.
    (1) Emissions from vapor displacement shall be calculated using 
Equation 11 of this subpart with T set equal to the temperature of the 
receiver and the HAP partial pressures determined at the temperature of 
the receiver.
    (2) Emissions from purging shall be calculated using Equation 12 of 
this subpart with T set equal to the temperature of the receiver and 
the HAP partial pressures determined at the temperature of the 
receiver.

[[Page 50362]]

    (3) Emissions from heating shall be calculated using either 
Equation 13 of this subpart or Equation 37 of this subpart. In Equation 
13, the HAP vapor pressures shall be determined at the temperature of 
the receiver. In Equations 13 and 37 of this subpart, 
 is equal to the number of moles of noncondensable 
displaced from the vessel, as calculated using Equation 15 of this 
subpart. In Equations 13 and 37 of this subpart, the HAP average 
molecular weight shall be calculated using Equation 17 with the HAP 
partial pressures determined at the temperature of the receiver. 
[GRAPHIC] [TIFF OMITTED] TR21SE98.033

Where:

E = mass of HAP emitted
 = moles of noncondensable gas displaced
PT = pressure in the receiver
Pi = partial pressure of the individual HAP at the receiver 
temperature
Pj = partial pressure of the individual condensable 
(including HAP) at the receiver temperature
n = number of HAP compounds in the emission stream
i = identifier for a HAP compound
MWHAP = the average molecular weight of HAP in vapor exiting 
the receiver, as calculated using Equation 17 of this subpart
m = number of condensable compounds (including HAP) in the emission 
stream
    (4)(i) Emissions from depressurization shall be calculated using 
Equation 38 of this subpart. 
[GRAPHIC] [TIFF OMITTED] TR21SE98.034

Where:

E = mass of HAP vapor emitted
Vnc1 = initial volume of noncondensable in the vessel, 
corrected to the final pressure, as calculated using Equation 39 of 
this subpart
Vnc2 = final volume of noncondensable in the vessel, as 
calculated using Equation 40 of this subpart
Pi = partial pressure of each individual HAP at the receiver 
temperature
Pj = partial pressure of each condensable (including HAP) at 
the receiver temperature
PT = receiver pressure
T = temperature of the receiver
R = ideal gas law constant
MWHAP = the average molecular weight of HAP calculated using 
Equation 17 of this subpart with partial pressures determined at the 
receiver temperature
i = identifier for a HAP compound
n = number of HAP compounds in the emission stream
m = number of condensable compounds (including HAP) in the emission 
stream
j = identifier for a condensable compound

    (ii) The initial and final volumes of noncondensable gas present in 
the vessel, adjusted to the pressure of the receiver, are calculated 
using Equations 39 and 40 of this subpart. 
[GRAPHIC] [TIFF OMITTED] TR21SE98.035

[GRAPHIC] [TIFF OMITTED] TR21SE98.036

Where:

Vnc1 = initial volume of noncondensable gas in the vessel
Vnc2 = final volume of noncondensable gas in the vessel
V = free volume in the vessel being depressurized
Pnc1 = initial partial pressure of the noncondensable gas, 
as calculated using Equation 41 of this subpart
Pnc2 = final partial pressure of the noncondensable gas, as 
calculated using Equation 42 of this subpart
PT = pressure of the receiver

    (iii) Initial and final partial pressures of the noncondensable gas 
in the vessel are determined using Equations 41 and 42 of this subpart. 

[GRAPHIC] [TIFF OMITTED] TR21SE98.037

 [GRAPHIC] [TIFF OMITTED] TR21SE98.038

Where:

Pnc1 = initial partial pressure of the noncondensable gas in 
the vessel
Pnc2 = final partial pressure of the noncondensable gas in 
the vessel
P1 = initial vessel pressure
P2 = final vessel pressure
Pj = partial pressure of each condensable compound 
(including HAP) in the vessel
m = number of condensable compounds (including HAP) in the emission 
stream
j = identifier for a condensable compound

    (5) Emissions from vacuum systems shall be calculated using 
Equation 33 of this subpart.
    (6) Emissions from gas evolution shall be calculated using Equation 
12 with V calculated using Equation 34 of this subpart, T set equal to 
the receiver temperature, and the HAP partial pressures determined at 
the receiver temperature. The term for time, t, in Equation 12 of this 
subpart is not needed for the purposes of this calculation.
    (7) Emissions from air drying shall be calculated using Equation 11 
of this subpart with V equal to the air flow rate and Pi 
determined at the receiver temperature.
    (8) Emissions from empty vessel purging shall be calculated using 
equation 43 of this subpart: 

[[Page 50363]]

[GRAPHIC] [TIFF OMITTED] TR21SE98.039


Where:

V = volume of empty vessel
R = ideal gas law constant
T1 = temperature of the vessel vapor space at beginning of 
purge
T2 = temperature of the receiver, absolute
(Pi)T1 = partial pressure of the individual HAP 
at the beginning of the purge
(Pi)T2 = partial pressure of the individual HAP 
at the receiver temperature
MWi = molecular weight of the individual HAP
F = flowrate of the purge gas
t = duration of the purge
n = number of HAP compounds in the emission stream
i = identifier for a HAP compound

    (ii) Large control devices. Except for condensers, controlled 
emissions for each process vent that is controlled using a large 
control device shall be determined by applying the control efficiency 
of the large control device to the estimated uncontrolled emissions. 
The control efficiency shall be determined by conducting a performance 
test on the control device as described in paragraphs (d)(3)(ii)(A) 
through (C) of this section, or by using the results of a previous 
performance test as described in paragraph (d)(4) of this section. If 
the control device is intended to control only hydrogen halides and 
halogens, the owner or operator may assume the control efficiency of 
organic HAP is zero percent. If the control device is intended to 
control only organic HAP, the owner or operator may assume the control 
efficiency for hydrogen halides and halogen is zero percent. Owners and 
operators are not required to conduct performance tests for devices 
described in paragraphs (a)(4) and (d)(4) of this section that are 
large control devices, as defined in Sec. 63.1251.
    (A) The performance test shall be conducted by performing emission 
testing on the inlet and outlet, or, if complying with the provisions 
of Sec. 63.1254(c), on the outlet of the control device, following the 
test methods and procedures of Sec. 63.1257(b). Concentrations shall be 
calculated from the data obtained through emission testing according to 
the procedures in paragraph (a)(2) of this section. If the control 
device is a combustion device that uses supplemental combustion air, 
the concentrations shall be corrected to 3 percent oxygen according to 
the procedures in paragraph (a)(3) of this section.
    (B) Performance testing shall be conducted under absolute, or 
hypothetical worst-case conditions, as defined in paragraphs 
(b)(8)(i)(A) through (B) of this section.
    (C) The owner or operator may elect to conduct more than one 
performance test on the control device for the purpose of establishing 
more than one operating condition at which the control device achieves 
the required control efficiency.
    (4) 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 
specified in Sec. 63.1257(b) over conditions typical of the appropriate 
worst-case, as defined in Sec. 63.1257(b)(8)(i). The results of the 
previous performance test shall be used to demonstrate compliance.
    (e) Compliance with wastewater provisions. (1) Determining annual 
average concentration and annual load. To determine the annual average 
concentration and annual load of partially soluble and/or soluble HAP 
compounds in a wastewater stream, as required by Sec. 63.1256(a)(1), an 
owner or operator shall comply with the provisions in paragraphs 
(e)(1)(i) through (iii) of this section. A wastewater stream is exempt 
from the requirements of Sec. 63.1256(a)(2) if the owner or operator 
determines the annual average concentration and annual load are below 
all of the applicability cutoffs specified in Sec. 63.1256(a)(1)(i)(A) 
through (D). For annual average concentration, only initial rinses are 
included. Concentration measurements based on Method 305 shall be 
adjusted by dividing each concentration by the compound-specific Fm 
factor listed in Table 8 of this subpart. Concentration measurements 
based on methods other than Method 305 may not be adjusted by the 
compound-specific Fm factor listed in Table 8 of this subpart.
    (i) Annual average concentration definition. (A) When complying 
with Sec. 63.1256(a)(1)(i)(A), the annual average concentration means 
the total mass of partially soluble HAP compounds occurring in the 
wastewater stream during the calendar year divided by the total mass of 
the wastewater stream discharged during the same calendar year.
    (B) When complying with Sec. 63.1256(a)(1)(i) (B) or (C), the 
annual average concentration means the total mass of partially soluble 
and/or soluble HAP compounds occurring in the wastewater stream during 
the calendar year divided by the total mass of the wastewater stream 
discharged during the same calendar year.
    (C) When complying with Sec. 63.1256(a)(1)(i)(D), the annual 
average concentration means the total mass of soluble HAP compounds 
occurring in the wastewater stream during the calendar year divided by 
the total mass of the wastewater stream discharged during the same 
calendar year.
    (ii) Determination of annual average concentration. An owner or 
operator shall determine annual average concentrations of partially 
soluble and/or soluble HAP compounds in accordance with the provisions 
specified in paragraph (e)(1)(ii)(A), (B), or (C) of this section. The 
owner or operator may determine annual average concentrations by 
process simulation. Data and other information supporting the 
simulation shall be reported in the Precompliance Report for approval 
by the Administrator. The annual average concentration shall be 
determined either at the POD or downstream of the POD with adjustment 
for concentration changes made according to paragraph (e)(1)(ii)(D) of 
this section.
    (A) Test methods. The concentration of partially soluble HAP, 
soluble HAP, or total HAP shall be measured using any of the methods 
described in paragraphs (b)(10)(i) through (iv) of this section.
    (B) Knowledge of the wastewater stream. The concentration of 
partially soluble HAP, soluble HAP, or total HAP shall be calculated 
based on knowledge of the wastewater stream according to the procedures 
in paragraphs (e)(1)(ii)(B)(1) and (2) of this section. The owner or 
operator shall document concentrations in the Notification of 
Compliance Status report described in Sec. 63.1260(f).

[[Page 50364]]

    (1) Mass balance. The owner or operator shall calculate the 
concentrations of HAP compounds in wastewater considering the total 
quantity of HAP discharged to the water, the amount of water at the 
POD, and the amounts of water and solvent lost to other mechanisms such 
as reactions, air emissions, or uptake in product or other processing 
materials. The quantities of HAP and water shall be based on batch 
sheets, manufacturing tickets, or FDA bills of materials. In cases 
where a chemical reaction occurs that generates or consumes HAP, the 
amount of HAP remaining after a reaction shall be based on stoichometry 
assuming 100 percent theoretical consumption or yield, as applicable.
    (2) Published water solubility data. For single components in 
water, owners and operators may use the water solubilities published in 
standard reference texts at the POD temperature to determine maximum 
HAP concentration.
    (C) Bench scale or pilot-scale test data. 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. Documentation of the pilot-scale 
or bench scale analysis shall be provided in the precompliance report.
    (D) Adjustment for concentrations determined downstream of the POD. 
The owner or operator shall make corrections to the annual average 
concentration when the concentration is determined downstream of the 
POD at a location where: two or more wastewater streams have been 
mixed; one or more wastewater streams have been treated; or, losses to 
the atmosphere have occurred. The owner or operator shall make the 
adjustments either to the individual data points or to the final annual 
average concentration.
    (iii) Determination of annual load. An owner or operator shall 
calculate the partially soluble and/or soluble HAP load in a wastewater 
stream based on the annual average concentration determined in 
paragraph (e)(1)(ii) (A), (B), or (C) of this section and the total 
volume of the wastewater stream, based on knowledge of the wastewater 
stream in accordance with paragraphs (e)(1)(ii)(B) of this section. The 
owner or operator shall maintain records of the total liters of 
wastewater discharged per year as specified in Sec. 63.1259(b).
    (2) Compliance with treatment unit control provisions. (i) 
Performance tests and design evaluations-general. To comply with the 
control options in Sec. 63.1256(g) (10) or (13), neither a design 
evaluation nor a performance test is required. For any other 
nonbiological treatment process, the owner or operator shall conduct 
either a design evaluation as specified in paragraph (e)(2)(ii) of this 
section, or a performance test as specified in paragraph (e)(2)(iii) of 
this section to demonstrate that each nonbiological treatment process 
used to comply with Sec. 63.1256(g) (8), (9), and/or (12) achieves the 
conditions specified for compliance. The owner or operator shall 
demonstrate by the procedures in either paragraph (e)(2) (ii) or (iii) 
of this section that each closed biological treatment process used to 
comply with Sec. 63.1256 (g)(8)(ii), (g)(9)(ii), (g)(11), or (g)(12) 
achieves the conditions specified for compliance. If an open biological 
treatment unit is used to comply with Sec. 63.1256 (g)(8)(ii), 
(g)(9)(ii), (g)(11), or (g)(12), the owner or operator shall comply 
with the performance test requirements in paragraph (e)(2)(iii) of this 
section.
    (ii) Design evaluation. A design evaluation and supporting 
documentation that addresses the operating characteristics of the 
treatment process and that is based on operation at a wastewater stream 
flow rate and a concentration under which it would be most difficult to 
demonstrate compliance. For closed biological treatment processes, the 
percent reduction from removal/destruction in the treatment unit and 
control device shall be determined by a mass balance over the unit. The 
mass flow rate of soluble and/or partially soluble HAP compounds 
exiting the treatment process shall be the sum of the mass flow rate of 
soluble and/or partially soluble HAP compounds in the wastewater stream 
exiting the biological treatment process and the mass flow rate of the 
vented gas stream exiting the control device. The mass flow rate 
entering the treatment process minus the mass flow rate exiting the 
process determines the actual mass removal. Compounds that meet the 
requirements specified in paragraph (e)(2)(iii)(A)(4) of this section 
are not required to be included in the design evaluation; the term 
``performance test'' in paragraph (e)(2)(iii)(A)(4) of this section 
shall mean ``design evaluation'' for the purposes of this paragraph.
    (iii) Performance tests. Performance tests shall be conducted using 
test methods and procedures that meet the applicable requirements 
specified in paragraphs (e)(2)(iii)(A) through (G) of this section.
    (A) General. This paragraph specifies the general procedures for 
performance tests that are conducted to demonstrate compliance of a 
treatment process with the control requirements specified in 
Sec. 63.1256(g).
    (1) Representative process unit operating conditions. Compliance 
shall be demonstrated for representative operating conditions. 
Operations during periods of malfunction and periods of nonoperation 
shall not constitute representative conditions. The owner or operator 
shall record the process information that is necessary to document 
operating conditions during the test.
    (2) Representative treatment process operating conditions. 
Performance tests shall be conducted when the treatment process is 
operating at a representative inlet flow rate and concentration. If the 
treatment process will be operating at several different sets of 
representative operating conditions, the owner or operator shall comply 
with paragraphs (e)(2)(iii)(A)(2)(i) and (ii) of this section. The 
owner or operator shall record information that is necessary to 
document treatment process or control device operating conditions 
during the test.
    (i) Range of operating conditions. If the treatment process will be 
operated at several different sets of representative operating 
conditions, performance testing over the entire range is not required. 
In such cases, the performance test results shall be supplemented with 
modeling and/or engineering assessments to demonstrate performance over 
the operating range.
    (ii) Consideration of residence time. If concentration and/or flow 
rate to the treatment process are not relatively constant (i.e., 
comparison of inlet and outlet data will not be representative of 
performance), the owner or operator shall consider residence time, when 
determining concentration and flow rate.
    (3) Testing equipment. All testing equipment shall be prepared and 
installed as specified in the applicable test methods, or as approved 
by the Administrator.
    (4) Compounds not required to be considered in performance tests. 
Compounds that meet the requirements specified in (e)(2)(iii)(A)(4)(i), 
(ii), or (iii) of this section are not required to be included in the 
performance test. Concentration measurements based on

[[Page 50365]]

Method 305 shall be adjusted by dividing each concentration by the 
compound-specific Fm factor listed in Table 8 of this subpart. 
Concentration measurements based on methods other than Method 305 shall 
not be adjusted by the compound-specific Fm factor listed in Table 8 of 
this subpart.
    (i) Compounds not used or produced by the PMPU; or
    (ii) Compounds with concentrations at the POD that are below 1 
ppmw; or
    (iii) Compounds with concentrations at the POD that are below the 
lower detection limit where the lower detection limit is greater than 1 
ppmw. The method shall be an analytical method for wastewater which has 
the compound of interest as a target analyte.
    (5) Treatment using a series of treatment processes. In all cases 
where the wastewater provisions in this subpart allow or require the 
use of a treatment process to comply with emissions limitations, the 
owner or operator may use multiple treatment processes. The owner or 
operator complying with the requirements of Sec. 63.1256(g)(7)(i), when 
wastewater is conveyed by hard-piping, shall comply with either 
paragraph (e)(2)(iii)(A)(5)(i) or (ii) of this section. The owner or 
operator complying with the requirements of Sec. 63.1256(g)(7)(ii) 
shall comply with the requirements of paragraph (e)(2)(iii)(A)(5)(ii) 
of this section.
    (i) The owner or operator shall conduct the performance test across 
each series of treatment processes. For each series of treatment 
processes, inlet concentration and flow rate shall be measured either 
where the wastewater enters the first treatment process in a series of 
treatment processes, or prior to the first treatment process as 
specified in paragraph (e)(2)(iii)(A)(6) of this section. For each 
series of treatment processes, outlet concentration and flow rate shall 
be measured where the wastewater exits the last treatment process in 
the series of treatment processes, except when the last treatment 
process is an open or a closed aerobic biological treatment process 
demonstrating compliance by using the procedures in paragraphs 
(e)(2)(iii)(E) or (F) of this section. When the last treatment process 
is either an open or a closed aerobic biological treatment process 
demonstrating compliance by using the procedures in paragraphs 
(e)(2)(iii)(E) or (F) of this section, inlet and outlet concentrations 
and flow rates shall be measured at the inlet and outlet to the series 
of treatment processes prior to the biological treatment process and at 
the inlet to the biological treatment process, except as provided in 
paragraph (e)(2)(iii)(A)(6)(ii) of this section. The mass flow rate 
destroyed in the biological treatment process for which compliance is 
demonstrated using paragraph (e)(2)(iii)(E) or (F) of this section 
shall be added to the mass flow rate removed or destroyed in the series 
of treatment units before the biological treatment unit. This sum shall 
be used to calculate the overall control efficiency.
    (ii) The owner or operator shall conduct the performance test 
across each treatment process in the series of treatment processes. The 
mass flow rate removed or destroyed by each treatment process shall be 
added together and the overall control efficiency calculated to 
determine whether compliance has been demonstrated using paragraphs 
(e)(2)(iii)(C), (D), (E), (F), or (G) of this section, as applicable. 
If a biological treatment process is one of the treatment processes in 
the series of treatment processes, the inlet to the biological 
treatment process shall be the point at which the wastewater enters the 
biological treatment process, or the inlet to the equalization tank if 
all the criteria of paragraph (e)(2)(iii)(A)(6)(ii) of this section are 
met.
    (6) The owner or operator determining the inlet for purposes of 
demonstrating compliance with paragraph (e)(2)(iii)(E), or (F)of this 
section may elect to comply with paragraph (e)(2)(iii)(A)(6)(i) or (ii) 
of this section.
    (i) When wastewater is conveyed exclusively by hard-piping from the 
point of determination to a treatment process that is either the only 
treatment process or the first in a series of treatment processes 
(i.e., no treatment processes or other waste management units are used 
upstream of this treatment process to store, handle, or convey the 
wastewater), the inlet to the treatment process shall be at any 
location from the point of determination to where the wastewater stream 
enters the treatment process. When samples are taken upstream of the 
treatment process and before wastewater streams have converged, the 
owner or operator shall ensure that the mass flow rate of all affected 
wastewater is accounted for when using Sec. 63.1256(g)(8)(ii), 
(g)(9)(ii) or (g)(12) of this subpart to comply and that the mass flow 
rate of all wastewater, not just affected wastewater, is accounted for 
when using Sec. 63.1256(g)(11) to comply, except as provided in 
paragraph (e)(2)(iii)(A)(4) of this section.
    (ii) The owner or operator may consider the inlet to the 
equalization tank as the inlet to the biological treatment process if 
the wastewater is conveyed by hard-piping from either the last previous 
treatment process or the point of determination to the equalization 
tank; or the wastewater is conveyed from the equalization tank 
exclusively by hard-piping to the biological treatment process and no 
treatment processes or other waste management units are used to store, 
handle, or convey the wastewater between the equalization tank and the 
biological treatment process; or the equalization tank is equipped with 
a fixed roof and a closed-vent system that routes emissions to a 
control device that meets the requirements of Sec. 63.1256(b)(1)(i) 
through (iv) and Sec. 63.1256(b)(2)(i). The outlet from the series of 
treatment processes prior to the biological treatment process is the 
point at which the wastewater exits the last treatment process in the 
series prior to the equalization tank, if the equalization tank and 
biological treatment process are part of a series of treatment 
processes. The owner or operator shall ensure that the mass flow rate 
of all affected wastewater is accounted for when using 
Sec. 63.1256(g)(9)(ii) or (12) to comply and that the mass flow rate of 
all wastewater, not just affected wastewater is accounted for when 
using Sec. 63.1256(g)(11) to comply, except as provided in paragraph 
(e)(2)(iii)(A)(4) of this section.
    (B) Noncombustion treatment process--concentration limits. This 
paragraph applies to performance tests that are conducted to 
demonstrate compliance of a noncombustion treatment process with the 
ppmw wastewater stream concentration limits at the outlet of the 
treatment process. This compliance option is specified in 
Sec. 63.1256(g)(8)(i) and (9)(i). Wastewater samples shall be collected 
using sampling procedures which minimize loss of organic compounds 
during sample collection and analysis and maintain sample integrity per 
paragraph (b)(10)(iii) of this section. Samples shall be collected and 
analyzed using the procedures specified in paragraphs (b)(10)(i), (ii), 
and (iii) of this section. Samples may be grab samples or composite 
samples. Samples shall be taken at approximately equally spaced time 
intervals over a 1-hour period. Each 1-hour period constitutes a run, 
and the performance test shall consist of a minimum of three runs. 
Concentration measurements based on methods other than Method 305 may 
be adjusted by multiplying each concentration by the compound-specific 
Fm factor listed in Table 8 of this subpart. (For affected wastewater 
streams that contains both partially soluble and soluble HAP compounds, 
compliance is

[[Page 50366]]

demonstrated only if the sum of the concentrations of partially soluble 
HAP compounds is less than 50 ppmw, and the sum of the concentrations 
of soluble HAP compounds is less than 520 ppmw.)
    (C) Noncombustion, nonbiological treatment process: percent mass 
removal/destruction option. This paragraph applies to performance tests 
that are conducted to demonstrate compliance of a noncombustion, 
nonbiological treatment process with the percent mass removal limits 
specified in Sec. 63.1256(g)(8)(ii) and (9)(ii) for partially soluble 
and soluble HAP compounds, respectively. The owner or operator shall 
comply with the requirements specified in paragraphs (e)(2)(iii)(C)(1) 
through (5) of this section.
    (1) Concentration. The concentration of partially soluble and/or 
soluble HAP compounds entering and exiting the treatment process shall 
be determined as provided in this paragraph. Wastewater samples shall 
be collected using sampling procedures which minimize loss of organic 
compounds during sample collection and analysis and maintain sample 
integrity per paragraph (b)(10)(v) of this section. The method shall be 
an analytical method for wastewater which has the compound of interest 
as a target analyte. Samples may be grab samples or composite samples. 
Samples shall be taken at approximately equally spaced time intervals 
over a 1-hour period. Each 1-hour period constitutes a run, and the 
performance test shall consist of a minimum of three runs. 
Concentration measurements based on Method 305 shall be adjusted by 
dividing each concentration by the compound-specific Fm factor listed 
in Table 8 of this subpart. Concentration measurements based on methods 
other than Method 305 shall not be adjusted by the compound-specific Fm 
factor listed in Table 8 of this subpart.
    (2) Flow rate. The flow rate of the entering and exiting wastewater 
streams shall be determined using inlet and outlet flow meters, 
respectively. Where the outlet flow is not greater than the inlet flow, 
a single flow meter may be used, and may be used at either the inlet or 
outlet. Flow rate measurements shall be taken at the same time as the 
concentration measurements.
    (3) Calculation of mass flow rate--for noncombustion, nonbiological 
treatment processes. The mass flow rates of partially soluble and/or 
soluble HAP compounds entering and exiting the treatment process are 
calculated using Equations 44 and 45 of this subpart.
[GRAPHIC] [TIFF OMITTED] TR21SE98.040

[GRAPHIC] [TIFF OMITTED] TR21SE98.041

Where:

QMWa, QMWb = mass flow rate of partially soluble 
or soluble HAP compounds, average of all runs, in wastewater entering 
(QMWa) or exiting (QMWb) the treatment process, 
kg/hr
 = density of the wastewater, kg/m3
Qa,k, Qbb,k = volumetric flow rate of wastewater 
entering (Qa,k) or exiting (Qb,k) the treatment 
process during each run k, m3/hr
CT,a,k, CT,b,k = total concentration of partially 
soluble or soluble HAP compounds in wastewater entering 
(CT,a,k) or exiting (CT,b,k) the treatment 
process during each run k, ppmw
p = number of runs
k = identifier for a run
106 = conversion factor, mg/kg

    (4) Percent removal calculation for mass flow rate. The percent 
mass removal across the treatment process shall be calculated as 
follows:
[GRAPHIC] [TIFF OMITTED] TR21SE98.042

Where:

E = removal or destruction efficiency of the treatment process, percent
QMWa, QMWb = mass flow rate of partially soluble 
or soluble HAP compounds in wastewater entering (QMWa) and 
exiting (QMWb) the treatment process, kg/hr (as calculated 
using Equations 44 and 45 of this subpart)

    (5) Compare mass removal efficiency to required efficiency. Compare 
the mass removal efficiency (calculated in Equation 44 of this subpart) 
to the required efficiency as specified in Sec. 63.1256(g)(8)(ii) or 
(9)(ii). If complying with Sec. 63.1256(g)(8)(ii), compliance is 
demonstrated if the mass removal efficiency is 99 percent or greater. 
If complying with Sec. 63.1256(g)(9)(ii), compliance is demonstrated if 
the mass removal efficiency is 90 percent or greater.
    (D) Combustion treatment processes: percent mass removal/
destruction option. This paragraph applies to performance tests that 
are conducted to demonstrate compliance of a combustion treatment 
process with the percent mass destruction limits specified in 
Sec. 63.1256(g)(8)(ii) for partially soluble HAP compounds, and/or 
Sec. 63.1256(g)(9)(ii) for soluble HAP compounds. The owner or operator 
shall comply with the requirements specified in paragraphs 
(e)(2)(iii)(D)(1) through (8) of this section.
    (1) Concentration in wastewater stream entering the combustion 
treatment process. The concentration of partially soluble and/or 
soluble HAP compounds entering the treatment process shall be 
determined as provided in this paragraph. Wastewater samples shall be 
collected using sampling procedures which minimize loss of organic 
compounds during sample collection and analysis and maintain sample 
integrity per paragraph (b)(10)(v) of this section. The method shall be 
an analytical method for wastewater which has the compound of interest 
as a target analyte. Samples may be grab samples or composite samples. 
Samples shall be taken at approximately equally spaced time intervals 
over a 1-hour period. Each 1-hour period constitutes a run, and the 
performance test shall consist of a minimum of three runs. 
Concentration measurements based on Method 305 of appendix A of this 
part shall be adjusted by dividing each concentration by the compound-
specific Fm factor listed in Table 8 of this subpart. Concentration 
measurements based on methods other than Method 305 shall not be 
adjusted by the compound-specific Fm factor listed in Table 8 of this 
subpart.

[[Page 50367]]

    (2) Flow rate of wastewater entering the combustion treatment 
process. The flow rate of the wastewater stream entering the combustion 
treatment process shall be determined using an inlet flow meter. Flow 
rate measurements shall be taken at the same time as the concentration 
measurements.
    (3) Calculation of mass flow rate in wastewater stream entering 
combustion treatment processes. The mass flow rate of partially soluble 
and/or soluble HAP compounds entering the treatment process is 
calculated as follows:
[GRAPHIC] [TIFF OMITTED] TR21SE98.043

Where:

QMWa = mass flow rate of partially soluble or soluble HAP 
compounds entering the combustion unit, kg/hr
= density of the wastewater stream, kg/m3
Qa,k = volumetric flow rate of wastewater entering the 
combustion unit during run k, m3/hr
CT,a,k = total concentration of partially soluble or soluble 
HAP compounds in the wastewater stream entering the combustion unit 
during run k, ppmw
 = number of runs
k = identifier for a run

    (4) Concentration in vented gas stream exiting the combustion 
treatment process. The concentration of partially soluble and/or 
soluble HAP compounds (or TOC) exiting the combustion treatment process 
in any vented gas stream shall be determined as provided in this 
paragraph. Samples may be grab samples or composite samples. Samples 
shall be taken at approximately equally spaced time intervals over a 1-
hour period. Each 1-hour period constitutes a run, and the performance 
test shall consist of a minimum of three runs. Concentration 
measurements shall be determined using Method 18 of 40 CFR part 60, 
appendix A. Alternatively, any other test method validated according to 
the procedures in Method 301 of appendix A of this part may be used.
    (5) Volumetric flow rate of vented gas stream exiting the 
combustion treatment process. The volumetric flow rate of the vented 
gas stream exiting the combustion treatment process shall be determined 
using Method 2, 2A, 2C, or 2D of 40 CFR part 60, appendix A, as 
appropriate. Volumetric flow rate measurements shall be taken at the 
same time as the concentration measurements.
    (6) Calculation of mass flow rate of vented gas stream exiting 
combustion treatment processes. The mass flow rate of partially soluble 
and/or soluble HAP compounds in a vented gas stream exiting the 
combustion treatment process shall be calculated as follows:
[GRAPHIC] [TIFF OMITTED] TR21SE98.044

where:

QMGb = mass rate of TOC (minus methane and ethane) or total 
partially soluble and/or soluble HAP, in vented gas stream, exiting 
(QMGb) the combustion device, dry basis, kg/hr
CGb,i = concentration of TOC (minus methane and ethane) or 
total partially soluble and/or soluble HAP, in vented gas stream, 
exiting (CGb,i) the combustion device, dry basis, ppmv
MWi = molecular weight of a component, kilogram/kilogram-
mole
QGb = flow rate of gas stream exiting (QGb) the 
combustion device, dry standard cubic meters per hour
K2 = constant, 41.57 x 10-9 (parts per 
million)-1 (gram-mole per standard cubic meter) (kilogram/
gram), where standard temperature (gram-mole per standard cubic meter) 
is 20 deg.C
i = identifier for a compound
n = number of components in the sample

    (7) Destruction efficiency calculation. The destruction efficiency 
of the combustion unit for partially soluble and/or soluble HAP 
compounds shall be calculated as follows:
[GRAPHIC] [TIFF OMITTED] TR21SE98.045

Where:

E = destruction efficiency of partially soluble or soluble HAP 
compounds for the combustion unit, percent
QMW2a = mass flow rate of partially soluble or soluble HAP 
compounds entering the combustion unit, kg/hr
QMGb = mass flow rate of TOC (minus methane and ethane) or 
partially soluble and/or soluble HAP compounds in vented gas stream 
exiting the combustion treatment process, kg/hr
    (8) Compare mass destruction efficiency to required efficiency. 
Compare the mass destruction efficiency (calculated in Equation 49 of 
this subpart) to the required efficiency as specified in 
Sec. 63.1256(g)(8)(ii) or (g)(9)(ii). If complying with 
Sec. 63.1256(g)(8)(ii), compliance is demonstrated if the mass 
destruction efficiency is 99 percent or greater. If complying with 
Sec. 63.1256(g)(9)(ii), compliance is demonstrated if the mass 
destruction efficiency is 90 percent or greater.
    (E) Open or closed aerobic biological treatment processes: 95-
percent mass destruction option. This paragraph applies to performance 
tests that are conducted for open or closed aerobic biological 
treatment processes to demonstrate compliance with the 95-percent mass 
destruction provisions in Sec. 63.1256(g)(11) for partially soluble 
and/or soluble HAP compounds.
    (1) Concentration in wastewater stream. The concentration of 
partially soluble and/or soluble HAP as provided in this paragraph. 
Concentration measurements to determine E shall be taken as provided in 
paragraph (e)(2)(iii)(A)(5) of this section for a series of treatment 
processes. Wastewater samples shall be collected using sampling 
procedures which minimize loss of organic compounds during sample 
collection and analysis and maintain sample integrity per paragraph 
(b)(10)(v) of this section. The method shall be an analytical method 
for wastewater which has the compound of interest as a target analyte. 
Samples may

[[Page 50368]]

be grab samples or composite samples. Samples shall be taken at 
approximately equally spaced time intervals over a 1-hour period. Each 
1-hour period constitutes a run, and the performance test shall consist 
of a minimum of three runs. Concentration measurements based on Method 
305 shall be adjusted by dividing each concentration by the compound-
specific Fm factor listed in Table 8 of this subpart. Concentration 
measurements based on methods other than Method 305 shall not be 
adjusted by the compound-specific Fm factor listed in Table 8 of this 
subpart.
    (2) Flow rate. Flow rate measurements to determine E shall be taken 
as provided in paragraph (e)(2)(iii)(A)(5) of this section for a series 
of treatment processes. Flow rate shall be determined using inlet and 
outlet flow measurement devices. Where the outlet flow is not greater 
than the inlet flow, a single flow measurement device may be used, and 
may be used at either the inlet or outlet. Flow rate measurements shall 
be taken at the same time as the concentration measurements.
    (3) Destruction efficiency. The owner or operator shall comply with 
the provisions in either paragraph (e)(2)(iii)(E)(3)(i), (ii) or (iii) 
of this section. Compliance is demonstrated if the destruction 
efficiency, E, is equal to or greater than 95 percent.
    (i) If the performance test is performed across the open or closed 
biological treatment system only, compliance is demonstrated if E is 
equal to Fbio, where E is the destruction efficiency of 
partially soluble and/or soluble HAP compounds and Fbio is 
the site-specific fraction of partially soluble and/or soluble HAP 
compounds biodegraded. Fbio shall be determined as specified 
in paragraph (e)(2)(iii)(E)(4) of this section and appendix C of 
subpart G of this part.
    (ii) If compliance is being demonstrated in accordance with 
paragraphs (e)(2)(iii)(A)(5)(i) or (ii) of this section, the removal 
efficiency shall be calculated using Equation 49 of this subpart. When 
complying with paragraph (e)(2)(iii)(A)(5)(i) of this section, the 
series of nonbiological treatment processes comprise one treatment 
process segment. When complying with paragraph (e)(2)(iii)(A)(5)(ii) of 
this section, each nonbiological treatment process is a treatment 
process segment.
[GRAPHIC] [TIFF OMITTED] TR21SE98.046

Where:

QMWa,i = the soluble and/or partially soluble HAP load 
entering a treatment process segment
QMWb,i = the soluble and/or partially soluble HAP load 
exiting a treatment process segment
n = the number of treatment process segments
i = identifier for a treatment process element
QMWbio = the inlet load of soluble and/or partially soluble 
HAP to the biological treatment process. The inlet is defined in 
accordance with paragraph (e)(2)(iii)(A)(6) of this section. If 
complying with paragraph (e)(2)(iii)(A)(6)(ii) of this section, 
QMWbio is equal to QMWb,n
Fbio = site-specific fraction of soluble and/or partially 
soluble HAP compounds biodegraded. Fbio shall be determined 
as specified in paragraph (e)(2)(iii)(E)(4) of this section and 
Appendix C of subpart G of this part.
QMWall = the total soluble and/or partially soluble HAP load 
to be treated.

    (4) Site-specific fraction biodegraded (Fbio). The 
procedures used to determine the compound-specific kinetic parameters 
for use in calculating Fbio differ for the compounds listed 
in Tables 2 and 3 of this subpart. An owner or operator shall calculate 
Fbio as specified in either paragraph (e)(2)(iii)(E)(4)(i) 
or (ii) of this section.
    (i) For biological treatment processes that do not meet the 
definition for enhanced biological treatment in Sec. 63.1251, the owner 
or operator shall determine the Fbio for the compounds in 
Tables 2 and 3 of this subpart using any of the procedures in appendix 
C to part 63, except procedure 3 (inlet and outlet concentration 
measurements). (The symbol ``Fbio'' represents the site-
specific fraction of an individual partially soluble or soluble HAP 
compound that is biodegraded.)
    (ii) If the biological treatment process meets the definition of 
``enhanced biological treatment process'' in Sec. 63.1251, the owner or 
operator shall determine Fbio for the compounds in Table 2 
of this subpart using any of the procedures specified in appendix C to 
part 63. The owner or operator shall calculate Fbio for the 
compounds in Table 3 of this subpart using the defaults for first order 
biodegradation rate constants (K1) in Table 9 of this 
subpart and follow the procedure explained in Form III of appendix C, 
40 CFR part 63, or any of the procedures specified in appendix C of 40 
CFR part 63.
    (F) Open or closed aerobic biological treatment processes: percent 
removal for partially soluble or soluble HAP compounds. This paragraph 
applies to the use of performance tests that are conducted for open or 
closed aerobic biological treatment processes to demonstrate compliance 
with the percent removal provisions for either partially soluble HAP 
compounds in Sec. 63.1256(g)(8)(ii) or soluble HAP compounds in 
Sec. 63.1256(g)(9)(ii) or (g)(12). The owner or operator shall comply 
with the provisions in paragraph (e)(2)(iii)(E) of this section, except 
that compliance with Sec. 63.1256(g)(8)(ii) shall be demonstrated when 
E is equal to or greater than 99 percent, compliance with 
Sec. 63.1256(g)(9)(ii) shall be demonstrated when E is equal to or 
greater than 90 percent, and compliance with Sec. 63.1256(g)(12) shall 
be demonstrated when E is equal to or greater than 99 percent.
    (G) Closed biological treatment processes: percent mass removal 
option. This paragraph applies to the use of performance tests that are 
conducted for closed biological treatment processes to demonstrate 
compliance with the percent removal provisions in 
Secs. 63.1256(g)(8)(ii), (g)(9)(ii), (g)(11), or (g)(12). The owner or 
operator shall comply with the requirements specified in paragraphs 
(e)(2)(iii)(G) (1) through (4) of this section.
    (1) Comply with the procedures specified in paragraphs 
(e)(2)(iii)(C) (1) through (3) of this section to determine 
characteristics of the wastewater entering the biological treatment 
unit, except that the term ``partially soluble and/or soluble HAP'' 
shall mean ``soluble HAP'' for the purposes of this section if the 
owner or operator is complying with Sec. 63.1256(g)(9)(ii) or (g)(12), 
and it shall mean ``partially

[[Page 50369]]

soluble HAP'' if the owner or operator is complying with 
Sec. 63.1256(g)(8)(ii).
    (2) Comply with the procedures specified in paragraphs 
(e)(2)(iii)(D) (4) through (6) of this section to determine the 
characteristics of gas vent streams exiting a control device, with the 
differences noted in paragraphs (e)(2)(iii)(G)(3) (i) and (ii) of this 
section.
    (i) The term ``partially soluble and/or soluble HAP'' shall mean 
``soluble HAP'' for the purposes of this section if the owner or 
operator is complying with Sec. 63.1256(g)(9)(ii) or (g)(12), and it 
shall mean ``partially soluble HAP'' if the owner or operator is 
complying with Sec. 63.1256(g)(8)(ii).
    (ii) The term ``combustion treatment process'' shall mean ``control 
device'' for the purposes of this section.
    (3) Percent removal/destruction calculation. The percent removal 
and destruction across the treatment unit and any control device(s) 
shall be calculated using Equation 51 of this subpart:
[GRAPHIC] [TIFF OMITTED] TR21SE98.047

Where:

E = removal and destruction efficiency of the treatment unit and 
control device(s), percent
QMWa, QMWb = mass flow rate of partially soluble 
or soluble HAP compounds in wastewater entering (QMWa) and 
exiting (QMWb) the treatment process, kilograms per hour (as 
calculated using Equations WW1 and WW2)
QMGb = mass flow rate of partially soluble or soluble HAP 
compounds in vented gas stream exiting the combustion treatment 
process, kg/hr

    (4) Compare mass removal/destruction efficiency to required 
efficiency. Compare the mass removal/destruction efficiency (calculated 
using Equation 51 of this subpart) to the required efficiency as 
specified in Sec. 63.1256(g)(8)(ii), (g)(9)(ii), (g)(11), or (g)(12). 
If complying with Sec. 63.1256(g)(8)(ii), compliance is demonstrated if 
the mass removal/destruction is 99 percent or greater. If complying 
with Sec. 63.1256(g)(9)(ii), compliance is demonstrated if the mass 
removal/destruction efficiency is 90 percent or greater. If complying 
with Sec. 63.1256(g)(11), compliance is demonstrated if the mass 
removal/destruction efficiency is 95 percent or greater. If complying 
with Sec. 63.1256(g)(12), compliance is demonstrated if the mass 
removal/destruction efficiency is 99 percent or greater.
    (3) Compliance with control device provisions. Except as provided 
in paragraph (e)(3)(iv) of this section, an owner or operator shall 
demonstrate that each control device or combination of control devices 
achieves the appropriate conditions specified in Sec. 63.1256(h)(2) by 
using one or more of the methods specified in paragraphs (e)(3)(i), 
(ii), or (iii) of this section.
    (i) Performance test for control devices other than flares. This 
paragraph applies to performance tests that are conducted to 
demonstrate compliance of a control device with the efficiency limits 
specified in Sec. 63.1256(h)(2). If complying with the 95-percent 
reduction efficiency requirement, comply with the requirements 
specified in paragraphs (e)(3)(i) (A) through (J) of this section. If 
complying with the 20 ppm by volume requirement, comply with the 
requirements specified in paragraphs (e)(3)(i) (A) through (G) and 
(e)(3)(i)(J) of this section.
    (A) General. The owner or operator shall comply with the general 
performance test provisions in paragraphs (e)(2)(iii)(A) (1) through 
(4) of this section, except that the term ``treatment unit'' shall mean 
``control device'' for the purposes of this section.
    (B) Sampling sites. Sampling sites shall be selected using Method 1 
or 1A of 40 CFR part 60, appendix A, as appropriate. For determination 
of compliance with the 95 percent reduction requirement, sampling sites 
shall be located at the inlet and the outlet of the control device. For 
determination of compliance with the 20 ppmv limit, the sampling site 
shall be located at the outlet of the control device.
    (C) Concentration in gas stream entering or exiting the control 
device. The concentration of total organic HAP or TOC in a gas stream 
shall be determined as provided in this paragraph. Samples may be grab 
samples or composite samples (i.e., integrated samples). Samples shall 
be taken at approximately equally spaced time intervals over a 1-hour 
period. Each 1-hour period constitutes a run, and the performance test 
shall consist of a minimum of three runs. Concentration measurements 
shall be determined using Method 18 of 40 CFR part 60, appendix A. 
Alternatively, any other test method validated according to the 
procedures in Method 301 of appendix A of this part may be used.
    (D) Volumetric flow rate of gas stream entering or exiting the 
control device. The volumetric flow rate of the gas stream shall be 
determined using Method 2, 2A, 2C, or 2D of 40 CFR part 60, appendix A, 
as appropriate. Volumetric flow rate measurements shall be taken at the 
same time as the concentration measurements.
    (E) Calculation of TOC concentration. The owner or operator shall 
compute TOC in accordance with the procedures in paragraph (a)(2) of 
this section.
    (F) Calculation of total organic HAP concentration. The owner or 
operator determining compliance based on total organic HAP 
concentration shall compute the total organic HAP concentration in 
accordance with the provisions in paragraph (a)(2) of this section.
    (G) Requirements for combustion control devices. If the control 
device is a combustion device, the owner or operator shall correct TOC 
and organic HAP concentrations to 3 percent oxygen in accordance with 
the provisions in paragraph (a)(3) of this section, and demonstrate 
initial compliance with the requirements for halogenated streams in 
accordance with paragraph (a)(6) of this section.
    (H) Mass rate calculation. The mass rate of either TOC (minus 
methane and ethane) or total organic HAP for each sample run shall be 
calculated using the following equations. Where the mass rate of TOC is 
being calculated, all organic compounds (minus methane and ethane) 
measured by methods specified in paragraph (e)(3)(i)(C) of this section 
are summed using Equations 52 and 53 of this subpart. Where the mass 
rate of total organic HAP is being calculated, only soluble and 
partially soluble HAP compounds shall be summed using Equations 52 and 
53.

[[Page 50370]]

[GRAPHIC] [TIFF OMITTED] TR21SE98.048


[GRAPHIC] [TIFF OMITTED] TR21SE98.049

Where:

CGa,i, CGb,i = concentration of TOC or total 
organic HAP, in vented gas stream, entering (CGa,i) and 
exiting (CGb,i) the control device, dry basis, ppmv
QMGa, QMGb = mass rate of TOC or total organic 
HAP, in vented gas stream, entering (QMGa) and exiting 
(QMGb) the control device, dry basis, kg/hr
Mwi = molecular weight of a component, kilogram/kilogram-
mole
QGa,QGb = flow rate of gas stream entering 
(QGa) and exiting (QGb) the control device, dry 
standard cubic meters per hour
K2 = constant, 41.57  x 10-9 (parts per 
million)-1 (gram-mole per standard cubic meter) (kilogram/
gram), where standard temperature (gram-mole per standard cubic meter) 
is 20 deg.C
i = identifier for a compound
n = number of components in the sample

    (I) Percent reduction calculation. The percent reduction in TOC or 
total organic HAP for each sample run shall be calculated using 
Equation 54 of this subpart:
[GRAPHIC] [TIFF OMITTED] TR21SE98.050

where:

E = destruction efficiency of control device, percent
QMGa,QMGb = mass rate of TOC or total organic 
HAP, in vented gas stream entering and exiting (QMGb) the 
control device, dry basis, kilograms per hour

    (J) Compare mass destruction efficiency to required efficiency. If 
complying with the 95-percent reduction efficiency requirement, 
compliance is demonstrated if the mass destruction efficiency 
(calculated in Equation 51 of this subpart) is 95 percent or greater. 
If complying with the 20 ppmv limit, compliance is demonstrated if the 
outlet TOC concentration is 20 ppmv, or less.
    (ii) Design evaluation. A design evaluation conducted in accordance 
with the provisions in paragraph (a)(1) of this section. Compounds that 
meet the requirements specified in paragraph (e)(2)(iii)(A)(4) of this 
section are not required to be included in the design evaluation.
    (iii) Compliance demonstration for flares. When a flare is used to 
comply with Sec. 63.1256(h), the owner or operator shall comply with 
the flare provisions in Sec. 63.11(b). An owner or operator is not 
required to conduct a performance test to determine percent emission 
reduction or outlet organic HAP or TOC concentration when a flare is 
used.
    (iv) Exemptions from compliance demonstrations. An owner or 
operator using any control device specified in paragraph (a)(4) of this 
section is exempt from the requirements in paragraphs (e)(3)(i) through 
(e)(3)(iii) of this section and from the requirements in Sec. 63.6(f).
    (f) Pollution prevention alternative standard. The owner or 
operator shall demonstrate compliance with Sec. 63.1252(e)(2) using the 
procedures described in paragraph (f)(1) and (f)(3) of this section. 
The owner or operator shall demonstrate compliance with 
Sec. 63.1252(e)(3) using the procedures described in paragraphs (f)(2) 
and (f)(3) 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 by at least 75 percent as 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 3-year period in which the PMPU was 
operational, beginning no earlier than the 1987 calendar year, or for a 
minimum period of 12 months from startup of the process until the 
present in which the PMPU was operational and data are available, 
beginning no earlier than the 1987 calendar year.
    (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). The annual factor shall be calculated every 5 
batches if the number of batches is less than 10 for the 12-month 
period preceding the 10th batch and shall be calculated every year if 
the number of batches is less than 5 for the 12-month period preceding 
the 5th batch.
    (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 (ii) 
of this section.

[[Page 50371]]

    (ii) The yearly reductions associated with add-on controls that 
meet the criteria of Secs. 63.1252(h)(3)(ii)(A) through (D) must be 
equal to or greater than the amounts calculated in paragraphs 
(f)(2)(ii)(A) and (B) of this section:
    (A) The mass of HAP calculated using Equation 55 of this subpart:

[kg reduced]a = [kg/kg]b(0.75-PR)[kg 
produced]a    (Eq. 55)

Where:
[kg/kg]b = the baseline production-indexed HAP consumption 
factor, in kg/kg
[kg produced]a = the annual HAP production rate, in kg/yr
[kg reduced]a = the annual reduction required by add-on 
controls, in kg/yr
PR = the fractional reduction in the annual kg/kg factor 
achieved using pollution prevention where PR is 
0.5

    (B) The mass of VOC calculated using Equation 56 of this subpart:

VOC reduced = (VFbase - VFP - 
VFannual)  x  Mprod    (Eq. 56)

Where:

VOCreduced = required VOC emission reduction from add-on 
controls, kg/yr
VFbase = baseline VOC factor, kg VOC emitted/kg production
VFp = reduction in VOC factor achieved by pollution 
prevention, kg VOC emitted/kg production
VFannual = target annual VOC factor, kg VOC emitted/kg 
production
Mprod = production rate, kg/yr

    (iii) Demonstration that the criteria in Sec. 63.1252(e)(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. 63.1257(d).
    (3) Each owner or operator of a PMPU complying with the P2 standard 
shall prepare a P2 demonstration summary that shall contain, at a 
minimum, the following information:
    (i) Descriptions of the methodologies and forms used to measure and 
record daily consumption of HAP compounds reduced as part of the P2 
standard.
    (ii) Descriptions of the methodologies and forms used to measure 
and record daily production of products which are included in the P2 
standard.
    (iii) Supporting documentation for the descriptions provided in 
paragraphs (f)(3)(i) and (ii) including, but not limited to, operator 
log sheets and copies of daily, monthly, and annual inventories of 
materials and products.
    (g) 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. 63.1253, as applicable, by 
fulfilling the requirements of paragraphs (g)(1) through (4) of this 
section.
    (1) The owner or operator shall develop and submit for approval an 
Implementation Plan containing all the information required in 
Sec. 63.1259(e) 6 months prior to the compliance date of the standard. 
The Administrator shall have 90 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 (ETi, 
ETo) shall be calculated for each storage tank included in 
the emissions average using the procedures specified in paragraph 
(c)(1), (2), or (3) of this section.
    (3) Equations 57 and 58 of this subpart shall be used to calculate 
total HAP emissions for those tanks subject to Sec. 63.1253(b) or (c):
[GRAPHIC] [TIFF OMITTED] TR21SE98.051

[GRAPHIC] [TIFF OMITTED] TR21SE98.052

Where:

Eij = yearly mass rate of total HAP at the inlet of the 
control device for tank j
Eoj = yearly mass rate of total HAP at the outlet of the 
control device for tank j
ETi = total yearly uncontrolled HAP emissions
ETo = total yearly actual HAP emissions
n = number of tanks included in the emissions average

    (4) The overall percent reduction efficiency shall be calculated as 
follows:
[GRAPHIC] [TIFF OMITTED] TR21SE98.053

where:

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

    (h) Compliance with process vent provisions by using emissions 
averaging. An owner or operator with two or more affected processes 
complying with Sec. 63.1254 by using emissions averaging shall 
demonstrate compliance with paragraphs (h)(1), (2) and (3) of this 
section.
    (1) The owner or operator shall develop and submit for approval an 
Implementation Plan at least 6 months prior to the compliance date of 
the standard containing all the information required in 
Sec. 63.1259(e). The Administrator shall have 90 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 90-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) and 
(3) of this section for each process included in the emissions average.
    (i) Equations 60 and 61 of this subpart shall be used to calculate 
total HAP emissions:
[GRAPHIC] [TIFF OMITTED] TR21SE98.054

where:

EUi = yearly uncontrolled emissions from process I
ECi = yearly actual emissions for process I
ETU = total yearly uncontrolled emissions
    ETC = total yearly actual emissions
n = number of processes included in the emissions average

    (3) The overall percent reduction efficiency shall be calculated 
using Equation 62 of this subpart:

[[Page 50372]]

[GRAPHIC] [TIFF OMITTED] TR21SE98.055


[GRAPHIC] [TIFF OMITTED] TR21SE98.056

where:

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


Sec. 63.1258  Monitoring Requirements.

    (a) The owner or operator of any existing, new, or reconstructed 
affected source shall provide evidence of continued compliance with the 
standard as specified in this section. During the initial compliance 
demonstration, maximum or minimum operating parameter levels, 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 control device design shall be 
used to establish the operating parameter level.
    (b) Monitoring for control devices.  (1) Parameters to monitor. 
Except as specified in paragraph (b)(1)(i) of this section, for each 
control device, the owner or operator shall install and operate 
monitoring devices and operate within the established parameter levels 
to ensure continued compliance with the standard. Monitoring parameters 
are specified for control scenarios in Table 4 of this subpart and in 
paragraphs (b)(1)(ii) through (xi) of this section.
    (i) Periodic verification. For control devices that control vent 
streams totaling less than 1 ton/yr HAP emissions, before control, 
monitoring shall consist of a daily verification that the device is 
operating properly. If the control device is used to control batch 
process vents alone or in combination with other streams, the 
verification may be on a per batch basis. This verification shall 
include, but not be limited to, a daily or per batch demonstration that 
the unit is working as designed and may include the daily measurements 
of the parameters described in (b)(1)(ii) through (x) of this section. 
This demonstration shall be included in the Precompliance report, to be 
submitted 6 months prior to the compliance date of the standard.
    (ii) Scrubbers. For affected sources using liquid scrubbers, the 
owner or operator shall establish a minimum scrubber liquid flow rate 
or pressure drop as a site-specific operating parameter which must be 
measured and recorded every 15 minutes during the period in which the 
scrubber is functioning in achieving the HAP removal required by this 
subpart. If the scrubber uses a caustic solution to remove acid 
emissions, the owner or operator shall establish a minimum pH of the 
effluent scrubber liquid as a site-specific operating parameter which 
must be monitored at least once a day. The minimum scrubber flowrate or 
pressure drop shall be based on the conditions anticipated under worst-
case conditions, as defined in Sec. 63.1257(b)(8)(i).
    (A) The monitoring device used to determine the pressure drop shall 
be certified by the manufacturer to be accurate to within a gage 
pressure of 10 percent of the maximum pressure drop 
measured.
    (B) The monitoring device used for measurement of scrubber liquid 
flowrate shall be certified by the manufacturer to be accurate within 
10 percent of the design scrubber liquid flowrate.
    (C) The monitoring device shall be calibrated annually.
    (iii) Condensers. For each condenser, the owner or operator shall 
establish the maximum condenser outlet gas temperature as a site-
specific operating parameter which must be measured and recorded at 
least every 15 minutes during the period in which the condenser is 
functioning in achieving the HAP removal required by this subpart.
    (A) The temperature monitoring device must be accurate to within 
2 percent of the temperature measured in degrees Celsius or 
2.5 deg.C, whichever is greater.
    (B) The temperature monitoring device must be calibrated annually.
    (iv) Regenerative carbon adsorbers. For each regenerative carbon 
adsorber, the owner or operator shall comply with the provisions in 
paragraphs (b)(1)(iv)(A) through (F) of this section.
    (A) Establish the regeneration cycle characteristics specified in 
paragraphs (b)(1)(iv)(A)(1) through (4) of this section under worst-
case conditions, as defined in Sec. 63.1257(b)(8)(i).
    (1) Minimum regeneration frequency (i.e., operating time since last 
regeneration);
    (2) Minimum temperature to which the bed is heated during 
regeneration;
    (3) Maximum temperature to which the bed is cooled, measured within 
15 minutes of completing the cooling phase; and
    (4) Minimum regeneration stream flow.
    (B) Monitor and record the regeneration cycle characteristics 
specified in paragraphs (b)(1)(iv)(B)(1) through (4) of this section 
for each regeneration cycle.
    (1) Regeneration frequency (operating time since end of last 
regeneration);
    (2) Temperature to which the bed is heated during regeneration;
    (3) Temperature to which the bed is cooled, measured within 15 
minutes of the completion of the cooling phase; and
    (4) Regeneration stream flow.
    (C) Use a temperature monitoring device that is accurate to within 
2 percent of the temperature measured in degrees Celsius or 
 2.5  deg.C, whichever is greater.
    (D) Use a regeneration stream flow monitoring device capable of 
recording the total regeneration stream flow to within  10 
percent of the established value (i.e., accurate to within  
10 percent of the reading).
    (E) Calibrate the temperature and flow monitoring devices annually.
    (F) Conduct an annual check for bed poisoning in accordance with 
manufacturer's specifications.
    (v) Nonregenerative carbon adsorbers. For each nonregenerative 
carbon adsorber, the owner or operator shall establish and monitor the 
maximum time interval between replacement based on the conditions 
anticipated under worst-case, as defined in Sec. 63.1257(b)(8)(i).
    (vi) Flares. For each flare, the presence of the pilot flame shall 
be monitored every 15 minutes during the period in which the flare is 
functioning in achieving the HAP removal required by this subpart.
    (vii) Thermal incinerators. For each thermal incinerator, the owner 
or operator shall establish the minimum temperature of the gases 
exiting the combustion chamber as the site-specific operating parameter 
which must be measured and recorded at least once every 15 minutes 
during the period in which the combustion device is functioning in 
achieving the HAP removal required by this subpart.
    (A) The temperature monitoring device must be accurate to within 
 0.75 percent of the temperature measured in degrees 
Celsius or  2.5  deg.C, whichever is greater.
    (B) The monitoring device must be calibrated annually.
    (viii) Catalytic incinerators. For each catalytic incinerator, the 
owner or operator shall monitor the temperature of the gas stream 
immediately before and after the catalyst bed. The owner or operator 
shall establish the minimum temperature of the gas stream immediately 
before the catalyst bed and the minimum temperature difference across 
the catalyst bed as the site-specific operating parameter which must be 
monitored and recorded at least

[[Page 50373]]

once every 15 minutes during the period in which the catalytic 
incinerator is functioning in achieving the HAP removal required by 
this subpart.
    (A) The temperature monitoring devices must be accurate to within 
 0.75 percent of the temperature measured in degrees 
Celsius or  2.5  deg.C, whichever is greater.
    (B) The temperature monitoring devices must be calibrated annually.
    (ix) Process heaters and boilers. (A) Except as specified in 
paragraph (b)(1)(ix)(B) of this section, for each boiler or process 
heater, the owner or operator shall establish the minimum temperature 
of the gases exiting the combustion chamber as the site-specific 
operating parameter which must be monitored and recorded at least once 
every 15 minutes during the period in which the boiler or process 
heater is functioning in achieving the HAP removal required by this 
subpart.
    (1) The temperature monitoring device must be accurate to within 
0.75 percent of the temperature measured in degrees Celsius 
or 2.5 deg.C, whichever is greater.
    (2) The temperature monitoring device must be calibrated annually.
    (B) The owner or operator is exempt from the monitoring 
requirements specified in paragraph (b)(1)(ix)(A) of this section if 
either:
    (1) All vent streams are introduced with primary fuel; or
    (2) The design heat input capacity of the boiler or process heater 
is 44 megawatts or greater.
    (x) Continuous emission monitor. As an alternative to the 
parameters specified in paragraphs (b)(1)(ii) through (ix) of this 
section, an owner or operator may monitor and record the outlet HAP 
concentration or both the outlet TOC concentration and outlet hydrogen 
halide and halogen concentration every 15 minutes during the period in 
which the control device is functioning in achieving the HAP removal 
required by this subpart. The owner or operator need not monitor the 
hydrogen halide and halogen concentration if, based on process 
knowledge, the owner or operator determines that the emission stream 
does not contain hydrogen halides or halogens. The HAP or TOC monitor 
must meet the requirements of Performance Specification 8 or 9 of 
appendix B of part 60 and must be installed, calibrated, and 
maintained, according to Sec. 63.8. As part of the QA/QC Plan, 
calibration of the device must include, at a minimum, quarterly 
cylinder gas audits.
    (xi) CVS visual inspections. The owner or operator shall perform 
monthly visual inspections of each closed vent system as specified in 
Sec. 63.1252(b).
    (2) Averaging periods. Averaging periods for parametric monitoring 
levels shall be established according to paragraphs (b)(2)(i) through 
(iii) of this section.
    (i) Except as provided in paragraph (b)(2)(iii) of this section, a 
daily (24-hour) or block average shall be calculated as the average of 
all values for a monitored parameter level set according to the 
procedures in (b)(3)(iii) of this section recorded during the operating 
day or block.
    (ii) The operating day or block shall be defined in the 
Notification of Compliance Status report. The daily average may be from 
midnight to midnight or another continuous 24-hour period. The block 
average is limited to a period of time that is, at a maximum, equal to 
the time from the beginning to end of a batch process.
    (iii) Monitoring values taken during periods in which the control 
devices are not functioning in controlling emissions, as indicated by 
periods of no flow, shall not be considered in the averages. Where flow 
to the device could be intermittent, the owner or operator shall 
install, calibrate and operate a flow indicator at the inlet or outlet 
of the control device to identify periods of no flow.
    (3) Procedures for setting parameter levels for control devices 
used to control emissions from process vents. (i) Small control 
devices. Except as provided in paragraph (b)(1)(i) of this section, for 
devices controlling less than 10 tons per year of HAP for which a 
performance test is not required, the parametric levels shall be set 
based on the design evaluation required in Sec. 63.1257(d)(3)(i). If a 
performance test is conducted, the monitoring parameter level shall be 
established according to the procedures in (b)(3)(ii) of this section.
    (ii) Large control devices. For devices controlling greater than 10 
tons per year of HAP for which a performance test is required, the 
parameter level must be established as follows:
    (A) If the operating parameter level to be established is a 
maximum, it must be based on the average of the values from each of the 
three test runs.
    (B) If the operating parameter level to be established is a 
minimum, it must be based on the average of the values from each of the 
three test runs.
    (C) 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.
    (iii) Parameters for control devices controlling batch process 
vents. For devices controlling batch process vents alone or in 
combination with other streams, the parameter level(s) shall be 
established in accordance with paragraph (b)(3)(iii)(A) or (B) of this 
section.
    (A) If more than one batch emission episode has been selected to be 
controlled, a single level for the batch process(es) shall be 
determined from the initial compliance demonstration.
    (B) Instead of establishing a single level for the batch 
process(es), as described in paragraph (b)(3)(iii)(A) of this section, 
an owner or operator may establish separate levels for each batch 
emission episode, selected to be controlled. If separate monitoring 
levels are established, the owner or operator must provide a record 
indicating at what point in the daily schedule or log of processes 
required to be recorded per the requirements of Sec. 63.1259(b)(9) the 
parameter being monitored changes levels and must record at least one 
reading of the new parameter level, even if the duration of monitoring 
for the new parameter is less than 15-minutes.
    (4) Request approval to monitor alternative parameters. An owner or 
operator may request approval to monitor parameters other than those 
required by paragraphs (b)(1)(ii) through (ix) of this section. The 
request shall be submitted according to the procedures specified in 
Sec. 63.8(f) or included in the Precompliance report.
    (5) Monitoring for the alternative standards. For control devices 
that are used to comply with the provisions of Sec. 63.1253(d) or 
63.1254(c), the owner or operator shall monitor and record the outlet 
TOC concentration and the outlet hydrogen halide and halogen 
concentration every 15 minutes during the period in which the device is 
functioning in achieving the HAP removal required by this subpart. A 
TOC monitor meeting the requirements of Performance Specification 8 or 
9 of appendix B of part 60 shall be installed, calibrated, and 
maintained, according to Sec. 63.8. The owner or operator need not

[[Page 50374]]

monitor the hydrogen halide and halogen concentration if, based on 
process knowledge, the owner or operator determines that the emission 
stream does not contain hydrogen halides or halogens.
    (6) Exceedances of operating parameters. An exceedance of an 
operating parameter is defined as one of the following:
    (i) If the parameter, averaged over the operating day or block, is 
below a minimum value established during the initial compliance 
demonstration.
    (ii) If the parameter, averaged over the operating day or block, is 
above the maximum value established during the initial compliance 
demonstration.
    (iii) Each loss of pilot flame for flares.
    (7) Excursions. Excursions are defined by either of the two cases 
listed in paragraphs (b)(7)(i) or (ii) of this section.
    (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)(7)(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 used in paragraphs (b)(7)(i) and (ii) of this section, if 
measured values are unavailable for any of the required 15-minute 
periods within the hour.
    (8) Violations. Exceedances of parameters monitored according to 
the provisions of paragraphs (b)(1)(ii) and (iv) through (ix) of this 
section or excursions as defined by paragraphs (b)(7)(i) through (iii) 
of this section constitute violations of the operating limit according 
to paragraphs (b)(8)(i), (ii), and (iv) of this section. Exceedances of 
the temperature limit monitored according to the provisions of 
paragraph (b)(1)(iii) of this section or exceedances of the outlet 
concentrations monitored according to the provisions of paragraph 
(b)(1)(x) of this section constitute violations of the emission limit 
according to paragraphs (b)(8)(i), (ii), and (iv) of this section. 
Exceedances of the outlet concentrations monitored according to the 
provisions of paragraph (b)(5) of this section constitute violations of 
the emission limit according to the provisions of paragraphs 
(b)(8)(iii) and (iv) of this section.
    (i) Except as provided in paragraph (b)(8)(iv) of this section, for 
episodes occurring more than once per day, exceedances of established 
parameter limits or excursions will result in no more than one 
violation per operating day for each monitored item of equipment 
utilized in the process.
    (ii) Except as provided in paragraph (b)(8)(iv) of this section, 
for control devices used for more than one process in the course of an 
operating day, exceedances or excursions will result in no more than 
one violation per operating day, per control device, for each process 
for which the control device is in service.
    (iii) Except as provided in paragraph (b)(8)(iv) of this section, 
exceedances of the 20 ppmv TOC outlet emission limit, averaged over the 
operating day, will result in no more than one violation per day per 
control device. Except as provided in paragraph (b)(8)(iv) of this 
section, exceedances of the 20 ppmv hydrogen halide or halogen outlet 
emission limit, averaged over the operating day, will result in no more 
than one violation per day per control device.
    (iv) 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.
    (c) Monitoring for emission limits. The owner or operator of any 
affected source complying with the provisions of Sec. 63.1254(a)(1) 
shall demonstrate continuous compliance with the 2,000 lb/yr emission 
limits by calculating daily a 365-day rolling summation of emissions. 
For owners and operators opting to switch compliance strategy from the 
93 percent control requirement to the 2,000 lb/yr compliance method, as 
decribed in Sec. 63.1254(a), the rolling average must include emissions 
from the past 365 days. Each day that the total emissions per process 
exceeds 2,000 lb/yr will be considered a violation of the emission 
limit.
    (d) Monitoring for equipment leaks. The owner or operator of any 
affected source complying with the requirements of Sec. 63.1255 of this 
subpart shall meet the monitoring requirements described Sec. 63.1255 
of this subpart.
    (e) Pollution prevention. The owner or operator of any affected 
source that chooses to comply with the requirements of 
Secs. 63.1252(e)(2) and (3) shall calculate a yearly rolling average of 
kg HAP consumption per kg production and kg VOC consumption per kg 
production every month or every 10 batches. Each rolling average kg/kg 
factor that exceeds the value established in Sec. 63.1257(f)(1)(ii) 
will be considered a violation of the emission limit.
    (f) Emissions averaging. The owner or operator of any affected 
source that chooses to comply with the requirements of Sec. 63.1252(d) 
shall meet all monitoring requirements specified in paragraphs (b)(1) 
and (3) of this section, as applicable, for all processes and storage 
tanks included in the emissions average.
    (g) Inspection and monitoring of waste management units and 
treatment processes. (1) For each wastewater tank, surface impoundment, 
container, individual drain system, and oil-water separator that 
receives, manages, or treats wastewater, a residual removed from 
wastewater, a recycled wastewater, or a recycled residual removed from 
wastewater, the owner or operator shall comply with the inspection 
requirements specified in Table 7 of this subpart.
    (2) For each biological treatment unit used to comply with 
Sec. 63.1256(g), the owner or operator shall monitor TSS, BOD, and the 
biomass concentration at a frequency approved by the permitting 
authority and using methods approved by the permitting authority. The 
owner or operator may request approval to monitor other parameters. The 
request shall be submitted in the Precompliance report according to the 
procedures specified in Sec. 63.1260(e), and shall include a 
description of planned reporting and recordkeeping procedures. The 
owner or operator shall include as part of the submittal the basis for 
the selected monitoring frequencies and the methods that will be used. 
The Administrator will specify appropriate reporting and recordkeeping 
requirements as part of the review of the permit application or by 
other appropriate means.
    (3) For nonbiological treatment units, the owner or operator shall 
request approval to monitor appropriate parameters that demonstrate 
proper operation of the selected treatment process. The request shall 
be submitted in the Precompliance report according to the procedures 
specified in Sec. 63.1260(e), and shall include a description of 
planned reporting and recordkeeping procedures. The Administrator will 
specify appropriate reporting and recordkeeping requirements as part of 
the review of the permit application or by other appropriate means.
    (h) Leak inspection provisions for vapor suppression equipment. (1) 
Except as provided in paragraph (h)(9) of this section, for each vapor 
collection system, closed-vent system, fixed roof, cover, or enclosure 
required to comply

[[Page 50375]]

with this section, the owner or operator shall comply with the 
requirements of paragraphs (h)(2) through (8) of this section.
    (2) Except as provided in paragraphs (h)(6) and (7) of this 
section, each vapor collection system and closed-vent system shall be 
inspected according to the procedures and schedule specified in 
paragraphs (h)(2)(i) and (ii) of this section and each fixed roof, 
cover, and enclosure shall be inspected according to the procedures and 
schedule specified in paragraph (h)(2)(iii) of this section.
    (i) If the vapor collection system or closed-vent system is 
constructed of hard-piping, the owner or operator shall:
    (A) Conduct an initial inspection according to the procedures in 
paragraph (h)(3) of this section, and
    (B) Conduct annual visual inspections for visible, audible, or 
olfactory indications of leaks.
    (ii) If the vapor collection system or closed-vent system is 
constructed of ductwork, the owner or operator shall:
    (A) Conduct an initial inspection according to the procedures in 
paragraph (h)(3) of this section, and
    (B) Conduct annual inspections according to the procedures in 
paragraph (h)(3) of this section.
    (C) Conduct annual visual inspections for visible, audible, or 
olfactory indications of leaks.
    (iii) For each fixed roof, cover, and enclosure, the owner or 
operator shall:
    (A) Conduct an initial inspection according to the procedures in 
paragraph (h)(3) of this section, and
    (B) Conduct semiannual visual inspections for visible, audible, or 
olfactory indications of leaks.
    (3) Each vapor collection system, closed-vent system, fixed roof, 
cover, and enclosure shall be inspected according to the procedures 
specified in paragraphs (h)(3)(i) through (v) of this section.
    (i) Inspections shall be conducted in accordance with Method 21 of 
40 CFR part 60, appendix A.
    (ii) Detection instrument performance criteria. (A) Except as 
provided in paragraph (h)(3)(ii)(B) of this section, the detection 
instrument shall meet the performance criteria of Method 21 of 40 CFR 
part 60, appendix A, except the instrument response factor criteria in 
section 3.1.2(a) of Method 21 shall be for the average composition of 
the process fluid not each individual VOC in the stream. For process 
streams that contain nitrogen, air, or other inerts which are not 
organic HAP or VOC, the average stream response factor shall be 
calculated on an inert-free basis.
    (B) If no instrument is available at the plant site that will meet 
the performance criteria specified in paragraph (h)(3)(ii)(A) of this 
section, the instrument readings may be adjusted by multiplying by the 
average response factor of the process fluid, calculated on an inert-
free basis as described in paragraph (h)(3)(ii)(A) of this section.
    (iii) The detection instrument shall be calibrated before use on 
each day of its use by the procedures specified in Method 21 of 40 CFR 
part 60, appendix A.
    (iv) Calibration gases shall be as follows:
    (A) Zero air (less than 10 parts per million hydrocarbon in air); 
and
    (B) Mixtures of methane in air at a concentration less than 10,000 
parts per million. A calibration gas other than methane in air may be 
used if the instrument does not respond to methane or if the instrument 
does not meet the performance criteria specified in paragraph 
(h)(2)(ii)(A) of this section. In such cases, the calibration gas may 
be a mixture of one or more of the compounds to be measured in air.
    (v) An owner or operator may elect to adjust or not adjust 
instrument readings for background. If an owner or operator elects to 
not adjust readings for background, all such instrument readings shall 
be compared directly to the applicable leak definition to determine 
whether there is a leak. If an owner or operator elects to adjust 
instrument readings for background, the owner or operator shall measure 
background concentration using the procedures in Sec. 63.180(b) and 
(c). The owner or operator shall subtract background reading from the 
maximum concentration indicated by the instrument.
    (vi) The background level shall be determined according to the 
procedures in Method 21 of 40 CFR part 60 appendix A.
    (vii) The arithmetic difference between the maximum concentration 
indicated by the instrument and the background level shall be compared 
with 500 parts per million for determining compliance.
    (4) Leaks, as indicated by an instrument reading greater than 500 
parts per million above background or by visual inspections, shall be 
repaired as soon as practicable, except as provided in paragraph (h)(5) 
of this section.
    (i) A first attempt at repair shall be made no later than 5 
calendar days after the leak is detected.
    (ii) Repair shall be completed no later than 15 calendar days after 
the leak is detected, except as provided in paragraph (h)(4)(iii) of 
this section.
    (iii) For leaks found in vapor collection systems used for transfer 
operations, repairs shall be completed no later than 15 calendar days 
after the leak is detected or at the beginning of the next transfer 
loading operation, whichever is later.
    (5) Delay of repair of a vapor collection system, closed-vent 
system, fixed roof, cover, or enclosure for which leaks have been 
detected is allowed if the repair is technically infeasible without a 
shutdown, as defined in Sec. 63.1251, or if the owner or operator 
determines that emissions resulting from immediate repair would be 
greater than the fugitive emissions likely to result from delay of 
repair. Repair of such equipment shall be complete by the end of the 
next shutdown.
    (6) Any parts of the vapor collection system, closed-vent system, 
fixed roof, cover, or enclosure that are designated, as described in 
paragraph (h)(8)(i) of this section, as unsafe to inspect are exempt 
from the inspection requirements of paragraphs (h)(2)(i), (ii), and 
(iii) of this section if:
    (i) The owner or operator determines that the equipment is unsafe 
to inspect because inspecting personnel would be exposed to an imminent 
or potential danger as a consequence of complying with paragraphs 
(h)(2)(i), (ii), or (iii) of this section; and
    (ii) The owner or operator has a written plan that requires 
inspection of the equipment as frequently as practicable during safe-
to-inspect times.
    (7) Any parts of the vapor collection system, closed-vent system, 
fixed roof, cover, or enclosure that are designated, as described in 
paragraph (h)(8)(ii) of this section, as difficult to inspect are 
exempt from the inspection requirements of paragraphs (h)(2)(i), (ii), 
and (iii)(A) of this section if:
    (i) The owner or operator determines that the equipment cannot be 
inspected without elevating the inspecting personnel more than 2 meters 
above a support surface; and
    (ii) The owner or operator has a written plan that requires 
inspection of the equipment at least once every 5 years.
    (8) Records shall be maintained as specified in Sec. 63.1259(i) (4) 
through (9).
    (9) If a closed-vent system subject to this section is also subject 
to the equipment leak provisions of Sec. 63.1255, the owner or operator 
shall comply with the provisions of Sec. 63.1255 and is exempt from the 
requirements of this section.

[[Page 50376]]

Sec. 63.1259  Recordkeeping requirements.

    (a) Requirements of subpart A of this part. The owner or operator 
of an affected source shall comply with the recordkeeping requirements 
in subpart A of this part as specified in Table 1 of this subpart and 
in paragraphs (a)(1) through (5) of this section.
    (1) Data retention. Each owner or operator of an affected source 
shall keep copies of all records and reports required by this subpart 
for at least 5 years, as specified in Sec. 63.10(b)(1).
    (2) Records of applicability determinations. The owner or operator 
of a stationary source that is not subject to this subpart shall keep a 
record of the applicability determination, as specified in 
Sec. 63.10(b)(3).
    (3) Startup, shutdown, and malfunction plan. The owner or operator 
of an affected source shall develop and implement a written startup, 
shutdown, and malfunction plan as specified in Sec. 63.6(e)(3). This 
plan shall describe, in detail, procedures for operating and 
maintaining the affected source during periods of startup, shutdown, 
and malfunction and a program for corrective action for malfunctioning 
process, air pollution control, and monitoring equipment used to comply 
with this subpart. The owner or operator of an affected source shall 
keep the current and superseded versions of this plan onsite, as 
specified in Sec. 63.6(e)(3)(v). The owner or operator shall keep the 
startup, shutdown, and malfunction records specified in paragraphs 
(b)(3)(i) through (iii) of this section. Reports related to the plan 
shall be submitted as specified in Sec. 63.1260(i).
    (i) The owner or operator shall record the occurrence and duration 
of each malfunction of air pollution control equipment used to comply 
with this subpart, as specified in Sec. 63.6(e)(3)(iii).
    (ii) The owner or operator shall record the occurrence and duration 
of each malfunction of continuous monitoring systems used to comply 
with this subpart.
    (iii) For each startup, shutdown, or malfunction, the owner or 
operator shall record all information necessary to demonstrate that the 
procedures specified in the affected source's startup, shutdown, and 
malfunction plan were followed, as specified in Sec. 63.6(e)(3)(iii); 
alternatively, the owner or operator shall record any actions taken 
that are not consistent with the plan, as specified in 
Sec. 63.6(e)(3)(iv).
    (4) Recordkeeping requirements for sources with continuous 
monitoring systems. The owner or operator of an affected source who 
elects to install a continuous monitoring system shall maintain records 
specified in Sec. 63.10(c)(1) through (14).
    (5) Application for approval of construction or reconstruction. For 
new affected sources, each owner or operator shall comply with the 
provisions in Sec. 63.5 regarding construction and reconstruction, 
excluding the provisions specified in Sec. 63.5(d)(1)(ii)(H), (d)(2), 
and (d)(3)(ii).
    (b) Records of equipment operation. The owner or operator must keep 
the following records up-to-date and readily accessible:
    (1) Each measurement of a control device operating parameter 
monitored in accordance with Sec. 63.1258 and each measurement of a 
treatment process parameter monitored in accordance with 
Sec. 63.1258(g)(2) and (3).
    (2) For processes subject to Sec. 63.1252(e), records of 
consumption, production, and the rolling average values of the 
production-indexed HAP and VOC consumption factors.
    (3) For each continuous monitoring system used to comply with this 
subpart, records documenting the completion of calibration checks and 
maintenance of continuous monitoring systems.
    (4) For processes in compliance with the 2,000 lb/yr emission limit 
of Sec. 63.1254(a)(1), records of the rolling annual total emissions.
    (5) Records of the following, as appropriate:
    (i) The number of batches per year for each batch process.
    (ii) The operating hours per year for continuous processes.
    (6) Uncontrolled and controlled emissions per batch for each 
process.
    (7) Wastewater concentration per POD or process.
    (8) Number of storage tank turnovers per year, if used in an 
emissions average.
    (9) Daily schedule or log of each operating scenario prior to its 
operation.
    (10) Description of worst-case operating conditions as determined 
using the procedures described in Sec. 63.1257(b)(8) for control 
devices.
    (11) Periods of planned routine maintenance as described in 
Sec. 63.1257 (c)(5).
    (c) Records of operating scenarios. The owner or operator of an 
affected source shall keep records of each operating scenario which 
demonstrates compliance with this subpart.
    (d) Records of equipment leak detection and repair programs. The 
owner or operator of any affected source implementing the leak 
detection and repair (LDAR) program specified in Sec. 63.1255 of this 
subpart, shall implement the recordkeeping requirements in Sec. 63.1255 
of this subpart.
    (e) Records of emissions averaging. The owner or operator of any 
affected source that chooses to comply with the requirements of 
Sec. 63.1252(d) 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 (e)(1)(i) through (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. 63.1257(g)(1) through (4) or 63.1257(h)(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. 63.1258(f) for each process and storage tank 
included in an average.
    (v) A statement that the compliance demonstration, monitoring, 
inspection, recordkeeping and reporting provisions in Secs. 63.1257(g) 
and (h), 63.1258(f), and 63.1260(k) 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 storage tanks and process vents were controlled 
according to the provisions in Secs. 63.1253 and 63.1254, respectively.
    (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.

[[Page 50377]]

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 Secs. 63.1253 and 63.1254.
    (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 rolling quarterly calculation of the annual percent reduction 
efficiency as specified in Sec. 63.1257(g) and (h).
    (f) Records of delay of repair. Documentation of a decision to use 
a delay of repair due to unavailability of parts, as specified in 
Sec. 63.1256(i), shall include a description of the failure, the reason 
additional time was necessary (including a statement of why replacement 
parts were not kept onsite and when delivery from the manufacturer is 
scheduled), and the date when the repair was completed.
    (g) Record of wastewater stream or residual transfer. The owner or 
operator transferring an affected wastewater stream or residual removed 
from an affected wastewater stream in accordance with 
Sec. 63.1256(a)(5) shall keep a record of the notice sent to the 
treatment operator stating that the wastewater stream or residual 
contains organic HAP which are required to be managed and treated in 
accordance with the provisions of this subpart.
    (h) Records of extensions. The owner or operator shall keep 
documentation of a decision to use an extension, as specified in 
Sec. 63.1256(b)(6)(ii) or (b)(9), in a readily accessible location. The 
documentation shall include a description of the failure, documentation 
that alternate storage capacity is unavailable, and specification of a 
schedule of actions that will ensure that the control equipment will be 
repaired and the tank will be emptied as soon as practical.
    (i) Records of inspections. The owner or operator shall keep 
records specified in paragraphs (i)(1) through (9) of this section.
    (1) A record that each waste management unit inspection required by 
Sec. 63.1256(b) through (f) was performed.
    (2) A record that each inspection for control devices required by 
Sec. 63.1256(h) was performed.
    (3) A record of the results of each seal gap measurement required 
by Sec. 63.1256(b)(5) and (f)(3). The records shall include the date of 
measurement, the raw data obtained in the measurement, and the 
calculations described in Sec. 63.120(b)(2) through (4).
    (4) Records identifying all parts of the vapor collection system, 
closed-vent system, fixed roof, cover, or enclosure that are designated 
as unsafe to inspect in accordance with Sec. 63.1258(h)(6), an 
explanation of why the equipment is unsafe to inspect, and the plan for 
inspecting the equipment.
    (5) Records identifying all parts of the vapor collection system, 
closed-vent system, fixed roof, cover, or enclosure that are designated 
as difficult to inspect in accordance with Sec. 63.1258(h)(7), an 
explanation of why the equipment is difficult to inspect, and the plan 
for inspecting the equipment.
    (6) For each vapor collection system or closed-vent system that 
contains bypass lines that could divert a vent stream away from the 
control device and to the atmosphere, the owner or operator shall keep 
a record of the information specified in either paragraph (i)(6)(i) or 
(ii) of this section.
    (i) Hourly records of whether the flow indicator specified under 
Sec. 63.1252(b)(1) was operating and whether a diversion was detected 
at any time during the hour, as well as records of the times and 
durations of all periods when the vent stream is diverted from the 
control device or the flow indicator is not operating.
    (ii) Where a seal mechanism is used to comply with 
Sec. 63.1252(b)(2), hourly records of flow are not required. In such 
cases, the owner or operator shall record that the monthly visual 
inspection of the seals or closure mechanisms has been done, and shall 
record the occurrence of all periods when the seal mechanism is broken, 
the bypass line valve position has changed, or the key for a lock-and-
key type lock has been checked out, and records of any car-seal that 
has broken.
    (7) For each inspection conducted in accordance with 
Sec. 63.1258(h)(2) and (3) during which a leak is detected, a record of 
the information specified in paragraphs (i)(7)(i) through (viii) of 
this section.
    (i) The instrument identification numbers; operator name or 
initials; and identification of the equipment.
    (ii) The date the leak was detected and the date of the first 
attempt to repair the leak.
    (iii) Maximum instrument reading measured by the method specified 
in Sec. 63.1258(h)(4) after the leak is successfully repaired or 
determined to be nonrepairable.
    (iv) ``Repair delayed'' and the reason for the delay if a leak is 
not repaired within 15 calendar days after discovery of the leak.
    (v) The name, initials, or other form of identification of the 
owner or operator (or designee) whose decision it was that repair could 
not be effected without a shutdown.
    (vi) The expected date of successful repair of the leak if a leak 
is not repaired within 15 calendar days.
    (vii) Dates of shutdowns that occur while the equipment is 
unrepaired. (viii) The date of successful repair of the leak.
    (8) For each inspection conducted in accordance with 
Sec. 63.1258(h)(3) during which no leaks are detected, a record that 
the inspection was performed, the date of the inspection, and a 
statement that no leaks were detected.
    (9) For each visual inspection conducted in accordance with 
Sec. 63.1258(h)(2)(i)(B) or (h)(2)(iii)(B) of this section during which 
no leaks are detected, a record that the inspection was performed, the 
date of the inspection, and a statement that no leaks were detected.


Sec. 63.1260  Reporting requirements.

    (a) The owner or operator of an affected source shall comply with 
the reporting requirements of paragraphs (b) through (l) of this 
section. Applicable reporting requirements of Secs. 63.9 and 63.10 are 
also summarized in Table 1 of this subpart.
    (b) Initial notification. The owner or operator shall submit the 
applicable initial notification in accordance with Sec. 63.9(b) or (d).
    (c) Application for approval of construction or reconstruction. An 
owner or operator who is subject to Sec. 63.5(b)(3) shall submit to the 
Administrator an application for approval of the construction of a new 
major affected source, the reconstruction of a major affected source, 
or the reconstruction of a major source such that the source becomes a 
major affected source subject to the standards. The application shall 
be prepared in accordance with Sec. 63.5(d).
    (d) Notification of CMS performance evaluation. An owner or 
operator who is required by the Administrator to conduct a performance 
evaluation for a continuous monitoring system shall notify the 
Administrator of the date of the performance evaluation as specified in 
Sec. 63.8(e)(2).
    (e) Precompliance report. The Precompliance report shall be 
submitted at least 6 months prior to the

[[Page 50378]]

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 90 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 90 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. To change any of the information 
submitted in the report, the owner or operator shall notify the 
Administrator 90 days before the planned change is to be implemented; 
the change shall be considered approved if the Administrator either 
approves the change in writing, or fails to disapprove the change in 
writing. The Precompliance report shall include:
    (1) Requests for approval to use alternative monitoring parameters 
or requests to set monitoring parameters according to 
Sec. 63.1258(b)(4).
    (2) Descriptions of the daily or per batch demonstrations to verify 
that control devices subject to Sec. 63.1258(b)(1)(i) are operating as 
designed.
    (3) A description of test conditions, and the corresponding 
monitoring parameter values for parameters that are set according to 
Sec. 63.1258(b)(3)(ii)(C).
    (4) For owners and operators complying with the requirements of 
Sec. 63.1252(e), the P2 demonstration summary required in 
Sec. 63.1257(f).
    (5) Data and rationale used to support an engineering assessment to 
calculate uncontrolled emissions from process vents as required in 
Sec. 63.1257(d)(2)(ii).
    (f) Notification of Compliance Status report. The Notification of 
Compliance Status report required under Sec. 63.9 shall be submitted no 
later than 150 days after the compliance date and shall include:
    (1) The results of any applicability determinations, emission 
calculations, or analyses used to identify and quantify HAP emissions 
from the affected source.
    (2) 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.
    (3) 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.
    (4) Listing of all operating scenarios.
    (5) Descriptions of worst-case operating and/or testing conditions 
for control devices.
    (6) Identification of emission points subject to overlapping 
requirements described in Sec. 63.1250(h) and the authority under which 
the owner or operator will comply.
    (g) Periodic reports. An owner or operator shall prepare Periodic 
reports in accordance with paragraphs (g)(1) and (2) of this section 
and submit them to the Administrator.
    (1) Submittal schedule. Except as provided in (g)(1) (i), (ii) and 
(iii) of this section, an owner or operator shall submit Periodic 
reports semiannually, beginning 60 operating days after the end of the 
applicable reporting period. The first report shall be submitted no 
later than 240 days after the date the Notification of Compliance 
Status is due and shall cover the 6-month period beginning on the date 
the Notification of Compliance Status is due.
    (i) When the Administrator determines on a case-by-case basis that 
more frequent reporting is necessary to accurately assess the 
compliance status of the affected source; or
    (ii) When the monitoring data are used directly for compliance 
determination and the source experience excess emissions, in which case 
quarterly reports shall be submitted. Once an affected source reports 
excess emissions, the affected source shall follow a quarterly 
reporting format until a request to reduce reporting frequency is 
approved. If an owner or operator submits a request to reduce the 
frequency of reporting, the provisions in Sec. 63.10(e)(3)(ii) and 
(iii) shall apply, except that the term ``excess emissions and 
continuous monitoring system performance report and/or summary report'' 
shall mean ``Periodic report'' for the purposes of this section.
    (iii) When a new operating scenario has been operated since the 
last report, in which case quarterly reports shall be submitted.
    (2) Content of Periodic report. The owner or operator shall include 
the information in paragraphs (g)(2)(i) through (vii) of this section, 
as applicable.
    (i) Each Periodic report must include the information in 
Sec. 63.10(e)(3)(vi)(A) through (I) and (K) through (M). For each 
continuous monitoring system, the Periodic report must also include the 
information in Sec. 63.10(e)(3)(vi)(J).
    (ii) If the total duration of excess emissions, parameter 
exceedances, or excursions for the reporting period is 1 percent or 
greater of the total operating time for the reporting period, or the 
total continuous monitoring system downtime for the reporting period is 
5 percent or greater of the total operating time for the reporting 
period, the Periodic report must include the information in paragraphs 
(g)(2)(ii)(A) through (D) of this section.
    (A) 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 report or operating permit.
    (B) Duration of excursions, as defined in Sec. 63.1258(b)(7).
    (C) Operating logs and operating scenarios for all operating 
scenarios for all operating days when the values are outside the levels 
established in the Notification of Compliance Status report or 
operating permit.
    (D) When a continuous monitoring system is used, the information 
required in Sec. 63.10(c)(5) through (13).
    (iii) For each inspection conducted in accordance with 
Sec. 63.1258(h)(2) or (3) during which a leak is detected, the records 
specified in Sec. 63.1259(i)(7) must be included in the next Periodic 
report.
    (iv) For each vapor collection system or closed vent system with a 
bypass line subject to Sec. 63.1252(b)(1), records required under 
Sec. 63.1259(i)(6)(i) of all periods when the vent stream is diverted 
from the control device through a bypass line. For each vapor 
collection system or closed vent system with a bypass line subject to 
Sec. 63.1252(b)(2), records required under Sec. 63.1259(i)(6)(ii) of 
all periods in which the seal mechanism is broken, the bypass valve 
position has changed, or the key to unlock the bypass line valve was 
checked out.
    (v) The information in paragraphs (g)(2)(iv)(A) through (D) of this 
section shall be stated in the Periodic report, when applicable.
    (A) No excess emissions.
    (B) No exceedances of a parameter.
    (C) No excursions.
    (D) No continuous monitoring system has been inoperative, out of 
control, repaired, or adjusted.
    (vi) For each tank subject to control requirements, periods of 
planned routine maintenance during which the control device does not 
meet the specifications of Sec. 63.1253(b) through (d).
    (vii) Each new operating scenario which has been operated since the 
time period covered by the last Periodic report. For the initial 
Periodic report,

[[Page 50379]]

each operating scenario for each process operated since the compliance 
date shall be submitted.
    (h) Notification of process change.
    (1) Except as specified in paragraph (h)(2) of this section, 
whenever a process change is made, or a change in any of the 
information submitted in the Notification of Compliance Status Report, 
the owner or operator shall submit a report quarterly. The report may 
be submitted as part of the next Periodic report required under 
paragraph (g) of this section. The report shall include:
    (i) A brief description of the process change.
    (ii) A description of any modifications to standard procedures or 
quality assurance procedures.
    (iii) Revisions to any of the information reported in the original 
Notification of Compliance Status Report under paragraph (f) of this 
section.
    (iv) Information required by the Notification of Compliance Status 
Report under paragraph (f) of this section for changes involving the 
addition of processes or equipment.
    (2) An owner or operator must submit a report 60 days before the 
scheduled implementation date of either of the following:
    (i) Any change in the activity covered by the Precompliance report.
    (ii) A change in the status of a control device from small to 
large.
    (i) Reports of startup, shutdown, and malfunction. For the purposes 
of this subpart, the startup, shutdown, and malfunction reports shall 
be submitted on the same schedule as the periodic reports required 
under paragraph (g) of this section instead of the schedule specified 
in Sec. 63.10(d)(5)(i). These reports shall include the information 
specified in Sec. 63.1259(a)(3)(i) through (iii) and shall contain the 
name, title, and signature of the owner or operator or other 
responsible official who is certifying its accuracy. Reports are only 
required if a startup, shutdown, or malfunction occurred during the 
reporting period. Any time an owner or operator takes an action that is 
not consistent with the procedures specified in the affected source's 
startup, shutdown, and malfunction plan, the owner or operator shall 
submit an immediate startup, shutdown, and malfunction report as 
specified in Sec. 63.10(d)(4)(ii).
    (j) Reports of LDAR programs. The owner or operator of any affected 
source implementing the LDAR program specified in Sec. 63.1255 of this 
subpart shall implement the reporting requirements in Sec. 63.1255 of 
this subpart. Copies of all reports shall be retained as records for a 
period of 5 years, in accordance with the requirements of 
Sec. 63.10(b)(1).
    (k) Reports of emissions averaging. The owner or operator of any 
affected source that chooses to comply with the requirements of 
Sec. 63.1252(d) shall submit the implementation plan described in 
Sec. 63.1259(e) 6 months prior to the compliance date of the standard 
and the following information in the periodic reports:
    (1) The records specified in Sec. 63.1259(e) for each process or 
storage tank included in the emissions average;
    (2) All information as specified in paragraph (g) of this section 
for each process or storage tank included in the emissions average;
    (3) Any changes of the processes or storage tanks included in the 
average.
    (4) The calculation of the overall percent reduction efficiency for 
the reporting period.
    (5) Changes to the Implementation Plan which affect the calculation 
methodology of uncontrolled or controlled emissions or the hazard or 
risk equivalency determination.
    (6) Every second semiannual or fourth quarterly report, as 
appropriate, shall include the results according to Sec. 63.1259(e)(4) 
to demonstrate the emissions averaging provisions of Secs. 63.1252(d), 
63.1257(g) and (h), 63.1258(f), and 63.1259(f) are satisfied.
    (l) Notification of performance test and test plan. The owner or 
operator of an affected source shall notify the Administrator of the 
planned date of a performance test at least 60 days before the test in 
accordance with Sec. 63.7(b). The owner or operator also must submit 
the test plan required by Sec. 63.7(c) and the emission profile 
required by 63.1257(b)(8)(ii) with the notification of the performance 
test.
    (m) Request for extension of compliance. An owner or operator may 
submit to the Administrator a request for an extension of compliance in 
accordance with Sec. 63.1250(f)(4).


Sec. 63.1261  Delegation of authority.

    (a) In delegating implementation and enforcement authority to a 
State under Sec. 112(d) of the Clean Air Act, the authorities contained 
in paragraph (b) of this section shall be retained by the Administrator 
and not transferred to a State.
    (b) The authority conferred in Sec. 63.177; the authority to 
approve applications for determination of equivalent means of emission 
limitation; and the authority to approve alternative test methods shall 
not be delegated to any State.

                    Table 1 To Subpart GGG.--General Provisions Applicability To Subpart GGG                    
----------------------------------------------------------------------------------------------------------------
                                                                   Applies to                                   
 General provisions reference      Summary of requirements         subpart GGG               Comments           
----------------------------------------------------------------------------------------------------------------
63.1(a)(1)...................  General applicability of the     Yes.............  Additional terms defined in   
                                General Provisions.                                Sec.  63.1251; when overlap  
                                                                                   between subparts A and GGG of
                                                                                   this part, subpart GGG takes 
                                                                                   precedence.                  
63.1(a)(2-7).................  ...............................  Yes               ..............................
63.1(a)(8)...................  ...............................  No..............  Discusses state programs.     
63.1(a)(9-14)................  ...............................  Yes               ..............................
63.1(b)(1)...................  Initial applicability            Yes.............  Subpart GGG clarifies the     
                                determination.                                     applicability in Sec.        
                                                                                   63.1250.                     
63.1(b)(2)...................  Title V operating permit--see    Yes.............  All major affected sources are
                                part 70.                                           required to obtain a title V 
                                                                                   permit.                      
63.1(b)(3)...................  Record of the applicability      Yes.............  All affected sources are      
                                determination.                                     subject to subpart GGG       
                                                                                   according to the             
                                                                                   applicability definition of  
                                                                                   subpart GGG.                 
63.1(c)(1)...................  Applicability after standards    Yes.............  Subpart GGG clarifies the     
                                are set.                                           applicability of each        
                                                                                   paragraph of subpart A to    
                                                                                   sources subject to subpart   
                                                                                   GGG.                         
63.1(c)(2)...................  Title V permit requirement.....  No..............  All major affected sources are
                                                                                   required to obtain a title V 
                                                                                   permit. Area sources are not 
                                                                                   subject to subpart GGG.      

[[Page 50380]]

                                                                                                                
63.1(c)(3)...................  Reserved                         ................  ..............................
63.1(c)(4)...................  Requirements for existing        Yes               ..............................
                                source that obtains an                                                          
                                extension of compliance.                                                        
63.1(c)(5)...................  No.............................  Notification      Yes                           
                                                                 requirements                                   
                                                                 for an area                                    
                                                                 source that                                    
                                                                 increases HAP                                  
                                                                 emissions to                                   
                                                                 major source                                   
                                                                 levels.                                        
63.1(d)......................  [Reserved].....................  NA                                              
63.1(e)......................  Applicability of permit program  Yes                                             
                                before a relevant standard has                                                  
                                been set.                                                                       
63.2.........................  Definitions....................  Yes.............  Additional terms defined in   
                                                                                   Sec.  63.1251; when overlap  
                                                                                   between subparts A and GGG of
                                                                                   this part occurs, subpart GGG
                                                                                   takes precedence.            
63.3.........................  Units and abbreviations........  Yes.............  Other units used in subpart   
                                                                                   GGG are defined in that      
                                                                                   subpart.                     
63.4.........................  Prohibited activities..........  Yes                                             
63.5(a)......................  Construction and                 Yes.............  Except replace the terms      
                                reconstruction--applicability.                     ``source'' and ``stationary  
                                                                                   source'' with ``affected     
                                                                                   source''.                    
63.5(b)(1)...................  Upon construction, relevant      Yes                                             
                                standards for new sources.                                                      
63.5(b)(2)...................  [Reserved].....................  NA                                              
63.5(b)(3)...................  New construction/reconstruction  Yes                                             
63.5(b)(4)...................  Construction/reconstruction      Yes                                             
                                notification.                                                                   
63.5(b)(5)...................  Construction/reconstruction      Yes                                             
                                compliance.                                                                     
63.5(b)(6)...................  Equipment addition or process    Yes                                             
                                change.                                                                         
63.5(c)......................  [Reserved].....................  NA                                              
63.5(d)......................  Application for approval of      Yes.............  Except for certain provisions 
                                construction/reconstruction.                       identified in 63.1259(a)(5)  
63.5(e)......................  ...............................  Construction/     Yes                           
                                                                 reconstruction                                 
                                                                 approval..                                     
63.5(f)......................  Construction/reconstruction      Yes.............  Except replace ``source'' with
                                approval based on prior State                      ``affected source''.         
                                review..                                                                        
63.6(a)(1)...................  Compliance with standards and    Yes                                             
                                maintenance requirements.                                                       
63.6(a)(2)...................  Requirements for area source     Yes                                             
                                that increases emissions to                                                     
                                become major.                                                                   
63.6(b)(1-2).................  Compliance dates for new and     No..............  Subpart GGG specifies         
                                reconstructed sources.                             compliance dates.            
63.6(b)(3-6).................  Compliance dates for area        Yes                                             
                                sources that become major                                                       
                                sources.                                                                        
63.6 (b)(7)..................  Compliance dates for new         No..............  Subpart GGG specifies NS      
                                sources resulting from new                         applicability and compliance 
                                unaffected area sources                            dates                        
                                becoming subject to standards.                                                  
63.6(c)......................  Compliance dates for existing    Yes.............   Except replace ``source''    
                                sources.                                           with ``affected source''.    
                                                                                   Subpart GGG specifies        
                                                                                   compliance dates.            
63.6(e)......................  Operation and maintenance        Yes.............  Startup, Shutdown, Malfunction
                                requirements.                                      Plan requirements            
                                                                                   specifically include         
                                                                                   malfunction process, control 
                                                                                   and monitoring equipment.    
63.6(f)-(g)..................  Compliance with nonopacity and   Yes.............  Except that subpart GGG       
                                alternative nonopacity                             specifies performance test   
                                emission standards.                                conditions.                  
63.6(h)......................  Opacity and visible emission     No..............  Subpart GGG does not contain  
                                standards.                                         any opacity or visible       
                                                                                   emission standards.          
63.6(i)......................  Extension of compliance with     No..............  Sec.  63.1250(f)(4) specifies 
                                emission standards.                                provisions for compliance    
                                                                                   extensions.                  
63.6(j)......................  Exemption from compliance with   Yes                                             
                                emission standards.                                                             
63.7(a)(1)...................  Performance testing              Yes.............  Subpart GGG specifies required
                                requirements..                                     testing and compliance       
                                                                                   procedures.                  
63.7(a)(2)(I-ix).............  ...............................  Yes                                             
63.7(a)(3)...................  ...............................  Yes                                             
63.7(b)(1)...................  Notification of performance      Yes                                             
                                test.                                                                           
63.7(b)(2)...................  Notification of delay in         Yes                                             
                                conducting a scheduled                                                          
                                performance test.                                                               

[[Page 50381]]

                                                                                                                
63.7(c)......................  Quality assurance program......  Yes.............  Except that the test plan must
                                                                                   be submitted with the        
                                                                                   notification of the          
                                                                                   performance test.            
63.7(d)......................  Performance testing facilities.  Yes.............  Except replace ``source'' with
                                                                                   ``affected source''.         
63.7(e)......................  Conduct of performance tests...  Yes.............  Subpart GGG also contains test
                                                                                   methods and procedures       
                                                                                   specific to pharmaceutical   
                                                                                   sources.                     
63.7(f)......................  Use of alternative test method.  Yes                                             
63.7(g)......................  Data analysis, recordkeeping,    Yes                                             
                                and reporting.                                                                  
63.7(h)......................  Waiver of performance tests....  Yes                                             
63.8(a)......................  Monitoring requirements........  Yes.............  See Sec.  63.1258.            
63.8(b)(1)...................  Conduct of monitoring..........  Yes                                             
63.8(b)(2)...................  CMS and combined effluents.....  No..............  Sec.  63.1258 of subpart GGG  
                                                                                   provides specific CMS        
                                                                                   requirements.                
63.8(b)(3)-(c)(3)............  CMS requirements...............  Yes                                             
63.8(c)(4-5).................  CMS operation requirements.....  Yes                                             
63.8 (c)6-8).................  CMS calibration and malfunction  Yes                                             
                                provisions.                                                                     
63.8(d)......................  CMS quality control program....  Yes                                             
63.8(e)(1)...................  Performance evaluations of CMS.  Yes                                             
63.8(e)(2)...................  Notification of performance      Yes               ..............................
                                evaluation.                                                                     
63.8(e)(3-4).................  CMS requirements/alternatives..  Yes               ..............................
63.8(e)(5)(i)................  Reporting performance            Yes.............  See Sec.                      
                                evaluation results.                                                             
63.1260 (a)..................                                                                                   
63.8(e)(5)(ii)...............  Results of COMS performance      No..............  Subpart GGG does not contain  
                                evaluation.                                        any opacity or visible       
                                                                                   emission standards.          
63.8(f)-(g)..................  Alternative monitoring method/   Yes               ..............................
                                reduction of monitoring data.                                                   
63.9(a)-(d)..................  Notification requirements--      Yes               ..............................
                                Applicability and general                                                       
                                information.                                                                    
63.9(e)......................  Notification of performance      Yes               ..............................
                                test.                                                                           
63.9(f)......................  Notification of opacity and      No..............  Subpart GGG does not contain  
                                visible emissions observations.                    any opacity or visible       
                                                                                   emission standards.          
63.9(g)(1)...................  Additional notification          Yes               ..............................
                                requirements for sources with                                                   
                                CMS.                                                                            
63.9(g)(2)...................  Notification of compliance with  No..............  Subpart GGG does not contain  
                                opacity emission standard.                         any opacity or visible       
                                                                                   emission standards.          
63.9(g)(3)...................  Notification that criterion to   Yes               ..............................
                                continue use of alternative to                                                  
                                relative accuracy testing has                                                   
                                been exceeded.                                                                  
63.9(h)......................  Notification of compliance       Yes.............  Due 150 days after compliance 
                                status..                                           date.                        
63.9(i)......................  Adjustment to time periods or    Yes               ..............................
                                postmark deadlines for                                                          
                                submittal and review of                                                         
                                required communications.                                                        
63.9(j)......................  Change in information provided.  Yes               ..............................
63.10(a).....................  Recordkeeping requirements.....  Yes.............  See Sec.                      
63.1259......................                                                                                   
63.10(b)(1)..................  Records retention..............  Yes               ..............................
63.10(b)(2)..................  Information and documentation    No..............  Subpart GGG specifies         
                                to support notifications.                          recordkeeping requirements.  
63.10(b)(3)..................  Records retention for sources    Yes.............   Applicability requirements   
                                not subject to relevant                            are given in Sec.  63.1250.  
                                standard.                                                                       
63.10(c)-(d)(2)..............  Other recordkeeping and          Yes.............                                
                                reporting provisions.                                                           
63.10(d)(3)..................  Reporting results of opacity or  No..............  Subpart GGG does not include  
                                visible emissions observations.                    any opacity or visible       
                                                                                   emission standards.          
63.10(d)(4-5)................  Other recordkeeping and          Yes.............                                
                                reporting provisions.                                                           
63.10(e).....................  Additional CMS reporting         Yes.............                                
                                requirements.                                                                   
63.10(f).....................  Waiver of recordkeeping or       Yes.............                                
                                reporting requirements..                                                        
63.11........................  Control device requirements for  Yes.............                                
                                flares.                                                                         
63.12........................  State authority and delegations  Yes.............  See Sec.  63.1261.            
63.13........................  Addresses of State air           Yes.............                                
                                pollution control agencies.                                                     
63.14........................  Incorporations by reference....  Yes.............                                
63.15........................  Availability of information and  Yes.............                                
                                confidentiality.                                                                
----------------------------------------------------------------------------------------------------------------


             Table 2 To Subpart GGG.--Partially Soluble HAP             
------------------------------------------------------------------------
                                                                        
-------------------------------------------------------------------------
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)                                                        
1,4-Dichlorobenzene                                                     
2-Nitropropane                                                          
4-Methyl-2-pentanone (mibk)                                             
Acetaldehyde                                                            
Acrolein                                                                
Acrylonitrile                                                           
Allyl chloride                                                          
Benzene                                                                 
Benzyl chloride                                                         
Biphenyl                                                                

[[Page 50382]]

                                                                        
Bromoform (tribromomethane)                                             
Bromomethane                                                            
Butadiene                                                               
Carbon disulfide                                                        
Chlorobenzene                                                           
Chloroethane (ethyl chloride)                                           
Chloroform                                                              
Chloromethane                                                           
Chloroprene                                                             
Cumene                                                                  
Dichloroethyl ether                                                     
Dinitrophenol                                                           
Epichlorohydrin                                                         
Ethyl acrylate                                                          
Ethylbenzene                                                            
Ethylene oxide                                                          
Hexachlorobenzene                                                       
Hexachlorobutadiene                                                     
Hexachloroethane                                                        
Methyl methacrylate                                                     
Methyl-t-butyl ether                                                    
Methylene chloride                                                      
N,N-dimethylaniline                                                     
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                                                                
------------------------------------------------------------------------


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


                     Table 4 to Subpart GGG.--Monitoring Requirements for Control Devices a                     
----------------------------------------------------------------------------------------------------------------
                                      Monitoring equipment        Parameters to be                              
          Control device                    required                  monitored                 Frequency       
----------------------------------------------------------------------------------------------------------------
All control devices..............  1. Flow indicator          1. Presence of flow       Hourly records of       
                                    installed at all bypass    diverted from the         whether the flow       
                                    lines to the atmosphere    control device to the     indicator was operating
                                    and equipped with          atmosphere or.            and whether a diversion
                                    continuous recorder or.                              was detected at any    
                                                                                         time during each hour. 
                                   2. Valves sealed closed    2. Monthly inspections    Monthly.                
                                    with car-seal or lock-     of sealed valves.                                
                                    and-key configuration.                                                      
Scrubber.........................  Liquid flow rate or        1. Liquid flow rate into  1. Every 15 minutes.    
                                    pressure drop mounting     or out of the scrubber                           
                                    device. Also a pH          or the pressure drop                             
                                    monitor if the scrubber    across the scrubber.                             
                                    is used to control acid                                                     
                                    emissions.                                                                  
                                                              2. pH of effluent         2. Once a day.          
                                                               scrubber liquid.                                 
Thermal incinerator..............  Temperature monitoring     Firebox temperature.....  Every 15 minutes.       
                                    device installed in                                                         
                                    firebox or in ductwork                                                      
                                    immediately downstream                                                      
                                    of firebox b.                                                               
Catalytic incinerator............  Temperature monitoring     Temperature difference    Every 15 minutes.       
                                    device installed in gas    across catalyst bed.                             
                                    stream immediately                                                          
                                    before and after                                                            
                                    catalyst bed.                                                               
Flare............................  Heat sensing device        Presence of a flame at    Every 15 minutes.       
                                    installed at the pilot     the pilot light.                                 
                                    light.                                                                      
Boiler or process heater <44 mega  Temperature monitoring     Combustion temperature..  Every 15 minutes.       
 watts and vent stream is not       device installed in                                                         
 mixed with the primary fuel.       firebox b.                                                                  
Condenser........................  Temperature monitoring     Condenser exit (product   Every 15 minutes.       
                                    device installed at        side) temperature.                               
                                    condenser exit.                                                             
Carbon adsorber (nonregenerative)  None.....................  Operating time since      N/A.                    
                                                               last replacement.                                
Carbon adsorber (regenerative)...  Stream flow monitoring     1. Total regeneration     1. For each regeneration
                                    device, and.               stream mass or            cycle, record the total
                                                               volumetric flow during    regeneration stream    
                                                               carbon bed regeneration   mass or volumetric     
                                                               cycle(s).                 flow.                  

[[Page 50383]]

                                                                                                                
                                   Carbon bed temperature     2. Temperature of carbon  2. For each regeneration
                                    monitoring device.         bed after regeneration.   cycle, record the      
                                                                                         maximum carbon bed-    
                                                                                         temperature.           
                                                              3. Temperature of carbon  3. Within 15 minutes of 
                                                               bed within 15 minutes     completing any cooling 
                                                               of completing any         cycle, record the      
                                                               cooling cycle(s).         carbon bed temperature.
                                                              4. Operating time since   4. Operating time to be 
                                                               end of last               based on worst-case    
                                                               regeneration.             conditions.            
                                                              5. Check for bed          5. Yearly.              
                                                               poisoning.                                       
----------------------------------------------------------------------------------------------------------------
a As an alternative to the monitoring requirements specified in this table, the owner or operator may use a CEM 
  meeting the requirements of Performance Specifications 8 or 9 of appendix B of part 60 to monitor TOC every 15
  minutes.                                                                                                      
b Monitor may be installed in the firebox or in the ductwork immediately downstream of the firebox before any   
  substantial heat exchange is encountered.                                                                     


  Table 5 To Subpart GGG.--Control Requirements for Items of Equipment  
               That Meet the Criteria of Sec.  63.1252(f)               
------------------------------------------------------------------------
      Item of equipment                  Control requirement a          
------------------------------------------------------------------------
Drain or drain hub...........  (a) Tightly fitting solid cover (TFSC);  
                                or                                      
                               (b) TFSC with a vent to either a process,
                                or to a fuel gas system, or to a control
                                device meeting the requirements of Sec. 
                                63.1256(h)(2); or                       
                               (c) Water seal with submerged discharge  
                                or barrier to protect discharge from    
                                wind.                                   
Manhole b....................  (a) TFSC; or                             
                               (b) TFSC with a vent to either a process,
                                or to a fuel gas system, or to a control
                                device meeting the requirements of Sec. 
                                63.1256(h)(2); or                       
                               (c) If the item is vented to the         
                                atmosphere, use a TFSC with a properly  
                                operating water seal at the entrance or 
                                exit to the item to restrict ventilation
                                in the collection system. The vent pipe 
                                shall be at least 90 cm in length and   
                                not exceeding 10.2 cm in nominal inside 
                                diameter.                               
Lift station.................  (a) TFSC; or                             
                               (b) TFSC with a vent to either a process,
                                or to a fuel gas system, or to a control
                                device meeting the requirements of Sec. 
                                63.1256(h)(2); or                       
                               (c) If the lift station is vented to the 
                                atmosphere, use a TFSC with a properly  
                                operating water seal at the entrance or 
                                exit to the item to restrict ventilation
                                in the collection system. The vent pipe 
                                shall be at least 90 cm in length and   
                                not exceeding 10.2 cm in nominal inside 
                                diameter. The lift station shall be     
                                level controlled to minimize changes in 
                                the liquid level.                       
  Trench.....................  (a) TFSC; or                             
                               (b) TFSC with a vent to either a process,
                                or to a fuel gas system, or to a control
                                device meeting the requirements of Sec. 
                                63.1256(h)(2); or                       
                               (c) If the item is vented to the         
                                atmosphere, use a TFSC with a properly  
                                operating water seal at the entrance or 
                                exit to the item to restrict ventilation
                                in the collection system. The vent pipe 
                                shall be at least 90 cm in length and   
                                not exceeding 10.2 cm in nominal inside 
                                diameter.                               
Pipe.........................  Each pipe shall have no visible gaps in  
                                joints, seals, or other emission        
                                interfaces                              
Oil/Water separator..........  (a) Equip with a fixed roof and route    
                                vapors to a process or to a fuel gas    
                                system, or equip with a closed-vent     
                                system that routes vapors to a control  
                                device meeting the requirements of Sec. 
                                63.1256(h)(2); or                       
                               (b) Equip with a floating roof that meets
                                the equipment specifications of Sec.    
                                60.693 (a)(1)(i), (a)(1)(ii), (a)(2),   
                                (a)(3), and (a)(4).                     
 Tank........................  Maintain a fixed roof.c If the tank is   
                                spargedd or used for heating or treating
                                by means of an exothermic reaction, a   
                                fixed roof and a system shall be        
                                maintained that routes the organic      
                                hazardous air pollutants vapors to other
                                process equipment or a fuel gas system, 
                                or a closed-vent system that routes     
                                vapors to a control device that meets   
                                the requirements of 40 CFR Sec.  63.119 
                                (e)(1) or (e)(2).                       
------------------------------------------------------------------------
 AAAa Where a tightly fitting solid cover is required, it shall be      
  maintained with no visible gaps or openings, except during periods of 
  sampling, inspection, or maintenance.                                 
 AAAb Manhole includes sumps and other points of access to a conveyance 
  system.                                                               
 AAAc A fixed roof may have openings necessary for proper venting of the
  tank, such as pressure/vacuum vent, j-pipe vent.                      
 AAA d The liquid in the tank is agitated by injecting compressed air or
  gas.                                                                  


 Table 6 to Subpart GGG.--Wastewater--Compliance Options for Wastewaster
                                  Tanks                                 
------------------------------------------------------------------------
                               Maximum true                             
       Capacity, m\3\              vapor         Control requirements   
                               pressure, kPa                            
------------------------------------------------------------------------
<75.........................  ..............  Sec.  63.1256(b)(1).      
75 and <151.................           <13.1  Sec.  63.1256(b)(1).      
                                        13.1  Sec.  63.1256(b)(2).      
151.........................            <5.2  Sec.  63.1256(b)(1).      
                                         5.2  Sec.  63.1256(b)(2).      
------------------------------------------------------------------------


[[Page 50384]]


                         Table 7 to Subpart GGG.--Wastewater--Inspection and Monitoring Requirements for Waste Management Units                         
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                      Inspection or monitoring   Frequency of inspection or                                                             
           To comply with                    requirement                 monitoring                                     Method                          
--------------------------------------------------------------------------------------------------------------------------------------------------------
TANKS:                                                                                                                                                  
    63.1256(b)(3)(i)...............  Inspect fixed roof and all  Initially Semiannually....  Visual.                                                    
                                      openings for leaks.                                                                                               
    63.1256(b)(4)..................  Inspect floating roof in    See Secs.  63.120(a)(2)     Visual.                                                    
                                      accordance with Secs.       and (a)(3).                                                                           
                                      63.120(a)(2) and (a)(3).                                                                                          
    63.1256(b)(5)..................  Measure floating roof seal  ..........................  See Sec.  63.120(b)(2)(i) through (b)(4).                  
                                      gaps in accordance with                                                                                           
                                      Secs.  63.120(b)(2)(i)                                                                                            
                                      through (b)(4).                                                                                                   
                                     --Primary seal gaps.......  Initially Once every 5      ...........................................................
                                                                  years (annually if no                                                                 
                                                                  secondary seal).                                                                      
                                     --Secondary seal gaps.....  Initially Semiannually....  ...........................................................
63.1256(b)(7)......................  Inspect wastewater tank     Initially Semiannually....  Visual.                                                    
63.1256(b)(8)......................   for control equipment                                                                                             
                                      failures and improper                                                                                             
                                      work practices.                                                                                                   
SURFACE IMPOUNDMENTS:                                                                                                                                   
    63.1256(c)(1)(i)...............  Inspect cover and all       Initially Semiannually....  Visual.                                                    
                                      openings for leaks.                                                                                               
    63.1256(c)(2)..................  Inspect surface             Initially Semiannually....  Visual.                                                    
                                      impoundment for control                                                                                           
                                      equipment failures and                                                                                            
                                      improper work practices.                                                                                          
CONTAINERS:                                                                                                                                             
    63.1256(d)(1)(i)...............  Inspect cover and all       Initially Semiannually....  Visual.                                                    
    63.1256(d)(1)(ii)..............   openings for leaks.                                                                                               
    63.1256(d)(3)(i)...............  Inspect enclosure and all   Initially Semiannually....  Visual.                                                    
                                      openings for leaks.                                                                                               
    63.1256(d)(4)..................  Inspect container for       Initially Semiannually....  Visual.                                                    
                                      control equipment                                                                                                 
                                      failures and improper                                                                                             
                                      work practices.                                                                                                   
INDIVIDUAL DRAIN SYSTEMS a:                                                                                                                             
    63.1256(e)(1)(i)...............  Inspect cover and all       Initially Semiannually....  Visual.                                                    
                                      openings to ensure there                                                                                          
                                      are no gaps, cracks, or                                                                                           
                                      holes.                                                                                                            
    63.1256(e)(2)..................  Inspect individual drain    Initially Semiannually....  Visual.                                                    
                                      system for control                                                                                                
                                      equipment failures and                                                                                            
                                      improper work practices.                                                                                          
    63.1256(e)(4)(i)...............  Verify that sufficient      Initially Semiannually....  Visual.                                                    
                                      water is present to                                                                                               
                                      properly maintain                                                                                                 
                                      integrity of water seals.                                                                                         
    63.1256(e)(4)(ii)..............  Inspect all drains using    Initially Semiannually....  Visual.                                                    
    63.1256(e)(5)(i)...............   tightly-fitted caps or                                                                                            
                                      plugs to ensure caps and                                                                                          
                                      plugs are in place and                                                                                            
                                      properly installed.                                                                                               
    63.1256(e)(5)(ii)..............  Inspect all junction boxes  Initially Semiannually....  Visual or smoke test or other means as specified.          
                                      to ensure covers are in                                                                                           
                                      place and have no visible                                                                                         
                                      gaps, cracks, or holes.                                                                                           
    63.1256(e)(5)(iii).............  Inspect unburied portion    Initially Semiannually....  Visual.                                                    
                                      of all sewer lines for                                                                                            
                                      cracks and gaps.                                                                                                  
OIL-WATER SEPARATORS:                                                                                                                                   
    63.1256(f)(2)(i)...............  Inspect fixed roof and all  Initially Semiannually....  Visual.                                                    
                                      openings for leaks.                                                                                               
    63.1256(f)(3)..................  Measure floating roof seal  Initially b...............  See 40 CFR 60.696(d)(1).                                   
                                      gaps in accordance with                                                                                           
                                      40 CFR 60.696(d)(1).                                                                                              
                                     --Primary seal gaps.......  Once every 5 years........  ...........................................................
    63.1256(f)(3)..................  --Secondary seal gaps.....  Initially b Annually.                                                                  
    63.1256(f)(4)..................  Inspect oil-water           Initially Semiannually....  Visual.                                                    
                                      separator for control                                                                                             
                                      equipment failures and                                                                                            
                                      improper work practices.                                                                                          
--------------------------------------------------------------------------------------------------------------------------------------------------------
a As specified in Sec.  63.1256(e), the owner or operator shall comply with either the requirements of Sec.  63.1256(e)(1) and (2) or Sec.              
  63.1256(e)(4) and (5).                                                                                                                                
b Within 60 days of installation as specified in Sec.  63.1256(f)(3).                                                                                   


[[Page 50385]]


  Table 8 To Subpart GGG.--Fraction Measured (Fm) for HAP Compounds in  
                           Wastewater Streams                           
------------------------------------------------------------------------
              Chemical name                  CAS No. a          Fm      
------------------------------------------------------------------------
Acetaldehyde............................           75070         1.00   
Acetonitrile............................           75058         0.99   
Acetophenone............................           98862         0.31   
Acrolein................................          107028         1.00   
Acrylonitrile...........................          107131         1.00   
Allyl chloride..........................          107051         1.00   
Benzene.................................           71432         1.00   
Benzyl chloride.........................          100447         1.00   
Biphenyl................................           92524         0.86   
Bromoform...............................           75252         1.00   
Butadiene (1,3-)........................          106990         1.00   
Carbon disulfide........................           75150         1.00   
Carbon tetrachloride....................           56235         1.00   
Chlorobenzene...........................          108907         0.96   
Chloroform..............................           67663         1.00   
Chloroprene (2-Chloro-1,3-butadiene)....          126998         1.00   
Cumene..................................           98828         1.00   
Dichlorobenzene (p-1,4-)................          106467         1.00   
Dichloroethane (1,2-) (Ethylene                                         
 dichloride)............................          107062         1.00   
Dichloroethylether (Bis(2-Chloroethyl                                   
 ether))................................          111444         0.76   
Dichloropropene (1,3-)..................          542756         1.00   
Diethyl sulfate.........................           64675         0.0025 
Dimethyl sulfate........................           77781         0.086  
Dimethylaniline (N,N-)..................          121697         0.00080
Dimethylhydrazine (1,1-)................           57147         0.38   
Dinitrophenol (2,4-)....................           51285         0.0077 
Dinitrotoluene (2,4-)...................          121142         0.085  
Dioxane (1,4-) (1,4-Diethyleneoxide)....          123911         0.87   
Epichlorohydrin(1-Chloro-2,3-                                           
 epoxypropane)..........................          106898         0.94   
Ethyl acrylate..........................          140885         1.00   
Ethylbenzene............................          100414         1.00   
Ethyl chloride (Chloroethane)...........           75003         1.00   
Ethylene dibromide (Dibromomethane).....          106934         1.00   
Ethylene glycol dimethyl ether..........          110714         0.86   
Ethylene glycol monobutyl ether acetate.          112072         0.043  
Ethylene glycol monomethyl ether acetate          110496         0.093  
Ethylene oxide..........................           75218         1.00   
Ethylidene dichloride (1,1-                                             
 Dichloroethane)........................           75343         1.00   
Hexachlorobenzene.......................          118741         0.97   
Hexachlorobutadiene.....................           87683         0.88   
Hexachloroethane........................           67721         0.50   
Hexane..................................          110543         1.00   
Isophorone..............................           78591         0.47   
Methanol................................           67561         0.85   
Methyl bromide (Bromomethane)...........           74839         1.00   
Methyl chloride (Chloromethane).........           74873         1.00   
Methyl ethyl ketone (2-Butanone)........           78933         0.99   
Methyl isobutyl ketone (Hexone).........          108101         0.98   
Methyl methacrylate.....................           80626         1.00   
Methyl tert-butyl ether.................         1634044         1.00   
Methylene chloride (Dichloromethane)....           75092         1.00   
Naphthalene.............................           91203         0.99   
Nitrobenzene............................           98953         0.39   
Nitropropane (2-).......................           79469         0.99   
Phosgene................................           75445         1.00   
Propionaldehyde.........................          123386         1.00   
Propylene dichloride (1,2-                                              
 Dichloropropane).......................           78875         1.00   
Propylene oxide.........................           75569         1.00   
Styrene.................................          100425         1.00   
Tetrachloroethane (1,1,2,2-)............           79345         1.00   
Tetrachloroethylene (Perchloroethylene).          127184         1.00   
Toluene.................................          108883         1.00   
Toluidine (o-)..........................           95534         0.15   
Trichlorobenzene (1,2,4-)...............          120821         1.00   
Trichloroethane (1,1,1-) (Methyl                                        
 chloroform)............................           71556         1.00   
Trichloroethane (1,1,2-) (Vinyl                                         
 Trichloride)...........................           79005         0.98   
Trichloroethylene.......................           79016         1.00   
Trichlorophenol (2,4,5-)................           95954         1.00   
Triethylamine...........................          121448         1.00   
Trimethylpentane (2,2,4-)...............          540841         1.00   
Vinyl acetate...........................          108054         1.00   
Vinyl chloride (Chloroethylene).........           75014         1.00   

[[Page 50386]]

                                                                        
Vinylidene chloride (1,1-                                               
 Dichloroethylene)......................           75354         1.00   
Xylene (m-).............................          108383         1.00   
Xylene (o-).............................           95476         1.00   
Xylene (p-).............................          106423         1.00   
------------------------------------------------------------------------
a CAS numbers refer to the Chemical Abstracts Service registry number   
  assigned to specific compounds, isomers, or mixtures of compounds.    


     Table 9 to Subpart GGG.--Default Biorates for List 1 Compounds     
------------------------------------------------------------------------
                                                           Biorate (K1),
                      Compound name                        L/g MLVSS-hr 
------------------------------------------------------------------------
Acetonitrile............................................           0.100
Acetophenone............................................           0.538
Diethyl sulfate.........................................           0.105
Dimethyl hydrazine(1,1).................................           0.227
Dimethyl sulfate........................................           0.178
Dinitrotoluene(2,4).....................................           0.784
Dioxane(1,4)............................................           0.393
Ethylene glycol dimethyl ether..........................           0.364
Ethylene glycol monomethyl ether acetate................           0.159
Ethylene glycol monobutyl ether acetate.................           0.496
Isophorone..............................................           0.598
Methanol................................................             (a)
Nitrobenzene............................................           2.300
Toluidine (-0)..........................................          0.859 
------------------------------------------------------------------------
a For direct dischargers, the default biorate for methanol is 3.5 L/g   
  MLVSS-hr; for indirect dischargers, the default biorate for methanol  
  is 0.2 L/g MLVSS-hr.                                                  

[FR Doc. 98-23168 Filed 9-18-98; 8:45 am]
BILLING CODE 6560-50-P