# National Emission Standards for Hazardous Air Pollutants Pharmaceuticals Production

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## Record

- **Collection:** Federal Register
- **Document type:** Proposed Rule
- **Published:** April 2, 1997
- **Citation:** 62 FR 15754

## Text

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

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

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

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

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

The information presented in this preamble is organized as follows:

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

[[Page 15755]]

I. List of Source Categories

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

II. Background

A. Summary of Considerations Made in Developing This Rule

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

B. Regulatory Background

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

[[Page 15756]]

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

A. Source of Authority for NESHAP Development

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

B. Criteria for Development of NESHAP

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

IV. Summary of Proposed Standards

A. Source Categories to be Regulated

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

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

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

C. Affected Sources

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

[[Page 15757]]

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

D. Format of the Standards

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

E. Basis and Level of Proposed Standards

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

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

[[Page 15758]]

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

[[Page 15759]]

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

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

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

F. Compliance and Performance Test Provisions

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

G. Monitoring Requirements

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

H. Reporting and Recordkeeping Requirements

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

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

A. Facilities Affected by These NESHAP

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

B. Air Impacts

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

[[Page 15760]]

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

C. Water and Solid Waste Impacts

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

D. Energy Impacts

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

E. Cost Impacts

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

F. Economic Impacts

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

VI. Emissions Averaging

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

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

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

[[Page 15761]]

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

VIII. Solicitation of Comments

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

[[Page 15762]]

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

[[Page 15763]]

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

IX. Administrative Requirements

A. Public Hearing

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

B. Docket

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

C. Executive Order 12866

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

D. Enhancing the Intergovernmental Partnership Under Executive Order
12875

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

E. Paperwork Reduction Act

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

F. Regulatory Flexibility Act

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

[[Page 15764]]

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

G. Unfunded Mandates

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

H. Miscellaneous

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

List of Subjects in 40 CFR Part 63

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

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

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

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

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

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

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

Subpart GGG--National Emission Standards for Pharmaceuticals Production

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

Subpart GGG--National Emission Standards for Pharmaceuticals

Sec. 63.1250 Applicability.

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

[[Page 15765]]

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

Sec. 63.1251 Definitions.

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

[[Page 15766]]

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

[[Page 15767]]

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

Sec. 63.1252 Standards.

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

[[Page 15768]]

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

FR = 0.02*(HL)-1,000

Where:

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

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

[[Page 15769]]

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

[[Page 15770]]

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

Sec. 63.1253 Test methods and compliance procedures.

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

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A97-7625. Public record. Not legal advice.