National Emission Standards for Hazardous Air Pollutants for Source Categories: Pharmaceuticals Production
Federal RegisterSep 21, 1998
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SUMMARY: This action promulgates national emission standards for
hazardous air pollutants (NESHAP) to reduce air emissions of hazardous
air pollutants (HAP) from existing and new facilities that manufacture
pharmaceutical products. The Agency intends that this promulgated rule
will have a common technology basis with a rule promulgated this date
under the Clean Water Act (CWA) and published elsewhere in this issue
of the Federal Register; this will allow coordinated and cost effective
compliance planning by the industry. The standards implement section
112 of the Clean Air Act (CAA) as amended in 1990. The standards apply
to major source facilities which produce pharmaceutical products.
The major HAP emitted by facilities covered by this final rule
include methylene chloride, methanol, toluene, and hydrogen chloride.
Methylene chloride is considered to be a probable human carcinogen and
the other pollutants can cause noncancer health effects in humans. The
promulgated rule is estimated to reduce HAP emissions from existing
facilities by 22,000 megagrams per year (Mg/yr) (24,000 tons per year
[tons/yr]). It also reduces volatile organic compound (VOC) emissions.
DATES: This regulation is effective on September 21, 1998. The
incorporation by reference of certain publications listed in the
regulation is approved by the Director of the Office of the Federal
Register as of September 21, 1998. See the SUPPLEMENTARY INFORMATION
section concerning judicial review.
ADDRESSES: Docket. Docket No. A-96-03, containing supporting
information used in developing the standards, is available for public
inspection and copying between 8:30 a.m. and 3:30 p.m., Monday through
Friday, at EPA's Air Docket Section, Waterside Mall, Room 1500, 1st
Floor, 401 M Street SW., Washington, DC 20460. A reasonable fee may be
charged for copying.
FOR FURTHER INFORMATION CONTACT: For information concerning the final
CAA standard, contact Mr. Randy McDonald at (919) 541-5402, Organic
Chemicals Group, Emission Standards Division (MD-13), U.S.
Environmental Protection Agency, Research Triangle Park, North Carolina
27711. For further information concerning the CWA effluent limitation
guidelines pretreatment standards and new source performance standards,
contact Dr. Frank H. Hund, at (202) 260-7786, Engineering and Analysis
Division (4303), U.S. Environmental Protection Agency, 401 M Street
SW., Washington, DC 20460. For information concerning applicability and
rule determinations, contact your State or local representative or the
appropriate EPA regional representatives. For a listing of EPA regional
contacts, see the following SUPPLEMENTARY INFORMATION section.
SUPPLEMENTARY INFORMATION: An electronic version of documents from the
Office of Air and Radiation (OAR) are available through EPA's OAR
Technology Transfer Network Web site (TTNWeb). The TTNWeb is a
collection of related Web sites containing information about many areas
of air pollution science, technology, regulation, measurement, and
prevention. The TTNWeb is directly accessible from the Internet via the
World Wide Web at the following address, ``http://www.epa.gov/ttn''.
Electronic versions of this preamble and rule are located under the OAR
Policy and Guidance Information Web site, ``http://www.epa.gov/ttn/
oarpg/'', under the Federal Register Notices section. If more
information on the TTNWeb is needed, contact the Systems Operator at
(919) 541-5384.
Regulated entities. Entities potentially regulated are those which
produce pharmaceutical products and intermediates and are located at
facilities that are major sources as defined in section 112 of the CAA.
Regulated categories and entities include:
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Category Regulated entities
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Industry............................... Facilities described by the SIC codes 2833 and 2834 and NAICS
codes 32541 and 325412.
Producers of finaished dosage forms of drugs, for example,
tablets, capsules, solutions, that contain an active ingredient
generally, but not necessarily, in association with inactive
ingredients.
Producers of components whose intended primary use is to
furnish pharmacological activity or other direct effect in the
diagnosis, cure, mitigation, treatment, or prevention of disease, or
to affect the structure or any function of the body of humans or other
animals.
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This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be regulated by this
action. This table lists the types of entities that EPA is now aware
could potentially be regulated by this action. Other types of entities
not listed in the table could also be regulated. To determine whether
your facility, company, business, organization, etc., is regulated by
this action, you should carefully examine the applicability criteria in
Sec. 63.1250 of the rule. If you have questions regarding the
applicability of this action to a particular entity, contact the
appropriate Regional representative:
Region I
NESHAP (MACT) Coordinator, U.S. EPA Region I, John F. Kennedy Federal
Building, One Congress Street, Boston, MA 02203-001, (617) 565-3438
Region II
Umesh Dholakia, U.S. EPA Region II, 290 Broadway Street, New York, NY
10007-1866, (212) 637-4023 (Umesh), (212) 637-4065 (Yue-On)
Region III
Bernard Turlinski, U.S. EPA Region III, 841 Chestnut Building,
Philadelphia, PA 19107, (215) 566-2150
Region IV
Lee Page, U.S. EPA Region IV, Atlanta Federal Center, 61 Forsyth Street
SW, Atlanta, GA 30303-3104, (404) 562-9131
Region V
Bruce Varner, U.S. EPA Region V, 77 West Jackson Boulevard, Chicago, IL
60604-3507, (312) 886-6793
Region VI
Robert Todd, U.S. EPA Region VI, First Interstate Bank Tower @ Fountain
Place, 1445 Ross Avenue, 12th Floor, Suite 1200, Dallas, TX 75202-2733,
(214) 665-2156
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Region VII
Richard Tripp, U.S. EPA Region VII, Air Toxics Coordinator, 726
Minnesota Avenue, Kansas City, KS 66101, (913) 551-7566
Region VIII
Ann Marie Patrie, U.S. EPA Region VIII, Air Toxics Coordinator, 999
18th Street, Suite 500, Denver, CO 80202-2466, (303) 312-6524
Region IX
Nahid Zoueshtiagh, U.S. EPA Region IX, Air Division-6, 75 Hawthorne
Street, San Francisco, CA 94105, (415) 744-1261
Region X
Andrea Wullenweber, U.S. EPA Region X, Air Toxics Coordinator, 1200
Sixth Avenue, Seattle, WA 98101, (206) 553-8760
Judicial review. Under section 307(b)(1) of the Act, judicial
review of NESHAP is available only by filing a petition for review in
the U.S. Court of Appeals for the District of Columbia Circuit within
60 days of today's publication of this final rule. Under section
307(b)(2) of the Act, the requirements that are the subject of today's
notice may not be challenged later in civil or criminal proceedings
brought by the EPA to enforce these requirements. The information
presented in this preamble is organized as follows:
I. List of Source Categories
II. Background
A. Summary of Considerations Made in Developing These Standards
B. Regulatory Background
C. Regulation of the Pharmaceutical Manufacturing Industry Under
the Clean Water Act
III. Authority for National Emission Standards for Hazardous Air
Pollutants (NESHAP) Decision Process
A. Source of Authority for NESHAP Development
B. Criteria for Development of NESHAP
IV. Summary of Promulgated Standards
A. Source Categories to be Regulated
B. Pollutants to be Regulated and Associated Environmental and
Health Benefits
C. Affected Sources
D. Storage Tank Provisions
E. Process Vent Provisions
F. Wastewater Provisions
G. Equipment Leaks
H. Pollution Prevention Alternative
I. Heat Exchange Provisions
J. Emissions Averaging Provisions
K. Alternative Standard
L. Test Methods and Compliance Procedures
M. Monitoring Requirements
N. Recordkeeping and Reporting Requirements
V. Summary of Environmental, Energy, Cost, and Economic Impacts
A. Air Impacts
B. Water and Solid Waste Impacts
C. Energy Impacts
D. Cost Impacts
E. Economic Impacts
VI. Major Comments and Changes to the Proposed Standards
A. Applicability Provisions and Definitions
B. Storage Tank Provisions
C. Process Vent Provisions
D. Wastewater Provisions
E. Equipment Leak Provisions
F. Pollution Prevention Alternative
G. Alternative Standard
H. Testing Provisions and Compliance Demonstrations
I. Equations
J. Monitoring Requirements
K. Recordkeeping and Reporting Requirements
L. Management of Change
VII. Technical Amendment to 40 CFR Part 9
VIII. Administrative Requirements
A. Docket
B. Executive Order 12866
C. Enhancing the Intergovernmental Partnership Under Executive
Order 12875
D. Paperwork Reduction Act
E. Regulatory Flexibility Act
F. Unfunded Mandates
G. Submission to Congress and the Comptroller General Office
H. National Technology Transfer and Advancement Act
I. Executive Order 13045
I. List of Source Categories
Section 112 of the amended Act requires that EPA evaluate and
control emissions of HAP. The control of HAP is achieved through
promulgation of emission standards under sections 112(d) and 112(f) and
work practice and equipment standards under section 112(h) for
categories of sources that emit HAP. On July 16, 1992, EPA published an
initial list of major and area source categories to be regulated (57 FR
31576). Included on that list were major sources emitting HAP from
pharmaceuticals production.
Production methods used in the manufacture of pharmaceutical
products include both batch and continuous operations, although batch
operations make up a majority of the processes. The sizes of the
facilities range from those that make one product at the rate of
several hundred kilograms per year (kg/yr) to those that produce
numerous pharmaceutical products on the scale of thousands of kilograms
(megagrams [Mg]) per year. Air emissions of HAP compounds originate
from breathing and withdrawal losses from storage tanks, venting of
process vessels, leaks from piping and equipment used to transfer HAP
compounds (equipment leaks), and volatilization of HAP from wastewater
streams. Pollutants emitted from the production processes include a
range of organic compounds, including VOC and several specific HAP.
Among the most prevalent are methylene chloride and methanol, which
account for nearly 70 percent of all HAP emissions from this industry.
Detailed information describing manufacturing processes and emissions
can be found in the basis and purpose document located in Docket A-96-
03, Item No. III-B-01.
As of 1992, over 80 U.S. companies at 270 facilities were producing
pharmaceutical products. Manufacturing operations covered by this
NESHAP include chemical synthesis, formulation, fermentation, and
extraction processes and are generally classified under standard
industrial classification 283. An estimated 101 facilities are
considered to be major sources according to the CAA criterion of having
the potential to emit 10 tons/yr of any one HAP or 25 tons/yr of
combined HAP, based on 1992 emissions data. Today's final standard
applies to all major sources that produce pharmaceutical products. Area
sources are not subject to this standard.
II. Background
A. Summary of Considerations Made in Developing These Standards
This regulation reduces emissions of many of the HAP listed in
section 112(b)(1) of the CAAA. The alternatives considered in the
development of this regulation, including those alternatives selected
as standards for new and existing sources, are based on process and
emissions data received from the existing facilities known by the EPA
to be in operation.
Regulatory alternatives more stringent than the maximum achievable
control technology (MACT) floor (minimum control level) were selected
when they were judged to be reasonable, considering cost, nonair
impacts, and energy requirements.
Today's final rule gives existing affected sources 3 years from the
date of promulgation to comply. This is the maximum amount of time
allowed by the Act. New affected sources are required to comply with
the standard upon startup.
Included in today's final rule are methods for determining initial
compliance as well as monitoring, recordkeeping, and reporting
requirements. All of these components are necessary to ensure that
affected sources comply with the standards both initially and over
time. However, the
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EPA has made every effort to simplify the requirements in the final
rule. In addition, EPA has significantly reduced the amount of cross-
referencing to other rules included in today's final standards at the
request of facilities affected by these standards.
In addition, this rule contains an important and innovative
pollution prevention alternative for the pharmaceutical industry that
provides an option to reduce HAP emissions through reductions in HAP
solvent consumption as opposed to installing end-of-pipe controls. The
EPA has developed a regulation that provides a pollution prevention
compliance alternative to the traditional control requirements, and the
EPA encourages the pharmaceutical industry to meet the CAA requirements
through its use. This alternative demonstrates EPA's commitment to
developing regulations that are cost effective and flexible, and that
reduce monitoring, recordkeeping, and reporting burdens.
Representatives from other interested EPA offices and programs,
including State and regional environmental agency personnel, and
representatives from industry participated in the regulatory
development process as MACT partnership members. For example, Region
II, acting as the lead, worked closely with the States of New York and
New Jersey as well as the pharmaceutical industry in developing the
pollution prevention alternative. The partnership members were given
opportunities to review and comment on the regulation prior to proposal
and had the opportunity to comment on the proposed standards and to
provide additional information during the public comment period that
followed proposal.
The standards were proposed in the Federal Register on April 2,
1997 [62 FR 15754]. The preamble to the proposed standards and the
basis and purpose document (Docket Item III-B-01) described the
rationale for the proposed standards. Public comments were solicited at
the time of proposal. To provide interested persons the opportunity for
oral presentation of data, views, or arguments concerning the proposed
standards, a public hearing was offered at proposal. However, the
public did not request a hearing and, therefore, one was not held. The
public comment period was from April 2, 1997 to July 2, 1997. More than
40 letters were received during the comment period. Commenters included
industry representatives and State agencies. The comments were
carefully considered, and changes were made in the proposed standards
when determined by the EPA to be appropriate. A detailed discussion of
these comments and responses can be found in the promulgation
background information document (BID) which is located in Docket No. A-
96-03, Item V-B-01, which is referenced in the ADDRESSES section of
this preamble. The promulgation BID (summary of comments and responses
document) serves as the basis for the revisions that have been made to
the standards between proposal and promulgation. Section VI of this
preamble discusses these major changes.
B. Regulatory Background
Today's final rule implements section 112(d) of the Clean Air Act
(CAA) amendments of 1990, which require the Administrator to regulate
emissions of HAP listed in section 112(b) of the CAA. The intent of
this rule is to protect the public health by requiring new and existing
major sources to reduce generation of emissions by using pollution
prevention strategies or to control emissions to the level achievable
by the maximum achievable control technology (MACT), taking into
consideration the cost of achieving such emission reductions, any
nonair quality and other air quality related health and environmental
impacts, and energy requirements.
In 1978, EPA published a control techniques document entitled
``Control of Volatile Organic Emissions from Manufacture of Synthesized
Pharmaceutical Products,'' EPA-450/2-78-029. The control technique
guidelines document (CTG) contains a presumptive norm for reasonably
available control technology (RACT) for the manufacturing operations
covered under SIC Codes 2833 and 2834. Today's final rule does not
affect the presumptive RACT guidelines, although a portion of emissions
sources are covered by both today's final regulation and the CTG
document.
In 1994, EPA promulgated National Emission Standards for Hazardous
Air Pollutants for Certain Processes Subject to the Negotiated
Regulation for Equipment Leaks. Pharmaceutical processes, defined as
processes that synthesize pharmaceutical intermediates or final
products using carbon tetrachloride or methylene chloride as a reactant
or process solvent, are subject to this rule. Today's final rule
requires control of leaking components that are currently not subject
to the Negotiated Regulation for Equipment Leaks, but that contain and/
or transport HAP and are associated with processes in this source
category. Today's rule also allows sources subject to the Negotiated
Regulation to comply with the LDAR provisions of this rule.
C. Regulation of the Pharmaceutical Manufacturing Industry Under the
Clean Water Act
The Clean Water Act (CWA) and a recent settlement agreement (see 59
FR 25869) require EPA to develop effluent limitations guidelines and
standards regulations for the pharmaceutical manufacturing industry.
On May 2, 1995 at 60 FR 21592, the EPA proposed best available
technology (BAT) economically achievable and new source performance
standards (NSPS) regulations for 53 volatile and semivolatile organic
pollutants of which 17 are HAP. The Agency also proposed pretreatment
standards for existing sources (PSES) and performance standards for new
sources (PSNS) for 45 volatile organic pollutants of which 16 are HAP.
The technology basis for the volatile organic limitations were based on
steam stripping and advanced biological treatment. The proposed NSPS
and PSNS differed from BAT and PSES, respectively, in that they were
based on steam stripping plus distillation.
In the April 2, 1997 proposal EPA indicated that it was considering
changing the BAT technology basis to advanced biological treatment
only. The EPA also described three options under consideration for
setting PSES and PSNS to address HAP and non-HAP wastewater pollutant
discharges not controlled by the MACT standards. Under the first option
compliance with the MACT standards would constitute compliance with
PSES and PSNS. Option 2 involved compliance with the MACT standards
plus additional PSES based on the performance data base for the 1995
proposed PSES for all volatile organic pollutants except alcohols and
related pollutants, and Option 3 was the same as Option 2 except the
additional pollutants included alcohols and related pollutants.
On August 8, 1997, at 62 FR 42720, the EPA published a Notice of
Availability (NOA) to allow public comment on the data received since
the May 2, 1995 CWA proposal and to further develop and revise options
for the control of volatile organic pollutant discharges presented in
the April 2, 1997 MACT proposal. The EPA provided the results of an EPA
sampling study designed to provide information concerning the pass-
through analysis for water soluble organic pollutants such as methanol
and provided a discussion thereafter of the final pass-through analysis
that EPA would be performing with respect to these and other
[[Page 50283]]
pollutants. The EPA also presented revisions to the pretreatment
options (Options 2 and 3) which were first suggested in the CWA section
of the April 2, 1997 MACT proposal.
Elsewhere in today's Federal Register EPA is publishing final
effluent limitation guideline and standards under the Clean Water Act
for the pharmaceutical manufacturing point source category.
III. Authority for National Emission Standards for Hazardous Air
Pollutants (NESHAP) Decision Process
A. Source of Authority for NESHAP Development
Section 112 of the Clean Air Act gives the EPA the authority to
establish national standards to reduce air emissions from sources that
emit one or more HAP. Section 112(b) contains a list of HAP to be
regulated by NESHAP. Section 112(c) directs the Agency to use this
pollutant list to develop and publish a list of source categories for
which NESHAP will be developed; this list was published in the Federal
Register on July 16, 1992 (57 FR 31576). The Agency must list all known
categories and subcategories of ``major sources'' that emit one or more
of the listed HAP. A major source is defined in section 112(a) as any
stationary source or group of stationary sources located within a
contiguous area and under common control that emits or has the
potential to emit in the aggregate, considering controls, 10 tons/yr or
more of any one HAP or 25 tons/yr or more of any combination of HAP.
B. Criteria for Development of NESHAP
The NESHAP are to be developed to control HAP emissions from both
new and existing sources according to the statutory directives set out
in section 112(d) of the Act. The statute requires the standards to
reflect the maximum degree of reduction in emissions of HAP that is
achievable for new or existing sources. This control level is referred
to as the ``maximum achievable control technology'' (MACT). The
selection of MACT must reflect consideration of the cost of achieving
the emission reduction, any nonair quality health and environmental
impacts, and energy requirements for control levels more stringent than
the floor (described below).
The MACT floor is the least stringent level for MACT standards. For
new sources, the standards for a source category or subcategory ``shall
not be less stringent than the emission control that is achieved in
practice by the best controlled similar source, as determined by the
Administrator'' [section 112(d)(3)]. Existing source standards should
be no less stringent than the average emission limitation achieved by
the best performing 12 percent of the existing sources for categories
and subcategories with 30 or more sources or the average emission
limitation achieved by the best performing 5 sources for categories or
subcategories with fewer than 30 sources [section 112(d)(3)]. The
determination of the MACT floor for existing sources under today's rule
is that the average emission limitation achieved by the best performing
sources is based on a measure of central tendency, such as the
arithmetic mean, median, or mode. The determination of percentage
reduction in the production-indexed consumption factors used in the
pollution prevention alternative is based on the criteria that the
alternative must achieve emissions reductions equivalent to what would
have been achieved by complying with the MACT.
IV. Summary of Promulgated Standards
A. Source Categories to be Regulated
Today's final rule regulates HAP emissions from pharmaceutical
production facilities that are determined to be major sources. These
standards apply to existing sources as well as new sources. The final
standards for existing and new source are summarized in Table 1.
BILLING CODE 6560-50-P
Table 1.--Standards for New and Existing Sources
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Applicability
Emission point New or existing? ---------------------------------------------- Requirement
Applicability Level Cutoff
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Process vents...................... New.................. Processes............ >400 lb HAP/yr 98 percent control or 20 ppmv TOC and 20 ppmv
uncontrolled. hydrogen halide and halogen outlet limit.
Existing............. Processes............ 2,000 lb 93 percent control or 2,000 lb HAP/yr or 20
HAP/yr controlled. ppmv TOC and 20 ppmv hydrogen halide and
halogen outlet limit (if there are any vents
in a process not manifolded to the control
device, process must still meet 93 percent
control); and 98 percent* for individual
vents (within a process) meeting cutoff based
on flow and emissions or 20 ppmv TOC and 20
ppmv hydrogen halide and halogen outlet
limit.
Storage tanks...................... New and existing..... 10,000 gal 1.9 psia 90 percent control or 20 ppmv TOC and 20 ppmv
and 20,000 gal 1.9 psia 95 percent control or 20 ppmv TOC and 20 ppmv
vapor pressure of hydrogen halide and halogen outlet limit**
liquid stored.
Wastewater......................... New and existing..... >Mg/yr total HAP load 1,300 ppm 99 percent reduction of Table 2 HAP.
from all POD from at POD of Table 2
PMPU. HAP.
5,200 ppmw 99 percent reduction of Table 2 HAP.
at POD of total HAP 90 percent reduction of Table 3 HAP.
load. 95 percent reduction of total HAP using
biotreatment.
>1 Mg/yr total HAP 10,000 99 percent reduction of Table 2 HAP.
load from facility. ppmw at POD of total 90 percent reduction of Table 3 HAP.
HAP load. 95 percent reduction of total HAP using
biotreatment.
New.................. >1 Mg/yr total HAP 110,000 99 percent reduction of Table 3 HAP and
load from all POD ppmw at POD of Table existing source requirements.
from PMPU. 3 HAP.
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Equipment leaks.................... New and existing..... All components in HAP LDAR program.
service.
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*For process vents controlled to 93 percent prior to April 2, 1997, no additional control is required.
**For tanks controlled to 90 percent prior to April 2, 1997, no additional control is required.
BILLING CODE 6560-50-M
B. Pollutants to be Regulated and Associated Environmental and Health
Benefits
Pharmaceutical production facilities emit an estimated 34,000 Mg/yr
of organic and inorganic HAP. Organic HAP include methylene chloride,
methanol, toluene, dimethylformamide, and hexane as well as other HAP.
Hydrogen chloride is an inorganic HAP emitted by this industry. Today's
final rule reduces HAP emissions from pharmaceutical facilities by 65
percent. Some of these pollutants are considered to be carcinogenic,
and all can cause toxic health effects following exposure, including
nausea, headaches, and possible reproductive effects. The EPA does
recognize that the degree of adverse effects to human health can range
from mild to severe. The extent and degree to which the human health
effects may be experienced is dependent upon (1) the ambient
concentration observed in the area (e.g., as influenced by emission
rates, meteorological conditions, and terrain); (2) the frequency of
and duration of exposures; (3) characteristics of exposed individuals
(e.g., genetics, age, pre-existing health conditions, and lifestyle)
which vary significantly with the population; and (4) pollutant
specific characteristics (toxicity, half-life in the environment,
bioaccumulation, and persistence).
Most of the organic HAP emitted from this industry are classified
as VOC. The emission controls for HAP will reduce non-HAP VOC emissions
as well. Emissions of VOC have been associated with a variety of health
and welfare impacts. Volatile organic compound emissions, together with
nitrogen oxides, are precursors to the formation of tropospheric ozone.
Exposure to ambient ozone is responsible for a series of public health
impacts, such as alterations in lung capacity; eye, nose, and throat
irritation; nausea; and aggravation of existing respiratory disease.
The welfare impacts from exposure to ambient ozone include damage to
selected commercial timber species and economic losses for commercially
valuable crops such as soybeans and cotton.
Hydrogen chloride is listed under section 112(r) of the CAA. The
intent of section 112(r), Prevention of Accidental Releases, is to
focus on chemicals that would pose a significant hazard to the
community in the event of an accident, to prevent their accidental
release, and to minimize consequences should a release occur. Hydrogen
chloride, along with the other substances listed under section
112(r)(3), is listed because it is known to cause, or may be reasonably
anticipated to cause death, injury, or serious adverse effects to human
health or the environment (see 59 FR 4478, January 31, 1994). Sources
that handle hydrogen chloride in greater quantities than the
established threshold quantity under section 112(r)(5) are subject to
the risk management program requirements under section 112(r)(7) (see
58 FR 54190, October 20, 1993).
In essence, the MACT standards mandated by the CAA will ensure that
all major sources of air toxic emissions achieve the level of control
already being achieved by the better controlled and lower emitting
sources in each category. This approach provides assurance to citizens
that each major source of toxic air pollution will be required to
effectively control its emissions. In addition, the emission reductions
achieved by today's final standards, when combined with the reductions
achieved by other MACT standards, will contribute to achieving the
primary goal of the CAA, which is to ``protect and enhance the quality
of the Nations's air resources so as to promote the public health and
welfare and the productive capacity of its population'' (the CAA,
section 101(b)(1)).
C. Affected Sources
Emission points identified from pharmaceuticals production include
process vents, equipment leaks, storage tanks, wastewater collection
and treatment systems, and heat exchange systems. The affected source
subject to this subpart is any pharmaceutical manufacturing operation,
as defined in Sec. 63.1251 of today's final rule, that meets the
following criteria: (1) it manufactures a pharmaceutical product, as
defined in Sec. 63.1251; (2) it is located at a plant site that is a
major source as defined in section 112(a) of the Act; and (3) it
processes, uses, or produces HAP. Based on this definition of affected
source, new sources are created by reconstructing existing sources,
constructing new ``greenfield'' facilities, or constructing an addition
to an existing source which is a dedicated pharmaceutical manufacturing
process unit (PMPU) and exceeds 10 tons/yr of an individual HAP or 25
tons/yr of combined HAP. Reconfigurations of existing equipment do not
constitute ``construction'' and therefore NSM would not be triggered
under this circumstance. Therefore, a new affected source subject to
this subpart is any affected source for which construction or
reconstruction commenced after April 2, 1997, and the standard was
applicable at the time of construction or reconstruction, or any PMPU
that is dedicated to manufacturing a single product that has the
potential to emit 10 tons per year of any one HAP or 25 tons per year
of combined HAP, for which construction commenced after April 2, 1997.
The PMPU is defined according to the equipment used to make a
pharmaceutical product. The PMPU also includes storage tanks that are
associated with the process.
D. Storage Tank Provisions
Today's final standards require existing and new sources to control
emissions from storage tanks having volumes greater than or equal to 38
cubic meters (m3) (10,000 gallons), and storing material
with a vapor pressure of greater than or equal to 13.1 kPa (1.9 psi).
The final standards require that emissions from storage tanks with
capacities greater than or equal to 38 m3 (10,000 gallons)
and less than 75 m3 (20,000 gallons) be reduced by 90
percent. Emissions from storage tanks greater than or equal to 75
m3 (20,000 gallons) must be reduced by 95 percent.
[[Page 50285]]
One of the following control systems can be applied to meet these
requirements:
1. An internal floating roof with specified seals and fittings;
2. An external floating roof with specified seals and fittings;
3. An external floating roof converted to an internal floating roof
with specified seals and fittings; or
4. A closed vent system with the appropriate 90 or 95 percent
efficient control device.
The final rule also includes an alternative standard for any
storage tank vents that are routed to an add-on control device. Under
the alternative standard, an owner or operator may choose to comply
with a total organic compound (TOC) and hydrogen halide and halogen
limit of 20 ppmv or less, measured prior to dilution and at the outlet
of the control device. The alternative standard is discussed in more
detail in sections IV.K and VI.G of this preamble and is included in
Sec. 63.1253(d) of the final rule. Today's final rule does not provide
for vapor balancing systems to be used as an alternative means of
control for storage tanks.
E. Process Vent Provisions
The MACT standard for most existing process vents was set at the
floor level of control, which was determined to be 93 percent control.
The final standards require existing sources to reduce emissions from
the sum of all vents within a process to 900 kg/yr (2,000 pounds per
year [lb/yr]), considering control, or meet an overall process control
level of 93 percent. The 2,000 lb/yr compliance option is limited to
seven processes per year per facility. Additionally, a regulatory
alternative beyond the floor was selected that requires 98 percent
control of some large emission vents. Individual process vents
(manifolded or nonmanifolded) meeting the annual emissions and flow
rate criteria are required to achieve 98 percent control, independent
of the overall 93 percent requirement. (Those process vents achieving
93 percent control prior to April 2, 1997 are not required to meet the
98 percent control requirement.) The MACT standard for process vents at
new sources was set at the floor level of control. The MACT floor was
determined from the best controlled similar source and is based on the
most stringent control level achieved for both chemical synthesis and
formulation type processes. Today's final standards for new sources
require 98 percent control of vents in a process that has uncontrolled
emissions greater than 182 kg/yr (400 lb/yr).
An alternative standard for process vents was added to the final
rule [see Sec. 63.1254(c)]. Under the alternative standard, an owner or
operator may choose to comply with a TOC and hydrogen halide and
halogen limit of 20 ppmv or less, measured prior to dilution and at the
outlet of the control device. If only a portion of the process vents
associated with a process comply with the alternative standard, then
the remaining process vents must be controlled to the levels required
by the standards (e.g., 93 percent for the sum of remaining vents and/
or 98 percent control of some individual vents for existing sources and
98 percent control of the sum of remaining vents for new sources).
The process vent and storage tank standards also contain provisions
for complying in essentially the same manner as is described by the
alternative standard--by routing streams to control devices achieving
an outlet concentration of TOC and hydrogen halide and halogen limit of
20 ppmv or less, measured prior to dilution. These provisions differ
from those described under the Alternative standard only in the
monitoring options available.
F. Wastewater Provisions
The MACT floor for wastewater at existing sources was determined to
be 54 percent control of HAP emissions from wastewater. The EPA
calculated HAP concentration cutoffs for wastewater streams, above
which steam stripping of wastewater streams would result in a level of
control as stringent as the floor. This approach is similar to the
hazardous organic NESHAP (HON) and allows for the control of those
wastewater streams containing the most significant amount of HAP. The
final standards require existing sources to control wastewater with the
following characteristics at the point of determination (POD):
1. Streams having partially soluble HAP compound concentrations of
1,300 ppmw or greater and a total PMPU HAP load of 1 Mg/yr or greater;
2. Streams having a combined total HAP concentration of 5,200 ppmw
or greater and a total PMPU load of 1 Mg/yr or greater;
3. Streams having a total HAP concentration of 10,000 ppmw with a
total facility HAP load of 1 Mg/yr or greater; or
The final standards require that air emissions from wastewater
collection systems be suppressed and that wastewater is treated.
Compliance is demonstrated by one of the following methods:
1. Using an enhanced biotreatment system for soluble HAP;
2. Demonstrating removals achieving 99 percent by weight of
partially soluble HAP compounds, and 90 percent by weight of soluble
HAP compounds, from treatment systems; or
3. Demonstrating a removal of 95 percent by weight of total organic
HAP from treatment systems.
For new sources, the MACT floor for wastewater is based on a
facility that currently incinerates a significant percentage of
wastewater containing HAP in an incinerator combusting a mixture of
wastes. The final standards require the same applicability and control
requirements described above for existing sources and an increased
removal of solubles (from 90 to 99 percent) for streams having a
soluble HAP concentration of 110,000 ppmw at any of the load criteria
(1 Mg/yr total HAP from the PMPU, or facility).
A de minimis HAP concentration and flow rate exemption was added to
today's final rule. Streams containing less than 5 ppmw of partially
soluble and/or soluble HAP and a total yearly load of 0.05 kg/yr of
partially soluble and/or soluble HAP are not considered wastewater, and
thus, are exempted from the wastewater provisions in today's final
rule.
G. Equipment Leaks
Today's final rule contains revisions to the proposed equipment
leak requirements that were originally based on subpart H (of the HON
rule). The final rule primarily contains changes to the standards for
valves and connectors in gas/vapor service and light liquid service.
The standards for valves in gas/vapor service and in light liquid
service were changed as follows: the requirement to implement a quality
improvement program and all references to Sec. 63.175 have been
removed; an allowance for monitoring every 2 years for those processes
with less than 0.25 percent leaking valves has been added; an allowance
for valve subgrouping was also added; the equation used to determine
the percent of leaking valves in a process was changed to eliminate the
optional credit for valves removed, Vc; and the rolling average of
leaking valves was revised so that it is calculated as an average of
the last 3 monitoring periods for annual or biannual monitoring
programs. The monitoring schedule for connectors in gas/vapor service
and light liquid service was revised to allow for decreased monitoring
for those components with the lowest leak rates. For leak rates less
than 0.25, the monitoring frequency for connectors is
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now once every 8 years. Finally, the equipment leak provisions were
removed from appendix GGGA to Section 63.1255.
H. Pollution Prevention Alternative
Today's final standards include a pollution prevention (P2)
alternative standard that meets the MACT floor for existing sources and
can be implemented in lieu of meeting the requirements for existing
process vents, storage tanks, wastewater streams and equipment leaks.
The P2 alternative only applies to existing sources and includes two
options which are shown in Table 2. Under option 1, owners or operators
can satisfy the requirements for all emission source types associated
with each pharmaceutical manufacturing process unit (PMPU) by
demonstrating that the production-indexed consumption of HAP has
decreased by at least 75 percent from a baseline set no earlier than
the 1987 calendar year. The production indexed HAP consumption factor
is expressed as kg HAP consumed/kg product produced. Under the second
P2 option, owners or operators must demonstrate at least a 50 percent
reduction in the production indexed HAP consumption factor, plus an
additional amount of reduction in HAP emissions through the use of add-
on controls, such that the overall reduction in HAP emissions is at
least 75 percent from the baseline period.
Table 2.--Alternative P2 Standard
------------------------------------------------------------------------
Option Description of P2 option
------------------------------------------------------------------------
1............................. Demonstrate at least a 75 percent
reduction in the kg consumption/kg
production factor from a baseline
period.
2............................. Demonstrate at least a 50 percent
reduction in the kg/kg factor, plus an
additional reduction from add-on
control equivalent to at least a 75
percent overall reduction in the kg/kg
factor from baseline.
------------------------------------------------------------------------
The following restrictions also apply to the pollution prevention
standards in today's final rule. For any reduction in the production-
indexed HAP consumption factor that is achieved by reducing a HAP that
is also a VOC, an equivalent reduction in the production-indexed VOC
consumption factor is required. For any reduction in the production-
indexed HAP consumption factor that is achieved by reducing a HAP that
is not a VOC, the production-indexed VOC consumption factor may not be
increased. Also, the final rule allows owners or operators of PMPU's
that generate HAP emissions to qualify for the pollution prevention
alternative, provided that the HAP emissions generated in the PMPU are
reduced to the required levels for process vents, storage tanks,
wastewater streams and equipment leaks specified in Secs. 63.1252
through 63.1256 of today's final standards. The baseline production-
indexed HAP and VOC consumption factors must be based on consumption
and production values averaged over the time period from startup of the
process until the present time (assuming the process has been in
operation at least 1 full year), or the first 3 years of operation
(beginning no earlier than 1987), whichever is the lesser time period.
Processes that began operation after April 2, 1997 are not eligible for
the P2 alternative.
Today's final standards also require owners and operators complying
with the P2 standard to submit a P2 Demonstration Summary as part of
the Precompliance Notification Report that describes how the P2
alternative will be applied at their facilities. The minimum data
requirements for the P2 Demonstration Summary are listed in
Sec. 63.1257(f) of today's final rule.
I. Heat Exchange Provisions
Today's final standards for heat exchange systems are unchanged
from proposal. Owners or operators must comply with the heat exchange
provisions listed in the HON at Sec. 63.104 with two exceptions: (1)
the monitoring frequency shall be no less than quarterly, and (2)
owners or operators of heat exchange systems that meet current good
manufacturing practice (CGMP) requirements at 21 CFR part 211 may elect
to use the physical integrity of the reactor as the surrogate indicator
of heat exchange system around reactors.
J. Emissions Averaging Provisions
The emissions averaging provisions in today's final rule are
unchanged from proposal. The final rule allows emissions averaging
among process vents and among storage tanks at existing sources.
Restrictions on the use of emissions averaging are listed in
Sec. 63.1252(d) of today's final rule and are essentially the same as
those contained in the HON. The alternative standard (see following
section K) is not to be included in the emissions averaging provisions
and/or calculations.
K. Alternative Standard
For owners or operators of affected sources that treat emissions
with an add-on control device, an alternative standard has been added
under Secs. 63.1253(d) (storage tanks) and 63.1254(c) (process vents).
To comply with today's alternative standard(s), the control device must
achieve an outlet, undiluted TOC concentration, as calibrated based on
methane or the predominant HAP, of 20 ppmv or less and a hydrogen
halide and halogen concentration of 20 ppmv or less, as demonstrated
through the test methods and procedures in Sec. 63.1257 and monitoring
provisions in Sec. 63.1258. The applicability level is the control unit
and all sources vented to the control unit which is considered one
regulated entity. Because the applicability of this standard is focused
on the control device, this scenario is considered one regulated entity
with regard to the number of violations that would apply if there is an
exceedance of the 20 ppmv TOC and 20 ppmv hydrogen halide and halogen
outlet concentration limit(s). The remaining process vents within a
process not controlled by the alternative standard must be controlled
to the percent reduction required by the standards.
L. Test Methods and Compliance Procedures
To determine compliance with the percent reduction requirement for
pharmaceutical process vents, uncontrolled and controlled emissions
from all process vents within the process shall be quantified to
demonstrate the appropriate overall reduction requirements (93 percent
or 98 percent). For process vents controlled by devices handling less
than 10 tons/yr, the owner or operator can either test or use
calculational methodologies to determine the uncontrolled and
controlled emission rates from individual process vents. For process
vents controlled by devices handling more than 10 tons/yr, tests are
required to determine the reduction efficiency of each device.
Performance test provisions require testing under worst-case
conditions, but the final rule provides flexibility in determining
these worst-case conditions. Control devices that have previously been
tested under conditions required by this standard and condensers are
exempt from emissions testing. Testing is not required for devices used
to control emission streams from storage or wastewater sources
exclusively. However, if testing is conducted, then the same methods
apply.
M. Monitoring Requirements
Monitoring is required in the final rule to determine whether a
source is in compliance on an ongoing basis. This monitoring is done
either by continuously measuring emission
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reductions directly or by continuously measuring a site-specific
operating parameter, the value of which is established by the owner or
operator during the initial compliance determination. The operating
parameter value is defined as a single point at either a minimum or
maximum value established for a control device that, if achieved on a
daily average or block average by itself or in combination with one or
more other operating parameter values, determines that an owner or
operator is complying with the applicable operating limits. These
parameters are required to be monitored at 15-minute intervals
throughout the operation of the control device for devices controlling
greater than 1 tons/yr. For devices controlling streams totaling less
than 1 ton/yr, only a site-specific periodic verification that the
devices are operating as designed is required to demonstrate continuous
compliance. Owners and operators must determine the most appropriate
method of verification and propose this method to the Agency for
approval in the precompliance report, which is due 6 months prior to
the compliance date of the standard. The monitoring requirements apply
to all control devices, even those used exclusively for storage tanks
or wastewater sources.
N. Recordkeeping and Reporting Requirements
Table 1 to subpart GGG was revised to clarify the specific
requirements of the final rule and the referenced requirements in the
General Provisions. A summary column describing the requirements of
each part of the General Provisions has been added to Table 1 and
additional comments address wording issues and exceptions to the
General Provisions language.
V. Summary of Environmental, Energy, Cost, and Economic Impacts
These NESHAP would affect pharmaceutical production facilities that
are major sources in themselves, or constitute a portion of a major
source. There are 270 existing facilities manufacturing
pharmaceuticals, 101 of which were assumed to be major sources for the
purpose of developing these standards and calculating impacts. The
expected rate of growth for the pharmaceutical industry is expected to
be 2.4 percent per year through 1998.
A. Air Impacts
Today's final standards will reduce HAP emissions from existing
sources by 22,000 Mg/yr (24,000 tons/yr) from the baseline level, a
reduction of 65 percent from baseline, and 75 percent from
uncontrolled. These reductions also will occur if facilities elect to
implement the alternative pollution prevention standard. Since many of
the HAP emitted by the pharmaceutical industry are also VOC, today's
final standards also will reduce VOC emissions.
B. Water and Solid Waste Impacts
Much of the steam stripping operations will result in recoverable
material. However, the new source requirement for very rich, soluble
HAP-containing wastewater is expected to generate solid waste. The EPA
estimates that an average of 900 tons of solid waste per year per
facility will be generated as a result of today's final standards.
However, biological treatment is a possible means of compliance.
C. Energy Impacts
Today's final standards for the pharmaceuticals source category
will require an additional energy usage of 2,400 x 10\9\ British
thermal units per year (Btu/yr).
D. Cost Impacts
The emission reductions required by this regulation can be achieved
using one or more of several different techniques. To determine costs,
certain control scenarios were assumed. The scenarios used in costing
were judged to be the most feasible scenarios possible for meeting the
requirements of the standards from a technical and cost standpoint. The
total control cost includes the capital cost to install the control
device, the costs involved in operating the control device, and costs
associated with monitoring the device to ensure compliance. Monitoring
costs include the cost to purchase and operate monitoring devices, as
well as reporting and recordkeeping costs required to demonstrate
compliance. Nationwide, the total annual cost of this standard to the
industry for existing and new sources is approximately $64 million and
$11 million, respectively (1998 dollars). To estimate these annual
costs, capital costs were annualized over 10 years (with no delay for
installation). (The annual costs presented in the preamble to the
effluent limitations guidelines and standards are lower than the above
costs because they are based on a longer annualization period. Costs
for the effluent guidelines limitations and standards are annualized
over 16 years (a 1-year installation period plus a 15-year project
life). As a result, annual costs for existing sources in the preamble
to the effluent limitations guidelines and standards (referred to as
pretax annualized costs for the MACT standards rule for all facilities)
are reported at $58.4 million.) The EPA believes that monitoring,
reporting, and recordkeeping costs will be substantially reduced for
those facilities that choose to comply with today's final rule through
either the P2 option or the alternative standard of 20 ppm TOC and 20
ppm hydrogen halides and halogens.
E. Economic Impacts
The economic impact analysis of this standard shows that the
estimated price increase from compliance with the recommended standards
for process vents, storage tanks, and wastewater is 1.1 percent.
Estimated reduction in market output is 1.9 percent.
No plant closures are expected from compliance with this set of
alternatives. For more information, consult the economic impact report
entitled ``Economic Analysis of Air Pollution Regulation Regulations:
Pharmaceutical Industry, August 1996.''
VI. Major Comments and Changes to the Proposed Standards
In response to comments received on the proposed standards, changes
have been made to the final standards. While some of these changes are
clarifications designed to make EPA's intent clearer, many of them are
significant changes to the requirements of the proposed standards. A
summary of the substantive comments and/or changes made since proposal
are described in the following sections. Detailed responses to public
comments are included in the promulgation BID: Summary of Public
Comments and Responses (Docket Item No. V-B-01). Additional information
on the final standards is contained in the docket for this rulemaking
(see ADDRESSES section of this preamble).
A. Applicability Provisions and Definitions
1. General Applicability: Definition of Pharmaceutical Product
At proposal, pharmaceutical product was defined as ``any material
described by the Standard Industrial Classification (SIC) Code 283, or
any other fermentation, biological or natural extraction, or chemical
synthesis product regulated by the Food and Drug Administration,
including components (excluding excipients) of pharmaceutical
formulations, or intermediates used in the production of a
pharmaceutical product.'' Many commenters stated that, based on the
proposed definition of pharmaceutical product, the general
applicability of the standard is too broad, ambiguous, and
[[Page 50288]]
appears to overlap with other MACT standards that cover the chemical
industry. Comments on the definition of pharmaceutical product focused
on the following four areas: (1) the use of Standard Industrial
Classification (SIC) codes, (2) the scope of products regulated by the
FDA, (3) the meaning of the term ``intermediates,'' and (4) the
exclusion of specific products/processes.
Many commenters suggested that instead of referencing SIC code 283,
the definition of pharmaceutical product should be narrowed to include
only SIC codes 2833 and 2834 because facilities classified under these
two SIC codes produce pharmaceuticals as their primary product, and
were the source of information and data that formed the basis for the
proposed rule. Two other commenters stated that the use of SIC codes or
the new North American Industrial Classification System (NAICS) codes
in defining pharmaceutical products was inappropriate because of the
ambiguous nature of SIC and NAICS code applicability, and that instead
of using SIC or NAICS codes, the definition should clearly describe the
characteristics of the processes that are subject to the rule. One of
the commenters also provided a recommended definition of pharmaceutical
product based upon the definition of ``drug product'' already
established by the Food and Drug Administration at 21 CFR 210.3
(Current Good Manufacturing Practice in Manufacturing, Processing,
Packing, or Holding of Drugs).
Many commenters stated that the inclusion of the phrase,
``regulated by the Food and Drug Administration'' should be deleted
from the definition of pharmaceutical products because many nondrug
products such as cosmetics, food additives, plastics (food contact
films) and dietary supplements, are regulated by the FDA and could be
interpreted as being pharmaceutical products based on the proposed
definition of pharmaceutical product. However, another commenter
requested that EPA expand the definition of pharmaceutical products to
include products regulated by the U.S. Department of Agriculture (USDA)
as well as the FDA because the pharmaceutical industry produces animal
biologics using the same processes used to produce human biologics, and
therefore, HAP emitted from the production of animal biologics also
should be regulated as part of the pharmaceutical NESHAP.
Many commenters stated that the use of the term ``intermediates''
in the definition of pharmaceutical product was confusing and brings
many unintended chemicals and processes into the pharmaceutical NESHAP;
and therefore, the term should be either clarified or deleted from the
definition of pharmaceutical product. One commenter stated that
inclusion of the term, ``intermediate,'' in the definition of
pharmaceutical product makes it unclear how far back in the
manufacturing chain a regulated entity must look when determining
applicability. Many commenters stated that operations that manufacture
raw materials (such as acids and solvents) that are not precursors to
active ingredients in pharmaceutical products should not be regulated
as part of the pharmaceutical NESHAP. Several commenters stated that
the rule should only apply to processes which produce materials which
exclusively or primarily are used to make drug active ingredients.
Another commenter stated that EPA needs to clarify that intermediates
already regulated by the HON are excluded from the pharmaceutical
NESHAP.
Four commenters requested that EPA specifically exclude certain
``nonpharmaceutical products'' from the definition of pharmaceutical
product. One commenter expressed concern that due to the inclusion of
SIC code 2835 and the phrase, ``regulated by the FDA,'' in the
pharmaceutical product definition, equipment used to manufacture
medical devices or substances used in the manufacture of medical
devices could be subject to the pharmaceutical NESHAP instead of the
miscellaneous organic NESHAP (MON). Therefore, the commenter requested
that ``medical devices'' be specifically excluded from the definition
of pharmaceutical product. A second commenter stated that the rule
should not apply to specialty chemical manufacturers who occasionally
engage in tolling a pharmaceutical intermediate. The commenter further
stated that tolling of pharmaceutical intermediates could be driven
overseas if U.S. specialty chemical opera tions require long lead times
to identify MACT requirements, develop compliance systems, and amend
title V requirements. A third commenter suggested that EPA exclude
contract manufacturing from the pharmaceutical rule, and allow it to be
covered by the MON. The fourth commenter requested that EPA
specifically exclude ``color additives and other inactive ingredients''
from the definition of pharmaceutical product because the commenter
interpreted EPA's exclusion of excipients from the definition of
pharmaceutical product to mean that the pharmaceutical NESHAP was only
intended to cover active ingredients. The fourth commenter also
provided a definition of excipients developed by the International
Pharmaceutical Excipients Council.
The EPA considered all of the above comments and revised the
definition of pharmaceutical product based on these and other
considerations. The rationale for the revised definition is presented
below.
The EPA agrees with the commenters that SIC codes may be ambiguous,
were not developed with environmental regula tion in mind, and may not
reflect individual processes within a facility, and therefore, that the
use of SIC codes to define pharmaceutical product may introduce
unintended ambiguity into applicability determinations. Also, EPA
believes that the use of the newer NAICS codes in defining
applicability would result in the same problems with ambiguity and
intended use. However, based on industry survey responses, EPA
recognizes that facilities primarily claiming SIC codes 2833 and 2834
and/or NAICS codes 325411 and 325412 produce medicinals and
pharmaceuticals as their primary products. Therefore, for the sake of
clarity and consistent with the survey responses, EPA has retained the
SIC Codes and added the NAICS codes in the definition of pharmaceutical
product.
The EPA also agrees that the term ``regulated by FDA'' is also
ambiguous. As noted by one commenter, in 21 CFR section 207.10(e), FDA
exempts from registration and drug listing, ``manufacturers of harmless
inactive ingredients that are excipients, coloring, flavorings,
emulsifiers, lubricants, preservatives, or solvents that become
components of drugs, and who otherwise would not be required to
register under this part.'' The EPA agrees that some of the processes
used to manufacture such substances were not intended for coverage by
this rule, and that was the intent of including the phrase ``regulated
by FDA'' in the definition of pharmaceutical product in the proposed
rule. Based on the comments, EPA believes that a less ambiguous way to
define pharmaceutical product would be to base it on definitions
contained in 21 CFR 210.3 (Current Good Manufacturing Practice in
Manufacturing, Processing, or Holding of Drugs; General) for drug
product or active ingredient. These definitions capture formulation
products as well as pharmaceutical active ingredients and their
precursors.
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The proposed rule also was intended to cover intermediates that are
manufactured prior to the final processing steps in which a compound
becomes a pharma ceutical product. However, EPA recognizes the
difficulty associated with defining an intermediate, especially the
point at which a chemical becomes associated with pharma ceutical
manufacturing. Because the pharmaceutical industry is characterized by
numerous processes that may be conducted prior to the actual synthesis
and isolation of active ingredients, EPA rejects the notion that, in
order to simplify applicability, only those processes yielding active
ingredients should be covered by the rule. Rather, EPA agrees with the
suggestion that the rule be based on the primary intended use of the
materials manufactured. By defining applicability according to primary
use as pharmaceutical products or as their precursors, intermediates
that are further processed to become active ingredients or drug
components are covered. Therefore, in order to clarify the boundaries
of the coverage of such precursors or intermediates, the definition of
process was changed in the final rule to clarify that the provisions of
the subpart apply to materials whose ``primary use'' is as a
pharmaceutical product or precursor.
The ``primary use'' approach also addresses the comment regarding
the exclusion of contract manufacturing from the pharmaceutical rule.
Simply put, contract manufacturers will be subject to this standard
during periods when they manufacture a pharmaceutical product. To
simplify the determination of applicability for facilities that conduct
contract manufacturing, some commenters suggested that the rule apply
to processes whose primary product is a pharmaceutical active
ingredient. The concept of primary product has been used in past
regulations (e.g., HON, P&R IV, etc.) and was not considered in the
proposed rule because there was a conscious effort to disengage
production equipment from products manufactured. Because the standards
are process-based, the intent of the proposal was to cover the
production of pharmaceutical products, regardless of what pieces of
equipment were used to manufacture them in the course of a year.
Conceptually, the primary product definition makes sense for process
lines that can be used to manufacture more than one product. In the
pharmaceutical manufacturing industry, however, process equipment is
reconfigured such that the same pieces of equipment may not always be
part of the same process line. Under the current concept of primary
product that appears in other rules, it would still be difficult to
determine the primary product of a nondedicated process, because not
all the same equipment would be associated with the ``process.''
However, by reverting back to the concept of ``primary use,'' owners
and operators can clearly delineate applicability based on the intended
use of materials they manufacture, and not the equipment they are
manufactured in.
The revised definition for pharmaceutical product in today's final
rule borrows heavily from definitions contained in 21 CFR 210.3
(Current Good Manufacturing Practice in Manufacturing, Processing, or
Holding of Drugs; General). The revised definition of pharmaceutical
product and a new definition for primary use are shown below. Also,
definitions for ``active ingredient,'' ``component,'' and ``excipient''
have been included in today's final rule.
Pharmaceutical product means: (1) any material described by the
standard industrial classification (SIC) code 2833 or 2834; (2) any
material whose manufacturing process is described by the north american
industrial classification system (NAICS) code 325411 or 325412; (3) a
finished dosage form of a drug, for example, a tablet, capsule,
solution, etc., that contains an active ingredient generally, but not
necessarily, in association with inactive ingredients; or (4) any
component whose intended primary use is to furnish pharmacological
activity or other direct effect in the diagnosis, cure, mitigation,
treatment, or prevention of disease, or to affect the structure or any
function of the body of man or other animals (the term does not include
excipients, but includes drug components such as raw starting materials
or precursors that undergo chemical change or processing before they
become active ingredients).
Primary use means the single largest use of a material.
For reasons described above and in response to related comments,
the applicability language in Sec. 63.1250(a) also has been changed in
the final rule such that the rule only applies to those pharmaceutical
manufacturing operations that meet the following criteria: (1) they
manufacture a pharmaceutical product, as defined in section 63.1251,
(2) they are located at a plant site that is a major source as defined
in section 112(a) of the Act, and (3) they process, use, or produce
HAP. The third criterion was included in response to one commenter's
concern that, while the rule covers all processes at a facility which
is determined to be major source, some processes at those major sources
do not emit HAP. The commenter also stated that although this situation
may not pose a significant compliance problem, the lack of an exclusion
for these non-HAP emitting processes posed an unwarranted regulatory
burden. The EPA agreed with the commenter, and modified the
applicability of the rule as described above.
2. Definition of PMPU and Pharmaceutical Manufacturing Operations
The EPA received several comments on the proposed definitions of
PMPU and pharmaceutical manufacturing operations. At proposal, PMPU was
defined as ``any processing equipment assembled to process materials
and manufacture a pharmaceutical product and associated storage tanks,
waste-water management units, or components such as pumps, compressors,
agitators, pressure relief devices, sampling connection systems, open-
ended valves or lines, valves, connectors, and instrumentation systems
that are used in the manufacturing of a pharmaceutical product.''
Pharmaceutical manufacturing operations were defined to ``include
PMPU's and other processes and operations as well as associated
equipment such as heat exchange systems that are located at a facility
for the purpose of manufacturing pharmaceuticals.''
One commenter stated that having both ``pharmaceutical
manufacturing operation'' and PMPU in the proposed rule was confusing
and redundant. The commenter stated that by having both terms, the rule
implies that the definition of PMPU does not cover all of the equipment
to be regulated by subpart GGG. The commenter further stated that the
inclusion of the phrase ``associated equipment'' in the pharmaceutical
manufacturing operations definition was unclear because the definition
of PMPU already covers ``associated'' equipment. The commenter also
stated that heat exchangers were given as an example of ``associated
equipment'' under the definition of pharmaceutical manufacturing
operation, but not included as an example in the definition of PMPU.
For these reasons, the commenter suggested that the definition of
pharmaceutical manufacturing operation be deleted entirely, and that
heat exchangers be added to the list of examples of ``associated
equipment'' in the PMPU definition.
[[Page 50290]]
Two commenters stated that wastewater management units should not
be included in the definition of PMPU. One commenter stated that
wastewater management units are not subject to the standard, but
instead are used to comply with the standard. This commenter also
pointed out that neither the HON's definition of chemical manufacturing
process unit (CMPU) nor the Polymers and Resin I NESHAP definition of
elastomer product process unit (EPPU) includes wastewater management
units. The commenter further stated that including wastewater
management units in the definition of PMPU could be interpreted to
require new source MACT at an existing wastewater management unit if a
new, major, dedicated PMPU is built that will contribute wastewaters to
that unit. Another commenter stated that packaging operations (e.g.,
``placement of dose forms, such as tablets, into containers, and
assembly, closure, and labeling of these containers'') are not
pharmaceutical manufacturing operations, and thus, should be explicitly
excluded from the definition of pharmaceutical manufacturing
operations.
Many commenters stated that the definition of PMPU should be
modified to make it clear that a PMPU is a group of equipment. These
commenters were concerned that, as written, the definition of PMPU
could be interpreted to mean that an individual piece of equipment
constitutes a PMPU, and thus, the addition of a single piece of
equipment to an existing dedicated process line could trigger new
source MACT.
Many commenters stated that a PMPU should be identified by its
primary product and suggested adding language to the definition that
makes it clear that PMPU's manufacture pharmaceutical products as their
primary product.
After consideration of the above comments on the definitions of
pharmaceutical manufacturing operations and PMPU, EPA has decided to
retain both terms, but with some modifications. The terms
``Pharmaceutical Manufacturing Operations'' and ``Pharmaceutical
Manufacturing Process Unit (PMPU)'' were not intended in the proposed
rule to refer to the same sources entirely. While the term
``Pharmaceutical Manufacturing Operations'' is the broadest term used
in the rule and covers all emission sources within a given facility
that are the direct or indirect result of pharmaceutical manufacturing,
the term ``PMPU'' was intended to encompass each process unit within
the facility and its associated equipment. Therefore, the
pharmaceutical manufacturing operations encompasse all PMPU's at a
given facility as well as equipment that is not included in individual
PMPU's. In the proposed rule, the PMPU was used exclusively to define
new source applicability in Sec. 63.1250(c). In today's final rule,
PMPU's also have replaced ``processes'' in the pollution prevention
standard, and therefore, PMPU's serve several functions in the final
rule. The PMPU also serves as the basis of the wastewater cutoffs for
the standard, at 1 Mg/yr applicability HAP load per PMPU. The EPA
believes that the broader term for pharmaceutical manufacturing
operations is necessary to include sources that cannot be associated
with single PMPU's.
By including wastewater management units in the definition of PMPU
at proposal, EPA intended that all wastewater streams and residuals
would be considered part of the PMPU. The EPA reviewed the definition
of process and PMPU for consistency with the HON and other MACT
standards. Wastewater management units are subject to the standard, but
manage wastewater from several PMPU. However, wastewater generated in a
PMPU is not specifically defined as part of the PMPU, but rather can be
associated with it. This convention is analogous to process vent
emissions; although they are not specifically identified as part of the
PMPU, a PMPU may generate process vent emissions. In deciding whether
the PMPU has the potential to emit 10 or 25 tons of HAP, all emissions
from all sources associated with the PMPU, including process vents and
wastewater, must be considered. Therefore, the definition of PMPU was
modified to not specify wastewater streams, residuals, and wastewater
management units, as part of the PMPU.
Although EPA recognizes that rarely will one piece of equipment
comprise a PMPU, the Agency disagrees with the commenters that a PMPU
must always be defined as a group of equipment. The definition of PMPU
in today's final rule, however, includes the term, ``process'' which is
defined as a ``logical grouping of processing equipment which
collectively function to produce a pharmaceutical product'' and ``may
consist of one or more unit operations.'' However, a PMPU is not always
associated with specific groupings of equipment associated with a given
process. (See also section VI.A.3 of this preamble and Sec. 63.1252 of
the final rule for a complete definition of process.)
In response to suggestions that EPA define a PMPU by its primary
product, the EPA has included a primary use concept in the definition
of pharmaceutical product in the final rule as discussed previously in
section VI.A.1, above. Based on the comments discussed above and
related comments, the definitions of PMPU and pharmaceutical
manufacturing operations in today's final rule are as follows:
Pharmaceutical manufacturing process unit (PMPU) means the process,
as defined in this subpart, and any associated storage tanks, equipment
identified in Sec. 63.1252(f), and components such as pumps,
compressors, agitators, pressure relief devices, sampling connection
systems, open-ended valves or lines, valves, connectors, and
instrumentation systems that are used in the manufacturing of a
pharmaceutical product.
Pharmaceutical manufacturing operations means the facility-wide
collection of PMPU's and any other equipment such as heat exchanger
systems or cooling towers, that are not associated with an individual
PMPU, but that are located at a facility for the purpose of
manufacturing pharmaceutical products and are under common control.
3. Definition of Process
The EPA received a number of comments on the proposed definition of
process. At proposal, process was defined as ``a logical grouping of
processing equipment which collectively function to produce a
pharmaceutical product or isolated intermediate. A process may consist
of one or more unit operations. For the purposes of this subpart,
process includes all or a combination of reaction, recovery,
separation, purification, or other activity, operation, manufacture, or
treatment which are used to produce a product or isolated intermediate.
The physical boundaries of a process are flexible, providing a process
ends with a product or isolated intermediate, or with cessation of
onsite processing. Nondedicated solvent recovery and nondedicated
formulation operations are considered single processes that are used to
recover or formulate numerous materials and/or products.''
Many commenters requested that the definition of process be
clarified to indicate that Quality Assurance and Quality Control (QA/
QC) laboratories are not considered part of the process. These
commenters were concerned that, although it may be clear that QA/QC
labs are not ``processing equipment'' or ``an activity or an operation
used to produce a product,'' the words, ``or
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other activity, operation,'' may lead to confusion as to whether QA/QC
labs are part of the process. The commenters suggested that EPA
explicitly exclude QA/QC labs from the definition of process because
QA/QC laboratories emit insignificant quantities of HAP, and therefore,
time-consuming nonapplicability demonstrations could be avoided.
Several commenters recommended that EPA include storage tanks in
the definition of process so that sources that choose to comply using
the pollution prevention alternative are not exempted from the storage
tank requirements in Sec. 63.1252(b) of the proposed rule. The
commenters stated that emissions from storage tanks may be significant,
and that sources should be required to comply with the storage tank
standards under all circumstances.
Many commenters requested that EPA modify the definition of process
to clarify how the process vent provisions will apply to formulation
facilities. These commenters were concerned that the use of the term
``nondedicated'' in reference to formulation facilities results in
confusion as to how to apply the standard. The commenters pointed out
that, unlike equipment used in pharmaceutical chemical synthesis
facilities, equipment in a formulation facility are only used to
formulate products, and therefore, formulation facilities are
``dedicated'' to formulation operations. However, the commenters also
pointed out that the equipment at the formulation facility is used to
produce many different products, and therefore, is ``nondedicated.''
For these reasons, the commenters recommended that, for formulation
operations, the term, ``nondedicated,'' be applied to the equipment
within the facility and not the facility itself. The commenters also
requested that for formulation operations, EPA limit the definition of
process to formulation activities within a contiguous area (such as a
formulation building or a contiguous area within a multipurpose
building in which formulation takes place). The commenters cited
examples where separate formulation operations are located at the same
plant site, but are physically separate, and thus would require
separate emission control systems.
Another commenter was concerned that use of the term
``nondedicated'' could be interpreted as including solvent recovery or
formulation operations that process small quantities of pharmaceutical-
related materials, but whose primary use is for a process subject to
another MACT rule. The commenter recommended that this issue be
resolved by (1) deleting the term ``nondedicated'' from the proposed
definition of process, and (2) adding the phrase, ``whose primary use
is associated with the manufacture of pharmaceutical products'' after
the word ``operations'' in the last sentence of the proposed definition
of process.
One commenter suggested that the phrase ``or isolated
intermediate'' (used throughout the definition) be deleted because
``processes produce products,'' but ``portions of processes produce
intermediates.'' The commenter further explained that although the
product of one process may be used as a raw material in another
process, the product serving as the raw material is not typically
thought of as an intermediate.
The EPA has modified the definition of process in the final rule in
response to the comments described above. The EPA agrees with the
commenters that QA/QC laboratories are not part of the process, and the
definition of process in the final rule excludes QA/QC laboratories.
To clarify EPA's intention that storage tanks be included as part
of the pollution prevention alternative, and in response to the
comments regarding the perceived exclusion of storage tanks from the P2
alternative, today's final rule includes storage tanks in the
definition of PMPU and refers to PMPU's instead of ``processes'' in the
pollution prevention provisions (see also section V.A.2 of this
preamble--Definition of PMPU and Pharmaceutical Manufacturing
Operations, and section VI.F--Pollution Prevention Alternative).
The EPA disagrees with the commenters who believe that the term,
``nondedicated,'' as applied to formulation facilities, should be
applied to the equipment within the facility and not to the facility
itself. As explained in section VI.A.1 of this preamble, the
pharmaceutical NESHAP regulates processes, not equipment, and the
concept of primary use is applied to the pharmaceutical product, not to
the equipment used to manufacture the product. However, today's final
rule clarifies the intent of the proposed rule with regard to
formulation and solvent recovery operations: those operations occurring
within a contiguous area are to be considered as single processes,
regardless of the final product of that formulation or recovery
operation.
The EPA agrees with the suggestions provided by one commenter to
delete all references to ``isolated intermediate'' and has incorporated
these comments into the definition of process in the final rule. Also,
the definition of pharmaceutical product in the final rule (see section
VI.A.1--General Applicability: Definition of Pharmaceutical Product)
states that pharmaceutical product ``includes drug components such as
raw starting materials or precursors that undergo chemical change or
processing before they become active ingredients.'' Therefore, drug
components such as raw materials and precursors, which are themselves
products of processes, are defined as products, rather than
``intermediates,'' thus eliminating the need for the concept of
``intermediates'' (see also section VI.A.6--Definition of Isolated
Intermediate).
For the reasons stated above, the definition of ``process'' in
today's final rule is as follows:
Process means all equipment which collectively function to produce
a pharmaceutical product. A process may consist of one or more unit
operations. For the purposes of this subpart, process includes all or a
combination of reaction, recovery, separation, purification, or other
activity, operation, manufacture, or treatment which are used to
produce a pharmaceutical product. Cleaning operations are considered
part of the process. The holding of the pharmaceutical product in tanks
or other holding equipment for more than 30 consecutive days, or
transfer of the pharmaceutical product to containers for shipment,
marks the end of a process, and the tanks are considered part of the
PMPU that produced the stored material. When material from one unit
operation is used as the feedstock for the production of two or more
different pharmaceutical products, the unit operation is considered the
endpoint of the process that produced the material, and the unit
operations into which the material is routed mark the beginning of the
other processes. Nondedicated recovery devices located within a
contiguous area within the affected source are considered single
processes. Nondedicated formulation operations occurring within a
contiguous area are considered single processes. Quality Assurance and
Quality Control laboratories are not considered part of any process.
The revised definition of process provided above clarifies when a
process ends. The EPA selected 30 days as a reasonable period of time,
beyond which, if a material has not been further processed or reacted,
a process can be considered complete for the purposes of this subpart.
Applicability determinations and control requirements would be more
difficult without such a time frame. The definition of process is a key
element of the rule because most of the
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applicability and compliance determinations are based on the process,
as a unit. Because of concerns that processes could be artificially
divided into smaller portions of processes in order to meet the 2,000
lb/yr limit, EPA limited the number of processes per facility that can
comply with the 2,000 lb/yr limit to seven per year. However, EPA also
added that processes with very low emissions (less than 100 lb/yr HAP,
uncontrolled) would not be counted as part of the seven process limit.
These limitations and exemptions are currently under review and may be
revised at a later time.
4. Definition of Process Vent
The EPA received several comments on the proposed definition of
process vent, primarily related to the following two issues: (1) the
establishment of a de minimis level or cutoff below which controls
would not be required and (2) how the rule applies to process vents
that are manifolded together. At proposal, process vent was defined as
``a vent from a unit operation through which a HAP-containing gas
stream is, or has the potential to be, released to the atmosphere.
Examples of process vents include, but are not limited to, vents on
condensers used for product recovery, bottom receivers, surge control
vessels, reactors, filters, centrifuges, and process tanks. Process
vents do not include vents on storage tanks regulated under
Sec. 63.1252(b), vents on wastewater emission sources regulated under
Sec. 63.1252(d), or pieces of equipment regulated under
Sec. 63.1252(e).''
Many commenters requested that EPA modify the definition of process
vent to exempt any vent that contains a gas stream with less than 50
ppmv HAP averaged over the unit operation. These commenters cited 40
CFR part 63.113(g) of the HON, which exempts vents with less than 50
ppmv from monitoring or any other provisions of sections 63.114 through
63.118. One of these commenters provided a cost analysis, using EPA's
recently released biofilter cost model, for an existing fermentation
operation, the emissions from which typically contain less than 50 ppmv
methanol. The cost effectiveness of biofiltration for this scenario was
estimated to be $27,000/Mg, with a percent control of 60 percent (i.e.,
from 50 ppmv to 20 ppmv, EPA's established practical limit of control),
a value that the commenter stated was ``clearly unreasonable.'' The
commenter further stated that for fermenter and fermenter preparation
vents, a cutoff of 100 to 200 ppmv could be justified (as opposed to 50
ppmv) and requested that EPA consider such a cutoff.
Two commenters stated that the proposed definition of process vent
implies that every process vent is connected to a single piece of unit
operations equipment, which often is not the case at multiproduct,
multibatch facilities. One of the commenters suggested that the
definition include a statement indicating that ``multiproduct
facilities having multiple production trains may have large numbers of
process vents, which could discharge directly to the atmosphere;
discharge through a dedicated control equipment; or which can be
manifolded from many process units into a common header leading to a
common control equipment.'' The other commenter stated that compliance
with the process vent standards would be more difficult and expensive
if the definition of process vent included the combined or commingled
vents from several pieces of unit operations equipment, rather than
just one piece of equipment. This commenter also questioned if standard
industrial hygiene type exhaust pickups and general room ventilation
exhaust points are meant to be included in the definition of process
vents. The commenter pointed out that those types of systems may
exhaust through a stack, which may be interpreted as being an emission
point, but noted that some states do not consider these emission points
for the purposes of Title V permits. The commenter stated that, if
these emission points were not considered in developing the MACT
floors, they should not be included as process vents, and requested
clarification from EPA.
As explained in section VI.C of this preamble, the definition of
process vent in today's final rule includes a de minimis cutoff for
uncontrolled and undiluted vent streams of 50 ppmv HAP. Regarding
multiple vents (from the same process) being manifolded together into a
common header, the Agency considers the common header in this rule to
be a single process vent, and has revised the definition of process
vent to reflect this view. In response to one commenter's question
about whether or not industrial hygiene exhausts and general room
ventilation exhausts would meet the definition of process vent, these
sources would not be considered process vents if they are under the 50
ppmv HAP cutoff. Based on the changes discussed above, the definition
of process vent in the final rule is as follows:
Process vent means a vent from a unit operation or vents from
multiple unit operations within a process that are manifolded together
into a common header, through which a HAP-containing gas stream is, or
has the potential to be, released to the atmosphere. Examples of
process vents include, but are not limited to, vents on condensers used
for product recovery, bottom receivers, surge control vessels,
reactors, filters, centrifuges, and process tanks. Emission streams
that are undiluted and uncontrolled containing less than 50 ppmv HAP,
as determined through process knowledge, test data using Methods 18 of
40 CFR part 60, appendix A, or any other test method that has been
validated according to the procedures in Method 301 or appendix A of
this part, are not considered process vents. Process vents do not
include vents on storage tanks regulated under Sec. 63.1253, vents on
wastewater emission sources regulated under Sec. 63.1256, or pieces of
equipment regulated under Sec. 63.1255.
5. Definition of Process Condenser
The EPA received numerous comments on the proposed definition of
process condenser. These comments primarily dealt with the dual role of
condensers as both process condensers and air pollution control
devices, and in which category recirculating condensation systems
should be class ified. At proposal, process condenser was defined as
``a condenser whose primary purpose is to recover material as an
integral part of a unit operation. The condenser must support vapor-to-
liquid phase change for periods of source equipment operation that are
above the boiling or bubble point of substances(s). Examples of process
condensers include distillation condensers, reflux condensers, process
condensers in line prior to the vacuum source, and process condensers
used in stripping or flashing operations.''
Many commenters took issue with the phrase ``integral part of a
unit operation'' and ``process condensers in line prior to the vacuum
source.'' These commenters cited examples where it could be concluded
that a condenser is not integral to a process because it does not
perform any necessary process function. The commenters also stated that
if there were two condensers in series prior to a vacuum source, and
the first condenser effected a phase change, then the second condenser
should be considered an air pollution control device, even though it is
located ``prior to a vacuum source.''
Three commenters suggested that the intended use be considered when
determining whether a condenser is a process condenser or an air
pollution control device. Two of these commenters stated that, ``if the
condenser is acting as a control unit, so
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that its presence is intended to prevent chemicals from reaching the
uncontrolled environment; if the materials collected are led towards
management and disposal systems; and if the collected materials are in
no way used, reused, nor sold for fuel value, then the condenser is
serving as a control unit regardless of the fact that the bubble point
is met or not at the source.'' The other commenter disagreed with the
condition that to be a process condenser, the condenser must support a
vapor-to-liquid phase change for periods of source equipment operation
that are above the boiling or bubble point of the substance(s). This
commenter pointed out that under the proposed definition, the same
condenser will sometimes be a process condenser and sometimes an air
pollution control device, and tracking when the condenser switches from
one to the other would be burdensome. Therefore, the commenter
recommended that the facility which operates the condenser (and knows
the process best) be allowed to determine whether it is a process
condenser or an air pollution control device.
Another commenter suggested that EPA distinguish between process
condensers and condensers serving as air pollution control devices by
including a specific temperature limit (i.e., 20 deg.C) such that
condensers that lower the temperature of the exit gas stream to a
colder temperature would be considered air pollution control devices
instead of process condensers.
Many commenters requested that EPA specifically address process
condensers that belong to recirculating drying systems. Most commenters
stated that condensers in recirculating drying systems should be
considered pollution control devices. However, one commenter stated
that recirculating condensation systems should be defined as neither
process condensers nor air pollution control devices, but defined
separately, with ``management systems to account for their pollution
prevention effects to be worked out at a later date for the promulgated
standard.'' The major concern of all of these commenters, however, was
that under the proposed definition, the recirculating condensation
systems would be considered process condensers, and thus, the
uncontrolled emissions and resulting emissions reductions would be
considerably lower than if the condenser was considered an air
pollution control device. Even though these systems generate
considerably lower emissions as compared to once-through systems,
owners and operators could not take advantage of the high emission
reductions in the process vent standard that requires 93 percent
control or 2,000 lb/yr after control from the entire process.
The EPA disagrees with the suggestion that the owner or operator
should be allowed to determine whether a condenser is a process
condenser or an air pollution control device based on ``intended use.''
Because one of the formats of the process vent standard requires that a
reduction from uncontrolled emissions be applied across a process
(i.e., achieve a 93 percent reduction in emissions from the process),
EPA is concerned about the opportunity for crediting reductions
achieved by condensing boiling streams on other sources in the process.
In fact, in requesting data from industry (which was later used to set
the MACT floor), the MACT partnership specifically confirmed from
responders that the data reported was based on the definition of
process condenser as described in the proposed rule. Therefore, EPA has
retained the intent of the proposed definition, but has made clarifying
changes. The definition of process condenser in the final rule is as
follows:
Process condenser means a condenser whose primary purpose is to
recover material as an integral part of a process. The condenser must
support a vapor-to-liquid phase change for periods of source equipment
operation that are at or above the boiling or bubble point of
substance(s) at the liquid surface. Examples of process condensers
include distillation condensers, reflux condensers, and condensers used
in stripping or flashing operations. In a series of condensers, all
condensers up to and including the first condenser with an exit gas
temperature below the boiling or bubble point of the substance(s) at
the liquid surface are considered to be process condensers. All
condensers in line prior to a vacuum source are included in this
definition.
The EPA also rejects the suggestion to use 20 deg.C as a
temperature cutoff in determining whether a condenser is a process
condenser or an air pollution control device. Because of the
differences in the chemical and physical properties of substances used
in the manufacture of pharmaceutical products, one temperature cannot
be used to represent all processes; in some cases, a condenser
operating at 20 deg.C could actually be an air pollution control device
and not a process condenser. Finally, EPA disagrees with the requests
that condensers in recirculating drying systems be considered as
pollution control devices or defined separately. Emissions from the
recirculating drying systems only occur during periodic
depressurizations, and these uncontrolled emissions may be low enough
such that the process may be under the 2,000 lb/yr cutoff. Processes
with recirculating drying systems also may be able to take advantage of
the pollution prevention standard.
6. Definition of Isolated Intermediate
At proposal, isolated intermediate was defined as ``any
intermediate that is removed from the process equipment for temporary
or permanent storage or transferred to shipping containers.'' The
concept of an intermediate was also included in the proposed definition
of pharmaceutical product which contained a reference to
``intermediates used in the production of pharmaceutical products (see
section VI.A.1 of this preamble). One commenter on the proposed rule
stated that EPA should not use or define the term, ``isolated
intermediate,'' in the pharmaceutical NESHAP. (The same commenter also
stated that the term, ``isolated intermediate,'' should be removed from
the definition of process [see also section VI.A.3--Definition of
Process].) The commenter pointed out that the term is ``peculiar to the
Toxic Substances Control Act (TSCA), where a long history of
interpretation has been developed,'' and if EPA uses this same term in
the pharmaceutical NESHAP, ``inconsistencies in interpretation will be
inevitable.''
Many other commenters suggested that the definition of isolated
intermediate be modified so that the physical removal of an
intermediate from the process equipment is not required as a condition
for meeting the definition of isolated intermediate. These commenters
pointed out that, in some cases, an intermediate may remain in a
storage tank or other retention equipment prior to being used in a
different process step, and without ever being removed from either set
of process equipment. The commenters further stated that the fact that
retention tanks are used as separation lines as an alternative to
storing the material in drums or separate containers ``is a matter of
convenience.'' Therefore, the commenters recommended the following
modified definition of isolated intermediate:
Isolated intermediate means any intermediate that is stored in
storage tanks or other holding equipment for later use, or that is
transferred to containers for shipment or storage.
After considering these and other related comments (see section
VI.A.3 of this preamble), EPA has deleted the
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term, ``isolated intermediate,'' from the definition of process to
avoid confusion and emphasize that products are the end result of
processes. Therefore, isolated intermediates are no longer defined or
referred to in today's final rule. Also, the definition of process in
the final rule incorporates the commenters' suggestion above regarding
the fact that physical removal of the ``product'' from the process
equipment should not be a required condition for meeting the definition
of ``product.'' In addition, the definition of process in the final
rule specifies when a process ``ends.''
7. Research and Development Facilities
Many commenters expressed support for the proposed definition of
research and development facilities because it draws a clear
distinction between activities related to manufacturing (which are
covered under today's final pharmaceutical production NESHAP) and those
related to research and development (which are not covered by today's
final rule). The commenters further stated that such a clear
distinction is necessary because pharmaceutical manufacturing
operations and research and development activities are often located at
the same site. Many commenters requested that EPA make it clear that
pilot plants are not subject to the proposed pharmaceutical standards
if they meet the definition of ``research and development facility.''
In determining whether an operation of facility constitutes a research
and development facility, it is EPA's intention that owners and
operators and implementing agencies should refer to the definition of
research and development facility which appears in Section 112(c)(7) of
the Clean Air Act, rather than relying on existing company designations
or facility names. For example, if a pilot plant is collocated with
pharmaceutical manufacturing operations that are subject to this
subpart, and the pilot plant meets the criteria outlined in the
definition of research and development facility, then the pilot plant
would not be subject to this subpart.
Two commenters were concerned that the term ``de minimis,'' as it
is used in the definition of research and development facility, was not
defined in the proposed rule. One of the commenters stated that,
without clarification (of de minimis) the definition will lead to
exhaustive and potentially contentious negotiations between sources and
regulatory agencies, and may result in inequitable exemption decisions
at similar facilities located in different jurisdictions. The commenter
also pointed out that some States have included more specific
provisions, such as limiting the number of products produced,
establishing maximum daily emission rates, or requiring segregation of
the R&D activities from the production areas. Although EPA recognizes
the concerns of the commenters, today's final rule does not establish a
de minimis level for research and development facilities. The EPA does
not have sufficient data to establish a de minimis level, and
therefore, such determinations will have to be made by the applicable
permitting authorities. Also, EPA is in the process of collecting
background information on the various segments of research and
development facilities nationwide and is considering development of a
NESHAP for one or more of these segments in the future.
8. Consistency With Other Rules
The EPA received numerous comments regarding the potential for
overlapping regulations. Commenters were strongly opposed to the idea
of the same sources being subject to multiple regulations and asked EPA
to clarify which regulations applied to pharmaceutical manufacturing
operations.
The EPA has identified several potential areas in which today's
final standards, the RCRA standards (subpart AA or CC), and/or subpart
I of 40 CFR part 63 could apply to the same situation. To avoid
inconsistent requirements, the EPA has tried to make the regulatory
language as specific as possible as to which regulation(s) the owner or
operator must comply with to satisfy the requirements of all regulatory
programs. For example, if an air pollution control device is subject to
the pharmaceuticals production NESHAP and RCRA requirements,
Sec. 63.1250(h)(2) of today's final rule states that the owner or
operator may elect to comply with the monitoring, recordkeeping and
reporting requirements of either rule, as long as they identify which
rule's requirements they have selected in the Notification of
Compliance Status report. However, if the owner/operator elects to go
with RCRA requirements, there may be additional (minimal) reporting
requirements.
Similarly, Secs. 63.1250(h)(1), (3) and (h)(4) address overlap with
other MACT standards, subpart Kb (the NSPS for organic liquid storage
tanks), and subpart I (the negotiated regulation for equipment leaks).
After the compliance date for today's final rule for pharmaceuticals
production, an affected source subject to Subpart I is required to
comply only with the provisions of today's final rule. For sources
subject to other MACT standards and NSPS Kb, reporting requirements may
be streamlined to the extent that the rules are consistent.
B. Storage Tank Provisions
The proposed and final standards for storage tanks with capacities
greater than 20,000 gallons (i.e., reduce HAP emissions by at least 95
percent) represent a control level that is beyond the MACT floor. In
deciding to go beyond the MACT floor, EPA determined that floating roof
technology was less costly than condensers (which represented the MACT
floor technology and 90 percent control) and resulted in greater
emission reductions. Many commenters stated that the proposed
requirements for storage tanks with capacities greater than or equal to
20,000 gallons represent an increase in stringency (beyond the MACT
floor) without precedent. These commenters suggested that 90 percent
control of HAP emissions was more appropriate and consistent with the
storage tank provisions of similar rules (e.g., the HON and 40 CFR 60,
Subpart Kb). The commenters also questioned EPA's assumption that
floating roof technology could and would be used to reduce emissions
from storage tanks, given the general lack of storage tanks at
pharmaceutical manufacturing facilities that are fitted with floating
roofs and the use of horizontal storage tanks (which cannot be fitted
with floating roofs) at some facilities.
In addition, commenters requested that EPA include in the final
rule: (1) an exemption for storage tanks emitting less than 500 lb/yr
of HAP (an alternative that was considered and then dropped during the
regulatory review .process), and (2) a provision that allows vapor
balancing systems as an alternative means of control. The commenters
reviewed what was gained by dropping the 500 lb/yr cutoff alternative
and concluded that in the top 12 percent of storage tanks, the
associated emissions that would not be controlled under the 500 lb/yr
cutoff alternative are 2,710 lb/yr (or 150 lb/yr/ tank). Based on an
annualized cost of $142,500/yr (to control the 2,710 lb/yr), the
commenters determined that the cost effectiveness of controlling the
emissions from storage tanks with emissions less than 500 lb/yr would
be $115,913/Mg. The commenters further stated that the EPA has
authority under the law to establish de minimis provisions for
exceptions from statutory directives when the benefits of regulation
are significantly outweighed by the associated costs and other
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burdens, and the 500 lb/yr cutoff alternative meets the criteria for
establishing such a de minimis provision, especially considering the
fact that the proposed storage tank provisions represent a control
level above the MACT floor.
Many commenters stated that the rule should specify that vapor
balancing systems meet the requirements of the storage tank provisions.
The commenters stated that vapor balancing systems are effective,
relatively easy to use, capable of achieving control efficiencies as
high as 90 to 98 percent, and are accepted under other rules (both NSPS
and NESHAP), and therefore, should be accepted in the pharmaceutical
NESHAP. One commenter also pointed out that, when vapor balancing is
used (i.e., the storage tank vapor space is routed to the truck), the
source of pollution is the vapor content of the truck; however, when
the storage tank is vented to a control device, there are two sources
of pollution: the HAP vapor from the truck and secondary pollutants
from the control device. The same commenter recommended that the State
of New Jersey requirements for vapor control (7:27-16.4 VOC Transfer
Operations, Other Than Gasoline) be incorporated into the storage tank
provisions.
In response to the comments on the proposed storage tank
provisions, today's final rule does not include provisions for vapor
balancing of storage tanks. However, this issue will be addressed in
the Organic Liquids distribution MACT standard. The MACT floor for
storage tanks was determined to be 90 percent control of HAP from
storage tanks and did not cover tank truck vapor. The EPA also
considered the commenters' request for a 500 lb/yr cutoff, but rejected
it because a sufficient number of small storage tanks in service at
pharmaceutical manufacturing facilities are controlled, and the 500 lb/
yr cutoff represents an alternative that is less stringent than the
MACT floor, and thus, is not acceptable. The control level for storage
tanks with capacities greater than or equal to 20,000 gallons in the
final rule is the same as proposed level (i.e., 95 percent). As
explained in the Basis and Purpose Document (see Docket A-96-03, Item
No. III-B-01 ), EPA chose 95 percent control (as opposed to the MACT
floor) for storage tanks greater than 20,000 gallons because floating
roof technology has been demonstrated to achieve 95 percent control and
is considerably less expensive than other technologies. Although
floating roofs currently may not be in use on storage tanks in the
pharmaceutical industry, EPA is not aware of any technical obstacles to
their use, except in the case of horizontal tanks. Also, owners or
operators still have the option of using add-on controls instead of
floating roofs.
C. Process Vent Provisions
The EPA received numerous comments on the proposed standards for
process vents. Comments focused on the following areas: (1)
establishment of a concentration-based applicability cutoff, (2)
implementation of the 98 percent control requirement, (3) new source
MACT for process vents, and (4) compliance periods.
1. Applicability Cutoff
Many commenters suggested that EPA establish a concentration
threshold below which an emission stream would not be considered a
process vent, and thus would be exempt from further applicability
determinations, control or monitoring requirements. The commenters
recommended a de minimis concentration of 50 ppmv or 50 ppmw for
process vents.
After consideration of the above recommendations and comments
related to the alternative standard (see section VI.G of this
preamble), EPA decided to establish a de minimis cutoff for process
vents equal to 50 ppmv HAP, based on uncontrolled, undiluted emissions.
The de minimis cutoff is incorporated into the definition of process
vent, which states that uncontrolled, undiluted emission streams
containing less than 50 ppmv HAP are not considered process vents.
2. Implementation of the 98 Percent Control Requirement
Today's final rule requires facilities to apply an equation in
Sec. 63.1254(a)(3) to determine if emissions from the process vent must
be controlled by 98 percent as opposed to 93 percent. The applicability
equation uses two variables, vent flow and yearly uncontrolled HAP
emissions, to calculate a flow rate. The calculated flow rate is then
compared to the process vent's actual flow rate, and if the actual flow
rate is less than or equal to the calculated flow rate, the process
vent requires 98 percent control. A number of commenters believe that
the 98 percent control applicability equation should be deleted because
it will create a significant recordkeeping burden, will be practically
impossible to implement, and will significantly hamper operational
flexibility.
The major concern noted by the commenters was that the
applicability equation, though fairly straight-forward for dedicated
single-product processes, is extremely difficult if not impossible to
apply to multipurpose nondedicated processes. The commenters stated
that, because nondedicated processes use individual pieces of equipment
to make numerous products over the course of a year, the emission
stream characteristics of the associated process vents will change
depending on the product being manufactured, and thus, the
recordkeeping requirements for a single process vent would be
burdensome. The commenters also pointed out that a facility may have
200 to 300 individual process vents.
Another concern raised by the commenters was that a slight variance
from forecasted production could result in a process vent previously
required to control emissions by 93 percent to become subject to the 98
percent control requirement, and the affected facility would not have
sufficient lead time to upgrade their control equipment from 93 to 98
percent. The commenters were concerned that such uncertainties will
hamper operational flexibility because facilities will be forced to
impose limitations on production to ensure that they will not trigger
98 percent control. The commenters also stated that applying the
applicability equation to manifolded vents would further complicate
matters because more sources emitted through the same vent will result
in greater variability of vent stream characteristics.
The commenters also requested that if EPA retains the 98 percent
control requirement for existing process vents in the final rule, that
Sec. 63.1252(c)(4) in the proposed rule be revised to clearly describe
how to apply the 98 percent control applicability equation. Commenters
noted that using the past actual annual HAP emissions versus projected
annual HAP emissions in the applicability equation is an issue because
the production of many products varies from year to year, and
historical and forecasted annual HAP emission estimates may be very
different. The commenters also were concerned that the proposed rule
did not clearly establish how to determine the process vent's actual
flow rate, which will be compared to the applicability equation's
calculated flow rate. Finally, the commenters suggested that EPA
specify that the applicability equation applies to individual pieces of
equipment in a formulation facility. The commenters were concerned with
how the applicability equation would be applied to nondedicated
formulation facilities. The commenters pointed out that nondedicated
formulation facilities often use multiple pieces of the same equipment
to perform one operation
[[Page 50296]]
(e.g., six tray dryers), and not all of these pieces of equipment will
be used to produce every product in the formulation facility (i.e., not
all trays of the dryer are always used).
After considering the comments above, EPA decided to retain the 98
percent control requirement for existing process vents that meet the
applicability criteria. (For those process vents already controlled to
93 percent prior to April 2, 1997, no additional control is necessary.)
The applicability equation applies to individual process vents within a
process; however today's final rule considers manifolded process vents
within each process to constitute a single process vent. With the
exception of formulation operations and recovery devices, the
definition of process is based on the product manufactured, not the
equipment used to manufacture it. Therefore, the determination of which
vents require control to the 98 percent level for nondedicated process
vents should be straightforward; namely, owners and operators need to
anticipate the total uncontrolled HAP emissions per year from each vent
from each process, and the average flow rate of the vent. The total
uncontrolled emissions should be based on the potential number of
batches per year that the facility can run for each process. Based on
this projection, the owner or operator can decide whether to install or
use an existing 98 percent control device or limit the number of
batches to stay below the applicability threshold. Today's final rule
also requires facilities to keep track of the number of batches of
products they make each year to show that their number of batches is
less than the number needed to trigger 98 percent.
In response to the commenters' request, the average flow rate has
been clarified in the final rule to mean the weighted average flow rate
of the emission events contributing to the process vent. For solvent
recovery or formulation operations, the definition of process in
today's final rule has been clarified to include all operations within
a contiguous area; therefore, for these operations, a single process
may be associated with several products. Like other processes, the
application of the 98 percent control applicability equation should be
based on individual process vents or manifolded vents. Thus, if each
piece of equipment that is located at a formulation facility,
considering processes by contiguous areas, has a separate vent, then
the applicability equation is applied to each vent separately; however,
if the vents from each piece of equipment are manifolded together, then
they are treated as one process vent and the equation is applied to the
aggregated flow.
As part of the rationale for retaining the 98 percent requirement,
EPA notes that this level of control is imposed only on vents that have
the potential to emit 25 tons/yr or more, on an uncontrolled basis.
Secondly, the applicability equation is indexed on cost-effectiveness.
Streams that are too dilute for cost effective control would not, per
the equation, be required to be controlled. Third, process vents
already controlled to levels of 93 percent or greater prior to April 2,
1997, would be grandfathered and not required to increase controls to
98 percent. The EPA believes that after these considerations are made,
only very large streams that are cost effective to control to 98
percent will trigger the 98 percent control requirement.
3. New Source MACT for Process Vents
At proposal, new source MACT for process vents was set at 98
percent control for process vents with uncontrolled emissions greater
than or equal to 400 lb/yr. The rationale for the 400 lb/yr cutoff
(uncontrolled) was that it represented the smallest controlled process
considered to be a similar source. Many commenters stated that the
standard for new process vents should include a 2,000 lb/yr controlled
emissions compliance alternative, because it is unreasonable and
unwarranted to require vents with low HAP emissions to achieve 98
percent control. The commenters agreed with EPA's conclusion that 98
percent control represents the best controls in practice for certain
sources; however, the commenters believe that the applicability cutoff
for new source MACT for process vents is legally flawed because the
cutoff did not consider two of the four process types in the industry
(fermentation and extraction). The commenters also stated that the
process on which the 400 lb/yr cutoff is based is not representative of
the industry's processes because the process emits primarily one HAP
(methanol) and is controlled by a dedicated scrubber and appears to be
only a portion of a process based on the EPA's definition of process in
the proposed rule. Citing other rules that set new source MACT as the
average level of control achieved by sources using new source MACT
control technology, the commenters performed an analysis of the MACT
floor data base and determined that the average level of controlled
emissions from the best-performing 12 plants was approximately 1,400
lb/yr. The commenters excluded two processes from their analysis that
had uncontrolled emissions greater than 1 million lb/yr because these
processes are much larger than the typical pharmaceutical manufacturing
process and would skew the data. According to the commenters, if these
two (larger) processes are included in the analysis, the average level
of controlled emissions from the best-performing 12 plants would equal
6,400 lb/yr.
The EPA has reviewed the data used to set the MACT floor for
process vents at new sources. Based on this review, the EPA has
concluded that the data support the level of the proposed standard for
new sources.
The EPA based the 98 percent control requirement on the 26
processes (under the proposed definition) at 7 plants in the data base
that achieve or exceed this control level. These processes include
dedicated and nondedicated formulation, chemical synthesis, and
fermentation processes. The EPA has concluded that these processes are
representative of the control challenges faced by the industry despite
the fact that the data do not include an extraction process. The EPA
has further concluded that the 98 percent control level achieved at the
best controlled processes is applicable to all four process types.
The EPA does not believe that the variation in exhaust gas
characteristics among the four types of processes in the industry is
significant enough to warrant individual evaluation of achievable
control levels. In any case, extraction processes are typically
solvent-intensive, resulting in the highest average HAP concentration
of the four types of processes. High HAP concentrations are conducive
to high percent control levels.
The commenters suggested that the EPA adopt a 2,000 lb/yr actual
emissions compliance alternative to account for variability within the
industry. The commenters based this alternative on the average level of
controlled emissions from 24 of the processes in the data base that
achieve 98 percent control or greater. (The commenters excluded the
other two processes in the data base because they were atypically
large.) The EPA does not believe that the analysis presented by the
commenters is an appropriate basis for a new source compliance
alternative. First, while the commenters imply that the alternative is
needed to account for variability in the control level that is
achievable by the wide variety of pharmaceutical processes, the
analysis does not address control efficiency at all. Because the
commenters evaluated only processes that achieve at least 98
[[Page 50297]]
percent control, only variability in uncontrolled emissions truly
figures into the analysis. Second, the alternative standard suggested
by the commenters is not equivalent to the percent reduction standard
and would result in greater total emissions of HAP from the industry.
Finally, the EPA analyses cited as precedents address different
situations and provide scant support for the commenters' analysis.
While the EPA has rejected the alternative standard suggested by
the commenters, the final rule provides a 20 ppmv outlet concentration
alternative to 98 percent control for process vents at new sources.
This alternative addresses the primary impediment to achieving 98
percent control, i.e., low inlet concentration gas streams.
The EPA based the proposed applicability cutoff for new source
process vents on the smallest representative process in the data base
that achieves 98 percent control or greater. The commenters questioned
whether this operation actually qualifies as an entire process under
the proposed definition of ``process'' and whether the operation is
representative of processes in the industry. Although the EPA continues
to believe that the formulation operation selected as the basis for the
proposed cutoff is a process under the proposed definition, it may not
qualify as a process under the final definition because nondedicated
formulation operations occurring within a contiguous area are now
considered single processes. Consequently, the EPA has reanalyzed the
data based on the final definition of ``process.'' In light of the new
analysis, it is no longer relevant whether the process upon which the
proposed cutoff was based is representative of the industry.
The new analysis was similar to the original analysis. After
revising the data base of well-controlled sources to conform to the
final definition of ``process,'' the EPA identified the smallest
processes that are controlled by 98 percent or more. As in the previous
analysis, formulation and chemical synthesis processes are the smallest
processes. Two chemical synthesis processes, one emitting 85 lb/yr
uncontrolled and another emitting 304 lb/yr uncontrolled, were
identified as achieving control of 98 percent. Although these processes
were reported as individual (single) processes, EPA summed emissions
from both, since the product name listed for each was very similar, and
EPA wanted to be conservative. The total uncontrolled emissions from
the sum of these two processes is 390 lb/yr, which is the same level of
emissions as the proposed cutoff. Therefore, the EPA has established in
the final rule the new source process applicability cutoff of 400 lb/yr
of uncontrolled HAP.
Despite the fact that no fermentation or extraction processes were
among the smallest well-controlled processes, the EPA believes that the
analysis is representative of the control capabilities of all process
types. As discussed previously, the EPA has concluded that the gas
streams generated by the four types of processes in this industry are
similar enough that an individual analysis by process type is not
warranted. Fermentation and extraction processes are typically much
larger than formulation and chemical synthesis processes. Thus, the
absence of fermentation and extraction processes in the list of the
smallest well-controlled processes is the result of this size
differential, not a difference in the control level that can be
achieved. In fact, the average uncontrolled HAP concentration of
fermentation and extraction process vents exceeds those of formulation
and chemical synthesis process vents. Higher concentrations are more
conducive to high percent control.
Practically speaking, new source MACT will apply to low HAP-
emitting processes only at new facilities, where the minimum control
requirement is 98 percent for all processes. (At existing sites, new
source MACT will apply only to dedicated new PMPU's with a potential to
emit 10 tons/yr of a single HAP or 25 tons/yr of all HAP combined.)
Thus, sources will not be faced with the need to install 98 percent-
efficient controls dedicated to small new processes, which could be
very costly for a small amount of emission reduction. Instead, the EPA
expects that sources will achieve the new source MACT standard using
large control devices that treat multiple manifolded gas streams.
Because this is the control situation most typically found for the
small processes in EPA's data base of well-controlled sources, the EPA
believes that the final rule's applicability cutoff accurately reflects
what will be achievable at new sources in this industry.
4. Compliance Period
Several commenters stated that they support the proposed annual
compliance period for process vents and noted the inconsistency with
the daily continuous compliance provisions. If the final rule includes
a shorter compliance period, the commenters have stated that either the
standards must be adjusted to avoid an increase in stringency above the
floor or a demonstration must be made that the increased stringency
(i.e., going above the floor) is justified according to the
requirements of the Clean Air Act. The EPA, in the final rule, has
clarified the compliance period of the standard to be either on a 24-
hour basis, or on a batch cycle or ``block'' basis. Additionally,
compliance periods for emissions averaging are on a quarterly basis,
while compliance periods for the P2 standard are on an annual basis, as
calculated on a monthly or 10-batch rolling average. An annual
compliance period for the standards was determined by EPA to be too
difficult to implement. The annual compliance period implies that
owners and operators could control processes to varying degrees during
the course of a year, as long as the yearly percent reduction target
could be met. While this format would offer flexibility to owners and
operators that would want to change control strategies to accommodate
production scheduling and operational changes, EPA believes that the
demonstration of compliance over such an extended time period would
result in delayed compliance determinations and the possibility for
extended periods of violations. The EPA notes that the final rule
offers some flexibility to owners and operators in addressing
variability within the processes themselves by providing numerous
compliance options. Therefore, EPA does not believe that by clarifying
the final rule to reflect a daily compliance period, the stringency of
the standard was increased.
D. Wastewater Provisions
1. MACT Floor
The EPA estimated that 101 pharmaceuticals facilities would be
major sources subject to the rule. The MACT floor is based on available
information about control levels at all of these sources. One commenter
asserted that the applicability section of the proposed rule covers
more types of facilities than those in the original MACT floor
analysis, and thus the MACT floor should be recalculated. The EPA did
not recalculate the MACT floor because, as noted in section VI.A.1 of
this preamble, the applicability in the final rule is clarified to
eliminate the likelihood that the rule would apply to types of
facilities other than those represented in the 101 in the initial
analysis.
2. DeMinimis Cutoff in Definition of Wastewater
The final rule includes de minimis cutoffs for determining if a
water stream is wastewater. One commenter requested that HAP
concentration and
[[Page 50298]]
flow rate cutoffs be added, as in the HON. The commenter contended that
the burden to characterize streams with very small HAP loadings would
be excessive without such cutoffs. For the final rule, EPA revised the
definition of wastewater to include de minimis HAP cutoffs of 5 ppmw
and 0.05 kg/yr, which is consistent with the HON. Although the owner or
operator is given some flexibility in the methods used to characterize
these streams, the Administrator may require the owner or operator to
validate this information through sampling and analysis or other
appropriate means.
3. Cross-References to the HON
The wastewater provisions in the proposed rule contained numerous
cross-references to the wastewater provisions in Secs. 63.132 through
63.148 of the HON. Many commenters requested that the applicable
provisions from the HON be included in the final rule because the
extensive cross-referencing made the proposed rule hard to understand
and would likely be hard to implement. Some comments also noted that
many cross references were not consistent with the most current version
of the HON. To address these concerns, EPA decided to incorporate the
applicable provisions from the HON in the final rule. These provisions
include the emission suppression requirements from Secs. 63.133 through
63.137, the control device requirements from Sec. 63.139, the general
procedures for determining compliance from Sec. 63.145, many of the
compliance options for treatment systems and control devices from
Secs. 63.138 and 63.145 (additional information about compliance
options is provided in section VI.D.4), the inspection and monitoring
provisions from Secs. 63.143 and 63.148, the requirements for certain
liquid streams in open systems within a PMPU from Sec. 63.149, and the
tables that are referenced from all of these sections.
4. Additional Treatment Options for Demonstrating Compliance
Several commenters requested that the rule include additional
treatment options for demonstrating compliance. Some comments requested
that all of the options in the HON be added to the rule. Other comments
specifically requested that the rule allow treatment in RCRA units and
that a concentration limit be developed for soluble HAP. In response to
the comments, EPA included additional treatment options in the final
rule that are consistent with the standards. All of the RCRA options
from the HON were added because treatment in these units will meet the
standards. A concentration option of 520 ppmw for soluble HAP was added
because this level is consistent with the 90 percent reduction
requirement for soluble HAP.
Four options from the HON were not added to the final rule. The
design steam stripper option was not added because the available
stripper designs that were used to estimate impacts have not been
tested in the field. The percent mass removal/destruction option based
on fraction removed (Fr) values was not added because the Fr values
would be identical to the percent reduction option. The 1 Mg/yr option
was not added because any facility with wastewater containing a load of
total partially soluble and/or soluble HAP less than 1 Mg/yr would have
no affected wastewater streams. The required mass removal options were
not included because wastewater discharges from batch pharmaceutical
processes are much more variable than those from continuous SOCMI
processes; therefore, the required mass removal is likely to be
different at any given time, and is not likely to correlate well with
the actual mass removal in the treatment unit at a given time.
5. General Compliance Procedures
The proposed rule cross-referenced the specific procedures in the
HON for determining compliance with the standards when using various
types of treatment units (i.e., noncombustion, combustion, or
biological), but the general procedures used to determine compliance
that are applicable to any performance test (or design evaluation) were
not cross-referenced. Several commenters requested that these general
procedures also be included in the rule. Specifically, the commenters
requested that the rule specify that: (1) performance tests be
conducted under representative operating conditions, (2) treatment may
be conducted using a series of treatment devices, (3) treatment may be
conducted offsite or in onsite treatment units not owned by the source,
and (4) any biological units in compliance with the standards need not
be covered and vented. Commenters also requested that the rule include:
(1) procedures for the preparation and installation of testing
equipment and (2) requirements for compounds that do not need to be
considered in performance tests or design evaluations. The final rule
includes all of these provisions; however, clarification of two points
is provided below.
Clarification of the provision for testing under representative
operating conditions is provided because the commenters misinterpreted
the meaning of this provision in the HON. This provision requires a
facility to conduct a single performance test under representative
operating conditions. If actual operating conditions vary, such that
there are multiple representative operating conditions, the owner or
operator must supplement the test results with modeling and/or
engineering assessments to demonstrate that the standard is met over
the entire range of operating conditions. Testing under representative
operating conditions does not mean the standard is an average that may
be exceeded under certain conditions.
A clarification of the provision that allows open biological
treatment units to be uncovered is also provided. Except for enhanced
biological treatment units used to treat certain wastewater streams, an
owner or operator demonstrates compliance for open biological treatment
units by conducting a performance test and following the procedures in
appendix C of part 63. If these procedures show the fraction
biodegraded meets or exceeds the applicable control level, the
treatment unit need not be covered. An enhanced biological treatment
unit that is used to treat wastewater containing soluble HAP and less
than 50 ppmw of partially soluble HAP is exempt from the performance
test requirements and need not be covered.
6. Default Biodegradation Rate for Methanol
One commenter urged EPA to revise the default methanol
biodegradation rate constant that is used in Table 37 of subpart G of
the HON because it cannot be scientifically supported with available
data. Based on data from a number of studies, the commenter concluded
that the rate in the proposed rule is low by a factor of 10 to 100. The
commenter noted that the geometric mean of the rates from the available
studies was 8.6 L/g MLVSS-hr, and the lower bound of the 90 percent
confidence interval was 3.5 L/g MLVSS-hr. The commenter also cited data
in the scientific literature that show hexachlorobenzene,
chlorobenzene, nitrobenzene, and biphenol (other list 1 compounds) to
be less biodegradable than methanol, whereas Table 37 of the HON shows
methanol to be less biodegradable than the other compounds.
The data submitted by the commenter show considerable variability,
but they also show the higher biodegradation rate constants tend to
correspond with higher methanol concentrations in the wastewater. The
EPA concluded that a
[[Page 50299]]
methanol biodegradation rate constant higher than the default is
appropriate for pharmaceutical facilities that are direct dischargers
because they tend to treat wastewater with higher methanol
concentrations than indirect dischargers or facilities in other
industries. The final rule allows these facilities to use a methanol
biodegradation rate constant of 3.5 L/g MLVSS-hr, the lower bound of
the 90 percent confidence interval; this is a conservative value that
minimizes the likelihood that the biodegradation rate will be
overestimated.
7. Maintenance Wastewater
The wastewater provisions apply to both process and maintenance
wastewater. Commenters requested that maintenance wastewater provisions
be less stringent than those for process wastewater, as in the HON.
According to one commenter, the same conveyance systems and controls
are not practical or cost effective for maintenance wastewater. The EPA
did not change the maintenance wastewater provisions because
maintenance wastewater is a potential source of significant emissions.
Furthermore, procedures to estimate maintenance wastewater
characteristics should be the same as those for most process wastewater
because both consist of batch discharges.
8. Control Requirements for Wastewater Tanks
The rule requires that wastewater tanks have either a fixed roof or
additional controls, depending on tank design and/or operating
characteristics. A number of commenters expressed confusion over these
provisions and offered their interpretations or preferences to clarify
the provisions. Under the rule, wastewater tanks that have a capacity
of less than 75 m3, a capacity between 75 and 151
m3 that contain material with a vapor pressure less than
13.1 kPa, or a capacity greater than or equal to 151 m3 that
contain material with a vapor pressure less than 5.2 kPa are required
to have a fixed roof unless the wastewater in the tank is heated,
treated with an exothermic reaction, or sparged. If any of these three
conditions is not satisfied, the owner or operator must install a
floating roof or use control techniques that achieve equivalent
emission reductions. These provisions match those in the HON. The
proposed rule also included an additional provision that caused the
confusion for the commenters. The intent of the provision was to exempt
wastewater tanks from the additional control provisions, but not the
fixed roof requirement, if the owner or operator demonstrates that the
total partially soluble and/or soluble HAP emissions from a fixed roof
tank that is heated, treated with an exothermic reaction, or sparged
are less than 5 percent higher than the emissions would be in the
absence of these activities. This additional provision is rewritten in
the final rule to improve clarity.
9. Compliance Requirements for Biological Treatment Units
The EPA received numerous comments on the initial compliance
procedures and monitoring requirements for enhanced biological
treatment units. Some commenters requested that compliance
demonstrations be based on parameters related to soluble HAP removal,
not general compliance with all NPDES permit limits; the commenters
suggested monitoring for surrogate parameters like COD, BOD, and/or
TSS. Some commenters stated that EPA's definition of significant
noncompliance in appendix A of 40 CFR 123.45 should be used as the
basis for defining acceptable enhanced biotreatment operation for both
POTW's and direct dischargers. One commenter stated that compliance
provisions should focus on the indirect discharger, not the POTW; for
example, the indirect discharger should be in compliance with the
pretreatment provisions in 40 CFR 403 and 439. Several commenters
stated that the provision allowing discharge to an enhanced biological
treatment unit at a POTW only if the indirect discharger demonstrates
that less than 5 percent of the soluble HAP in the wastewater from the
POD's is emitted from the municipal sewer system is unnecessary and
burdensome.
The compliance procedures for biological treatment units are
rewritten in the final rule for clarity, simplification, and as noted
above, to eliminate cross-references to the HON. Because the changes
are extensive, all of the compliance procedures and monitoring
requirements for biological treatment units, not just the issues raised
by the commenters, are summarized below.
Onsite or offsite biological treatment units may be used to comply
with the standards for soluble HAP, and onsite biological treatment
units may be used to comply with the standard for total soluble and
partially soluble HAP. The compliance requirements vary depending on
the concentration of partially soluble HAP in the wastewater, whether
the treatment unit is open or closed, whether the biological treatment
unit is enhanced, and whether the wastewater is treated onsite or
offsite.
If wastewater containing soluble HAP and any concentration of
partially soluble HAP is treated in an open, onsite biological
treatment unit that does not meet the definition of an enhanced
biological treatment unit, the owner or operator must conduct an
initial performance test to determine the fraction biodegraded
(fbio) in the unit; the fbio for the compounds
may be calculated using any of the procedures in appendix C to 40 CFR
part 63, except procedure 3 (inlet and outlet concentration
measurements). As noted in section VI.D.5, the treatment unit may
remain open if the fraction biodegraded meets or exceeds the level of
the standard. For a closed biological treatment system, the owner or
operator may follow the same procedure; alternatively, the owner or
operator of a closed biological treatment unit may conduct either a
design evaluation using procedure 3 or a performance test to determine
the mass reduction of soluble HAP (or total soluble and partially
soluble HAP) in the unit. Under the proposed rule, the owner or
operator of open and closed biological treatment units would have been
required to specify appropriate monitoring parameters in the
Notification of Compliance Status Report, subject to approval of the
permitting authority. Based on consideration of the comments, EPA
decided to specify continuous monitoring requirements for TSS and BOD
in the final rule. To be in compliance, the TSS and BOD concentrations
must not exceed the TSS and BOD criteria in 40 CFR 439 more frequently
than, or by amounts greater than, allowed by the noncompliance
reporting criteria in 40 CFR 123.45, appendix A.
If wastewater containing soluble HAP and more than 50 ppmw of
partially soluble HAP is treated in an onsite, enhanced biological
treatment system, the compliance procedures are the same as described
above, except that the fbio for soluble compounds may be
calculated using either the default for first order biodegradation
constants or any of the procedures in appendix C of 40 CFR part 63. As
noted in section VI.D.6, the owner or operator may use a biodegradation
rate constant of 3.5 L/g MLVSS-hr for methanol. The owner or operator
also must monitor for TSS and BOD as described above. In addition, to
demonstrate continuous compliance with the 1 kg/m3 level in
the definition of enhanced biological treatment unit, the owner or
operator must monitor the concentration of MLVSS.
[[Page 50300]]
If wastewater containing soluble HAP and less than 50 ppmw of
partially soluble HAP is treated in an onsite, enhanced biological
treatment unit, the owner or operator is exempt from the performance
test requirement for the treatment unit. Monitoring for TSS, BOD, and
biomass is required as described above.
Wastewater containing soluble HAP and less than 50 ppmw of
partially soluble HAP may be transferred for offsite treatment or
onsite treatment in a unit not owned by the source. Before the source
may transfer such wastewater, the transferee must submit to EPA written
certification that the transferee will manage and treat any affected
wastewater or residuals in accordance with the requirements of the
rule. The initial compliance procedures and monitoring requirements to
show continuous compliance are the same as for similar onsite units
treating the same wastewater. In response to the comments, EPA
reexamined emissions from municipal sewer systems and determined that
the major potential for emissions is from the headworks. Thus, if the
wastewater is discharged to a POTW, the final rule requires the owner
or operator to demonstrate that less than 5 percent of HAPs are lost.
However, if the headworks at the POTW are covered, no such
demonstration is required. The same emission suppression requirements
apply if the wastewater is discharged for treatment in any other type
of offsite treatment unit or onsite treatment unit not owned by the
source.
10. Control Requirements for Individual Drain Systems
The rule requires emission suppression and control measures for all
individual drain systems that manage affected wastewater or residuals
onsite. Several commenters requested that EPA exempt individual drain
systems from these requirements, and allow them to be vented to the
atmosphere, if they either manage wastewater that contains only soluble
HAP compounds and de minimis amounts of partially soluble HAP compounds
or demonstrate that emissions from the individual drain system and
associated wastewater tanks are less than 5 percent of the loading in
the affected wastewater. The commenter's rationale for this request was
that: (1) a PhRMA study of municipal sewers, which was submitted to
EPA, showed the potential emissions from individual drain systems that
manage wastewater containing primarily soluble HAP are low; (2) the
control is not cost effective; and (3) emissions of combustion products
would increase because facilities would meet the requirement with steam
strippers or incinerators.
For wastewater, EPA determined that MACT consists of hard-piping to
a steam stripper. Because this configuration was determined to be a
reasonable MACT floor requirement, any alternative must achieve
equivalent emission reductions. As in the HON, a covered individual
drain system is considered equivalent to hard piping. Thus, EPA did not
change the requirements for individual drain systems in the final rule.
E. Equipment Leak Provisions
Several commenters raised a number of issues related to equipment
leaks and EPA's proposed requirements for the LDAR program developed
for the pharmaceutical manufacturing industry. The proposed general
equipment leak requirements were based on subpart H (from the HON rule)
and included slight changes tailored for the pharmaceutical industry.
Some commenters were confused by the requirements and others were
concerned that some facilities will be subject to two different LDAR
programs because some pharmaceutical manufacturing operations are
already subject to subpart I (which requires compliance with subpart H
of the HON for components at pharmaceutical production processes that
use carbon tetrachloride or methylene chloride). Today's final rule
clarifies EPA's intent that affected sources that are subject to
today's final rule and subpart I of 40 CFR part 63 will no longer be
required to comply with subpart I after the compliance dates for
today's final rule. Many commenters argued that EPA is bound by the
subpart I regulatory negotiation and therefore, is not allowed to
expand the LDAR requirements to include any HAP other than carbon
tetrachloride and methylene chloride. The Clean Air Act requires that
EPA regulate all major sources of HAP. The regulatory negotiations
conducted in the development of subpart I included only a certain
fraction of components from the industry because that was the extent of
information that EPA had at the time the negotiations were conducted.
The Agency does not agree that the negotiated rule for equipment leaks
precludes further regulation of equipment leaks for pharmaceutical
manufacturing operations.
Some of the changes and assumptions made in estimating the
uncontrolled emissions for the industry used in determining the
proposed LDAR requirements were questioned by the commenters. A group
of commenters disapproved of the Agency's revised method to estimate
uncontrolled emissions using the uncontrolled SOCMI average emission
factors. The commenters argued that none of the studies used in
developing the SOCMI emission factors involved pharmaceutical
manufacturing operations.
Commenters also questioned EPA's assumptions and data used in some
of the LDAR cost calculations. In general, commenters stated that the
actual cost-effectiveness value associated with the proposed LDAR
program was much higher than EPA's estimate due to overestimated
emission reductions and underestimated costs. In response to these
comments, the Agency reviewed its cost analysis and recalculated the
cost effectiveness of several LDAR programs. The most acceptable
program, in terms of cost effectiveness, is based on requirements
similar to those of other recent regulations for similar manufacturing
industries and the provisions developed for the SOCMI Consolidated Air
Rule (CAR) which is yet to be proposed. The most significant difference
between the CAR equipment leaks subpart and the proposed equipment
leaks provisions is the innovative approach taken in the CAR to
monitoring valves and connectors for leaks.
The CAR program significantly reduces the amount of burden
associated with monitoring these types of equipment for leaks without
increasing the emissions of regulated pollutants to the environment. In
calculating the impacts of requiring an LDAR program meeting the
requirements of the CAR, EPA calculated monitoring costs based on
established guidance and calculated uncontrolled emissions using
initial leak frequencies reported from the industry. The details of
this analysis are included in the project docket (A-96-03) as Item No.
IV-B-5. The EPA, in reassessing industry leak data, addressed many of
the concerns of the commenters relative to the inclusion or exclusion
of specific data.
Using as a starting point leak data that was confirmed as initial
survey data by PhRMA, EPA reviewed the data base and further defined
the pool of data. Some data from PhRMA's compilation was revised to
reflect reported leak definitions, also, some data was excluded based
on the facility's explanation of frequency of monitoring and calculated
leak rates and the conclusion that the leak rates did not indeed
reflect initial monitoring data. The resulting initial leak rate data
was
[[Page 50301]]
1.45 percent for valves, 6.88 percent for pumps, and 1.5 percent for
connectors.
The subsequent leak rates are a critical parameter in calculating
the overall cost effectiveness of any LDAR program. Limited data were
available to determine the leak rates at pharmaceutical manufacturing
frequencies after the application of LDAR. Therefore, EPA assumed that
the equipment leak frequency occurrence rate after implementation of
LDAR was equal to the performance levels required in the draft CAR,
that repairs were 100 percent effective, and that there were no
recurrences of leaks. For the CAR rule, where several performance
levels and corresponding monitoring schedules are available, occurrence
rates were based on the best performance levels and longest monitoring
intervals available. For flanges and valves, this performance level is
0.25 percent leakers. The corresponding monitoring interval for flanges
is once every 8 years; for valves, it is once every 2 years. For light
liquid pumps there is no performance level specified, therefore it was
assumed that the leak occurrence rate was equal to 50 percent of the
initial leak frequency. Subsequent leak frequencies for the revised EPA
analysis were estimated to be 0.25 percent for valves, 3.44 percent for
pumps, and 0.25 percent for connectors.
Emission reductions for the program were estimated to be the
difference between the uncontrolled emission rate, as calculated using
the mass emission rate, in kg/hr-source, calculated from the Average
Leak Rate (ALR) equations and initial leak data, and the controlled
emission rate, calculated using the ALR equations and assumed
subsequent leak frequencies. The controlled emission rate was based on
one-half of the occurrence rate. This assumption was necessary to
account for the average leak frequency over the entire monitoring
cycle.
The EPA, in the revised analysis, also addressed concerns of the
commenters related to specific cost items. In general, capital and
annualized costs for monitoring instruments, data management systems,
and actual monitoring are not unreasonable and fall within the costs
quoted by vendors and LDAR contract services, based on recent inquiries
by EPA. Therefore, EPA did not revise significantly any cost items used
in the model facility analysis.
Based on this revised analysis, the Agency found that the cost
effectiveness of the CAR LDAR program was approximately $1000/Mg HAP
for a model pharmaceutical facility.
After consideration of the above comments, EPA revised the proposed
leak detection and repair provisions to be consistent with the Agency's
recent efforts toward consolidation of equipment leak requirements for
air regulations, the increased focus on processes with leaking
components, and a general lessening of monitoring and recordkeeping and
reporting requirements for processes with nonleaking components. Most
of the changes to the proposed rule involve the requirements for valves
and connectors in gas/vapor service and in light liquid service. These
changes include the addition of 2 year monitoring (instead of once
every four quarters) for those processes with less than 0.25 percent
leaking valves; extending the monitoring period for connectors with low
leak rates; provisions for valve subgrouping; deletion of the quality
improvement program implementation requirement and the credit for
valves removed; and revisions to the calculations for determining the
percentage of leaking valves. The Agency believes that the equipment
leak requirements included in today's final rule greatly reduce the
administrative burden associated with LDAR recordkeeping and reporting,
and at the same time, result in a significant reduction in emissions.
F. Pollution Prevention Alternative
Many comments were received on the proposed pollution prevention
alternative, primarily relating to the proposed restrictions to the use
of this alternative and the lack of specific recordkeeping and
reporting requirements. The following sections summarize the
commenters' concerns regarding the proposed pollution prevention
alternative, EPA's response to these concerns, and subsequent changes
made in today's final rule.
1. Restrictions on the Pollution Prevention (P2) Alternative
At proposal, processes emitting HAP that are generated in the
process were perceived by commenters as being prohibited from using the
pollution prevention alternative. Many commenters stated that processes
that generate HAP should be allowed to use the P2 alternative as long
as these quantities were included in the analysis. These commenters
also recommended that the rule provide a de minimis HAP generation
cutoff below which facilities could use the P2 alternative. The EPA
agrees with the commenters that PMPU's that generate HAP emissions
should be eligible for the P2 standard, provided the HAP emissions
generated by the PMPU are controlled to the required levels. Therefore,
today's final rule clarifies that processes that generate HAP can use
the P2 alternative, provided that the HAP emissions generated in the
PMPU are controlled to the required levels for storage tanks, process
vents, wastewater and equipment leaks in Secs. 63.1253 through 63.1256
of today's final, and the remaining requirements of the P2 alternative
are met. Because the final rule requires sources to account for HAP
generated in the process, a de minimis HAP generation cutoff is not
needed.
No increase in the production-indexed VOC consumption factor was
allowed as the result of compliance with the P2 alternative at
proposal. One commenter stated that the stipulation in the P2
alternative
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