15754 Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 63

[AD–FRL–5802–8]

RIN–2060–AE83

National Emission Standards for

Hazardous Air Pollutants

Pharmaceuticals Production

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule and notice of

public hearing.

SUMMARY: The proposed standard would

reduce air emissions of hazardous air

pollutants (HAP) from existing and new

facilities that manufacture

pharmaceutical products. The agency

intends that this proposed rule will

have a common technology basis with a

rule yet to be issued by EPA’s Office of

Water (OW); this will allow coordinated

and cost effective compliance planning

by the industry. In addition to soliciting

comments on various aspects of the

proposed rule, this document also

solicits comments on possible

approaches for the OW rule.

The major HAP emitted by facilities

covered by this proposed rule include

methylene chloride, methanol, toluene,

and hydrogen chloride. Methylene

chloride is considered to be a human

carcinogen and the other pollutants can

cause noncancer health effects in

humans. The proposed rule is estimated

to reduce HAP emissions from existing

facilities by 22,000 megagrams per year

(Mg/yr). It also reduces volatile organic

compound (VOC) emissions.

DATES: Comments. Comments must be

received on or before June 2, 1997.

Public Hearing. If anyone contacts

EPA requesting to speak at a public

hearing by April 23, 1997, a public

hearing will be held on May 2, 1997

beginning at 10 a.m. Persons interested

in attending the hearing should call Ms.

Marguerite Thweatt at (919) 541–5673 to

verify that a hearing will be held.

Request to Speak at Hearing. Persons

wishing to present oral testimony must

contact EPA by April 23, 1997, by

contacting Ms. Marguerite Thweatt.

ADDRESSES: Comments. Comments

should be submitted (in duplicate, if

possible) to: Air Docket Section (LE–

131), Attention: Docket No. A–96–03,

U.S. Environmental Protection Agency,

401 M Street SW., Washington, DC

20460. The EPA requests that separate

copies also be sent to the appropriate

contact persons listed below. The public

hearing, if required, will be held at the

EPA’s Office of Administration

Auditorium, Research Triangle Park,

North Carolina.

SUPPLEMENTARY INFORMATION: The

information contained in this notice is

also on the Technology Transfer

Network (TTN). The TTN, EPA’s

electronic bulletin board, provides

information and technology exchange in

various areas of air pollution control.

The service is free, except for the cost

of a telephone call. Dial (919) 541–5472

for up to a 14,400 bps modem transfer.

In addition, the basis and purpose

document (BPD), containing much of

the rationale for these proposed

standards, is also available on the TTN.

The supplementary information

document (SID) for the proposed

standard, which contains a compilation

of technical memoranda, may be

obtained from the docket (entry

#ΙΙ–Β–1).

Docket. Docket No. A–96–03,

containing supporting information used

in developing the proposed standards, is

available for public inspection and

copying between 8:30 a.m. and 3:30

p.m., Monday through Friday, at EPA’s

Air Docket Section, Waterside Mall,

Room 1500, 1st Floor, 401 M Street SW.,

Washington, DC 20460. A reasonable fee

may be charged for copying.

For information concerning the

MACT standard, contact Mr. Randy

McDonald at (919) 541–5402, Organic

Chemicals Group, Emission Standards

Division (MD–13), U.S. Environmental

Protection Agency, Research Triangle

Park, North Carolina 27711. For further

information concerning the effluent

limitation guidelines pretreatment

standards and new source performance

standards, contact Dr. Frank H. Hund, at

(202) 260–7786, Engineering and

Analysis Division (4303), U.S.

Environmental Protection Agency, 401

M Street SW., Washington, DC. 20460.

Regulated entities. Entities potentially

regulated are those which produce

pharmaceutical products and

intermediates and are located at

facilities that are major sources as

defined in section 112 of the CAA.

Regulated categories and entities

include:

Category Regulated entities

Industry .... • Producers of material described by the SIC code 283.

• Producers of fermentation, biological or natural extraction,

chemical synthesis, and formulation products regulated

by the Food and Drug Administration.

Category Regulated entities

• Producers of components (excluding excipients) of a pharmaceutical formulations or

intermediates used in the production of a pharmaceutical

product.

This table is not intended to be exhaustive,

but rather provides a guide for readers regarding entities likely to be regulated by this action. This table lists the types of entities that

EPA is now aware could potentially be regulated by this action. Other types of entities not

listed in the table could also be regulated. To

determine whether your facility, company,

business, organization, etc., is regulated by

this action, you should carefully examine the

applicability criteria in § 63.1250 of the rule. If

you have questions regarding the applicability

of this action to a particular entity, consult the

person listed in the preceding FOR FURTHER INFORMATION CONTACT section.

The information presented in this

preamble is organized as follows:

I. List of Source Categories

II. Background

A. Summary of Considerations Made in

Developing this Rule

B. Regulatory Background

III. Authority for National Emission

Standards for Hazardous Air Pollutants

(NESHAP) Decision Process

A. Source of Authority for NESHAP

Development

B. Criteria for Development of NESHAP

IV. Summary of Proposed Standards

A. Source Categories to be Regulated

B. Pollutants to be Regulated and

Associated Environmental and Health

Benefits

C. Affected Sources

D. Format of the Standards

E. Basis and Level of Proposed Standards

F. Compliance and Performance Test

Provisions

G. Monitoring Requirements

H. Reporting and Recordkeeping

Requirements

V. Summary Of Environmental, Energy, Cost,

and Economic Impacts

A. Facilities Affected by These NESHAP

B. Air Impacts

C. Water and Solid Waste Impacts

D. Energy Impacts

E. Cost Impacts

F. Economic Impacts

VI. Emissions Averaging

VII. Regulation of the Pharmaceutical

Manufacturing Industry Under the Clean

Water Act

VIII. Solicitation of Comments

IX. Administrative Requirements

A. Public Hearing

B. Docket

C. Executive Order 12866

D. Enhancing the Intergovernmental

Partnership Under Executive Order

12875

E. Paperwork Reduction Act

F. Regulatory Flexibility Act

G. Unfunded Mandates

H. Miscellaneous
Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules 15755

I. List of Source Categories

Section 112 of the amended Act

requires that EPA evaluate and control

emissions of HAP. The control of HAP

is achieved through promulgation of

emission standards under sections

112(d) and 112(f) and work practice and

equipment standards under section

112(h) for categories of sources that emit

HAP. On July 16, 1992, EPA published

an initial list of major and area source

categories to be regulated (57 FR 31576).

Included on that list were major sources

emitting HAP from pharmaceuticals

production.

Production methods used in the

manufacture of pharmaceutical products

include both batch and continuous

operations, although batch operations

make up a majority of the processes.

The sizes of the facilities range from

those that make one product at the rate

of several hundred kilograms per year

(kg/yr) to those that produce numerous

intermediates and final products on the

scale of thousands of kilograms

(megagrams [Mg]) per year. Air

emissions of HAP compounds originate

from breathing and withdrawal losses

from storage tanks, venting of process

vessels, leaks from piping and

equipment used to transfer HAP

compounds (equipment leaks), and

volatilization of HAP from wastewater

streams. Pollutants (HAP) emitted from

the production processes include a

range of compounds, including VOC.

Among the most prevalent are

methylene chloride and methanol,

which account for nearly 70 percent of

all HAP emissions from this industry.

Detailed information describing

manufacturing processes and emissions

can be found in the Basis and Purpose

Document.

As of 1992, over 80 U.S. companies at

270 facilities were producing

pharmaceutical products.

Manufacturing operations covered by

this NESHAP include chemical

synthesis, formulation, fermentation,

and extraction processes and are

generally classified under standard

industrial classification 283. An

estimated 101 facilities are considered

to be major sources according to the

CAA criterion of having the potential to

emit 10 tons per year of any one HAP

or 25 tons per year of combined HAP,

based on 1992 emissions data. The

proposed standard would apply to all

major sources that produce

pharmaceuticals. Area sources would

not be subject to this standard.

II. Background

A. Summary of Considerations Made in

Developing This Rule

This regulation reduces emissions of

many of the HAP listed in section

112(b)(1) of the CAAA. The alternatives

considered in the development of this

regulation, including those alternatives

selected as standards for new and

existing sources, are based on process

and emissions data received from the

existing facilities known by the EPA to

be in operation.

Regulatory alternatives more stringent

than the MACT floor (minimum control

level) were selected when they were

judged to be reasonable, considering

cost, nonair impacts, and energy

requirements.

The proposed standards give existing

affected sources 3 years from the date of

promulgation to comply. This is the

maximum amount of time allowed by

the Act. New affected sources are

required to comply with the standard

upon startup.

Included in the proposed rule are

methods for determining initial

compliance as well as monitoring,

recordkeeping and reporting

requirements. All of these components

are necessary to ensure that affected

sources will comply with the standards

both initially and over time. However,

the EPA has made every effort to

simplify the requirements in the rule.

The EPA has also attempted to maintain

consistency with existing regulations by

either incorporating text from existing

regulations or referencing the applicable

sections.

In addition, this rule contains an

important and innovative pollution

prevention alternative for the

pharmaceutical industry that provides

an option to reduce solvent

consumption in lieu of installing end-ofpipe controls. The EPA has developed a

regulation that provides a pollution

prevention compliance alternative to the

traditional control requirements, and

the EPA encourages the pharmaceutical

industry to meet the CAA requirements

through its use. This alternative

demonstrates EPA’s commitment to

developing regulations that are cost

effective and flexible, and that reduce

monitoring, recordkeeping, and

reporting burdens.

Representatives from other interested

EPA offices and programs, including

State and Regional environmental

agency personnel, and representatives

from industry participated in the

regulatory development process as

MACT partnership members. For

example, Region II, acting as the lead,

worked closely with the States of New

York and New Jersey as well as the

pharmaceutical industry in developing

the pollution prevention alternative.

The partnership members were given

opportunities to review and comment

on the regulation prior to proposal.

Several issues presented in the

solicitation of comments section reflect

these comments. Industry, regulatory

authorities, and environmental groups

will have another opportunity to

comment on the proposed standards

and provide additional information

during the public comment period.

B. Regulatory Background

The proposed rule implements

section 112(d) of the Clean Air Act

(CAA) amendments of 1990, which

require the Administrator to regulate

emissions of HAP listed in section

112(b) of the CAA. The intent of this

rule is to protect the public health by

requiring new and existing major

sources to reduce generation of

emissions by using pollution prevention

strategies or to control emissions to the

level achievable by the maximum

achievable control technology (MACT),

taking into consideration the cost of

achieving such emission reductions, any

nonair quality and other air quality

related health and environmental

impacts, and energy requirements.

In 1978, EPA published a control

techniques document entitled ‘‘Control

of Volatile Organic Emissions from

Manufacture of Synthesized

Pharmaceutical Products,’’ EPA–450/2–

78–029. The control technique

guidelines document (CTG) contains a

presumptive norm for reasonably

available control technology (RACT) for

the manufacturing operations covered

under SIC Codes 2833 and 2834. This

proposed rule does not affect the

presumptive RACT guidelines, although

a portion of emissions sources are

covered by both the proposed regulation

and the CTG document.

In 1994, EPA promulgated National

Emission Standards for Hazardous Air

Pollutants for Certain Processes Subject

to the Negotiated Regulation for

Equipment Leaks. Pharmaceutical

processes, defined as processes that

synthesize pharmaceutical

intermediates or final products using

carbon tetrachloride or methylene

chloride as a reactant or process solvent,

are subject to this rule. The EPA is

proposing today to require control of

leaking components that are currently

not subject to the Negotiated Regulation

for Equipment Leaks, but that contain

HAP and are associated with processes

in this source category.
15756 Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules

III. Authority for National Emission

Standards for Hazardous Air Pollutants

(NESHAP) Decision Process

A. Source of Authority for NESHAP

Development

Section 112 of the Clean Air Act gives

the Environmental Protection Agency

the authority to establish national

standards to reduce air emissions from

sources that emit one or more HAP.

Section 112(b) contains a list of HAP to

be regulated by NESHAP. Section 112(c)

directs the Agency to use this pollutant

list to develop and publish a list of

source categories for which NESHAP

will be developed; this list was

published in the Federal Register on

July 16, 1992 (57 FR 31576). The

Agency must list all known categories

and subcategories of ‘‘major sources’’

that emit one or more of the listed HAP.

A major source is defined in section

112(a) as any stationary source or group

of stationary sources located within a

contiguous area and under common

control that emits or has the potential to

emit in the aggregate, considering

controls, 10 tons per year or more of any

one HAP or 25 tons per year or more of

any combination of HAP.

B. Criteria for Development of NESHAP

The NESHAP are to be developed to

control HAP emissions from both new

and existing sources according to the

statutory directives set out in section

112(d) of the Act. The statute requires

the standards to reflect the maximum

degree of reduction in emissions of HAP

that is achievable for new or existing

sources. This control level is referred to

as the ‘‘maximum achievable control

technology’’ (MACT). The selection of

MACT must reflect consideration of the

cost of achieving the emission

reduction, any nonair quality health and

environmental impacts, and energy

requirements for control levels more

stringent than the floor (described

below).

The MACT floor is the least stringent

level for MACT standards. For new

sources, the standards for a source

category or subcategory ‘‘shall not be

less stringent than the emission control

that is achieved in practice by the best

controlled similar source, as determined

by the Administrator’’ (section

112(d)(3)). Existing source standards

should be no less stringent than the

average emission limitation achieved by

the best performing 12 percent of the

existing sources for categories and

subcategories with 30 or more sources

or the average emission limitation

achieved by the best performing 5

sources for categories or subcategories

with fewer than 30 sources (section

112(d)(3)). The determination of the

MACT floor for existing sources under

today’s rule is that the average emission

limitation achieved by the best

performing sources is based on a

measure of central tendency, such as the

arithmetic mean, median, or mode. The

determination of percentage reduction

in the production-indexed consumption

factors used in the pollution prevention

alternative is based on the criteria that

the alternative must achieve emissions

reductions equivalent to what would

have been achieved by complying with

the MACT.

IV. Summary of Proposed Standards

A. Source Categories to be Regulated

The proposed standards would

regulate HAP emissions from

pharmaceutical production facilities

that are determined to be major sources.

The standards would apply to existing

sources as well as new sources.

B. Pollutants to be Regulated and

Associated Environmental and Health

Benefits

Pharmaceutical production facilities

emit an estimated 34,000 Mg/yr of

organic and inorganic HAP’s. Organic

HAP’s include methylene chloride,

methanol, toluene, dimethylformamide,

and hexane as well as other HAP’s.

Hydrogen chloride is an inorganic HAP

emitted by this industry. The proposed

rule would reduce HAP emissions from

pharmaceutical facilities by 65 percent.

Some of these pollutants are considered

to be carcinogenic, and all can cause

toxic health effects following exposure,

including nausea, headaches, and

possible reproductive effects. The EPA

does recognize that the degree of

adverse effects to human health can

range from mild to severe. The extent

and degree to which the human health

effects may be experienced is dependent

upon (1) the ambient concentration

observed in the area (e.g., as influenced

by emission rates, meteorological

conditions, and terrain), (2) the

frequency of and duration of exposures,

(3) characteristics of exposed

individuals (e.g., genetics, age, preexisting health conditions, and lifestyle)

which vary significantly with the

population, and (4) pollutant specific

characteristics (toxicity, half-life in the

environment, bioaccumulation, and

persistence).

Most of the organic HAP’s emitted

from this industry are classified as VOC.

The proposed emission controls for

HAP’s will reduce non-HAP VOC

emissions as well. Emissions of VOC

have been associated with a variety of

health and welfare impacts. Volatile

organic compound emissions, together

with nitrogen oxides, are precursors to

the formation of tropospheric ozone.

Exposure to ambient ozone is

responsible for a series of public health

impacts, such as alterations in lung

capacity; eye, nose, and throat irritation;

nausea; and aggravation of existing

respiratory disease. Among the welfare

impacts from exposure to ambient ozone

include damage to selected commercial

timber species and economic losses for

commercially valuable crops such as

soybeans and cotton.

Hydrogen chloride is listed under

section 112(r) of the CAA. The intent of

section 112(r), Prevention of Accidental

Releases, is to focus on chemicals that

pose a significant hazard to the

community should an accident occur, to

prevent their accidental release, and to

minimize consequences should a release

occur. Hydrogen chloride, along with

the other substances listed under

section 112(r)(3), is listed because it is

known to cause, or may be reasonably

anticipated to cause death, injury, or

serious adverse effects to human health

or the environment (see 59 FR 4478,

January 31, 1994). Sources that handle

hydrogen chloride in greater quantities

than the established threshold quantity

under section 112(r)(5) will be subject to

the risk management program

requirements under section 112(r)(7)

(see 58 FR 54190, October 20, 1993).

In essence, the MACT standards

mandated by the CAA will ensure that

all major sources of air toxic emissions

achieve the level of control already

being achieved by the better controlled

and lower emitting sources in each

category. This approach provides

assurance to citizens that each major

source of toxic air pollution will be

required to effectively control its

emissions. In addition, the emission

reductions achieved by these proposed

standards, when combined with the

reductions achieved by other MACT

standards, will contribute to achieving

the primary goal of the CAA, which is

to ‘‘protect and enhance the quality of

the Nations’s air resources so as to

promote the public health and welfare

and the productive capacity of its

population’’ (the CAA, section

101(b)(1)).

C. Affected Sources

Emission points identified from

pharmaceuticals production include

process vents, equipment leaks, storage

tanks, wastewater collection and

treatment systems, and heat exchange

systems.

The affected source for the purpose of

this regulation is the facility-wide

collection of process vents, storage
Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules 15757

tanks, wastewater and associated

treatment residuals, heat exchange

systems, cooling towers, and equipment

components that are associated with

pharmaceutical manufacturing

operations. Based on this definition of

affected source, new sources are created

by reconstructing existing sources or

constructing new ‘‘greenfield’’ facilities.

Also, if an additional pharmaceutical

manufacturing process unit(s) is added

to a plant site that is a major source, the

addition will be subject to the

requirements for a new source provided

that the addition meets the definition of

construction in § 63.2 of subpart A

(General Provisions); the new unit has

the potential to emit 10 tons per year or

more of any one HAP or 25 tons per year

or more of any combination of HAP; and

the process unit(s) is dedicated.

D. Format of the Standards

The standards for process vents are

presented in a combination of percent

reduction and mass limit format.

Facilities will have the option of using

any control technology, as long as the

HAP reductions or mass limitations are

achieved. The format of the standards

for storage tanks are a combination of

equipment standard and performance

standard—tanks which require control

are required to be fitted with floating

roofs or with add-on devices meeting a

percent removal requirement. The

standards for wastewater emission

sources offer two alternative formats for

achieving compliance, a percent

removal, or the use of reference control

technologies. Equipment leak standards

are in the form of equipment/work

practice standards. Facilities would be

required to implement the program

specified in the proposed regulation to

achieve compliance with the standard.

An alternative pollution prevention

standard is also being proposed. This

standard can be met in lieu of meeting

separate standards for the four emission

source types associated with each

pharmaceutical production process. The

format for this alternative standard is in

a kg HAP consumption reduction per kg

product format.

E. Basis and Level of Proposed

Standards

Detailed information describing the

approach used to determine MACT

floors and regulatory alternatives for the

pharmaceuticals production source

category can be found in the basis and

purpose document.

The proposed standards for existing

and new affected sources are

summarized in Table 1. The MACT

standard for most existing process vents

was set at the floor level of control. The

MACT floor was determined from the 12

facilities that represented the best

performing 12 percent of the existing

101 major sources. The floor was

calculated to be 93 percent control

facility-wide. The proposed standards

would require existing sources to reduce

emissions from the sum of all vents

within a process to 900 kg/yr (2,000

pounds per year [lb/yr]), considering

control, or meet an overall process

control level of 93 percent. Both

calculations meet the requirements of

the floor as determined on a facility

wide basis. Additionally, a regulatory

alternative beyond the floor was

developed that requires 98 percent

control of some large vents. An

applicability cutoff was developed for

this alternative based on a linear

equation relating vent flowrate and HAP

load. The cost of this alternative above

the floor is $1,000/Mg and was judged

to be reasonable. Process vents meeting

the annual emissions and flowrate

criteria are required to achieve 98

percent control, independent of the

overall 93 percent requirement.

TABLE 1.—PROPOSED STANDARDS FOR NEW AND EXISTING SOURCES

Emission

source

New or existing?

Applicability Requirement

Applicability level Cutoff Control efficiency Emission limit

Process .......... New ............... Processes ............................ ≥400 lb/yr uncontrolled ........ 98%

Existing ......... Processes ............................ ≥2,000 lb/yr controlled ......... 93%; 98% for individual

vents meeting cutoff

based on flow and emissions.

2,000 lb/yr.

Storage tanks New and existing.≥10,000 gal and <20,000 gal ≥1.9 psia vapor pressure of

liquid stored.

90%

≥20,000 ................................ ≥1.9 psia vapor pressure of

liquid stored.

95%.

Wastewater .... New and existing.>1 Mg/yr total HAP load

from all POD within a

process or any single

POD.

≥1,300 ppm at POD of Table

2 HAP.

99% reduction of Table 2

HAP.

≥5,200 ppmw at POD of

total HAP load.

99% reduction of Table 2

HAP.

90% reduction of Table 3

HAP.

95% reduction of total HAP

using biotreatment.

>1 Mg/yr total HAP load

from facility.

≥10,000 ppmw at POD of

total HAP load.

99% reduction of Table 2

HAP.

90% reduction of Table 3

HAP.

95% reduction of total HAP

using biotreatment.

New ............... >1 Mg/yr total HAP load

from all POD within a

process or any single

POD.

≥110,000 ppmw at POD of

Table 3 HAP.

99% reduction of Table 3

HAP.

Equipment

leaks.

New and existing.All components in HAP service excluding components

covered by subpart H.

.............................................. LDAR program.
15758 Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules

The MACT standard for process vents

at new sources was set at the floor level

of control. The MACT floor was

determined from the best controlled

similar source and is based on the most

stringent control level achieved for both

chemical synthesis and formulation

type processes. The proposed standards

for new sources would require 98

percent control of process vents with

uncontrolled emissions greater than 180

kg/yr (400 lb/yr).

The MACT floor for small, medium,

and large storage tanks is 90 percent

control for tanks storing liquids with

total HAP vapor pressure greater than or

equal to 1.9 psia at existing sources. The

floor was determined from the twelve

facilities that had the highest control

level for storage tanks. The EPA

evaluated the impacts of a regulatory

alternative beyond the floor that would

require 95 percent control of tanks

greater than or equal to 20,000 gallons.

Floating roof technology has been

demonstrated to achieve 95 percent

control and is considerably less

expensive than add-on control; and it

can be applied to 20,000 gallon tanks.

Therefore, there is no additional cost for

the regulatory alternative above the

floor. The MACT for new sources is set

at the same level as the MACT for

existing sources because it has been

determined that no facility is controlling

tanks beyond the level required by the

regulatory alternative for existing

sources; therefore MACT would be no

less stringent than the floor. The

proposed standards would require

existing and new sources to control

storage tanks having volumes greater

than or equal to 38 cubic meters (m3)

(10,000 gallons), and storing material

with a vapor pressure of greater than or

equal to 13.1 kPa (1.9 psi). The

proposed standards require that tanks

with capacities greater than or equal to

38 m3 and less than 75 m3 be controlled

to a level of 90 percent and tanks greater

than or equal to 75 m3 be controlled to

95 percent. One of the following control

systems can be applied to meet these

requirements:

1. An internal floating roof with

specified seals and fittings;

2. An external floating roof with

specified seals and fittings;

3. An external floating roof converted

to an internal floating roof with

specified seals and fittings; or

4. A closed vent system with the

appropriate 90 or 95 percent efficient

control device.

The MACT floor for wastewater at

existing sources was determined to be

54 percent control of HAP from the total

wastewater streams at the top twelve

facilities. The EPA calculated HAP

concentration cutoffs for wastewater

streams, cutoffs above which steam

stripping of wastewater streams would

result in a level of control as stringent

as the floor. This approach is similar to

the HON and allows for the control of

those wastewater streams containing the

most significant amount of HAP. The

cutoffs represent the MACT floor level

of control. The proposed standards

would require existing sources to

control wastewater with the following

characteristics at the point of

determination (POD):

1. Streams having partially soluble

HAP compound concentrations of 1,300

ppmw or greater and a total yearly

process HAP load of 1 Mg/yr or greater

or any single POD load of 1 Mg/yr or

greater;

2. Streams having a combined total

HAP concentration of 5,200 ppmw or

greater and a total yearly process HAP

load of 1 Mg/yr or greater or any single

POD load of 1 Mg/yr or greater; or

3. Streams having a total HAP

concentration of 10,000 ppmw with a

total facility HAP load of 1 Mg/yr or

greater.

The proposed standards require that

the control of wastewater emissions be

accomplished in one of the following

manners:

1. Using a design biotreatment system

for soluble HAP;

2. Demonstrating removals achieving

99 percent by weight of partially soluble

compounds, and 90 percent by weight

of soluble compounds, from treatment

systems; or

3. Demonstrating a removal of 95

percent by weight of total organic HAP

from treatment systems.

For new sources, the MACT floor for

wastewater is based on a facility that

currently incinerates a significant

percentage of wastewater containing

HAP’s in an incinerator combusting a

mixture of wastes. The proposed

standards would require the same

applicability and control requirements

described above for existing sources

plus require an increased removal of

solubles (from 90 to 99 percent) for

streams having a soluble HAP

concentration of 110,000 ppmw at any

of the load criteria (1 Mg/yr total HAP

from the process, POD, or facility).

The MACT floor for equipment leaks

was found to be negligible for new and

existing sources. The regulatory

alternative above the floor is the

implementation of a leak detection and

repair program, patterned after 40 CFR

part 63 subpart H. The cost of the

regulatory alternative was estimated to

be $1,000/Mg and was judged to be

reasonable. The proposed standards

would require that new and existing

sources implement a leak detection and

repair (LDAR) program that is modified

from the program specified in the

Negotiated Regulation for Equipment

Leaks (40 CFR part 63, subpart H) to

apply specifically to the pharmaceutical

industry. The LDAR program specified

under subpart H requires specific

equipment modifications and work

practices that reduce emissions from

equipment leaks. Modifications to this

program for this rule include the

lessening of the monitoring frequency

for pumps from monthly to quarterly

monitoring (based on the specific data

from pharmaceutical manufacturing

operations) and the treatment of

emissions from receivers and surge

control vessels in the process vent

provisions. In response to comments

received from industry during the

standard development process, EPA will

consider consolidating the equipment

leaks program specified in this subpart

(appendix GGGA) with the part of the

40 CFR part 63 subpart H LDAR

program that applies to pharmaceutical

facilities after promulgation of subpart

GGG. The EPA is currently in the

process of separately proposing

clarifying changes to certain provisions

of 40 CFR part 63 subpart H, among

them, provisions relating to the

monitoring requirements for unsafe and

difficult to monitor components. Lastly,

based on current industry comments

that suggest minimal use of a Quality

Improvement Plan (QIP) at

pharmaceutical plants, EPA is

considering eliminating the requirement

of implementing a QIP for the

pharmaceutical rule in favor of allowing

more frequent monitoring when

nominal leakage rates are exceeded and

is soliciting comments on whether the

QIP should be included in the subpart

GGG LDAR program.

1. Alternative Pollution Prevention

Standard

The proposed rule also includes a

pollution prevention (P2) alternative

standard that meets the requirement of

the MACT floor and can be

implemented in lieu of the requirements

described above for existing sources.

Two options included in the alternative

standard are described in Table 2. The

P2 options were developed to provide a

way for facilities to comply with the

MACT standard by reducing overall

consumption of HAP in their processes.

This alternative does not apply to HAP

that are used as reactants. In the first

option, which is applicable to existing

processes, owners and operators can

satisfy the MACT requirements for all

emission source types associated with

each process by demonstrating that the
Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules 15759

production-indexed consumption of

HAP has decreased by 75 percent from

a baseline set no earlier than the 1987

calendar year. The production-indexed

consumption factor is expressed as kg

HAP consumed/kg product produced.

The numerator in the kg/kg factor is the

total consumption of material, which

describes all the different areas where

material can be consumed, either

through losses to the environment,

consumption in the process as a

reactant, or otherwise destroyed.

Consumption, rather than emissions, is

tracked because it can be used as a true

measure of pollution prevention; any

decrease in consumption for the same

unit of product generated must involve

some type of increase in process

efficiency, including reduction of waste,

increased product yield, and in-process

recycling. Because HAP are used

generally as solvents in this industry,

reductions in consumption can be

generally associated with reductions in

losses to air, water, or solid waste.

TABLE 2.—ALTERNATIVE P2

STANDARD

Option Description of P2 option

1 ............... Demonstrate a 75% reduction in

the kg consumption/kg production factor from a baseline

year of 1987.

2 ............... Demonstrate a 50% reduction in

the kg/kg and additional reduction from add-on control

equivalent to yield 75% overall

reduction in kg/kg.

The second option also uses the

production-indexed consumption factor

and is also applied to existing processes.

It encourages and allows owners and

operators to supplement reductions

achieved with P2 with add-on controls.

The EPA believes that such an option

will provide greater flexibility and cost

efficiency to the operators who already

may have some add-on controls. Owners

and operators must demonstrate

reductions in the kg/kg factor of 50

percent via P2 measures and the

remaining 25 percent by add-on

controls. A total reduction of 75 percent

will be required under both P2 options.

F. Compliance and Performance Test

Provisions

1. Proposed Standards

a. Process Vents. To determine

compliance with the percent reduction

requirement for pharmaceutical process

vents, uncontrolled and controlled

emissions from all process vents within

the process shall be quantified to

demonstrate the appropriate overall

reduction requirements (93 percent or

98 percent). For process vents

controlled by devices handling less than

10 tons per year, the owner or operator

can either test or use calculational

methodologies to determine the

uncontrolled and controlled emission

rates from individual process vents. For

process vents controlled by devices

handling more than 10 tons per year,

tests are required to determine the

reduction efficiency of each device.

Performance test provisions have been

structured to account for the worst case

emissions for devices controlling

streams with batch characteristics.

Control devices that have previously

been tested under conditions required

by this standard and condensers are

exempt from performance testing.

b. Storage Tanks and Wastewater. For

demonstrating compliance with various

requirements, the proposed rule allows

the owners or operators to either

conduct performance tests or to

document compliance using engineering

calculations. Appropriate compliance

and monitoring provisions are specified

in the regulation.

c. Equipment Leaks. To determine

compliance with the standard for

equipment leaks, facilities will have to

demonstrate that a LDAR program

meeting the requirements of the LDAR

program specified in the rule is in use.

2. Pollution Prevention Alternative

Standards

Initial demonstration of compliance

with the P2 alternative standards would

be accomplished by documenting yearly

quantities of HAP raw materials and

products using available records,

including standard purchasing and

accounting records, and calculating the

kg/kg values. Procedures are also

specified to demonstrate that the

required reductions are achieved by the

control devices used to meet option 2.

G. Monitoring Requirements

1. Actual Standards

Monitoring is required by the

proposed standards to determine

whether a source is in compliance on an

ongoing basis. This monitoring is done

either by continuously measuring

emission reductions directly or by

continuously measuring a site-specific

operating parameter, the value of which

is established by the owner or operator

during the initial compliance

determination. The operating parameter

value is defined as the minimum or

maximum value established for a

control device or process parameter

that, if achieved on a daily average by

itself or in combination with one or

more other operating parameter values,

determines that an owner or operator is

complying with the applicable emission

standards. These parameters are

required to be monitored at 15-minute

intervals throughout the operation of the

control device. For devices controlling

streams totaling less than 1 ton/yr, only

a site-specific periodic verification that

the devices are operating as designed is

required to demonstrate continuous

compliance. Owners and operators must

determine the most appropriate method

of verification and propose this method

to the Agency for approval in the

precompliance report, which is due 1

year prior to the compliance date of the

standard.

2. Alternative Standard

Owners and operators electing to use

the P2 alternative can demonstrate

ongoing compliance by calculating a

monthly rolling average of the kg HAP/

kg factor for each applicable process or

portions of the process. In addition,

owners and operator electing to use P2

Option 2 would have to monitor the

emission reduction obtained through

the use of traditional controls using the

methods described above.

H. Reporting and Recordkeeping

Requirements

The owner or operator of any

pharmaceutical source subject to these

standards would be required to fulfill all

reporting requirements outlined in the

General Provisions to 40 CFR part 63. A

table included in the proposed rule

designates which sections of subpart A

apply to the proposed rule. Specific

recordkeeping and reporting

requirements for each type of emission

point are also included in the proposed

rule.

V. Summary of Environmental, Energy,

Cost, and Economic Impacts

A. Facilities Affected by These NESHAP

These NESHAP would affect

pharmaceutical production facilities

that are major sources in themselves, or

constitute a portion of a major source.

There are 270 existing facilities

manufacturing pharmaceuticals, 101 of

which were assumed to be major

sources for the purpose of developing

these standards and calculating impacts.

The expected rate of growth for the

pharmaceutical industry is expected to

be 2.4 percent per year through 1998.

B. Air Impacts

The proposed standards would reduce

HAP emissions from existing sources by

22,000 (Mg/yr) (24,000 tons per year

(tons/yr)) from the baseline level, a

reduction of 65 percent from baseline,
15760 Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules

and 75 percent from uncontrolled.

These reductions would also occur if

facilities elect to implement the

alternative pollution prevention

standard. The proposed standard would

also reduce VOC emissions.

C. Water and Solid Waste Impacts

Much of the steam stripping

operations will result in recoverable

material. However, the new source

requirement for very rich soluble HAPcontaining wastewater is expected to

generate solid waste. An average of 900

tons per year per facility was estimated

to determine impacts.

D. Energy Impacts

The proposed standards for the

pharmaceuticals source category would

require an additional energy usage of

2,400 x 109 British thermal units per

year (Btu/yr).

E. Cost Impacts

The emission reductions that would

be required by this regulation could be

met using one or more of several

different techniques. To determine

costs, certain control scenarios were

assumed. The scenarios used in costing

were judged to be the most feasible

scenarios possible for meeting the

requirements of the proposed standards

from a technical and cost standpoint.

The total control cost includes the

capital cost to install the control device,

the costs involved in operating the

control device, and costs associated

with monitoring the device to ensure

compliance. Monitoring costs include

the cost to purchase and operate

monitoring devices, as well as reporting

and recordkeeping costs required to

demonstrate compliance. Nationwide,

the total annual cost of this standard to

the industry for existing and new

sources is approximately $62 million

and $11 million respectively. The EPA

believes that monitoring, reporting, and

recordkeeping costs will be

substantially reduced for the facilities

opting to comply via the P2 option.

Additionally, EPA also believes that

overall control costs will also be

substantially reduced as a result of

compliance with the P2 option.

F. Economic Impacts

The economic impact analysis of this

standard shows that the estimated price

increase from compliance with the

recommended standard for process

vents, storage tanks, and wastewater is

1.1 percent. Estimated reduction in

market output is 1.9 percent.

No plant closures are expected from

compliance with this set of alternatives.

For more information, consult the

economic impact report entitled

‘‘Economic Analysis of Air Pollution

Regulation Regulations: Pharmaceutical

Industry, August 1996.’’

VI. Emissions Averaging

Emissions averaging is being

considered as part of this rule. The rule

includes provisions that permit

emissions averaging within existing

process vent and storage tank planks.

The industry is interested in emissions

averaging for only these two emission

point types. The provisions consist of a

streamlined version of the Hazardous

Organic NESHAP (HON) emissions

averaging provisions (40 CFR part 63

subpart G) modified specifically for the

pharmaceutical industry. However, the

constraints are essentially the same as

those contained in the HON.

VII. Regulation of the Pharmaceutical

Manufacturing Industry Under the

Clean Water Act

The Clean Water Act (CWA) and a

recent settlement agreement (see 59 FR

25869) require EPA to develop effluent

limitations guidelines and standards

regulations for certain industrial

categories. The Pharmaceutical

Manufacturing Industry is one of the

categories required to be regulated by

this settlement agreement. The EPA’s

most recent regulatory proposal for the

pharmaceutical industry was on May 2,

1995 (60 FR 21592.)

In the May 2, 1995 proposal, EPA

proposed best available technology

(BAT) economically achievable and new

source performance standards (NSPS)

regulations for 53 volatile and

semivolatile organic pollutants of which

17 are HAP. The Agency also proposed

PSES and PSNS for 45 volatile organic

pollutants of which 16 are HAP. (Air

emissions of HAP by major sources will

be controlled by this MACT rule

provided that the wastewater streams

containing the HAP meet concentration

criteria for soluble and partially soluble

HAP in today’s proposal.)

The EPA identified the following

industry subcategories in the proposed

effluent guidelines: Fermentation (A),

biological and natural extraction (B),

chemical synthesis (C) and formulation

(D).

The proposed BAT end-of-pipe

limitations would control the discharge

of 17 HAP and 36 non-HAP at both A

and C and B and D manufacturing

facilities. The technology basis for the

BAT limitations for A and C subcategory

facilities was in-plant steam stripping

followed by advanced biological

treatment while the technology basis of

the BAT limitations for B and D

subcategory facilities was advanced

biological treatment. Since these

proposed limitations are set at the endof-pipe, they would not prevent air

emissions of these pollutants prior to

discharge.

Also proposed in the May 2, 1995

notice (see coproposal A) were PSES for

8 HAP and 4 non-HAP set in-plant at a

point roughly equivalent to the MACT

standards point of determination while

PSES for 8 other HAP and 25 non-HAP

were proposed at the end-of-pipe

discharge point. The technology basis

for the HAP and non-HAP pollutants

alike was steam stripping. Under

coproposal B, only in-plant PSES for the

eight HAP would be established. The

Agency decided to establish an in-plant

monitoring point for 12 highly volatile

pollutants (including the 8 HAP)

because measuring compliance at the

end-of-pipe monitoring point was not

considered practical for these pollutants

due to the high potential for air

stripping associated with them and

commingling with other process

wastewater not containing any of the 12

pollutants. As is the case with the BAT

end-of-pipe limitations, the end-of-pipe

proposed PSES would not prevent air

emissions of HAP at facilities prior to

the discharge point to the municipal

sewer systems.

The MACT standards being proposed

today will control HAP emissions (if

promulgated) at major source

pharmaceutical plants with steam

stripping as the reference control

technology. The EPA is considering

revising the BAT limitations for

subcategories A and C based on only

advanced biological treatment

performance data. This would in effect

shift control of HAP air emissions and

wastewater pollutant discharges of the

HAP to the MACT standards. With

regard to control of non-HAP at major

sources, the Agency believes that the

significant reductions in HAP emissions

required by the proposed MACT

standards will also result in incidental

reductions in non-HAP air emissions

because many non-HAP are found in the

same wastewater streams as the HAP,

and thus will be steam stripped along

with the HAP. While control of air

emissions of HAP and non-HAP VOC’s

will be addressed to some extent under

the CAA, additional control of water

discharges of the VOC’s from direct

dischargers needs to be addressed under

the Clean Water Act using as a basis the

BAT limitations and NSPS proposed on

May 2, 1995.

The MACT standards being proposed

today would apply to select streams at

60, out of a possible 259,

pharmaceutical indirect dischargers

deemed to be major sources of air
Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules 15761

emissions. Only those streams which

meet the flow and concentration cutoffs

established for HAP would require

control. Assuming that EPA’s passthrough analysis does not change and

coproposal A is chosen, EPA estimates

that today’s proposed MACT rule would

reduce the load of VOC’s to POTW’s

from pharmaceutical manufacturing

plants by approximately 48 percent. Part

or all of the remainder of the pollutant

loadings to POTW’s may need to be

controlled by additional pretreatment

requirements. The Agency is

considering three options for setting

pretreatment standards (PSES and

PSNS) to address HAP and non-HAP

wastewater pollutant discharges not

controlled by today’s proposed MACT

standard.

Under the first option (which has

been suggested by commenters),

compliance with today’s MACT

standards would constitute compliance

with final PSES and PSNS for all

manufacturing subcategories. However,

since compliance with the MACT

regulation requires only one

demonstration by the facility, EPA is

considering some form of regular

monitoring to verify compliance with

wastewater discharge standards.

Facilities could either monitor for

individual HAP or non-HAP on a

regular basis or for some indicator

pollutant parameter whose regulatory

compliance level would be established

at the same time that MACT rule

compliance demonstration is performed.

This option would result in control of

about 48 percent of the VOC pollutant

load that is currently being discharged

to POTW’s by pharmaceutical facilities.

Under the second option, and in

addition to the MACT regulations on

selected streams at 60 indirect

dischargers, EPA would establish

pretreatment standards for the streams

and pollutants not controlled by the

MACT regulations. The level of control

dictated by these additional standards

would be the same level as that of the

MACT standards (90 percent reduction

for soluble organics and 99 percent for

partially soluble organics). The

pretreatment standards could either be

in the form of percent reduction

requirements for individual pollutants

or single number standards resulting

from the application of the MACT

percent reduction requirements. The

EPA estimates that this option would

reduce the discharge of pollutants to

POTW’s by an additional 45 percent

over the first option.

The third option would involve

promulgating the coproposal A

pretreatment standards for all indirect

dischargers at the end-of-pipe regulatory

point. These pretreatment standards

would apply to all streams at facilities

designated as major sources regardless

of whether the streams were within the

concentration cutoffs for HAP and

would be established for all pollutants

which pass-through. The level of control

dictated by these standards would be

the coproposal A level with the

exception that standards for 12

pollutants which were established inplant will now be set at the end-of-pipe

and adjusted downward to account for

dilution due to mixing with other waste

streams. Other changes in parameters or

limitations may result from the

evaluation of comments and receipt of

additional performance data. Using the

proposed limitations, EPA estimates

that this option would reduce the

discharge of pollutants to POTW’s by an

additional 29 percent over the first

option.

The EPA is considering revising its

pass-through analysis for water soluble,

biodegradable pollutants such as

methanol, acetone, isopropanol and

ethanol based on approaches suggested

by commenters on the May 2, 1995

pharmaceutical proposal as well as the

approaches used in the Pesticide

Chemicals Manufacturing and Organic

Chemicals, Plastics, and Synthetic

Fibers (OCPSF) rulemakings. In general,

pollutants are considered to passthrough POTW’s if the average percent

removal achieved by well operated

POTW’s is less than that achieved by

the BAT model treatment systems. The

EPA is considering specifically the

methodology modifications employed in

the evaluation for phenol, a

biodegradable water soluble pollutant as

discussed in the Pesticides and OCPSF

rulemakings (see 59 FR 50638, 50664–

65, September 28, 1993 and 58 FR

36872, 36885–86, July 9, 1993). Among

the modifications suggested by the

commenters were: (1) Using only data

from acclimated POTW systems to

determine POTW removal; (2) finding

no pass-through for pollutants if the

differential between the model BAT

percent removal and the POTW percent

removal for a pollutant is less than 5

percent and; (3) utilizing a higher

Henry’s Law Constant cutoff when pass

through is determined by the volatile

override approach (pollutants which

have a higher Henry’s Law Constant

value than the cutoff are presumed to

pass-through using this methodology).

The Agency is reevaluating its

proposed pass-through analysis because

of the comments received concerning it

and to be more consistent with today’s

proposed MACT standards for soluble

organic HAP which allows the

biodegradation achieved by POTW’s to

be included in the compliance

demonstration for these pollutants.

Today’s MACT standards require a

demonstration of at least a 90 percent

reduction in air emissions from

wastewater of water soluble

biodegradable HAP. As a result, a

finding of pass-through may result in

duplicative and somewhat inconsistent

control (by water and air regulations) for

some pollutants. The EPA solicits

comments on possible revisions to its

pass-through methodology as applied to

water soluble, biodegradable pollutants.

The EPA is soliciting comments on

approaches for revising the limitations

for direct and indirect dischargers in the

proposed effluent guidelines for the

pharmaceutical industry (60 FR 21592,

May 2, 1995). The intent of all of these

approaches is to integrate the regulation

of emissions into the air and waters of

the United States. If EPA develops any

additional data related to the possible

revisions, those data will be made

available to the public.

The EPA may proceed with final

action on the effluent guidelines, taking

into account comments and data

received in response to this notice.

VIII. Solicitation of Comments

The Administrator welcomes

comments from interested persons on

any aspect of the proposed rule, and on

any statement in the preamble or the

referenced supporting documents. The

proposed rule was developed on the

basis of information available. The

Administrator is specifically requesting

factual information that may support

either the approach taken in the

proposed standards or an alternate

approach. In order to receive proper

consideration, documentation or data

should be provided. This section

requests comments on specific issues

identified during the development of

the standard. Additionally, EPA is

soliciting comments regarding the

interaction of this standard with the

Title V operating permits program.

The EPA is requesting comments and

data on establishing the applicability of

process vent control requirements on a

process basis, as opposed to an

equipment or facility basis. The basis

and purpose document included in the

administrative record outlines the

rationale for establishing applicability

on a process basis. Second, the EPA is

soliciting general comments on the

adequacy of emission estimation

procedures to determine compliance for

batch processes. Comments from State

partnership members indicate that some

batch operations, such as distillation,

may contribute to considerably more

emissions than would otherwise be
15762 Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules

predicted. In some cases, unless 100

percent capture is achieved by the

condenser acting as a recovery device

on boiling operations, there may be

uncontrolled emissions that are not

being estimated. The State partnership

members recommend that facilities

compare their HAP mass balance to

estimated HAP losses. When large

discrepancies exist, the facility may

need to monitor large process

condensers. Third, the EPA is soliciting

comments on the definition of a

pharmaceutical product and isolated

intermediate. In particular, whether

Standard Industrial Classification code

#283 and coverage by the Food and Drug

Administration (FDA) rules are

adequate to identify a pharmaceutical

process covered by this regulation. The

proposed rule considers isolated

intermediates to be the same as

pharmaceutical products in

applicability determinations, e.g., the

2,000 lb/yr cutoff applies to isolated

intermediates. The EPA is soliciting

comments on the definition of isolated

intermediates and the appropriateness

of applying the cutoff to isolated

intermediates. Fourth, EPA is soliciting

comment on the adequacy and

appropriateness of the new source

MACT requirements for process vents.

As set out in the basis and purpose

document, EPA set the cutoff and level

of control for the floor based on its

analysis of the data showing that the

characteristics of the emission streams

are similar. The industry, however,

believes that the basis of the cutoff is

not representative of the industry as a

whole. The EPA will consider other

proposals for setting the cutoff at a less

stringent level, taking into consideration

statutory and regulatory requirements.

The EPA is soliciting comments on

several aspects of performance testing

and monitoring. The rule currently

requires performance testing to

document efficiencies for control

devices that are used to reduce

uncontrolled emissions of 10 tons per

year or more. The rule currently

requires that the performance test be

conducted under ‘‘worst-case’’

conditions and provides for three

options—absolute, representative, and

hypothetical worst-case. The rule also

allows for testing during normal

operations. However, because of the

noncontinuous, batch nature of

processing in this industry, testing

under normal conditions may not

indicate control device performance

under more challenging conditions.

Therefore, the proposed rule requires

that the test conditions be defined and

operation be limited by those conditions

that existed during testing. The rule

requires that the test conditions be

defined in the Precompliance report and

characterized by the HAP composition

and conditions of vent stream entering

the control device. It is because of the

batch nature of processing in this

industry that the EPA has a higher level

of confidence in a facility’s compliance

with the standard if the performance of

the control device has been tested under

worst-case conditions. Therefore, testing

under less rigorous, normal conditions

limits the range of vent stream

conditions for which initial compliance

has been demonstrated. The EPA is

soliciting comments on appropriate test

conditions to be defined for different

types of control devices, especially

scrubbers and carbon adsorbers.

The proposed rule provides for

parametric monitoring to comply with

the standard and includes specific

operating parameters to be monitored.

The EPA is soliciting comments on the

use of alternative parameters without

the requirement of prior notification in

the Precompliance report. Parameters

other than those specified in the rule

that could be used to demonstrate

compliance include: (1) or condensers,

coolant temperature and flow (only with

emissions testing), (2) for scrubbers,

measurement of pressure drop or

scrubber fluid composition, and (3) for

carbon adsorbers, periodic vent testing

and/or predetermined scheduled

replacement. The EPA is soliciting

comment on the adequacy of these

parameters for demonstrating

continuous compliance with the rule.

An issue raised by industry associated

with parametric monitoring is related to

the setting of a parameter based on an

initial compliance determination at

conditions which represent the upper

limit (with regard to achievable control)

of conditions that will be encountered

during the course of operations. The

concern is that the rule effectively

requires a control level that is greater

than the standard because the control

devices will presumably achieve higher

control on conditions that are below this

upper limit, which may occur

frequently in this industry because of

the predominance of batch processes.

The EPA has tried to resolve this issue

by allowing owners and operators to set

more than one parameter level for a

given control device for processes or

portions of processes not requiring

control levels as high as the worst-case

or upper limit. These parametric levels

are required to be defined in advance in

the Notification of compliance report. If

more than one level is set, owners and

operators must make a determination of

compliance with the standards based on

what processes or emission

characteristics are routed to the device

at the time in which a monitoring

reading is taken. Additionally, the

determination of an exceedance is based

on a maximum of 24 hours worth of

data, or 96 15-minute readings, per

process. Therefore, readings outside of

acceptable ranges can be averaged in

with readings that are within range and

effectively normalized. The EPA

believes that the approach taken offers

the industry needed flexibility while

preserving the assurance of continuous

compliance.

Another issue raised by industry is

related to predictability of operations.

The industry believes that

nondedicated, multiproduct facilities

using control devices other than

condensers (and, perhaps, combustion

devices) for multiple vents may not be

able to anticipate all possible operating

scenarios for which a separate

parametric level would need to be set.

The industry has given the example of

a scrubber that is used to control

emissions from multiple processes. The

parametric level that represents

compliance with the applicable

standard for each process may change

depending on what is happening in

each process and they argue it would be

essentially impossible to predict the

exact scrubber flow needed to achieve

compliance at any given time. The

industry has requested that the standard

provide that an excursion from a

parametric level does not automatically

constitute a violation of the rule, but

instead triggers reporting requirements

that initiate a permitting authority’s

review to decide whether the excursion

resulted in a violation for this type

situation. The EPA has generally taken

the position that ‘‘after-the-fact’’

justification of excursions is not an

appropriate compliance strategy. Based

on currently available information, the

EPA has not seen a need to change this

position. The proposed rule allows the

facility flexibility in establishing the

parameter monitoring level based on

tests, engineering assessments, and/or

manufacturers recommendations if

included in the Precompliance report

and approved. The EPA believes it is

necessary to know the HAP load going

to the control device to be able to

properly operate the device to meet the

emission limit (the agency has concerns

about the industry’s stated inability to

predict or know the HAP load at certain

times). In cases where the owner cannot

predict exactly what is going to the

control device over time, the standard

provides for doing testing under

conditions worse than average to cover
Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules 15763

periods of uncertainty. In fact this is the

reason for the focus on worst-case in the

rule. The EPA is seeking comment on

this part of the rule.

Related to testing and monitoring are

management of change issues. The EPA

is soliciting general comments on the

clarity of the rule as it applies to process

changes. Management of change issues

are also related to title V of the Clean

Air Act.

Currently, the Notification of

Compliance report is the compliance

‘‘blueprint’’ for implementation of the

standard. All information regarding

documentation of the facility’s

compliance status with regard to the

standard should be included in this

report. Process descriptions, emission

estimates, control device performance

documentation, and continuous

compliance demonstration strategies,

including monitoring, are to be

presented in the report. This report

could be incorporated by reference into

the facility’s title V permit. If a change

occurred at the facility which required

the submittal of additional information,

or if the plant chose to revise

procedures that had been previously

documented in the notification, this

information would be submitted in

quarterly reports, thus ensuring that the

notification and associated reports

would always contain the most current

compliance strategy for the facility.

Only changes requiring site-specific

approval, such as the use of a

monitoring parameter that was not

specifically identified in the standard,

would trigger some significant review

action under title V. This would allow

the facility enough flexibility to change

processes, operating, and compliance

procedures as necessary without prior

approval, if the changes were

straightforward, and would assure that

the compliance plan for the facility

would always be current. The EPA is

also soliciting comments on the

incorporation by reference of the

Notification of Compliance report into

the title V permit, and comments on the

types of changes that should trigger

review actions under title V.

IX. Administrative Requirements

A. Public Hearing

A public hearing will be held, if

requested, to discuss the proposed

standard in accordance with section

307(d)(5) of the Clean Air Act. Persons

wishing to make oral presentation on

the proposed standards for

pharmaceutical production processes

should contact EPA at the address given

in the ADDRESSES section of this

preamble. Oral presentations will be

limited to 15 minutes each. Any

member of the public may file a written

statement before, during, or within 30

days after the hearing. Written

statements should be addressed to the

Air Docket Section address given in the

ADDRESSES section of this preamble and

should refer to Docket No. A–96–03.

A verbatim transcript of the hearing

and written statements will be available

for public inspection and copying

during normal working hours at EPA’s

Air Docket Section in Washington, DC

(see ADDRESSES section of this

preamble).

B. Docket

The docket is an organized and

complete file of all the information

submitted to or otherwise considered by

EPA in the development of this

proposed rulemaking. The principal

purposes of the docket are:

1. To allow interested parties to

readily identify and locate documents

so that they can intelligently and

effectively participate in the rulemaking

process; and

2. To serve as the record in case of

judicial review (except for interagency

review materials (section 307(d)(7)(A))).

C. Executive Order 12866

Under Executive Order 12866, (58 FR

51735 (October 4, 1993)) the Agency

must determine whether the regulatory

action is ‘‘significant’’ and therefore

subject to Office of Management and

Budget (OMB) review and the

requirements of this Executive Order.

The Order defines ‘‘significant

regulatory action’’ as one that is likely

to result in a rule that may:

1. Have an annual effect on the

economy of $100 million or more or

adversely affect in a material way the

economy, a sector of the economy,

productivity, competition, jobs, the

environment, public health or safety, or

State, local, or Tribal governments or

communities;

2. Create a serious inconsistency or

otherwise interfere with an action taken

or planned by another agency;

3. Materially alter the budgetary

impact of entitlements, grants, user fees,

or loan programs or the rights and

obligations of recipients thereof; or

4. Raise novel legal or policy issues

arising out of legal mandates, the

President’s priorities, or the principles

set forth in this Executive Order.

Pursuant to the terms of the Executive

Order, the OMB has notified the EPA

that it considers this a ‘‘significant

regulatory action’’ within the meaning

of the Executive Order. The EPA

submitted this action to the OMB for

review. Changes made in response to

suggestions or recommendations from

the OMB were documented and

included in the public record.

D. Enhancing the Intergovernmental

Partnership Under Executive Order

12875

In compliance with Executive Order

12875, EPA has involved State

governments in the development of this

rule. These governments will be

required to implement the rule. They

will collect permit fees which will be

used to offset the resource burden of

implementing the rule. Representatives

of six State governments are members of

the MACT partnership. This partnership

group was consulted throughout the

development of this proposed

regulation. Comments from the

partnership members were carefully

considered. In addition, all States are

encouraged to comment on this

proposed rule during the public

comment period, and the EPA intends

to fully consider these comments in the

final rulemaking.

E. Paperwork Reduction Act

The information collection

requirements in this proposed rule have

been submitted for approval to OMB

under the Paperwork Reduction Act, 44

U.S.C. 3501 et seq. An Information

Collection Request (ICR) document has

been prepared by EPA (ICR No.

1781.01), and a copy may be obtained

from Sandy Farmer, Information Policy

Branch, U. S. Environmental Protection

Agency, 401 M Street SW. (2137),

Washington, DC 20460, or by calling

202–260–2740. The public reporting

burden for this collection of information

is estimated to average 4,800 hours per

respondent for the first year and 2,600

hours per respondent for each of the

second and third years, including time

for reviewing instructions, searching

existing data sources, gathering and

maintaining the data needed, and

completing and reviewing the collection

of information.

Send comments regarding the burden

estimate or any other aspect of this

collection of information, including

suggestions for reducing this burden, to

Chief, Information Policy Branch, 2137,

U. S. Environmental Protection Agency,

401 M Street SW., Washington, DC

20503, marked ‘‘Attention: Desk Officer

for EPA.’’ The final rule will respond to

any OMB or public comments on the

information collection requirements

contained in this proposal.

F. Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA)

provides that, whenever an agency

promulgates a final rule under 5 U.S.C.
15764 Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules

553, after being required to publish a

general notice of proposed rulemaking,

an agency must prepare a final

regulatory flexibility analysis unless the

head of the agency certifies that the final

rule will not have a significant

economic impact on a substantial

number of small entities. Pursuant to

section 605(b) of the Regulatory

Flexibility Act, 5 U.S.C. 605(b), I certify

that this rule will not have a significant

impact on a substantial number of small

entities.

The EPA analyzed the potential

impact of the rule on small entities and

determined that only 16 of 56 pharmaceutical producing firms are small

entities—not a substantial number of

entities. Of these 16 firms, only four will

experience an increase in costs as a

result of the promulgation of today’s

rule that are greater than 1 percent of

revenues. Therefore, the Agency did not

prepare an initial regulatory flexibility

analysis.

Although the statute does not require

EPA to prepare an RFA because the

Administrator has certified that the rule

will not have a significant economic

impact on a substantial number of small

entities, EPA did undertake a limited

assessment, to the extent it could, of

possible outcomes and the economic

effect of these on small pharmaceutical

entities. The initial version of that

evaluation is available in the

administrative record for today’s action.

G. Unfunded Mandates

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA), Public

Law 104–4, establishes requirements for

Federal agencies to assess the effects of

their regulatory actions on State, local,

and Tribal governments, and the private

sector. Under section 202 of the UMRA,

EPA generally must prepare a written

statement, including a cost-benefit

analysis, for proposed and final rules

with ‘‘Federal mandates’’ that may

result in expenditures to State, local,

and Tribal governments, in the

aggregate, or to the private sector, of

$100 million or more in any 1 year.

Before promulgating an EPA rule for

which a written statement is needed,

section 205 of the UMRA generally

requires EPA to identify and consider a

reasonable number of regulatory

alternatives and adopt the least costly,

most cost effective or least burdensome

alternative that achieves the objectives

of the rule. The provisions of section

205 do not apply when they are

inconsistent with applicable law.

Moreover, section 205 allows EPA to

adopt an alternative other than the least

costly, most cost effective or least

burdensome alternative if the

Administrator publishes with the final

rule an explanation why that alternative

was not adopted. Before EPA establishes

any regulatory requirements that may

significantly or uniquely affect small

governments, including Tribal

governments, it must have developed

under section 203 of the UMRA a small

government agency plan. The plan must

provide for notifying potentially

affected small governments, enabling

officials of affected small governments

to have meaningful and timely input in

the development of EPA regulatory

proposals with significant Federal

intergovernmental mandates, and

informing, educating, and advising

small governments on compliance with

the regulatory requirements.

The EPA has determined that the

proposed standards do not include a

Federal mandate that may result in

estimated costs of, in the aggregate, $100

million or more to either State, local or

Tribal governments, or to the private

sector, nor do the standards

significantly or uniquely impact small

governments, because they contain no

requirements that apply to such

governments or impose obligations

upon them. Therefore, the requirements

of the Unfunded Mandates Act do not

apply to this final rule.

H. Miscellaneous

In accordance with section 117 of the

Act, publication of this proposal was

preceded by consultation with

appropriate advisory committees,

independent experts, and Federal

departments and agencies. The

Administrator will welcome comments

on all aspects of the proposed

regulation, including health, economic

and technical issues, and on the

proposed test methods.

This regulation will be reviewed 8

years from the date of promulgation.

This review will include an assessment

of such factors as evaluation of the

residual health and environmental risks,

any overlap with other programs, the

existence of alternative methods,

enforceability, improvements in

emission control technology and health

data, and the recordkeeping and

reporting requirements.

List of Subjects in 40 CFR Part 63

Environmental protection, Air

pollution control, Hazardous

substances, Reporting and

recordkeeping requirements.

Dated: March 20, 1997.

Carol M. Browner,

Administrator.

For the reasons set out in the

preamble, title 40, chapter I, part 63 of

the Code of Federal Regulations is

proposed to be amended as follows:

PART 63—NATIONAL EMISSION

STANDARDS FOR HAZARDOUS AIR

POLLUTANTS FOR SOURCE

CATEGORIES

1. The authority citation for part 63

continues to read as follows:

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

2. It is proposed that part 63 be

amended by adding subpart GGG to read

as follows:

Subpart GGG—National Emission

Standards for Pharmaceuticals Production

Sec.

63.1250 Applicability.

63.1251 Definitions.

63.1252 Standards.

63.1253 Test methods and compliance

procedures.

63.1254 Monitoring requirements.

63.1255 Recordkeeping requirements.

63.1256 Reporting requirements.

63.1257 Delegation of authority.

Table 1 to subpart GGG—General Provisions

Applicability to Subpart GGG

Table 2 to subpart GGG—Partially Soluble

HAPs

Table 3 to subpart GGG—Soluble HAPs

Appendix A to Subpart GGG—Equipment

Leaks

Subpart GGG—National Emission

Standards for Pharmaceuticals

§ 63.1250 Applicability.

(a) Except as specified in paragraph

(d) of this section, the provisions of this

subpart apply to pharmaceutical

manufacturing operations located at a

major source of hazardous air pollutant

emissions.

(b) The affected source subject to this

subpart is the facility-wide collection of

pharmaceutical process vents, storage

tanks, wastewater and associated

treatment residuals, heat exchange

systems, cooling towers, and equipment

components (pumps, compressors,

agitators, pressure relief devices,

sampling connection systems, openended valves or lines, valves,

connectors, and instrumentation

systems) associated with

pharmaceutical manufacturing

operations.

(c) If an additional pharmaceutical

manufacturing process unit(s) is added

to a plant site that is a major source, as

defined in section 112(a) of the Act, the

addition shall be subject to the

requirements for a new source in this

subpart if: It is an addition that meets

the definition of construction in § 63.2

of subpart A of this part; the addition

has the potential to emit 10 tons per

year or more of any HAP or 25 tons per

year or more of any combination of
Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules 15765

HAP, unless the Administrator

establishes a lesser quantity; and the

process unit(s) is dedicated to the

manufacture of a single product or

isolated intermediate.

(d) Table 1 specifies the provisions of

subpart A that apply to an owner or

operator of an affected source subject to

this subpart, and clarifies specific

provisions in subpart A as necessary for

this subpart.

(e) The provisions of this subpart do

not apply to research and development

facilities.

(f) The compliance dates for affected

sources are as follows:

(1) An owner or operator of an

existing affected source must comply

with the provisions of this subpart

within 3 years after the effective date of

the standard.

(2) An owner or operator of a new or

reconstructed affected source must

comply with the provisions of this

subpart immediately upon startup.

(3) Notwithstanding the requirements

of paragraphs (f)(1) and (2) of this

section, a new source which commences

construction or reconstruction after

April 2, 1997 and before effective date

of final rule shall not be required to

comply with such promulgated standard

until 3 years after the date of

promulgation if:

(i) The promulgated standard is more

stringent than the proposed standard;

and

(ii) The owner or operator complies

with the standard as proposed during

the 3-year period immediately after the

effective date.

(g) For batch processes, the provisions

of this subpart also apply during startup

and shutdown. Periods of malfunction

are regulated according to § 63.6 of

subpart A.

(h) This subpart applies to all

equipment leak emissions in the source

category not covered by 40 CFR part 63

subpart I, which requires the

implementation of subpart H

requirements for components in

methylene chloride and carbon

tetrachloride service in pharmaceutical

chemical synthesis operations. The

requirements proposed in this rule do

not affect the requirements of subpart I

or H for these components. Only

components not currently identified and

affected by subpart I are considered in

this standard.

§ 63.1251 Definitions.

Terms used in this subpart are

defined in the Act, in subpart A of this

part, or in this section. If the same term

is defined in subpart A of this part and

in this section, it shall have the meaning

given in this section for the purposes of

subpart GGG.

Air pollution control device means

equipment installed on a process vent

storage tank, wastewater treatment

exhaust stack, or combination thereof

that reduces the mass of HAP emitted to

the air. Examples include incinerators,

carbon adsorption units, condensers,

and gas absorbers. Process condensers

are not considered air pollution control

devices.

Batch cycle refers to manufacturing an

intermediate or product from start to

finish in a batch unit operation.

Batch emission episode means a

discrete venting episode that may be

associated with a single unit operation.

A unit operation may have more than

one batch emission episode. For

example, a displacement of vapor

resulting from the charging of a vessel

with HAP will result in a discrete

emission episode that will last through

the duration of the charge and will have

an average flowrate equal to the rate of

the charge. If the vessel is then heated,

there will also be another discrete

emission episode resulting from the

expulsion of expanded vapor. Both

emission episodes may occur in the

same vessel or unit operation. There are

possibly other emission episodes that

may occur from the vessel or other

process equipment, depending on

process operations.

Batch operation or Batch process

means a noncontinuous operation

involving intermittent or discontinuous

feed into equipment, and, in general,

involves the emptying of the equipment

after the batch operation ceases and

prior to beginning a new operation.

Addition of raw material and

withdrawal of product do not occur

simultaneously in a batch operation.

Closed-vent system means a system

that is not open to the atmosphere and

is composed of piping, ductwork,

connections, and, if necessary, flow

inducing devices that transport gas or

vapor from an emission point to a

control device or back into the process.

Combustion device means an

individual unit of equipment, such as a

flare, incinerator, process heater, or

boiler, used for the combustion of HAP

vapors.

Consumption means the makeup

quantity of HAP entering a process that

are not used as reactant. The quantity of

material used as reactant is the

theoretical amount needed assuming a

100 percent stoichiometric conversion.

Makeup is the net amount of material

that must be added to the process to

replenish losses.

Container, as used in the wastewater

provisions, means any portable waste

management unit that has a capacity

greater than or equal to 0.1 m3 in which

a material is stored, transported, treated,

or otherwise handled. Examples of

containers are drums, hoses, barrels,

tank trucks, barges, dumpsters, tank

cars, dump trucks, and ships.

Continuous process means a process

where the inputs and outputs flow

continuously throughout the duration of

the process. Continuous processes are

typically steady state.

Continuous seal means a seal that

forms a continuous closure that

completely covers the space between

the wall of the storage vessel and the

edge of the floating roof. A continuous

seal may be a vapor-mounted, liquidmounted, or metallic shoe seal.

Controlled HAP emissions means the

quantity of HAP discharged to the

atmosphere. If no air pollution control

devices are present, controlled

emissions are the same as uncontrolled

emissions.

Cover, as used in the wastewater

provisions, means a device or system

which is placed on or over a waste

management unit containing wastewater

or residuals so that the entire surface

area is enclosed and sealed to minimize

air emissions. A cover may have

openings necessary for operation,

inspection, and maintenance of the

waste management unit such as access

hatches, sampling ports, and gauge

wells provided that each opening is

closed and sealed when not in use.

Examples of covers include a fixed roof

installed on a wastewater tank, a lid

installed on a container, and an airsupported enclosure installed over a

waste management unit.

External floating roof means a

pontoon-type or double-deck type cover

that rests on the liquid surface in a

storage vessel or waste management unit

with no fixed roof.

Fill or filling means the introduction

of hazardous air pollutant into a storage

vessel or the introduction of a

wastewater stream or residual into a

waste management unit, but not

necessarily to complete capacity.

Fixed roof means a cover that is

mounted on a waste management unit

or storage vessel in a stationary manner

and that does not move with

fluctuations in liquid level.

Floating roof means a cover consisting

of a double deck, pontoon single deck,

internal floating cover or covered

floating roof, which rests upon and is

supported by the liquid being

contained, and is equipped with a

closure seal or seals to close the space

between the roof edge and waste

management unit or storage vessel wall.
15766 Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules

Hard-piping means tubing that is

manufactured and properly installed

using good engineering judgment and

standards, such as ANSI B31–3.

Individual drain system means the

stationary system used to convey

wastewater streams or residuals to a

waste management unit. The term

includes hard piping, all process drains

and junction boxes, together with their

associated sewer lines and other

junction boxes, manholes, sumps, and

lift stations, conveying wastewater

streams or residuals. A segregated

stormwater sewer system, which is a

drain and collection system designed

and operated for the sole purpose of

collecting rainfall-runoff at a facility,

and which is segregated from all other

individual drain systems, is excluded

from this definition.

Internal floating roof means a cover

that rests or floats on the liquid surface

(but not necessarily in complete contact

with it) inside a storage vessel or waste

management unit that has a

permanently affixed roof.

Isolated intermediate means any

intermediate that is removed from

process equipment for temporary or

permanent storage or transferred to

shipping containers.

Junction box means a manhole or

access point to a wastewater sewer

system line or a lift station.

Liquid-mounted seal means a foam

liquid-filled seal mounted in contact

with the liquid between the wall of the

storage vessel or waste management and

the floating roof. The seal is mounted

continuously around the vessel or unit.

Maximum true vapor pressure means

the equilibrium partial pressure exerted

by the total organic HAP in the stored

or transferred liquid at the temperature

equal to the highest calendar-month

average of the liquid storage or

transferred temperature for liquids

stored or transferred above or below the

ambient temperature or at the local

maximum monthly average temperature

as reported by the National Weather

Service for liquids stored or transferred

at the ambient temperature, as

determined:

(1) In accordance with methods

described in American Petroleum

Institute Publication 2517, Evaporative

Loss From External Floating-Roof Tanks

(incorporated by reference as specified

in § 63.14 of subpart A of this part); or

(2) As obtained from standard

reference texts; or

(3) As determined by the American

Society for Testing and Materials

Method D2879–83 (incorporated by

reference as specified in § 63.14 of

subpart A of this part); or

(4) Any other method approved by the

Administrator.

Metallic shoe seal or mechanical shoe

seal means a metal sheet that is held

vertically against the wall of the storage

vessel by springs, weighted levers, or

other mechanisms and is connected to

the floating roof by braces or other

means. A flexible coated fabric

(envelope) spans the annular space

between the metal sheet and the floating

roof.

Partially soluble HAP means a HAP

listed in Table 2 of this subpart.

Pharmaceutical manufacturing

process unit (PMPU) means any

processing equipment assembled to

process materials and manufacture a

pharmaceutical product and associated

storage tanks, wastewater management

units, or components such as pumps,

compressors, agitators, pressure relief

devices, sampling connection systems,

open-ended valves or lines, valves,

connectors, and instrumentation

systems that are used in the

manufacturing of a pharmaceutical

product.

Pharmaceutical manufacturing

operations include PMPU’s and other

processes and operations as well as

associated equipment such as heat

exchange systems that are located at a

facility for the purpose of manufacturing

pharmaceuticals.

Pharmaceutical product means any

material described by the standard

Industrial Classification (SIC) Code 283,

or any other fermentation, biological or

natural extraction, or chemical synthesis

product regulated by the Food and Drug

Administration, including components

(excluding excipients) of

pharmaceutical formulations, or

intermediates used in the production of

a pharmaceutical product.

Point of determination means the

point where a wastewater stream exits

the process or processes, storage tank, or

equipment. The POD may be at the

equipment or following the last recovery

device.

Process means a logical grouping of

processing equipment which

collectively function to produce a

pharmaceutical product or isolated

intermediate. A process may consist of

one or more unit operations. For the

purpose of this subpart, process

includes all or a combination of

reaction, recovery, separation,

purification, or other activity, operation,

manufacture, or treatment which are

used to produce a product or isolated

intermediate. The physical boundaries

of a process are flexible, providing a

process ends with a product or isolated

intermediate, or with cessation of onsite

processing. Nondedicated solvent

recovery and nondedicated formulation

operations are considered single

processes that are used to recover or

formulate numerous materials and/or

products.

Process condenser means a condenser

whose primary purpose is to recover

material as an integral part of a unit

operation. The condenser must support

a vapor-to-liquid phase change for

periods of source equipment operation

that are above the boiling or bubble

point of substance(s). Examples of

process condensers include distillation

condensers, reflux condensers, process

condensers in line prior to the vacuum

source, and process condensers used in

stripping or flashing operations.

Process tank means a tank that is

physically located within the bounds of

a process that is used to collect material

discharged from a feedstock storage tank

or unit operation within the process and

transfer this material to another unit

operation within the process or a

product storage tank. Surge control

vessels and bottoms receivers that fit

these conditions are considered process

tanks.

Process vent means a vent from a unit

operation through which a HAPcontaining 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

§ 63.1252(b), vents on wastewater

emission sources regulated under

§ 63.1252(d), or pieces of equipment

regulated under § 63.1252(e).

Production-indexed HAP

consumption factor is the result of

dividing the annual consumption of

total HAP by the annual production

rate, per process.

Production-indexed volatile organic

compound (VOC) consumption factor is

the result of dividing the annual

consumption of total VOC by the annual

production rate, per process.

Publicly owned treatment works

(POTW) means any devices and systems

used in the storage, treatment, recycling,

and reclamation of municipal sewage or

industrial wastes of a liquid nature as

defined in section 212(2)(A) of the Clean

Water Act, as amended (33 U.S.C.

1292(2)(A)). A POTW includes the

treatment works, intercepting sewers,

outfall sewers, sewage collection

systems, pumping, power, and other

equipment. The POTW is defined at 40

CFR 403.3(0).

Reactor means a device or vessel in

which one or more chemicals or
Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules 15767

reactants, other than air, are combined

or decomposed in such a way that their

molecular structures are altered and one

or more new organic compounds are

formed.

Recovery device means an individual

unit of equipment used for the purpose

of recovering chemicals for fuel value

(i.e., net positive heating value), use,

reuse, or for sale for fuel value, use, or

reuse. Air pollution control devices are

not recovery devices. Process

condensers are recovery devices. Other

examples of equipment that may be

recovery devices include organic

removal devices such as decanters,

strippers, or thin-film evaporation units.

Research and development facility

means research or laboratory operations

whose primary purpose is to conduct

research and development into new

processes and products, where the

operations are under the close

supervision of technically trained

personnel, and is not engaged in the

manufacture of products for commercial

sale, except in a de minimis manner.

Residual means any HAP-containing

liquid or solid material that is removed

from a wastewater stream by a waste

management unit or treatment process

that does not destroy organics

(nondestructive unit). Examples of

residuals from nondestructive

wastewater management units are: The

organic layer and bottom residue

removed by a decanter or organic-water

separator and the overheads from a

steam stripper or air stripper. Examples

of materials which are not residuals are:

Silt; mud; leaves; bottoms from a steam

stripper or air stripper; and sludges, ash,

or other materials removed from

wastewater being treated by destructive

devices such as biological treatment

units and incinerators.

Sewer line means a lateral, trunk line,

branch line, or other conduit including,

but not limited to, grates, trenches, etc.,

used to convey wastewater streams or

residuals to a downstream waste

management unit.

Single-seal system means a floating

roof having one continuous seal that

completely covers the space between

the wall of the storage vessel and the

edge of the floating roof. This seal may

be a vapor-mounted, liquid-mounted, or

metallic shoe seal.

Soluble HAP means a HAP listed in

Table 3 of this subpart.

Storage tank means a tank or other

vessel that is used to store organic

liquids that contain one or more HAP.

The following are not considered

storage tanks for the purposes of this

subpart:

(1) Vessels permanently attached to

motor vehicles such as trucks, railcars,

barges, or ships;

(2) Pressure vessels designed to

operate in excess of 204.9 kilopascals

and without emissions to the

atmosphere;

(3) Vessels storing organic liquids that

contain HAP only as impurities;

(4) Wastewater storage tanks; and

(5) Process tanks.

Surface impoundment means a waste

management unit which is a natural

topographic depression, manmade

excavation, or diked area formed

primarily of earthen materials (although

it may be lined with manmade

materials), which is designed to hold an

accumulation of liquid wastes or waste

containing free liquids. A surface

impoundment is used for the purpose of

treating, storing, or disposing of

wastewater or residuals, and is not an

injection well. Examples of surface

impoundments are equalization,

settling, and aeration pits, ponds, and

lagoons.

Treatment process means a specific

technique that removes or destroys the

organics in a wastewater or residual

stream such as a stream stripping unit,

thin-film evaporation unit, waste

incinerator, biological treatment unit, or

any other process applied to wastewater

streams or residuals to comply with

§ 63.138 of this subpart. Most treatment

processes are conducted in tanks.

Treatment processes are a subset of

waste management units.

Uncontrolled HAP emissions means a

gas stream containing HAP which has

exited the last recovery device, but

which has not yet been introduced into

an air pollution control device to reduce

the mass of HAP in the stream. If the

process vent is not routed to an air

pollution control device, uncontrolled

emissions are those HAP emissions

released to the atmosphere.

Unit operation means those

processing steps that occur within

distinct equipment that are used, among

other things, to prepare reactants,

facilitate reactions, separate and purify

products, and recycle materials.

Equipment used for these purposes

includes but is not limited to reactors,

distillation columns, extraction

columns, absorbers, decanters, dryers,

condensers, and filtration equipment.

Vapor-mounted seal means a

continuous seal that completely covers

the annular space between the wall, the

storage vessel or waste management unit

and the edge of the floating roof and is

mounted such that there is a vapor

space between the stored liquid and the

bottom of the seal.

Volatile organic compounds are

defined in 40 CFR part 51, § 51.100.

Wastewater means water containing

partially soluble or soluble HAP that is

discarded from equipment that is part of

the affected source and that is not

exempted by the provisions of

§ 63.1252(d)(2). For the purposes of this

subpart, noncontact cooling water is not

considered a wastewater stream.

Waste management unit means a

component, piece of equipment,

structure, or transport mechanism in

conveying, storing, treating, or

disposing of wastewater streams or

residuals. Examples of waste

management units include wastewater

tanks, air flotation units, surface

impoundments, containers, oil-water or

organic-water separators, individual

drain systems, biological treatment

units, waste incinerators, and organic

removal devices such as steam and air

stripper units, and thin film evaporation

units. If such equipment is used for

recovery then it is part of a

pharmaceutical process and is not a

waste management unit.

Wastewater tank means a stationary

waste management unit that is designed

to contain an accumulation of

wastewater or residuals and is

constructed primarily of nonearthen

materials (e.g., wood, concrete, steel,

plastic) which provide structural

support. Wastewater tanks used for flow

equalization are included in this

definition.

Water seal controls means a seal pot,

p-leg trap, or other type of trap filled

with water (e.g., flooded sewers that

maintain water levels adequate to

prevent air flow through the system)

that creates a water barrier between the

sewer line and the atmosphere. The

water level of the seal must be

maintained in the vertical leg of a drain

in order to be considered a water seal.

§ 63.1252 Standards.

(a) Each owner or operator of any

affected source subject to the provisions

of this subpart shall control HAP

emissions to the level specified in this

section on and after the compliance

dates specified in § 63.1250 of this

subpart.

(b) Storage tanks:

(1) The owner or operator of a storage

tank meeting the criteria of paragraph

(b)(1)(i) of this section is subject to the

requirements of paragraph (b)(2) of this

section. The owner or operator of a

storage tank meeting the criteria of

paragraph (b)(1)(ii) of this section is

subject to the requirements of paragraph

(b)(3) of this section.

(i) A storage tank with a design

capacity greater than or equal to 38 m3
15768 Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules

(10,000 gallons) but less than 75 m3

(20,000 gallons), and storing a liquid for

which the maximum true vapor

pressure of total HAP is greater than or

equal to 13.1 kPa (1.9 psia).

(ii) A storage tank with a design

capacity greater than or equal to 75 m3

storing a liquid for which the maximum

true vapor pressure of total HAP is

greater than or equal to 13.1 kPa.

(2) The owner or operator of a storage

tank shall equip the affected storage

tank with either a fixed roof with

internal floating roof, an external

floating roof, an external floating roof

converted to an internal floating roof, or

a closed vent system with control device

that reduces inlet emissions of total

HAP by 90 percent or greater, as

demonstrated through the test methods

and procedures in § 63.1253(c).

(3) The owner or operator of a storage

tank shall equip the affected storage

tank with either a fixed roof with

internal floating roof, an external

floating roof, an external floating roof

converted to an internal floating roof, or

a closed vent system with control device

that meets the requirements of

paragraphs (b)(3)(i) and (b)(3)(ii) of this

section.

(i) Except as provided in paragraph

(b)(3)(ii) of this section, the control

device shall be designed and operated to

reduce inlet emissions of total HAP by

95 percent or greater, as demonstrated

through the test methods and

procedures in § 63.1253(c).

(ii) If the owner or operator can

demonstrate that a control device

installed on a storage tank on or before

April 2, 1997, is designed to reduce

inlet emissions of total HAP by greater

than or equal to 90 percent but less than

95 percent, then the control device is

required to be operated to reduce inlet

emissions of total HAP by 90 percent or

greater, as demonstrated through the test

methods and procedures in § 63.1253(c).

(c) Process vents:

(1) The owner or operator of an

existing affected source must comply

with the process vent requirements of

paragraphs (c)(2) and (c)(4) of this

section or the requirements of

paragraphs (c)(3) and (c)(4) of this

section. The owner or operator of a new

affected source must comply with the

process vent requirements of paragraph

(c)(5) of this section. Compliance with

the required emission reductions shall

be demonstrated through the applicable

test methods and compliance

procedures described in § 63.1253 of

this subpart.

(2) Annual controlled HAP emissions

shall not exceed 900 kilograms per year

(2,000 pounds per year) from the sum of

all process vents within a process that

do not meet the criteria specified in

paragraph (c)(4)(i) of this section.

(3) Annual uncontrolled HAP

emissions from the sum of all process

vents within a process that do not meet

the criteria specified in paragraph

(c)(4)(i) of this section shall be reduced

by 93 percent or greater.

(4) Annual uncontrolled HAP

emissions from each process vent

meeting the requirements of paragraph

(c)(4)(i) of this section and not meeting

the requirements of paragraph (c)(4)(ii)

of this section shall be reduced by 98

percent or greater.

(i) Process vents having a flowrate

equal to or less than the flowrate

calculated when multiplying the annual

uncontrolled HAP emissions, in lb/yr,

by 0.02 and subtracting 1,000 according

to the following equation:

FR = 0.02*(HL)-1,000

Where:

FR = flowrate, scfm,

HL = yearly uncontrolled HAP

emissions, lb/yr;

(ii) If the owner or operator can

demonstrate that a control device,

installed on a process vent subject to the

requirements of paragraph (c)(4)(i) of

this section on or before April 2, 1997,

was designed to reduce uncontrolled

HAP emissions of total HAP by greater

than or equal to 93 percent but less than

98 percent, then the control device is

required to be operated to reduce inlet

emissions of total HAP by 93 percent or

greater.

(5) If the annual uncontrolled HAP

emissions from the sum of all the

process vents within a process is greater

than 180 kg/yr (400 lb/yr) then the

owner or operator shall reduce annual

uncontrolled HAP emissions from the

sum of all process vents within a

process by 98 percent.

(d) Wastewater:

(1) The owner or operator of a new or

existing affected source discharging

wastewater with the concentrations

described in paragraphs (d)(1)(i) through

(d)(1)(v) of this section at the point of

determination (POD) must comply with

the provisions of paragraphs (d)(3)

through (d)(4)(ii) of this section. The

owner or operator of a new source

discharging wastewater with

concentrations described in paragraph

(d)(1)(vi) of this section at the POD must

comply with the provisions of

paragraph (d)(4)(i) or (d)(4)(ii)(A) and

(d)(4)(iii) of this section.

(i) Wastewater containing partially

soluble HAP at a total concentration of

greater than 1,300 parts per million by

weight (ppmw) from any POD within a

process with a total yearly load of

soluble and/or partially soluble HAP of

greater than 1 megagram per year (Mg/

yr).

(ii) Wastewater containing partially

soluble and/or soluble HAP at a total

concentration of greater than 5,200

ppmw from any POD within a process

with a total yearly load of soluble and/

or partially soluble HAP of greater than

1 Mg/yr of total HAP.

(iii) Wastewater with a concentration

of partially soluble and/or soluble HAP

of greater than 10,000 ppmw total HAP

at facilities that discharge greater than 1

Mg/yr of soluble and/or partially soluble

HAP in the total yearly volume of all

wastewaters generated.

(iv) Wastewater containing partially

soluble HAP at a total concentration of

greater than 1,300 parts per million by

weight (ppmw) from any single POD

with a total yearly load of soluble and/

or partially soluble HAP of greater than

1 Mg/yr.

(v) Wastewater containing partially

soluble and/or soluble HAP at a total

concentration of greater than 5,200

ppmw from any single POD with a total

yearly load of soluble and/or partially

soluble HAP from any single POD of

greater than 1 Mg/yr.

(vi) Wastewater containing soluble

HAP at a total concentration of greater

than 110,000 ppmw from any POD

within a process or from any single POD

with a total yearly load of soluble and/

or partially soluble HAP of greater than

1 Mg/yr of total HAP.

(2) The following wastewaters are not

subject to the wastewater provisions of

this part:

(i) Stormwater from segregated

sewers;

(ii) Water from fire-fighting and

deluge systems, including testing of

such systems;

(iii) Spills; and

(iv) Water from safety showers.

(3) An owner or operator of a facility

shall comply with the requirements of

§§ 63.133 through 63.137, and the

control device requirements and

inspection requirements of §§ 63.139

and 63.148, respectively, of subpart G

for each waste management unit or

treatment process that receives an

affected wastewater. The affected

wastewater for purposes of this subpart

is synonymous with the ‘‘Group 1’’

identification for wastewater used in the

provisions of subpart F and G. Also for

the purposes of this subpart, tanks for

which it can be demonstrated that less

than 5 percent of the total soluble and/

or partially soluble HAP is emitted from

a wastewater tank described in

§ 63.133(a)(1), in addition to a tank with

surface agitation, shall be equipped with

a fixed roof. The owner or operator shall

also comply with the treatment
Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules 15769

requirements specified in paragraphs

(d)(4) or (d)(5) of this section for each

affected wastewater stream.

(4) Each affected wastewater stream

shall be treated by one of the following

methods:

(i) Recycle to the process in

accordance with the requirements

specified in § 63.138(f). Once a

wastewater stream is returned to the

process, the wastewater stream is no

longer subject to this section.

(ii) Treat using a waste management

unit or treatment process which meets

conditions in paragraph (d)(4)(ii)(A) and

(B) or (C) of this section:

(A) Reduces, by removal or

destruction, the total mass of each

individual partially soluble HAP by 99

percent, as determined by the

procedures specified in § 63.145(c),

63.145(d), or 63.138(j); or to a level less

than 50 parts per million by weight of

total partially soluble HAP as

determined by the procedures specified

in § 63.145(b). This option shall not be

used when the treatment process is a

biological treatment process, or when

the wastewater stream is designated as

a Group 1 wastewater stream as

specified in § 63.132(e). Dilution shall

not be used to achieve compliance with

this option. Treatment process residuals

shall be treated according to § 63.138(h)

or § 63.138(m).

(B) Reduces, by removal or

destruction, the total mass of each

individual soluble HAP by 90 percent,

as determined by the procedures

specified in §§ 63.145(c), 63.145(d), or

§ 63.138(j). Treatment process residuals

shall be treated according to § 63.138(h)

or § 63.138(m).

(C) Reduces, by biological treatment,

the mass of total soluble and partially

soluble HAP in wastewater for all

pharmaceutical processes at the facility

by 95 percent, as determined by the

procedures specified in 40 CFR part 63

appendix C.

(iii) Treat using a waste management

unit or treatment process which

reduces, by removal or destruction, the

total mass of each soluble HAP by 99

percent, as determined by the

procedures specified in §§ 63.145(c),

63.145(d), or § 63.138(j). Treatment

process residuals shall be treated

according to § 63.138(h) or § 63.138(m).

(5) As an alternative to the treatment

requirements in paragraph (d)(4)(ii)(B)

of this section, an owner or operator

may elect to treat affected wastewaters

containing soluble HAP and less than 50

ppmw partially soluble HAP in the

following manner if it can be

demonstrated that less than 5 percent of

the total soluble HAP is emitted from

the municipal sewer system:

(i) Treat in an enhanced biological

treatment system that meets all of the

following criteria:

(A) The biological treatment system is

an aerated treatment unit(s) that

contains biomass suspended in water

followed by a clarifier that removes

biomass from the treated water and

recycles the recovered biomass to the

aeration unit;

(B) The mixed liquor volatile

suspended solids (biomass) is greater

than 1 kg/m3 homogeneously

distributed throughout each aeration

unit;

(C) The biomass in the enhanced

biotreatment system is suspended and

aerated in the water of the aeration

unit(s) by either submerged air flow or

mechanical agitation; and

(D) The enhanced biotreatment

system is in compliance with

requirements of the permitting

authority.

(ii) Treat in a publicly-owned

treatment works (POTW) that meets all

of the following criteria:

(A) The POTW uses biological

treatment that meets the criteria of

paragraph (d)(5)(i) of this section.

(B) The POTW is in compliance with

the General Pretreatment Regulations in

40 CFR part 403, including any

applicable categorical pretreatment

standards, and has pretreatment permit

or equivalent approval under the

authority of 40 CFR part 403.

(C) The POTW is in compliance with

all applicable pretreatment standards

adopted at 40 CFR part 439.

(6) For each treatment process used to

comply with the requirements of

paragraph (d)(4) of this section, the

owner or operator shall comply with

§ 63.138(i), (k), and (l).

(7) Except as provided in paragraph

(d)(7)(i) and (ii) of this section, the

owner or operator shall not discharge a

separate phase that can be isolated

through gravity separation from the

aqueous phase to a wastewater

management or treatment unit.

(i) Owners and operators discharging

a separate organic phase shall separate

and treat the organic according to

§ 63.138(h).

(ii) Owners and operators shall treat

any aqueous phases having the

characteristics of paragraphs (d)(1)(i)

through (d)(1)(iv) of this section

according to the requirements of

paragraphs (d)(3) through (d)(6) of this

section.

(e) Equipment leaks: The owner or

operator shall comply with the

requirements of Appendix A to this

subpart GGG.

(f) Planned routine maintenance: The

specifications and requirements in

paragraphs (b) and (c) of this section for

control devices do not apply during

periods of planned routine

maintenance. Maintenance wastewaters

meeting the criteria for control as

specified in paragraph (d)(1) of this

section shall be treated in accordance

with the requirements of paragraphs

(d)(3) through (d)(7) of this section.

(g) Periods of planned routine

maintenance of the control device,

during which the control device does

not meet the specifications of

paragraphs (b) and (c) of this section, as

applicable, shall not exceed 240 hours

per year.

(h) Pollution prevention alternative:

Except as provided in paragraph (h)(1)

of this section, owners and operators

may choose to meet the pollution

prevention alternative requirement

specified in either paragraph (h)(2) or

(h)(3) of this section for any process, in

lieu of the requirements specified in

paragraphs (b), (c), (d), and (e) of this

section. Compliance with paragraphs

(h)(2) and (h)(3) of this section shall be

demonstrated through the procedures in

§ 63.1253(f).

(1) Processes emitting HAP that are

generated in the process must be

controlled according to the

requirements of paragraphs (b), (c), (d),

and (e) of this section.

(2) The production-indexed HAP

consumption factor (kg HAP consumed/

kg produced) shall be reduced by 75

percent from an average baseline

established no earlier than the 1987

calendar year, or the first year thereafter

in which the process was operational

and data are available. No increase in

the production-indexed VOC

consumption factor for the applicable

period of demonstration shall occur.

(3) Both requirements specified in

paragraphs (h)(3)(i) and (ii) of this

section are met.

(i) The production-indexed HAP

consumption factor (kg HAP consumed/

kg produced) shall be reduced by 50

percent from an average baseline

established no earlier than the 1987

calendar year, or the first year thereafter

in which the process was operational

and data is available. No increase in the

production-indexed VOC consumption

factor for the applicable period of

demonstration shall occur.

(ii) The total process HAP emissions

shall be reduced from an uncontrolled

baseline by an amount, in kg/yr, that,

when divided by the annual production

rate, in kg, will yield a value of at least

25 percent of the average baseline HAP

production-indexed consumption factor

established in paragraph (h)(3)(i) of this

section. The annual reduction in HAP
15770 Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules

air emissions must be due to the use of

the following control devices:

(A) Combustion control devices such

as incinerators, flares or process heaters.

(B) Recovery control devices such as

condensers and carbon adsorbers whose

recovered product is destroyed or

shipped offsite for destruction.

(C) Any control device that does not

ultimately allow for recycling of

material back to the process.

(D) Any control device for which the

owner or operator can demonstrate that

the use of the device in controlling HAP

emissions will have no effect on the

production-indexed consumption factor

for the process.

(i) Heat exchange systems: Except as

provided in paragraph (i)(2) of this

section, owners and operators of

affected sources shall comply with the

requirements in paragraphs (i)(1) of this

section for heat exchange systems that

cool process equipment or materials

used in pharmaceutical manufacturing

operations.

(1) The heat exchange system shall be

treated according to the provisions of

§ 63.104.

(2)(i) The monitoring frequency shall

be no less than quarterly.

(ii) The owner or operator of heat

exchange systems which meet current

good manufacturing practice (CGMP)

requirements at 21 CFR part 211 may

elect to use the physical integrity of the

reactor as the surrogate indicator of heat

exchange system leaks.

(j) Emissions averaging provisions:

With the exception of paragraphs (j)(1)

through (j)(5) of this section, owners or

operators of storage tanks or processes

subject to paragraph (b) or (c) of this

section may choose to comply with the

emission standards in paragraph (b) or

(c) of this section by using emissions

averaging requirements specified in

§ 63.1253(h) or (i) of this subpart for any

storage tank or process.

(1) A State may restrict the owner or

operator of an existing source to use

only the procedures in § 63.1252(b) and

(c) to comply with the emission

standards where State Authorities

prohibit averaging of HAP emissions.

(2) Emission sources subject to the

requirements of paragraphs (b)(3)(ii) and

(c)(2), (c)(4), and (c)(5) of this section

may not be included in any averaging

group.

(3) Processes which have been

permanently shutdown or storage tanks

permanently taken out of HAP service

may not be included in any averaging

group.

(4) Processes and storage tanks

already controlled on or before

November 15, 1990 may not be included

in an emissions averaging group, except

where the level of control is increased

after November 15, 1990. In these cases,

the uncontrolled emissions shall be the

controlled emissions as calculated on

November 15, 1990 for the purpose of

determining the uncontrolled emissions

as specified in § 63.1253(h) and (i) of

this subpart.

(5) Emission points controlled to

comply with a State or Federal rule

other than this subpart, unless the level

of control has been increased after

November 15, 1990 above what is

required by the other State or Federal

rule. Only the control above what is

required by the other State or Federal

rule will be credited. However, if an

emission point has been used to

generate emissions averaging credit in

an approved emissions average, and the

point is subsequently made subject to a

State or Federal rule other than this

subpart, the point can continue to

generate emissions averaging credit for

the purpose of complying with the

previously approved average.

(6) Not more than 20 processes and 20

tanks at an affected source may be

included in an emissions averaging

group.

(7) Compliance with the emissions

standards in paragraph (b) of this

section shall be satisfied when the

overall percent reduction efficiency is

greater than or equal to 90 percent for

those tanks meeting the requirements of

paragraph (b)(1)(i) of this section and 95

percent for those tanks meeting the

requirements of paragraph (b)(1)(ii) of

this section, as demonstrated using the

test methods and compliance

procedures specified in § 63.1253(h) of

this subpart.

(8) Compliance with the emissions

standards in paragraph (c) of this

section shall be satisfied when the

overall percent reduction efficiency is

greater than or equal to 93 percent, as

demonstrated using the test methods

and compliance procedures specified in

§ 63.1253(i) of this subpart.

§ 63.1253 Test methods and compliance

procedures.

(a) Emissions testing or engineering

evaluations, as specified in paragraphs

(c), (d), (e), and (f) of this section, are

required to demonstrate initial

compliance with § 63.1252 (b), (c), (d),

and (h) respectively, of this subpart.

(b) Test methods: When testing is

conducted to measure emissions from

an affected source, the test methods

specified in paragraphs (b)(1) through

(b)(9) of this section shall be used.

(1) EPA Method 1 or 1A of appendix

A of part 60 is used for sample and

velocity traverses.

(2) EPA Method 2, 2A, 2C, or 2D of

appendix A of part 60 is used for

velocity and volumetric flow rates.

(3) EPA Method 3 of appendix A of

part 60 is used for gas analysis.

(4) EPA Method 4 of appendix A of

part 60 is used for stack gas moisture.

(5) EPA Methods 2, 2A, 2C, 2D, 3, and

4 shall be performed, as applicable, at

least twice during each test period.

(6) Methods 25A, 26 and/or Methods

18 and 25A, as appropriate, of appendix

A of part 60 shall be used to determine

the HAP concentration of air exhaust

streams.

(7) Test conditions and durations

shall be as specified in paragraphs

(b)(7)(i) through (b)(7)(v) of this section,

as appropriate.

(i) Testing of process vents on

equipment operating as part of a

continuous process will consist of three

l-hour runs. Gas stream volumetric flow

rates shall be measured every 15

minutes during each 1-hour run. The

HAP concentration shall be determined

from samples collected in an integrated

sample over the duration of each l-hour

test run, or from grab samples collected

simultaneously with the flow rate

measurements (every 15 minutes). If an

integrated sample is collected for

laboratory analysis, the sampling rate

shall be adjusted proportionally to

reflect variations in flow rate. For

continuous gas streams, the emission

rate used to determine compliance shall

be the average emission rate of the three

test runs.

(ii) Testing of process vents on

equipment where the flow of gaseous

emissions is intermittent (batch

operations) shall include testing for the

worst-case episode or aggregated

episodes in the batch cycle or cycles (in

the event that equipment may be

manifolded and vented through a

common stack) or testing under normal

conditions, provided that the operation

of the device is limited to those

conditions that existed during testing

under representative worst-case or

normal conditions. Testing shall be

conducted at absolute worst-case

conditions, representative worst-case

conditions, hypothetical worst-case

conditions, or normal conditions as

required by paragraph (d)(3)(iii) of this

section. Gas stream volumetric flow

rates shall be measured at 15-minute

intervals. The HAP or TOC

concentration shall be determined from

samples collected in an integrated

sample over the duration of the test, or

from grab samples collected

simultaneously with the flow rate

measurements (every 15 minutes). If an

integrated sample is collected for

laboratory analysis, the sampling rate
Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules 15771

shall be adjusted proportionally to

reflect variations in flow rate. The

absolute worst-case, representative

worst-case, or hypothetical worst-case

conditions shall be characterized by the

criteria presented in paragraphs (b)(7)(ii)

(A), (B), and (C) of this section. In all

cases, a site-specific plan shall be

submitted to the administrator for

approval prior to testing in accordance

with § 63.7(c). The test plan shall

include the emissions profile described

in paragraph (b)(7)(iii) of this section.

(A) Absolute worst-case conditions

are defined by any of the criteria

presented in paragraphs (b)(7)(ii) (A) (1)

through (3) of this section.

(1) The period in which the inlet to

the control device will contain at least

50 percent of the maximum HAP load

(in lb) capable of being vented to the

control device over any 8 hour period.

An emission profile as described in

paragraph (b)(7)(iii) of this section shall

be used to identify the 8-hour period

that includes the maximum projected

HAP load.

(2) A 1-hour period of time in which

the inlet to the control device will

contain the highest HAP mass loading

rate, in lb/hr, capable of being vented to

the control device. An emission profile

as described in paragraph (b)(7)(iii) of

this section shall be used to identify the

1-hour period of maximum HAP

loading.

(3) If a condenser is used as a control

device, absolute worst-case conditions

shall represent a 1-hour period of time

in which the gas stream capable of being

vented to the condenser will require the

maximum heat removal capacity, in

Btu/hr, to cool the stream to a

temperature that, upon calculation of

HAP concentration, will yield the

required removal efficiency for the

process. The calculation of maximum

heat load shall be based on the emission

profile described in paragraph (b)(7)(iii)

of this section and a concentration

profile that will allow calculation of

sensible and latent heat loads.

(B) Representative worst-case

conditions are defined by any of the

criteria presented in paragraph

(b)(7)(ii)(A) (1) through (2) of this

section. Representative worst-case

conditions shall include the worst-case

process as well as any other processes

that are emitting to the control device

during the test.

(1) A 1-hour period of time that

contains the highest HAP mass loading

rate, in lb/hr, from a single process;

(2) If a condenser is used as the

control device, the 1-hour period of time

in which the vent from a single process

will require the maximum heat removal

capacity, in BTU/hr, to cool the stream

to a temperature that, upon calculation

of HAP concentration, will yield the

required removal efficiency for the

process.

(C) Hypothetical worst-case

conditions are simulated test conditions

that, at a minimum, contain the highest

total average hourly HAP load of

emissions that would be predicted to be

vented to the control device from the

emissions profile described in

paragraph (b)(7)(iii) of this section.

(iii) For batch operations, the owner

or operator may choose to perform tests

only during those periods of the worstcase conditions that the owner or

operator selects to control as part of

achieving the required emission

reduction. The owner or operator must

develop an emission profile for the vent

to the control device, based on either

process knowledge, engineering

analyses, or test data collected, to

identify the appropriate test conditions.

The emission profile must include

average HAP loading rate (in lb/hr)

versus time for all emission episodes

within processes that could contribute

to the vent stack for a period of time that

is sufficient to include all processes

venting to the stack. Examples of

information that could constitute

process knowledge include calculations

based on material balances, and process

stoichiometry. Previous test results may

be used provided the results are still

relevant to the current process vent

stream conditions. The average hourly

HAP loading rate may be calculated by

first dividing the HAP emissions from

each episode by the duration of each

episode, in hours, and selecting the

highest hourly block average.

(iv) For testing of process vents of

duration greater than 8 hours, the owner

or operator is required to perform a

maximum of 8 hours of testing. The test

period must include the one hour

period in which the highest HAP

loading rate, in lb/hr, is predicted by the

emission profile.

(v) For testing durations of greater

than 1 hour, the emission rate from a

single test run may be used to determine

compliance. For testing durations less

than or equal to 1 hour, testing shall

include three 1-hour runs.

(8) For emission streams controlled

using condensers, a direct measurement

of condenser outlet gas temperature to

be used in predicting upper

concentration limits at saturated

conditions is allowed in lieu of

concentration measurements described

in paragraph (b)(6) of this section.

(9) Wastewater analysis shall be

conducted in accordance with

paragraph (b)(9)(i) or (b)(9)(ii) of this

section.

(i) Use the equations in paragraphs

(b)(9)(i) (A) and (B) of this section to

determine the total HAP concentration

of a wastewater stream.

(A) The following equation shall be

used to calculate the HAP concentration

of an individually speciated HAP.

C C MW P

T i c

i t L M

i

= s





 



 * . * * * * * /

24 055 760

293 103

Where:

Ci=HAP concentration of the

individually-speciated organic HAP

in the wastewater, parts per million

by weight.

CC=concentration of the organic HAP (i)

in the gas stream, parts per million

by volume on a dry basis

MS=mass of sample, milligrams

MW=molecular weight of the organic

HAP (i), grams per gram-mole

24.055=ideal gas molar volume at 293°

Kelvin and 760 millimeters of

mercury, liters per gram-mole

Pi=barometric pressure at the time of

sample analysis, millimeters

mercury absolute

760=reference or standard pressure,

millimeters mercury absolute

293=reference or standard temperature,

°Kelvin

Ti=sample gas temperature at the time of

sample analysis, °Kelvin

t=actual purge time minutes

L=actual purge rate liters per minute

103=conversion factor, milligrams per

gram

(B) Total HAP concentration can be

determined by summing the HAP

concentrations of all individually

speciated organic HAP in the

wastewater.

C C stream i

i

n

=

=

∑

1

Where:
15772 Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules

Cstream=total HAP concentration of

wastewater stream

n=number of individual organic HAP (i)

in the wastewater stream

Ci=HAP concentration of individual

HAP (i) calculated according to the

procedures in paragraph (b)(7)(i)(A)

of this section

(ii) Use a test method or results from

a test method that measures HAP

concentrations in the wastewater, and

that has been validated according to

section 5.1 or 5.3 of Method 301 of 40

CFR part 63 appendix A.

(iii) Use Methods 624, 625, 1624,

1625, and 8270, and the alternative

validation procedures presented in

§ 63.144.

(c) Compliance with storage tank

provisions. The owner or operator of an

affected storage tank shall demonstrate

compliance with §§ 63.1252(b)(2) and

63.1252(b)(3)(i) and (ii), as applicable,

by fulfilling the requirements of either

paragraph (c)(1) or (c)(2) or (c)(3) of this

section.

(1) To demonstrate compliance with

the percent reduction requirement of

§ 63.1252(b)(2) or § 63.1252(b)(3) (i) or

(ii), the mass rate of total HAP (Ei, Eo)

shall be computed.

(i) The following equations shall be

used:

E K C M Q

E K C M Q

i ij ij

j

n

i

o oj oj

j

n

o

= 











= 











=

=

∑

∑

2

1

2

1

Where:

Cij, Coj=concentration of sample

component j of the gas stream at the

inlet and outlet of the control

device, respectively, dry basis, parts

per million by volume

Ei, Eo=mass rate of total HAP at the inlet

and outlet of the control device,

respectively, dry basis, kilogram per

hour

Mij, Moj=molecular weight of sample

component j of the gas stream at the

inlet and outlet of the control

device, respectively, gram/grammole

Qi, Qo=flow rate of gas stream at the

inlet and outlet of the control

device, respectively, dry standard

cubic meter per minute

K2=constant, 2.494×10¥6 (parts per

million)¥1 (gram-mole per standard

cubic meter) (kilogram/gram)

(minute/hour), where standard

temperature is 20°C

(ii) The percent reduction in total

HAP shall be calculated as follows:

where:

R

E E

E

i o

i

= − ( ) 100

Where:

R=control efficiency of control device,

percent

Ei=mass rate of total HAP at the inlet to

the control device as calculated

under paragraph (c)(1)(i) of this

section, kilograms organic HAP per

hour

Eo=mass rate of total HAP at the outlet

of the control device, as calculated

under paragraph (c)(1)(i) of this

section, kilograms organic HAP per

hour

(iii) A performance test is not required

to be conducted if the control device

used to comply with § 63.1252(b)

(storage tank provisions) is also used to

comply with § 63.1252(c) (process vent

provisions), and compliance with

§ 63.1252(c) has been demonstrated in

accordance with paragraph (d)(2) of this

section.

(2) To demonstrate compliance with

the percent reduction requirement of

§ 63.1252(b)(2) or § 63.1252(b)(3)(i) or

(ii), a design evaluation shall be

prepared. The design evaluation shall

include documentation demonstrating

that the control device being used

achieves the required control efficiency

during reasonably expected maximum

filling rate. This documentation is to

include a description of the gas stream

which enters the control device,

including flow and organic HAP content

under varying liquid level conditions,

and the information specified in

paragraphs (c)(2)(i) through (c)(2)(v) of

this section, as applicable.

(i) If the control device receives

vapors, gases or liquids, other than

fuels, from emission points other than

storage vessels subject to this subpart,

the efficiency demonstration is to

include consideration of all vapors,

gases, and liquids, other than fuels,

received by the control device.

(ii) If an enclosed combustion device

with a minimum residence time of 0.5

seconds and a minimum temperature of

760°C is used to meet the emission

reduction requirement specified in

§ 63.1252(b)(2)(i) (or (ii)),

documentation that those conditions

exist is sufficient to meet the

requirements of paragraph (c)(2) of this

section.

(iii) Except as provided in paragraph

(c)(2)(ii) of this section, for thermal

incinerators, the design evaluation shall

include the autoignition temperature of

the organic HAP, the flow rate of the

organic HAP emission stream, the

combustion temperature, and the

residence time at the combustion

temperature.

(iv) For carbon adsorbers, the design

evaluation shall include the affinity of

the organic HAP vapors for carbon, the

amount of carbon in each bed, the

number of beds, the humidity of the

feed gases, the temperature of the feed

gases, the flow rate of the organic HAP

emission stream, the desorption

schedule, the regeneration stream

pressure or temperature, and the flow

rate of the regeneration stream. For

vacuum desorption, pressure drop shall

be included.

(v) For condensers, the design

evaluation shall include the final

temperature of the organic HAP vapors,

the type of condenser, and the design

flow rate of the organic HAP emission

stream.

(3) If the owner or operator of an

affected source chooses to comply with

the provisions of § 63.1252(b)(2) or

§ 63.1252(b)(3) by installing a floating

roof, the owner or operator shall comply

with the procedures described in 40

CFR 63.119(b), (c), (d), and 63.120.

(d) Compliance with process vent

provisions. An owner or operator of an

affected source complying with the

process vent standards in § 63.1252(c)

shall demonstrate compliance using the

procedures described in paragraphs

(d)(1) through (d)(4) of this section.

(1) Except as provided in paragraph

(d)(4) of this section, compliance with

the process vent standards in

§ 63.1252(c) shall be demonstrated using

the procedures specified in paragraphs

(d)(1)(i) through (v), as applicable.

(i) Compliance with § 63.1252(c)(2) is

demonstrated when the controlled

emissions of HAP from the sum of all

process vents within a process that do

not meet the criteria specified in

§ 63.1252(c)(4)(ii) is less than or equal to

2,000 pound per year. Controlled

emissions of HAP shall be determined

using the procedures described in

paragraph (d)(3) of this section.

(ii) Compliance with § 63.1252(c)(3) is

demonstrated when the annual

uncontrolled HAP emissions from the

sum of all process vents within a

process that do not meet the criteria

specified in § 63.1252(c)(4)(ii) is

reduced by 93 percent. This

demonstration shall be based on

controlled emissions of HAP

determined using the procedures

described in paragraph (d)(3) of this

section and uncontrolled emissions of

HAP determined using the procedures

described in paragraph (d)(2) of this

section or by controlling the process

vents using a device meeting the criteria

specified in paragraph (d)(4) of this

section.

(iii) Compliance with § 63.1252(c)(5)

is demonstrated when the annual
Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules 15773

uncontrolled HAP emissions from all

process vents within a process is

reduced by 98 percent, or when the sum

of uncontrolled HAP emissions of all

process vents within a process is less

than or equal to 180 kg/yr (400 lb/yr).

This demonstration shall be based on

controlled emissions of HAP

determined using the procedures

described in paragraph (d)(3) of this

section and uncontrolled emissions of

HAP determined using the procedures

described in paragraph (d)(2) of this

section or by controlling the process

vents using a device meeting the criteria

specified in paragraph (d)(4) of this

section.

(iv) Compliance with § 63.1252(c)(4)

is demonstrated when the annual

uncontrolled HAP emissions from each

process vent meeting the requirements

of § 63.1252(c)(4)(i) is reduced by 98

percent. This demonstration shall be

based on controlled emissions of HAP

determined using the procedures

described in paragraph (d)(3) of this

section and uncontrolled emissions of

HAP determined using the procedures

described in paragraph (d)(2) of this

section or by controlling the process

vents using a device meeting the criteria

specified in paragraph (d)(4) of this

section.

(v) Compliance with

§ 63.1252(c)(4)(ii) is demonstrated when

the annual uncontrolled HAP emissions

from each process vent meeting the

requirements of § 63.1252(c)(4)(ii) is

reduced by 93 percent. This

demonstration shall be based on

controlled emissions of HAP

determined using the procedures

described in paragraph (d)(3) of this

section and uncontrolled emissions of

HAP determined using the procedures

described in paragraph (d)(2) of this

section or by controlling the process

vents using a device meeting the criteria

specified in paragraph (d)(4) of this

section.

(2) An owner or operator of an

affected source complying with the

emission limitation required by

§ 63.1252(c)(2), or emissions reductions

specified in § 63.1252(c)(3), (c)(4), or

(c)(5) of this subpart for each process

vent within a process, shall calculate

uncontrolled emissions according to the

procedures described in paragraph

(d)(2)(i) or (d)(2)(ii) of this section, as

appropriate.

(i) Owners or operators shall

determine uncontrolled emissions of

HAP using measurements and/or

calculations for each batch emission

episode within each unit operation

according to the engineering evaluation

methodology in paragraphs (d)(2)(i)(A)

through (d)(2)(i)(E) of this section.

Individual HAP partial pressures in

multicomponent systems shall be

determined by the following methods: If

the components are miscible in one

another, use Raoult’s law to calculate

the partial pressures; if the solution is

a dilute aqueous mixture, use Henry’s

law to calculate partial pressures; if

Raoult’s law or Henry’s law are not

appropriate or available, use

experimentally obtained activity

coefficients or models such as the

group-contribution models, to predict

activity coefficients, or assume the

components of the system behave

independently and use the summation

of all vapor pressures from the HAP as

the total HAP partial pressure. Chemical

property data can be obtained from

standard reference texts.

(A) Emissions from vapor

displacement due to transfer of material

shall be calculated according to

equation (1):

E y V P MW

R T

i T = ( )( )( )( )

( )( ) ( )1

Where:

E = mass emission rate

yi = saturated mole fraction of HAP in

the vapor phase

V = volume of gas displaced from the

vessel

R = ideal gas law constant

T = temperature of the vessel vapor

space; absolute

PT = pressure of the vessel vapor space

MW = molecular weight of the HAP

(B) Emissions from purging shall be

calculated using equation (1), except

that for purge flow rates greater than 100

standard cubic feet per minute (scfm),

the mole fraction of HAP will be

assumed to be 25 percent of the

saturated value.

(C) Emissions caused by the heating of

a vessel shall be calculated using the

procedures in either paragraph (d)(2)(i)

(C)(1), (C)(2), or (C)(3) of this section, as

appropriate.

(1) If the final temperature to which

the vessel contents is heated is lower

than 50° K below the boiling point of

the HAP in the vessel, then emissions

shall be calculated using the equations

(2) through (5) in paragraphs (d)(2)(i)

(C)(1)(i) through (iv) of this section.

(i) The mass of HAP emitted per

episode shall be calculated as follows:

E

P

Pa

P

Pa MW

i T i T

= HAP

( ) + ( )

× × ( )

∑ ∑ 1

1

2

2

2

∆η 2

Where:

E = mass of HAP vapor displaced from

the vessel being heated

(Pi)Tn = partial pressure of each HAP in

the vessel headspace at initial (n=1)

and final (n=2) temperature

Pa1 = initial gas pressure in the vessel

Pa2 = final gas pressure

MWHAP = the average molecular weight

of HAP present in the vessel

(ii) The moles of gas displaced is

represented by:

∆η = 



 



 − 



 



















 ( ) V

R

Pa

T

Pa

T

1

1

2

2

3

Where:

∆η = number of lb-moles of gas

displaced

V = volume of free space in the vessel

R = ideal gas law constant

Pa1 = initial gas pressure in the vessel

Pa2 = final gas pressure

T1 = initial temperature of vessel

T2 = final temperature of vessel

(iii) The initial and final pressure of

the noncondensable gas in the vessel

shall be calculated according to the

following equation:

Pa P P T n atm i n = − Σ( ) ( ) 4

Where:

Pan = partial pressure of gas in the vessel

headspace at initial (n=1) and final

(n=2) temperature

Patm = atmospheric pressure

(Pi)Tn = partial pressure of each

condensable volatile organic

compound (including HAP) in the

vessel headspace at the initial

temperature (n=1) and final (n=2)

temperature

(iv) The average molecular weight of

HAP in the displaced gas shall be

calculated as follows:
15774 Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules

MW

mass of HAP

mass of HAP

HAP molecular weight

HAP

i

i

n

i

i i

n =

( )

( )

( )

( ) =

=

∑

∑

1

1

5

where n is the number of different HAP

compounds in the emission stream.

(2) If the vessel contents are heated to

a temperature greater than 50°K below

the boiling point, then emissions from

the heating of a vessel shall be

calculated as the sum of the emissions

calculated in accordance with

paragraphs (d)(2)(i) (C)(2)(i) and

(C)(2)(ii) of this section.

(i) For the interval from the initial

temperature to the temperature 50°K

below the boiling point, emissions shall

be calculated using Equation 2, where

T2 is the temperature 50°K below the

boiling point.

(ii) For the interval from the

temperature 50°K below the boiling

point to the final temperature, emissions

shall be calculated as the summation of

emissions for each 5°K increment,

where the emission for each increment

shall be calculated using Equation 2.

(A) If the final temperature of the

heatup is lower than 5°K below the

boiling point, the final temperature for

the last increment shall be the final

temperature of the heatup, even if the

last increment is less than 5°K.

(B) If the final temperature of the

heatup is higher than 5°K below the

boiling point, the final temperature for

the last increment shall be the

temperature 5°K below the boiling

point, even if the last increment is less

than 5°K.

(C) If the vessel contents are heated to

the boiling point and the vessel is not

operating with a process condenser, the

final temperature for the final increment

shall be the temperature 5°K below the

boiling point, even if the last increment

is less than 5°K.

(3) If the vessel is operating with a

process condenser, and the vessel

contents are heated to the boiling point,

the primary condenser is considered

part of the process. Emissions shall be

calculated as the sum of Equation 2,

which calculates emissions due to

heating the vessel contents to the

temperature of the gas exiting the

condenser, and Equation 1, which

calculates emissions due to the

displacement of the remaining saturated

noncondensable gas in the vessel. The

final temperature in Equation 2 shall be

set equal to the exit gas temperature of

the process condenser. In Equation 1, V

shall be set equal to the free space

volume, and T2 shall be set equal to the

condenser exit gas temperature.

(D) Emissions from depressurization

shall be calculated using the procedures

in paragraphs (d)(2)(i) (D)(1) through

(D)(5) of this section.

(1) The moles of HAP vapor initially

in the vessel are calculated using the

ideal gas law as follows:

n

Y V P

RT HAP

HAP = ( )( )( ) ( ) 1 6

Where:

YHAP = mole fraction of HAP (the sum

of the individual HAP fractions,

ΣYi)

V = free volume in the vessel being

depressurized

P1 = initial vessel pressure

R = gas constant

T = vessel temperature, absolute units

(2) The moles of noncondensable gas

present initially in the vessel are

calculated as follows:

n

VP

RT

nc

1 1 = ( ) 7

Where:

V = free volume in the vessel being

depressurized

Pnc1 = initial partial pressure of the

noncondensable gas, P1¥ΣPi

R = gas law constant, K

T = temperature, absolute units

(3) The moles of noncondensable gas

present at the end of depressurization

are calculated as follows:

n

VP

RT

NC

2 2 = ( ) 8

Where:

V = free volume in the vessel being

depressurized

PNC2 = Final partial pressure of the

noncondensable gas, P2¥ΣPi

R = gas law constant

T = temperature, absolute

(4) The moles of HAP emitted during

the depressurization are calculated by

taking an approximation of the average

ratio of moles of HAP to moles of

noncondensable and multiplying by the

total moles of noncondensables released

during the depressurization, or:

n

n

n

n

n n n

HAP HAP

HAP

1 2

2 1 2

9

+ 



 





[ ] − = ( )

Where:

nHAP = moles of HAP emitted

(5) The moles of HAP emitted can be

converted to a mass rate using the

following equation:

n MW

t

Er HAP HAP

HAP

* = ( ) 10

Where:

Ervoc = emission rate of the HAP

MWvoc = molecular weight of the HAP

t = time of the depressurization

(E) Emissions from vacuum systems

may be calculated if the air leakage rate

is known or can be approximated, using

the following equation:

E MWs La P

P P r

system

system i

= − − 









 ( ) 29

1 11 *

Where:

Er = rate of HAP emission, in lb/hr

Psystem = absolute pressure of receiving

vessel or ejector outlet conditions, if

there is no receiver

Pi* = vapor pressure of the HAP at the

receiver temperature, in mmHg

La = total air leak rate in the system, lb/

hr

29 = molecular weight of air, lb/lbmole

(ii) For emission episodes in which

the owner or operator can demonstrate

that the methods in paragraph (d)(2)(i)

of this section are not appropriate

according to paragraph (d)(2)(iii) of this

section, owners and operators shall

calculate uncontrolled emissions by

conducting an engineering assessment

which includes, but is not limited to,

the following:

(A) Previous test results provided the

tests are representative of current

operating practices at the process unit.

(B) Bench-scale or pilot-scale test data

representative of the process under

representative operating conditions.

(C) Maximum flow rate, HAP

emission rate, concentration, or other

relevant parameter specified or implied

within a permit limit applicable to the

process vent.

(D) Design analysis based on accepted

chemical engineering principles,

measurable process parameters, or
Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules 15775

physical or chemical laws or properties.

Examples of analytical methods include,

but are not limited to:

(1) Use of material balances based on

process stoichiometry to estimate

maximum organic HAP concentrations,

(2) Estimation of maximum flow rate

based on physical equipment design

such as pump or blower capacities,

(3) Estimation of HAP concentrations

based on saturation conditions.

(E) All data, assumptions, and

procedures used in the engineering

assessment shall be documented in

accordance with § 63.1255(b). Data or

other information supporting a finding

that the emissions estimation equations

are inappropriate shall be reported in

the Notification of Compliance Status.

(iii) The emissions estimation

equations in paragraph (d)(2)(i) of this

section shall be considered

inappropriate for estimating emissions

for a given batch emissions episode if

one or more of the criteria in paragraphs

(d)(2)(iii)(A) and (d)(2)(iii)(B) of this

section are met.

(A) Previous test data are available

that show a greater than 20 percent

discrepancy between the test value and

the estimated value.

(B) The owner or operator can

demonstrate to the Administrator

through any other means that the

emissions estimation equations are not

appropriate for a given batch emissions

episode.

(3) Owners and operators shall

determine controlled emissions using

measurements and/or calculations for

each process vent using the control

efficiency calculated from each device

that controls process vents with total

emissions of less than 10 tons per year,

before control, according to the design

evaluation described in paragraph

(d)(3)(i) of this section, or using the

emission estimation equations described

in paragraph (d)(2) of this section, as

appropriate. Owners and operators shall

determine controlled emissions for each

process vent using the control efficiency

determined from each device that

controls process vents with total

emissions of greater than 10 tons per

year, before control, by conducting a

performance test on the control device

as described in paragraphs (d)(3)(ii)

through (iv) of this section, or by using

the results of a previous performance

test as described in paragraph (d)(5) of

this section. Owners and operators are

not required to conduct performance

tests for devices described in paragraphs

(d)(4) and (d)(5) of this section that

control total emissions of greater than

10 tons per year, before control.

(i) The design evaluation shall

include documentation demonstrating

that the control device being used

achieves the required control efficiency

during the emission episodes in which

it is functioning in reducing emissions.

This documentation is to include a

description of the gas stream which

enters the control device, including flow

and HAP concentration, and the

information specified in paragraphs

(c)(2)(i) through (c)(2)(v) of this section,

as applicable.

(ii) The performance test shall be

conducted by performing emission

testing on the inlet and outlet of the

control device following the test

methods and procedures of § 63.1253(b).

Concentrations shall be calculated from

the data obtained through emission

testing according to the following

procedures:

(A) The total HAP concentration

(CHAP) is the sum of the concentrations

of the individual HAP and shall be

computed for each run using the

following equation:

C

C

x HAP

ji

j

n

i

x

=











 =

=

∑

∑ 1

1

Where:

CHAP = concentration of total HAP, dry

basis, parts per million by volume

Cji = concentration of individual HAP j

of sample i, dry basis, parts per

million by volume

n = number of HAP in the sample

x = number of samples in the sample

run

(B) The concentration of total HAP

shall be corrected to 3 percent oxygen

if a combustion device is the control

device. The emission rate correction

factor for excess air, based on the

integrated sampling and analysis

procedures of Method 3B of 40 CFR part

60, appendix A shall be used to

determine the oxygen concentration

(%02d). The samples shall be taken

during the same time that the total HAP

samples are taken. The concentration

corrected to 3 percent oxygen (Cc) shall

be computed as:

C C c m

d

= −











 17 9

20 9 2

.

. %0

where:

Cc=concentration of organic HAP

corrected to 3 percent oxygen, dry

basis, parts per million by volume

Cm=concentration of organic HAP, dry

basis, parts per million by volume

%02d=concentration of oxygen, dry

basis, percent by volume

(iii) Performance testing shall be

conducted under the following

conditions:

(A) For all control devices, the owner

or operator shall test over absolute or

hypothetical worst-case conditions, or

over normal conditions, provided the

operation of the devices is limited to the

conditions that existed during testing.

For testing during normal conditions,

test conditions and their corresponding

operating limits shall be established in

the precompliance report and

characterized according to stream

composition, temperature, and flowrate.

The owner or operator must

demonstrate in the precompliance

report that emission stream conditions

entering the control device shall be

within the test conditions at all times.

(B) For thermal incinerators, the

owner or operator may also choose to

test over representative worst-case

conditions; however, if the owner or

operator chooses to test over

representative worst-case conditions,

the maximum allowable vent stream

flowrate into the thermal incinerator is

restricted to the level for which it was

designed. The design basis of the

incinerator shall be included as part of

the Notification of Compliance Status.

(iv) The owner or operator may elect

to conduct more than one performance

test on the control device for the

purpose of establishing operating

conditions associated with a range of

achievable control efficiencies.

(4) An owner or operator is not

required to conduct a performance test

when a control device specified in

paragraphs (d)(4)(i) through (4)(iii) of

this section is used to comply with the

emission reductions required by

§ 63.1252(c)(4) or (c)(5) of this subpart.

(i) A boiler or process heater with a

design heat input capacity of 44

megawatts or greater.

(ii) A boiler or process heater where

the vent stream is introduced with the

primary fuel or is used as the primary

fuel.

(iii) A boiler or process heater burning

hazardous waste for which the owner or

operator:

(A) Has been issued a final permit

under 40 CFR part 270 and complies

with the requirements of 40 CFR part

266, subpart H, or

(B) Has certified compliance with the

interim status requirements of 40 CFR

part 266, subpart H.

(5) An owner or operator is not

required to conduct a performance test

for the following:

(i) Any control device for which a

previous performance test was

conducted, provided the test was

conducted using the same procedures
15776 Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules

specified in § 63.1253(b) of this subpart

over conditions typical of the

appropriate worst-case, as defined in

paragraph (d)(3)(iii)(A) of this section,

or typical of normal operations, as

defined in paragraph (d)(3)(iii)(A) of this

section and restricted to the conditions

described therein. The results of the

previous performance test shall be used

to demonstrate compliance.

(ii) A condenser system that is

equipped with a temperature sensor and

recorder, such that the condenser exit

gas temperature can be measured at 15-

minute intervals when the condenser is

functionning in cooling a vent stream.

The condenser exit gas temperature

shall be used to calculate removal

efficiency of the condenser in

demonstrating compliance.

(e) Compliance with wastewater

provisions.

(1) An owner or operator of a

wastewater stream shall comply with

paragraphs (e)(1)(i) through (1)(iii) of

this section in determining streams that

are exempt from the control

requirements of § 63.1252(d).

(i) Compliance is demonstrated when

the concentration of partially soluble

HAP is less than 1,300 ppmw at the

POD, or the concentration of total HAP

is less than 5,200 ppmw at the POD, as

measured or estimated using one of the

procedures described in paragraphs

(e)(1)(i) (A) through (C) of this section.

(A) The concentration of partially

soluble HAP, soluble HAP, or total HAP

shall be measured using methods

validated under the procedures

described in paragraphs (b)(8)(ii) and

(iii) of this section.

(B) The concentration of partially

soluble HAP, soluble HAP, or total HAP

shall be calculated based on knowledge

of the process wastewater. The owner or

operator shall provide sufficient

information to document

concentrations. Examples of information

that could constitute such knowledge

include material balances, records of

chemical purchases, process

stoichiometry, or previous test results

provided the results are still

representative of current operating

practices at the process unit(s).

(C) The concentration of partially

soluble HAP, soluble HAP, or total HAP

shall be calculated based on bench scale

or pilot-scale test data. The owner or

operator shall provide sufficient

information to demonstrate that the

bench-scale or pilot-scale test

concentration data are representative of

actual HAP concentrations. The owner

or operator shall also provide

documentation describing the testing

protocol, and the means by which

sample variability and analytical

variability were accounted for in the

determination of HAP concentrations.

(ii) Compliance is demonstrated when

the total HAP load calculated by

summing the load from all POD’s at a

facility is less than 1 Mg/yr. The total

wastewater load shall be calculated by

converting the concentration of partially

soluble HAP, soluble HAP, or total HAP,

as appropriate from a concentration

(ppmw), to a measure of the kg of HAP

per liter of wastewater. The load shall

be calculated by multiplying the

kilograms of HAP per liter by the total

liters of wastewater per year at the POD.

The total liters of wastewater discharged

per year shall be demonstrated through

the records required by § 63.1255(b) of

this subpart.

(iii) Compliance is demonstrated for

each stream with a concentration

exceeding 1,300 ppmw partially soluble

HAP or 5,200 ppmw total HAP at the

POD, but less than 10,000 ppmw total

HAP at the POD, and the HAP load at

the POD or the total HAP load

calculated from summing the load from

all POD’s within a process is less than

1 Mg/yr. Concentrations may be

measured or estimated using the

procedures described in paragraphs

(e)(1)(i)(A) through (C) of this section.

(2) Compliance with the control

requirements of § 63.1252(d)(4) is

demonstrated through the procedures

outlined in §§ 63.145(b), 63.145(c),

63.145(d), 63.138(j) or 63.145(i) as

appropriate.

(3) Compliance with the control

device requirements for devices used to

comply with the provisions in §§ 63.133

through 63.138 is demonstrated by

compliance with the provisions of

§ 63.139(d).

(4) Compliance with the inspection

requirements for vapor collection

systems, closed vent systems, fixed

roofs, covers, or enclosures is

demonstrated by compliance with the

provisions of § 63.148.

(5) Compliance with the inspection

requirements for wastewater tanks,

surface impoundments, containers,

individual drain systems, and oil-water

separators is demonstrated through the

provisions of § 63.143.

(f) Pollution prevention alternative

standard: The owner or operator shall

demonstrate compliance with

§ 63.1252(h)(2) of this subpart using the

procedures described in paragraph (f)(1)

of this section. The owner or operator

shall demonstrate compliance with

§ 63.1252(h)(3) of this subpart using the

procedures described in paragraph (f)(2)

of this section.

(1) Compliance is demonstrated when

the annual kg/kg factor, calculated

according to the procedure in

paragraphs (f)(1)(i) and (iii) of this

section, is reduced to a value equal to

or less than 25 percent of the baseline

factor calculated according to the

procedure in paragraph (f)(1)(i) and (ii)

of this section.

(i) The production-indexed HAP

consumption factors shall be calculated

by dividing annual consumption of total

HAP by the annual production rate, per

process. The production-indexed total

VOC consumption factor shall be

calculated by dividing annual

consumption of total VOC by the annual

production rate, per process.

(ii) The baseline factor is calculated

from yearly production and

consumption data for the first 12-month

period of time for which data was

available, to begin no earlier than

January 1, 1987.

(iii) The annual factor is calculated on

the following bases:

(A) For continuous processes, the

annual factor shall be calculated every

30 days for the 12-month period

preceding the 30th day (30-day rolling

average).

(B) For batch processes, the annual

factor shall be calculated every 10

batches for the 12-month period

preceding the 10th batch (10-batch

rolling average).

(2) Compliance is demonstrated when

the requirements of paragraphs (f)(2)(i)

through (iv) of this section are met.

(i) The annual kg/kg factor, calculated

according to the procedure in

paragraphs (f)(1)(i) and (f)(1)(iii) of this

section, is reduced to a value equal to

or less than 50 percent of the baseline

factor calculated according to the

procedure in paragraphs (f)(1)(i) and

(f)(1)(ii) of this section.

(ii) The yearly reduction, in kg HAP/

yr, associated with add-on controls that

meet the criteria of

§§ 63.1252(h)(3)(ii)(A) through (D), is

equal to or greater than the mass of HAP

calculated by the following equation:

kg kg kg produced kg reduced b a a [ ] [ ] / *. * 25 = [ ]
Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules 15777

where:

[kg/kg]b = the baseline productionindexed consumption factor, in kg/

kg

[kg produced]a = the annual production

rate, in kg/yr

[kg reduced]a = the annual reduction

required by add-on controls, in kg/

yr

(iii) Demonstration that the criteria in

§§ 63.1252(h)(3)(ii)(A) through (D) are

met shall be accomplished through a

description of the control device and of

the material streams entering and

exiting the control device.

(iv) The annual reduction achieved by

the add-on control shall be quantified

using the methods described in

§ 63.1253(d).

(g) Planned maintenance: The owner

or operator shall demonstrate

compliance with the requirements of

§ 63.1252(b), and (c) of this subpart by

including in each Periodic Report

required by § 63.1256 of this subpart the

periods of planned routine maintenance

specified by date and time (planned

routine maintenance of a control device,

during which the control device does

not meet the specifications of § 63.1252

of this subpart, as applicable, shall not

exceed 240 hours per year).

(h) Compliance with storage tank

provisions by using emissions

averaging: An owner or operator with

two or more affected storage tanks may

demonstrate compliance with

§ 63.1252(b)(2) and § 63.1252(b)(3)(i)

and (ii), as applicable, by fulfilling the

requirements of paragraphs (h)(1)

through (4) or paragraphs (h)(1), (2), (5)

and (6) of this section, as appropriate.

(1) The owner or operator shall

develop and submit for approval an

Implementation Plan containing all the

information required in § 63.1255(f) of

this subpart 18 months prior to the

compliance date of the standard. The

Administrator shall have 60 days to

approve or disapprove the emissions

averaging plan after which time the plan

shall be considered approved.

(2) The annual mass rate of total

organic HAP (ETi, ETo) shall be

calculated for each storage tank

included in the emissions average using

the requirements specified in either

paragraph (c)(1) or (c)(2) or (c)(3) of this

section.

(3) The following equations shall be

used to calculate total HAP emissions

for those tanks subject to

§ 63.1252(b)(1)(i):

E E

E E

Ti ij

j

n

To oj

j

n

=

=

=

=

∑

∑

1

1

where:

Eij = yearly mass rate of total organic

HAP at the inlet of the control

device for tank j

Eoj = yearly mass rate of total organic

HAP at the outlet of the control

device for tank j

ETi = total yearly uncontrolled emissions

ETo = total yearly controlled emissions

n = number of tanks included in the

emissions average

(4) The overall percent reduction

efficiency shall be calculated as follows:

R

E D E

E

Ti To

Ti

= − ( ) 100%

where:

R = overall percent reduction efficiency.

D = discount factor = 1.1 for all

controlled storage tanks.

(5) The following equations shall be

used to calculate total HAP emissions

for those tanks subject to

§ 63.1252(b)(1)(ii):

E E

E E

Ti ij

j

n

To oj

j

n

=

=

=

=

∑

∑

1

1

Where:

Eij = yearly mass rate of total organic

HAP at the inlet of the control

device for tank j

Eoj = yearly mass rate of total organic

HAP at the outlet of the control

device for tank j

ETi = total yearly uncontrolled emissions

ETo = total yearly controlled emissions

n = number of tanks included in the

emissions average

(6) The overall percent reduction

efficiency shall be calculated as follows:

R

E D E

E

Ti To

Ti

= − ( ) 100%

Where:

R = overall percent reduction efficiency

D = discount factor = 1.1 for all

controlled storage tanks

(i) Compliance with process vent

provisions by using emissions

averaging:

An owner or operator with two or

more affected processes complying with

§ 63.1252(c) by using emissions

averaging shall demonstrate compliance

with paragraphs (i)(1), (2) and (3) of this

section.

(1) The owner or operator shall

develop and submit for approval an

Implementation Plan 18 months prior to

the compliance date of the standard

containing all the information required

in § 63.1255(f) of this subpart. The

Administrator shall have 60 days to

approve or disapprove the emissions

averaging plan. The plan shall be

considered approved if the

administrator either approves the plan

in writing, or fails to disapprove the

plan in writing. The 60 day period shall

begin when the administrator receives

the request. If the request is denied, the

owner or operator must still be in

compliance with the standard by the

compliance date.

(2) Owners or operators shall

calculate uncontrolled and controlled

emissions of HAP by using the methods

specified in paragraph (d)(2) or (d)(3) of

this section for each process included in

the emissions average.

(i) The following equations shall be

used to calculate total HAP emissions:

E E

E E

TU Ui

i

n

TC Ci

i

n

=

=

=

=

∑

∑

1

1

Where:

EUi = yearly uncontrolled emissions

from process i

ECi = yearly controlled emissions for

process i

ETU = total yearly uncontrolled

emissions

ETC = total yearly controlled emissions

n = number of processes included in the

emissions average

(3) The overall percent reduction

efficiency shall be calculated as follows:

R

E D E

E

TU TC

TU

= − ( ) 100%

Where:

R = overall percent reduction efficiency

D = discount factor = 1.1 for all

controlled emission points

§ 63.1254 Monitoring requirements.

(a) The owner or operator of any

existing, new, or reconstructed affected

source shall provide evidence of

continued compliance with the

standard. During the initial compliance

demonstration, maximum or minimum

operating parameters, as appropriate,

shall be established for emission sources

that will indicate the source is in

compliance. Test data, calculations, or

information from the evaluation of the
15778 Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules

control device design shall be used to

establish the operating parameter. If the

operating parameter to be established is

a maximum and if performance testing

has been required, the value of the

parameter shall be the average of the

maximum values from each of the three

test runs. If the operating parameter to

be established is a minimum and if

performance testing has been required,

the value of the parameter shall be the

average of the minimum values from

each of the three test runs. Parameter

values for process vents from batch

operations shall be determined as

specified in paragraph (b)(1) and (2) of

this section. The owner or operator shall

operate processes and control devices

within these parameters to ensure

continued compliance with the

standard. Monitoring parameters are

specified for continuous process vent

control scenarios in paragraphs (a)(1)

through (7) of this section.

(1) For all control devices that are

used to control process vent streams

totaling less than 1 ton/yr HAP

emissions, before control, monitoring

shall consist of a periodic verification

that the device is operating properly.

This verification shall include, but not

be limited to, a periodic demonstration

that the unit is working as designed.

This demonstration shall be included in

the precompliance report, to be

submitted 12 months prior to the

compliance date of the standard.

(2) For affected sources using water

scrubbers that are used to control

process vent streams totaling greater

than 1 ton/yr HAP, before controls, the

owner or operator shall establish a

minimum scrubber water flow rate as a

site-specific operating parameter which

must be measured and recorded every

15 minutes. The affected source will be

considered to be out of compliance if

the scrubber water flow rate, averaged

over the operating day, is below the

minimum value established during the

initial compliance demonstration.

(3) For affected sources using

condensers that are used to control

process vent streams totaling greater

than 1 ton/yr, before controls, the owner

or operator shall establish the maximum

condenser outlet gas temperature as a

site-specific operating parameter which

must be measured and recorded every

15 minutes. The affected source will be

considered to be out of compliance if

the condenser outlet gas temperature,

averaged over the operating day, is

greater than the maximum value

established during the initial

compliance demonstration.

(4) For affected sources using carbon

adsorbers that are used to control

process vent streams totaling greater

than 1 ton/yr, before controls, the owner

or operator shall establish a maximum

outlet HAP concentration as the sitespecific operating parameter which

must be measured and recorded every

15 minutes. The affected source will be

considered to be out of compliance if

the outlet HAP concentration, averaged

over the operating day, is greater than

the maximum value established during

the initial compliance demonstration.

(5) For affected sources using flares

that are used to control process vent

streams totaling greater than 1 ton/yr,

before controls, the presence of the pilot

flame shall be monitored every 15

minutes. The affected source will be

considered to be out of compliance

upon loss of pilot flame.

(6) For each wastewater management

unit, treatment process, or control

device used to comply with §§ 63.138

and 63.139, the owner or operator shall

comply with either paragraph (a)(6)(i) or

(a)(6)(ii) of this section.

(i) The owner or operator shall

monitor the parameters specified in

Tables 11, 12, or 13 of subpart 63.

(ii) The owner or operator shall

submit a request for approval to monitor

alternative parameters according to the

procedures specified in

§ 63.1256(a)(2)(i).

(7) For affected sources using

combustion devices that are used to

control process vents totaling greater

than 1 ton/yr, before controls, the owner

or operator shall monitor the

temperature of the gases exiting the

combustion chamber as the site-specific

operating parameter which must be

measured and recorded every 15

minutes. The affected sources will be

considered to be out of compliance if

the chamber temperature averaged over

the operating day, is greater than the

maximum value established during the

initial compliance demonstration.

(b) The owner or operator of any

existing, new, or reconstructed affected

source that chooses to comply with the

emission limit or emission reduction

requirement for batch process vents and

combined streams from process vents

and storage tanks shall provide evidence

of continued compliance with the

standard. As part of the initial

compliance demonstrations for batch

process vents and storage tanks, test

data, compliance calculations, or

information from the control device

design evaluation shall be used to

establish a maximum or minimum level

of a relevant operating parameter for

each control device that the owner or

operator selects to operate as part of

achieving the required emission

reduction or emission limitation. The

owner or operator shall operate

processes and control devices within

these parameters to ensure continued

compliance with the standard.

(1) For devices that are used to control

batch process vent streams totaling less

than 1 ton/yr HAP emissions, before

control, monitoring shall consist of a

periodic verification that the device is

operating properly. This verification

shall include, but not be limited to, a

periodic demonstration that the unit is

working as designed. This

demonstration shall be included in the

precompliance report, to be submitted

12 months prior to the compliance date

of the standard.

(2) For batch process vents that are

routed to a device that receives HAP in

excess of 1 ton per year, before control,

the level(s) shall be established in

accordance with paragraphs (b)(2)(i)

through (iv) of this section.

(i) If more than one batch emission

episode or more than one portion of a

batch emission episode has been

selected to be controlled, a single level

for the batch cycle(s) or process(es) shall

be calculated from the initial

compliance demonstration. The

appropriate parameter shall be

determined for the worst-case

conditions, as determined in

§ 63.1253(b)(7)(ii) and (b)(7)(iii) selected

to be controlled. The average parameter

monitoring level for the cycle(s) or

process(es) shall be based on the

parameter value determined from the

worst-case conditions.

(ii) Instead of establishing a single

level for the batch cycle(s) or

process(es), as described in paragraph

(b)(2)(i) of this section, an owner or

operator may establish separate levels

for each batch emission episode, or

portion thereof, selected to be

controlled.

(iii) For devices controlling at least 10

tons per year for which a performance

test is required, the owner or operator

may establish the parametric monitoring

level(s) based on the performance test

supplemented by engineering

assessments and manufacturer’s

recommendations. Performance testing

is not required to be conducted over the

entire range of expected parameter

values. The rationale for the specific

level for each parameter, including any

data and calculations used to develop

the level(s) and a description of why the

level indicates proper operation of the

control device shall be provided in the

Precompliance report. The procedures

specified in this section have not been

approved by the Administrator and

determination of the parametric

monitoring level using these procedures

is subject to review and approval by the

Administrator.
Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules 15779

(iv) For devices controlling at least 10

tons per year for which a performance

test is conducted at routine conditions,

the owner or operator shall establish the

parametric monitoring level(s) at

conditions of the test. The level(s)

established shall be provided in the

notification of compliance status report.

(3) If the sum of HAP emissions,

before control, routed to the device is

greater than 1 tons/yr, the appropriate

parameter shall be monitored at 15-

minute intervals for the entire period in

which the control device is functioning

in achieving required removals.

(4) Affected sources with condensers

on process vents shall establish the

maximum condenser outlet gas

temperature as a site-specific operating

parameter, which, except as provided in

paragraph (b)(3) of this section, must be

measured every 15 minutes or at least

once for batch emission episodes less

than 15 minutes in duration. The

affected source will be considered to be

out of compliance if the condenser

outlet gas temperature, averaged over

the operating day for each process is

greater than the value established

during the initial compliance

demonstration.

(5) For affected sources using water

scrubbers, the owner or operator shall

establish a minimum scrubber water

flow rate as a site-specific operating

parameter which, except as provided in

paragraph (b)(3) of this section, must be

measured and recorded every 15

minutes, or at least once for batch

emission episodes less than 15 minutes

in duration. The affected source will be

considered to be out of compliance if

the scrubber water flow rate, averaged

over the operating day for each process,

is below the minimum flow rate

established during the initial

compliance demonstration.

(6) For affected sources using carbon

adsorbers or having uncontrolled

process vents, the owner or operator

shall establish a maximum outlet HAP

concentration as the site-specific

operating parameter which, except as

provided in paragraph (b)(3) of this

section, must be measured and recorded

every 15 minutes, or at least once for

batch emission episodes of duration

shorter than 15 minutes. The affected

source will be considered to be out of

compliance if the outlet HAP

concentration, averaged over the

operating day for each process, is greater

than the value established during the

initial compliance demonstration.

(7) For affected sources using flares,

the presence of the pilot flame shall be

monitored every 15 minutes, or at least

once for batch emission episodes less

than 15 minutes in duration. The

affected source will be considered to be

out of compliance upon loss of pilot

flame.

(8) For affected sources using

combustion devices, the temperature of

the gases exiting the combustion

chamber shall be monitored every 15

minutes, or at least once for episodes

less than 15 minutes in duration. The

affected source will be considered out of

compliance if the combustion chamber

temperature, averaged over the

operating day for each process, is less

than the value established during the

initial compliance demonstration.

(c) An owner or operator may request

approval to monitor parameters other

than those required by paragraphs (a)(2)

through (7) and paragraphs (b)(5)

through (8) of this section. The request

shall be submitted according to the

procedures specified in § 63.8(f) of

subpart A or included in the

Precompliance report.

(d) Periods of time when monitoring

measurements exceed the parameter

values as well as periods of inadequate

monitoring data do not constitute a

violation if they occur during a startup,

shutdown, or malfunction, and the

facility follows its startup, shutdown,

and malfunction plan.

(e) The owner or operator of any

affected source complying with the

requirements of appendix GGGA of this

section shall meet the monitoring

requirements described in the appendix.

(f) The owner or operator of any

affected source that chooses to comply

with the requirements of

§§ 63.1252(h)(2) and (3) shall calculate

rolling average values of kg HAP

consumption per kg production and kg

VOC consumption per kg production.

The owner or operator will be

considered out of compliance if either

rolling average kg/kg factor exceeds the

value established in § 63.1253(f)(1)(ii).

(g) Owners or operators of any

affected source that chooses to comply

with the requirements of § 63.1252(j)

shall meet all monitoring requirements

specified in § 63.1254 (a), (b), (c), and

(d), as applicable, for all processes and

storage tanks included in the emissions

average.

§ 63.1255 Recordkeeping requirements.

(a) The owner or operator of any

affected source shall keep records of

daily values of equipment operating

parameters specified to be monitored

under § 63.1254, or specified by the

Administrator. Records shall be kept in

accordance with the requirements of

applicable paragraphs of § 63.10 of

subpart A of this part, as specified in the

General Provisions applicability table of

this subpart. The owner or operator

shall keep records up-to-date and

readily accessible.

(1) A daily (24-hour) average shall be

calculated as the average of all values

for a monitored parameter recorded

during the operating day.

(2) The operating day shall be the

period defined in the operating permit

or the Notification of Compliance Status

in § 63.9(h). It may be from midnight to

midnight or another continuous 24-hour

period.

(3) For every operating day in which

the daily average value for an operating

parameter is outside its established

range, the owner or operator must keep

records of each parameter value reading

taken during the day on which the

excursion occurred.

(4) For processes subject to

§ 63.1252(h), records shall be

maintained of rolling average values of

kg HAP/kg production and kg VOC/kg

production.

(b) The owner or operator of any

affected source that complies with the

standards for process vents, storage

tanks, and wastewater systems shall

maintain up-to-date, readily accessible

records of the following information to

document that HAP emissions or HAP

loadings (for wastewater) are below the

limits specified in § 63.1252:

(1) The emissions per batch for each

process.

(2) The wastewater concentrations per

POD and process.

(3) The number of batches per year for

each batch process.

(4) The operating hours per year for

continuous processes.

(5) The number of tank turnovers per

year.

(c) The owner or operator of any

affected source implementing the leak

detection and repair program specified

in appendix A of this subpart, shall

implement the recordkeeping

requirements in appendix A to this

subpart. All records shall be retained for

a period of 5 years, in accordance with

the requirements of 40 CFR 63.10(b)(1).

(d) For unit operations occurring more

than once per day, exceedances of

established parameter limits shall result

in no more than one violation per

operating day for each monitored item

of equipment utilized in the unit

operation.

(e) For certain items of monitored

equipment used for more than one type

of unit operation in the course of an

operating day, exceedances shall result

in no more than one violation per

operating day, per item of monitored

equipment, for each type of unit

operation in which the item is in

service.
15780 Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules

(f) Owners or operators of any affected

source that chooses to comply with the

requirements of § 63.1252(j) shall

maintain up-to-date records of the

following information:

(1) An Implementation Plan which

shall include in the plan, for all process

vents and storage tanks included in each

of the averages, the information listed in

paragraphs (f)(1)(i) through (f)(1)(v) of

this section.

(i) The identification of all process

vents and storage tanks in each

emissions average.

(ii) The uncontrolled and controlled

emissions of HAP and the overall

percent reduction efficiency as

determined in §§ 63.1253(h) (1) through

(6) or §§ 63.1253(i) (1) through (3) as

applicable.

(iii) The calculations used to obtain

the uncontrolled and controlled HAP

emissions and the overall percent

reduction efficiency.

(iv) The estimated values for all

parameters required to be monitored

under § 63.1254(g) for each process and

storage tank included in an average.

These parameter values, or as

appropriate, limited ranges for

parameter values, shall be specified as

enforceable operating conditions for the

operation of the process or storage tank.

Changes to the parameters must be

reported as required by § 63.1256(d).

(v) A statement that the compliance

demonstration, monitoring, inspection,

recordkeeping and reporting provisions

in §§ 63.1253(h) and (i), § 63.1254(g),

and § 63.1256(d) that are applicable to

each emission point in the emissions

average will be implemented beginning

on the date of compliance.

(2) The Implementation Plan must

demonstrate that the emissions from the

processes and storage tanks proposed to

be included in the average will not

result in greater hazard or, at the option

of the operating permit authority,

greater risk to human health or the

environment than if the processes and

storage tanks were controlled according

to the provisions in § 63.1252(b) or (c).

(i) This demonstration of hazard or

risk equivalency shall be made to the

satisfaction of the operating permit

authority.

(A) The Administrator may require

owners and operators to use specific

methodologies and procedures for

making a hazard or risk determination.

(B) The demonstration and approval

of hazard or risk equivalency shall be

made according to any guidance that the

Administrator makes available for use or

any other technically sound information

or methods.

(ii) An emissions averaging plan that

does not demonstrate hazard or risk

equivalency to the satisfaction of the

Administrator shall not be approved.

The Administrator may require such

adjustments to the emissions averaging

plan as are necessary in order to ensure

that the average will not result in greater

hazard or risk to human health or the

environment than would result if the

emission points were controlled

according to § 63.1252 (b) or (c).

(iii) A hazard or risk equivalency

demonstration must:

(A) Be a quantitative, comparative

chemical hazard or risk assessment;

(B) Account for differences between

averaging and non-averaging options in

chemical hazard or risk to human health

or the environment; and

(C) Meet any requirements set by the

Administrator for such demonstrations.

(3) Records as specified in paragraphs

(a), (b) and (d) of this section.

(4) A calculation of the overall

percent reduction efficiency as specified

in § 63.1253(h) and (i) of this subpart for

the last quarter and the prior four

quarters.

§ 63.1256 Reporting requirements

(a) The owner or operator of any

affected source that elects to comply

with the emission limit or emission

reduction requirements for process

vents, storage tanks, and wastewater

systems, shall comply with the

reporting requirements of applicable

paragraphs of 40 CFR 63.9 and 63.10, as

specified in the General Provisions

applicability table.

(1) The Notification of Compliance

Status report required under § 63.9 shall

be submitted within 150 days of the

compliance date and shall include:

(i) The results of any applicability

determinations, emission calculations,

or analyses used to identify and

quantify HAP emissions from applicable

sources.

(ii) The results of emissions profiles,

performance tests, engineering analyses,

design evaluations, or calculations used

to demonstrate compliance. For

performance tests, results should

include descriptions of sampling and

analysis procedures and quality

assurance procedures.

(iii) Descriptions of monitoring

devices, monitoring frequencies, and the

values of monitored parameters

established during the initial

compliance determinations, including

data and calculations to support the

levels established.

(2) The precompliance report shall be

submitted 12 months prior to the

compliance date of the standard. For

new sources, the Precompliance report

shall be submitted to the Administrator

with the application for approval of

construction or reconstruction. The

Administrator shall have 60 days to

approve or disapprove the plan. The

plan shall be considered approved if the

administrator either approves the plan

in writing, or fails to disapprove the

plan in writing. The 60 day period shall

begin when the administrator receives

the request. If the request is denied, the

owner or operator must still be in

compliance with the standard by the

compliance date. The Precompliance

report shall include:

(i) Requests for approval to use

alternative monitoring parameters or

requests to set monitoring parameters

according to § 63.1254(b)(2)(iii).

(ii) Descriptions of how the control

devices subject to §§ 63.1254(a)(1) and

63.1254(b)(1) will be checked to verify

that they are operating as designed.

(iii) A description of test conditions

and limits of operation for control

devices tested under normal conditions,

and the corresponding monitoring

parameter values.

(b) The owner or operator shall also

submit to the Administrator, as part of

the quarterly excess emissions and

continuous monitoring system

performance report and summary report

required by 40 CFR 63.10(e)(3), the

following recorded information.

(1) Reports of monitoring data,

including 15-minute monitoring values

as well as daily average values of

monitored parameters for all operating

days when the average values were

outside the ranges established in the

Notification of Compliance Status or

operating permit.

(2) Reports of the duration of periods

when monitoring data is not collected

for each excursion caused by

insufficient monitoring data. An

excursion means any of the two cases

listed in paragraphs (b)(2)(i) or (b)(2)(ii)

of this section. For a control device

where multiple parameters are

monitored, if one or more of the

parameters meets the excursion criteria

in paragraphs (a)(2)(i) or (a)(2)(ii) of this

section, this is considered a single

excursion for the control device.

(i) When the period of control device

operation is 4 hours or greater in an

operating day and monitoring data are

insufficient to constitute a valid hour of

data, as defined in paragraph (b)(2)(iii)

of this section, for at least 75 percent of

the operating hours.

(ii) When the period of control device

operation is less than 4 hours in an

operating day and more than one of the

hours during the period of operation

does not constitute a valid hour of data

due to insufficient monitoring data.

(iii) Monitoring data are insufficient

to constitute a valid hour of data, as
Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules 15781

used in paragraphs (b)(2)(i) and (b)(2)(ii)

of this section, if measured values are

unavailable for any of the 15-minute

periods within the hour.

(3) Whenever a process change, as

defined in 40 CFR 63.115(e), is made

that causes the emission rate from a de

minimis emission point to become a

process vent with an emission rate of 1

pound per year or greater, or a change

in any of the information submitted in

the Notification of Compliance Report,

the owner or operator shall submit a

report within 180 calendar days after

the process change. The report may be

submitted as part of the next summary

report required under 40 CFR

63.10(e)(3). The report shall include:

(i) A description of the process

change.

(ii) The results of the recalculation of

the emission rate.

(iii) Revisions to any of the

information reported in the original

Notification of compliance under

§ 63.1256(a)(1).

(iv) Information required by the

Notification of compliance under

§ 63.1256(a)(1) for changes involving the

addition of processes or equipment.

(c) The owner or operator of any

affected source implementing the leak

detection and repair program specified

in subpart H of this part, shall

implement the reporting requirements

in 40 CFR 63.182. Copies of all reports

shall be retained as records for a period

of 5 years, in accordance with the

requirements of 40 CFR 63.10(b)(1).

(d) Owners or operators of any

affected source that chooses to comply

with the requirements of § 63.1252(j)

shall submit all information as specified

in § 63.1255(f) for each process or

storage tank included in the emissions

average. The owner or operator shall

also submit to the administrator all

information as specified in paragraph

(b) of this section for each process or

storage tank included in the emissions

average.

(1) The reports must also include the

information listed in paragraphs (c)(1)(i)

through (c)(1)(iv) of this section:

(i) Any changes of the processes or

storage tanks included in the average.

(ii) The calculation of the overall

percent reduction efficiency for the

reporting period.

(iii) Changes to the Implementation

Plan which affect the calculation

methodology of uncontrolled or

controlled emissions or the hazard or

risk equivalency determination.

(iv) Any changes to the parameters

monitored according to § 63.1254(g).

(2) Every 4th quarter report shall

include the results according to

§ 63.1255(f)(4) to demonstrate the

emissions averaging provisions of

§§ 63.1252(j), 63.1253(h) and (i),

63.1254(g), and 63.1255(f) are satisfied.

§ 63.1257 Delegation of authority

[Reserved]

TABLE 1 TO SUBPART GGG.—GENERAL PROVISIONS APPLICABILITY TO SUBPART GGG

Reference to subpart A Applies to

subpart GGG Comment

§ 63.1(a)(1) .................... Yes ............................ Additional terms defined in § 63.1251.

§ 63.1(a)(2) .................... Yes ............................

§ 63.1(a)(3) .................... Yes ............................

§ 63.1(a)(4) .................... Yes ............................ Subpart GGG specifies applicability of each paragraph in subpart A to subpart GGG.

§ 63.1(a)(5) .................... N/A ............................ Reserved.

§ 63.1(a)(6) .................... Yes ............................

§ 63.1(a)(7) .................... Yes ............................

§ 63.1(a)(8) .................... No .............................. Discusses State programs.

§ 63.1(a)(9) .................... N/A ............................ Reserved.

§ 63.1(a)(10) .................. Yes ............................

§ 63.1(a)(11) .................. Yes ............................

§ 63.1(a)(12)–(14) ......... Yes ............................

§ 63.1(b)(1) .................... No .............................. § 63.1250 of subpart GGG specifies applicability.

§ 63.1(b)(2) .................... Yes ............................

§ 63.1(b)(3) .................... Yes ............................

§ 63.1(c)(1) .................... Yes ............................ Subpart GGG specifies applicability of each paragraph in subpart A to sources subject to

subpart GGG.

§ 63.1(c)(2) .................... No .............................. Area sources are not subject to subpart GGG.

§ 63.1(c)(3) .................... N/A ............................ Reserved.

§ 63.1(c)(4) .................... Yes ............................

§ 63.1(c)(5) .................... Yes ............................

§ 63.1(d) ........................ N/A ............................ Reserved.

§ 63.1(e) ........................ Yes ............................

§ 63.2 ............................. Yes ............................ Additional terms are defined in § 63.1251 of subpart GGG; when overlap between subparts A

and GGG occurs, subpart GGG takes precedence.

§ 63.3 ............................. Yes ............................ Other units used in subpart GGG are defined in that subpart.

§ 63.4(a)(1)–(3) ............. Yes ............................

§ 63.4(a)(4) .................... N/A ............................ Reserved.

§ 63.4(a)(5) .................... Yes ............................

§ 63.4(b) ........................ Yes ............................

§ 63.4(c) ........................ Yes ............................

§ 63.5(a) ........................ Yes ............................ Except replace the terms ‘‘source’’ and ‘‘stationary source’’ in § 63.5(a)(1) of subpart A with

‘‘affected source’’.

§ 63.5(b)(1) .................... Yes ............................

§ 63.5(b)(2) .................... N/A ............................ Reserved.

§ 63.5(b)(3) .................... Yes ............................

§ 63.5(b)(4) .................... Yes ............................

§ 63.5(b)(5) .................... Yes ............................

§ 63.5(b)(6) .................... Yes ............................

§ 63.5(c) ........................ N/A ............................ Reserved.

§ 63.5(d)(1)(i) ................. Yes ............................

§ 63.5(d)(1)(ii) ................ Yes ............................
15782 Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules

TABLE 1 TO SUBPART GGG.—GENERAL PROVISIONS APPLICABILITY TO SUBPART GGG—Continued

Reference to subpart A Applies to

subpart GGG Comment

§ 63.5(d) (1)(iii) .............. Yes ............................

§ 63.5(d)(2) .................... Yes ............................

§ 63.5(d)(3)–(4) ............. Yes ............................

§ 63.5(e) ........................ Yes ............................

§ 63.5(f)(1) ..................... Yes ............................ Except replace ‘‘source’’ in § 63.5(f)(1) of subpart A with ‘‘affected source’’.

§ 63.5(f)(2) ..................... Yes ............................

§ 63.6(a) ........................ Yes ............................

§ 63.6(b)(1)–(2) ............. No .............................. Subpart GGG specifies compliance dates.

§ 63.6(b)(3)–(4) ............. Yes ............................

§ 63.6(b)(5) .................... Yes ............................

§ 63.6(b)(6) .................... N/A ............................ Reserved.

§ 63.6(b)(7) .................... Yes ............................

§ 63.6(c)(1)–(2) .............. Yes ............................ Except replace ‘‘source’’ in § 63.6(c)(1)–(2) of subpart A with ‘‘affected source’’.

§ 63.6(c)(3)–(4) .............. N/A ............................ Reserved.

§ 63.6(c)(5) .................... Yes ............................

§ 63.6(d) ........................ N/A ............................ Reserved.

§ 63.6(e) ........................ Yes ............................

§ 63.6(f)(1) ..................... Yes ............................

§ 63.6(f)(2)(i)–(ii) ............ Yes ............................

§ 63.6(f)(2)(iii) ................ Yes ............................

§ 63.6(f)(2)(iv) ................ Yes ............................

§ 63.6(f)(3) ..................... Yes ............................

§ 63.6(g) ........................ Yes ............................ An alternative standard has been proposed; however, affected sources will have the opportunity to demonstrate other alternatives to the Administrator.

§ 63.6(h) ........................ No .............................. Subpart GGG does not contain any opacity or visible emissions standards.

§ 63.6(i)(1) ..................... Yes ............................

§ 63.6(i)(2) ..................... Yes ............................ Except replace ‘‘source’’ in § 63.6(2)(i) and (ii) of subpart A with ‘‘affected source’’.

§ 63.6(i)(3) ..................... Yes ............................

§ 63.6(i)(4)(i) .................. Yes ............................

§ 63.6(i)(4)(ii) ................. Yes ............................

§ 63.6(i)(5)–(14) ............. Yes ............................

§ 63.6(i)(15) ................... N/A ............................ Reserved.

§ 63.6(i)(16) ................... Yes ............................

§ 63.6(j) ......................... Yes ............................

§ 63.7(a)(1) .................... Yes ............................ Subpart GGG specifies required testing and compliance procedures.

§ 63.7(a)(2)(i)–(vi) .......... Yes ............................

§ 63.7(a)(2) (vii)–(viii) .... N/A ............................ Reserved.

§ 63.7(a)(2) (ix) .............. Yes ............................

§ 63.7(a)(3) .................... Yes ............................

§ 63.7(b)(1) .................... Yes ............................

§ 63.7(b)(2) .................... Yes ............................

§ 63.7(c) ........................ Yes ............................

§ 63.7(d) ........................ Yes ............................ Except replace ‘‘source’’ in § 63.7(d) of subpart A with ‘‘affected source’’.

§ 63.7(e)(1) .................... Yes ............................ Subpart GGG also contains test methods specific to pharmaceutical sources.

§ 63.7(e)(2) .................... Yes ............................

§ 63.7(e)(3) .................... Yes ............................ Subpart GGG specifies test methods and procedures.

§ 63.7(f) ......................... Yes ............................

§ 63.7(g)(1) .................... Yes ............................

§ 63.7(g)(2) .................... N/A ............................ Reserved.

§ 63.7(g)(3) .................... Yes ............................

§ 63.7(h)(1)–(2) ............. Yes ............................

§ 63.7(h)(3)(i) ................. Yes ............................

§ 63.7(h)(3) (ii)–(iii) ........ Yes ............................

§ 63.7(h)(4)–(5) ............. Yes ............................

§ 63.8(a)(1) .................... Yes ............................

§ 63.8(a)(2) .................... Yes ............................

§ 63.8(a)(3) .................... N/A ............................ Reserved.

§ 63.8(a)(4) .................... Yes ............................

§ 63.8(b)(1) .................... Yes ............................

§ 63.8(b)(2) .................... No .............................. Subpart GGG has CMS requirements.

§ 63.8(b)(3) .................... Yes ............................

§ 63.8(c)(1)(i) ................. Yes ............................

§ 63.8(c) (1)(ii) ............... Yes ............................

§ 63.8(c) (1)(iii) .............. Yes ............................

§ 63.8(c)(2)–(3) .............. Yes ............................

§ 63.8(c)(4)–(8) .............. No .............................. Subpart GGG specifies monitoring frequencies.

§ 63.8(d) ........................ Yes ............................

§ 63.8(e) ........................ Yes ............................

§ 63.8(f)(1) ..................... Yes ............................

§ 63.8(f)(2) ..................... Yes ............................

§ 63.8(f)(3) ..................... Yes ............................
Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules 15783

TABLE 1 TO SUBPART GGG.—GENERAL PROVISIONS APPLICABILITY TO SUBPART GGG—Continued

Reference to subpart A Applies to

subpart GGG Comment

§ 63.8(f)(4) ..................... Yes ............................

§ 63.8(f)(5) ..................... Yes ............................

§ 63.8(f)(6) ..................... Yes ............................

§ 63.8(g) ........................ Yes ............................

§ 63.9(a) ........................ Yes ............................

§ 63.9(b)(1) (i)–(ii) ......... Yes ............................

§ 63.9(b) (1)(iii) .............. Yes ............................

§ 63.9(b)(2) .................... Yes ............................

§ 63.9(b)(3) .................... Yes ............................

§ 63.9(b)(4) .................... Yes ............................

§ 63.9(b)(5) .................... Yes ............................

§ 63.9(c) ........................ Yes ............................

§ 63.9(d) ........................ Yes ............................

§ 63.9(e) ........................ No ..............................

§ 63.9(f) ......................... No ..............................

§ 63.9(g) ........................ No ..............................

§ 63.9(h)(1)–(3) ............. Yes ............................

§ 63.9(h)(4) .................... N/A ............................ Reserved.

§ 63.9(h)(5)–(6) ............. Yes ............................

§ 63.9(i) ......................... Yes ............................

§ 63.9(j) ......................... Yes ............................

§ 63.10(a) ...................... Yes ............................

§ 63.10(b)(1) .................. Yes ............................

§ 63.10(b)(2) .................. No .............................. Subpart GGG specifies recordkeeping requirements.

§ 63.10(b)(3) .................. Yes ............................

§ 63.10(c)(1)–(6) ............ Yes ............................

§ 63.10(c)(7)–(8) ............ Yes ............................

§ 63.10(c)(9)–(15) .......... Yes ............................

§ 63.10(d)(1) .................. Yes ............................ Subpart GGG specifies performance test reporting requirements.

§ 63.10(d)(2) .................. Yes ............................ Subpart GGG specifies performance test reporting requirements.

§ 63.10(d)(3) .................. No ..............................

§ 63.10(d)(4) .................. Yes ............................

§ 63.10(d)(5) .................. Yes ............................

§ 63.10(e)(1)–(2) ........... Yes ............................

§ 63.10(e)(3) .................. Yes ............................

§ 63.10(e)(4) .................. Yes ............................

§ 63.10(f) ....................... Yes ............................

§ 63.11–§ 63.15 ............. Yes ............................

TABLE 2 TO SUBPART GGG.—PARTIALLY SOLUBLE HAP

Compound

1,1,1-Trichloroethane (methyl chloroform)

1,1,2,2-Tetrachloroethane

1,1,2-Trichloroethane

1,1-Dichloroethylene (vinylidene chloride)

1,2-Dibromoethane

1,2-Dichloroethane (ethylene dichloride)

1,2-Dichloropropane

1,3-Dichloropropene

2,4,5-Trichlorophenol

2-Butanone (mek)

2-Nitropropane

4-Methyl-2-pentanone (mibk)

Acetaldehyde

Acrolein

Acrylonitrile

Allyl chloride

Benzene

Benzyl chloride

Biphenyl

Bromoform (tribromomethane)

Bromomethane

Butadiene

Carbon disulfide

Chlorobenzene

Chloroethane (ethyl chloride)

Chloroform

Chloromethane
15784 Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules

TABLE 2 TO SUBPART GGG.—PARTIALLY SOLUBLE HAP—Continued

Compound

Chloroprene

Cumene

Dichloroethyl ether

Dinitrophenol

Ethyl acrylate

Ethylbenzene

Ethylene oxide

Hexachlorobenzene

Hexachlorobutadiene

Hexachloroethane

Methyl methacrylate

Methyl-t-butyl ether

Methylene chloride

N,N-dimethylaniline

Naphthalene

Phosgene

Propionaldehyde

Propylene oxide

Styrene

Tetrachloroethene (perchloroethylene)

Tetrachloromethane (carbon tetrachloride)

Toluene

Trichlorobenzene (1,2,4-)

Trichloroethylene

Triethylamine

Trimethylpentane

Vinyl acetate

Vinyl chloride

Xylene (m)

Xylene (o)

Xylene (p)

N-hexane

P-dichlorobenzene

TABLE 3.—SOLUBLE HAP’S

Compound

1,1-Dimethylhydrazine

1,4-Dioxane

Acetonitrile

Acetophenone

Diethyl sulfate

Dimethyl sulfate

Dinitrotoluene

Epichlorohydrin

Ethylene glycol dimethyl ether

Ethylene glycol monobutyl ether acetate

Ethylene glycol monomethyl ether acetate

Isophorone

Methanol (methyl alcohol)

Nitrobenzene

Toluidene

Appendix A to Subpart GGG—

Equipment Leaks

§ GGGA–1 General Equipment Leak

Requirements

(a) The provisions of this appendix apply

to pumps, compressors, agitators, pressure

relief devices, sampling connection systems,

open-ended valves or lines, valves,

connectors, instrumentation systems, control

devices, and closed-vent systems required by

this subpart that are intended to operate in

organic hazardous air pollutant service 300

hours or more during the calendar year

within a source subject to the provisions of

this subpart.

(b) After the compliance date for a process,

equipment to which this subpart applies that

are also subject to the provisions of:

(1) 40 CFR part 60 will be required to

comply only with the provisions of this

subpart.

(2) 40 CFR part 61 will be required to

comply only with the provisions of this

subpart.

(c) [Reserved]

(d) The provisions in § 63.1(a)(3) of subpart

A of this part do not alter the provisions in

paragraph (b) of this section.

(e) Lines and equipment not containing

process fluids are not subject to the

provisions of this appendix. Utilities, and

other nonprocess lines, such as heating and

cooling systems which do not combine their

materials with those in the processes they

serve, are not considered to be part of a

process.

(f) The provisions of this appendix do not

apply to bench-scale processes, regardless of

whether the processes are located at the same

plant site as a process subject to the

provisions of this subpart.

(g) Each piece of equipment to which this

appendix applies shall be identified such
Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules 15785

that it can be distinguished readily from

equipment that is not subject to this

appendix. Identification of the equipment

does not require physical tagging of the

equipment. For example, the equipment may

be identified on a plant site plan, in log

entries, or by designation of process

boundaries by some form of weatherproof

identification. If changes are made to the

affected source subject to the leak detection

requirements, equipment identification for

each type of component shall be updated, if

needed, within 15 calendar days of the end

of each monitoring period for that

component.

(h) Equipment that is in vacuum service is

excluded from the requirements of this

appendix.

(i) Equipment that is in organic HAP

service, but is in such service less than 300

hours per calendar year, is excluded from the

requirements of this appendix if it is

identified as required in § GGGA–8(j) of this

appendix.

(j) When each leak is detected by visual,

audible, or olfactory means, or by monitoring

as described in 63.180 (b) or (c), the

following requirements apply:

(1) A weatherproof and readily visible

identification, marked with the equipment

identification number, shall be attached to

the leaking equipment.

(2) The identification on a valve or

connector in light liquid or gas/vapor service

may be removed after it has been monitored

as specified in § GGGA–6(f)(3), § 63.174(e),

and § 63.175(e)(7)(i)(D), and no leak has been

detected during the follow-up monitoring.

(3) The identification on equipment, except

on a valve or connector in light liquid or gas/

vapor service, may be removed after it has

been repaired.

§ GGGA–2 Definitions

Bench-scale batch process means a batch

process (other than a research and

development facility) that is capable of being

located on a laboratory bench top. This

bench-scale equipment will typically include

reagent feed vessels, a small reactor and

associated product separator, recovery and

holding equipment. These processes are only

capable of producing small quantities of

product.

Closed-loop system means an enclosed

system that returns process fluid to the

process and is not vented to the atmosphere

except through a closed-vent system.

Closed-purge system means a system or

combination of system and portable

containers, to capture purged liquids.

Containers must be covered or closed when

not being filled or emptied.

Connector means flanged, screwed, or

other joined fittings used to connect two pipe

lines or a pipe line and a piece of equipment.

A common connector is a flange. Joined

fittings welded completely around the

circumference of the interface are not

considered connectors for the purpose of this

regulation. For the purpose of reporting and

recordkeeping, connector means joined

fittings that are not inaccessible, ceramic, or

ceramic-lined as described in § GGGA–3(a)(7)

and § GGGA–7(c).

Control device, for purposes of this

appendix, means any equipment used for

recovering or oxidizing organic hazardous air

pollutant vapors. Such equipment includes,

but is not limited to, absorbers, carbon

adsorbers, condensers, flares, boilers, and

process heaters.

Double block and bleed system means two

block valves connected in series with a bleed

valve or line that can vent the line between

the two block valves.

Duct work means a conveyance system

such as those commonly used for heating and

ventilation systems. It is often made of sheet

metal and often has sections connected by

screws or crimping. Hard-piping is not

ductwork.

Equipment, for purposes of this appendix,

means each pump, compressor, agitator,

pressure relief device, sampling connection

system, open-ended valve or line, valve,

connector, surge control vessel, bottoms

receiver, and instrumentation system in

organic hazardous air pollutant service; and

any control devices or closed-vent systems

required by this subpart.

First attempt at repair means to take action

for the purpose of stopping or reducing

leakage of organic material to the

atmosphere.

Flow indicator means a device which

indicates whether gas flow is, or whether the

valve position would allow gas flow to be

present, in a line.

In gas/vapor service means that a piece of

equipment in organic hazardous air pollutant

service contains a gas or vapor at operating

conditions.

In heavy liquid service means that a piece

of equipment in organic hazardous air

pollutant service is not in gas/vapor service

or in light liquid service.

In light liquid service means that a piece

of equipment in organic hazardous air

pollutant service contains a liquid that meets

the following conditions:

1. The vapor pressure of one or more of the

organic compounds is greater than 0.3

kilopascals at 20 °C;

2. The total concentration of the pure

organic compounds constituents having a

vapor pressure greater than 0.3 kilopascals at

20 °C is equal to or greater than 20 percent

by weight of the total process stream; and

3. The fluid is a liquid at operating

conditions.

(Note: Vapor pressures may be determined

by the methods described in 40 CFR

60.485(e)(1).)

In liquid service means that a piece of

equipment in organic hazardous air pollutant

service is not in gas/vapor service.

In organic hazardous air pollutant or in

organic HAP service means that a piece of

equipment either contains or contacts a fluid

(liquid or gas) that is at least 5 percent by

weight of total organic HAP’s as determined

according to the provisions of § 63.180(d).

The provisions of § 63.180(d) also specify

how to determine that a piece of equipment

is not in organic HAP service.

In vacuum service means that equipment is

operating at an internal pressure which is at

least 5 kilopascals below ambient pressure.

In-situ sampling systems means

nonextractive samplers or in-line samplers.

Initial startup means the first time a new

or reconstructed source begins production.

Initial startup does not include operation

solely for testing equipment. Initial startup

does not include subsequent startups (as

defined in this section) of processes

following malfunctions or process

shutdowns.

Instrumentation system means a group of

equipment components used to condition

and convey a sample of the process fluid to

analyzers and instruments for the purpose of

determining process operating conditions

(e.g., composition, pressure, flow, etc.).

Valves and connectors are the predominant

type of equipment used in instrumentation

systems; however, other types of equipment

may also be included in these systems. Only

valves nominally 0.5 inches and smaller, and

connectors nominally 0.75 inches and

smaller in diameter are considered

instrumentation systems for the purposes of

this subpart. Valves greater than nominally

0.5 inches and connectors greater than

nominally 0.75 inches associated with

instrumentation systems are not considered

part of instrumentation systems and must be

monitored individually.

Liquids dripping means any visible leakage

from the seal including dripping, spraying,

misting, clouding, and ice formation.

Indications of liquid dripping include

puddling or new stains that are indicative of

an existing evaporated drip.

Nonrepairable means that it is technically

infeasible to repair a piece of equipment from

which a leak has been detected without a

process shutdown.

Open-ended valve or line means any valve,

except pressure relief valves, having one side

of the valve seat in contact with process fluid

and one side open to atmosphere, either

directly or through open piping.

Plant site means all contiguous or

adjoining property that is under common

control, including properties that are

separated only by a road or other public

right-of-way. Common control includes

properties that are owned, leased, or operated

by the same entity, parent entity, subsidiary,

or any combination thereof.

Pressure release means the emission of

materials resulting from the system pressure

being greater than the set pressure of the

pressure relief device. This release can be

one release or a series of releases over a short

time period due to a malfunction in the

process.

Pressure relief device or valve means a

safety device used to prevent operating

pressures from exceeding the maximum

allowable working pressure of the process

equipment. A common pressure relief device

is a spring-loaded pressure relief valve.

Devices that are actuated either by a pressure

of less than or equal to 2.5 psig or by a

vacuum are not pressure relief devices.

Process shutdown means a work practice

or operational procedure that stops

production from a process or part of a

process during which it is technically

feasible to clear process material from a

process or part of a process consistent with

safety constraints and during which repairs

can be effected. An unscheduled work

practice or operational procedure that stops

production from a process or part of a

process for less than 24 hours is not a process
15786 Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules

shutdown. An unscheduled work practice or

operational procedure that would stop

production from a process or part of a

process for a shorter period of time than

would be required to clear the process or part

of the process of materials and start up the

process, and would result in greater

emissions than delay of repair of leaking

components until the next scheduled process

shutdown, is not a process shutdown. The

use of spare equipment and technically

feasible bypassing of equipment without

stopping production are not process

shutdowns.

Repaired means that equipment is

adjusted, or otherwise altered, to eliminate a

leak as defined in the applicable sections of

this appendix.

Sampling connection system means an

assembly of equipment within a process unit

used during periods of representative

operation to take samples of the process

fluid. Equipment used to take nonroutine

grab samples is not considered a sampling

connection system.

Sensor means a device that measures a

physical quantity or the change in a physical

quantity, such as temperature, pressure, flow

rate, pH, or liquid level.

Set pressure means the pressure at which

a properly operating pressure relief device

begins to open to relieve atypical process

system operating pressure.

Startup means the setting in operation of

a piece of equipment or a control device that

is subject to this subpart.

§ GGGA–3 References

(a) The owner or operator of a source

subject to this appendix shall comply with

the following sections of subpart H, except

that references to § 63.160 and § 63.162 shall

mean § GGGA–1 of this appendix; references

to § 63.161 shall mean § GGGA–2 of this

appendix; references to § 63.163 and § 63.173

shall mean § GGGA–4 of this appendix;

references to § 63.167 shall mean § GGGA–5

of this appendix; references to § 63.168 shall

mean § GGGA–6 of this appendix; references

to § 63.170 shall be included in the

requirements set forth in § 63.1252(c);

references to § 63.171 shall mean § GGGA–

3(a)(5) of this appendix; references to

§ 63.172 shall mean § GGGA–3(a)(6) of this

appendix; references to § 63.181 shall mean

§ GGGA–8 of this appendix; and references to

§ 63.182 shall mean § GGGA–9 of this

appendix. The term ‘‘process unit’’ as used

in subpart H shall be considered to be

defined the same as ‘‘process’’ for sources

subject to this subpart GGG:

(1) § 63.164, Compressors;

(2) § 63.165, Pressure relief devices in gas/

vapor service;

(3) § 63.166, Sampling connection systems;

(4) § 63.169, Pumps, valves, connectors,

and agitators in heavy liquid service;

instrumentation systems; and pressure relief

devices in liquid service;

(5) § 63.171, Delay of repair, except

Section 63.171(a) shall be changed to read:

Delay of repair of equipment for which leaks

have been detected is allowed if one of the

following conditions exist:

(i) § 63.171(a)(1) is added to read: The

repair is technically infeasible without a

process shutdown. Repair of this equipment

shall occur by the end of the next scheduled

process shutdown.

(ii) § 63.171(a)(2) is added to read: The

owner or operator determines that repair

personnel would be exposed to an immediate

danger if attempting to repair without a

process shutdown. Repair of this equipment

shall occur by the end of the next scheduled

process shutdown.

(6) § 63.172, Closed-vent systems and

control devices, for closed-vent systems used

to comply with this subpart, and for control

devices used to comply with this appendix

only, except

(i) § 63.172(k) and (l) shall not apply.

Instead, references to these paragraphs shall

mean § GGGA–7.

(ii) Owners or operators may, instead of

complying with the provisions of § 63.172(f),

design a closed-vent system to operate at a

pressure below atmospheric pressure. The

system shall be equipped with at least one

pressure gage or other pressure measurement

device that can be read from a readily

accessible location to verify that negative

pressure is being maintained in the closedvent system when the associated control

device is operating.

(7) § 63.174, Connectors, except

(i) § 63.174(f) and (g) shall not apply.

Instead, references to these paragraphs shall

mean § GGGA–7.

(ii) Days that the connector are not in

organic HAP service shall not be considered

part of the 3 month period in § 63.174(e).

(8) § 63.175, Quality improvement program

for valves, except

(i) § 63.175(a) is changed to read: An owner

or operator may elect to comply with one of

the alternative quality improvement

programs specified in paragraphs (d) and (e)

of this section. The decision to use one of

these alternative provisions to comply with

the requirements of § 63.168(d)(1)(ii) of this

subpart must be made during the second year

of compliance for existing and new

processes.

(ii) The ‘‘start of Phase III’’ shall mean the

‘‘compliance date’’ as specified in § 63.1250.

The phrase ‘‘of Phase III’’ shall mean ‘‘after

the compliance date’’ as specified in

§ 63.1250.

(9) § 63.176, Quality improvement program

for pumps, except

(i) § 63.176(a) is changed to read: If, on a

1-year rolling average, the greater of either 10

percent of the pumps in a process (or affected

source) or three pumps in a process (or

affected source) leak, the owner or operator

may elect to comply with the requirements

of this section as specified. The decision to

use this provision to comply with the

requirements of § 63.163(d)(2) of this subpart

must be made during the second year of

compliance for existing and new processes.

(ii) § 63.176(a)(1) and (2), and (d)(8) shall

not apply.

(10) § 63.177, Alternative means of

emission limitation: General;

(11) § 63.178, Alternative means of

emission limitation: Batch processes;

(12) § 63.179, Alternative means of

emission limitation: Enclosed-vented process

units;

(13) § 63.180, Test methods and

procedures, except § 63.180(b)(4)(ii)(A–C) are

replaced by (b)(4)(ii) that reads: A mixture of

methane and air at concentration of

approximately, but less than, 10,000 parts per

million methane for agitators; 2,000 parts per

million for pumps; and 500 parts per million

for all other equipment, except as provided

in paragraph (b)(4)(iii) of this section.

§ GGGA–4 Standards: Pumps in Light

Liquid Service and Agitators in Gas/Vapor

Service and in Light Liquid Service

(a) The provisions of this section apply to

each pump that is in light organic HAP liquid

service, and to each agitator in organic HAP

gas/vapor service or in light organic HAP

liquid service.

(b)(1) Each pump and agitator subject to

this section shall be monitored quarterly to

detect leaks by the method specified in

§ 63.180(b) of this subpart, except as

provided in § 63.177, § GGGA–7, and

paragraphs (e) through (i) of this section.

(2) The instrument reading, as determined

by the method as specified in § 63.180(b),

that defines a leak is:

(i) For agitators, an instrument reading of

10,000 parts per million or greater.

(ii) For pumps, an instrument reading of

2,000 parts per million or greater.

(3) Each pump and agitator shall be

checked by visual inspection each calendar

week for indications of liquids dripping from

the pump or agitator seal. If there are

indications of liquids dripping from the seal,

a leak is detected.

(c)(1) When a leak is detected, it shall be

repaired as soon as practicable, but not later

than 15 calendar days after it is detected,

except as provided in paragraph (c)(3) of this

section or § GGGA–3(a)(5) of this appendix.

(2) A first attempt at repair shall be made

no later than 5 calendar days after the leak

is detected. First attempts at repair include,

but are not limited to, the following practices

where practicable:

(i) Tightening of packing gland nuts.

(ii) Ensuring that the seal flush is operating

at design pressure and temperature.

(d) For pumps:

(1) The owner or operator shall decide no

later than the first monitoring period whether

to calculate percent leaking pumps on a

process basis or on an affected source-wide

basis. Once the owner or operator has

decided, all subsequent percent calculations

shall be made on the same basis.

(2) If, calculated on a 1-year rolling

average, the greater of either 10 percent of the

pumps in a process or three pumps in a

process leak, the owner or operator shall

either:

(i) Monitor each pump once per month; or

(ii) Implement a quality improvement

program for pumps that complies with the

requirements of § 63.176 and monitor

quarterly.

(3) The number of pumps at a process shall

be the sum of all the pumps in organic HAP

service, except that pumps found leaking in

a continuous process within 1 quarter after

startup of the pump shall not count in the

percent leaking pumps calculation for that

one monitoring period only.

(4) Percent leaking pumps shall be

determined by the following equation:

%PL=[(PL¥PS)/(PT¥PS)]×100

Where:
Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules 15787

%PL=Percent leaking pumps

PL=Number of pumps found leaking as

determined through quarterly monitoring

as required in paragraphs (b)(1) and

(b)(2) of this section.

PT=Total pumps in organic HAP service,

including those meeting the criteria in

paragraphs (e) and (f) of this section.

PS=Number of pumps leaking within 1

quarter of startup during the current

monitoring period.

(e) Each pump or agitator equipped with a

dual mechanical seal system that includes a

barrier fluid system is exempt from the

requirements of paragraphs (a) through (d) of

this section, provided the following

requirements are met:

(1) Each dual mechanical seal system is:

(i) Operated with the barrier fluid at a

pressure that is at all times greater than the

pump/agitator stuffing box pressure; or

(ii) Equipped with a barrier fluid degassing

reservoir that is connected by a closed-vent

system to a control device that complies with

the requirements of § GGGA–3(a)(6); or

(iii) Equipped with a closed-loop system

that purges the barrier fluid into a process

stream.

(2) The barrier fluid is not in light liquid

service.

(3) Each barrier fluid system is equipped

with a sensor that will detect failure of the

seal system, the barrier fluid system, or both.

(4) Each pump/agitator is checked by

visual inspection each calendar week for

indications of liquids dripping from the

pump/agitator seal.

(i) If there are indications of liquids

dripping from the pump/agitator seal at the

time of the weekly inspection, the pump/

agitator shall be monitored as specified in

§ 63.180(b) to determine if there is a leak of

organic HAP in the barrier fluid.

(ii) If an instrument reading of 2,000 parts

per million or greater is measured for pumps,

or 10,000 parts per million or greater is

measured for agitators, a leak is detected.

(5) Each sensor as described in paragraph

(e)(3) of this section is observed daily or is

equipped with an alarm unless the pump is

located within the boundary of an unmanned

plant site.

(6)(i) The owner or operator determines,

based on design considerations and operating

experience, criteria applicable to the

presence and frequency of drips and to the

sensor that indicates failure of the seal

system, the barrier fluid system, or both.

(ii) If indications of liquids dripping from

the pump/agitator seal exceed the criteria

established in paragraph (e)(6)(i) of this

section, or if, based on the criteria

established in paragraph (e)(6)(i) of this

section, the sensor indicates failure of the

seal system, the barrier fluid system, or both,

a leak is detected.

(iii) When a leak is detected, it shall be

repaired as soon as practicable, but not later

than 15 calendar days after it is detected,

except as provided in § GGGA–3(a)(5) of this

appendix.

(iv) A first attempt at repair shall be made

no later than 5 calendar days after each leak

is detected.

(f) Any pump/agitator that is designed with

no externally actuated shaft penetrating the

pump/agitator housing is exempt from the

requirements of paragraphs (a) through (c) of

this section.

(g) Any pump/agitator equipped with a

closed-vent system capable of capturing and

transporting any leakage from the seal or

seals back to the process or to a control

device that complies with the requirements

of § GGGA–3(a)(6) is exempt from the

requirements of paragraphs (b) through (e) of

this section.

(h) Any pump/agitator that is located

within the boundary of an unmanned plant

site is exempt from the weekly visual

inspection requirement of paragraphs (b)(3)

and (e)(4) of this section, and the daily

requirements of paragraph (e)(5) of this

section, provided that each pump/agitator is

visually inspected as often as practicable and

at least monthly.

(i) If more than 90 percent of the pumps

at a process meet the criteria in either

paragraph (e) or (f) of this section, the process

is exempt from the requirements of paragraph

(d) of this section.

§ GGGA–5 Standards: Open-Ended Valves

or Lines

(a)(1) Each open-ended valve or line shall

be equipped with a cap, blind flange, plug,

or a second valve, except as provided in

§ 63.177 and paragraph (d) of this section.

(2) The cap, blind flange, plug, or second

valve shall seal the open end at all times

except during operations requiring process

fluid flow through the open-ended valve or

line, or during maintenance or repair. The

cap, blind flange, plug, or second valve shall

be in place within 1 hour of cessation of

operations requiring process fluid flow

through the open-ended valve or line, or

within 1 hour of cessation of maintenance or

repair.

(b) Each open-ended valve or line

equipped with a second valve shall be

operated in a manner such that the valve on

the process fluid end is closed before the

second valve is closed.

(c) When a double block and bleed system

is being used, the bleed valve or line may

remain open during operations that require

venting the line between the block valves but

shall comply with paragraph (a) of this

section at all other times.

(d) Open-ended valves or lines in an

emergency shutdown system which are

designed to open automatically in the event

of a process upset are exempt from the

requirements of paragraphs (a), (b) and (c) of

this section.

(e) Open-ended valves or lines containing

materials which would autocatalytically

polymerize or, would prevent an explosion,

serious overpressure, or other safety hazard

if capped or equipped with a double block

and bleed system as specified in paragraphs

(a) through (c) of this section are exempt from

the requirements of paragraph (a) through (c)

of this section.

§ GGGA–6 Standards: Valves in Gas/Vapor

Service and in Light Liquid Service

(a) The provisions of this section apply to

valves that are either in gas organic HAP

service or in light liquid organic HAP service.

(1) For existing and new affected sources,

all valves subject to this section shall be

monitored, except as provided in § 63.177

and § GGGA–7, by no later than 1 year after

the compliance date.

(b) The owner or operator of a source

subject to this appendix shall monitor all

valves, except as provided in § 63.177 and

§ GGGA–7, at the intervals specified in

paragraph (d) of this section and shall

comply with all other provisions of this

section, except as provided in § GGGA–

3(a)(5), § 63.178, and § 63.179.

(1) The valves shall be monitored to detect

leaks by the method specified in § 63.180(b).

(2) An instrument reading of 500 parts per

million or greater defines a leak.

(c) [Reserved]

(d) After conducting the initial survey

required in paragraph (a)(1) of this section,

the owner or operator shall monitor valves

for leaks at the intervals specified below:

(1) At processes with 2 percent or greater

leaking valves, calculated according to

paragraph (e) of this section, the owner or

operator shall either:

(i) Monitor each valve once per month; or

(ii) Implement a quality improvement

program for valves that complies with the

requirements of § 63.175(d) or (e) and

monitor quarterly.

(2) At processes with less than 2 percent

leaking valves, the owner or operator shall

monitor each valve once each quarter, except

as provided in paragraphs (d)(3) and (d)(4) of

this section.

(3) At processes with less than 1 percent

leaking valves, the owner or operator may

elect to monitor each valve once every 2

quarters.

(4) At processes with less than 0.5 percent

leaking valves, the owner or operator may

elect to monitor each valve once every 4

quarters.

(e)(1) Percent leaking valves at a process

shall be determined by the following

equation:

%VL=[VL/(VT+VC)]×100

Where:

%VL=Percent leaking valves.

VL=Number of valves found leaking

excluding nonrepairables as provided in

paragraph (e)(3)(i) of this section.

VT=Total valves monitored, in a monitoring

period excluding valves monitored as

required by (f)(3) of this section.

VC=Optional credit for removed

valves=0.67×net number (i.e., total

removed-total added) of valves in

organic HAP service removed from

process after the effective date for

existing processes, and after the date of

initial startup for new sources. If credits

are not taken, then VC=0.

(2) For use in determining monitoring

frequency, as specified in paragraph (d) of

this section, the percent leaking valves shall

be calculated as a rolling average of two

consecutive monitoring periods for monthly,

quarterly, or semiannual monitoring

programs; and as an average of any three out

of four consecutive monitoring periods for

annual monitoring programs.

(3)(i) Nonrepairable valves shall be

included in the calculation of percent leaking

valves the first time the valve is identified as

leaking and nonrepairable and as required to
15788 Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules

comply with paragraph (e)(3)(ii) of this

section. Otherwise, a number of

nonrepairable valves (identified and

included in the percent leaking calculation in

a previous period) up to a maximum of 1

percent of the total number of valves in

organic HAP service at a process may be

excluded from calculation of percent leaking

valves for subsequent monitoring periods.

(ii) If the number of nonrepairable valves

exceeds 1 percent of the total number of

valves in organic HAP service at a process,

the number of nonrepairable valves

exceeding 1 percent of the total number of

valves in organic HAP service shall be

included in the calculation of percent leaking

valves.

(f)(1) When a leak is detected, it shall be

repaired as soon as practicable, but no later

than 15 calendar days after the leak is

detected, except as provided in § GGGA–

3(a)(5) of this appendix.

(2) A first attempt at repair shall be made

no later than 5 calendar days after each leak

is detected.

(3) When a leak is repaired, the valve shall

be monitored at least once within the first 3

months after its repair. Days that the valve

are not in organic HAP service shall not be

considered part of this 3-month period.

(g) First attempts at repair include, but are

not limited to, the following practices where

practicable:

(1) Tightening of bonnet bolts,

(2) Replacement of bonnet bolts,

(3) Tightening of packing gland nuts, and

(4) Injection of lubricant into lubricated

packing.

(h) Any equipment located at a plant site

with fewer than 250 valves in organic HAP

service in the affected source is exempt from

the requirements for monthly monitoring and

a quality improvement program specified in

paragraph (d)(1) of this section. Instead, the

owner or operator shall monitor each valve

in organic HAP service for leaks once each

quarter, or comply with paragraphs (d)(3) or

(d)(4) of this section.

§ GGGA–7 Unsafe To Monitor, Difficult To

Monitor, and Inaccessible Equipment

(a) Equipment subject to this appendix

shall not be required to comply with the

monitoring requirements of this appendix if

it meets the definition of difficult to monitor

or unsafe to monitor as specified in

paragraphs (b) or (c) of this section. Agitators

and connectors will also be subject to the

inaccessible to monitor requirements in

paragraph (d) of this section. Specific

paragraphs that will no longer apply to such

equipment are as follows:

(1) For pumps and agitators, §§ GGGA–4

(b), (c), and (d) shall not apply.

(2) For valves, § GGGA–6 (b), (c), (d), (e),

and (f) shall not apply.

(3) For closed-vent systems, § 63.172(f) (1)

and (2), and (g) shall not apply.

(4) For connectors, § 63.174 (b), (c), (d), and

(e) shall not apply.

(b) Equipment that is designated, as

described in § GGGA–8(b)(7) of this

appendix, as unsafe-to-monitor is subject to

the exemptions of paragraph (a) of this

section if:

(1) The owner or operator of the equipment

determines that it is unsafe to monitor

because monitoring personnel would be

exposed to an immediate danger as a

consequence of complying with the

paragraphs referenced in (a)(1) through (4) of

this section.

(2) The owner or operator has a written

plan that requires monitoring of the

equipment as frequently as practicable

during safe-to-monitor times, but not more

frequently than the periodic monitoring

schedule otherwise applicable.

(c) Equipment that is designated, as

described in § GGG–8(b)(7) of this appendix,

as difficult to monitor is subject to the

exemptions of paragraph (a) of this section if:

(1) The owner or operator of the equipment

determines that the equipment cannot be

monitored without elevating the monitoring

personnel more than 2 meters above a

support surface or it is not accessible at

anytime in a safe manner;

(2) The process unit within which the

equipment is located is an existing source or

the owner or operator designates less than 3

percent of the total number of valves in a

new source as difficult to monitor; and

(3) The owner or operator of the equipment

follows a written plan that requires

monitoring of the equipment at least once per

calendar year.

(d) Agitators and connectors designated as

inaccessible are subject to the exemptions of

paragraph (a) of this section if:

(1) The equipment is inaccessible because

it is:

(i) Buried;

(ii) Insulated in a manner that prevents

access to the equipment by a monitor probe;

(iii) Obstructed by equipment or piping

that prevents access to the equipment by a

monitor probe;

(iv) Unable to be reached from a wheeled

scissor-lift or hydraulic-type scaffold which

would allow access to equipment up to 7.6

meters (25 feet) above the ground;

(v) Not able to be accessed at any time in

a safe manner to perform monitoring. Unsafe

access includes, but is not limited to, the use

of a wheeled scissor-lift on unstable or

uneven terrain, the use of a motorized manlift basket in areas where an ignition

potential exists, or access would require near

proximity to hazards such as electrical lines,

or would risk damage to equipment.

(2) For pumps, agitators, and valves, the

process within which the equipment is

located is an existing source or the owner or

operator designates less than 3 percent of the

total number of components of that type (e.g.,

pumps, agitators, or valves) in a new source

as inaccessible; and

(3) If any inaccessible equipment is

observed by visual, audible, olfactory, or

other means to be leaking, the leak shall be

repaired as soon as practicable, but no later

than 15 calendar days after the leak is

detected, except as provided in § GGGA–8 of

this appendix.

§ GGGA–8 Recordkeeping Requirements

(a) An owner or operator of more than one

process subject to the provisions of this

appendix may comply with the

recordkeeping requirements for these

processes in one recordkeeping system if the

system identifies with each record the

program being implemented (e.g., quarterly

monitoring, quality improvement) for each

type of equipment. All records and

information required by this section shall be

maintained in a manner that can be readily

accessed at the plant site. This could include

physically locating the records at the plant

site or accessing the records from a central

location by computer at the plant site.

(b) Except as provided in paragraph (e) of

this section and in paragraph GGGA–1(i), the

following information pertaining to all

equipment subject to the requirements in this

appendix shall be recorded:

(1)(i) A list of identification numbers for

equipment (except connectors exempt from

monitoring and recordkeeping identified in

§ 63.174 and instrumentation systems)

subject to the requirements of this appendix.

Equipment need not be individually

identified if all equipment in a designated

area or length of pipe subject to the

provisions of this appendix are identified as

a group, and the number of components of

each type of equipment (pumps, valves, etc.)

subject is indicated. The list for each type of

equipment shall be complete no later than

the completion of the initial survey required

for that component. The list of identification

numbers shall be updated, if needed, to

incorporate equipment changes within 15

calendar days of the completion of each

monitoring survey for the type of equipment

component monitored.

(ii) A schedule for monitoring connectors

subject to the provisions of § 63.174(a) and

valves subject to the provisions of § GGGA–

6(d) of this appendix.

(iii) Physical tagging of the equipment to

indicate that it is in organic HAP service is

not required. Equipment subject to the

provisions of this appendix may be identified

on a plant site plan, in log entries, or by other

appropriate methods.

(2)(i) A list of identification numbers for

equipment that the owner or operator elects

to equip with a closed-vent system and

control device, under the provisions of

§ GGGA–4(g), § 63.164(h), or § 63.165(c).

(ii) A list of identification numbers for

compressors that the owner or operator elects

to designate as operating with an instrument

reading of less than 500 parts per million

above background, under the provisions of

§ 63.164(i).

(3)(i) A list of identification numbers for

pressure relief devices subject to the

provisions in § 63.165(a).

(ii) A list of identification numbers for

pressure relief devices equipped with rupture

disks, under the provisions of § 63.165(d).

(4) Identification of instrumentation

systems subject to the provisions of this

appendix. Individual components in an

instrumentation system need not be

identified.

(5) The owner or operator may develop a

written procedure that identifies the

conditions that justify a delay of repair. The

written procedures may be included as part

of the startup/shutdown/malfunction plan,

required by § 63.6(e)(3), for the source or may

be part of a separate document that is

maintained at the plant site. In such cases,

reasons for delay of repair may be

documented by citing the relevant sections of

the written procedure.
Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules 15789

(6) The following information shall be

recorded for each dual mechanical seal

system:

(i) Design criteria required in §§ GGGA–

4(e)(6)(i) and 63.164(e)(2), and an

explanation of the design criteria; and

(ii) Any changes to these criteria and the

reasons for the changes.

(7) The following information pertaining to

all equipment subject to the requirements of

§ GGGA–7, and all equipment subject to the

requirements of § GGGA–3(a)(5)(iii) shall be

recorded:

(i) Identification of equipment designated

as unsafe to monitor, difficult to monitor, or

inaccessible and the plan for monitoring or

inspecting this equipment.

(8)(i) A list of valves removed from and

added to the process, as described in

§ GGGA–6(e)(1) of this appendix, if the net

credits for removed valves is expected to be

used.

(ii) A list of connectors removed from and

added to the process, as described in

§ 63.174(i)(1), and documentation of the

integrity of the weld for any removed

connectors, as required in § 63.174(j). This is

not required unless the net credits for

removed connectors is expected to be used.

(9) For batch processes that the owner or

operator elects to monitor as provided under

§ 63.178(c), a list of equipment added to

batch product processes since the last

monitoring period required in

§§ 63.178(c)(3)(ii) and (3)(iii). This list must

be completed for each type of equipment

within 15 calendar days of the completion of

the each monitoring survey for the type of

equipment monitored.

(c) For visual inspections of equipment

subject to the provisions of this appendix

(e.g., §§ GGGA–4(b)(3), GGGA–4(e)(4)(i)), the

owner or operator shall document that the

inspection was conducted and the date of the

inspection. The owner or operator shall

maintain records as specified in paragraph

(d) of this section for leaking equipment

identified in this inspection, except as

provided in paragraph (e) of this section.

These records shall be retained for 2 years.

(d) When each leak is detected as specified

in §§ GGGA–4 and 63.164; §§ GGGA–6 and

63.169; and §§ 63.172 and 63.174 of this

subpart, the following information shall be

recorded and kept for 2 years:

(1) The instrument and the equipment

identification number and the operator name,

initials, or identification number.

(2) The date the leak was detected and the

date of first attempt to repair the leak.

(3) The date of successful repair of the leak.

(4) If postrepair monitoring is required,

maximum instrument reading measured by

Method 21 of 40 CFR part 60, appendix A

after it is successfully repaired or determined

to be nonrepairable.

(5) ‘‘Repair delayed’’ and the reason for the

delay if a leak is not repaired within 15

calendar days after discovery of the leak.

(i) The owner or operator may develop a

written procedure that identifies the

conditions that justify a delay of repair. In

such cases, reasons for delay of repair may

be documented by citing the relevant

sections of the written procedure.

(ii) If delay of repair was caused by

depletion of stocked parts, there must be

documentation that the spare parts were

sufficiently stocked onsite before depletion

and the reason for depletion.

(6) If repairs were delayed, dates of process

shutdowns that occur while the equipment is

unrepaired.

(7)(i) If the alternative in § 63.174(c)(1)(ii)

is not in use for the monitoring period,

identification, either by list, location (area or

grouping), or tagging of connectors disturbed

since the last monitoring period required in

§ 63.174(b), as described in § 63.174(c)(1).

(ii) The date and results of follow-up

monitoring as required in § 63.174(c). If

identification of disturbed connectors is

made by location, then all connectors within

the designated location shall be monitored.

(8) The date and results of the monitoring

required in § 63.178(c)(3)(i) for equipment

added to a batch process since the last

monitoring period required in

§§ 63.178(c)(3)(ii) and (c)(3)(iii). If no leaking

equipment is found in this monitoring, the

owner or operator shall record that the

inspection was performed. Records of the

actual monitoring results are not required.

(9) Copies of the periodic reports as

specified in § GGGA–9(d) of this appendix, if

records are not maintained on a

computerized data base capable of generating

summary reports from the records.

(e) The owner or operator of a batch

product process who elects to pressure test

the batch product process equipment train to

demonstrate compliance with this appendix

is exempt from the requirements of

paragraphs (b), (c), (d), and (f) of this section.

Instead, the owner or operator shall maintain

records of the following information:

1(1) The identification of each product,

or product code, produced during the

calendar year. It is not necessary to

identify individual items of equipment

in a batch product process equipment

train.

(2) Records demonstrating the proportion

of the time during the calendar year the

equipment is in use in a batch process that

is subject to the provisions of this subpart.

Examples of suitable documentation are

records of time in use for individual pieces

of equipment or average time in use for the

process unit. These records are not required

if the owner or operator does not adjust

monitoring frequency by the time in use, as

provided in § 63.178(c)(3)(iii).

(3) Physical tagging of the equipment to

identify that it is in organic HAP service and

subject to the provisions of this appendix is

not required. Equipment in a batch product

process subject to the provisions of this

appendix may be identified on a plant site

plan, in log entries, or by other appropriate

methods.

(4) The dates of each pressure test required

in § 63.178(b), the test pressure, and the

pressure drop observed during the test.

(5) Records of any visible, audible, or

olfactory evidence of fluid loss.

(6) When a batch product process

equipment train does not pass two

consecutive pressure tests, the following

information shall be recorded in a log and

kept for 2 years:

(i) The date of each pressure test and the

date of each leak repair attempt.

(ii) Repair methods applied in each attempt

to repair the leak.

(iii) The reason for the delay of repair.

(iv) The expected date for delivery of the

replacement equipment and the actual date

of delivery of the replacement equipment.

(v) The date of successful repair.

(f) The dates and results of each

compliance test required for compressors

subject to the provisions in § 63.164(i) and

the dates and results of the monitoring

following a pressure release for each pressure

relief device subject to the provisions in

§§ 63.165(a) and (b). The results shall

include:

(1) The background level measured during

each compliance test.

(2) The maximum instrument reading

measured at each piece of equipment during

each compliance test.

(g) The owner or operator shall maintain

records of the information specified in

paragraphs (g)(1) through (g)(3) of this section

for closed-vent systems and control devices

subject to the provisions of § GGGA–3(a)(6).

The records specified in paragraph (g)(1) of

this section shall be retained for the life of

the equipment. The records specified in

paragraphs (g)(2) and (g)(3) of this section

shall be retained for 2 years.

(1) The design specifications and

performance demonstrations specified in

paragraphs (g)(1)(i) through (g)(1)(iv) of this

section.

(i) Detailed schematics, design

specifications of the control device, and

piping and instrumentation diagrams.

(ii) The dates and descriptions of any

changes in the design specifications.

(iii) The flare design (i.e., steam-assisted,

air assisted, or nonassisted) and the results of

the compliance demonstration required by

§ 63.11(b) of subpart A of this part.

(iv) A description of the parameter or

parameters monitored, as required in

§ GGGA–3(a)(6)(e), to ensure that control

devices are operated and maintained in

conformance with their design and an

explanation of why that parameter (or

parameters) was selected for the monitoring.

(2) Records of operation of closed-vent

systems and control devices.

(i) Dates and durations when the closedvent systems and control devices required in

§ GGGA–4 and §§ 63.164 through 63.166 are

not operated as designed as indicated by the

monitored parameters, including periods

when a flare pilot light system does not have

a flame.

(ii) Dates and durations during which the

monitoring system or monitoring device is

inoperative.

(iii) Dates and durations of startups and

shutdowns of control devices required in

§ GGGA–4 and §§ 63.164 through 63.166.

(3) Records of inspections of closed-vent

systems subject to the provisions of § 63.172.

(i) For each inspection conducted in

accordance with the provisions of

§ 63.172(f)(1) or (f)(2) during which no leaks

were detected, a record that the inspection

was performed, the date of the inspection,

and a statement that no leaks were detected.

(ii) For each inspection conducted in

accordance with the provisions of

§ 63.172(f)(1) or (f)(2) during which leaks
15790 Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules

were detected, the information specified in

paragraph (d) of this section shall be

recorded.

(h) Each owner or operator of equipment

subject to the requirements of §§ 63.175 and

63.176 shall maintain the records specified in

paragraphs (h)(1) through (h)(9) of this

section for the period of the quality

improvement program for the equipment.

(1) For owners or operators who elect to

use a reasonable further progress quality

improvement program, as specified in

§ 63.175(d):

(i) All data required in § 63.175(d)(2).

(ii) The percent leaking valves observed

each quarter and the rolling average percent

reduction observed in each quarter.

(iii) The beginning and ending dates while

meeting the requirements of § 63.175(d).

(2) For owners or operators who elect to

use a quality improvement program of

technology review and improvement, as

specified in § 63.175(e):

(i) All data required in § 63.175(e)(2).

(ii) The percent leaking valves observed

each quarter.

(iii) Documentation of all inspections

conducted under the requirements of

§ 63.175(e)(4), and any recommendations for

design or specification changes to reduce

leak frequency.

(iv) The beginning and ending dates while

meeting the requirements of § 63.175(e).

(3) For owners or operators who elect to

use the pump quality improvement program

as specified in § 63.176:

(i) All data required in § 63.176(d)(2).

(ii) The rolling average percent leaking

pumps.

(iii) Documentation of all inspections

conducted under the requirements of

§ 63.176(d)(4), and any recommendations for

design or specification changes to reduce

leak frequency.

(iv) The beginning and ending dates while

meeting the requirements of § 63.176(d).

(4) If a leak is not repaired within 15

calendar days after discovery of the leak, the

reason for the delay and the expected date of

successful repair.

(5) Records of all analyses required in

§§ 63.175(e) and 63.176(d). The records will

include the following:

(i) A list identifying areas associated with

poorer than average performance and the

associated service characteristics of the

stream, the operating conditions and

maintenance practices.

(ii) The reasons for rejecting specific

candidate superior emission performing

valve or pump technology from performance

trials.

(iii) The list of candidate superior emission

performing valve or pump technologies, and

documentation of the performance trial

program items required under

§§ 63.175(e)(6)(iii) and 63.176(d)(6)(iii).

(iv) The beginning date and duration of

performance trials of each candidate superior

emission performing technology.

(6) All records documenting the quality

assurance program for valves or pumps as

specified in §§ 63.175(e)(7) and 63.176(d)(7).

(7) Records indicating that all valves or

pumps replaced or modified during the

period of the quality improvement program

are in compliance with the quality assurance

requirements in § 63.175(e)(7) and

§ 63.176(d)(7).

(8) Records documenting compliance with

the 20 percent or greater annual replacement

rate for pumps as specified in § 63.176(d)(8).

(9) If exempted by § 63.175(e)(6)(v) or

§ 63.176(d)(6)(v), information and data to

show the corporation has fewer than 100

employees, including employees providing

professional and technical contracted

services.

(i) Information, data, and analysis used to

determine that a piece of equipment or

process is in heavy liquid service shall be

recorded. Such a determination shall include

an analysis or demonstration that the process

fluids do not meet the criteria of ‘‘in light

liquid or gas service.’’ Examples of

information that could document this

include, but are not limited to, records of

chemicals purchased for the process,

analyses of process stream composition,

engineering calculations, or process

knowledge.

(j) Identification, either by list, location

(area or group) of equipment in organic HAP

service less than 300 hours per year subject

to the provisions of this appendix.

(k) Owners and operators choosing to

comply with the requirements of § 63.179

shall maintain the following records:

(1) Identification of the process(es) and the

organic HAP’s they handle.

(2) A schematic of the process, enclosure,

and closed-vent system.

(3) A description of the system used to

create a negative pressure in the enclosure to

ensure that all emissions are routed to the

control device.

§ GGGA–9 Reporting Requirements

(a) Each owner or operator of a source

subject to this appendix shall submit the

reports listed in paragraphs (a)(1) through

(a)(5) of this section. Owners or operators

requesting an extension of compliance shall

also submit a report as described in § 63.6 of

subpart A.

(1) An Initial Notification as described in

§ 63.9 of subpart A, and

(2) A Notification of Compliance Status

described in paragraph (c) of this section,

(3) Periodic Reports described in paragraph

(d) of this section, and

(4) [Reserved]

(5) [Reserved]

(b) Each owner or operator of a source

subject to this appendix shall submit a

Notification of Compliance Status within 90

days after the compliance dates specified in

§ 63.1250(e).

(1) The notification shall provide the

information listed in paragraphs (b)(1)(i)

through (b)(1)(iii) of this section for each

process subject to the requirements of

§§ GGGA–3 through GGGA–8 of this

appendix.

(i) Process identification.

(ii) Approximate number of each

equipment type (e.g., valves, pumps) in

organic HAP service, excluding equipment in

vacuum service.

(iii) Method of compliance with the

standard (for example, ‘‘monthly leak

detection and repair’’ or ‘‘equipped with dual

mechanical seals’’).

(2) The notification shall provide the

information listed in paragraphs (b)(2)(i) and

(b)(2)(ii) of this section for each process

subject to the requirements of § 63.178(b).

(i) Batch products or product codes subject

to the provisions of this appendix, and

(ii) Planned schedule for pressure testing

when equipment is configured for production

of products subject to the provisions of this

appendix.

(3) The notification shall provide the

information listed in paragraphs (b)(3)(i) and

(b)(3)(ii) of this section for each process

subject to the requirements in § 63.179.

(i) Process identification.

(ii) A description of the system used to

create a negative pressure in the enclosure

and the control device used to comply with

the requirements of § GGGA–3(a)(6).

(4) Any change in the information

submitted under this paragraph (b) shall be

provided to the Administrator as a part of

subsequent Periodic Reports. Section 63.9(j)

shall not apply to the Notification of

Compliance Status described in this

paragraph (b).

(c) The owner or operator of a source

subject to this appendix shall submit

Periodic Reports.

(1) A report containing the information in

paragraphs (c)(2), (c)(3), and (c)(4) of this

section shall be submitted semiannually

starting 6 months after the Notification of

Compliance Status, as required in paragraph

(b) of this section. The first periodic report

shall cover the first 6 months after the

compliance date specified in § 63.1250(e).

Each subsequent periodic report shall cover

the 6 month period following the preceding

period.

(2) For equipment complying with the

provisions of §§ GGGA–3 through GGGA–8 of

this appendix, the summary information

listed in paragraphs (i) through (xii) of this

paragraph for each monitoring period during

the 6-month period.

(i) The number of valves for which leaks

were detected as described in § GGGA–6(b) of

this appendix, the percent leakers, and the

total number of valves monitored;

(ii) The number of valves for which leaks

were not repaired as required in § GGGA–6(f)

of this appendix, identifying the number of

those that are determined nonrepairable;

(iii) The number of pumps and agitators for

which leaks were detected as described in

§ GGGA–4(b) of this appendix, the percent

leakers, and the total number of pumps and

agitators monitored;

(iv) The number of pumps and agitators for

which leaks were not repaired as required in

§ GGGA–4(c) of this appendix;

(v) The number of compressors for which

leaks were detected as described in

§ 63.164(f);

(vi) The number of compressors for which

leaks were not repaired as required in

§ 63.164(g);

(vii) The number of connectors for which

leaks were detected as described in

§ 63.174(a), the percent of connectors leaking,

and the total number of connectors

monitored;

(viii) The number of connectors for which

leaks were not repaired as required in

§ 63.174(d), identifying the number of those

that are determined nonrepairable;
Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Proposed Rules 15791

(ix) The facts that explain any delay of

repairs and, where appropriate, why a

process shutdown was technically infeasible.

(x) The results of all monitoring to show

compliance with §§ 63.164(i), 63.165(a), and

63.172(f) conducted within the semiannual

reporting period.

(xi) If applicable, the initiation of a

monthly monitoring program under either

§§ GGGA4–(d)(2)(i) or GGGA–6(d)(1)(i) of

this appendix, or a quality improvement

program under either § 63.175 or 63.176.

(xii) If applicable, notification of a change

in connector monitoring alternatives as

described in § 63.174(c)(1).

(3) For owners or operators electing to meet

the requirements of § 63.178(b), the report

shall include the information listed in

paragraphs (i) through (v) of this paragraph

for each process.

(i) Batch product process equipment train

identification;

(ii) The number of pressure tests

conducted;

(iii) The number of pressure tests where

the equipment train failed either the retest or

two consecutive pressure tests;

(iv) The facts that explain any delay of

repairs; and

(v) The results of all monitoring to

determine compliance with § 63.172(f) of this

subpart.

(4) Any revisions to items reported in

earlier Notification of Compliance Status, if

the method of compliance has changed since

the last report or any other changes to the

information reported has occurred.

[FR Doc. 97–7625 Filed 4–1–97; 8:45 am]

BILLING CODE 6560–50–P