[Federal Register Volume 65, Number 69 (Monday, April 10, 2000)]
[Proposed Rules]
[Pages 19152-19186]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7450]



[[Page 19151]]

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Part III





Environmental Protection Agency





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40 CFR Part 63



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

  Federal Register / Vol. 65, No. 69 / Monday, April 10, 2000 / 
Proposed Rules  

[[Page 19152]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[FRL-6564-6]
RIN 2060-AE83


National Emission Standards for Hazardous Air Pollutants for 
Pharmaceuticals Production

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; amendments.

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SUMMARY: On September 21, 1998 (63 FR 50280), EPA promulgated national 
emission standards for hazardous air pollutants (NESHAP) for 
Pharmaceuticals Production. On November 17 and 20, 1998, petitions for 
reconsideration and review of the September 1998 rule were filed in the 
U.S. Court of Appeals for the District of Columbia Circuit. The 
petitioners raised over 12 technical issues and concerns with the rule. 
Additional issues were raised by intervenors on the side of the 
petitioners. In this action, EPA proposes amendments to the 
Pharmaceuticals Production NESHAP to address these issues and to 
correct any other inconsistencies that were discovered during the 
review process.

DATES: The EPA will accept comments regarding this proposal on or 
before May 10, 2000.

ADDRESSES: Comments: Comments should be submitted (in duplicate, if 
possible) to: Air and Radiation Docket and Information Center (6102), 
Attention Docket Number A-96-03, Room M-1500, U.S. Environmental 
Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460. 
The EPA requests that a separate copy of each public comment be sent to 
the contact person listed below (see FOR FURTHER INFORMATION CONTACT). 
Comments may also be submitted electronically by following the 
instructions provided in SUPPLEMENTARY INFORMATION. 
    Docket: A docket, No. A-96-03, containing information relevant to 
these proposed amendments, is available for public inspection and 
copying between 8:30 a.m. and 5:30 p.m., Monday through Friday (except 
for Federal holidays) at the following address: U. S. Environmental 
Protection Agency, Air and Radiation Docket and Information Center 
(6102), 401 M Street, SW, Washington, DC 20460. The docket is located 
at the above address in Room M-1500, Waterside Mall (ground floor). 
Alternatively, a docket index, as well as individual items contained 
within the docket, may be obtained by calling (202) 260-7548 or (202) 
260-7549. A reasonable fee may be charged for copying docket items.

FOR FURTHER INFORMATION CONTACT: Mr. Randy McDonald, Organic Chemicals 
Group, Emission Standards Division (MD-13), U.S. Environmental 
Protection Agency, Research Triangle Park, North Carolina 27711, 
telephone number (919) 541-5402, electronic mail address 
[email protected].

SUPPLEMENTARY INFORMATION:

Docket

    The docket is an organized and complete file of all the information 
considered by the EPA in the development of this rulemaking. The docket 
is a dynamic file because material is added throughout the rulemaking 
process. The docketing system is intended to allow members of the 
public and industries involved to readily identify and locate documents 
so that they can effectively participate in the rulemaking process. 
Along with the proposed and promulgated standards and their preambles, 
the contents of the docket will serve as the record in the case of 
judicial review. (See section 307(d)(7)(A) of the Clean Air Act.) The 
regulatory text and other materials related to this rulemaking are 
available for review in the docket or copies may be mailed on request 
from the Air Docket by calling (202) 260-7548. A reasonable fee may be 
charged for copying docket materials.

Comments

    Comments and data may be submitted by electronic mail (e-mail) to: 
[email protected]. Electronic comments must be submitted as an 
ASCII file to avoid the use of special characters and encryption 
problems and will also be accepted on disks in WordPerfect 
version 5.1, 6.1 or Corel 8 file format. All comments and data 
submitted in electronic form must note the docket number: A-96-03. No 
confidential business information (CBI) should be submitted by e-mail. 
Electronic comments may be filed online at many Federal Depository 
Libraries.
    Commenters wishing to submit proprietary information for 
consideration must clearly distinguish such information from other 
comments and clearly label it as CBI. Send submissions containing such 
proprietary information directly to the following address, and not to 
the public docket, to ensure that proprietary information is not 
inadvertently placed in the docket: Attention: Ms. Melva Toomer, U.S. 
EPA, OAQPS Document Control Officer, 411 W. Chapel Hill Street, Room 
740B, Durham, NC 27701. The EPA will disclose information identified as 
CBI only to the extent allowed by the procedures set forth in 40 CFR 
part 2. If no claim of confidentiality accompanies a submission when it 
is received by the EPA, the information may be made available to the 
public without further notice to the commenter.

Worldwide Web (WWW)

    In addition to being available in the docket, an electronic copy of 
this proposed rule will be available on the WWW through the Technology 
Transfer Network (TTN). Following signature, a copy of the rule will be 
posted on the TTN's policy and guidance page for newly proposed or 
promulgated rules http://www.epa.gov/ttn/oarpg. The TTN provides 
information and technology exchange in various areas of air pollution 
control. If more information regarding the TTN is needed, call the TTN 
HELP line at (919) 541-5384.

Regulated Entities

    The regulated category and entities affected by this action 
include:

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                                                                                                 Examples of
        Category                         NAICS                          SIC codes            regulated entities
----------------------------------------------------------------------------------------------------------------
Industry................  325411 and 325412.................  2833 and 2834...............   Producers
                                                                                             of finished dosage
                                                                                             forms of drugs
                                                                                             (e.g., tablets,
                                                                                             capsules, and
                                                                                             solutions), active
                                                                                             ingredients, or
                                                                                             precursors.
                          Typically 325199..................  Typically 2869..............   Producers
                                                                                             of material whose
                                                                                             primary use is as
                                                                                             an active
                                                                                             ingredient or
                                                                                             precursor.
----------------------------------------------------------------------------------------------------------------

This table is not intended to be exhaustive, but rather provides a 
guide for readers likely to be interested in the revisions to the 
regulation affected by this action. To determine whether your facility, 
company, business, organization, etc., is regulated by this action, you 
should carefully examine all of the applicability criteria in 
Sec. 63.1250

[[Page 19153]]

of the promulgated rule, as well as in the proposed amendments to the 
applicability sections contained in this proposal. If you have 
questions regarding the applicability of these amendments to a 
particular entity, consult the person listed in the preceding FOR 
FURTHER INFORMATION CONTACT section.
    We are soliciting comment on the specific proposed amendments to 
the Pharmaceuticals Production NESHAP that are described below. We are 
not seeking comment on portions of the Pharmaceuticals Production 
NESHAP that we are not currently proposing to change.

I. Why Are We Proposing Changes to the Rule?

    On September 21, 1998, we promulgated NESHAP for Pharmaceuticals 
Production as subpart GGG in 40 CFR part 63. On November 17 and 20, 
1998, the Pharmaceutical Research and Manufacturers of America (PhRMA) 
filed petitions for reconsideration and review of the promulgated 
Pharmaceuticals Production NESHAP in the U.S. Court of Appeals for the 
District of Columbia Circuit, PhRMA v. EPA, 98-1551 (D.C. Cir.). Issues 
raised by the petitioners included applicability of the rule, 
definition of a process, the 98 percent reduction requirement for 
certain process vents, the alternative standard, and recordkeeping 
requirements. The intervenors raised additional issues regarding the 
applicability of the rule to specialty chemical manufacturers and the 
clarity of the rule, especially with respect to the leak detection and 
repair (LDAR) provisions. On December 21, 1999, the parties filed a 
motion to lodge a settlement agreement with the court. The settlement 
agreement established a schedule by which EPA would propose revisions 
to the NESHAP and the preamble language agreed to by the parties. The 
settlement agreement provided that EPA would sign proposed rule 
amendments no later than 60 days after execution of the settlement. The 
settlement agreement also provided that EPA would sign final rule 
amendments no later than 180 days after the date on which the proposed 
amendments were signed. On February 22, 2000, the parties filed a 
motion to lodge a stipulation to modify the settlement agreement. The 
parties agreed to change the date by which EPA must sign the proposed 
rule amendments from 60 to 90 days after the execution of the 
settlement agreement (March 20, 2000). The date by which EPA must sign 
the final amendments was not changed (August 21, 2000). Today's 
proposed amendments address the issues raised by PhRMA and the 
intervenors of the promulgated Pharmaceuticals Production NESHAP and 
include corrections and clarifications to ensure that the rule is 
implemented as intended. Today's proposed amendments also provide some 
new compliance options, as well as new provisions that would reduce the 
burden associated with demonstrating compliance. For example, vapor 
balancing is proposed as a compliance option for storage tanks in 
Sec. 63.1253(f), and the concept of a standard batch is proposed in 
Sec. 63.1259(b)(5) that would allow an owner or operator to reduce the 
amount of recordkeeping by defining an operating scenario based on a 
range of process operating conditions.

II. What Changes Are We Proposing?

    This section of the preamble describes the changes that we are 
proposing to make to subpart GGG and the rationale for the revisions.

A. Applicability of the Rule

    We are proposing three minor changes to Secs. 63.1250 and 63.1251 
to clarify how applicability determinations are to be reported and what 
constitutes a new affected source. First, in Sec. 63.1250(a), we are 
proposing to add a sentence specifying that applicability 
determinations are to be reported either as part of an operating permit 
application or as otherwise specified by the permitting authority. This 
change clarifies how to report applicability determinations. Second, 
Sec. 63.1250(b) of the Pharmaceuticals Production NESHAP specifies the 
date after which construction of a dedicated pharmaceutical 
manufacturing process unit (PMPU) is to be considered a new source, but 
it did not address reconstructed PMPUs. To correct this oversight, we 
are proposing additional language in Sec. 63.1250(b) to specify that 
dedicated PMPUs that are reconstructed after October 21, 1999 are new 
sources. This date corresponds with the completion of the settlement 
discussions (see section II.B of this preamble for a discussion of 
other changes to compliance dates). Third, in Sec. 63.1251, we are 
proposing to add a sentence to the definition of the term 
``construction'' to specify that adding equipment to a PMPU that is 
subject to existing source standards does not constitute construction, 
but it may constitute reconstruction. We are proposing this change to 
prevent any misinterpretation of the definition.
    In addition to these changes, we are also proposing to clarify the 
intended applicability of the Pharmaceuticals Production NESHAP by 
revising the definition of pharmaceutical product and related 
definitions that are used to define the affected source. These changes 
would clarify when an intermediate is considered a pharmaceutical 
product and, therefore, subject to the rule.
1. Pharmaceutical Product Definition
    We propose to revise the definition of ``pharmaceutical product.'' 
In the Pharmaceuticals Production NESHAP, the definition of 
``pharmaceutical product,'' along with the definitions of ``primary 
use,'' ``active ingredient,'' and ``precursor,'' are used to identify 
those manufacturing operations and facilities to which the NESHAP 
apply. Our intent is that the NESHAP apply to the manufacture of 
pharmaceutical active ingredients, final dosage products, and the 
manufacture of precursor chemical(s) whose ultimate primary use is to 
be subsequently processed through additional chemical transformations 
and separations into final drug products and pharmaceutical active 
ingredients. The definition of the term ``pharmaceutical product'' 
specifically excludes chemicals that are used as non-reactive solvents, 
excipients, binders, and fillers in the pharmaceutical manufacturing 
process. We also did not intend to regulate the manufacture of 
commodity chemicals under the NESHAP. The following discussion, in 
conjunction with the clarification in the regulatory text, is provided 
to assist in properly identifying those operations subject to the 
NESHAP.
    Most pharmaceutical products are produced in a multi-step 
manufacturing process. Pharmaceutical manufacturers themselves may 
perform all of the manufacturing steps that take comparatively basic 
chemicals and transform them into the typically complex molecules that 
are the active ingredients. The active ingredients are combined with 
excipients, binders, and fillers to produce finished dosage forms of 
the drug. Manufacturers might perform all of the steps at one site or 
they may perform steps at the manufacturer's different production 
sites. The production of active ingredients and precursors by 
pharmaceutical manufacturers is always subject to this standard. The 
sites performing these manufacturing operations are typically described 
by Sec. 63.1251, paragraph (4) of the pharmaceutical product definition 
in 40 CFR part 63, subpart GGG, as they usually will have a primary 
standard industrial classification (SIC) code of 2833 or 2834.

[[Page 19154]]

    Pharmaceutical manufacturers can also purchase commercially 
available pharmaceutical active ingredients and intermediates from 
other manufacturers or chemical brokers and rely on other manufacturers 
to perform some of the early or intermediate steps in the 
pharmaceutical manufacturing process. Many chemical manufacturers have 
divisions that specifically manufacture these pharmaceutical active 
ingredients and intermediates for sale to pharmaceutical manufacturers. 
Finally, pharmaceutical manufacturers often contract with another 
manufacturer to have a particular pharmaceutical intermediate produced. 
The sites performing these manufacturing operations are typically 
described by Sec. 63.1251, paragraph (5) of the pharmaceutical product 
definition in 40 CFR part 63, subpart GGG, and their pharmaceutical 
manufacturing operations are subject to the Pharmaceuticals Production 
NESHAP, even though the site's primary operations are chemical 
production, not pharmaceutical production.
    The Pharmaceuticals Production NESHAP are not intended to apply to 
the manufacture of commodity chemicals which are typically the basic 
building blocks of the chemicals that eventually become pharmaceutical 
products. Commodity chemicals are chemicals manufactured and sold in 
large quantities by chemical manufacturers using their own processes 
and formulas to meet specifications typically established by the 
marketplace. Commodity chemicals typically have a wide variety of 
applications, uses, and customers. The definition of the term 
``pharmaceutical product'' has been clarified to specifically exclude 
chemicals that are produced in a manufacturing process subject to 
subparts F and G of 40 CFR part 63, commonly referred to as the 
Hazardous Organic NESHAP (HON). The remainder of this discussion 
provides guidance on how to identify chemicals that we consider to be 
commodity chemicals for the purposes of the Pharmaceuticals Production 
NESHAP.
    First, we consider the chemicals identified in the ``Industrial 
Organic Chemical Use Trees'' (Final Report, October 1983, U.S. EPA) to 
be commodity chemicals (sometimes also referred to as industrial 
chemicals) that are not regulated by the Pharmaceuticals Production 
NESHAP. This list, which contains approximately 650 chemicals, is 
simply an illustration of some of the chemicals that are not regulated 
by the Pharmaceuticals Production NESHAP. Chemicals listed in subparts 
NNN and RRR of 40 CFR part 60, many of which are referenced in the 
chemical use tree report, are also to be considered commodity 
chemicals. There are also many inorganic chemicals, gases, other 
organic chemicals and mixtures with non-pharmaceutical uses that are 
considered commodity chemicals, not active ingredients, and are not 
covered by the Pharmaceuticals Production NESHAP even though some 
portion of their production is sold to and used by the pharmaceutical 
industry. It would not be possible or practical to list all such 
chemicals in the text of the proposed amendments or in this preamble. 
The list would be too long and always out of date as new chemicals and 
mixtures are constantly created and new uses for existing chemicals and 
mixtures continue to be discovered. We do not intend to bring under the 
Pharmaceuticals Production NESHAP the manufacture of chemicals which 
are not produced specifically for use as an active ingredient or as a 
precursor to the manufacture of an active ingredient and which are not 
primarily used in the manufacture of pharmaceuticals.
    Second, chemicals subject to the inventory update report (IUR) 
requirement of the Toxic Substances Control Act (TSCA), section 8(a), 
and the implementing regulations found in 40 CFR part 710 are likely to 
be commodity chemicals or chemicals that do not have any significant 
pharmaceutical use and, thus, will not likely be subject to the 
pharmaceutical standards. Unlike the reference to the chemical tree 
that broadly applies to the manufacture of the listed chemicals at any 
site, this paragraph applies to site-specific manufacturing. The IUR 
requires chemical manufacturers (including importers) to provide 
information every 4 years about chemical substances they manufacture 
(including imports) in annual quantities of 10,000 pounds or more at 
each plant site they own or control. The information required includes 
company name, plant site location, plant site Dun and Bradstreet 
number, the identity of the chemical substance, and the production 
volume of the chemical substance. A material that is regulated by the 
Food and Drug Administration (FDA) is not a ``chemical substance'' 
regulated by TSCA, and as such, would not have to be on the TSCA 
Inventory and would not be subject to the IUR. If a chemical 
manufacturing facility is reporting its production of a particular 
chemical under the IUR, that chemical is most likely a commodity 
chemical and not primarily an active ingredient or a pharmaceutical 
precursor. Conversely, the fact that a manufacturer does not have an 
IUR reporting obligation for a chemical does not necessarily have any 
bearing on whether the material would be a ``pharmaceutical product.'' 
For example, under the IUR requirements, chemicals that are 
manufactured in annual quantities of less than 10,000 pounds do not 
have to be reported under the IUR, nor do certain polymers, inorganic 
chemicals, and naturally occurring materials which are not required to 
be placed on the TSCA Inventory.
    We expect that manufacturers of finished drug products and active 
ingredients will have sufficiently complete knowledge of their 
products' use to enable them to make applicability determinations that 
fully comport with our intended implementation of the ``pharmaceutical 
product'' definition. Likewise, chemical manufacturing companies who 
market particular chemicals for use as pharmaceutical intermediates and 
active ingredients at the time they manufacture a chemical should be 
able to make accurate applicability determinations (i.e., to know 
whether the primary use is as a pharmaceutical active ingredient or 
precursor). We recognize that there may be cases where the customer of 
the manufacturer does not inform the manufacturer of the intended use 
of the material due to the customer's interest in protecting its trade 
secrets or other competitive concerns. Chemical manufacturers who 
market a chemical as being used in the pharmaceutical industry or 
manufacture a chemical under a specific contract (toll manufacturing) 
with a pharmaceutical manufacturer will need to make an applicability 
determination at the time of manufacturing by considering information 
about the past and projected use of the chemical, the location to which 
the chemical is shipped, and other circumstances regarding the 
production of the chemical.
2. Definition of Precursor
    We are proposing to add a definition of ``precursor'' to more 
clearly identify what materials are pharmaceutical intermediates. Our 
intent is to regulate the intermediate materials that are integral to 
the production of ``active ingredients.'' Typically, pharmaceutical 
precursors are complex chemicals that have few if any commercially 
recognized uses outside of the production of pharmaceuticals. We are 
not aware of the existence of any comprehensive list of pharmaceutical 
intermediates and even if such a list existed, it would be difficult to 
keep up-

[[Page 19155]]

to-date. As stated above, we do not intend to bring within the 
Pharmaceuticals Production NESHAP the manufacture of commodity 
chemicals. We intend for the precursor definition to clarify where this 
line between pharmaceutical intermediates and commodity chemicals can 
be drawn.
    The term ``precursor'' means a material produced for the purpose of 
producing a pharmaceutical product. It does not mean any and every 
chemical upstream of the finished dosage form or the active ingredient 
because that would ultimately encompass commodity chemicals. For 
example, if the pharmaceutical active or intermediate is a chemical 
ABCD, the precursors are those chemicals specifically produced to 
manufacture ABCD. If the way this pharmaceutical material is produced 
is to manufacture the materials AB and CD and then react AB and CD, 
then the precursors to ABCD are AB and CD. If the raw materials for 
making AB and CD are chemicals A, B, C, and D, and these chemicals are 
commodity chemicals or chemicals that have many uses unrelated to 
pharmaceutical manufacturing, they are not ``precursors'' for the 
purposes of the Pharmaceuticals Production NESHAP. Alternatively, if 
chemicals A, B, C, and D are primarily produced for the purpose of 
producing AB and CD, then they would be considered precursors and, 
thus, ``pharmaceutical products'' under the Pharmaceuticals Production 
NESHAP.
    Materials that are intended to be pharmaceutical intermediates 
(i.e., precursors) frequently are manufactured according to current 
Good Manufacturing Practices (cGMP) (21 CFR parts 210 and 211), which 
have been promulgated by the FDA. The requirement for cGMP is 
determined by the FDA and the pharmaceutical manufacturer when the drug 
manufacturing process is first described in a master file or drug 
application. Considerations the FDA uses in requiring cGMP include the 
commercial availability of starting materials and how close an 
intermediate is to the final product form. Once the FDA and the 
pharmaceutical manufacturer have documented the manufacturing 
requirements and the process in the master file and/or drug 
application, this process and the requirements of cGMP must be followed 
no matter where the manufacturing process occurs. Thus, chemicals which 
are required to be manufactured according to cGMP, as shown in the 
master file or drug application for the ultimate active ingredient or 
drug product, would be considered precursors. However, a chemical may 
be manufactured under cGMP for reasons other than because the chemical 
is a precursor or active ingredient. Chemicals intended for use as 
binders, excipients, or fillers may be manufactured under cGMP, but 
these materials are excluded from coverage under the Pharmaceuticals 
Production NESHAP. Other chemicals or materials manufactured under cGMP 
are not covered by the Pharmaceuticals Production NESHAP because they 
do not meet the definition of an ``active ingredient'' (e.g., food, 
food additives, color additives, in-vitro diagnostic substances, x-ray 
file, test indicator devices, and medical devices such as implants, 
artificial joints, surgical bandages, and stitching materials).
3. Definition of Primary Use
    We are proposing changes to the primary use criteria that apply to 
active ingredients and precursors to avoid the unintended regulation of 
chemical manufacturing processes that produce chemicals that have a 
minor use as a pharmaceutical active ingredient or precursor. If 
greater than 50 percent of the projected use of a material produced by 
a chemical manufacturing site will be either as an active ingredient or 
a precursor to an active ingredient, then the material is a 
``pharmaceutical product,'' and the manufacturing operation is subject 
to regulation under the Pharmaceuticals Production NESHAP for the 
period of time it is manufacturing that material. A number of other 
Clean Air Act (CAA) standards have in place some type of 50 percent 
test to classify the manufacturing operation for regulatory 
applicability purposes.
    A chemical manufacturer will have to consider information about 
past and projected uses of a chemical that is not a commodity chemical 
to determine whether the chemical's primary use is as a pharmaceutical 
product. A manufacturer should consider specific information about how 
its customers are using a material, if that information is available to 
the manufacturer. Otherwise, the chemical manufacturer will have to 
make assumptions about uses depending on who the customers are and 
based on the nature of the chemical. For example, if the manufacturer 
is manufacturing a chemical that is an intermediate (i.e., a chemical 
that will be used in a process to produce other chemicals), then the 
manufacturer should consider what products the customer manufactures. 
If the customer manufacturers pharmaceutical products (i.e., has 
operations covered under SIC codes 2833 and 2834), the chemical 
manufacturer may inquire as to whether the chemical is used to 
manufacture an active ingredient or precursor or may assume that some 
or all of the chemical intermediate sent to the customer may be used as 
an active ingredient or precursor and produce that material subject to 
the Pharmaceuticals Production NESHAP. If the material sent to the same 
customer is not an intermediate, but rather a trade name product with a 
specific use or set of uses and that use or those uses would not be as 
an active ingredient, or as a precursor, then that quantity would not 
have to be considered as having a pharmaceutical use. For example, 
shipping a heat transfer fluid or cooling tower water treatment 
chemical to a pharmaceutical manufacturer does not create the 
presumption that the chemical is being used in the manufacture of 
pharmaceutical products in such a manner as to bring its manufacture 
under the Pharmaceuticals Production NESHAP.
    The period of time to use for making the primary use determination 
will vary depending on the circumstances under which the chemical is 
manufactured. For example, if a chemical is manufactured under a 
specific contract with a customer or customers, then the projected use 
of the chemical by the customers during the period of time of the 
contract would be considered. Another example would be if a chemical is 
produced in a single campaign. The manufacturer will have to consider 
its customer's projected use at the start of the campaign for the 
material based on how the manufacturer markets the chemical and other 
available information to determine whether greater than 50 percent of 
the chemical to be produced in the upcoming campaign will be used as a 
pharmaceutical product, in which case the manufacturing operation would 
be subject to the Pharmaceuticals Production NESHAP. For the situation 
in which a material is manufactured on a continued basis, the primary 
use determination should be based on a projected annual use.
    To make the primary use determination, the chemical manufacturer 
will use the total amount of the chemical projected to be produced over 
each specified period of time as the denominator, and then use as the 
numerator the amount of that chemical that is projected to be either 
used as an active ingredient and/or as a precursor for the same period 
of time. The chemical manufacturer will exclude from the numerator the 
amount of material that is used for non-

[[Page 19156]]

pharmaceutical uses and the amount used in the pharmaceutical industry 
for such uses as an excipient, binder, filler, or non-reactive solvent.
4. Definition of Active Ingredient
    We are proposing to clarify the definition of ``active ingredient'' 
by identifying some of the materials that are not intended to come 
within the scope of this term. Because the definition of the term 
``active ingredient'' is based on terminology used by the Federal Food 
Drug and Cosmetic Act, the language of what is excluded is also 
borrowed from that. Excluded from the definition are foods, food 
additives (other than vitamins and materials described in SIC codes 
2833 and 2834), color additives, in-vitro diagnostic substances, x-ray 
film, test indicator devices, and medical devices such as implants, 
artificial joints, surgical bandages, and stitching materials. We never 
intended for the manufacture of these materials to be subject to the 
Pharmaceuticals Production NESHAP. The Pharmaceuticals Production 
NESHAP were developed to regulate the emissions from manufacturing 
processes that produce active ingredients and precursors.

B. Compliance Dates

1. Existing Sources
    The Pharmaceuticals Production NESHAP promulgated on September 21, 
1998, specifies that existing sources must be in compliance with the 
NESHAP no later than September 21, 2001, unless an extension is granted 
in accordance with Sec. 63.1250(f)(4). We are proposing a new 
compliance date of October 21, 2002 because the proposed amendments are 
sufficiently far reaching and complex that an amended rule would 
effectively be a new rule warranting a new compliance date.
    Section 112(a)(3) of the CAA provides that existing sources are to 
be in compliance with applicable emission standards ``as expeditiously 
as practicable, but in no event later than 3 years after the effective 
date of such standard.'' The September 21, 1998, Pharmaceuticals 
Production NESHAP specifies a compliance date 3 years from the issuance 
of that rule. Section 112(d)(6) provides authority for the 
Administrator to revise the emission standards issued under section 112 
``no less often than every 8 years.'' We believe the authority to 
revise the standards inherently includes the authority to set new 
compliance dates for revised rules. Congress provided us discretion to 
set a compliance date for existing sources of up to 3 years in order to 
provide time for retrofitting of controls where necessary. Thus, due to 
the extensive nature of the proposed amendments, we are proposing a new 
compliance date.
    We believe that 13 months from the otherwise applicable compliance 
date will be sufficient for all sources to come into compliance with 
the proposed amendments. However, should any source be unable to meet 
that compliance date because of the need to install controls that 
cannot be installed by that date, each source may request an extension 
of up to 1 year in accordance with Sec. 63.1250(f)(6) of the proposed 
amendments.
2. New Sources
    The Pharmaceuticals Production NESHAP specifies that new sources 
must comply with the NESHAP on September 21, 1998, or upon startup, 
whichever is later. However, an exception to this requirement was also 
provided. If the Pharmaceuticals Production NESHAP were more stringent 
than the proposed rule, the owner or operator would have until 3 years 
after September 21, 1998 to comply with the NESHAP. We are proposing 
comparable language to address the event that the final amendments 
would be more stringent than either the Pharmaceuticals Production 
NESHAP or these proposed amendments. The compliance date for complying 
with the final amendments and the requirements with which the owner or 
operator must comply until that date vary depending on the date 
construction or reconstruction commenced. Separate requirements are 
proposed for three time periods. In each case, we believe the allotted 
times, based on the settlement agreement, will be sufficient for all 
sources to come into compliance with the proposed amendments.
    The first set of requirements would apply to new sources that 
commenced construction or reconstruction between the proposal and 
promulgation dates (i.e., April 2, 1997 and September 21, 1998) if 
final amendments were to be more stringent than the Pharmaceuticals 
Production NESHAP. We are proposing that these sources come into 
compliance by September 21, 2001, and we are proposing that they comply 
with the April 12, 1997 proposed rule until that date.
    The second set of requirements would apply to new sources that 
commenced construction or reconstruction between September 21, 1998 and 
April 10, 2000 if final amendments were to be more stringent than the 
Pharmaceuticals Production NESHAP. We are proposing that these sources 
come into compliance by October 21, 2002. In the absence of the 
proposed amendments, these sources would be required to comply with the 
NESHAP upon startup. Therefore, we are proposing that they continue to 
comply with the NESHAP until October 21, 2002.
    The third set of requirements would apply to new sources that 
commence construction or reconstruction between April 10, 2000 and the 
date the final amendments are published if the final amendments were to 
be more stringent than the proposed amendments. We are proposing that 
these sources come into compliance by the date 1 year after publication 
of the final amendments, and we are proposing that they comply with the 
NESHAP between startup and the date 1 year after publication of the 
final amendments.

C. Overlapping Regulations

1. Overlap with Subpart PPP of 40 CFR Part 63
    We are proposing to add a new paragraph at Sec. 63.1250(h)(6) that 
would specify alternative procedures to address overlap situations 
between the pharmaceuticals NESHAP and the polyether polyols NESHAP in 
40 CFR part 63, subpart PPP. This paragraph would specify that an owner 
or operator may elect to demonstrate compliance with the process vent 
standards in Sec. 63.1254 by either controlling all process vents 
within the process by the most stringent requirements in subpart PPP 
(i.e., Sec. 63.1425(b), (c)(1), (c)(3), (d), and/or (f)), or by 
identifying those vents that would require control under Sec. 63.1254 
and controlling only those vents by the most stringent requirements in 
subpart PPP. If you own or operate an affected source and you elect to 
demonstrate compliance with an amended subpart GGG by controlling 
process vents within the process in accordance with the requirements in 
subpart PPP, you would still be required to comply with all other 
requirements in subpart GGG for the corresponding PMPU (e.g., the 
storage tank, wastewater, and equipment leak standards and their 
corresponding initial and continuous compliance requirements and 
recordkeeping and reporting requirements). The proposed paragraph does 
not simply state that compliance with the requirements of subpart PPP 
would constitute compliance with an amended subpart GGG because it is 
possible that certain process vents that require control under an 
amended subpart GGG would not meet the applicability requirements for

[[Page 19157]]

control under subpart PPP. We believe the proposed requirements are 
reasonable because the control achieved for process vents complying 
with subpart PPP would be equal to or greater than the control achieved 
for process vents complying with an amended subpart GGG. In addition, 
the monitoring, recordkeeping, and reporting requirements for process 
vents in the two rules are similar.
2. Overlap With Resource Conservation and Recovery Act Wastewater 
Provisions
    We are proposing several changes to Sec. 63.1250(h)(5) to clarify 
compliance requirements and options for wastewater that is subject to 
both subpart GGG and 40 CFR parts 260 through 272. Some of the changes 
are needed because it is possible that the promulgated language could 
be interpreted to mean that every owner or operator must determine 
which provisions are the most stringent. This was not our intent. 
However, we do believe an owner or operator must determine the most 
stringent requirements if the owner or operator wants to comply with 
only one of the rules. We believe this determination is necessary 
because it is not possible to categorically state which rule is the 
most stringent. One reason for this is that wastewater conditions and 
systems vary from site to site. Furthermore, subpart GGG includes 
requirements for individual drain systems, but 40 CFR parts 260 through 
272 do not.
    To clarify our intent, we are proposing to delete the last sentence 
in the section, state in the first sentence that the owner or operator 
``may elect to determine'' which provisions are the most stringent, and 
add several new statements. One of the new statements specifies that 
compliance with provisions of 40 CFR parts 260 through 272 that are 
determined to be more stringent than the requirements of subpart GGG 
constitutes compliance with subpart GGG. As an example of more 
stringent requirements that constitute compliance with subpart GGG, a 
second statement cites the provisions of 40 CFR parts 260 through 272 
for treatment units that meet the conditions specified in 
Sec. 63.1256(g)(13). This example may help to reduce the burden of 
making a stringency determination. To address a reporting oversight in 
the Pharmaceuticals Production NESHAP, the third proposed statement 
would require the owner or operator to identify in the Notification of 
Compliance Status report both the more stringent provisions of 40 CFR 
parts 260 through 272 with which the owner or operator will comply, and 
the information and procedures used to make any stringency 
determinations. The last of the proposed new statements specifies that 
Sec. 63.1250(h)(6) does not apply if the owner or operator elects not 
to determine which provisions are the most stringent, and that the 
owner or operator must comply with the provisions in both rules. 
Finally, we are also proposing minor editorial changes to clarify our 
intent.
3. Overlap with Subpart I
    Section 63.1250(h)(4) specifies procedures for equipment that is 
subject to both subpart GGG and 40 CFR part 63, subpart I. We are 
proposing several editorial changes to this section to clarify that, 
for equipment subject to both rules, an owner or operator may elect to 
comply with either the provisions in Sec. 63.1255 or with the 
provisions in subpart H of 40 CFR part 63.
4. Overlapping Requirements for Offsite Cleaning and Reloading 
Facilities
    Section II.J. of this preamble describes proposed vapor balancing 
provisions for storage tanks. One of these provisions is that offsite 
reloading and cleaning facilities must control emissions from railcars 
and tank trucks used in vapor balancing at the affected source by 
either connecting them to a closed vent system with a control device 
that reduces emissions by 90 percent by weight, or by connecting them 
to a vapor balancing system during reloading. However, we are proposing 
to add a new paragraph at Sec. 63.1250(h)(1)(ii) to state that an 
offsite reloading or cleaning facility in compliance with all of the 
control requirements of any other standard in 40 CFR part 63 is in 
compliance with the requirements of subpart GGG.

D. Definition of Process

    We are proposing to revise the definition of the term ``process'' 
in order to achieve a more uniform and replicable entity for basing 
applicability of the rule. The Pharmaceuticals Production NESHAP uses 
the concept of a process as the defining entity for applicability. The 
NESHAP require that the owner or operator consider emissions from all 
sources within a process in order to determine what requirements apply. 
Therefore, it is important to the overall effectiveness and uniformity 
of the NESHAP that the definition of process is consistently applied 
across the industry.
    In the April 2, 1997, proposed rule, the definition of process 
included the concept of isolated intermediates, which was intended to 
encompass essentially the same set of unit operations that we are 
proposing today. However, during the public comment period following 
proposal, some commenters objected to the requirement that material be 
removed from the process equipment in order to be considered an 
isolated intermediate. Other commenters believed the concept of 
isolated intermediates was unnecessary; they believed that all 
operations leading to the production of a final pharmaceutical product 
could be considered a single process. In addition, we realized that the 
definition of isolated intermediate could be problematic because it 
could be interpreted in many ways. To address these concerns we decided 
to eliminate the concept of isolated intermediates from the definition 
of process for the promulgated rule. We also revised the definition to 
consider all operations leading up to a final pharmaceutical product, 
except in two circumstances. One exception is where an intermediate is 
used to manufacture more than one product, and the second is where an 
intermediate is stored for more than 30 days before subsequent 
processing. Although we made these changes in an effort to eliminate 
confusion in how to define a process, the changes had other, unintended 
consequences.
    Since promulgation, we have learned that the 30-day storage 
provision could lead to different interpretations of the number of 
operations considered within the same process boundaries. For example, 
the period for which a given intermediate could or would be stored 
prior to further processing might vary according to production 
scheduling depending upon availability of materials and processing 
equipment, demand, and other reasons. The 30-day holding time could 
therefore result in constantly changing, unpredictable, and 
unrepeatable process boundaries. We also now realize that including all 
intermediate steps in the definition of process may have the same 
effect. This could occur because not all intermediate steps are 
manufactured in the same process sequence or at the same facility all 
the time. Nonrepeatable process boundaries are problematic because they 
could result in inconsistencies in the way in which the NESHAP is 
implemented.
    To address these concerns, we are proposing to eliminate the 30-day 
storage provision and redraw the boundaries of a process around a more 
repeatable unit. The unit we selected is that of the single process 
``step'' that results in the production of a pharmaceutical product, 
which could be an isolated intermediate, active

[[Page 19158]]

ingredient, or final dosage form of drug. The defining characteristic 
of the proposed process definition is that it considers all unit 
operations associated with generating one or more materials that are 
stable, isolated, and ultimately stored (see definition of product and 
isolated intermediate). The concept of storage has intentionally not 
been defined by a period of time to prevent problems comparable to 
those caused by the 30-day storage period in the promulgated 
definition. Moreover, the intent of the storage reference in the 
definition of isolated intermediate is to draw the boundaries of the 
process around the unit operations that generate a product that is 
stored at any time (see discussion of isolated intermediate in section 
II.E of this preamble). These proposed changes provide a more clearly 
defined final step for a process than in the originally proposed 
definition. In addition, because of the proposed facilitywide cap on 
emissions from process vents for which the owner or operator complies 
with the annual mass emission limit (see section II.G. of this 
preamble), any incentive to create additional processes would be 
minimized.
    As a result of this proposed change in the definition of process, 
we are proposing changes to other provisions to ensure that an amended 
rule would provide the same level of emissions reductions as the 
promulgated rule. For details on these other proposed changes, see 
discussions on definition of storage tank, annual mass emission limit 
standards for process vents, pollution prevention (P2) provisions, and 
wastewater load cutoffs in sections II.F., II.G., II.K., and II.M., 
respectively.

E. Definition of Isolated Intermediate

    As part of the change in the definition of process, we are 
proposing to add the term ``isolated intermediate.'' The purpose of the 
term ``isolated intermediate'' is to provide a bright line guide for 
identifying the boundaries between processes. This definition, in 
conjunction with the definition of ``process,'' simply provides that a 
process ends when an intermediate compound is placed in equipment that 
is used solely within the given process for purposes of storage. For 
example, if a compound is produced in Reactor A and then transferred 
directly to Reactor B, where a subsequent reaction takes place, then 
Reactor A and Reactor B belong to the same process because the product 
of Reactor A is not placed in storage equipment prior to further 
processing. This would be true even if two or more batches from Reactor 
A must be accumulated in Reactor B prior to initiating the reaction in 
Reactor B. As another example, assume that the compound produced in 
Reactor A is sometimes put into drums for temporary storage prior to 
subsequent processing in Reactor B. In this case, the drum storage 
marks the end of a process, and Reactor B represents the beginning of 
the next process. This would be true even if the storage is for a short 
time and even if the material is drummed off infrequently. All that 
matters for the purposes of identifying the process boundary is that 
storage occurs. It may sometimes be necessary to put off-spec material 
into storage for the period until it can be reprocessed or disposed of. 
We do not intend that infrequent, unplanned events such as these should 
create process boundaries.

F. Definition of Storage Tank

    To be consistent with the proposed changes to the definition of 
``process,'' we are also proposing to revise the definition of 
``storage tank.'' The promulgated definition of ``storage tank'' 
specifies that a storage tank contains either a feedstock or a product 
of a process (i.e., on a process flow diagram, a storage tank is 
located on one side of the process--either before or after it). Process 
tanks are tanks within a process; the tanks receive material from the 
process and discharge material to the same process (i.e., they would 
have the process on both sides). Because the promulgated process 
definition encompassed many processing steps, we believed that the 
promulgated storage tank definition would mostly capture raw material 
and solvent storage tanks. We believed there would be few product tanks 
because final products would most likely not contain solvents and would 
be stored in drums or other containers suitable for small quantities.
    However, the proposed process definition would result in far more 
products of processes, such as isolated intermediates. The vessels 
storing these products would be considered storage tanks under the 
promulgated definition, but the characteristics of these tanks would 
more likely resemble process tanks. Isolated intermediate tanks would 
most likely have smaller capacities than raw material or solvent 
storage tanks, would be expected to operate at higher than ambient 
temperatures, and would be more likely to experience higher throughputs 
and possibly more constant levels. Emissions from these process tanks 
could also be linked with the other operations conducted in a process 
on a per-batch basis. Therefore, we decided to clarify the definition 
of ``storage tank'' to include only raw material coming into the 
process.
    We are also proposing to revise the ``storage tank'' definition to 
include solvent storage tanks located in tank farms that receive spent 
solvent from one or more processes. Typically, these tanks (which are 
generally 20,000 gallons or higher) are considered storage tanks in 
previous MACT standards; therefore, the proposed change would make the 
rule consistent with previous rules.

G. Annual Mass Emission Limit Standards for Process Vents

    As a result of the proposed change to the definition of 
``process,'' we were concerned that the ``shortening'' of the process 
might have some unintended consequences relating to a reduction in the 
amount of HAP emissions reductions resulting from NESHAP. Under the 
promulgated rule, the owner or operator of an existing source can 
comply with the annual mass emission limit standard for as many as 
seven processes. The seven process limit was based on a review of 
emissions from the industry which showed only 168,000 pounds per year 
(lb/yr), out of 16,246,000 lb/yr nationwide, were emitted from 
processes with emissions less than 2,000 lb/yr. On average, there were 
seven processes per facility that contributed to this 168,000 lb/yr. 
With the proposed change in the definition of ``process,'' however, an 
owner or operator could conceivably exempt more emissions than the 
168,000 lb/yr that were originally anticipated if they could redraw 
process boundaries to utilize all 2,000 lb/yr of the exemption per 
process. An analysis of the database also indicated that, of the 
approximately 12 million lb/yr reduction of HAP associated with the 
process vent MACT alternative, about 0.5 million lb/yr of reductions 
would be attributed to processes left uncontrolled or to processes 
controlled down to 2,000 lb/yr, and the remaining 11 million lb/yr 
would be attributed to achieving 93 percent reduction. For the expected 
100 facilities in the source category, the amount of emissions exempted 
by using the 2,000 lb/yr alternative would average 5,000 lbs/yr (2.5 
tons) per facility.
    The average emissions per facility from processes for which an 
owner or operator complies with the 2,000 lb/yr limit could be much 
higher than 5,000 lb/yr, and nationwide emissions reductions could be 
much lower, under these proposed amendments than under the NESHAP. To 
prevent this unintended result, we are proposing several changes. One 
change is to replace the seven process limit with a facilitywide 
emission limit of 4,000 lb/

[[Page 19159]]

yr. This change would not only preserve the emissions reductions 
originally anticipated from the process definition, but would also 
simplify the process vent provisions. A second proposed change is to 
extend the 2,000 lb/yr/process emission limit to include vents in 
processes where at least one stream was required to meet the 98 percent 
reduction requirement. Under the promulgated rule, the owner or 
operator was required to reduce emissions from these ``leftover'' vents 
by 93 percent. However, this restriction is no longer necessary because 
the 4,000 lb/yr facility cap would preserve the intended overall 
emissions reductions. Similarly, we propose eliminating the 100 lb/yr 
process de minimis cutoff because the 2,000 lb/yr process limit, or the 
4,000 lb/yr facility limit, would apply to these processes as well. 
Finally, we are proposing to express the limits only in metric units 
(i.e., 900 kilograms per year (kg/yr) and 1,800 kg/yr, respectively).
    We are also proposing to replace the 400 lb/yr (uncontrolled) 
cutoff for new sources with an 1,800 kg/yr (uncontrolled) facility cap. 
This change was needed because the new source MACT standard would have 
been more stringent than the existing source MACT standard had the 
format and emission limit not been changed.

H. 98 Percent Standard for Process Vents at Existing Sources

    We are proposing to make changes to the applicability of the 98 
percent individual process vent requirement. The promulgated rule 
requires 98 percent control of emissions from process vents that meet 
the total resource effectiveness (TRE) criteria. This requirement is 
accompanied by a ``grandfathering'' provision that exempts these 
process vents from the 98 percent control requirement if they were 
controlled to at least 93 percent prior to the proposal date.
    The original basis for the grandfathering provision provided in the 
promulgated rule is that it was not cost effective to replace existing 
devices that could meet the floor level of control, 93 percent, for the 
incremental 5 percent control. However, upon replacement (i.e., 
starting from scratch after the useful life of the device is over), 
upgrading from 93 percent to 98 percent control is cost effective. The 
promulgated rule language inadvertently grandfathered the process 
rather than the control device. As a result, the promulgated rule has 
an unintended adverse effect on one segment of the industry (i.e., 
nondedicated processes). Since nondedicated, multipurpose facilities 
are constantly undergoing product changes, the introduction of new 
processes, which could not be grandfathered, would drive these 
facilities toward replacing existing devices with devices that could 
meet 98 percent almost immediately. However, for dedicated processes, 
the promulgated grandfathering provision exempted the existing process 
from the 98 percent requirement indefinitely.
    To correct this unintended inequity, the proposed revisions 
grandfather the ``control device'' rather than the process vent. As 
noted above, an aspect of the original analysis was that it was cost 
effective to upgrade to 98 percent control when replacing the control 
device. In addition, further consideration was given to the useful life 
of a control device. The useful life typically is 10 to 20 years, 
depending on the type of device. Therefore, today's proposed amendments 
would require an owner or operator of both types of processes to meet 
the 98 percent control requirement upon replacement or reconstruction 
of the control device, or upon reaching a date either 15 years from 
issuance of a facility's preconstruction permit, or April 2, 2007, 
whichever is later. This proposed language provides a definite date by 
which all such devices must be replaced. Thus, in 2007, control devices 
installed before the Pharmaceuticals Production NESHAP proposal will be 
more than 10 years old and, on average, should be about at the end of 
their useful lives.
    In addition to these changes, we are also proposing two additional 
exemptions from the 98 percent control requirement. The first of these 
proposed provisions is designed to encourage pollution prevention (P2). 
Specifically, the owner or operator would be exempt from the 98 percent 
control requirement if the TRE vent is controlled to at least the MACT 
floor level of control (93 percent), and the production-indexed HAP 
consumption factor for the process is reduced by at least 50 percent. 
The second of the new provisions would allow processes containing 
hydrogenation vents to maintain the level of control achieved on the 
date of these proposed amendments while requiring at least 95 percent 
reduction on all other vents within the process. This provision would 
allow an owner or operator to control processes containing 
hydrogenation vents at higher levels than the floor, but less than the 
98 percent requirement. We are proposing to add this language to 
address concerns that controlling some hydrogenation vents can be 
unsafe.

I. The Alternative Standard

    We are proposing several changes to the alternative standard. These 
changes include new terminology and additional language clarifying when 
HAP concentrations in gas streams exiting control devices must be 
corrected for dilution. We are also proposing additional procedures for 
demonstrating compliance that an owner or operator may use in lieu of 
the concentration corrections. The following discussion describes our 
rationale for developing an alternative standard, summarizes our 
reasons for requiring concentration corrections and how these 
requirements were included in the promulgated rule, and describes our 
proposed changes to the alternative standard.
1. Rationale for an Alternative Standard
    The Pharmaceuticals Production NESHAP and today's proposed 
amendments contain several options that allow an owner or operator to 
meet a concentration cutoff at the outlet of a control device as a 
means of achieving compliance with the standards. The most common 
option is referred to as the alternative standard which requires 
continuous (15-minute) monitoring of control device outlet 
concentration. The alternative standard also enables compliance to be 
evaluated at a single point (the outlet of the device) regardless of 
how many processes or unit operations are tied into the control device 
inlet. In addition, only one violation per day is assigned for each 
device complying with the alternative standard. In contrast, compliance 
with other options is evaluated on a process basis even if multiple 
processes are tied into a common control device. If monitoring 
parameters for these devices are exceeded, these exceedances could 
result in one violation per process per day. Therefore, the alternative 
standard is viewed as a critical element of the NESHAP and proposed 
amendments for end-of-line control devices that service numerous unit 
operations and processes, and it is expected to be utilized widely by 
the industry.
2. Correcting Concentrations for Dilution
    In establishing the alternative standard, we were concerned that an 
owner or operator could use dilution as a means of achieving compliance 
with the standard. Although this practice is addressed in the General 
Provisions (see Sec. 63.4(b)), we recognize that there are valid 
circumstances where air or inert gases are introduced into manifolds 
for safety and design considerations, and that these practices should 
not be

[[Page 19160]]

viewed as strictly prohibited by the above-referenced passage in the 
General Provisions if the effect of adding these gases can somehow be 
considered. Therefore, we sought to address these situations in the 
proposed amendments in several ways.
    In Sec. 63.1257(b)(6), the NESHAP requires that concentration 
measurements ``be adjusted to negate the dilution effects of 
introducing nonaffected gaseous streams into the vent streams prior to 
control or measurement * * *.'' One of the intended results of this 
language was to require owners or operators complying with the 
alternative standard to adjust their measured concentrations by 
considering the amount of diluent gas introduced into the system prior 
to comparing this value against the concentration limit. (Another 
intended result of Sec. 63.1257(b)(6) was to consider diluent gases in 
defining a process vent--process vents must contain at least 50 parts 
per million by volume (ppmv) HAP, on an undiluted and uncontrolled 
basis.)
    Another requirement addressed combustion devices specifically. 
Because combustion devices operate such that the characteristics of the 
incoming stream are chemically changed, a simple correction for 
dilution at the inlet of the device will not directly and 
proportionally correct the concentration at the outlet of the device. 
Therefore, for combustion devices, the NESHAP also requires that an 
owner or operator consider dilution by correcting the outlet 
concentration to 3 percent oxygen (see Sec. 63.1257(a)(3)). The NESHAP 
further states in Sec. 63.1257(d)(3)(ii) that this correction should be 
made when the control device is a combustion device that uses 
supplemental combustion air.
    The intent of the provisions described above was to require the 
correction only when nonaffected streams (i.e., diluent gases or 
supplemental combustion air) were introduced into the vent or manifold. 
However, supplemental combustion air was not specifically defined, and 
the location of the referenced language (under the process vent 
compliance determination procedures, rather than the general compliance 
determination procedures) made the intent of this requirement somewhat 
unclear.
    The 3 percent correction factor was first used in the new source 
performance standards (NSPS) for air oxidation unit processes, 
distillation operations, and reactor processes in the synthetic organic 
chemical manufacturing industry (40 CFR part 60, subparts III, NNN, and 
RRR), and later, the HON. The value of 3 percent originates from good 
engineering practices. For the oxygen deficient streams found in these 
industries, if the proper amount of supplemental combustion air is 
added, the outlet stream would contain approximately 3 percent oxygen. 
The concept of requiring the correction to 3 percent oxygen only when 
supplemental combustion air is used has a precedent in the Polymer 
Manufacturing NSPS (40 CFR part 60, subpart DDD). In the development of 
that standard, commenters suggested that requiring the 3 percent 
correction factor for high volume, low concentration streams would make 
compliance with a 20 part per million by volume (ppmv) outlet 
concentration standard difficult. We responded by identifying 
situations where additional air was added to the vent streams (e.g., 
supplemental combustion air) prior to the control devices and required 
the correction only when these situations were encountered. In other 
words, if the vent streams originating from the processes and affected 
sources themselves were high volume, low concentration, then no 
correction was required. However, if nonaffected streams were added 
prior to control, then the NESHAP requires the correction.
    This same concept was incorporated into the Pharmaceutical MACT. 
However, as mentioned previously, the promulgated rule was not clear on 
several aspects of the requirement, including the definition of 
supplemental combustion air, and when the requirement to correct to 3 
percent oxygen should apply. In addition, the predominant reasons 
pharmaceutical facilities add excess air or other diluents to manifolds 
is not to provide the supplemental air necessary for combustion of 
emissions streams (the high volume, low concentration streams in the 
pharmaceuticals industry, by their very nature, should not require 
additional air for combustion), but rather for safety and design 
considerations. We also recognize that for these high oxygen streams, 
the correction requirement has the effect of lowering the 20 ppmv 
compliance level, perhaps significantly.

3. Proposed Changes in Terminology and Dilution Correction Requirements

    To clarify the dilution correction requirements, we are proposing 
to revise terminology, to use the new terminology in the provisions 
describing the conditions under which outlet concentrations from 
combustion devices must be corrected, to explicitly state the 
procedures for correcting outlet concentrations from noncombustion 
devices, and to increase the compliance level for noncombustion devices 
from 20 ppmv to 50 ppmv.
    In today's proposed amendments, we define a more general term 
called ``supplemental gases.'' This term distinguishes air added to the 
vent stream for combustion and gases added for design or safety 
purposes from the affected vent streams and air required to operate 
combustion device burner(s). In addition, because this is a general 
term, it applies in all situations; it is not limited to combustion 
devices. The definition also clarifies that air used to operate 
combustion device burner(s) is not considered supplemental gas. Failure 
to include this clarification could allow the interpretation that every 
combustion device uses supplemental gases.
    Using this new terminology, we are proposing to revise the current 
compliance option for combustion devices to require that the correction 
to 3 percent oxygen be made in cases where supplemental gases are added 
to affected streams prior to combustion. For noncombustion devices, we 
are proposing to add a new Sec. 63.1257(a)(3)(ii) requiring correction 
to adjust outlet concentrations by the amount of supplemental gas 
added. This was the intent of the language in the promulgated rule. In 
addition to these changes, we are proposing to increase the 
concentration limit for noncombustion devices from 20 ppmv to 50 ppmv 
to be consistent with the definition of a process vent. This change 
would also provide a greater allowance to meet the concentration limit 
for devices that are perceived to be more environmentally-friendly in 
terms of potential for material recovery and the minimizing of 
secondary air pollution.
    We believe an explanation of how to determine which streams are 
supplemental gases is warranted at this point. We are not requiring 
owners and operators to measure the concentration of total organic 
compounds (TOC) in gas streams. The proposed definition of supplemental 
gases indicates that process knowledge is adequate in identifying such 
streams. We intend that the owner or operator can qualitatively 
identify these streams based on their knowledge of the process and use 
reasonable judgement in estimating TOC or HAP concentrations. 
Similarly, these proposed amendments also allow owners and operators to 
use process knowledge in identifying affected process vents (defined by 
containing 50 ppmv HAP) and affected wastewater streams (defined by 
containing 5 ppmw HAP and a load of at least 0.05 kg/yr).

[[Page 19161]]

For characterizing affected wastewater, two ``process knowledge''-based 
approaches, the use of a mass balance, and the use of published water 
solubility data are identified as adequate for determination of HAP 
wastewater concentrations. For defining process vents, these proposed 
amendments state that process knowledge that no HAP are present in an 
emission stream or the use of engineering assessments are both 
allowable approaches. Consistent with other guidance on process 
knowledge, the proposed amendments define engineering assessments 
broadly in Sec. 63.1257(d)(2)(ii) and do not specify exact procedures 
or formulas for determining vent stream characteristics. In many cases, 
the exercise of identifying process vents will also result in 
identification of supplemental gases.
4. Proposed Alternative to HAP Concentration Correction for Combustion 
Devices
    In addition to the proposed clarification of the 3 percent oxygen 
correction factor for combustion devices, we are also proposing to add 
an option that would allow owners and operators to monitor combustion 
devices for good operating practices in lieu of correcting to 3 percent 
oxygen when supplemental gases are used. The 20 ppmv concentration 
limit is based on concentrations achievable by properly operated 
incinerators--those with adequate residence times and combustion 
chamber temperatures. With the additional constraints of maintaining 
residence times and combustion chamber temperatures, owners and 
operators have economic incentives to minimize the amount of 
supplemental gases that are introduced prior to combustion devices. 
Nevertheless, we believe that it is reasonable to allow for monitoring 
of parameters in lieu of correcting to 3 percent oxygen when 
supplemental gas is added.
    Therefore, we are proposing two sets of parameter levels as 
alternatives to correcting for dilution when supplemental gases are 
used in combustion devices. If the owner or operator complies with the 
alternative standard instead of a percent reduction requirement of 95 
percent or less (e.g., for some process vents and storage tanks), the 
owner or operator would be required to monitor for a minimum residence 
time of 0.5 seconds and a minimum combustion chamber temperature of 
760 deg.C. These values are consistent with parameters specified in 
subpart GGG for controlling emission streams from vents at wastewater 
collection and treatment systems. If the owner or operator complies 
with the alternative standard instead of a percent reduction 
requirement of 98 percent, the owner or operator would be required to 
monitor for a minimum residence time of 0.75 seconds and a minimum 
combustion chamber temperature of 816 deg.C. Based on a considerable 
amount of data, we have concluded that properly designed and operated 
incinerators reduce emissions by 98 percent if they maintain these 
residence times and temperatures.
5. Proposed Alternative to HAP Concentration Correction for 
Noncombustion Devices
    In addition to the proposed clarification of the concentration 
correction requirements described above, we are proposing an option to 
allow owners and operators of ``dense gas'' systems a simplified 
procedure for correction. Dense gas systems are defined as systems that 
are designed and operated to limit oxygen levels to less than 12 
percent. We are proposing the simplified correction for dense gas 
systems because these systems are generally used to convey concentrated 
streams (above 5,000 ppmv). The proposed procedure would allow owners 
and operators to calculate a system flowrate setpoint. This setpoint is 
an indicator of stream concentration and would be monitored to 
demonstrate that significant dilution is not occurring. The owner or 
operator of a dense gas system would also be able to choose to operate 
at a higher flowrate than the system setpoint by making a concentration 
correction.

J. Vapor Balancing for Storage Tanks

    We are proposing to allow vapor balancing in conjunction with the 
use of a pressure setting to comply with the storage tank control 
requirements. The vapor balancing provisions also would require that 
displaced vapors from the tank trucks and railcars be controlled at the 
reloading or cleaning facility to at least 90 percent or be vapor 
balanced. To demonstrate compliance with the offsite provisions, the 
owner or operator must obtain a certification from the cleaning and 
reloading facility indicating that the control requirements will be 
met. In general, a pressure setting of at least 2.5 pounds per square 
inch gage (psig) was determined to eliminate breathing losses from 
tanks that are typically found in this industry. As a means of 
demonstrating continuous compliance with the pressure setting 
requirement, the proposed provisions would also require the owner or 
operator to record the pressure vent setting during each transfer 
operation and to monitor the pressure relief valve on a quarterly basis 
to ensure no breathing losses.

K. Wastewater Standards

    We are proposing several changes to the wastewater provisions. 
Because the proposed change in the definition of process reduces the 
number of steps in a process, we are proposing to reduce the wastewater 
load point of determination (POD) cutoffs in Sec. 63.1256(a)(1)(i) from 
1 megagram per year (Mg/yr) per process to 0.25 Mg/yr per process.
    In Sec. 63.1256(a)(5), we are proposing to clarify the offsite 
wastewater treatment options. Under the Pharmaceuticals Production 
NESHAP, offsite treatment was allowed only if the wastewater contained 
less than 50 ppmw of partially soluble HAP to prevent discharges that 
could result in significant volatilization of HAP prior to treatment. 
Since this objective would be met if the wastewater or residual is 
always managed and treated, we are proposing to add a provision to 
allow the wastewater to be discharged if the transferee (i.e., the 
company or other organization accepting the discharged wastewater or 
residual) certifies that the wastewater or residual will be managed and 
treated in accordance with an amended subpart GGG. The 50 ppmw limit 
would still apply if this certification is not obtained, but we are 
also proposing to clarify the management and treatment requirements for 
these streams. The treatment options would be either enhanced 
biological treatment (Sec. 63.1256(g)(10)) or the 95 percent mass 
reduction option for biological treatment (Sec. 63.1256(g)(11)(i), 
(ii), and Sec. 63.1256 (h)), and the management options would be either 
to cover the waste management units up to the activated sludge units or 
to demonstrate that less than 5 percent of the total soluble HAP is 
emitted from waste management units up to the activated sludge unit.
    Another proposed change is to add specific provisions in 
Sec. 63.1256(a)(3) for maintenance wastewater that differ from the 
provisions for process wastewater. The proposed provisions are 
equivalent to the provisions in the HON and other recent rules. They 
would require an owner or operator to prepare a description of 
maintenance procedures for management of maintenance wastewater as part 
of the startup, shutdown, and malfunction plan. Modification of the 
procedures would be required, as necessary.

[[Page 19162]]

L. Equipment Leak Provisions

    We are proposing numerous clarifying changes within the LDAR 
provisions. One set of changes would make the difficult-to-monitor, 
unsafe-to-monitor, and inaccessible provisions consistent with language 
used in past and pending regulations (changes made to subpart H of the 
HON and in the proposed consolidated air rule). These changes would 
clarify which provisions apply to a given component and how to deal 
with components that cannot be accessed at any time in a safe manner. 
Another proposed change is to revise Sec. 63.1255(b) to clarify which 
provisions in subpart H of the HON apply in these proposed amendments.

M. Pollution Prevention Provisions

    We are proposing to add language to Sec. 63.1252(e) that would 
allow owners and operators to merge processes for the purposes of 
complying with P2 provisions. This proposed change is being made 
because of the proposed change in the definition of a process. Our 
intent with regard to compliance under P2 provisions is that the owner 
or operator can make the P2 demonstration around the same starting and 
ending materials, regardless of how many ``processes'' the manufacture 
of these materials encompass. For example, consider the sequential 
manufacturing of four intermediates (A, B, C, and D) and the final 
product (E). Under the promulgated process definition, these five steps 
would be considered a single process. However, under the proposed 
revised definition, there are five processes. The proposed P2 language 
clarifies that owners and operators are allowed to consider any or all 
of these processes when demonstrating a reduction in the production-
indexed consumption factor, as long as the activities covered under P2 
provisions are limited to the same starting and ending materials for 
the baseline (before) and annual (after) demonstrations. In the above 
example, therefore, the owner or operator could make the P2 
demonstration around processes A through E. Additionally, if the 
facility eliminated middle products C or D through a process 
optimization or improvement measure, the owner or operator could take 
credit for reducing the amount of HAP consumed by these steps. However, 
we stress that under P2 provisions, eliminating steps within a process 
by transferring operations elsewhere is not allowed. In addition, 
because the P2 provisions apply beyond the individual process level, 
other constraints are needed to make the provisions practical for 
documentation purposes. The baseline date for merged processes is 1992 
(approximately 10 years prior to the compliance date) and merging a 
nondedicated formulation process or a nondedicated solvent recovery 
process with another process to claim a reduction from both processes 
is not allowed.

N. Initial Compliance Demonstration Provisions

1. Use of Equations in the 1978 Control Techniques Guideline (CTG) 
Document
    In Sec. 63.1257(d)(2), we are proposing to revise equations 13, 25, 
26, and 33. These equations are used to estimate uncontrolled emissions 
from heating, depressurization, and vacuum system events. One of the 
proposed changes is to eliminate the requirement to use an average 
molecular weight in calculations for emission streams that contain more 
than one HAP. This change has no effect on the emissions estimates, but 
it makes the equations look more consistent with the equations in the 
1978 CTG, which was our original intent. This change also does not 
apply to the optional approaches in the NESHAP to calculate emissions 
from heating and depressurization. We are also proposing to correct 
equation 33 and add new language that would provide additional 
flexibility in calculating emissions.
    The proposed change to equation 13 (heating) is accomplished by 
simply removing the average molecular weight variable and adding the 
individual molecular weight to the summation term in the numerator. The 
NESHAP also includes instructions on how to modify equation 17 when it 
is used to calculate the average molecular weight for use in equation 
13. The proposed change to equation 13 eliminates the need for these 
instructions, which were included with the definition of the HAP 
partial pressure in the variable list for equations 13 through 17. 
Therefore, we are proposing to delete these instructions.
    The steps in the 1978 CTG to calculate emissions from 
depressurization are inconsistent with each other. Steps 6 through 9 
describe how to calculate the ratio of air to total volatile organic 
compounds (VOC), but step 10 describes how to estimate the mass 
emissions of individual VOC assuming the previous steps were used to 
calculate the ratio of air to that individual VOC. We are proposing to 
replace the average molecular weight in equation 26 with individual 
compound molecular weights because this is consistent with the final 
step in the 1978 CTG. It appears this was the intent in the CTG (i.e., 
procedures to calculate emissions from all other types of emission 
events are for single compounds), and we understand that this is how 
many pharmaceutical facilities calculate emissions from 
depressurization. To be consistent with this change in equation 26, we 
are also proposing to remove the summations from equation 25 so that it 
will calculate the average ratio of moles of noncondensables to moles 
of an individual HAP instead of the average ratio of moles of 
noncondensables to total HAP.
    We are proposing two changes to equation 33, which is used to 
estimate emissions from vacuum systems. The first change is to replace 
the variable for the average molecular weight with one for an 
individual HAP molecular weight. This change alone would make the 
equation valid for emission streams with a single pollutant. To make 
the equation valid for multicomponent systems, the portion of the 
equation that represents the ratio of moles of condensable compounds to 
moles of noncondensable compounds must be replaced. To calculate the 
emissions of each HAP individually, the numerator of the revised ratio 
would be the partial pressure of the individual HAP, and the 
denominator would be the system pressure minus the sum of the partial 
pressures of all condensable compounds. Because we want to know the 
total HAP emissions, the proposed equation 33 multiplies the partial 
pressure of an individual HAP (in the numerator) by the molecular 
weight for that HAP, and sums over the number of HAPs in the emission 
stream.
    To provide additional flexibility in calculating emissions, we are 
also proposing to add a statement in Sec. 63.1257(d)(2)(ii) that would 
allow an owner or operator to calculate emissions using modified 
versions of the equations in Sec. 63.1257(d)(2)(i) if they meet two 
conditions. First, the modified equations must have been used to meet 
other regulatory obligations. Second, the owner or operator must 
demonstrate that the results obtained using the modified equations do 
not affect applicability assessments or compliance determinations under 
these proposed amendments.
2. Process Condenser Demonstration
    We are proposing to revise the initial compliance demonstration 
procedures for process condensers. These changes exclude from the 
demonstration requirement any process condensers followed by either 
secondary condensers that would be considered air pollution control 
devices or air

[[Page 19163]]

pollution control devices complying with the alternative standard. The 
original compliance procedure for process condensers was promulgated to 
ensure that owners and operators would accurately characterize 
uncontrolled emissions. If a process condenser was not operating 
properly, then the load to a secondary condenser or an air pollution 
control device (APCD) would be higher than the equations contained in 
the NESHAP would predict.
    However, if a secondary condenser operates to cool a stream down to 
a temperature that corresponds to the required removal, assuming HAP 
load is at the level estimated by the equations (even though the load 
is actually higher because the process condenser doesn't work as 
anticipated), then the secondary condenser actually removes more HAP 
than is estimated by the equations and, in effect, accounts for the 
ineffectiveness of the process condenser. A similar effect occurs for 
other devices whose monitoring parameters are correlated directly with 
compliance, such as devices meeting the outlet concentration 
alternative standard. For these devices, the continuous compliance 
demonstration (monitoring) procedures will provide an indication that 
the requirements of the NESHAP are met, regardless of whether the 
process condenser is effective. However, in cases where no control 
device follows a process condenser, or where the APCD monitoring is 
based on testing or design evaluation at worst case conditions, either 
the validity of monitoring correlated to worst case conditions or 
actual emissions to the atmosphere depend on the effectiveness of the 
process condenser. Therefore, these proposed amendments require a 
process condenser initial demonstration for these cases.
3. Clarification of Worst-Case Testing Conditions
    Although we are proposing only a minor change to the language in 
Sec. 63.1257(b)(8) regarding the testing conditions for batch 
processes, we believe additional clarification of the intent of the 
worst-case provisions is warranted. Worst-case conditions are the most 
challenging conditions that the control device will encounter when used 
to control emission streams subject to the NESHAP which defines two 
categories of worst-case conditions: Absolute and hypothetical. 
Absolute worst-case conditions are based on actual emission stream 
characteristics. If the most challenging conditions are associated with 
the maximum HAP load, the NESHAP provides two time periods for defining 
the absolute worst-case conditions: (1) The period of time when the 
inlet to the control device contains at least 50 percent of the HAP 
load in the 8-hour period that contains the maximum HAP load, or (2) 
The 1-hour period when the inlet to the control device contains the 
maximum hourly HAP load. If the most challenging conditions are 
associated with a characteristic(s) other than the maximum HAP load, 
the absolute worst-case conditions are defined as the 1-hour period 
when those characteristics occur. The NESHAP cites three examples of 
such conditions: (1) Periods of time when the emission streams contain 
the maximum combined VOC and HAP load, (2) periods of time when the 
emission streams contain HAP(s) that approach limits of solubility for 
scrubbing media, and (3) periods of time when the emission streams 
contain HAP(s) that approach limits of adsorptivity for carbon 
adsorption systems. To determine the absolute worst-case conditions, 
the owner or operator must develop an emission profile that considers 
the characteristics of all of the vent streams to the control device, 
the design and operating characteristics of the control device, and 
scheduling of processes that generate the emission streams.
    Hypothetical worst-case conditions are simulated conditions that 
are at least as challenging as the absolute worst-case conditions. As 
with absolute worst-case conditions, the owner or operator must develop 
an emission profile to determine the hypothetical worst-case 
conditions. The NESHAP provides two options for developing these 
emission profiles. One option is to determine the 1-hour period of time 
with the most challenging actual conditions. After these conditions are 
defined, the owner or operator must describe the equipment 
configuration, type of material to be processed, and any other 
characteristics of the simulated conditions under which test runs will 
be conducted. The owner or operator must also provide rationale for why 
the simulated conditions are considered to be as challenging as the 
most challenging actual conditions. The second option is to develop an 
emissions profile based on characteristics of the capture and control 
system that limit the maximum hourly emissions that can be routed to 
the control device. For example, a fan may limit the flowrate, and the 
concentration may be limited to a certain percentage of the lower 
explosive limit before a bypass valve opens.

O. Recordkeeping To Demonstrate Compliance With Process Vent Standards

    We are proposing several changes to the recordkeeping and reporting 
procedures to clarify our intent. The provisions of Sec. 63.1259 
originally required owners and operators to calculate uncontrolled and 
controlled emissions for all processes in the PMPU. However, because 
some compliance options, such as the alternative standard, do not 
require such calculations to demonstrate compliance, we are proposing 
to specify the records required to demonstrate compliance with each 
option. We are also proposing the concept of a ``standard'' batch to 
clarify when uncontrolled and controlled emissions must be recalculated 
as part of ongoing compliance demonstrations.
    The language of Sec. 63.1259(b)(6) in the NESHAP states that the 
owners or operators must keep records of uncontrolled and controlled 
emissions per batch for each process. In specifying this recordkeeping 
requirement, we intended that owners and operators keep detailed 
records of uncontrolled and controlled emissions for each process to be 
operated at the facility and the number of batches of each process 
operated at the facility. In order to demonstrate compliance with the 
percent reduction requirement, only a showing of the process 
uncontrolled and controlled emissions would be needed since the ongoing 
continuous compliance demonstration was achieved through the monitoring 
of process parameters. Similarly, in order to demonstrate compliance 
with the 2,000 lb/yr emissions limit, we required records of the number 
of batches run at the facility, in addition to the controlled 
emissions, for use in calculating a summation of yearly emissions. 
However, because each batch in a campaign does not necessarily operate 
under exactly the same conditions, the emissions may vary from batch to 
batch. The promulgated rule does not clearly describe how to handle 
these variations in the continuous compliance demonstration. It could 
be interpreted to mean that the owner or operator must recalculate 
emissions for every variation in operating conditions, but this was not 
our intent.
    To clarify our intent, we are proposing to add the concept of a 
standard batch. The owner or operator would create a standard batch 
based on a range of operating characteristics and other processing 
variables that affect emissions. The standard batch would become part 
of an operating scenario for

[[Page 19164]]

the process (i.e., the standard batch consists of the same operating 
parameters as are required in the operating scenario, but the owner or 
operator may specify a range instead of only a single, fixed value). 
The owner or operator would calculate emissions for the standard batch 
using the characteristics that result in the highest emissions, and 
these results would be used in the demonstration of initial compliance 
with the process vent standards. If, during the processing of a 
particular batch, one such process variable was operated outside of the 
standard batch, the owner or operator would be required to recalculate 
uncontrolled and controlled emissions for that batch and demonstrate 
compliance with an amended subpart GGG. If the batch was operated 
within the standard batch constraints, then only a record that the 
batch was operated accordingly would be required.
    In establishing the standard batch, owners and operators have 
flexibility in determining how to identify and record nonstandard 
batches. For example, the owner or operator should focus on the 
episodes that affect emissions or control efficiency. Likewise, in some 
cases, tracking control device parameters would be an adequate means of 
detecting nonstandard batches. Moreover, insignificant episodes, under 
the revised standard batch concept, would not require any further 
monitoring for ``nonstandardness'' during the operating period. For 
example, a one-time demonstration would be appropriate where a given 
process vent handles only a small fraction of the uncontrolled 
emissions from the given process, or where it is not physically 
possible to exceed the standard batch conditions. As another example, 
facilities often have head tanks within their processes. These tanks 
are used to measure a specified quantity of raw material prior to 
addition to the reactor or other unit operation. Typically, the 
capacity of these tanks is small--often no more than 100 or 200 
gallons. If operated at ambient conditions, the potential emissions 
from the tank are limited only by the design capacity of the tank. In 
this situation, it would be sufficient to make a one-time showing that 
emissions from filling of the tank to capacity cannot exceed emissions 
under standard batch conditions.

P. Minor Technical Corrections

1. Tables 1 and 5
    In Table 1, we are proposing several changes to clarify how subpart 
A (the General Provisions) applies to these proposed amendments. Some 
proposed changes correct inconsistencies. For example, we are proposing 
to change the requirement to conduct a performance test within 180 days 
of the compliance date to 150 days to be consistent with the time 
period to conduct necessary performance tests and submit the 
Notification of Compliance Status report. Other changes direct the 
reader to appropriate sections of the NESHAP that contain language 
related to the specific requirements in the General Provisions. We are 
also proposing to specify that the preconstruction approval requirement 
in Sec. 63.5(b)(3) would not apply to facilities that are covered by 40 
CFR 52.2454.
    In Table 5, we are proposing to delete references to fuel gas 
systems. We inadvertently included these references in the NESHAP. They 
should be deleted because we did not include requirements specific to 
fuel gas systems anywhere in the NESHAP. Our intent is that fuel gas 
systems are a form of control device, and the requirements for control 
devices apply. We are also proposing changes to the control 
requirements for in-process tanks that meet the criteria of 
Sec. 63.1252(f). Table 5 of the promulgated rule required an owner or 
operator to maintain a fixed roof on these tanks, and if the tank meets 
certain criteria, to control vent streams from the tank. However, 
because the tank is within the process, vents from the tank are also 
process vents and subject to the process vent standards. To eliminate 
this overlap, we are proposing to replace the vent stream control 
requirements in Table 5 with a statement that vents on these tanks are 
process vents.
2. Definitions
    In addition to the changes to definitions described in other 
sections of this preamble, we are also proposing minor changes to 
definitions of many other terms to correct errors, improve clarity, or 
to make them consistent with other regulations.
3. Wastewater Provisions
    We are proposing several minor changes and corrections to the 
wastewater provisions. In Sec. 63.1256(a)(3), we are proposing to add 
an exemption for wastewater samples of a size not greater than 
reasonably necessary for the method of analysis. If the owner or 
operator determines that it is unsafe to perform the required seal gap 
measurements or inspections of a wastewater tank at the specified time, 
the HON specifies two compliance options. Although we intended to 
include both of these options in the promulgated pharmaceuticals rule, 
one of them was inadvertently left out. Therefore, we are proposing to 
add Sec. 63.1256(b)(6)(i), which would specify that an owner or 
operator may measure the seal gaps or inspect the tank within 30 
calendar days of the determination that the floating roof is unsafe. In 
Sec. 63.1256(d)(2), we are proposing to add an option to vapor balance 
wastewater loading operations from containers back to the process.
    In Sec. 63.1256(g)(8), (11), and (12), the promulgated rule 
specifies that compliance with treatment options must be determined 
based on a performance test; to be consistent with other rules, we are 
proposing to clarify that compliance with all treatment options, except 
open biological treatment, may also be determined using a design 
evaluation. Paragraphs (g)(8) and (12) in Sec. 63.1256 of the 
promulgated rule cross referenced two paragraphs that describe 
compliance procedures for biological treatment; we are proposing 
editorial changes to clarify which cross referenced section applies to 
open biological treatment and which applies to closed biological 
treatment.
    Finally, to be consistent with other recent rules, we are proposing 
to add a provision in Sec. 63.1257(b)(10) that would allow an owner or 
operator to analyze wastewater using Method 8260, as well as Method 
8270 in ``Test Methods for Evaluating Solid Waste, Physical/Chemical 
Methods'' (EPA Publication No. SW-846, Third Edition, September 1986, 
as amended by Update I, November 15, 1992).
4. Emissions Averaging
    According to Sec. 63.1252(d)(6) of the promulgated rule, an 
affected source may include, in emissions averaging groups, no more 
than 20 storage tanks that are subject to the 90 percent reduction 
requirement, and no more than 20 storage tanks that are subject to the 
95 percent reduction requirement. However, this provision is 
inconsistent with the policy we established in the HON of limiting to 
20 the number of emission points in an emissions average (59 FR 19428, 
April 22, 1994). Section 63.1257(g) specifies that emissions averaging 
for storage tanks applies to all storage tanks at an affected source 
(i.e., all storage tanks are emission points that may be grouped for 
emissions averaging). Therefore, we are proposing to correct 
Sec. 63.1252(d)(6) by specifying that not more than 20 storage tanks at 
an affected source may be included in emissions averaging.

[[Page 19165]]

5. Initial Compliance and Monitoring
    We are proposing several minor changes and corrections to the 
initial compliance and monitoring provisions. In 
Sec. 63.1257(b)(6)(iii), we are proposing to add that Method 26A of 
appendix A of 40 CFR part 60 may be used to determine hydrogen chloride 
concentrations, and we are proposing to specify that both Methods 26 
and 26A also may be used to determine hydrogen halide and halogen 
concentrations. In Sec. 63.1257(d)(2)(i)(H), we are proposing a 
correction to the note associated with equation 36 so that an owner or 
operator may elect to disregard the effect of time on the emissions and 
simply assume all HAP in the vapor space are emitted. In 
Sec. 63.1257(e), (f), and (g), we are proposing to correct symbols used 
to define variables in several equations, and we are proposing to 
correct references to several equation numbers. To reduce the burden of 
demonstrating compliance with the P2 provisions, we are proposing to 
add a statement in Sec. 63.1257(f) that would allow an owner or 
operator to calculate the annual HAP consumption factor once per month 
if more than 10 batches are produced in a month. We are proposing to 
move equation 61 from Sec. 63.1257(h)(3) to its proper location in 
Sec. 63.1257(h)(2)(i). In Sec. 63.1258(b)(6)(iii), we are proposing a 
change to clarify that an exceedance for a flare occurs only upon the 
loss of all pilot flames. Because we are proposing to change the annual 
mass emission limit compliance option for process vents by adding an 
1,800 kg/yr facilitywide limit, we are also proposing to add a 
requirement in Sec. 63.1258(c) that owners and operators demonstrate 
continuous compliance with this limit by calculating daily 365-day 
rolling summations; this requirement parallels the requirement for 
demonstrating compliance with the 2,000 lb/yr limits for individual 
processes. We are also proposing to delete from this paragraph the 
sentence that describes what will be considered a violation.
6. Recordkeeping and Reporting
    The promulgated rule did not include any recordkeeping and 
reporting requirements for storage tanks with floating roofs. To 
correct this oversight we are proposing to add requirements to: (1) 
record the results of each inspection and seal gap measurement, as 
specified in Sec. 63.123(c) through (e); and (2) submit the results of 
inspections that detected a failure or seal gap measurements that 
exceed required limits, as specified in Sec. 63.122(d) through (f). 
Clearly, these are the same recordkeeping and reporting requirements in 
the HON, and they have been applied in other rules as well.
    To document compliance with the annual mass emission limit for 
process vents, Sec. 63.1259(b)(4) of the NESHAP requires records of 
rolling annual total emission calculations, but it did not specify the 
recordkeeping frequency. Because the NESHAP specifies that the emission 
limit not be exceeded in any 365-day period, we are proposing to 
require daily recordkeeping. In addition, we are proposing that this 
requirement apply to the proposed 4,000 lb/yr facilitywide emission 
limit, as well as to the 2,000 lb/yr limit for individual processes.
    Table 1 in the NESHAP states that Sec. 63.10(b)(2) does not apply 
to the NESHAP because we have specified applicable records within the 
NESHAP. We did not include a requirement in the NESHAP to record all 
maintenance performed on the air pollution control equipment, but these 
are important records that we should have required. Therefore, we are 
proposing to add a requirement to record this information in 
Sec. 63.1259(a)(3)(iii).
    We are proposing several statements to clarify our intent. In 
Sec. 63.1260(e), we are proposing to add paragraphs (6) and (7) to 
reiterate requirements already stated in Sec. 63.1257(e)(1)(ii) that 
data used in determining the annual average concentration of wastewater 
streams must be included in the precompliance report. We are proposing 
to edit Sec. 63.1260(g)(1)(ii) to clarify when quarterly reporting is 
required. We are proposing to move a statement from the definition of 
the term ``operating scenario'' to Sec. 63.1260(g)(2)(vii) because it 
deals with information the owner or operator must provide to verify 
that requirements for new operating scenarios have been met. In 
Sec. 63.1260(h)(1), we are proposing to add a statement to clarify that 
process changes for which the owner or operator must submit a 
notification of process change means the startup of a new process.
7. Units
    The NESHAP specifies most emission limits and other numerical 
requirements in two sets of units. This can create confusion when a 
parameter meets the value in one set of units but not the other. One 
approach to resolve this problem would be to specify the values using 
an unreasonable number of significant figures. However, we are 
proposing to simply specify all terms using only one set of units.

III. What are the administrative requirements of the rule?

A. Executive Order 12866, Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), EPA 
must determine whether the regulatory action is ``significant'' and 
therefore subject to Office of Management and Budget (OMB) review and 
the requirements of the Executive Order. The Executive 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 
the Executive Order.
    Pursuant to the terms of Executive Order 12866, it has been 
determined that these proposed amendments do not constitute a 
``significant regulatory action'' because they do not add any new 
control requirements. Consequently, this action was not submitted to 
OMB for review under Executive Order 12866.

B. Executive Order 13132, Federalism

    Executive Order 13132 (64 FR 43255, August 10, 1999) requires EPA 
to develop an accountable process to ensure ``meaningful and timely 
input by State and local officials in the development of regulatory 
policies that have federalism implications.'' ``Policies that have 
federalism implications'' is defined in the Executive Order to include 
regulations that have ``substantial direct effects on the States, on 
the relationship between the national government and the States, or on 
the distribution of power and responsibilities among the various levels 
of government.'' Under Executive Order 13132, EPA may not issue a 
regulation that has federalism implications, that imposes substantial 
direct compliance costs, and that is not required by statute, unless 
the Federal government provides the funds necessary to pay the direct 
compliance costs incurred by State and local

[[Page 19166]]

governments, or EPA consults with State and local officials early in 
the process of developing the proposed regulation. The EPA also may not 
issue a regulation that has federalism implications and that preempts 
State law unless the Agency consults with State and local officials 
early in the process of developing the proposed regulation.
    If EPA complies by consulting, Executive Order 13132 requires EPA 
to provide to OMB, in a separately identified section of the preamble 
to the rule, a federalism summary impact statement (FSIS). The FSIS 
must include a description of the extent of EPA's prior consultation 
with State and local officials, a summary of the nature of their 
concerns and EPA's position supporting the need to issue the 
regulation, and a statement of the extent to which the concerns of 
State and local officials have been met. Also, when EPA transmits a 
draft final rule with federalism implications to OMB for review 
pursuant to Executive Order 12866, EPA must include a certification 
from the Agency's Federalism Official stating that EPA has met the 
requirements of Executive Order 13132 in a meaningful and timely 
manner.
    Today's proposed amendments will not have substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 13132, because State and local governments do not 
own or operate any sources that would be subject to these proposed 
amendments. Thus, the requirements of section 6 of the Executive Order 
do not apply to today's action.

C. Executive Order 13084, Consultation and Coordination With Indian 
Tribal Governments

    Under Executive Order 13084, EPA may not issue a regulation that is 
not required by statute, that significantly or uniquely affects the 
communities of Indian tribal governments, and that imposes substantial 
direct compliance costs on those communities, unless the Federal 
government provides the funds necessary to pay the direct compliance 
costs incurred by the tribal governments, or EPA consults with those 
governments. If EPA complies by consulting, Executive Order 13084 
requires EPA to provide to OMB, in a separately identified section of 
the preamble to the rule, a description of the extent of EPA's prior 
consultation with representatives of affected tribal governments, a 
summary of the nature of their concerns, and a statement supporting the 
need to issue the regulation. In addition, Executive Order 13084 
requires EPA to develop an effective process permitting elected and 
other representatives of Indian tribal governments ``to provide 
meaningful and timely input in the development of regulatory policies 
on matters that significantly or uniquely affect their communities.''
    Today's proposed amendments to subpart GGG do not significantly or 
uniquely affect the communities of Indian tribal governments. No tribal 
governments own or operate sources subject to these proposed 
amendments. Accordingly, the requirements of section 3(b) of Executive 
Order 13084 do not apply to today's action.

D. Executive Order 13045, Protection of Children From Environmental 
Health Risks and Safety Risks

    Executive Order 13045 (62 FR 19885, April 23, 1997) applies to any 
rule that: (1) Is determined to be ``economically significant'' as 
defined under Executive Order 12866, and (2) concerns an environmental 
health or safety risk that EPA has reason to believe may have a 
disproportionate effect on children. If the regulatory action meets 
both criteria, EPA must evaluate the environmental health or safety 
effects of the planned rule on children, and explain why the planned 
regulation is preferable to other potentially effective and reasonably 
feasible alternatives considered by EPA.
    The EPA interprets Executive Order 13045 as applying only to those 
regulatory actions that are based on health or safety risks, such that 
the analysis required under section 5-501 of the Executive Order has 
the potential to influence the regulation. Today's proposed amendments 
are not subject to Executive Order 13045 because they are based on 
technology performance, not health or safety risks. Furthermore, this 
rule has been determined not to be ``economically significant'' as 
defined under Executive Order 12866.

E. Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub. 
L. 104-4, establishes requirements for Federal agencies to assess the 
effects of their regulatory actions on State, local, and tribal 
governments and the private sector. Under section 202 of the UMRA, EPA 
generally must prepare a written statement, including a cost-benefit 
analysis, for proposed and final rules with Federal mandates that may 
result in expenditures by State, local, and tribal governments, in 
aggregate, or by 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 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 amendments do not contain 
a Federal mandate that may result in expenditures of $100 million or 
more for State, local, or tribal governments, in the aggregate, or the 
private sector in any 1 year. The maximum total annual cost of the 
Pharmaceuticals Production NESHAP for any year has been estimated to be 
approximately $64 million (63 FR 50287, September 21, 1998), and 
today's proposed amendments do not add new requirements that would 
increase this cost. Thus, today's proposed amendments are not subject 
to the requirements of sections 202 and 205 of the UMRA. In addition, 
EPA has determined that these proposed amendments contain no regulatory 
requirements that might significantly or uniquely affect small 
governments because they contain no requirements that apply to such 
governments or impose obligations upon them. Therefore, today's 
proposed amendments are not subject to the requirements of section 203 
of the UMRA.

[[Page 19167]]

F. Regulatory Flexibility Act (RFA), as Amended by the Small Business 
Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 USC 601 et. 
seq.

    The RFA generally requires an agency to prepare a regulatory 
flexibility analysis of any rule subject to notice and comment 
rulemaking requirements under the Administrative Procedure Act or any 
other statute unless the agency certifies that the rule will not have a 
significant economic impact on a substantial number of small entities. 
Small entities include small businesses, small organizations, and small 
governmental jurisdictions.
    For purposes of assessing the impacts of today's proposed 
amendments on small entities, a small entity is defined as: (1) A small 
business in SIC code 2833 or 2834 that has as many as 750 employees; 
(2) a small business in SIC code 2869 that has as many as 1,000 
employees; (3) a small governmental jurisdiction that is a government 
of a city, county, town, school district or special district with a 
population of less than 50,000; and (4) a small organization that is 
any not-for-profit enterprise which is independently owned and operated 
and is not dominant in its field.
    After considering the economic impacts of today's proposed 
amendments on small entities, I certify that this action will not have 
a significant economic impact on a substantial number of small 
entities. The EPA has determined that none of the small entities will 
experience a significant impact because the proposed amendments impose 
no additional regulatory requirements on owners or operators of 
affected sources.
    Although these proposed amendments will not have a significant 
economic impact, EPA nonetheless has tried to reduce the impact of the 
proposed amendments on small entities. Many of the proposed amendments 
define optional means of compliance. For example, vapor balancing was 
added as an optional means of compliance for storage tanks, a 
facilitywide limit on the mass of process vent emissions replaces the 
limit on the number of processes that may comply with the process-based 
emission limit, additional compliance alternatives are included for 
process vents that meet the criteria for 98 percent control, and 
optional parameter monitoring is included as an alternative to 
correcting to 3 percent O2 when supplemental gas is 
introduced to a dense gas system or a system controlled with a 
combustion device and the owner or operator complies with the 
alternative standard. The proposed amendments also include simplified 
recordkeeping requirements when the owner or operator documents 
conditions that define a standard batch, and the process is operated 
within that range of conditions. We continue to be interested in the 
potential impacts of the proposed amendments on small entities and 
welcome comments on issues related to such impacts.

G. Paperwork Reduction Act

    The OMB has approved the information collection requirements 
contained in the 1998 NESHAP under the provisions of the Paperwork 
Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB control No. 
2060-0358. An Information Collection Request (ICR) document has been 
prepared by EPA (ICR No. 1781.01), and a copy may be obtained from 
Sandy Farmer by mail at U.S. Environmental Protection Agency, Office of 
Environmental Information, Collection Strategies Division (2822), 1200 
Pennsylvania Avenue, NW, Washington DC 20460, by email at 
[email protected], or by calling (202) 260-2740.
    Today's proposed amendments to the NESHAP will have no net impact 
on the information collection burden estimates made previously. An 
oversight has been corrected by adding recordkeeping and reporting 
requirements for storage tanks equipped with floating roofs. The 
promulgated rule only included recordkeeping and reporting requirements 
for add-on control devices for storage tanks even though add-on control 
devices and floating roofs were considered in the cost impacts and 
burden estimates. Also, the proposed amendments clarify the intent of 
several provisions in the 1998 NESHAP and correct inadvertent omissions 
and minor drafting errors in the 1998 NESHAP. Consequently, the ICR has 
not been revised.

H. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA), Pub. L. 104-113 (March 7, 1996), directs all Federal 
agencies to use voluntary consensus standards instead of government-
unique standards in their regulatory activities unless to do so would 
be inconsistent with applicable law or otherwise impractical. Voluntary 
consensus standards are technical standards (e.g., material 
specifications, test methods, sampling and analytical procedures, and 
business practices) that are developed or adopted by one or more 
voluntary consensus bodies. Examples of organizations generally 
regarded as voluntary consensus standards bodies include the American 
Society for Testing and Materials (ASTM), the National Fire Protection 
Association (NFPA), and the Society of Automotive Engineers (SAE). The 
NTTAA requires Federal agencies like EPA to provide Congress, through 
OMB, with explanations when an agency does not use available and 
applicable voluntary consensus standards.
    The proposed amendments to subpart GGG do not involve the proposal 
of any new technical standards or incorporate by reference existing 
technical standards. The EPA welcomes comments on this aspect of these 
proposed amendments and, specifically, invites the public to identify 
potentially applicable voluntary consensus standards and to explain why 
such standards should be used in this regulation.

List of Subjects in 40 CFR Part 63

    Environmental protection, Administrative practice and procedure, 
Air pollution control, Hazardous substances, Intergovernmental 
relations, Reporting and recordkeeping requirements.

    Dated: March 20, 2000.
Carol M. Browner,
Administrator.

    For the reasons set out in the preamble, part 63 of title 40, 
chapter I 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.

Subpart GGG--National Emission Standards for Pharmaceuticals 
Production

    2. Section 63.1250 is amended by:
    a. Revising paragraph (a),
    b. Revising paragraph (b),
    c. Revising paragraph (c),
    d. Revising paragraph (f);
    e. Revising paragraph (h)(1);
    f. Revising paragraphs (h)(4) and (5); and
    g. Adding paragraph (h)(6).
    The revisions and additions read as follows:


Sec. 63.1250  Applicability.

    (a) Definition of affected source. (1) The affected source subject 
to this subpart consists of the pharmaceutical

[[Page 19168]]

manufacturing operations as defined in Sec. 63.1251. Except as 
specified in paragraph (d) of this section, the provisions of this 
subpart apply to pharmaceutical manufacturing operations that meet the 
criteria specified in paragraphs (a)(1)(i) through (iii) of this 
section as follows:
    (i) Manufacture a pharmaceutical product as defined in 
Sec. 63.1251;
    (ii) Are located at a plant site that is a major source as defined 
in section 112(a) of the Act; and
    (iii) Process, use, or produce HAP.
    (2) Determination of the applicability of this subpart shall be 
reported as part of an operating permit application or as otherwise 
specified by the permitting authority.
    (b) New source applicability. A new affected source subject to this 
subpart and to which the requirements for new sources apply is: an 
affected source for which construction or reconstruction commenced 
after April 2, 1997, and the standard was applicable at the time of 
construction or reconstruction; or a pharmaceutical manufacturing 
process unit (PMPU) dedicated to manufacturing a single product that 
has the potential to emit 10 tons per year of any one HAP or 25 tons 
per year of combined HAP for which construction commenced after April 
2, 1997 or reconstruction commenced after October 21, 1999.
    (c) General provisions. Table 1 of this subpart specifies and 
clarifies the provisions of subpart A of this part that apply to an 
owner or operator of an affected source subject to this subpart. The 
provisions of subpart A specified in Table 1 are the only provisions of 
subpart A that apply to an affected source subject to this subpart.
* * * * *
    (f) Compliance dates. The compliance dates for affected sources are 
as follows:
    (1) An owner or operator of an existing affected source must comply 
with the provisions of this subpart no later than October 21, 2002.
    (2) An owner or operator of a new or reconstructed affected source 
must comply with the provisions of this subpart on [date of publication 
of the final amendments] or upon startup, whichever is later.
    (3) Notwithstanding the requirements of paragraph (f)(2) of this 
section, a new source which commences construction or reconstruction 
after April 2, 1997 and before September 21, 1998 shall not be required 
to comply with this subpart until September 21, 2001 if:
    (i) The requirements of this subpart are more stringent than 
requirements of this subpart in effect before [effective date of the 
final rule] and contained in the 40 CFR, part (63.1200-end), edition 
revised as of July 1, 2000; and
    (ii) The owner or operator complies with the requirements published 
on April 2, 1997 (62 FR 15754) during the period until September 21, 
2001.
    (4) Notwithstanding the requirements of paragraph (f)(2) of this 
section, a new source which commences construction or reconstruction 
after September 21, 1998 and before April 10, 2000 shall not be 
required to comply with this subpart until October 21, 2002 if:
    (i) The requirements of this subpart are more stringent than the 
requirements of this subpart in effect before [effective date of the 
final rule]; and
    (ii) The owner or operator complies with the requirements of this 
subpart in effect before [effective date of the final rule] during the 
period between startup and October 21, 2002.
    (5) Notwithstanding the requirements of paragraph (f)(2) of this 
section, a new source which commences construction or reconstruction 
after April 10, 2000 and before [date of publication of final 
amendments] shall not be required to comply with this subpart until 
[date 1 year after publication of final amendments] if:
    (i) The requirements of this subpart are more stringent than the 
requirements published on April 2, 1997 (62 FR 15754); and
    (ii) The owner or operator complies with the requirements of this 
subpart in effect before [effective date of the final rule] during the 
period between startup and [date 1 year after publication of final 
amendments].
    (6) Pursuant to section 112(i)(3)(B) of the Act, an owner or 
operator may request an extension allowing the existing source up to 1 
additional year to comply with section 112(d) standards.
    (i) For purposes of this subpart, a request for an extension shall 
be submitted no later than 120 days prior to the compliance dates 
specified in paragraphs (f)(1) through (5) of this section, except as 
provided in paragraph (f)(6)(ii) of this section. The dates specified 
in Sec. 63.6(i) for submittal of requests for extensions shall not 
apply to sources subject to this subpart.
    (ii) An owner or operator may submit a compliance extension request 
after the date specified in paragraph (f)(6)(i) of this section 
provided the need for the compliance extension arose after that date 
and before the otherwise applicable compliance date, and the need arose 
due to circumstances beyond reasonable control of the owner or 
operator. This request shall include the data described in 
Sec. 63.6(i)(6)(i)(A), (B), (C), and (D).
* * * * *
    (h) * * *
    (1) Compliance with other MACT standards. (i) After the compliance 
dates specified in this section, an affected source subject to the 
provisions of this subpart that is also subject to the provisions of 
any other subpart of this part 63 may elect to comply with either the 
provisions of this subpart of the provisions of another subpart 
governing the maintenance of records and reporting to EPA. The affected 
source shall identify in the Notification of Compliance Status report 
required by Sec. 63.1260(f) under which authority such records will be 
maintained.
    (ii) After the compliance dates specified in paragraph (f) of this 
section, at an offsite reloading or cleaning facility subject to 
Sec. 63.1253(f), compliance with the emission standards and associated 
initial compliance, monitoring, recordkeeping, and reporting provisions 
of any other subpart of this part 63 constitutes compliance with the 
provisions of Sec. 63.1253(f)(7)(ii) or (iii). The owner or operator of 
the affected storage tank shall identify in the Notification of 
Compliance Status report required by Sec. 63.1260(f) the subpart of 
this part 63 with which the owner or operator of the offsite reloading 
or cleaning facility complies.
* * * * *
    (4) Compliance with subpart I of this part. After the compliance 
dates specified in this section, an affected source with equipment 
subject to subpart I of this part may elect to comply with either the 
provisions of Sec. 63.1255 or the provisions of subpart H of this part 
for all such equipment. The owner or operator shall identify in the 
Notification of Compliance Status report required by Sec. 63.1260(f) 
the provisions with which the owner elects to comply.
    (5) Compliance with other regulations for wastewater. After the 
compliance dates specified in this section, the owner or operator of an 
affected wastewater stream that is also subject to provisions in 40 CFR 
parts 260 through 272 may elect to determine whether this subpart or 40 
CFR parts 260 through 272 contain the more stringent control 
requirements (e.g., design, operation, and inspection requirements for 
waste management units; numerical treatment standards; etc.) and the 
more stringent testing, monitoring, recordkeeping and reporting. 
Compliance with provisions of 40 CFR parts 260 through 272 that are 
determined to be more stringent than the requirements of this subpart

[[Page 19169]]

constitutes compliance with this subpart. For example, provisions of 40 
CFR parts 260 through 272 for treatment units that meet the conditions 
specified in Sec. 63.1256(g)(13) constitute compliance with this 
subpart. In the Notification of Compliance Status report required by 
Sec. 63.1260(f), the owner or operator shall identify the more 
stringent provisions of 40 CFR parts 260 through 272 with which the 
owner or operator will comply. The owner or operator shall also 
identify in the Notification of Compliance Status report required by 
Sec. 63.1260(f) the information and procedures used to make any 
stringency determinations. If the owner or operator does not elect to 
determine the more stringent requirements, the owner or operator must 
comply with both the provisions of 40 CFR parts 260 through 272 and the 
provisions of this subpart.
    (6) Compliance with subpart PPP of this part. After the compliance 
dates specified in this section, an affected source with equipment in a 
pharmaceutical manufacturing process unit that is also part of an 
affected source under subpart PPP of this part may elect to demonstrate 
compliance with Sec. 63.1254 by controlling all process vents in 
accordance with Sec. 63.1425(b), (c)(1), (c)(3), (d), and/or (f) of 
subpart PPP of this part. Alternatively, the owner or operator may 
elect to determine which process vents must be controlled to comply 
with the percent reduction requirements of Sec. 63.1254 and control 
only those vents in accordance with Sec. 63.1425(b), (c)(1), (c)(3), 
(d), and/or (f) of subpart PPP of this part. For any pharmaceutical 
manufacturing process unit controlled in accordance with the 
requirements of Sec. 63.1425 of subpart PPP of this part, the owner or 
operator must also comply with all other requirements in subpart PPP of 
this part. In the Notification of Compliance Status report required by 
Sec. 63.1260(f), the owner or operator shall identify which 
pharmaceutical manufacturing process units are meeting the control 
requirements for process vents and all other requirements of subpart 
PPP of this part, and the owner or operator shall describe the 
calculations and other information used to identify which process vents 
must be controlled to comply with the percent reduction requirements of 
Sec. 63.1254, if applicable.
* * * * *
    3. Section 63.1251 is amended by:
    a. Revising the definitions for ``Active ingredient,'' Annual 
average concentration,'' ``Construction,'' ``Consumption,'' 
``Excipient,'' ``Large control device,'' ``Pharmaceutical manufacturing 
operations,'' ``Pharmaceutical product,'' ``Primary use,'' ``Process,'' 
``Process tank,'' ``Repaired,'' ``Shutdown,'' ``Small control device,'' 
``Startup,'' ``Storage tank,'' and ``Vapor-mounted seal'';
    b. Removing the definition of ``Component'';
    c. Removing the last sentence from the definition of ``Wastewater 
stream'';
    d. Revising paragraphs (3) and (8) in the definition for 
``Operating scenario'';
    e. Adding definitions in alphabetical order for ``Combustion device 
burner,'' ``Dense gas system,'' ``Isolated intermediate,'' 
``Maintenance wastewater,'' ``Precursor,'' ``Reconstruction,'' 
``Standard batch,'' ``Supplemental gases,'' and ``System flowrate.''
    The revisions and additions read as follows:


Sec. 63.1251  Definitions.

* * * * *
    Active ingredient means any material that is intended to furnish 
pharmacological activity or other direct effect in the diagnosis, cure, 
mitigation, treatment, or prevention of disease, or to affect the 
structure or any function of the body of man or other animals. This 
term does not include food, food additives (except vitamins and other 
materials described by SIC code 2833 or 2834), color additives, 
cosmetics, in-vitro diagnostic substances, x-ray film, test indicator 
devices, and medical devices such as implants, artificial joints, 
surgical bandages, and stitching material.
* * * * *
    Annual average concentration, as used in the wastewater provisions 
in Sec. 63.1256, means the total mass of partially soluble and/or 
soluble HAP compounds in a wastewater stream during the calendar year 
divided by the total mass of the wastewater stream discharged during 
the same calendar year, as determined according to the procedures 
specified in Sec. 63.1257(e)(1)(i) and (ii).
* * * * *
    Combustion device burner means a device designed to mix and ignite 
fuel and air to provide a flame to heat and oxidize waste organic 
vapors in a combustion device.
* * * * *
    Construction means the onsite fabrication, erection, or 
installation of an affected source or a PMPU. Addition of new equipment 
to a PMPU subject to existing source standards does not constitute 
construction, but it may constitute reconstruction of the affected 
source or PMPU if it satisfies the definition of ``Reconstruction'' in 
this section.
    Consumption means the quantity of all HAP raw materials entering a 
process in excess of the theoretical amount used as reactant, assuming 
100 percent stoichiometric conversion. The raw materials include 
reactants, solvents, and any other additives. If a HAP is generated in 
the process as well as added as a raw material, consumption includes 
the quantity generated in the process.
* * * * *
    Dense gas system means a conveyance system operated to limit oxygen 
levels below 12 percent.
* * * * *
    Excipient means any substance other than the active drug or product 
which has been appropriately evaluated for safety and is included in a 
drug delivery system to either aid the processing of the drug delivery 
system during its manufacture; protect, support, or enhance stability, 
bioavailablity, or patient acceptability; assist in product 
identification; or enhance any other attribute of the overall safety 
and effectiveness of the drug delivery system during storage or use.
* * * * *
    Isolated intermediate is obtained as the product of a process. An 
isolated intermediate is usually a product of a chemical synthesis, 
fermentation, or biological extraction process; several different 
isolated intermediates may be produced in the manufacture of a finished 
dosage form of a drug. Precursors, active ingredients, or finished 
dosage forms are considered isolated intermediates. An isolated 
intermediate is stored before subsequent processing. Storage occurs at 
any time the intermediate is placed in equipment used solely for 
storage, such as drums, totes, day tanks, and storage tanks. The 
storage of an isolated intermediate marks the end of a process.
* * * * *
    Large control device means a control device that controls total HAP 
emissions of greater than or equal to 10 tons/yr, before control.
* * * * *
    Maintenance wastewater means wastewater generated by the draining 
of process fluid from components in the pharmaceutical manufacturing 
process unit into an individual drain system in preparation for or 
during maintenance activities. Maintenance wastewater can be generated 
during planned and unplanned shutdowns and during periods not 
associated with a shutdown. Examples of activities that can generate 
maintenance wastewater include

[[Page 19170]]

descaling of heat exchanger tubing bundles, cleaning of distillation 
column traps, draining of pumps into an individual drain system, and 
draining of portions of the pharmaceutical manufacturing process unit 
for repair. Wastewater from cleaning operations is not considered 
maintenance wastewater.
* * * * *
    Operating scenario, * * *
    (3) The applicable control requirements of this subpart, including 
the level of required control, and for vents, the level of control for 
each vent;
* * * * *
    (8) For reporting purposes, a change to any of these elements not 
previously reported, except for paragraph (5) of this definition, shall 
constitute a new operating scenario.
* * * * *
    Pharmaceutical manufacturing operations means the facilitywide 
collection of PMPUs and any other equipment such as heat exchanger 
systems, wastewater and waste management units, or cooling towers that 
are not associated with an individual PMPU, but that are located at a 
facility for the purpose of manufacturing pharmaceutical products and 
are under common control.
* * * * *
    Pharmaceutical product means any of the following materials, 
excluding any material that is a nonreactive solvent, excipient, 
binder, or filler, or any material that is produced in a chemical 
manufacturing process unit that is subject to the requirements of 
subparts F and G of this part 63:
    (1) Any material described by the standard industrial 
classification (SIC) code 2833 or 2834; or
    (2) Any material whose manufacturing process is described by North 
American Industrial Classification System (NAICS) code 325411 or 
325412; or
    (3) A finished dosage form of a drug, for example, a tablet, 
capsule, solution, etc.; or
    (4) Any active ingredient or precursor that is produced at a 
facility whose primary manufacturing operations are described by SIC 
code 2833 or 2834; or
    (5) At a facility whose primary operations are not described by SIC 
code 2833 or 2834, any material whose primary use is as an active 
ingredient or precursor.
* * * * *
    Precursor means a material that is manufactured to undergo further 
chemical change or processing to ultimately manufacture an active 
ingredient or finished dosage form of a drug. This term does not 
include commodity chemicals produced by the synthetic organic chemical 
manufacturing industry.
* * * * *
    Primary use means 50 percent or more of a material is used for a 
particular purpose.
    Process means all equipment which collectively function to produce 
a pharmaceutical product or isolated intermediate (which is also a 
pharmaceutical product). A process may consist of one or more unit 
operations. For the purposes of this subpart, process includes any, 
all, or a combination of reaction, recovery, separation, purification, 
or other activity, operation, manufacture, or treatment which are used 
to produce a pharmaceutical product or isolated intermediate. Cleaning 
operations conducted are considered part of the process. Nondedicated 
solvent recovery operations located within a contiguous area within the 
affected source are considered single processes. A storage tank that is 
used to accumulate used solvent from multiple batches of a single 
process for purposes of solvent recovery does not represent the end of 
the process. Nondedicated formulation operations occurring within a 
contiguous area are considered a single process that is used to 
formulate numerous materials and/or products. Quality assurance and 
quality control laboratories are not considered part of any process. 
Ancillary activities are not considered a process or part of any 
process. Ancillary activities include boilers and incinerators (not 
used to comply with the provisions of Sec. 63.1253, Sec. 63.1254, or 
Sec. 63.1256(h)), chillers and refrigeration systems, and other 
equipment and activities that are not directly involved (i.e., they 
operate within a closed system and materials are not combined with 
process fluids) in the processing of raw materials or the manufacturing 
of a pharmaceutical product.
* * * * *
    Process tank means a tank that is used to collect material 
discharged from a feedstock storage tank or unit operation and transfer 
this material to another unit operation within the process or to a 
product storage tank. Surge control vessels and bottoms receivers that 
fit these conditions are considered process tanks. Product storage 
tanks are considered process tanks and are part of the PMPU that 
produce the stored material. For the purposes of this subpart, vents 
from process tanks are considered process vents.
* * * * *
    Reconstruction, as used in Sec. 63.1250(b), shall have the meaning 
given in Sec. 63.2, except that ``affected or previously unaffected 
stationary source'' shall mean either ``affected facility'' or 
``PMPU.'' As used in Sec. 63.1254(a)(3)(ii)(A)(3), reconstruction shall 
have the meaning given in Sec. 63.2, except that ``source'' shall mean 
``control device.''
* * * * *
    Repaired means that equipment:
    (1) Is adjusted, or otherwise altered, to eliminate a leak as 
defined in the applicable paragraphs of Sec. 63.1255, and;
    (2) Unless otherwise specified in applicable provisions of 
Sec. 63.1255, is monitored as specified in Sec. 63.180(b) and (c) as 
appropriate, to verify that emissions from the equipment are below the 
applicable leak definition.
* * * * *
    Shutdown means the cessation of operation of a continuous process 
for any purpose. Shutdown also means the cessation of a batch process 
or any related individual piece of equipment required or used to comply 
with this subpart as a result of a malfunction or for replacement of 
equipment, repair, or any other purpose not excluded from this 
definition. Shutdown also applies to emptying and degassing storage 
vessels. Shutdown does not apply to cessation of a batch process at the 
end of a campaign, for routine maintenance, for rinsing or washing of 
equipment between batches, or other routine operations.
* * * * *
    Small control device means a control device that controls total HAP 
emissions of less than 10 tons/yr, before control.
* * * * *
    Standard batch means a batch process operated within a range of 
operating conditions that are documented in an operating scenario. 
Emissions from a standard batch are based on the operating conditions 
that result in highest emissions. The standard batch defines the 
uncontrolled and controlled emissions for each emission episode defined 
under the operating scenario.
    Startup means the setting in operation of a continuous process unit 
for any purpose; the first time a new or reconstructed batch process 
unit begins production; for new equipment added, including equipment 
used to comply with this subpart, the first time the equipment is put 
into operation; or, for the introduction of a new product/process, the 
first time the product or process is run in equipment. For batch 
process units, startup does not apply to the first time the equipment 
is put into operation at the start of a campaign to

[[Page 19171]]

produce a product that has been produced in the past, after a shutdown 
for maintenance, or when the equipment is put into operation as part of 
a batch within a campaign. As used in Sec. 63.1255, startup means the 
setting in operation of a piece of equipment or a control device that 
is subject to this subpart.
    Storage tank means a tank or other vessel that is used to store 
organic liquids that contain one or more HAP as raw material 
feedstocks. Storage tank also means a tank or other vessel in a tank 
farm that receives and accumulates used solvent from multiple batches 
of a process or processes for purposes of solvent recovery. 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 (including product tanks and isolated 
intermediate tanks).
    Supplemental gases are any gaseous streams that are not defined as 
process vents, or closed-vent systems from wastewater management and 
treatment units, storage tanks, or equipment components and that 
contain less than 50 ppmv TOC, as determined through process knowledge, 
that are introduced into vent streams or manifolds. Air required to 
operate combustion device burner(s) is not considered supplemental gas.
* * * * *
    System flowrate means the flowrate of gas entering the control 
device.
* * * * *
    Vapor-mounted seal means a continuous seal that completely covers 
the annular space between the wall of the storage tank or waste 
management unit and the edge of the floating roof and is mounted such 
that there is a vapor space between the stored liquid and the bottom of 
the seal.
* * * * *
    4. Section 63.1252 is amended by:
    a. Revising the introductory paragraph;
    b. Revising paragraph (d)(2);
    c. Revising the first sentence in paragraph (d)(5);
    d. Revising paragraph (d)(6);
    e. Revising paragraph (e) introductory text;
    f. Revising the second sentence in paragraph (e)(1); and
    g. Adding paragraph (e)(4).
    The revisions and additions read as follows:


Sec. 63.1252  Standards: General.

    Each owner or operator of any affected source subject to the 
provisions of this subpart shall control HAP emissions to the level 
specified in this section on and after the compliance dates specified 
in Sec. 63.1250(f). Initial compliance with the emission limits is 
demonstrated in accordance with the provisions of Sec. 63.1257, and 
continuous compliance is demonstrated in accordance with the provisions 
of Sec. 63.1258.
* * * * *
    (d) * * *
    (2) Only emission sources subject to the requirements of 
Sec. 63.1253(b)(1) and (c)(1) or Sec. 63.1254(a)(1)(i) or (a)(3) may be 
included in any averaging group.
* * * * *
    (5) Emission points controlled to comply with a State or Federal 
rule other than this subpart may not be credited in an emission 
averaging group, unless the level of control has been increased after 
November 15, 1990 above what is required by the other State or Federal 
rule. * * *
    (6) Not more than 20 processes subject to Sec. 63.1254(a)(2), and 
20 storage tanks subject to Sec. 63.1253(b)(1) or (c)(1)(i) at an 
affected source may be included in an emissions averaging group.
* * * * *
    (e) Pollution prevention alternative. Except as provided in 
paragraph (e)(1) of this section, an owner or operator may choose to 
meet the pollution prevention alternative requirement specified in 
either paragraph (e)(2) or (3) of this section for any PMPU or for any 
situation described in paragraph (e)(4) of this section, in lieu of the 
requirements specified in Secs. 63.1253, 63.1254, 63.1255, and 63.1256. 
Compliance with paragraphs (e)(2) and (3) of this section shall be 
demonstrated through the procedures in Sec. 63.1257(f). Any PMPU for 
which the owner or operator seeks to comply by using the pollution 
prevention alternative shall begin with the same starting material(s) 
and end with the same product(s). The owner or operator may not comply 
with the pollution prevention alternative by eliminating any steps of a 
process by transferring the step offsite (to another manufacturing 
location).
    (1) * * * The hydrogen halides that are generated as a result of 
combustion control of emissions must be controlled according to the 
requirements of paragraph (g)(1) of this section.
* * * * *
    (4) The owner or operator may comply with the requirements in 
either paragraph (e)(2) or (3) of this section for a series of 
processes, including situations where multiple processes are merged, 
subject to the following conditions:
    (i) The baseline period shall be a single year beginning no earlier 
than the 1992 calendar year.
    (ii) The term ``PMPU'' shall have the meaning provided in 
Sec. 63.1251 except that the baseline and modified PMPUs may include 
multiple processes (i.e., precursors, active ingredients, and final 
dosage form) if the owner or operator demonstrates to the satisfaction 
of the Administrator that the multiple processes were merged after the 
baseline period into an existing process or processes.
    (iii) Nondedicated formulation and solvent recovery processes may 
not be merged with any other processes.
    5. Section 63.1253 is amended by:
    a. Revising paragraph (a);
    b. Revising paragraph (d); and
    c. Adding paragraph (f).
    The revisions and additions read as follows:


Sec. 63.1253  Standards: Storage tanks.

    (a) Except as provided in paragraphs (d), (e), and (f) of this 
section, the owner or operator of a storage tank meeting the criteria 
of paragraph (a)(l) of this section is subject to the requirements of 
paragraph (b) of this section. Except as provided in paragraphs (d), 
(e), and (f) of this section, the owner or operator of a storage tank 
meeting the criteria of paragraph (a)(2) of this section is subject to 
the requirements of paragraph (c) of this section. Compliance with the 
provisions of paragraphs (b) and (c) of this section is demonstrated 
using the initial compliance procedures in Sec. 63.1257(c) and the 
monitoring requirements in Sec. 63.1258.
    (1) A storage tank with a design capacity greater than or equal to 
38 m\3\ but less than 75 m\3\ storing a liquid for which the maximum 
true vapor pressure of total HAP is greater than or equal to 13.1 kPa.
    (2) A storage tank with a design capacity greater than or equal to 
75 m\3\ storing a liquid for which the maximum true vapor pressure of 
total HAP is greater than or equal to 13.1 kPa.
* * * * *
    (d) As an alternative standard, the owner or operator of an 
existing or new affected source may comply with the storage tank 
standards by routing storage tank vents to a combustion control device 
achieving an outlet TOC concentration, as calibrated on methane or the 
predominant HAP, of 20 ppmv or

[[Page 19172]]

less, and an outlet concentration of hydrogen halides and halogens of 
20 ppmv or less. If the owner or operator is routing emissions to a 
noncombustion control device, it must achieve an outlet TOC 
concentration, as calibrated on methane or the predominant HAP, of 50 
ppmv or less, and an outlet concentration of hydrogen halides and 
halogens of 50 ppmv or less. Compliance with the outlet concentrations 
shall be determined by the initial compliance procedures of 
Sec. 63.1257(c)(4) and the continuous emission monitoring requirements 
of Sec. 63.1258(b)(5).
* * * * *
    (f) Vapor balancing alternative. As an alternative to the 
requirements in paragraphs (b) and (c) of this section, the owner or 
operator of an existing or new affected source may implement vapor 
balancing in accordance with paragraphs (f)(1) through (7) of this 
section.
    (1) The vapor balancing system must be designed and operated to 
route organic HAP vapors displaced from loading of the storage tank to 
the railcar or tank truck from which the storage tank is filled.
    (2) Tank trucks and railcars must have a current certification in 
accordance with the U.S. Department of Transportation (DOT) pressure 
test requirements of 49 CFR part 180 for tank trucks and 49 CFR 173.31 
for railcars.
    (3) Hazardous air pollutants must only be unloaded from tank trucks 
or railcars when vapor collection systems are connected to the storage 
tank's vapor collection system.
    (4) No pressure relief device on the storage tank, or on the 
railcar, or tank truck shall open during loading or as a result of 
diurnal temperature changes (breathing losses).
    (5) Pressure relief devices on affected storage tanks must be set 
to no less than 2.5 psig at all times to prevent breathing losses. The 
owner or operator shall record the setting as specified in 
Sec. 63.1259(b)(12) and comply with the following requirements for each 
pressure relief valve:
    (i) The pressure relief valve shall be monitored quarterly using 
the method described in Sec. 63.180(b).
    (ii) An instrument reading of 500 ppmv or greater defines a leak.
    (iii) When a leak is detected, it shall be repaired as soon as 
practicable, but no later than 5 days after it is detected, and the 
owner or operator shall comply with the recordkeeping requirements of 
Sec. 63.1255(g)(4)(i) through (iv).
    (6) Railcars or tank trucks that deliver HAPs to an affected 
storage tank must be reloaded or cleaned at a facility that utilizes 
one of the following control techniques:
    (i) The railcar or tank truck must be connected to a closed-vent 
system with a control device that reduces inlet emissions of HAP by 90 
percent by weight or greater; or
    (ii) A vapor balancing system designed and operated to collect 
organic HAP vapor displaced from the tank truck or railcar during 
reloading must be used to route the collected HAP vapor to the storage 
tank from which the liquid being transferred originated.
    (7) The owner or operator of the facility where the railcar or tank 
truck is reloaded or cleaned must comply with the following 
requirements:
    (i) Submit to the owner or operator of the affected storage tank 
and to the Administrator a written certification that the reloading or 
cleaning facility will meet the requirements of this section. The 
certifying entity may revoke the written certification by sending a 
written statement to the owner or operator of the affected storage tank 
giving at least 90 days notice that the certifying entity is rescinding 
acceptance of responsibility for compliance with the requirements of 
this paragraph.
    (ii) If complying with paragraph (f)(6)(i) of this section, 
demonstrate initial compliance in accordance with Sec. 63.1257(c), 
demonstrate continuous compliance in accordance with Sec. 63.1258, keep 
records as specified in Sec. 63.1259, and prepare reports as specified 
in Sec. 63.1260.
    (iii) If complying with paragraph (f)(6)(ii) of this section, keep 
records of:
    (A) The equipment to be used and the procedures to be followed when 
reloading the railcar or tank truck and displacing vapors to the 
storage tank from which the liquid originates, and (B) Each time the 
vapor balancing system is used to comply with paragraph (f)(6)(ii) of 
this section.
    6. Section 63.1254 is revised to read as follows:


Sec. 63.1254  Standards: Process vents.

    (a) Existing sources. For each process, the owner or operator of an 
existing affected source must comply with the requirements in either 
paragraphs (a)(1) and (3) of this section or paragraphs (a)(2) and (3) 
of this section. Initial compliance with the required emission limits 
or reductions in paragraphs (a)(1) through (3) of this section is 
demonstrated in accordance with the initial compliance procedures 
described in Sec. 63.1257(d), and continuous compliance is demonstrated 
in accordance with the monitoring requirements described in 
Sec. 63.1258.
    (1) Process-based emission reduction requirement.
    (i) Uncontrolled HAP emissions from the sum of all process vents 
within a process that are not subject to the requirements of paragraph 
(a)(3) of this section shall be reduced by 93 percent or greater by 
weight, or as specified in paragraph (a)(1)(ii) of this section. 
Notification of changes in the compliance method shall be reported 
according to the procedures in Sec. 63.1260(h).
    (ii) Any one or more vents within a process may be controlled in 
accordance with any of the procedures in paragraphs (a)(1)(ii)(A) 
through (D) of this section. All other vents within the process must be 
controlled as specified in paragraph (a)(1)(i) of this section.
    (A) To outlet concentrations less than or equal to 20 ppmv as TOC 
and less than or equal to 20 ppmv as hydrogen halides and halogens;
    (B) By a flare that meets the requirements of Sec. 63.11(b);
    (C) By a control device specified in Sec. 63.1257(a)(4); or
    (D) In accordance with the alternative standard specified in 
paragraph (c) of this section.
    (2) Process-based annual mass limit. (i) Actual HAP emissions from 
the sum of all process vents within a process must not exceed 900 
kilograms (kg) in any 365-day period.
    (ii) Actual HAP emissions from the sum of all process vents within 
processes complying with paragraph (a)(2)(i) of this section are 
limited to a maximum of 1,800 kg in any 365-day period.
    (iii) Emissions from vents that are subject to the requirements of 
paragraph (a)(3) of this section and emissions from vents that are 
controlled in accordance with the procedures in paragraph (c) of this 
section may be excluded from the sums calculated in paragraphs 
(a)(2)(i) and (ii) of this section.
    (iv) The owner or operator may switch from compliance with 
paragraph (a)(2) of this section to compliance with paragraph (a)(1) of 
this section only after at least 1 year of operation in compliance with 
paragraph (a)(2) of this section. Notification of such a change in the 
compliance method shall be reported according to the procedures in 
Sec. 63.1260(h).
    (3) Individual vent emission reduction requirements.
    (i) Except as provided in paragraph (a)(3)(ii) of this section, 
uncontrolled HAP emissions from a process vent must be reduced by 98 
percent or in accordance with any of the procedures

[[Page 19173]]

in paragraphs (a)(1)(ii)(A) through (D) of this section if the 
uncontrolled HAP emissions from the vent exceed 25 tons per year, and 
the flow-weighted average flowrate (FRa) calculated using 
Equation 1 of this subpart is less than or equal to the flowrate index 
(FRI) calculated using Equation 2 of this subpart.
[GRAPHIC] [TIFF OMITTED] TP10AP00.080

[GRAPHIC] [TIFF OMITTED] TP10AP00.081

Where:

FRa=flow-weighted average flowrate for the vent, scfm
Di=duration of each emission event, min
FRi=flowrate of each emission event, scfm
n=number of emission events
FRI=flowrate index, scfm
HL=annual uncontrolled HAP emissions, lb/yr, as defined in Sec. 63.1251
    (ii) Grandfathering provisions. As an alternative to the 
requirements in paragraph (a)(3)(i) of this section, the owner or 
operator may comply with the provisions in paragraphs (a)(3)(ii)(A), 
(B), or (C) of this section, if applicable.
    (A) Control device operation. If the owner or operator can 
demonstrate that a process vent is controlled by a control device 
meeting the criteria specified in paragraph (a)(3)(ii)(A)(1) of this 
section, then the control device is required to be operated according 
to paragraphs (a)(3)(ii)(A)(2), (3), and (4) of this section:
    (1) The control device was installed on any process vent that met 
the conditions of paragraph (a)(3)(i) of this section on or before 
April 2, 1997, and was operated to reduce uncontrolled emissions of 
total HAP by greater than or equal to 93 percent by weight, but less 
than 98 percent by weight;
    (2) The device must be operated to reduce inlet emissions of total 
HAP by 93 percent or by the percent reduction specified for that 
control device in any preconstruction permit issued pursuant to 
regulations approved or promulgated through rulemaking under title I 
(including parts C or D) of the Clean Air Act, whichever is greater;
    (3) The device must be replaced or upgraded to achieve at least 98 
percent reduction of HAP or meet any of the conditions specified in 
paragraphs (a)(1)(ii)(A) through (D) of this section upon 
reconstruction or replacement.
    (4) The device must be replaced or upgraded to achieve at least 98 
percent reduction of HAP or meet any of the conditions specified in 
paragraphs (a)(1)(ii)(A) through (D) of this section by April 2, 2007, 
or 15 years after issuance of the preconstruction permit, whichever is 
later.
    (B) Process operations. If a process meets all of the conditions 
specified in paragraphs (a)(3)(ii)(B)(1) through (3) of this section, 
the required level of control for the process is the level that was 
achieved on or before April 2, 1997. This level of control is 
demonstrated using the same procedures that are used to demonstrate 
compliance with paragraph (a)(1) of this section.
    (1) At least one vent in the process met the conditions of 
paragraph (a)(3)(i) of this section on or before April 2, 1997; and
    (2) The overall control for the process on or before April 2, 1997 
was greater than or equal to 93 percent by weight, but less than 98 
percent by weight; and
    (3) The production-indexed HAP consumption factor for the 12-month 
period in which the process was operated prior to the compliance date 
is less than one-half of the 3-year average baseline value established 
no earlier than the 1987 through 1989 calendar years.
    (C) Hydrogenation vents. Processes meeting the conditions of 
paragraphs (a)(3)(ii)(C)(1) through (3) of this section are required to 
be operated to maintain the level of control achieved on or before 
April 2, 1997. For all other processes meeting the conditions of 
paragraph (a)(3)(ii)(C)(3) of this section, uncontrolled HAP emissions 
from the sum of all process vents within the process must be reduced by 
95 percent or greater by weight.
    (1) Processes containing a process vent that met the conditions of 
paragraph (a)(3)(i) of this section on or before April 2, 1997; and
    (2) Processes that are controlled to greater than or equal to 93 
percent by weight, but less than 98 percent by weight; and
    (3) Processes with a hydrogenation vent that, in conjunction with 
all other process vents from the process that do not meet the 
conditions of paragraph (a)(3)(i) of this section, cannot meet the 
requirements of paragraph (a)(1) or (2) of this section.
    (b) New sources. (1) Except as provided in paragraph (b)(2) of this 
section, uncontrolled HAP emissions from the sum of all process vents 
within a process at a new affected source shall be reduced by 98 
percent or greater by weight or controlled in accordance with any of 
requirements of paragraphs (a)(1)(ii)(A) through (D) of this section. 
Initial compliance with the required emission limit or reduction is 
demonstrated in accordance with the initial compliance procedures in 
Sec. 63.1257(d), and continuous compliance is demonstrated in 
accordance with the monitoring requirements described in Sec. 63.1258.
    (2) Annual mass limit. The actual HAP emissions from the sum of all 
process vents for which the owner or operator is not complying with 
paragraph (b)(1) of this section are limited to 900 kg in any 365-day 
period.
    (c) Alternative standard. As an alternative standard, the owner or 
operator of an existing or new affected source may comply with the 
process vent standards by routing vents from a process to a combustion 
control device achieving an outlet TOC concentration, as calibrated on 
methane or the predominant HAP, of 20 ppmv or less, and an outlet 
concentration of hydrogen halides and halogens of 20 ppmv or less. If 
the owner or operator is routing emissions to a noncombustion control 
device, it must achieve an outlet TOC concentration, as calibrated on 
methane or the predominant HAP, of 50 ppmv or less, and an outlet 
concentration of hydrogen halides and halogens of 50 ppmv or less. Any 
process vents within a process that are not routed to this control 
device must be controlled in accordance with the provisions of 
paragraph (a) or (b) of this section, as applicable. Initial compliance 
with the outlet concentrations is demonstrated in accordance with the 
initial compliance procedures described in Sec. 63.1257(d)(1)(iv), and 
continuous compliance is demonstrated in accordance with the emission 
monitoring requirements described in Sec. 63.1258(b)(5).
    7. Section 63.1255 is amended by:
    a. Revising paragraph (a)(1);
    b. Revising paragraph (a)(7);
    c. Revising paragraphs (a)(10)(ii) and (iii);
    d. Adding paragraphs (a)(11) and (12);
    e. Revising paragraph (b);
    f. Revising paragraph (c)(2)(i);
    g. Revising ``paragraph (b)(1)(v)'' to read ``paragraph (b)(4)(i)'' 
in paragraph (c)(3)(i);
    h. Revising the definitions of the terms ``PL'' and 
``PT'' following Equation 3 in paragraph (c)(4)(iv);
    i. Removing the definition of the term ``PS'' following 
Equation 3 in paragraph (c)(4)(iv) and adding the definition of the 
term ``PS'' following Equation 3 in paragraph (c)(4)(iv);
    j. Revising ``paragraph (b)(1)(vi)'' to read ``paragraph 
(b)(4)(ii)'' in paragraph (c)(5)(i)(B);

[[Page 19174]]

    k. Revising paragraphs (c)(5)(vi)(B) and (C);
    l. Revising paragraphs (c)(6) and (7);
    m. Revising paragraph (c)(9);
    n. Revising paragraphs (d)(1)(i) and (ii);
    o. Revising paragraph (e)(2);
    p. Revising paragraph (e)(3) introductory text;
    q. Revising paragraph (e)(3)(i);
    r. Revising the definition of the term ``%VL'' following 
Equation 5 in paragraph (e)(6)(ii);
    s. Revising ``paragraph (b)(1)(v)'' to read ``paragraph (b)(4)(i)'' 
in paragraph (e)(7)(i);
    t. Adding paragraphs (e)(7)(iii)(A) through (C);
    u. Revising the second sentence in paragraph (e)(9);
    v. Revising paragraph (f);
    w. Revising paragraph (g)(2) introductory text;
    x. Revising paragraph (g)(2)(i)(A);
    y. Removing paragraph (g)(2)(v), redesignating paragraphs 
(g)(2)(vi) through (ix) as paragraphs (g)(2)(v) through (viii), and 
revising redesignated paragraphs (g)(2)(vi) and (viii);
    z. Revising the first sentence in paragraph (g)(3);
    aa. Revising paragraph (g)(4) introductory text;
    bb. Revising paragraph (g)(4)(iv);
    cc. Revising paragraph (g)(4)(v)(A);
    dd. Revising ``Sec. 63.174(c)'' to read ``Sec. 63.174(c)(1)(i) and 
(c)(2)(ii)'' in the first sentence in paragraph (g)(4)(vii)(B);
    ee. Revising ``Secs. 63.178(c)(3)(ii) and (c)(3)(iii)'' to read 
``Sec. 63.178(c)(3)(ii) and (iii)'' in the first sentence in paragraph 
(g)(4)(viii);
    ff. Revising the first sentence in paragraph (g)(5) introductory 
text;
    gg. Removing paragraph (g)(5)(ii), redesignating paragraphs 
(g)(5)(iii) through (vi) as paragraphs (g)(5)(ii) through (v), and 
revising ``appendix'' to read ``section'' in the second sentence of 
redesignated paragraph (g)(5)(ii);
    hh. Revising paragraph (g)(6) heading;
    ii. Revising the first sentence in paragraph (g)(7) introductory 
text;
    jj. Revising ``paragraph (b)(1)(vi)'' to read ``paragraph 
(b)(4)(ii)'' in paragraph (g)(7)(i)(D);
    kk. Revising paragraph (h)(2) heading;
    ll. Revising paragraph (h)(2)(i)(B);
    mm. Revising ``paragraph (b)(1)(ix)'' to read ``paragraph 
(b)(4)(iv)'' in paragraph (h)(2)(ii);
    nn. Revising ``paragraph (b)(1)(vi)'' to read ``paragraph 
(b)(4)(ii)'' in paragraph (h)(2)(iii)(B);
    oo. Revising paragraph (h)(2)(iv);
    pp. Revising ``Sec. 63.1250(e)'' to read ``Sec. 63.1250(f)'' in the 
second sentence in paragraph (h)(3)(i);
    qq. Revising paragraph (h)(3)(ii) introductory text;
    rr. Revising paragraphs (h)(3)(ii)(C) and (D); and
    ss. Revising paragraph (h)(3)(iv);
    The revisions and additions read as follows:


Sec. 63.1255  Standards: Equipment leaks.

    (a) * * *
    (1) The provisions of this section apply to pumps, compressors, 
agitators, pressure relief devices, sampling connection systems, open-
ended valves or lines, valves, connectors, instrumentation systems, 
control devices, and closed-vent systems required by this section 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.
* * * * *
    (7) Equipment to which this section applies shall be identified 
such that it can be distinguished readily from equipment that is not 
subject to this section. Identification of the equipment does not 
require physical tagging of the equipment. For example, the equipment 
may be identified on a plant site plan, in log entries, or by 
designation of process boundaries by some form of weatherproof 
identification. If changes are made to the affected source subject to 
the leak detection requirements, equipment identification for each type 
of component shall be updated, if needed, within 90 calendar days, or 
by the next Periodic Report, following the end of the monitoring period 
for that component, whichever is later.
* * * * *
    (10) * * *
    (ii) The identification on a valve in light liquid or gas/vapor 
service may be removed after it has been monitored as specified in 
paragraph (e)(7)(iii) of this section, and no leak has been detected 
during the follow-up monitoring.
    (iii) The identification on equipment, except on a valve in light 
liquid or gas/vapor service, may be removed after it has been repaired.
    (11) Except as provided in paragraph (a)(11)(i) of this section, 
all terms in this subpart that define a period of time for completion 
of required tasks (e.g., weekly, monthly, quarterly, annual) refer to 
the standard calendar periods unless specified otherwise in the section 
or paragraph that imposes the requirement.
    (i) If the initial compliance date does not coincide with the 
beginning of the standard calendar period, an owner or operator may 
elect to utilize a period beginning on the compliance date, or may 
elect to comply in accordance with the provisions of paragraph 
(a)(11)(ii) or (iii) of this section.
    (ii) Time periods specified in this subpart for completion of 
required tasks may be changed by mutual agreement between the owner or 
operator and the Administrator, as specified in subpart A of this part. 
For each time period that is changed by agreement, the revised period 
shall remain in effect until it is changed. A new request is not 
necessary for each recurring period.
    (iii) Except as provided in paragraph (a)(11)(i) or (ii) of this 
section, where the period specified for compliance is a standard 
calendar period, if the initial compliance date does not coincide with 
the beginning of the calendar period, compliance shall be required 
according to the schedule specified in paragraph (a)(11)(iii)(A) or (B) 
of this section, as appropriate.
    (A) Compliance shall be required before the end of the standard 
calendar period within which the initial compliance date occurs if 
there remain at least 3 days for tasks that must be performed weekly, 
at least 2 weeks for tasks that must be performed monthly, at least 1 
month for tasks that must be performed each quarter, or at least 3 
months for tasks that must be performed annually; or
    (B) In all other cases, compliance shall be required before the end 
of the first full standard calendar period after the period within 
which the initial compliance date occurs.
    (iv) In all instances where a provision of this subpart requires 
completion of a task during each of multiple successive periods, an 
owner or operator may perform the required task at any time during each 
period, provided the task is conducted at a reasonable interval after 
completion of the task during the previous period.
    (12) In all cases where the provisions of this subpart require an 
owner or operator to repair leaks by a specified time after the leak is 
detected, it is a violation of this section to fail to take action to 
repair the leaks within the specified time. If action is taken to 
repair the leaks within the specified time, failure of that action to 
successfully repair the leak is not a violation of this section. 
However, if the repairs are unsuccessful, a leak is detected and the 
owner or operator shall take further action as required by applicable 
provisions of this section.
    (b) References. (1) The owner or operator of a source subject to 
this section shall comply with the provisions of subpart H of this 
part, as specified in paragraphs (b)(2) through (4) of this section. 
The term ``process unit'' as used in subpart H of this part

[[Page 19175]]

shall be considered to be defined the same as ``group of processes'' 
for sources subject to this subpart GGG. The term ``fuel gas system,'' 
as used in subpart H of this part, shall not apply for the purposes of 
this subpart GGG.
    (2) Sections 63.160, 63.161, 63.162, 63.163, 63.167, 63.168, 
63.170, 63.173, 63.175, 63.176, 63.181, and 63.182 shall not apply for 
the purposes of this subpart GGG. The owner or operator shall comply 
with the provisions specified in paragraphs (b)(2)(i) through (viii) of 
this section.
    (i) Sections 63.160 and 63.162 shall not apply; instead, the owner 
or operator shall comply with paragraph (a) of this section;
    (ii) Section 63.161 shall not apply; instead, the owner or operator 
shall comply with Sec. 63.1251;
    (iii) Sections 63.163 and 63.173 shall not apply; instead, the 
owner or operator shall comply with paragraph (c) of this section;
    (iv) Section 63.167 shall not apply; instead, the owner or operator 
shall comply with paragraph (d) of this section;
    (v) Section 63.168 shall not apply; instead, the owner or operator 
shall comply with paragraph (e) of this section;
    (vi) Section 63.170 shall not apply; instead, the owner or operator 
shall comply with Sec. 63.1254;
    (vii) Section 63.181 shall not apply; instead, the owner or 
operator shall comply with paragraph (g) of this section; and
    (viii) Section 63.182 shall not apply; instead, the owner or 
operator shall comply with paragraph (h) of this section.
    (3) The owner or operator shall comply with Secs. 63.164, 63.165, 
63.166, 63.169, 63.177, and 63.179 in their entirety, except that when 
these sections reference other sections of subpart H of this part, the 
references shall mean those sections as specified in paragraphs (b)(2) 
and (4) of this section. Section 63.164 applies to compressors. Section 
63.165 applies to pressure relief devices in gas/vapor service. Section 
63.166 applies to sampling connection systems. Section 63.169 applies 
to pumps, valves, connectors, and agitators in heavy liquid service; 
instrumentation systems; and pressure relief devices in liquid service. 
Section 63.177 applies to general alternative means of emission 
limitation. Section 63.179 applies to alternative means of emission 
limitation for enclosed-vented process units.
    (4) The owner or operator shall comply with Secs. 63.171, 63.172, 
63.174, 63.178, and 63.180 with the differences specified in paragraphs 
(b)(4)(i) through (vi) of this section.
    (i) Section 63.171, shall apply, except Sec. 63.171(a) shall not 
apply. Instead, delay of repair of equipment for which leaks have been 
detected is allowed if one of the following conditions exists:
    (A) The repair is technically infeasible without a process 
shutdown. Repair of this equipment shall occur by the end of the next 
scheduled process shutdown.
    (B) The owner or operator determines that repair personnel would be 
exposed to an immediate danger if attempting to repair without a 
process shutdown. Repair of this equipment shall occur by the end of 
the next scheduled process shutdown.
    (ii) Section 63.172, shall apply for closed-vent systems used to 
comply with this section, and for control devices used to comply with 
this section only, except:
    (A) Section 63.172(k) and (l) shall not apply. The owner or 
operator shall instead comply with paragraph (f) of this section.
    (B) Owners or operators may, instead of complying with the 
provisions of Sec. 63.172(f), design a closed-vent system to operate at 
a pressure below atmospheric pressure. The system shall be equipped 
with at least one pressure gage or other pressure measurement device 
that can be read from a readily accessible location to verify that 
negative pressure is being maintained in the closed-vent system when 
the associated control device is operating.
    (iii) Section 63.174, shall apply except:
    (A) Section 63.174(f), (g), and (h) shall not apply. Instead of 
Sec. 63.174(f), (g), and (h), the owner or operator shall comply with 
paragraph (f) of this section. Section 63.174(b)(3) shall not apply. 
Instead of Sec. 63.174(b)(3), the owner or operator shall comply with 
paragraphs (b)(3)(iii)(B) through (F) of this section.
    (B) If the percent leaking connectors in a group of processes was 
greater than or equal to 0.5 percent during the initial monitoring 
period, monitoring shall be performed once per year until the percent 
leaking connectors is less than 0.5 percent.
    (C) If the percent leaking connectors in the group of processes was 
less than 0.5 percent, but equal to or greater than 0.25 percent, 
during the initial or last required monitoring period, the owner or 
operator may elect to monitor once every 4 years. An owner or operator 
may comply with the requirements of this paragraph by monitoring at 
least 40 percent of the connectors in the first 2 years and the 
remainder of the connectors within the next 2 years. The percent 
leaking connectors will be calculated for the total of all required 
monitoring performed during the 4-year period.
    (D) Except as provided in paragraph (b)(4)(iii)(B) of this section, 
if leaking connectors comprise at least 0.5 percent but less than 1.0 
percent of the connectors during the last monitoring period, the owner 
or operator shall monitor at least once every 2 years for the next 
monitoring period. At the end of that 2-year monitoring period, the 
owner or operator shall monitor once per year if the percent leaking 
connectors is greater than or equal to 0.5 percent; if the percent 
leaking connectors is less than 0.5 percent, the owner or operator 
shall monitor in accordance with paragraph (b)(4)(iii)(C) or (F) of 
this section, as appropriate.
    (E) If an owner or operator determines that 1 percent or greater of 
the connectors in a group of processes are leaking, the owner or 
operator shall monitor the connectors once per year. The owner or 
operator may elect to use the provisions of paragraph (b)(4)(iii)(C), 
(D), or (F) of this section, as appropriate, after a monitoring period 
in which less than 1 percent of the connectors are determined to be 
leaking.
    (F) The owner or operator may elect to perform monitoring once 
every 8 years if the percent leaking connectors in the group of 
processes was less than 0.25 percent during the initial or last 
required monitoring period. An owner or operator shall monitor at least 
50 percent of the connectors in the first 4 years and the remainder of 
the connectors within the next 4 years. If the percent leaking 
connectors in the first 4 years is equal to or greater than 0.35 
percent, the monitoring program shall revert at that time to the 
appropriate monitoring frequency specified in paragraph (b)(4)(iii)(C), 
(D), or (E) of this section.
    (iv) Section 63.178, shall apply except:
    (A) Section 63.178(b), requirements for pressure testing, may be 
applied to all processes (not just batch processes) and to supply lines 
between storage and processing areas.
    (B) For pumps, the phrase ``at the frequencies specified in Table 1 
of this subpart'' in Sec. 63.178(c)(iii) shall mean ``quarterly'' for 
the purposes of this subpart.
    (v) Section 63.180 shall apply except Sec. 63.180(b)(4)(ii)(A) 
through (C) shall not apply. Instead, calibration gases shall be a 
mixture of methane and air at a concentration of approximately, but 
less than, 10,000 parts per million methane for agitators; 2,000 parts 
per million for pumps; and 500 parts per

[[Page 19176]]

million for all other equipment, except as provided in 
Sec. 63.180(b)(4)(iii).
    (vi) When Secs. 63.171, 63.172, 63.174, 63.178, and 63.180 
reference other sections in subpart H of this part, the references 
shall mean those sections specified in paragraphs (b)(2) and (b)(4)(i) 
through (v) of this section, as applicable.
    (c) * * *
    (2)(i) Monitoring. Each pump and agitator subject to this section 
shall be monitored quarterly to detect leaks by the method specified in 
Sec. 63.180(b) except as provided in Sec. 63.177, Sec. 63.178(b) 
paragraph (f) of this section, and paragraphs (c)(5) through (9) of 
this section.
    (4) * * *
    (iv) * * *

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

    (5) * * *
    (vi) * * *
    (B) If indications of liquids dripping from the pump/agitator seal 
exceed the criteria established in paragraph (c)(5)(vi)(A) of this 
section, or if, based on the criteria established in paragraph 
(c)(5)(vi)(A) of this section, the sensor indicates failure of the seal 
system, the barrier fluid system, or both, a leak is detected.
    (C) When a leak is detected, it shall be repaired as soon as 
practicable, but not later than 15 calendar days after it is detected, 
except as provided in paragraph (b)(4)(i) of this section.
* * * * *
    (6) Any pump/agitator that is designed with no externally actuated 
shaft penetrating the pump/agitator housing is exempt from the 
requirements of paragraphs (c)(1) through (3) of this section.
    (7) Any pump/agitator equipped with a closed-vent system capable of 
capturing and transporting any leakage from the seal or seals back to 
the process or to a control device that complies with the requirements 
of paragraph (b)(4)(ii) of this section is exempt from the requirements 
of paragraphs (c)(2) through (5) of this section.
* * * * *
    (9) If more than 90 percent of the pumps in a group of processes 
meet the criteria in either paragraph (c)(5) or (6) of this section, 
the group of processes is exempt from the requirements of paragraph 
(c)(4) of this section.
    (d) * * *
    (1)(i) Each open-ended valve or line shall be equipped with a cap, 
blind flange, plug, or a second valve, except as provided in 
Sec. 63.177 and paragraphs (d)(4) through (6) of this section.
    (ii) The cap, blind flange, plug, or second valve shall seal the 
open end at all times except during operations requiring process fluid 
flow through the open-ended valve or line, or during maintenance or 
repair. The cap, blind flange, plug, or second valve shall be in place 
within 1 hour of cessation of operations requiring process fluid flow 
through the open-ended valve or line, or within 1 hour of cessation of 
maintenance or repair. The owner or operator is not required to keep a 
record documenting compliance with the 1-hour requirement.
* * * * *
    (e) * * *
    (2) For existing and new affected sources, all valves subject to 
this section shall be monitored, except as provided in paragraph (f) of 
this section and in Sec. 63.177 by no later than 1 year after the 
compliance date.
    (3) Monitoring. The owner or operator of a source subject to this 
section shall monitor all valves, except as provided in paragraph (f) 
of this section and in Sec. 63.177 at the intervals specified in 
paragraph (e)(4) of this section and shall comply with all other 
provisions of this section, except as provided in paragraph (b)(4)(i) 
of this section, Sec. 63.178(b) and Sec. 63.179.
    (i) The valves shall be monitored to detect leaks by the method 
specified in Sec. 63.180(b).
* * * * *
    (6) * * *
    (ii) * * *
%VL = percent leaking valves as determined through periodic 
monitoring required in paragraphs (e)(2) through (4) of this section. * 
* *
* * * * *
    (7) * * *
    (iii) * * *
    (A) The monitoring shall be conducted as specified in 
Sec. 63.180(b) and (c) as appropriate, to determine whether the valve 
has resumed leaking.
    (B) Periodic monitoring required by paragraphs (e)(2) through (4) 
of this section may be used to satisfy the requirements of paragraph 
(e)(7)(iii) of this section, if the timing of the monitoring period 
coincides with the time specified in paragraph (e)(7)(iii) of this 
section. Alternatively, other monitoring may be performed to satisfy 
the requirements of paragraph (e)(7)(iii) of this section, regardless 
of whether the timing of the monitoring period for periodic monitoring 
coincides with the time specified in paragraph (e)(7)(iii) of this 
section.
    (C) If a leak is detected by monitoring that is conducted pursuant 
to paragraph (e)(7)(iii) of this section, the owner or operator shall 
follow the provisions of paragraphs (e)(7)(iii)(C)(1) and (2) of this 
section to determine whether that valve must be counted as a leaking 
valve for purposes of paragraph (e)(6) of this section.
    (1) If the owner or operator elects to use periodic monitoring 
required by paragraphs (e)(2) through (4) of this section to satisfy 
the requirements of paragraph (e)(7)(iii) of this section, then the 
valve shall be counted as a leaking valve.
    (2) If the owner or operator elects to use other monitoring prior 
to the periodic monitoring required by paragraphs (e)(2) through (4) of 
this section to satisfy the requirements of paragraph (e)(7)(iii) of 
this section, then the valve shall be counted as a leaking valve unless 
it is repaired and shown by periodic monitoring not to be leaking.
* * * * *
    (9) * * * Instead, the owner or operator shall monitor each valve 
in organic HAP service for leaks once each quarter, or comply with 
paragraph (e)(4)(iii) or (iv) of this section, except as provided in 
paragraph (f) of this section.
    (f) Unsafe to monitor/inspect, difficult to monitor/inspect, and 
inaccessible equipment. (1) Equipment that is designated as unsafe to 
monitor, unsafe to inspect, difficult to monitor, difficult to inspect, 
or inaccessible is exempt from the monitoring requirements as specified 
in paragraphs (f)(1)(i) through (iv) of this section provided the owner 
or operator meets the requirements specified in paragraph (f)(2), (3), 
or (4) of this section, as applicable. All equipment must be assigned 
to a group of processes. Ceramic or ceramic-lined connectors are 
subject to the same requirements as inaccessible connectors.
    (i) For pumps and agitators, paragraphs (c)(2), (3), and (4) of 
this section do not apply.
    (ii) For valves, paragraphs (e)(2) through (7) of this section do 
not apply.
    (iii) For connectors, Sec. 63.174(b) through (e) and paragraphs 
(b)(3)(iii)(B) through (F) of this section do not apply.
    (iv) For closed-vent systems, Sec. 63.172(f)(1) and (2), and 
Sec. 63.172(g) do not apply.

[[Page 19177]]

    (2) Equipment that is unsafe to monitor or unsafe to inspect. (i) 
Valves, connectors, agitators, and pumps may be designated as unsafe to 
monitor if the owner or operator determines that monitoring personnel 
would be exposed to an immediate danger as a consequence of complying 
with the monitoring requirements referred to in paragraphs (f)(1)(i) 
through (iii) of this section.
    (ii) Any part of a closed-vent system may be designated as unsafe 
to inspect if the owner or operator determines that monitoring 
personnel would be exposed to an immediate danger as a consequence of 
complying with the monitoring requirements referred to in paragraph 
(f)(1)(iv) of this section.
    (iii) The owner or operator of equipment that is designated as 
unsafe to monitor must have a written plan that requires monitoring of 
the equipment as frequently as practicable during safe to monitor 
times, but not more frequently than the periodic monitoring schedule 
otherwise applicable to the group of processes in which the equipment 
is located.
    (iv) For any parts of a closed-vent system designated as unsafe to 
inspect, the owner or operator must have a written plan that requires 
inspection of the closed-vent systems as frequently as practicable 
during safe to inspect times, but not more frequently than annually.
    (3) Equipment that is difficult to monitor or difficult to inspect. 
(i) A valve, agitator, or pump may be designated as difficult to 
monitor if the owner or operator determines that the valve, agitator, 
or pump cannot be monitored without elevating the monitoring personnel 
more than 2 meters above a support surface, or it is not accessible in 
a safe manner when it is in organic HAP service.
    (ii) Any part of a closed-vent system may be designated as 
difficult to inspect if the owner or operator determines that the 
equipment cannot be inspected without elevating the monitoring 
personnel more than 2 meters above a support surface, or it is not 
accessible in a safe manner when it is in organic HAP service.
    (iii) At an existing source, any valve, agitator or pump within a 
group of processes that meets the criteria of paragraph (f)(3)(i) of 
this section may be designated as difficult to monitor, and any parts 
of a closed-vent system that meet the requirements of paragraph 
(f)(3)(ii) of this section may be designated as difficult to inspect. 
At a new affected source, an owner or operator may designate no more 
than 3 percent of valves as difficult to monitor.
    (iv) The owner or operator of valves, agitators, or pumps 
designated as difficult to monitor must have a written plan that 
requires monitoring of the equipment at least once per calendar year or 
on the periodic monitoring schedule otherwise applicable to the group 
of processes in which the equipment is located, whichever is less 
frequent. For any part of a closed-vent system designated as difficult 
to inspect, the owner or operator must have a written plan that 
requires inspection of the closed-vent system at least once every 5 
years.
    (4) Inaccessible, ceramic, or ceramic-lined connectors. (i) A 
connector may be designated as inaccessible if it is:
    (A) Buried;
    (B) Insulated in a manner that prevents access to the connector by 
a monitor probe;
    (C) Obstructed by equipment or piping that prevents access to the 
connector by a monitor probe;
    (D) Unable to be reached from a wheeled scissor-lift or hydraulic-
type scaffold which would allow access to equipment up to 7.6 meters 
(25 feet) above the ground; or
    (E) Not able to be accessed at any time in a safe manner to perform 
monitoring. Unsafe access includes, but is not limited to, the use of a 
wheeled scissor-lift on unstable or uneven terrain, the use of a 
motorized man-lift basket in areas where an ignition potential exists, 
or access would require near proximity to hazards such as electrical 
lines, or would risk damage to equipment.
    (ii) A connector may be designated as inaccessible if it would 
require elevating the monitoring personnel more than 2 meters above a 
permanent support surface or would require the erection of scaffold.
    (iii) At an existing source, any connector that meets the criteria 
of paragraph (f)(4)(i) or (ii) of this section may be designated as 
inaccessible. At a new affected source, an owner or operator may 
designate no more than 3 percent of connectors as inaccessible.
    (iv) If any inaccessible, ceramic, or ceramic-lined connector is 
observed by visual, audible, olfactory, or other means to be leaking, 
the leak shall be repaired as soon as practicable, but no later than 15 
calendar days after the leak is detected, except as provided in 
paragraph (b)(3)(i) of this section.
    (v) Any connector that is inaccessible or that is ceramic or 
ceramic-lined is exempt from the recordkeeping and reporting 
requirements of paragraphs (g) and (h) of this section.
    (g) * * *
    (2) General recordkeeping. Except as provided in paragraph 
(g)(5)(i) of this section and in paragraph (a)(9) of this section, the 
following information pertaining to all equipment subject to the 
requirements in this section shall be recorded:
    (i)(A) A list of identification numbers for equipment (except 
connectors that are subject to paragraph (f)(4) of this section) 
subject to the requirements of this section. Except for equipment 
subject to the recordkeeping requirements in paragraphs (g)(2)(ii) 
through (viii) of this section, equipment need not be individually 
identified if, for a particular type of equipment, all items of that 
equipment in a designated area or length of pipe subject to the 
provisions of this section are identified as a group, and the number of 
subject items of equipment is indicated. The list for each type of 
equipment shall be completed no later than the completion of the 
initial survey required for that component. The list of identification 
numbers shall be updated, if needed, to incorporate equipment changes 
identified during the course of each monitoring period within 90 
calendar days, or by the next Periodic Report, following the end of the 
monitoring period for the type of equipment component monitored, 
whichever is later.
* * * * *
    (vi) A list of equipment designated as unsafe to monitor/inspect or 
difficult to monitor/inspect under paragraph (f) of this section and a 
copy of the plan for monitoring or inspecting this equipment.
* * * * *
    (viii) For equipment that the owner or operator elects to monitor 
as provided under Sec. 63.178(c), a list of equipment added to batch 
product processes since the last monitoring period required in 
Sec. 63.178(c)(3)(ii) and (iii). This list must be completed for each 
type of equipment within 90 calendar days, or by the next Periodic 
Report, following the end of the monitoring period for the type of 
equipment monitored, whichever is later. Also, if the owner or operator 
elects to adjust monitoring frequency by the time in use, as provided 
in Sec. 63.178(c)(3)(iii), records demonstrating the proportion of the 
time during the calendar year the equipment is in use in a manner 
subject to the provisions of this section are required. Examples of 
suitable documentation are records of time in use for individual pieces 
of equipment or average time in use for the process unit.
    (3) Records of visual inspections. For visual inspections of 
equipment subject to the provisions of paragraphs (c)(2)(iii)

[[Page 19178]]

and (c)(5)(iv) of this section, the owner or operator shall document 
that the inspection was conducted and the date of the inspection. * * *
    (4) Monitoring records. When each leak is detected as specified in 
paragraph (c) of this section and Sec. 63.164, paragraph (e) of this 
section and Sec. 63.169, and Secs. 63.172 and 63.174, the following 
information shall be recorded and kept for 5 years (at least 2 years 
onsite, with the remaining 3 years either onsite or offsite):
* * * * *
    (iv) The maximum instrument reading measured by Method 21 of 40 CFR 
part 60, appendix A, after the leak is successfully repaired or 
determined to be nonrepairable.
    (v) * * *
    (A) The owner or operator may develop a written procedure that 
identifies the conditions that justify a delay of repair. The written 
procedures shall be included either as part of the startup/shutdown/
malfunction plan, required by Sec. 63.1259(a)(3), or in a separate 
document that is maintained at the plant site. Reasons for delay of 
repair may be documented by citing the relevant sections of the written 
procedure.
* * * * *
    (5) Records of pressure tests. The owner or operator who elects to 
pressure test a process equipment train or supply lines between storage 
and processing areas to demonstrate compliance with this section is 
exempt from the requirements of paragraphs (g)(2), (3), (4), and (6) of 
this section. * * *
* * * * *
    (6) Records of compressor and relief device compliance tests. * * *
* * * * *
    (7) Records for closed-vent systems. The owner or operator shall 
maintain records of the information specified in paragraphs (g)(7)(i) 
through (iii) of this section for closed-vent systems and control 
devices subject to the provisions of paragraph (b)(4)(ii) of this 
section. * * *
* * * * *
    (h) * * *
    (2) Notification of compliance status report. * * *
    (i) * * *
    (B) Number of each equipment type (e.g., valves, pumps) in organic 
HAP service, excluding equipment in vacuum service.
* * * * *
    (iv) Section 63.9(j) shall not apply to the Notification of 
Compliance Status report described in this paragraph (h)(2).
    (3) * * *
    (ii) For equipment complying with the provisions of paragraphs (b) 
through (g) of this section, except paragraph (b)(3)(iv) of this 
section and Sec. 63.179 the summary information listed in paragraphs 
(h)(3)(ii)(A) through (L) of this section for each monitoring period 
during the 6-month period.
* * * * *
    (C) Separately, the number of pumps and agitators for which leaks 
were detected as described in paragraph (c)(2) of this section, the 
total number of pumps and agitators monitored, and, for pumps, the 
percent leakers;
    (D) Separately, the number of pumps and agitators for which leaks 
were not repaired as required in paragraph (c)(3) of this section;
* * * * *
    (iv) Any revisions to items reported in earlier Notification of 
Compliance Status report, if the method of compliance has changed since 
the last report.
    8. Section 63.1256 is amended by:
    a. Revising paragraphs (a)(1)(i)(A) and (B);
    b. Revising paragraph (a)(3);
    c. Revising paragraph (a)(5) introductory text;
    d. Revising paragraph (a)(5)(ii)(C);
    e. Adding paragraph (a)(5)(ii)(D);
    f. Adding paragraph (b)(6)(i);
    g. Revising paragraphs (d)(2) introductory text and paragraph 
(d)(2)(i);
    h. Revising paragraph (g)(8)(ii);
    i. Revising paragraph (g)(11)(ii); and
    j. Revising paragraph (g)(12).
    The revisions and additions read as follows:


Sec. 63.1256  Standards: Wastewater.

    (a) * * *
    (1) * * *
    (i) * * *
    (A) The wastewater stream contains partially soluble HAP compounds 
at an annual average concentration greater than 1,300 ppmw, and the 
total soluble and partially soluble HAP load in all wastewater from the 
PMPU exceeds 0.25 Mg/yr.
    (B) The wastewater stream contains partially soluble and/or soluble 
HAP compounds at an annual average concentration of 5,200 ppmw, and the 
total soluble and partially soluble HAP load in all wastewater from the 
PMPU exceeds 0.25 Mg/yr.
* * * * *
    (3) Exemptions from wastewater requirements. (i) The following 
wastewaters are not subject to the wastewater provisions of this 
subpart:
    (A) Stormwater from segregated sewers;
    (B) Water from fire-fighting and deluge systems, including testing 
of such systems;
    (C) Spills;
    (D) Water from safety showers; and
    (E) Samples of a size not greater than reasonably necessary for the 
method of analysis that is used.
    (ii) Maintenance wastewater. Each owner or operator of a source 
subject to this subpart shall comply with the requirements of 
paragraphs (a)(3)(ii)(A) through (D) of this section for maintenance 
wastewater containing partially soluble or soluble HAPs listed in 
Tables 2 and 3 of this subpart.
    (A) The owner or operator shall prepare a description of 
maintenance procedures for management of wastewater generated from the 
emptying and purging of equipment in the process during temporary 
shutdowns for inspections, maintenance, and repair (i.e., a maintenance 
turnaround) and during periods which are not shutdowns (i.e., routine 
maintenance). The descriptions shall:
    (1) Specify the process equipment or maintenance tasks that are 
anticipated to create wastewater during maintenance activities; and
    (2) Specify the procedures that will be followed to properly manage 
the wastewater and minimize organic HAP emissions to the atmosphere; 
and
    (3) Specify the procedures to be followed when clearing materials 
from process equipment.
    (B) The owner or operator shall modify and update the information 
required by paragraph (a)(3)(ii)(A) of this section as needed following 
each maintenance procedure based on the actions taken and the 
wastewater generated in the preceding maintenance procedure.
    (C) The owner or operator shall implement the procedures described 
in paragraphs (a)(3)(ii)(A) and (B) of this section as part of the 
startup, shutdown, and malfunction plan required under Sec. 63.6(e)(3).
    (D) The owner or operator shall maintain a record of the 
information required by paragraphs (a)(3)(ii)(A) and (B) of this 
section as part of the startup, shutdown, and malfunction plan required 
under Sec. 63.6(e)(3).
* * * * *
    (5) Offsite treatment or onsite treatment not owned or operated by 
the source. The owner or operator may elect to transfer affected 
wastewater streams or a residual removed from such affected wastewater 
to an onsite treatment operation not owned or operated by the owner or 
operator of the source generating the wastewater or

[[Page 19179]]

residual, or to an offsite treatment operation.
* * * * *
    (ii) * * *
    (C) Section 63.6(g); or
    (D) If the affected wastewater streams or residuals removed from 
affected wastewater streams received by the transferee contain less 
than 50 ppmw of partially soluble HAP, then the transferee must, at a 
minimum, manage and treat the affected wastewater streams and residuals 
in accordance with one of the following:
    (1) Comply with paragraph (g)(10) of this section and cover the 
waste management units up to the activated sludge unit; or
    (2) Comply with paragraphs (g)(11)(i), (ii), and (h) of this 
section and cover the waste management units up to the activated sludge 
unit; or
    (3) Comply with paragraph (g)(10) of this section provided that the 
owner or operator of the affected source demonstrates that less than 5 
percent of the total soluble HAP is emitted from waste management units 
up to the activated sludge unit; or
    (4) Comply with paragraphs (g)(11)(i), (ii), and (h) of this 
section provided that the owner or operator of the affected source 
demonstrates that less than 5 percent of the total soluble HAP is 
emitted from waste management units up to the activated sludge unit.
* * * * *
    (b) * * *
    (6) * * *
    (i) The owner or operator shall measure the seal gaps or inspect 
the wastewater tank within 30 calendar days of the determination that 
the floating roof is unsafe.
* * * * *
    (d) * * *
    (2) Filling of large containers. Pumping affected wastewater or a 
residual removed from affected wastewater into a container with a 
capacity greater than or equal to 0.42 m \3\ shall be conducted in 
accordance with the conditions in paragraphs (d)(2)(i) and (ii) of this 
section.
    (i) Comply with any one of the procedures specified in paragraphs 
(d)(2)(i)(A), (B), or (C) of this section.
    (A) Use a submerged fill pipe. The submerged fill pipe outlet shall 
extend to no more than 6 inches or within two fill pipe diameters of 
the bottom of the container while the container is being filled.
    (B) Locate the container within an enclosure with a closed-vent 
system that routes the organic HAP vapors vented from the container to 
a control device.
    (C) Use a closed-vent system to vent the displaced organic vapors 
vented from the container to a control device or back to the equipment 
from which the wastewater is transferred.
* * * * *
    (g) * * *
    (8) * * *
    (ii) Percent mass removal/destruction option. The owner or operator 
shall reduce, by removal or destruction, the mass of total partially 
soluble HAP compounds by 99 percent or more. The removal destruction 
efficiency shall be determined by the procedures specified in 
Sec. 63.1257(e)(2)(ii) or (iii)(C) for noncombustion, nonbiological 
treatment processes; Sec. 63.1257(e)(2)(ii) or (iii)(D) for combustion 
processes; Sec. 63.1257(e)(2)(iii)(F) for open biological treatment 
processes; and Sec. 63.1257(e)(2)(ii) or (iii)(G) for closed biological 
treatment processes.
* * * * *
    (11) * * *
    (ii) For open biological treatment processes, compliance shall be 
determined using the procedures specified in 
Sec. 63.1257(e)(2)(iii)(E). For closed aerobic biological treatment 
processes, compliance shall be determined using the procedures 
specified in Sec. 63.1257(e)(2)(ii), (iii)(E), or (iii)(G). For closed 
anaerobic biological treatment processes, compliance shall be 
determined using the procedures specified in Sec. 63.1257(e)(2)(ii) or 
(iii)(G).
* * * * *
    (12) Percent mass removal/destruction option for soluble HAP 
compounds at new sources. The owner or operator of a new source shall 
reduce, by removal or destruction, the mass flow rate of total soluble 
HAP from affected wastewater by 99 percent or more. The removal/
destruction efficiency shall be determined by the procedures in 
Sec. 63.1257(e)(2)(ii) or (iii)(C) for noncombustion, nonbiological 
treatment processes; Sec. 63.1257(e)(2)(ii) and (iii)(D) for combustion 
processes; Sec. 63.1257(e)(2)(iii)(F) for open biological treatment 
processes; and Sec. 63.1257(e)(2)(ii) or (iii)(G) for closed biological 
treatment processes.
* * * * *
    9. Section 63.1257 is amended by:
    a. Revising paragraph (a)(3);
    b. Revising paragraph (a)(5);
    c. Revising paragraph (b)(6) introductory text;
    d. Revising paragraph (b)(6)(iii);
    e. Adding a new sentence at the end of paragraph (b)(8)(i)(A) 
introductory text;
    f. Revising paragraph (b)(8)(i)(A)(3)(i);
    g. Revising paragraph (b)(10) introductory text;
    h. Revising paragraphs (b)(10)(i) and (ii);
    i. Redesignating paragraphs (b)(10)(iii) through (v) as paragraphs 
(b)(10)(iv) through (vi) and revising redesignated paragraphs 
(b)(10)(iv) introductory text and (b)(10)(v);
    j. Adding paragraph (b)(10)(iii);
    k. Revising the second sentence in paragraph (c)(1) introductory 
text;
    l. Revising paragraph (c)(3)(v);
    m. Revising paragraphs (d)(1)(i) through (iii);
    n. Revising equation 13 and the definitions of the terms 
``(Pi)Tn'' and ``MWi'' for Equations 
13 through 17 in paragraph (d)(2)(i)(C)(1);
    o. Removing the definitions of the terms ``(Pi*)'' and 
``(Pj*)'' for Equations 13 through 17 in paragraph 
(d)(2)(i)(C)(1) and adding definitions for the terms ``Pi*'' 
and ``Pj*'' for Equations 13 through 17 in paragraph 
(d)(2)(i)(C)(1);
    p. Removing the last sentence in paragraph (d)(2)(i)(C)(2)(i);
    q. Revising paragraph (d)(2)(i)(C)(4) introductory text;
    r. Revising paragraph (d)(2)(i)(C)(4)(ii);
    s. Revising the definition of the term ``xj'' after 
Equation 24 in paragraph (d)(2)(i)(D)(2);
    t. Revising paragraphs (d)(2)(i)(D)(3) and (4);
    u. Revising paragraph (d)(2)(i)(E);
    v. Revising paragraph (d)(2)(i)(H);
    w. Adding a new sentence between the third and fourth sentences in 
paragraph (d)(2)(ii);
    x. Revising paragraph (d)(3) introductory text;
    y. Revising paragraph (d)(3)(ii)(A);
    z. Adding paragraph (d)(3)(iii);
    aa. Removing the definition of the term ``P'' following Equation 45 
in paragraph (e)(2)(iii)(C)(3) and adding in its place the definition 
of the term ``''' in paragraph (e)(2)(iii)(C)(3);
    bb. Revising ``Equation 44'' to read ``Equation 46'' in the first 
sentence in paragraph (e)(2)(iii)(C)(5);
    cc. Removing the definition of the term ``'' for Equation 
47 in paragraph (e)(2)(iii)(D)(3) and revising the definition of the 
term ``''' for Equation 47 in paragraph (e)(2)(iii)(D)(3);
    dd. Adding the definition of the term ``'' for Equation 47 
in paragraph (e)(2)(iii)(D)(3);
    ee. Revising paragraph (e)(2)(iii)(E)(3) introductory text;
    ff. Revising ``Equation 49'' to read ``Equation 50'' in the first 
sentence in paragraph (e)(2)(iii)(E)(3)(ii);
    gg. Revising the definitions of the terms ``QMWa, 
QMWb'' and ``QMGb'' for Equation 51 in paragraph 
(e)(2)(iii)(G)(3);
    hh. Revising the first sentence in paragraph (f)(1)(iii)(B);

[[Page 19180]]

    ii. Revising paragraph (f)(2)(ii)(A); and
    jj. Redesignating paragraphs (h)(2)(i) and (h)(3) as paragraphs 
(h)(3) and (4), revising redesignated paragraph (h)(3), and removing 
Equation 61 from redesignated paragraph (h)(4).
    The revisions and additions read as follows:


Sec. 63.1257  Test methods and compliance procedures.

    (a) * * *
    (3) Outlet concentration correction for supplemental gases. (i) 
Combustion devices. Except as provided in Sec. 63.1258(b)(5)(ii)(A), 
for a combustion device used to comply with an outlet concentration 
standard, the actual TOC, organic HAP, and hydrogen halide and halogen 
must be corrected to 3 percent oxygen if supplemental gases, as defined 
in Sec. 63.1251, are added to the vent stream or manifold. The 
integrated sampling and analysis procedures of Method 3B of 40 CFR part 
60, appendix A, shall be used to determine the actual oxygen 
concentration (%02d). The samples shall be taken during the 
same time that the TOC or total organic HAP or hydrogen halides and 
halogen samples are taken. The concentration corrected to 3 percent 
oxygen (Cd) shall be computed using Equation 7A of this 
subpart:
[GRAPHIC] [TIFF OMITTED] TP10AP00.082

Where:

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

    (ii) Noncombustion devices. Except as provided in 
Sec. 63.1258(b)(5)(ii)(B), if a control device other than a combustion 
device is used to comply with a TOC, organic HAP, or hydrogen halide 
outlet concentration standard, the owner or operator must correct the 
actual concentration for supplemental gases using Equation 7B of this 
subpart; process knowledge and representative operating data may be 
used to determine the fraction of the total flow due to supplemental 
gas.
[GRAPHIC] [TIFF OMITTED] TP10AP00.083

Where:

Ca = corrected outlet TOC, organic HAP, and hydrogen halides 
and halogens concentration, dry basis, ppmv
Cm = actual TOC, organic HAP, and hydrogen halides and 
halogens concentration measured at control device outlet, dry basis, 
ppmv
Va = total volumetric flow rate of all gas streams vented to 
the control device, except supplemental gases
Vs = total volumetric flow rate of supplemental gases
* * * * *
    (5) Initial compliance with alternative standard. Initial 
compliance with the alternative standards in Secs. 63.1253(d) and 
63.1254(c) for combustion devices is demonstrated when the outlet TOC 
concentration is 20 ppmv or less, and the outlet hydrogen halide and 
halogen concentration is 20 ppmv or less. Initial compliance with the 
alternative standards in Secs. 63.1253(d) and 63.1254(c) for 
noncombustion devices is demonstrated when the outlet TOC concentration 
is 50 ppmv or less, and the outlet hydrogen halide and hydrogen 
concentration is 50 ppmv or less. To demonstrate initial compliance, 
the owner or operator shall be in compliance with the monitoring 
provisions in Sec. 63.1258(b)(5) on the initial compliance date. The 
owner or operator shall use Method 18 to determine the predominant 
organic HAP in the emission stream if the TOC monitor is calibrated on 
the predominant HAP.
* * * * *
    (b) * * *
    (6) The following methods are specified for concentration 
measurements:
* * * * *
    (iii) Method 26 or 26A of appendix A of part 60 shall be used to 
determine hydrogen chloride, hydrogen halide and halogen concentrations 
in control device efficiency determinations or in the 20 ppmv outlet 
hydrogen halide concentration standard.
* * * * *
    (8) * * *
    (i) * * *
    (A) * * * The owner or operator must consider all relevant factors, 
including load and compound-specific characteristics in defining 
absolute worst-case conditions.
* * * * *
    (3) * * *
    (i) Periods when the stream contains the highest combined VOC and 
HAP load, in lb/hr, described by the emission profiles in paragraph 
(b)(8)(ii) of this section;
* * * * *
    (10) Wastewater testing. Wastewater analysis shall be conducted in 
accordance with paragraph (b)(10)(i), (ii), (iii), (iv), or (v) of this 
section.
    (i) Method 305. Use procedures specified in Method 305 of 40 CFR 
part 63, appendix A, and comply with requirements specified in 
paragraph (b)(10)(vi) of this section.
    (ii) Method 624, 625, 1624, or 1625. Use procedures specified in 
Method 624, 625, 1624, or 1625 of 40 CFR part 136, appendix A, and 
comply with requirements in paragraph (b)(10)(vi) of this section.
    (iii) Method 8260 or 8270. Use procedures specified in Method 8260 
or 8270 in ``Test Methods for Evaluating Solid Waste, Physical/Chemical 
Methods,'' EPA Publication No. SW-846, Third Edition, September 1986, 
as amended by Update I, November 15, 1992. As an alternative, an owner 
or operator may use any more recent, updated version of Method 8260 or 
8270 approved by the EPA. For the purpose of using Method 8260 or 8270 
to comply with this subpart, the owner or operator must maintain a 
formal quality assurance program consistent with either Section 8 of 
Method 8260 or Method 8270, and this program must include the following 
elements related to measuring the concentrations of volatile compounds:
    (A) Documentation of site-specific procedures to minimize the loss 
of compounds due to volatilization, biodegradation, reaction, or 
sorption during the sample collection, storage, and preparation steps.
    (B) Documentation of specific quality assurance procedures followed 
during sampling, sample preparation, sample introduction, and analysis.
    (C) Measurement of the average accuracy and precision of the 
specific procedures, including field duplicates and field spiking of 
the material source before or during sampling with compounds having 
similar chemical characteristics to the target analytes.
    (iv) Other EPA methods. Use procedures specified in the method, 
validate the method using the procedures in paragraph (b)(10)(iv)(A) or 
(B) of this section, and comply with the procedures in paragraph 
(b)(10)(vi) of this section.
* * * * *
    (v) Methods other than an EPA method. Use procedures specified in 
the method, validate the method using the procedures in paragraph 
(b)(10)(iv)(A) of this section, and comply with the requirements in 
paragraph (b)(10)(vi) of this section.
* * * * *

[[Page 19181]]

    (c) * * *
    (1) * * * Initial compliance with the outlet concentration 
requirement of Sec. 63.1253(d) is demonstrated by fulfilling the 
requirements of paragraph (a)(5) of this section.
* * * * *
    (3) * * *
    (v) When the phrase ``the maximum true vapor pressure of the total 
organic HAP's in the stored liquid falls below the values defining 
Group 1 storage vessels specified in table 5 or table 6 of this 
subpart'' is referred to in Sec. 63.120(b)(1)(iv), the phrase ``the 
maximum true vapor pressure of the total organic HAP in the stored 
liquid falls below 13.1 kPa'' shall apply for the purposes of this 
subpart.
* * * * *
    (d) * * *
    (1) * * *
    (i) Initial compliance with Sec. 63.1254(a)(2)(i) is demonstrated 
when the actual emissions of HAP from the sum of all process vents 
within a process is less than or equal to 900 kg/yr. Initial compliance 
with Sec. 63.1254(a)(2)(ii) is demonstrated when the actual emissions 
of HAP from the sum of all process vents in compliance with 
Sec. 63.1254(a)(2)(i) is less than or equal to 1,800 kg/yr. 
Uncontrolled HAP emissions and controlled HAP emissions shall be 
determined using the procedures described in paragraphs (d)(2) and (3) 
of this section.
    (ii) Initial compliance with the percent reduction requirements in 
Sec. 63.1254(a)(1)(i), Sec. 63.1254(a)(3), and Sec. 63.1254(b) is 
demonstrated by:
    (A) Determining controlled HAP emissions using the procedures 
described in paragraph (d)(3) of this section, and uncontrolled HAP 
emissions determined using the procedures described in paragraph (d)(2) 
of this section, and demonstrating that the reductions required by 
Sec. 63.1254(a)(1)(i), Sec. 63.1254(a)(3), and Sec. 63.1254(b) are met; 
or
    (B) Controlling the process vents using a device meeting the 
criteria specified in paragraph (a)(4) of this section.
    (iii) Initial compliance with the outlet concentration requirements 
in Sec. 63.1254(a)(1)(ii)(A), Sec. 63.1254(a)(3), and 
Sec. 63.1254(b)(1) is demonstrated when the outlet TOC concentration is 
20 ppmv or less and the outlet hydrogen halide and halogen 
concentration is 20 ppmv or less. The owner or operator shall 
demonstrate compliance by fulfilling the requirements in paragraph 
(a)(6) of this section.
* * * * *
    (2) * * *
    (i) * * *
    (C) * * *
    (1) * * *
    [GRAPHIC] [TIFF OMITTED] TP10AP00.084
    
* * * * *
Pi* = vapor pressure of each HAP in the vessel headspace at 
any temperature between the initial and final heatup temperatures, mmHg
Pj* = vapor pressure of each condensable VOC (including HAP) 
in the vessel headspace at any temperature between the initial and 
final heatup temperatures, mmHg * * *
(Pi)Tn = partial pressure of each HAP in the 
vessel headspace at initial (T1) and final (T2) temperature
MWi = molecular weight of the individual HAP * * *
* * * * *
    (4) If the vessel contents are heated to the boiling point, 
emissions must be calculated using the procedure in paragraphs 
(d)(2)(i)(C)(4)(i) and (ii) of this section.
* * * * *
    (ii) While boiling, the vessel must be operated with a properly 
operated process condenser. An initial demonstration that a process 
condenser is properly operated is required for some process condensers, 
as described in paragraph (d)(2)(iii) of this section.
    (D) * * *
    (2) * * *
xj = mole fraction of each condensable (including HAP) in 
the liquid phase
* * * * *
    (3) The average ratio of moles of noncondensable to moles of an 
individual HAP in the emission stream is calculated using Equation 25 
of this subpart; this calculation must be repeated for each HAP in the 
emission stream:
[GRAPHIC] [TIFF OMITTED] TP10AP00.085

Where:

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

    (4) The mass of HAP emitted shall be calculated using Equation 26 
of this subpart:
[GRAPHIC] [TIFF OMITTED] TP10AP00.086

Where:

E = mass of HAP emitted
Vnc1 = initial volume of noncondensable gas in the vessel, 
as calculated using Equation 21 of this subpart
Vnc2 = final volume of noncondensable gas in the vessel, as 
calculated using Equation 22 of this subpart
nRi = average ratio of moles of noncondensable to moles of 
individual HAP, as calculated using Equation 25 of this subpart
Patm = atmospheric pressure, standard
R = ideal gas law constant
T = temperature of the vessel, absolute
MWi = molecular weight of each HAP
* * * * *
    (E) Vacuum systems. Emissions from vacuum systems may be calculated 
using Equation 33 of this subpart if the air leakage rate is known or 
can be approximated.
[GRAPHIC] [TIFF OMITTED] TP10AP00.087

Where:

E = mass of HAP emitted
Psystem = absolute pressure of receiving vessel or ejector 
outlet conditions, if there is no receiver

[[Page 19182]]

Pi = partial pressure of the HAP at the receiver temperature 
or the ejector outlet conditions
Pj = partial pressure of condensable (including HAP) at the 
receiver temperature or the ejector outlet conditions
La = total air leak rate in the system, mass/time
MWnc = molecular weight of noncondensable gas
t = time of vacuum operation
MWi = molecular weight of the individual HAP in the emission stream, 
with HAP partial pressures calculated at the temperature of the 
receiver or ejector outlet, as appropriate
* * * * *
    (H) Empty vessel purging. Emissions from empty vessel purging shall 
be calculated using Equation 36 of this subpart (Note: The term e 
@Ft/v can be assumed to be 0):
* * * * *
    (ii) * * * Modified versions of the engineering evaluation methods 
in paragraphs (d)(2)(i)(A) through (H) may be used if the owner or 
operator demonstrates that they have been used to meet other regulatory 
obligations and they do not affect applicability assessments or 
compliance determinations under this subpart GGG. * * *
* * * * *
    (3) Controlled emissions. An owner or operator shall determine 
controlled emissions using the procedures in either paragraph (d)(3)(i) 
or (ii) of this section.
* * * * *
    (ii) * * *
    (A) The performance test shall be conducted by performing emission 
testing on the inlet and outlet of the control device following the 
test methods and procedures of Sec. 63.1257(b). Concentrations shall be 
calculated from the data obtained through emission testing according to 
the procedures in paragraph (a)(2) of this section.
* * * * *
    (iii) Initial compliance demonstration for condensers.
    (A) Air pollution control devices. During periods in which a 
condenser functions as an air pollution control device, controlled 
emissions shall be calculated using the emission estimation equations 
described in paragraph (d)(3)(i)(B) of this section.
    (B) Process condensers. During periods when the condenser is 
operating as a process condenser, the owner or operator is required to 
demonstrate that the process condenser is properly operated if the 
process condenser meets either of the criteria described in paragraphs 
(d)(2)(iii)(B)(1) and (2) of this section. The owner or operator must 
either measure the condenser exhaust gas temperature and show it is 
less than the boiling or bubble point of the substance(s) in the 
vessel, or perform a material balance around the vessel and condenser 
to show that at least 99 percent of the material vaporized while 
boiling is condensed. The initial demonstration shall be conducted for 
all appropriate operating scenarios and documented in the Notification 
of Compliance report described in Sec. 63.1260(f).
    (1) The process condenser is not followed by an air pollution 
control device; or
    (2) The air pollution control device following the process 
condenser is not a condenser or is not meeting the alternative standard 
of Sec. 63.1254(c).
* * * * *
    (e) * * *
    (2) * * *
    (iii) * * *
    (C) * * *
    (3) * * *

= density of the wastewater, kg/m \3\
* * * * *
    (D) * * *
    (3) * * *

= density of the wastewater stream, kg/m \3\
* * * * *
p = number of runs
* * * * *
    (E) * * *
    (3) Destruction efficiency. The owner or operator shall comply with 
the provisions in either paragraph (e)(2)(iii)(E)(3)(i) or (ii) of this 
section. Compliance is demonstrated if the destruction efficiency, E, 
is equal to or greater than 95 percent.
* * * * *
    (G) * * *
    (3) * * *

QMWa, QMWb = mass flow rate of partially soluble 
and/or soluble HAP compounds in wastewater entering (QMWa) 
and exiting (QMWb) the treatment process, kilograms per hour 
(as calculated using Equations 44 and 45)
QMGb = mass flow rate of partially soluble and/or soluble 
HAP compounds in vented gas stream exiting the control device, kg/hr
* * * * *
    (f) * * *
    (1) * * *
    (iii) * * *
    (B) For batch processes, the annual factor shall be calculated 
either every 10 batches for the 12-month period preceding the 10th 
batch (10-batch rolling average) or a maximum of once per month, if the 
number of batches is greater than 10 batches per month. * * *
    (2) * * *
    (ii) * * *
    (A) The mass of HAP calculated using Equation 55 of this subpart:

    [GRAPHIC] [TIFF OMITTED] TP10AP00.088
    
Where:

[kg/kg]b = the baseline production-indexed HAP consumption 
factor, in kg/kg
Mprod = the annual production rate, in kg/yr
M = the annual reduction required by add-on controls, in kg/yr
PR = the fractional reduction in the annual kg/kg factor 
achieved using pollution prevention where PR is 
0.5
* * * * *
    (h) * * *
    (3) Equations 60 and 61 of this subpart shall be used to calculate 
total HAP emissions:
[GRAPHIC] [TIFF OMITTED] TP10AP00.089

[GRAPHIC] [TIFF OMITTED] TP10AP00.090

Where:

EUi = yearly uncontrolled emissions from process i
ECi = yearly actual emissions for process i
ETU = total yearly uncontrolled emissions
ETC = total yearly actual emissions
n = number of processes included in the emissions average
* * * * *
    10. Section 63.1258 is amended by:
    a. Revising paragraph (b)(5);
    b. Revising paragraph (b)(6)(iii);
    c. Revising the first sentence in paragraph (b)(8) introductory 
text; and
    d. Revising paragraph (c).
    The revisions read as follows:


Sec. 63.1258  Monitoring requirements.

* * * * *
    (b) * * *
    (5) Monitoring for the alternative standards. (i) For control 
devices that are used to comply with the provisions of Sec. 63.1253(d) 
or 63.1254(c), the owner or operator shall monitor and record the 
outlet TOC concentration and the outlet hydrogen halide and halogen 
concentration every 15 minutes during the period in which the device is

[[Page 19183]]

functioning in achieving the HAP removal required by this subpart. A 
TOC monitor meeting the requirements of Performance Specification 8 or 
9 of appendix B of part 60 shall be installed, calibrated, and 
maintained according to Sec. 63.8. The owner or operator need not 
monitor the hydrogen halide and halogen concentration if, based on 
process knowledge, the owner or operator determines that the emission 
stream does not contain hydrogen halides or halogens.
    (ii) An owner or operator complying with the alternative standard 
using control devices in which supplemental gases are added to the 
vents or manifolds must either correct for supplemental gases as 
specified in Sec. 63.1257(a)(3) or comply with the requirements of 
paragraph (b)(5)(ii)(A) or (B) of this section.
    (A) Provisions for combustion devices. As an alternative to 
correcting for supplemental gases as specified in Sec. 63.1257(a)(3), 
the owner or operator may monitor residence time and firebox 
temperature according to the requirements of paragraphs 
(b)(5)(ii)(A)(1) and (2) of this section. Monitoring of residence time 
may be accomplished by monitoring flowrate into the combustion chamber.
    (1) If complying with the alternative standard instead of achieving 
a control efficiency of 95 percent or less, the owner or operator must 
maintain a minimum residence time of 0.5 seconds and a minimum 
combustion chamber temperature of 760 deg.C.
    (2) If complying with the alternative standard instead of achieving 
a control efficiency of 98 percent or less, the owner or operator must 
maintain a minimum residence time of 0.75 seconds and a minimum 
combustion chamber temperature of 816 deg.C.
    (B) Provisions for dense gas systems. As an alternative to 
correcting for supplemental gases as specified in Sec. 63.1257(a)(3), 
for noncombustion devices used to control emissions from dense gas 
systems, as defined in Sec. 63.1251, the owner or operator shall 
monitor flowrate as specified in paragraphs (b)(5)(ii)(B)(1) through 
(4) of this section.
    (1) Use Equation 63 of this subpart to calculate the system 
flowrate setpoint at which the average concentration is 5,000 ppmv TOC:
[GRAPHIC] [TIFF OMITTED] TP10AP00.091

Where:

Fs = system flowrate setpoint, scfm
Ean = annual emissions entering the control device, lbmols/
yr

    (2) Annual emissions used in Equation 63 of this subpart must be 
based on the actual mass of organic compounds entering the control 
device, as calculated from the most representative emissions inventory 
data submitted within the 5 years before the Notification of Compliance 
Status report is due. The owner or operator must recalculate the system 
flowrate setpoint once every 5 years using the annual emissions from 
the most representative emissions inventory data submitted during the 
5-year period after the previous calculation. Results of the initial 
calculation must be included in the Notification of Compliance Status 
report, and recalculated values must be included in the next Periodic 
report after each recalculation. For all calculations after the initial 
calculation, to use emissions inventory data calculated using 
procedures other than those specified in Sec. 63.1257(d), the owner or 
operator must submit the emissions inventory data calculations and 
rationale for their use in the Notification of Process Change report or 
an application for a part 70 permit renewal or revision.
    (3) In the Notification of Compliance Status report, the owner or 
operator may elect to establish both a maximum daily average operating 
flowrate limit above the flowrate setpoint and a reduced outlet 
concentration limit corresponding to this flowrate limit. The owner or 
operator may also establish reduced outlet concentration limits for any 
daily average flowrates between the flowrate setpoint and the flowrate 
limit. The correlation between these elevated flowrates and the 
corresponding outlet concentration limits must be established using 
Equation 64 of this subpart:
[GRAPHIC] [TIFF OMITTED] TP10AP00.092

Where:

Ca = adjusted outlet concentration limit, dry basis, ppmv
50 = outlet concentration limit associated with the flowrate setpoint, 
dry basis, ppmv
Fs = system flowrate setpoint, scfm
Fa = actual system flowrate limit, scfm

    (4) The owner or operator must install and operate a monitoring 
system for measuring system flowrate. The flowrate into the control 
device must be monitored and recorded at least once every hour. The 
system flowrate must be calculated as the average of all values 
measured during each 24-hour operating day. The flowrate monitoring 
device must be accurate to within 5 percent of the system flowrate 
setpoint, and the flowrate monitoring device must be calibrated 
annually.
    (C) Flow rate evaluation for noncombustion devices. To demonstrate 
continuous compliance with the requirement to correct for supplemental 
gases as specified in Sec. 63.1257(a)(3)(ii) for noncombustion devices, 
the owner or operator must evaluate the volumetric flow rate of 
supplemental gases, Vs, and the volumetric flow rate of all 
gases, Va, each time a new operating scenario is implemented 
based on process knowledge and representative operating data. The 
procedures used to evaluate the flow rates, and the resulting 
correction factor used in Equation 7B of this subpart, must be included 
in the Notification of Compliance Status report and in the next 
Periodic report submitted after an operating scenario change.
    (6) * * *
    (iii) Each loss of all pilot flames for flares.
* * * * *
    (8) Violations. Exceedances of parameters monitored according to 
the provisions of paragraphs (b)(1)(ii), (iv) through (ix), and 
(b)(5)(ii)(A) and (B) of this section, or excursions as defined by 
paragraphs (b)(7)(i) through (iii) of this section, constitute 
violations of the operating limit according to paragraphs (b)(8)(i), 
(ii), and (iv) of this section. * * *
* * * * *
    (c) Monitoring for emission limits. The owner or operator of any 
affected source complying with the provisions of Sec. 63.1254(a)(2) 
shall demonstrate continuous compliance with the 900 and 1,800 kg/yr 
emission limits by calculating daily 365-day rolling summations of 
emissions. For any owner or operator opting to switch compliance 
strategy from the 93 percent control requirement to the annual mass 
emission limit method, as described in Sec. 63.1254(a)(1)(i), the 
rolling summations, beginning with the first day after the switch, must 
include emissions from the past 365 days.
* * * * *
    11. Section 63.1259 is amended by:
    a. Revising paragraph (a)(3)(i);
    b. Revising paragraph (a)(3)(iii);
    c. Revising paragraph (b)(4);
    d. Revising paragraphs (b)(5)(i) and (b)(5)(ii);
    e. Removing paragraph (b)(6), redesignating paragraphs (b)(7) 
through (b)(11) as paragraphs (b)(6) through (b)(10), and revising the 
redesignated paragraphs (b)(6) and (b)(9); and
    f. Adding paragraphs (b)(11) and (12).
    The revisions and additions read as follows:

[[Page 19184]]

Sec. 63.1259  Recordkeeping requirements.

    (a) * * *
    (3) * * *
    (i) The owner or operator shall record the occurrence and duration 
of each malfunction of the process operations or of air pollution 
control equipment used to comply with this subpart, as specified in 
Sec. 63.6(e)(3)(iii).
* * * * *
    (iii) For each startup, shutdown, or malfunction, the owner or 
operator shall record all information necessary to demonstrate that the 
procedures specified in the affected source's startup, shutdown, and 
malfunction plan were followed, as specified in Sec. 63.6(e)(3)(iii), 
and shall record all maintenance performed on the air pollution control 
equipment, as specified in Sec. 63.10(b)(2)(iii); alternatively, the 
owner or operator shall record any actions taken that are not 
consistent with the plan, as specified in Sec. 63.6(e)(3)(iv).
* * * * *
    (b) * * *
    (4) For purposes of compliance with the annual mass limits of 
Sec. 63.1254(a)(2) and Sec. 63.1254(b)(2), daily records of the rolling 
annual total emissions.
    (5) * * *
    (i) For processes or process vents that are in compliance with the 
percent reduction requirements of Sec. 63.1254(a)(1), (a)(3), or 
Sec. 63.1254(b)(1) and containing vents controlled to less than the 
percent reduction requirement, the following records are required:
    (A) Standard batch uncontrolled and controlled emissions for each 
process;
    (B) Actual uncontrolled and controlled emissions for each 
nonstandard batch; and
    (C) A record whether each batch operated was considered a standard 
batch.
    (ii) For processes in compliance with the annual mass limits of 
Sec. 63.1254(a)(2) or Sec. 63.1254(b)(2), the following records are 
required:
    (A) The number of batches per year for each batch process;
    (B) The operating hours per year for continuous processes;
    (C) Standard batch uncontrolled and controlled emissions for each 
process;
    (D) Actual uncontrolled and controlled emissions for each 
nonstandard batch;
    (E) A record whether each batch operated was considered a standard 
batch.
    (6) Wastewater concentration per POD or process, except as provided 
in Sec. 63.1256(a)(1)(ii).
* * * * *
    (9) Description of worst-case operating conditions as required in 
Sec. 63.1257(b)(8).
* * * * *
    (11) If the owner or operator elects to comply with Sec. 63.1253(b) 
or (c) by installing a floating roof, the owner or operator must keep 
records of each inspection and seal gap measurement in accordance with 
Sec. 63.123(c) through (e) as applicable.
    (12) If the owner or operator elects to comply with the vapor 
balancing alternative in Sec. 63.1253(f), the owner or operator must 
keep records of the DOT certification required by Sec. 63.1253(f)(2) 
and the pressure relief vent setting and the leak detection records 
specified in Sec. 63.1253(f)(5).
* * * * *
    12. Section 63.1260 is amended by:
    a. Adding paragraphs (e)(6) and (7);
    b. Revising paragraph (g)(1)(ii);
    c. Revising paragraph (g)(2)(vii);
    d. Adding paragraph (g)(2)(viii);
    e. Adding a new sentence after the first sentence in paragraph 
(h)(1) introductory text; and
    f. Revising the reference ``Sec. 63.10(d)(4)(ii)'' to read 
``Sec. ``63.10(d)(5)(ii)'' in the last sentence in paragraph (i).
    The revisions and additions read as follows:


Sec. 63.1260  Reporting requirements.

* * * * *
    (e) * * *
    (6) Data and other information supporting the determination of 
annual average concentrations by process simulation as required in 
Sec. 63.1257(e)(1)(ii).
    (7) Bench scale or pilot-scale test data and rationale used to 
determine annual average concentrations as required in 
Sec. 63.1257(e)(1)(ii)(C).
* * * * *
    (g) * * *
    (1) * * *
    (ii) Quarterly reports shall be submitted when the source 
experiences an exceedance of a temperature limit monitored according to 
the provisions of Sec. 63.1258(b)(1)(iii) or an exceedance of the 
outlet concentration monitored according to the provisions of 
Sec. 63.1258(b)(1)(x) or Sec. 63.1258(b)(5). Once an affected source 
reports quarterly, the affected source shall follow a quarterly 
reporting format until a request to reduce reporting frequency is 
approved. If an owner or operator submits a request to reduce the 
frequency of reporting, the provisions in Sec. 63.10(e)(3)(ii) and 
(iii) shall apply, except that the phrase ``excess emissions and 
continuous monitoring system performance report and/or summary report'' 
shall mean ``Periodic report'' for the purposes of this section.
* * * * *
    (2) * * *
    (vii) Each new operating scenario which has been operated since the 
time period covered by the last Periodic report. For each new operating 
scenario, the owner or operator shall provide verification that the 
operating conditions for any associated control or treatment device 
have not been exceeded, and that any required calculations and 
engineering analyses have been performed. For the initial Periodic 
report, each operating scenario for each process operated since the 
compliance date shall be submitted.
    (viii) If the owner or operator elects to comply with the 
provisions of Sec. 63.1253(b) or (c) by installing a floating roof, the 
owner or operator shall submit the information specified in 
Sec. 63.122(d) through (f) as applicable. References to Sec. 63.152 
from Sec. 63.122 shall not apply for the purposes of this subpart.
    (h) * * *
    (1) * * * For the purposes of this section, a process change means 
the startup of a new process, as defined in Sec. 63.1251. * * *
* * * * *
    13. Section 63.1261 is revised to read as follows:


Sec. 63.1261  Delegation of Authority.

    (a) This subpart can be administered by EPA, or a delegated 
authority such as a State, local, or tribal agency. If the 
Administrator has delegated authority to a State, local, or tribal 
agency, then that agency has the authority to administer and enforce 
this subpart. To find out if this subpart is delegated to a State, 
local, or tribal agency, the appropriate EPA Regional Office should be 
contacted.
    (b) In delegating implementation and enforcement authority of this 
subpart to a State, local, or tribal agency under 40 CFR part 63, 
subpart E, the authorities contained in paragraph (c) of this section 
are retained by the Administrator and are not transferred to the State, 
local, or tribal agency.
    (c) The authorities that will not be delegated to State, local, or 
tribal agencies are as follows:
    (1) Approval of alternatives to the emission standards in 
Secs. 63.1252 through 63.1256 under Sec. 63.6(g).
    (2) Approval of major alternatives to test methods under 
Sec. 63.1257 as defined in Sec. 63.90.
    (3) Approval of major alternatives to monitoring under Sec. 63.1258 
as defined in Sec. 63.90.

[[Page 19185]]

    (4) Approval of major alternatives to recordkeeping and reporting 
under Secs. 63.1259 and 63.1260 as defined in Sec. 63.90.
    14. Table 1 to subpart GGG is amended by:
    a. Revising the column heading ``Comments'' to read 
``Explanation'';
    b. Revising the entries ``63.5(b)(3),'' ``63.7(a)(1),'' 
``63.9(h),'' ``63.9(j),'' ``63.9(a)-(d),'' ``63.9(e),'' ``63.9(g)(1),'' 
``63.9(g)(3),'' ``63.10(a),'' ``63.10(b)(1),'' ``63.10(b)(3),'' and 
``63.10(c)-(d)(2);''
    c. Removing the entry ``63.7(a)(2)(i-ix)'' and adding in its place 
the entry ``63.7(a)(2)(i)-(ix);''
    d. Removing the entry ``63.8(b)(3)-(c)(3)'' and adding in its place 
the entry ``63.8(b)(3)-(c)(4);''
    e. Removing the entry ``63.8(c)(4-5)'' and adding in its place the 
entry ``63.8(c)(5);''
    f. Removing the entry ``63.8(c)6)-(8)'' and adding in its place the 
entry ``63.8(c)(6)-(8).''
    The revisions and additions read as follows:

                    Table 1.--To Subpart GGG. General Provisions Applicability to Subpart GGG
----------------------------------------------------------------------------------------------------------------
General provisions reference    Summary of requirements     Applies to  subpart GGG    Explanation and comments
----------------------------------------------------------------------------------------------------------------
 
                          *         *         *         *         *         *         *
63.5(b)(3)..................  New construction/            Yes......................  Except for changes and
                               reconstruction.                                         additions authorized
                                                                                       under Sec.  52.2454 of
                                                                                       this title. However, the
                                                                                       requirement to submit the
                                                                                       Precompliance report at
                                                                                       least 90 days before the
                                                                                       compliance date still
                                                                                       applies
 
                          *         *         *         *         *         *         *
63.7(a)(1)..................  Performance testing          Yes......................  Subpart GGG also specifies
                               requirements.                                           required testing and
                                                                                       compliance procedures
63.7(a)(2)(i-ix)............  ...........................  Yes......................  Except substitute ``150
                                                                                       days'' instead of ``180
                                                                                       days.''
 
                          *         *         *         *         *         *         *
63.8(b)(3)-(c)(4)...........  CMS requirements...........  Yes......................  Sec.  63.1259 also
                                                                                       specifies recordkeeping
                                                                                       for CMS.
63.8(c)(5)..................  COMS operation requirements  No.......................
63.8 (c)(6-8)...............  CMS calibration and          No.......................  Calibration procedures are
                               malfunction provisions.                                 provided in Sec.
                                                                                       63.1258.
 
                          *         *         *         *         *         *         *
63.9(a)-(d).................  Notification requirements--  Yes......................  Sec.  63.1260(b) also
                               Applicability and general                               specifies initial
                               information.                                            notification requirement.
63.9(e).....................  Notification of performance  Yes......................  Sec.  63.1260(l) also
                               test.                                                   specifies notification
                                                                                       requirement for
                                                                                       performance test.
 
                          *         *         *         *         *         *         *
63.9(g)(1)..................  Additional notification      Yes......................  Sec.  63.1260 (d) also
                               requirements for sources                                specifies notification
                               with CMS.                                               requirement for
                                                                                       performance evaluation.
 
                          *         *         *         *         *         *         *
63.9(g)(3)..................  Notification that criterion  Yes......................  Sec.  63.1260(d) also
                               to continue use of                                      specifies notification
                               alternative to relative                                 requirement for
                               accuracy testing has been                               performance evaluation.
                               exceeded.
63.9(h).....................  Notification of compliance   Yes......................  Specified in Sec.
                               status.                                                 63.1260(f). Due 150 days
                                                                                       after compliance date.
 
                          *         *         *         *         *         *         *
63.9(j).....................  Change in information        No.......................  Subpart GGG specifies
                               provided.                                               procedures for
                                                                                       notification of changes.
 
                          *         *         *         *         *         *         *
63.10(a)....................  Recordkeeping requirements.  Yes......................
63.10(b)(1).................  Records retention..........  Yes......................  Also stated in Sec.
                                                                                       63.1259.
 
                          *         *         *         *         *         *         *
63.10(b)(3).................  Records retention for        Yes......................  Also stated in Sec.
                               sources not subject to                                  63.1259 (a)(2).
                               relevant standard.
63.10(c)-(d)(2).............  Other recordkeeping and      Yes......................  Also stated in Sec.
                               reporting provisions.                                   63.1259 (a)(4).
----------------------------------------------------------------------------------------------------------------

    15. Table 5 to subpart GGG is revised to read as follows:

Table 5. to Subpart GGG.--Control Requirements for Items of Equipment That Meet the Criteria of Sec.  63.1252(f)
----------------------------------------------------------------------------------------------------------------
                  Item of equipment                                     Control requirement\a\
----------------------------------------------------------------------------------------------------------------
Drain or drain hub..................................  (a) Tightly fitting solid cover (TFSC); or
                                                      (b) TFSC with a vent to either a process or to a control
                                                       device meeting the requirements of Sec.  63.1256(h)(2);
                                                       or

[[Page 19186]]

 
                                                      (c) Water seal with submerged discharge or barrier to
                                                       protect discharge from wind.
Manhole\b\..........................................  (a) TFSC; or
                                                      (b) TSFC with a vent to either a process or to a control
                                                       device meeting the requirements of Sec.  63.1256(h)(2);
                                                       or
                                                      (c) If the item is vented to the atmosphere, use a TFSC
                                                       with a properly operating water seal at the entrance or
                                                       exit to the item to restrict ventilation in the
                                                       collection system. The vent pipe shall be at least 90 cm
                                                       in length and not exceeding 10.2 cm in nominal inside
                                                       diameter.
Lift station........................................  (a) TFSC; or
                                                      (b) TFSC with a vent to either a process or to a control
                                                       device meeting the requirements of Sec.  63.1256(h)(2);
                                                       or
                                                      (c) If the lift station is vented to the atmosphere, use a
                                                       TFSC with a properly operating water seal at the entrance
                                                       or exit to the item to restrict ventilation in the
                                                       collection system. The vent pipe shall be at least 90 cm
                                                       in length and not exceeding 10.2 cm in nominal inside
                                                       diameter. The lift station shall be level controlled to
                                                       minimize changes in the liquid level.
Trench..............................................  (a) TFSC; or
                                                      (b) TFSC with a vent to either a process or to a control
                                                       device meeting the requirements of Sec.  63.1256(h)(2);
                                                       or
                                                      (c) If the item is vented to the atmosphere, use a TFSC
                                                       with a properly operating water seal at the entrance or
                                                       exit to the item to restrict ventilation in the
                                                       collection system. The vent pipe shall be at least 90 cm
                                                       in length and not exceeding 10.2 cm in nominal inside
                                                       diameter.
Pipe................................................  Each pipe shall have no visible gaps in joints, seals, or
                                                       other emission interfaces.
Oil/Water separator.................................  (a) Equip with a fixed roof and route vapors to a process
                                                       or equip with a closed-vent system that routes vapors to
                                                       a control device meeting the requirements of Sec.
                                                       63.1256(h)(2); or
                                                      (b) Equip with a floating roof that meets the equipment
                                                       specifications of Sec.  60.693(a)(1)(i), (a)(1)(ii),
                                                       (a)(2), (a)(3), and (a)(4).
Tank................................................  Maintain a fixed roof and consider vents as process
                                                       vents.\c\
----------------------------------------------------------------------------------------------------------------
\a\ Where a tightly fitting solid cover is required, it shall be maintained with no visible gaps or openings,
  except during periods of sampling, inspection, or maintenance.
\b\ Manhole includes sumps and other points of access to a conveyance system.
\c\ A fixed roof may have openings necessary for proper venting of the tank, such as pressure/vacuum vent, j-
  pipe vent.

[FR Doc. 00-7450 Filed 4-7-00; 8:45 am]
BILLING CODE 6560-50-U