United States
Environmental Protection
Agency
Enforcement and
Compliance Assurance
(2224A)
EPA-305-S-97-001
December 1997
Pharmaceutical Manufacturing
Statutory and Regulatory Summaries
EPA Office of Compliance
Chemical Industry Branch
y4^A Printed on paper that contains at least
'O;"_7 20 percent postconsumer fiber.
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Background: The pharmaceutical manufacturing industry is subject to numerous
Federal regulations that have been enacted to protect human health and the
environment. A complex web of requirements results from the fact that little correlation
exists among regulations that target the same medium or activity. Industrial facilities
are responsible for understanding and complying with these requirements. Historically,
EPA has relied on a command and control approach to regulate industrial facilities, but
now is combining its traditional method with innovative compliance assessment
techniques such as self-assessments and facility management systems.
Many industrial facilities have found that using a complete facility Environmental
Management System (EMS) approach uncovers cost effective solutions for tackling all
the requirements as a whole instead of as individual components. In line with this
discovery, EPA is encouraging self-assessments using a complete facility EMS
approach to evaluate compliance with environmental regulations. A facility's drive to
identify cheaper, more effective ways to achieve compliance is consistent with EPA's
mission of clarifying and simplifying environmental regulatory control.
Purpose of document:This guide is a resource on Federal environmental regulations
for pharmaceutical manufacturing facilities. This manual identifies and clarifies
industry-specific regulatory information necessary to conduct a self-assessment. This
document describes portions of environmental statutes that may apply to the
pharmaceutical manufacturing industry and summarizes regulatory requirements of
each (including applicability, exemptions, monitoring, record keeping, and reporting
requirements).
Approach:The statutes are discussed in the following sections:
• Clean Air Act (CAA): Clean Air Act Titles I, III, V, and VI are summarized in this
section. Topics include NAAQS, NESHAPs, MACTs, permitting, chemical
accident protection, and stratospheric ozone protection. This appendix also
includes a section on assessment considerations that should be evaluated
during the on-site facility assessment. Regulatory summaries are provided for
performance standards, national emission standards, provisions for prevention
of chemical accidents, and protection of stratospheric ozone.
• Safe Drinking Water Act (SDWA):This section describes the public water
system program, underground injection control program, considerations for
assessors, and regulatory requirements. Detailed descriptions of the regulatory
requirements include national primary and secondary drinking water regulations
which may be applicable to facilities that produce their own potable water and
the underground injection control program.
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• Resource Conservation and Recovery Act (RCRAT:his section delineates
the requirements for generation, transportation, treatment, storage, and disposal
of hazardous waste. Land disposal restrictions and underground storage tank
regulations are discussed, as are specific RCRA assessment considerations.
RCRA legislation summarized for pharmaceutical manufacturers includes
classification of generators; requirements for hazardous waste generators and
transporters; regulations for hazardous waste treatment, storage, and disposal;
and restrictions on land disposal and underground storage tanks.
• Emergency Planning and Community Right-to-Know Act (EPCRATihe
EPCRA section describes four regulatory programs applicable to pharmaceutical
manufacturers: hazardous substance notification, emergency planning and
notification, hazardous chemical reporting to the community, and toxic chemical
release inventory. The section also suggests key areas to evaluate during
compliance assessments. Regulatory summaries are included for the following:
designation, notification, and reportable quantities of hazardous substances;
emergency planning and notification; and reporting of hazardous chemicals and
toxic chemical releases.
• Clean Water Act (CWA):This section includes effluent limit guidelines,
categorical pretreatment standards, NPDES and pretreatment programs, effluent
trading, spills and pollution prevention of oil and hazardous substances, and
reportable quantities of hazardous substances. This chapter also includes a
section on assessment considerations and summaries of regulations pertaining
to pretreatment and discharge of effluent, discharge and pollution prevention of
oil, and designation of hazardous substances and reportable quantities.
This manual may not include all the Federal environmental regulations that an
pharmaceutical manufacturer must comply with, but it should serve as a starting point.
Site assessors should be aware that, in many instances, State or local regulations may
be more stringent than Federal requirements. Also, site-specific Federal, State, or
local permits may contain additional requirements beyond those specified in the
regulations. As such, part of a facility's EMS should be to check Federal, State and
local regulations regularly and keep abreast of pending legislation that may impact the
facility.
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DISCLAIMER
This document is intended as an aid to compliance with federal
regulatory requirements. The document does not, however, substitute
for EPA's regulations, nor is it a regulation itself. Thus, it cannot impose
legally binding requirements on EPA, States, or the regulated
community. Because circumstances vary, this document may not apply
to a particular situation based on the circumstances, and facilities may be
subject to requirements that are different from or in addition to thos e
described in this document. EPA may change this guidance in the future,
as appropriate.
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NOTE TO USERS OF THIS DOCUMENT
This document contains internal hyperlinks. Internal links, noted
with magenta text, link the reader to the applicable
section, figure, appendix, etc. being referenced. In addition,
selecting the bookmark option from the top menu in the Adobe
Acrobat Reader provides the user with a point and click table of
contents to the first page of each statute to simplify navigation in
the document.
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TABLE OF CONTENTS
Clean Air Act Regulatory Requirements
National Primary and Secondary Ambient Air Quality Standards CAA-2
National Emissions Standards for Hazardous Air Pollutants (NESHAP) and Maximum
Achievable Control Technology (MACT) Standards CAA-6
Permitting Program CAA-7
Stratospheric Ozone Protection CAA-8
CAA Assessment Considerations CAA-9
CAA Regulatory Requirements CAA-12
Safe Drinking Water Act Regulatory Requirements
Underground Injection Control Program SDWA-1
Public Water System Program SDWA-2
SDWA Assessment Considerations SDWA-3
SDWA Regulatory Requirements SDWA-4
Resource Conservation and Recovery Act Regulatory Requirements
Hazardous Waste Generation RCRA-2
Hazardous Waste Transportation Regulations RCRA-7
Hazardous Waste Treatment, Storage, and Disposal Regulations RCRA-7
Land Disposal Restrictions RCRA-8
Underground Storage Tank Regulations RCRA-9
RCRA Assessment Considerations RCRA-11
RCRA Regulatory Requirements RCRA-12
Emergency Planning and Community Right-to-Know Act Regulatory
Requirements
Hazardous Substance Notification EPCRA-1
Emergency Planning and Notification EPCRA-1
Hazardous Chemical Reporting: Community Right-to-Know EPCRA-2
Toxic Chemical Release Inventory EPCRA-2
EPCRA Assessment Considerations EPCRA-3
EPCRA Regulatory Requirements EPCRA-4
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Clean Water Act Regulatory Requirements
Effluents Limitations Guidelines and Categorical Pretreatment Standards CWA-2
NPDES Program CWA-4
Pretreatment Program CWA-8
Policy on Effluent Trading in Watersheds CWA-9
Spills of Oil and Hazardous Substances CWA-10
Oil Pollution Prevention CWA-10
Reportable Quantities for Hazardous Substances CWA-11
CWA Assessment Considerations CWA-11
CWA Regulatory Requirements CWA-12
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Clean Air Act (CAA)
The Clean Air Act (CAA), with its 1990 amendments, sets the framework for air pollution
control as it affects the pharmaceutical manufacturing industry. This framework has several
elements based upon individual titles in the CAA. The applicable CAA titles and the
regulations and guidelines developed pursuant to the CAA are illustrated in Exhibit CAA-1 and
are discussed below.
Exhibit C
Clean Air Act
Title I Attainment and Maintenance of National Air Ambient Quality Standards
Title III Air Toxics
Title V Permitting of Title I and III Sources
Title VI Stratospheric Ozone Sources
Title 1
40 CFR Part 50 NAAQS
40 CFR Part 60 New Source
Performance Standards
New Source Review (NSR)
Reasonable Available Control
Technology (RACT)
Guidelines
Title III
40 CFR Part 61 NESHAP
40 CFR Part 63 NESHAP
Maximum Achievable
Control Technology
(MACT) Standards
Title V
40 CFR Part 70
or
40 CFR Part 71
Title VI
40 CFR Part 82
Several portions of Title I of the CAA
address requirements for the attainment
and maintenance of National Ambient Air
Quality Standards (NAAQS). The central
components of the regulatory scheme of
the Act may be said to include the
following:
Clean Air Act
National Primary and Secondary Ambient Air
Quality Standards CAA-2
National Emissions Standards for Hazardous
Air Pollutants (NESHAP) and Maximum
Achievable Control Technology (MACT)
Standards CAA-6
Permitting Program CAA-7
Stratospheric Ozone Protection CAA-8
CAA Assessment Considerations CAA-9
CAA Regulatory Requirements CAA-12
Pharmaceutical Manufacturing
CAA-1
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* Section 107 pertaining to Air Quality Control Regions
*• Section 109 pertaining to National Ambient Air Quality Standards
> Section 110 pertaining to State Implementation Plans
*• Section 111 pertaining to New Source Performance Standards
> Section 112 pertaining to National Emission Standards for Hazardous Air
Pollutants.
Title V Permits will apply to major sources covered under Title I, as well as sources covered
under other Title of the Act.
Title VI of the CAA deals with ozone-depleting chemicals. Several solvents used in the
pharmaceutical industry are affected by this law. Regulations under Title VI which affect the
pharmaceutical industry are discussed in a section of the appendix.
Finally, the specific regulatory requirements developed pursuant to the CAA are described in
the last section of this appendix.
National Primary and Secondary Ambient Air Quality Standards
Title I of the CAA establishes the statutory authority for EPA's National Ambient Air Quality
Standards (NAAQS) that are to be applied uniformly throughout regions in the United States.
The Air Quality Act of 1967 required the designation of air quality control regions (AQCRs) based
on "jurisdictional boundaries, urban-industrial concentrations, and other factors including atmospheric
areas necessary to provide adequate implementation of air quality standards" [Section 107(a)
(1967)]. Today, the United States is divided into 247 AQCRs. Many AQCRs are subdivided
into smaller areas based on munidpal boundaries, latitudes and longitudes, and other
boundaries. A complete list of AQCRs (and their attainment status) is codified at 40 CFR Part
81. An air quality control region is classified as a "nonattainment" area if an NAAQS is violated
anywhere in the region. (In the case of ozone, a violation occurs if the 4th highest reading
over any 24-hour period in the past 3 years exceeds the NAAQS for ozone.) Two types of
NAAQS are set:
(1) Primary standards that define the level of air quality necessary to prevent any
adverse impact on human health
(2) Secondary standards that define the level of air quality necessary to protect the
public welfare from any known or anticipated adverse effects of a pollutant.
These standards, promulgated in 40 CFR Part 50, recognize that the severity of the adverse
health effects assodated with exposure often depends on the duration of exposure.
Accordingly, "short-term" standards set limits for a 1-hour, an 8-hour, or a 24-hour period,
while "long-term" standards are established on an annual basis.
Pharmaceutical Manufacturing CAA-2
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The EPA has set NAAQS for ozone, carbon monoxide, participate matter of 10 microns or
less (PM-10), sulfur dioxide (SOX), nitrogen dioxide (NOX), and lead. These standards are
used as a foundation for the regulatory framework discussed in this section. Of the six
pollutants, the NAAQS for ozone, NOX, CO, SOX and participate matter are likely to have a
significant impact on the pharmaceuticals industry.
Existing Sources of Emissions
Ozone Non-attainment Areas - The "design value" shown in the third column of Exhibit CAA-2
is compared to the 4th highest reading taken over any 24-hour period during 3 concurrent
years in a nonattainment area. Based on this value, a nonattainment area is classified as
Marginal, Moderate, Serious, Severe, or Extreme. As shown in Exhibit CAA-2, attainment
deadlines are based on a sliding scale that reflects the severity of the pollution, where the
trigger date is the date when an area is designated as nonattainment.
Exhibit CAA-2 Classification of Ozone Nonattainment Areas
Classification
Marginal
Moderate
Serious
Severe
Extreme
Deadlines to Attain
(from November 15, 1990)
3 Years
6 Years
9 Years
15 Years
17 Years
20 Years
Design Value (ppm)
0.121-0.138
0.138-0.160
0.160-0.180
0.180-0.190
0.190-0.280
Above 0.280
A major source is defined both by the size of the source's facility-wide emissions and the
category of the nonattainment area. These conditions are presented in Exhibit CAA-3. In
addition, if a firm has the potential to emit more than 100 tons per year (TPY), it is also
considered to be a major source. The statement "potential to emit" means the maximum
capadty of a stationary source to emit a pollutant under its physical and operational design.
Thus operating below capacity does not exclude a plant from being defined as a major
source. Any physical or operational limitations on the capacity of the source to emit a
pollutant, provided the limitation or its effect on emissions is federally-enforceable, are treated
as part of its design and therefore, could mean exclusion from the major category.
Each State is required to develop a State Implementation Plan (SIP) for all nonattainment
areas. SIPs contain a range of requirements that are designed to decrease ambient ozone
concentrations. Part D of Title I of the CAA provides the authority for implementation of
Reasonably Available Control Technology (RACT). A source defined as "major" in a
nonattainment area must install the RACT as prescribed in the applicable SIP.
Pharmaceutical Manufacturing
CAA-3
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Exhibit CAA-3 Major Source Classifications
Category of Nonattainment Area
Extreme
Severe
Serious
Moderate and Marginal
Size of VOC or NOX Sources Affected
(Tons/Year)
10
25
50
100
EPA has defined RACT as the lowest emission limitation that a particular source is capable of
meeting by the application of control technology that is reasonably available considering
technological and economic feasibility. RACT for a particular source is determined on a
case-by-case basis, considering the technological and economic drcumstances of the
individual source. Further guidance for RACT is provided in the General Preamble published
on April 16, 1992, in 57 FR13498-13570.
EPA regulations provide that less stringent emission limitations than those achievable with
RACT are acceptable only if the State plan shows that the less stringent limitations are
sufficient to attain and maintain NAAQS, and show reasonable further progress during the
interim before attainment.
A single ozone transport region exists for eleven states and the District of Columbia (the
northeast ozone transport region). States included in the ozone transport region must submit
SIPs to the EPA with special requirements pertaining to enhanced vehicle inspection and
maintenance programs and implementation of RACT with respect to all sources of volatile
organic compounds in the States. In addition, a stationary source in the ozone transport
region that emits or has the potential to emit at least 50 TPY of VOCs for NO xis
considered a major source and is subject to the requirements which would be applicable to
major stationary sources if the area were classified as a Moderate nonattainment area.
A determination of the applicable RACT requirements for major sources is usually made by a
State on the basis of a case-by-case review of each facility. In an attempt to issue uniform
source guidelines, EPA issues Control Techniques Guidelines (CTGs) for industrial categories.
The specific CTGs for a source are available through EPA's Technology Transfer Network.
There are several CTGs relevant to pharmaceutical plants regarding the control of Volatile
Organic Compounds (VOCs) from organic chemical and polymer manufacturing, petroleum
and volatile organic liquid storage, and wastewater operations.
New Source Review
Persons constructing new major stationary sources of air pollution or making modifications to
major stationary sources are required by the Clean Air Act to obtain a permit before
Pharmaceutical Manufacturing CAA-4
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commencing construction. The process is called new source review (NSR) and is required
whether the major source or modification is planned for an area where the NAAQS are
exceeded (nonattainment areas) or an area where air quality is acceptable (attainment and
unclassifiable areas). Permits for sources in attainment areas are referred to as prevention of
significant air quality deterioration (PSD) requirements and include the following:
Installation of Best Available „„, t „, „„ . ,
/-.IT,,, m * /-in EPA determines BACT requirements by:
Control Technology (BACT) ,., . 4 . J
^ (1) identifying all control technologies;
. , , ., , . ... , . (2) eliminating technically infeasible
A detailed air quality analysis v '. /0\ i • • • * i
, . x, x xi. -111- options; (3) ranking remaining control
showing that there will be no r b b
violation of PSD "increments"
Prediction of future air quality
standards
Possible monitoring of air
quality for 1 year prior to the
issuance of the permit
options by control effectiveness; (4)
evaluating the most effective controls
and documenting results; and (5)
selecting BACT. See Draft New Source
Review Workshop Manual, U.S. EPA,
Office of Air Quality Planning and
Standards, October 1990.
> Demonstration of standard attainment through the undertaking of an air quality
analysis.
Restrictions in nonattainment areas are more severe. The principal requirements of NSR in
nonattainment areas are:
> Installation of Lowest Achievable Emission Rate (LAER) technology; LAER is
derived from either of the following: (1) the most stringent emission limitation
contained in the implementation plan of any State for such class or category of
source; or (2) the most stringent emission limitation achieved in practice by
such class or category of source. See CAA Part 171 (3).
> Provision for "offsets" representing emission reductions that must be made
from other sources. Emissions offsets are generally obtained from existing
sources located in the vicinity of a proposed source and must (1) offset the
emissions increase from the new source or modification and (2) provide a net
air quality benefit. The emission offset ratio depends on the category of the
nonattainment area and is listed in Exhibit CAA-4. In general, emission reductions
which have resulted from some other regulatory action are not available as
offsets. Nonattainment area major source permitting provisions are described
in 40 CFR Part 52.24. The PSD permitting provisions are described in 40 CFR
Part 52.21.
Pharmaceutical Manufacturing CAA-5
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Exhibit CAA-4 Major Source Definitions and Offset Ratios in Ozone
Nonattainment Areas
Category
Marginal
Moderate
Serious
Severe
Extreme
Size of Major Source
(Tons/Year of VOCs for NOX)
100
100
50
25
10
Offset Ratios
1.1:1
1.15:1
1.2:1
1.3:1
1.5:1
New Source Performance Standards (NSPS)
Major pharmaceutical industry sources must also comply with certain standards of
performance developed by EPA (promulgated as 40 CFR Part 60), irrespective of its location
in an attainment or nonattainment area. These are technology-based standards and are
commonly referred to as the New Source Performance Standards (NSPS). NSPS affect new
sources that are to be constructed or existing sources that undergo modifications after the
applicable deadlines. NSPS requirements for pharmaceutical industry sources include
monitoring, record keeping, and reporting. Further details on affected processes at major
pharmaceutical industry sources, dates of applicability and regulatory requirements are
provided later in this section.
National Emissions Standards for Hazardous Air Pollutants (NESHAP) and
Maximum Achievable Control Technology (MACT) Standards
The NAAQS apply to five primary pollutants and one secondary pollutant: ozone. Ozone
precursors typically regulated include VOC emissions from pharmaceutical industry sources as
part of the Part 60 requirements, discussed earlier in this section. However, additional risk-
based technology standards were developed by EPA for a few selected hazardous air
pollutants prior to enactment of the 1990 Amendments to the CAA. These are commonly
referred to as NESHAP and were promulgated at 40 CFR Part 61. Like NSPS, NESHAP
requirements for pharmaceutical industry sources include monitoring, record keeping, and
reporting. Further details on affected processes at major pharmaceutical industry sources,
dates of applicability and regulatory summaries are provided later in this section.
Section 112 of the 1990 CAA identified 189 hazardous air pollutants (HAP) for which
standards of performance were to be developed based on maximum achievable control
technology rather than risk. Existing NESHAPs for those HAPs on the list of 189 would
however still apply. Accordingly, EPA promulgated the so-called hazardous organic NESHAP
(HON) rule as under 40 CFR Part 63 that sets the MACT standards applicable to specific
Pharmaceutical Manufacturing
CAA-6
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industrial sectors. MACT standards for the pharmaceutical production industry are currently
being developed and are scheduled to be promulgated in 1998. Only major sources under
Section 112(d) of the Clean Air Act will be regulated. The standards codified under Subparts
F, G, H, and I of 40 CFR Part 63 regulate emissions of 112 of the 189 HAPs listed in the
CAA.
Section 129 was added to the CAA in 1990 and directs EPA to establish MACT-based
regulations for solid waste incinerators. Regulations are currently under development for
industrial and commercial waste indnerators.
Permitting Program
The CAA Title V (promulgated as 40 CFR Part 70) defines the minimum standards and
procedures required for State operating permit programs. The permit system is a new
approach established under the Amendments that is designed to consolidate all of a source's
requirements in one document (permit). In addition, State permit fees will generate revenue
to fund implementation of the program.
Any facility defined as a "major source" is required to obtain a permit. Part 70.2 defines a
source as a single point from which emissions are released or as an entire industrial facility that
is under the control of the same person(s), and a major source is defined as any source that
emits or has the potential to emit:
* 10 TPY or more of any hazardous air pollutant
> 25 TPY or more of any combination of hazardous air pollutants
•> 100 TPY of any air pollutant.
For ozone nonattainment areas, major sources are defined as sources with the potential to
emit:
> 100 TPY or more of volatile organic compounds (VOCs) or nitrogen oxides
(NOX) in areas defined as marginal or moderate
* 50 TPY or more of VOCs or NOxin areas classified as serious
* 25 TPY or more of VOCs or NOX in areas classified as severe
* 10 TPY or more of VOCs or NOX in areas classified as extreme.
Other sources requiring permits regardless of source size include:
•> NSPS
> NESHAP
Pharmaceutical Manufacturing CAA-7
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* PSD/NSR
* Acid Rain.
The permit requirement for non-major sources (i.e., area sources) has been deferred for five
years.
By November 15, 1993, each State must submit a design for an operating permit program to
the EPA for approval. The EPA must either approve or disapprove the State's program
within 1 year after submission. Once approved, the State program goes into effect.
Major sources, as well as the other sources identified above, must then develop and submit
their permit applications to the State within 1 year (this will take place near the end of 1995).
Once a source submits an application, it may continue to operate until the permit is issued.
This may take years because permit processing allows time for terms and conditions to be
presented to and reviewed by the public and neighboring States, as well as by the EPA.
When issued, the permit will include all air requirements applicable to the facility. Among
these are compliance schedules, emissions monitoring, emergency provisions, self-reporting
responsibilities, and emissions limitations. Five years is the maximum permit term.
As established in Title V (40 CFR Part 70), the States are required to develop fee schedules
to ensure the collection and retention of revenues sufficient to cover permit program costs.
CAA sets a presumptive fee of $25 per ton for all regulated pollutants (except carbon
monoxide), but States can set higher or lower fees so long as they collect sufficient revenues
to cover program costs.
Stratospheric Ozone Protection (40 CFR Part 82)
The CAA Amendments provide for a phase-out of the production and consumption of
chlorofluorocarbons (CFCs) and other chemicals that are causing the destruction of the
stratospheric ozone layer. Requirements apply to any individual, corporate, or government
entity that produces, transforms, imports, or exports these controlled substances.
Section 602 of the Clean Air Act identifies ozone-depleting substances and divides them into
two classes. Class I substances are divided into five groups. Section 604 of the Clean Air Act
calls for a complete phase-out of Class I substances by January 1, 2000 (January i, 2002 for
methyl chloroform). Class II chemicals, which are hydrochlorofluorocarbons (HCFCs), are
generally seen as interim substitutes for Class I CFCs.
Class II substances consist of 33 HCFCs. The law calls for a complete phase-out of Class II
substances by January 1, 2030. The schedule for the HCFC phase-out has not yet been
finalized; however, EPA has proposed to begin phase-out of some HCFCs by 2002, with a
complete phase-out of all HCFCs to take place by 2030. This same proposal would
phase-out CFCs, carbon tetrachloride, hydrobromofluorocarbons, and methyl chloroform by
Pharmaceutical Manufacturing CAA-8
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January 1,1996. Federal regulations do provide essential-use allowances for specific Class I
controlled substances for use in metered dose inhalers, as manufactured by the
pharmaceutical industry.
On February 11, 1993, EPA issued a rule under Section 611 of the CAA that, effective May
15, 1993, requires both domestically produced and imported goods containing or
manufactured with Class I chemicals to carry a warning label. The rule covers items whose
manufacture involves the use of Class I chemicals, even if the final product does not contain
such chemicals.
Exports are exempt from this rule's labeling requirements, as are products that do not have
direct contact with these chemicals. In addition, if direct contact occurs but is non-routine
and intermittent (e.g., spot-cleaning of textiles), no labeling is required. Moreover, if a second
manufacturer incorporates a product made with an ozone-depleting chemical into another
item, the final product need not carry a label.
Section 608 of the CAA established the National Recycling and Emissions Reduction
Program. Effective July 1, 1992, EPA prohibited the venting of ozone-depleting compounds
used as refrigerants into the atmosphere during maintenance, service, repair, or disposal of
air-conditioning or refrigeration equipment. EPA also promulgated regulations at 40 CFR Part
82, Subpart F. Under 40 CFR Part 82, Subpart F on May 14, 1993 which establish standards
for service and disposal practices and to require leak repair. Under these regulations,
technicians servicing air-conditioning and refrigeration equipment must evacuate refrigerant
according to the prescribed guidelines. In addition, recovery and/or recycling equipment
used must be certified and all persons who maintain, service, repair, or dispose of appliances
must be certified.
Owners of industrial process refrigeration equipment (those with charges greater than 50
pounds) are required to repair substantial leaks. A 35 percent annual leak rate is established
for the industrial process and commercial refrigeration sectors as the trigger for requiring leak
repairs. Leak repair is required within 30 days of discovery or a 1-year retrofit or retirement
plan must be developed for the leaking equipment.
CAA Assessment Considerations
Under Title V of the 1990 Amendments, many CAA requirements have been summarized
into one comprehensive permit (risk management is an exception). In general, Title V
requirements (40 CFR Part 70 or 71) are the same as compliance provisions previously
required under the CAA. The facility's compliance assessors) should consider reviewing
data derived from previous facility self-assessments or when determine compliance with
Title V requirements. The regulatory inspection forms are generally organized around
process equipment (called emission units) and stacks or vents (called emission points).
The facility assessor should develop an assessment format where any enforceable limits and
Pharmaceutical Manufacturing CAA-9
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the underlying regulatory requirements applying to the emission unit or the emission point is
listed so that it can be confirmed during the assessment.
In general, not all of the applicable requirements can be verified during a single self-
assessment and each assessment represents a "snapshot" of compliance. In recognition of
the fact that a facility assessor can not always be in place to detect violations, "baseline"
assessment techniques stress the importance of maintenance plans to ensure proper
operation and maintenance of equipment. Baseline assessment techniques also emphasize
tracking of operating parameters (such as indnerator temperatures) during assessments for
future use in accessing equipment performance. This focus on self-monitoring and self-
reporting was reinforced under Title V with requirements for enhanced monitoring, periodic
monitoring, compliance plans and programs and maintenance plans. The facility self-assessor
can rely upon baseline techniques to ensure that the systems and programs established for
self-monitoring and self reporting are appropriately designed and successfully implemented.
The draft Compliance Assurance Monitoring (CAM) Rule will supplant enhanced and periodic
monitoring requirements and focuses on the same type of monitoring of equipment
performance or other parameters that indicate compliance with applicable requirements. As
an example, a emission unit that controls emissions of volatile organic compounds (VOCs)
through exhaust gas incineration might have a lower allowable operating temperature of
1800°F. Using baseline assessment techniques, the assessor routinely records this operating
temperature. If this unit had traditionally operated at 2000 °F, and now operated at 1825 °F,
this would not constitute a violation of the 1800 °F limit, but might indicate a potential for
violation and a need for follow-up actions. Under the CAM Rule, the facility might choose to
record and report this temperature to demonstrate continued compliance with applicable
requirements. However, the facility assessor should also initiate appropriate follow-up
actions to investigate the existence of a problem that might result in a violation of the
requirement, and pursue proactive compliance assurance measures.
The applicable CAA regulations for a pharmaceutical manufacturing fadlity will vary with
location. Those facilities located near urban areas are much more likely to be subject to
nonattainment provisions. Ozone nonattainment areas have RACT requirements on all major
sources of VOCs and NOX. RACT requirements vary with location and severity on
nonattainment; however, pharmaceutical manufacturing facilities would generally have RACT
requirements on reactors, distillation units, storage tanks, pumps and valves. NSPS
requirements are based on the capacity and on the age of regulated units, but apply nationally
to conforming units. NSR requirements generally contain the most stringent emissions or
performance limits and apply to new units as they are constructed. BACT applies under the
PSD program in areas that meet NAAQS; LAER applies under NSR permits issued in
nonattainment areas. MACT standards apply nationally based on magnitude of emissions of
189 HAPs. Units that are subject to these requirements would receive priority in an air
quality inspection.
Pharmaceutical Manufacturing CAA-10
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The process oriented self-assessment approach focuses on following a process from
start to finish and developing process flow diagrams to identify key points for inspection.
Previous facility assessment techniques generally focused more on individual emission
units and emission points without as much attention to understanding the process. An
example of an assessment process diagram is included as Exhibit CAA-5. This type of
approach is also more compatible with a multimedia self-assessment technique in that the
process diagrams could contain information on other items such as wastewater discharge
or pollution prevention activities.
Title V (or Part 70) permits will present new challenges to the compliance self-assessment.
One of these challenges will be inclusion of plant wide emissions limits or caps. Plant wide
caps offer operational flexibility to the permittee because changes in use of different processes
can occur and as long as overall emissions remain under the limits, no permit terms are
violated. The assessor will need to sum emissions from multiple processes in order to
determine compliance. Alternative operating scenarios are another example of Part 70
permit conditions that offer operational flexibility. Alternative operating scenarios describe
different methods of operation for process equipment; these scenarios will contain different
emissions limits based on different production modes. Confirmation of different limits on one
process substantially complicates the self-assessment. One other aspect of the Part 70 permit
is the permit shield. If a facility is operating within the limits of the Part 70 permit, then the
permit shields the facility against charges of noncompliance for those activities.
Exhibit CAA-5. Example Inspection Process Diagram
Aggregate
Recycle
Asphalt
binder
Asphalt
concrete
Flowchart of an asphalt plant
Pharmaceutical Manufacturing
CAA-11
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As mentioned in the description of baseline inspection techniques, self-monitoring and self-
reporting activities are important to maintaining compliance. Part 70 requires compliance
programs for units operating out of compliance with applicable regulations. Maintenance and
compliance plans are required for all facilities. These programs would be used to document
efforts to maintain control equipment and replace parts prior to break-downs that could result
in excess emissions. The investigator should attempt to verify through evaluation of records
the adequacy of these programs.
CAA Regulatory Requirements
The following sections provide summaries of the prindpal regulations developed pursuant to
the CAA that may apply to the pharmaceutical industry. The section includes:
* 40 CFR Part 60
- Subparts Da Db Dc Standards of Performance for Steam Generating Units
- Subpart Kb Standards of Performance for VOC Storage Vessels
- Subpart GG Standards of Performance for Stationary Gas Turbines
40 CFR Part 61
- Subpart J
- Subpart M
- Subpart V
- Subpart Y
40 CFR Part 63
- Subpart H
- Subpart I
- Subpart Q
40 CFR Part 68
National Emissions Standards for Equipment Leaks
(Benzene)
National Emissions Standards for Asbestos
National Emissions Standards for Equipment Leaks
(Fugitive Emission Sources)
National Emissions Standards for Benzene Emissions
from Benzene Storage Vessels
National Emissions Standards for Organic Hazardous Air
Pollutants from SOCMI for Equipment Leaks
National Emissions Standards for Organic Hazardous Air
Pollutants for Certain Processes Subject to the
Negotiated Regulation for Equipment Leaks
National Emissions Standards for Hazardous Air Pollutants
for Industrial Cooling Towers
Chemical Accident Prevention Provisions
40 CFR Part 82 Protection of Stratospheric Ozone
Pharmaceutical Manufacturing
CAA-12
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Applicability:
Electric utility steam
generating units capable
of combusting > 73 MW
(250 million BTU/hr)
heat input alone, or in
combination with other
fossil fuels.
Electric utility combined
cycle gas turbines with
duct burners capable of
combusting > 73 MW
(250 million BTU/hr) heat input of fossil fuel.
40 CFR Part 60 - Subpart Da
Standards of Performance for Electric Utility
Steam Generating Units for which
construction is commenced after September
18, 1978.
-Standards for:, participate matter 60.42a, sulfur
dioxide 60.43a, nitrogen oxides 60.44a
-Test Methods 60.48a
-Monitoring 60.47a
-Reporting and record keeping 60.49a
Date of Applicability:
• Sources constructed, reconstructed, or modified after September 18, 1978.
Affected Processes:
Emission standards for all affected facilities for:
• Participate Matter (PM) of 13 ng/J (0.03 Ib/mmBtu) heat input from the combustion of
solid, liquid or gaseous fuel.
• Opacity of 20%, averaged over 6 minutes, except for one 6 min. period per hour of
27% opadty (block average).
• SO2 when combusting solid or solid-derived fuels: 520 ng/J (1.20 Ib/mmBtu) heat
input and 90% reduction; or 70% reduction when emissions are < 260 ng/J (0.60
Ib/mmBtu heat input). All limits and percent reductions are based on a 30-day rolling
average (continuous compliance by CEMS).
• SO2 when combusting liquid or gaseous fuels: 340 ng/J (0.80 Ib/mmBtu) heat input
and 90% reduction; or 86 ng/J (0.20 Ib/mmBtu heat input). All limits and percent
reduction requirements are based on a 30-day rolling avg. (continuous compliance by
CEMS).
s.
CO
Pharmaceutical Manufacturing
CAA-13
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Alternative limits for SO 2 apply if facility meets one of the following criteria
combusts solid solvent refined coal (SRC-I) (60.43a(c))
combusts 100% anthracite (60.43a(d)(l))
is classified as a resource recovery facility (60.43a(d)(2))
is located in a noncontinental area and combusts solid or solid-derived
fuel (60.43a(d)(3))
is located in a noncontinental area and combusts liquid or gaseous fuel
(60.43a(e))
combusts different fuels simultaneously (60.43a(h))
• Nox (NO2) of various limits in ng/J (Ib/mmBtu) heat input depending on fuel type,
based a 30-day rolling avg (continuous compliance by CEMS). If two or more fuels
are combusted simultaneously, the formula in 60.44a(c) should be used.
Exemptions:
• Subpart Da applies to emissions from fossil fuels only. Gas turbine emissions are
subject to Subpart GG.
• Changes to existing fossil fuel-fired steam generating units to allow for the use of
combustible materials, other than fossil fuels.
• Changes to existing fossil fuel-fired steam generating units from its original design of
gaseous or liquid fossil fuels to accommodate the use of any other fossil or nonfossil
fuel.
Partial Exemptions:
Emissions reduction requirements for SO 2 do not apply if facility is operated under an SO 2
commercial demonstration permit issued by the Administrator under the provisions of
60.45a.
Emissions levels for NOX do not apply if unit is combusting coal-derived liquid fuel and is
operating under a commercial demonstration permit issued by the Administrator under the
provisions of 60.45a.
Pharmaceutical Manufacturing CAA-14
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Monitoring Requirements:
1) Maintenance and operation of continuous emission monitoring system (CEMS), for
monitoring opacity according to 60.47a(a),(h) and (j) except where only gaseous fuel is
combusted.
2) Maintenance and operation of continuous emission monitoring system (CEMS), for
monitoring SO2 except where only natural gas is combusted. SO 2 is to be monitored
at the sulphur dioxide control device inlet and outlet, unless subject to 68.47a(b)(2) or
(3).
3) Maintenance and operation of continuous emission monitoring system (CEMS), for
monitoring NOX emissions according to 60.47a(c).
4) Maintenance and operation of continuous emission monitoring system (CEMS) for
monitoring O2 or CO2 content of flue gases at each location where SO 2 or NOX is
monitored.
5) CEMS minimum data availability > 18 hours a day for >22 days a month.
Reporting Requirements:
1) Initial performance test data and CEMS performance evaluation data for SO 2, NOX
and opacity.
2) Quarterly reports including:
the information collected for 30 successive boiler operating days as specified in
60.49a(b) for sulfur dioxide and nitrogen oxides. If the minimum quantity of
data is outlined n 60.49a(c) and/or is information is not collected over 30 days
or the data is not available, then the information to be reported is outlined in
60.49a(c) and/or 60.49a(f)
the information in 60.49a(d) if standards are exceeded during emergency
conditions because of control system malfunction
the information in 60.49a(e) if SO2 fuel pretreatment is claimed
signed statement in 60.49a(g)
excess emission reports as under 60.7
Pharmaceutical Manufacturing CAA-15
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Applicability:
Steam generating units with a
heat input capadty from fuels
combusted in the steam
generating unit >29 MW (100
million BTU/hr).
Date of Applicability:
40 CFR Part 60 - Subpart Db
Standards of Performance for Industrial,
Commercial, Institutional Steam Generating
Units
-Standards for: sulfur dioxide 60.42b, participate matter 60.43b,
nitrogen oxides 60.44b
-Test Methods 60.45b, 60.46b
-Monitoring 60.47b, 60.48b
-Reporting and record keeping 60.49b
• Sources constructed, reconstructed, or modified after June 19, 1984.
• Sources meeting applicability and constructed, reconstructed, or modified after June
19, 1984 but before June 19, 1986 (PM, NOX, SO2)
Affected Processes:
For all affected fadlities which combust coal, oil, wood or municipal waste (alone, or in
combination with other fuels):
Emission standards for:
Particulate Matter (PM) of 22 ng/J (0.05 Ib/mmBtu) to 86 ng/J (0.20 Ib/mmBtu)
depending on fuel type and other factors, over 6 hr period
Opacity of 20%, averaged over 6 minutes, except for one 6 min. period per hour of
27% opadty (block average).
SO2 of various limits in ng/J (Ib/mmBtu) heat input depending on fuel type and other
factors, based on a 30-day rolling average (continuous compliance by CEMS) unless
unit has Federally enforceable low capacity factor for oil (10% or less), combusts only
very low sulphur oil, and does not combust other fuels.
Nox (NO 2) of various limits in ng/J (Ib/mmBtu) heat input depending on fuel type
based a 30-day rolling avg. (continuous compliance by CEMS), unless unit has a
Federally enforceable low capacity factor, or low nitrogen fuels. In this case,
compliance determined based on performance tests (specified in 60.44b(j)(l)-(3)).
-c
£3
I
Pharmaceutical Manufacturing
CAA-16
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Exemptions:
• Steam generating units meeting Subpart D c applicability or Subpart Da (electric utility
steam generating units) applicability are not subject to Subpart D b.
• Existing steam generating units modified for the sole purpose of combusting gases
containing TRS as defined under 60.28.
Partial Exemptions:
Steam generating units at petroleum refineries subject to 40 CFR Part 60, Subpart J or
indnerators subject to 40 CFR Part 60, Subpart E are subject to Subpart Db only for PM and
NOx.
Steam generators subject to Subpart J who have a heat input capacity of <73 MW (260
mmBtu/hr) are not subject to NOX emissions standards.
Percent reduction requirements not applicable to affected facilities
• for SO2 if one of the following criteria apply:
annual capacity for coal and oil < 30% (subject to Federal enforceable
permit limiting operation to annual capacity factor < 30%)
located in noncontinental areas
facility is combusting coal or oil in a gas turbine duct burner and > 70%
of the heat input is from exhaust gases entering the duct burner.
burning very low sulfur oil.
Monitoring Requirements:
1) If subject to SO2 standard in 60.42(b), maintenance and operation of inlet/outlet
continuous emission monitoring system (CEMS), for monitoring SO 2 concentrations
and either O2 or CO2. Or, measurement of SO2 emissions according to 60.47b(l)-
(4). If burning low sulfur oil, may use fuel supplier certification.
2) If subject to opacity standard under 60.43(b) maintenance and operation of continuous
monitoring system (COMS) to measure opacity of emissions.
Pharmaceutical Manufacturing CAA-17
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3) If subject to the nitrous oxides standards of 60.44b, maintenance and operation of
COMS to measure NOX emissions not required for duct burners used in combined
cycle system or low capadty nitrogen fuel facilities that are subject to the performance
test emission standards.
4) CEMS minimum data availability >75 percent of hours per day and >75 percent of
days per month.
Record keeping Requirements (2 years):
1) All opacity data
2) Amount of each fuel combusted daily with recorded calculation of annual capacity
factors, maintained on a quarterly basis
3) Performance test data and initial performance test data
4) Nitrogen content of residual oil combusted in affected facility.
5) For facility subject to nitrous oxide standards: daily records of steam generating unit
operations (60.49b(g)(l)-(10))
Reporting Requirements:
1) Compliance reports quarterly for each applicable pollutant (NO x and SO2); semi-
annually if no exceedances.
2) Quarterly report of information specified in 60.49b(g) for nitrous oxide if subject to
CEMS requirement under 60.48b(b).
3) Plan for NOX monitoring operating conditions, if applicable.
4) Quarterly report for sulfur dioxide as described in 60.49b(j)-(m).
Pharmaceutical Manufacturing CAA-18
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Applicability:
Steam generating unit with
maximum design heat input
capadty of < 29 MW (100
mmBtu/hr) but > 2.9 MW (10
mmBtu/hr).
Date of Applicability:
• Sources constructed,
reconstructed, or
modified after June 9, 1989.
Affected Processes:
40 CFR Part 60 - Subpart Dc
Standards of Performance for Small Industrial-
Commercial-Institutional Steam Generating
Units
-Standards for: sulfur dioxide 60.42c and participate matter
60.43c
-Test Methods 60.44c, 60.45c
-Monitoring 60.46c, 60.47c
-Reporting and Record keeping 60.48c
Emission standards for:
• SO2 of various levels of ng/J (Ib/mmBtu), depending on fuel type and other factors.
Based on a 30-day rolling average unless facility listed in 60.42c(h)(l), (2), or (3); then
compliance with emission limits or fuel oil sulphur limits may be determined based on
certification from fuel supplier as in 60.48c(f)(l), (2), or (3).
Particulate Matter (PM) of 22 ng/J (0.05 Ib/mmBtu) to 130 ng/J (0.30 Ib/mmBtu)
depending on fuel type and other factors
• Opacity of 20% for facilities with heat input capadty > 8.7 MW and combusting coal,
wood, or oil, averaged over 6 minutes, except for on 6 minute period per hour of
27% opacity.
Exemptions:
• Percent reduction for SO 2 not applicable to facilities that combust coal (alone or in
combination with other fuels) that meet the following criteria:
heat input capadty < 2 2MW
annual capacity factor for coal < 55% and subject to Federally enforceable low
capacity factor
located in noncontinental areas
facility is combusting coal in a duct burner and > 70% of the heat input is from
exhaust gases entering the duct burner.
S,
CO
Pharmaceutical Manufacturing
CAA-19
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• Percent reduction for SO2 not applicable to facilities that combust oil as in 60.42c(d).
Monitoring Requirements:
• If subject to SO 2 standard, maintenance and operation of outlet continuous emission
monitoring system (CEMS) for monitoring SO 2 and either O2 or CO2. Inlet CEMs for
SO2 and either O2 or CO2 if % reduction requirements apply. Or, measurement of
SO2 emissions according to 60.46c(d)(l)-(3).
• Facilities subject to 60.42c(h)(l), (2), or (3) that demonstrate compliance with SO 2
standards based on fuel supplier certification, must keep records of certifications in lieu
of CEMS.
• For PM: Maintenance of continuous monitoring system (COMS) for opadty if
combust coal, wood or residual oil (alone or in combination with other fuels).
Record keeping Requirements (2 years):
1) All SO2 monitor data as described in 60.46c(f)
2) Fuel supplier certification records (specified 60.48c(f)(l)-(3)).
3) Amounts of each fuel combusted during each day
4) If subject to a Federally enforceable low-capacity factor, calculation of annual capacity
factor for each fuel combusted.
Reporting Requirements:
1) Notification of date of construction, reconstruction, anticipated and actual startup as in
60.48c(a)(l-4).
2) Initial and subsequent performance tests
3) Excess emission reports (EER) quarterly for opacity; semi-annually if no exceedances.
4) Quarterly report for SO2 emissions/monitoring data (specified in 60.48c(e)(l)-(l 1)).
Pharmaceutical Manufacturing CAA-20
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Applicability:
• Stationary gas turbines
with heat input at peak
load>10.7gigajoules/
hour, based on lower
heating value of the fuel
fired.
Date of Applicability:
40 CFR Part 60 - Subpart GG
Standards of Performance for Stationary Gas
Turbines
-Standards for: nitrogen oxides 60.332, sulfur dioxide
60.333
-Monitoring 60.334
-Test Methods 60.335
-Reporting and record keeping 60.334
• Sources constructed, reconstructed, or modified after October 3,1977, except as
provided in 60.332(e) and (j).
Affected Processes:
Emission standards for:
NOX according to the standard (STD) equation outlined in 60.332(a)(l) or (2), as
directed in 60.332(b),(c), and (d)
• SO2 emissions of < 0.015% by volume at 15% O 2 on a dry basis or fuel which
contains <0.8% sulfur by weight.
Exemptions:
• Standards for NOX are not applicable for gas turbines outlined in 60.332(e) - (I).
Monitoring Requirements:
• For units using water injection to control NO x, continuous monitoring system to
monitor and record the fuel consumption and ratio of water to fuel being fired in the
turbine, within 5% accuracy
• Monitoring of fuel sulfur and nitrogen content as specified in 60.334(b)(l)-(2).
s.
CO
Pharmaceutical Manufacturing
CAA-21
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Reporting Requirements:
Quarterly reports as required under 60.7, including reports of excess emissions data. The
periods of excess emissions to be reported are outlined in 60.334 (c)(l)-(4). The calculation
of emissions rates are outlined in 60.335.
Pharmaceutical Manufacturing CAA-22
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Applicability:
Storage vessels with
design capacity >151m3,
containing a VOL with
TVP > 5.2 kPa but less
than 76.6 kPa
40 CFR Part 60 - Subpart Kb
Standards of Performance for VOC Storage
Vessels
-Monitoring 60.116b
- Record keeping and Reporting 60.115b
-Testmethods 60.113b
Storage vessels with design capacity > 75m3, but < 151m3, containing VOL with TVP
> 27.6 kPa but less than 76.6 kPa
Storage vessels with design capacity > 75m3 and TVP > 76.6 kPa
40 CFR PART 60 - SUBPART KB
AFFECTED PROCESSES
Storage vessel must be equipped with either:
Fixed roof with internal floating roof meeting the specifications in
60.112b(a)(l)
External floating roof meeting the specifications in 60.112b(a)(2)
Closed vent systems and control device meeting the specifications
in60.112b(a)(3)
Vessels with design capacity > 75m3 and TVP > 76.6kPa must be
equipped with a closed vent system and control device, or
equivalent
REGULATORY THRESHOLD
If detectible emissions > 500 ppm
above background
Reduce VOC emissions by 95% or
greater.
Flares must meet requirements of 60.18
Date of Applicability:
Sources constructed, reconstructed or modified after July 23, 1984.
Exemptions:
• Coke oven by-product plants
• Pressure vessels designed to operate in excess of 204.9 kPa
• Vessels permanently attached to mobile vehicle
• Vessels with design capacity < 1,589.874 m3 used for petroleum or condensate
stored, processed, or treated prior to transfer
• Vessels at bulk gasoline plants
• Storage vessels at gasoline service stations
• Vessels to storage beverage alcohol
Pharmaceutical Manufacturing
-Q
s,
CO
CAA-23
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Monitoring Requirements:
1) Visual inspections of vessels and fixed roof and internal floating roof as described in
60.113b(a) and of vessels with external floating roofs as described in 60.113b(a) and
of vessels with external floating roofs as described in 60.113b(b)(6)
2) Determine gap areas and maximum gap widths of vessels with external floating roofs
as described in 60.113b(b).
3) Monitor parameters of closed vent system and control device in accordance to
operating plan
4) Monitor flares as required in 60.18
Record Keeping Requirements (at least 2 years):
1) Visual inspection data
2) Storage vessel dimensions and capadty
3) VOL storage information as applicable under 60.116b(c)
4) Gap measurements if floating roof
5) Storage vessels with design capacity > 40m3, must keep records of vessel dimension
and capadty
Reporting Requirements:
1) Notification to the Administrator 30 days prior to filling storage vessel required to be
inspected under 60.113b(a)(l), 60.113b(a)(4), or 60.113b(b)(6) or required to
determine gap measurements required under 60.113b(b)(l)
2) Operating plan for closed vent system and control device as in 60.113b(c)(l)
3) Initial report describing control equipment and certification, and required
measurements
4) Report any defects within 30 days
Pharmaceutical Manufacturing CAA-24
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Applicability:
40CFRPart61 -SubpartJ
National Emission Standard for Equipment
Leaks (Fugitive Emission Sources of Benzene)
• Sources intended to
operate in benzene
service including pumps,
compressors, pressure
relief devices, sampling connections, systems, open-ended valves or lines, valve flanges
and other connectors, product accumulator vessels, and control devices
• Required to comply with Part 61, Subpart V
Date of Applicability:
All existing sources
Exemptions:
• Sources located in coke by-product plants
• Plant sites designed to produce or use less than 1,000 mg/year
• Any process unit that has no equipment in benzene service
Monitoring Requirements:
Requirements in Part 61, Subpart V
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Pharmaceutical Manufacturing CAA-25
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Pharmaceutical Manufacturing CAA-26
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Applicability:
61.145 is applicable to
owners or operators of
a demolition or
renovation activity
61.146 is applicable to
owners or operators of
an operation in which
asbestos-containing
materials are spray
applied.
40 CFR Part 61 - Subpart M
National Emission Standard for Asbestos
- Standard for Demolition and Renovation 61.145
- Standard for Spraying 61.146
- Standard for Insulating Materials 61.148
- Standard for Waste Disposal for Manufacturing,
Fabricating, Demolition, Renovation, and Spraying
Operations
Affected Processes:
• For demolition, requirements in 6 1.1 45 (b) and (c) apply if the combined amount of
Regulated Asbestos- Containing Material (RACM) meets criteria listed in 6 1. 145 (a) (1) (I)
For renovation, requirements in 61.145(b)( and (c) apply if the combined amount of
RACM to be stripped, removed, dislodged, cut, drilled, or disturbed meets the criteria
in 6 1.1 45 (4) (I) or (ii)
All RACM must be removed from a facility being demolished or renovated before any
activity begins that would break up, dislodge, or disturb the material or preclude
access to the material for removal
When a fadlity component that contains, is covered with, or is coated with RACM is
being taken out of the facility as a unit or in sections, the procedures in 61.145(c)(2)
must be followed; and when RACM is stripped from a facility component while it
remains in place at the facility, procedures in 61.145(c)(3) must be met
After a fadlity component covered with, coated, with, or containing RACM is taken
out of the facility, it must be handled according to the procedures in 61.145(c)(4).
Large components such as reactor vessels, large tanks, and steam generators must be
handled according to procedures in 61.145(c)(5)
All RACM must be handled according to procedures in 61.145(c)(6)
No RACM can be stripped, removed, or otherwise handled or disturbed at a fadlity
unless at least one onsite representative is trained in compliance with the regulations
Under 61.146, material that contains more than 1% asbestos cannot be used for
spray application on buildings, structures, pipes, and conduits
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Pharmaceutical Manufacturing
CAA-27
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• Under 61.148, no owner or operator may install or reinstall on a facility component
any insulating materials that contain commercial asbestos if the materials are either
molded and friable or wet-applied and friable after drying; and this does not apply to
spray-applied insulating materials regulated under 61.146
• Under 61.150, each owner or operator of any source covered under 61.145 or
61.146 must:
Discharge no visible emissions to the outside air during the collection,
processing, packaging, or transporting any asbestos-containing waste material
generated by the source, or use one of the emission control and waste
treatment methods specified in 61.150(a)((l) through (4)
Dispose of all asbestos-containing waste material as soon as practical at sites as
Iistedin61.150(b)
Mark vehicles used to transport asbestos-containing waste material as in
61.150(c)
Exemptions:
• If the facility is being demolished under State or local government order because the
facility is structurally unsound or in danger of imminent collapse, only 61.145(b)(l),
(b)(2), b(3)(iii), (b)(4) (except (b)(4)(VIII)), (b)(5), and (c)(4) through (c)(9)
• RACM does not need to be removed before demolition if it meets the criteria in
61.145(c)(l)(I), (ii), (iii), or (iv)
• Spray-on application of materials is not subject to 61.146 when the asbestos fibers in
the materials are encapsulated with a bituminous or resinous binder during spraying
and the materials are not friable after drying
• Owners and operators of sources subject to 61.146 are exempt from the
requirements of 61.05(a), 61.07, and 61.09.
• Requirements in 61.150(a) do not apply to demolition and renovation for Category I
nonfriable ACM waste and Category II nonfriable ACM waste that did not become
crumbled, pulverized, or reduced to powder
Reporting and Record Keeping Requirements
• Owner or operator of demolition or renovation activity must submit and update
written notice containing the information in 61.145(b)(4)(I) through (xvii)
Pharmaceutical Manufacturing CAA-28
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Spray-on application of materials that contain more than 1% asbestos on equipment
and machinery are subject to the notification and procedural requirements in
61.146(b)(l) and (2)
Waste shipment records must be maintained for all asbestos-containing waste as
described in 61.150(d)
Pharmaceutical Manufacturing CAA-29
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Pharmaceutical Manufacturing CAA-30
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Applicability:
Sources intended to
operate in VHAP service
including pumps,
compressors, pressure
relief devices, sampling
connection systems,
open-ended valves or
lines, valves, flanges and
other connectors,
product accumulator vessels, and control devices.
40 CFR Part 61 - Subpart V
National Emission Standard for Equipment
Leaks (Fugitive Emission Sources)
-Monitoring 61.242, 61.245
- Reporting 61.247
-Record Keeping 61.246
40 CFR PART 61 - SUBPART V
AFFECTED PROCESSES
Pumps
Compressors
Valves
Pressure relief devices in gas/vapor service
Pressure relief devices in liquid service and flanges and other
connectors
Closed-Vent Systems
Control devices
REGULATORY THRESHOLD
If measured leak 10,000 ppm or more,
or if indication of liquids dripping from
pump seal.
Facility required to determine a criterion
that indicates failure of the seal system
and/or barrier fluid system.
If measured leak 10,000 ppm or more.
Alternative standards 1 and 2, leak is
detected if more than 2% if valves
emitting 10,000 ppm or more.
If detectable emissions greater than
500 ppm above background.
If measured leak 10,000 ppm or more.
Leak is detected if detectable emissions
greater than 500 ppm.
Vapor recovery systems must recover
vapors with 95% efficiency or greater.
Combustion devices must recover
vapors with 95% efficiency or greater
and must provide a minimum residence
time of 0.5 seconds at minimum
temperature of 760 °C.
Date of Applicability:
After date of promulgation of specific Subpart in Part 61.
Exemptions:
Pharmaceutical Manufacturing
S,
CO
CAA-31
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None
Monitoring Requirements:
1) Pumps—Weekly visual inspection (not required if pump within boundary of
unmanned plant site) and monthly instrumental monitoring using RM 21. Instrumental
monitoring of pumps equipped with a dual mechanical seal system is required only if
indication of liquid drippings from pump seal. Instrumental monitoring of pumps
designated for no detectable emission is required annually.
2) Compressors—Daily check of sensor or equip sensor with audible alarm. If
compressor is equipped with closed vent system capable of capturing and transporting
leak to control device, annual monitoring using RM 21.
3) Valves—Monthly instrumental monitoring using RM 21 (unless leak not detected for 2
successive months, then quarterly monitoring) or implementation of Alternative 1 or
2.
4) Pressure relief devices in gas/vapor service—Monitoring using RM 21 within 5 days of
pressure release.
5) Pressure relief devices in liquid service and flanges and other connectors—Monitoring
using RM 21 within 5 days of detecting potential leak.
6) Closed vent systems—Initial and annual monitoring.
Reporting requirements:
1) Initial notification that requirement is being implemented as required under 61.247(a).
2) Semiannual report (including information on leaks and repairs) as required under
61.247(b).
Record keeping requirements:
1) Tagging leaking equipment with ID# until after 2 successive months with no detected
leaks.
2) Information on leaking equipment and repairs as required under 61.246(c), kept for 2
years.
3) Equipment design information for closed-vent systems and control devices as
described in 61.246(d).
4) Information on equipment to which a standard applies as described in 61.2 46 (e).
Pharmaceutical Manufacturing CAA-32
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5) Information on valves as required under 61.246(0 and (g).
6) Design criterion as described in 61.246(h).
7) Information related to exemptions as described in 61.246(1) and (j).
Pharmaceutical Manufacturing CAA-33
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Pharmaceutical Manufacturing CAA-34
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Applicability:
• All benzene storage
vessels with a design
capacity >38 m3 (10,000
gal)
Affected Processes:
40 CFR Part 61 - Subpart Y
National Emission Standard for Benzene
Emissions from Benzene Storage Vessels
- Monitoring 61.272
- Record keeping 61.276
-Reporting 61.274 & 61.275
• Storage vessels storing
benzene having specific gravities as indicated in 6 1.2 70 (a)
• Storage vessel must be equipped with either:
1) Fixed roof and internal floating roof, meeting the specifications in 6 1.271 (a).
2) External floating roof meeting the specifications in 6 1 . 2 7 1 (b) .
3) Closed vent system and control device meeting the specifications in 6 1.2 71 (c).
Operated with emissions < 500 ppm above background and a control device
to reduce benzene emissions by 95% or greater.
Date of Applicability:
All existing sources.
Exemptions:
• Vessels at coke-byproduct facilities
• Vessels permanently attached to trucks, rails cars, barges or ships
• Pressure vessels designed to operate in excess of 204.9 kPa and without emissions to
the atmosphere
• If also subject to 40 CFR Part 60, Subparts K, K a, Kb, must comply only with the
Subpart with the most stringent standards.
Monitoring Requirements:
1) Visual inspections of vessels with fixed roof and internal floating roof as described in
61.272(a).
I
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Pharmaceutical Manufacturing CAA-35
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2) Determine gap areas and widths between primary and secondary seals and the vessel
wall as in 61.2 72 (b), and conduct visual inspections of each time a vessel with external
floating roof is emptied and degassed as in 61.272(b)(6).
3) Monitor parameters of closed vent systems and control devices in accordance with
operating plan.
4) Monitor flares as required in 60.18
Record keeping requirements:
1) Maintain records showing dimensions of storage vessel and analysis of capacity as long
as vessel is in operation. This requirement is also applicable to storage vessels with a
design capacity < 38 m .
2) Records related to vessels equipped with closed vent systems with control devices as
described in 61.276(c) (maintain for at least 2 years).
Reporting requirements:
1) Vessels with fixed roofs and internal floating roofs, and vessels with external roofs:
Notification to the Administrator 30 days prior to filling storage vessel required to be
inspected under 61.272(a)(l), (a)(3), or b(6).
2) Operating plan for closed vent system and control device that meets the requirements
of61.272(c)(l).
3) Initial report describing control equipment and other information as required under
61.274(a) and (b) (all affected storage vessels).
4) Periodic reports describing inspection results of vessels with fixed roof and internal
floating roofs [61.275(a), (b) and (c)], and describing results of seal gap measurements
of vessels with external floating roofs [61.275(d)].
5) Quarterly reports of each occurrence that results in excess emissions for vessels
equipped with closed vent systems with control devices [61.275(e)].
Pharmaceutical Manufacturing CAA-36
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Applicability:
40 CFR Part 63- Subpart H
National Emissions Standards for Organic
Hazardous Air Pollutants from the Synthetic
Organic Chemical Manufacturing Industry for
Equipment Leaks
-Monitoring 63.180
- Record keeping 63.181
-Reporting 63.182
Applies to pumps,
compressors, agitators,
pressure relief devices,
sampling connection
systems, open-ended
valves or lines, valves,
connectors, surge
control vessels, bottoms
receivers,
instrumentation systems,
and control devices or systems used to operate an organic HAP for 300 hours or
more during a calendar year
40 CFR PART 63 - SUBPART H
AFFECTED PROCESSES
REGULATORY THRESHOLD
Pumps in light liquid service
Compressors
Pressure relief devices in gas/vapor service
Sampling connection systems
Valves in gas/vapor service and in light liquid
service
Pumps, valves, connectors, and agitators in heavy
liquid service; instrumentation systems; and
pressure relief devices in liquid service
Surge control vessels and bottoms receivers
Closed-vent system and control devices
Agitators in gas/vapor and light liquid service
Connectors in gas/vapor and light liquid service
Must determine Phase 0, II, or III) as per provisions in
63.163 and the applicable threshold for leak detection
Must be equipped with a seal system that prevents leakage
to atmosphere and complies with provisions in 63.164
Must have detectable emissions < 500 ppm above
background and must comply with other provisions in
63.165
Must be equipped with a closed-vent system that returns
the purge to the process and complies with provisions in
63.166
Must determine Phase 0, II, or III) as per provisions in
63.168 and the applicable threshold for leak detection
Must report leaks detected by visual, olfactory, audible or
any other method must be repaired by methods specified
in 63.180
If not routed back to the process and meets conditions
specified in Table 2 or 3 must be equipped with closed-
vent system
Must comply with requirements as per 63.172
Must be monitored monthly to detect leaks as per 63.173
and comply with all provisions therein
Must be monitored to detect leaks as per 63.174 and
comply with all provisions therein
s.
CO
Date of Applicability:
Pharmaceutical Manufacturing
CAA-37
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Dates are specified in Subpart F (63.100(k))
Exemptions:
• Lines and equipment not containing process fluids
Monitoring Requirements:
Compliance with Method 21 of 40 CFR 60, App. A, and other provisions in 63.180(b)
Record Keeping Requirements:
Only one record keeping system must be maintained for all process units at one plant.
Information must be maintained as described in 63.181(b)-(k) including: identification
numbers for all affected process units; initial and periodic reports, delay of repair records;
design specifications and performance demonstration activities; documentation for all quality
assurance programs implemented; notifications of compliance status
Reporting Requirements:
1) Initial notification as described in 63.182(b)
2) Notification of compliance status as described in 63.182(c)
3) Semiannual reports as described in 63.182(d)
Pharmaceutical Manufacturing CAA-38
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Applicability:
Major sources (including
pumps, compressors,
agitators, pressure relief
devices, sampling connection
systems, open-ended valves
or lines, valves, connectors,
surge control vessels, bottoms
receivers, and instrumentation
systems that are intended to operate in organic hazardous air pollutant services for 300 hours
or more during the calendar year)
Affected Processes:
40 CFR Part 63 - Subpart I
National Emission Standards for Organic
Hazardous Air Pollutants Certain Processes
Subject to the Negotiated Regulation for
Equipment Leaks
Emissions of designated organic HAPs from the following processes: styrene-butadiene
rubber production, polybutadiene rubber production, agricultural chemicals as identified in
§63.190(b)(3), polymers/resins or other chemical products listed in §63.190(b)(4),
pharmaceutical production processes using carbon tetrachloride or methylene chloride, and
processes producing the polymers/resins or other chemical products listed in §63.190(b)(6).
Date of Application:
Variable dates, but not later than April 22, 1997
Exemptions:
Temporary exemption, provided that notification and certification is provided, for facilities that
emit less than 10 tons per year of any individual HAP, and less than 25 tons per year of any
combination of HAPs.
Requirements:
Owners and operators of subject sources must comply with the requirements of Subpart H
for the processes and designated organic HAPs and certain provisions of Subpart A, as
identified in §63.192(b). Also, all facilities subject to this subpart must receive a permit under
40 CFR Part 70 or 71.
Record Keeping:
All records required in Subpart H and in §63.192(0(2) for at least two years, except as
otherwise specified in Subpart H.
s.
CO
Pharmaceutical Manufacturing
CAA-39
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40 CFR Part 63 - Subpart Q
National Emission Standards for Hazardous
Air Pollutants for Industrial Process Cooling
Towers
Applicability:
All new and existing industrial
process cooling towers (IPCTs)
which use chromium-based
water treatment chemicals and
are either a major source or are
integral parts of a facility which
is a major source (defined in
64.401).
Date of Applicability:
Existing IPCTs must comply with subpart Q no later than 18 months from September 8,
1994. New IPCTs that have initial startup before September 8, 1994 must comply by
September 8, 1994. New IPCTs that have initial startup on or after September 8, 1994,
must comply upon initial startup.
Affected Processes:
No owner/operator of an IPCT shall use chromium-based water treatment chemicals in any
affected IPCT (63.402).
Monitoring Requirements:
No monitoring is required unless there is evidence to indicate that the IPCT is not in
compliance with the requirements of 63.402.
Record Keeping:
Copies of initial notification and notification of compliance status are required to be kept onsite
for at least 5 years as specified in 63.405(a).
Reporting Requirements (as per 63.405):
Initial notification, notification of compliance status (in accordance with Part 63, subpart A):
Table 1 of Subpart Q indicates general provisions applicability.
CO
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Pharmaceutical Manufacturing CAA-41
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40 CFR Part 68
Chemical Accident Prevention Provision
Applicability:
Owners or operators of
stationary sources that have
more than a threshold
quantity of a regulated substance in a process, as determined under §68.115.
Date of Applicability:
The latest of the following dates:
June 21, 1999
Three years after the date on which a regulated substance is first listed
The date on which a regulated substance is first present above a threshold quantity
Applicable Program:
Program 1 - For five years prior to submission of the RMP, the process has not had an
accidental release of a regulated substance that led to death, injury, or response or restoration
activities for exposure to an environmental receptor, and the distance to a toxic or flammable
endpoint for a worst-case release assessment is less than the distance to any public receptor,
and emergency response procedures have been coordinated between the stationary source
and local emergency planning and response organizations.
Program 2 - A covered process not subject to Program 1 or Program 3
Program 3 - A covered process, not subject to Program 1 and either; the process is in SIC
code 2611, 2812, 1821, 2865, 2869, 2873, 2879, or 2911, or, the process is subject to
the OSHA process safety management standard 29 CFR §1910.119.
General Requirements:
Submit a Risk Management Plan (RMP) with a registration that includes all covered processes.
Risk Management Plan Requirements: RMPs shall include:
- an executive summary describing elements of the RMP
- a single registration form covering all regulated substances
- worst-case release scenario information
- five-year accident history information
- emergency response program information
- certification statement
- regular review and updates to the RMP
- additional Programs 2 and 3 information.
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40 CFR Part 82
Protection of Stratospheric Ozone
Subpart A: Production and Consumption Controls
Subpart E: The Labelling of Products Using Ozone-
Depleting Substances
Subpart F: Recycling and Emissions Reduction
Other Requirements:
- Maintain records for five years
- Information available to the
public
- Additional permit
requirements for facilities
permitted pursuant to Parts 70
or 71.
- Provide access to
implementing agency for RMP audits.
Additional Program 1 Requirements:
- Analyze worst-case release scenarios, document public receptor is beyond endpoint, and
submit
- Complete five year accident history for the process and submit
- Ensure that response actions coordinated with local agendes
- Certify as specified in §68.12(b)(4).
Additional Program 2 Requirements:
- Develop and implement a management system, assigning a qualified person with the overall
responsibility for the program
- Conduct a hazard assessment
- Implement a Program 2 or Program 3 Prevention Program
- Develop and implement an emergency response program
- Submit the data on prevention program elements for Program 2 processes.
Additional Program 3 Requirements:
- Develop and implement a management system, assigning a qualified person with the overall
responsibility for the program
- Conduct a hazard assessment
- Implement a Program 3 Prevention Program
- Develop and implement an emergency response program
- Submit the data on prevention program elements for Program 3 processes.
Applicability:
Pharmaceutical Manufacturing CAA-43
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Any individual, corporate or government entity that produces, transforms, imports, or exports
these controlled substances.
40 CFR PART 82
REQUIREMENTS
EFFECTIVE DATE
Subpart A: Production and Consumption Controls
Prohibition on the production and consumption of any Class I
substance in annual quantities greater than the relevant percentage
specified in the regulations (based on quantity of substance
produced in the baseline year)
Prohibition on the production of all Class I substances
Prohibition on the production of all Class II substances
Reporting Requirements:
Reports on production, imports, and exports of Class I and II
substances
Subpart E: The Labelling of Products Using Ozone-Depleting
Substances
Containers in which Class I and II refrigerants are stored or
transported are required to be labelled with a warning stating that
it contains a substance which harms public health and environment
by destroying ozone in the upper atmosphere
Subpart F: Recyling and Emissions Reduction
Prohibition on knowingly venting ozone-depleting compounds
used as refrigerants into the atmosphere during maintenance,
service, repair, or disposal or air-conditioning or refrigeration
equipment
Technicians servicing air-conditioning and refrigeration equipment
are required to evacuate refrigerant in the line according to
prescribed guidelines
January 1 of each year specified in the
regulations
January 1, 2000 (January 1, 2002 for
methyl chloroform)
January 1, 2030
Quarterly
July 1, 1992
July 13, 1993
Recovery and/or recycling equipment must be tested by an EPA-
approved third-party testing organization
Require repair of substantial leaks in industrial process refrigeration
equipment (charge greater than 50 pounds).
All persons who maintain, service, repair, or dispose of appliances
are required to be certified.
All equipment sold after November 15,
1993
Equipment manufactured prior to this
date is grandfathered
Within 30 days of recovery
November 14, 1994
00
Pharmaceutical Manufacturing
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40 CFR PART 82
REQUIREMENTS
Persons servicing or disposing of air-conditioning and refrigeration
equipment are required to certify that certified recovery and
recycling equipment has been acquired and they are complying
with the applicable requirements of 40 CFR Part 82, Subpart F.
EFFECTIVE DATE
August 12, 1993
Pharmaceutical Manufacturing
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Safe Drinking Water Act (SDWA)
The Safe Drinking Water Act (SDWA) mandates that EPA establish regulations to protect
human health from contaminants in drinking water. The law authorizes EPA to develop
national drinking water standards and to create a joint Federal/State system to ensure
compliance with these standards. The SDWA also directs EPA to protect underground
sources of drinking water through the control of underground injection of liquid wastes. The
Public Water System Program (i.e., the National Primary and Secondary Drinking Water
Regulations) and the Underground Injection Control (UIC) Program are two components of
the SDWA that may be applicable to pharmaceutical manufacturing facilities. The
requirements of the programs are summarized below.
Public Water System Program
Under the SDWA, EPA has established primary and secondary drinking water regulations
designed to protect the public health. The primary drinking water regulations cover
contaminants that have been determined to have adverse effects on human health or are
enforceable by EPA or a State. The secondary drinking water regulations cover contaminants
that affect the aesthetic quality of drinking water and are intended as guidelines that are not
enforceable by EPA but a State can choose to enforce some or all of the secondary drinking
water regulations. Most of the States have "primacy" for the program; that is, they have
adopted the primary drinking water regulations and are responsible for implementing and
enforcing the regulations. The States can develop regulations more stringent than the national
drinking water regulations. The national drinking water regulations apply to public water
systems. A public water system is defined as a system that either (1) has at least 15 service
connections or (2) regularly serves an average of at least 25 individuals daily at least 60 days
out of the year. There are three types of public water systems: community water systems,
non-transient non-community water systems and transient non-community water systems.
Facilities employing at least 25 people and regularly providing potable water from its private
well, lake, river or reservoir to these same employees for over 6 months of the year would
be classified as a non-transient non-community public water system.
National Primary Drinking Water
Regulations have been established for 78 i
contaminants: 50 organics, 18 inorganics, 2 Safe Drinking Water Act
radionudides, and 8 microbiological. For Pub]ic Water Supply Program SDWA-1
each contaminant, the national primary Underground Injection Control Program SDWA-2
drinking water regulations establish SDWA Assessment Considerations ... SDWA-3
SDWA Regulatory Requirements SDWA-4
Pharmaceutical Manufacturing SDWA-1
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Maximum Contaminant Level Goals (MCLGs) and Maximum Contaminant Levels (MCLs) or
treatment techniques.
The National Primary Drinking Water Regulations also establish testing procedures,
monitoring requirements such as minimum monitoring frequencies, record-keeping
requirements, public notification requirements and requirements for routine reporting to the
State or EPA. Specific analytical methods must be used and the analyses must be conducted
by laboratories certified by EPA or the State. Some state programs require that the analyses
be conducted by the State laboratory.
Monitoring requirements vary by contaminant, by source of supply, and by system size. The
State customizes the sampling frequency to the local circumstances and may even waive
sampling requirements for specific contaminants.
Underground Injection Control Program
The SDWA UIC program (40 CFR Parts 144-148) is a permit program that protects
underground sources of drinking water through regulation of five different classes of injection
wells. A "well" is defined at 40 CFR §144.3 as a bored, drilled, or driven shaft, or a dug hole,
whose depth is greater than the largest surface dimension. The five well classes are as
follows:
Class I: Technologically sophisticated wells that inject large volumes of
hazardous and non-hazardous wastes into deep isolated rock
formations that are separated from the lowermost underground source
of drinking water (USD W) by many layers of impermeable clay and
rock.
Class II: Wells that inject fluids associated with oil and natural gas production.
Most of the injected fluid is brine that is produced when oil and gas are
extracted from the earth (about 10 barrels for every barrel of oil).
Class III: Wells that inject super-hot steam or water into mineral formations,
which are then pumped to the surface and extracted. Generally, the
fluid is treated and reinjected into the same formation. More than 50
percent of the salt and 80 percent of the uranium extraction in the
United States is produced this way.
Class IV: Wells that inject hazardous or radioactive wastes into or above
underground sources of drinking water. These wells are banned under
the UIC program because they directly threaten the quality of
underground sources of drinking water.
Pharmaceutical Manufacturing
SDWA-2
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Class V: Wells that use injection practices not included in the other classes.
Some Class V wells are technologically advanced wastewater disposal
systems used by a variety of manufacturing facilities, but most are "low-
tech" holes in the ground. Generally, these wells are shallow and
depend upon gravity to drain or "inject" liquid waste into the ground.
Their simple construction provides little or no protection against
possible ground water contamination, so it is important to control what
goes into them.
Class I and V UIC permitting programs are of significance to manufacturing facilities. The UIC
permit program is primarily state-run, since EPA has authorized all but a few states. UIC
permits include design, operating, inspection, and monitoring requirements. Operation of
injection wells may also be authorized by rule (i.e., permit by rule). Wells used to inject
hazardous waste must also comply with RCRA corrective action standards and must meet
applicable RCRA LDR standards.
Any underground injection is unlawful unless authorized by a permit or a rule. Additionally,
the construction of any well required to have a permit is also prohibited until issuance of that
permit. All owners or operators are required to apply for a permit, even if authorized by
rule, unless the authorization was for the life of the well.
Currently, there are limited Federal requirements for the injection into Class V wells.
However, if injection into these wells could cause the water in the receiving USDW to violate
primary drinking water regulations, then EPA or an authorized state could require the
issuance of a permit that could include the substantive requirements of the UIC program (40
CFR §144.12(c)).
SDWA Assessment Considerations
Compliance evaluations should determine whether the facility has its own potable water
supply and if so, whether the fadlity regularly provides this potable water to at least 25 of the
same people at least six months of the year. If it is determined that the facility is subject to the
national drinking water regulations, then the inspection team should evaluate whether the
facility has conducted monitoring of required contaminants at required frequency. The
inspector should verify that the facility is using an approved laboratory and approved tests and
is maintaining the required records. The inspectors should confirm that the facility has
notified employees of violations through continuous posting in conspicuous places in the
workplace or through hand delivered or mailed written notices.
Compliance evaluations should determine if wastes are being injected at the site, and if so, if
the facility is operating under a permit or by rule. If permitted, the inspection team should
verify that all terms of the permit are being met. The inspection team should confirm that
Pharmaceutical Manufacturing SDWA-3
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wastes being injected are identified in the permit and no unpermitted wastes are injected.
Also, the inspectors should evaluate well records and verify that the volume of waste being
injected is within the limitations of the permit. If operating under rule, inspectors should
verify that a permit application has been submitted in accordance with the Federal or State
requirements unless the facility is authorized by rule to inject during the life of the well. If
operating under permit by rule conditions, the inspectors should verify that the facility is
complying with applicable regulations identified in 40 CFR Part 144, Subpart C.
SDWA Regulatory Requirements
The following section provides a summary of the principal regulations developed pursuant to
the SDWA that may apply to the pharmaceutical manufacturing industry: 40 CFR Part 141 -
National Primary Drinking Water Regulations; 40 CFR Part 143 - National Secondary
Drinking Water Regulations; and 40 CFR Part 144 - Underground Injection Control Program.
Pharmaceutical Manufacturing SDWA-4
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Applicable Subparts:
Public water systems
classifications applicable to
pharmaceutical manufacturers:
40 CFR Part 141
National Primary Drinking Water Regulations
Community water system - A public water system which serves at least 15 service
connections used by year round residents or regularly serves at least 25 year-round
residents.
Non-transient non-community water system - A public water system that is not a
community water system and that regularly serves at least 25 of the same persons over 6
months per year.
40 CFR PART 141
REQUIREMENTS
EFFECTIVE DATE
Maximum Containment Levels Subpart B, G
Maximum Containment Level Goals Subpart F
Monitoring and Analytical Requirements Subpart C
Treatment Techniques Subparts H, I
Reporting, Public Notification and Record Keeping
Subpart D, H, I
All regulations in effect
Required Sampling and Testing Frequencies, §§141.21-141.30
TESTS
Inorganics
Organics: except THMs
Organics: THMs
FREQUENCY
(COMMUNITY SYSTEM)
• Systems using surface water:
every year
• Systems using groundwater only:
every 3 years
• Systems using surface water:
every 3 years
• Systems using groundwater only:
state option
• Systems serving populations of
10,000 or more: 4 samples per
quarter per plant
FREQUENCY
(NON-COMMUNITY)
State option except for nitrate*
State option
State option
ical Manufacturing
SDWA-5
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TESTS
FREQUENCY
(COMMUNITY SYSTEM)
FREQUENCY
(NON-COMMUNITY)
Coliform bacteria*
Radiochemicals: natural
Radiochemicals:
man-made
Dependent on number of
people served by the water
system
Systems using surface water:
every 4 years (exceptions
included in §141.26(a)(3))
Systems using groundwater only:
every 4 years (exceptions
included in §141.26(a)(3))
System using surface water
serving population greater than
100 000: every 4 years. All other
systems: state option
Same as community system unless only
groundwater not under the influence is
used and serves less than 1,000 people
then 1 per quarter (for each quarter
water is served to public)
State option
System using surface and/or
groundwater: state option
* Although routine nitrate monitoring is established at state option, the initial monitoring is required and
should have been completed by June 1979.
** Repeat sampling required if routine sampling is total coliform-positive.
Special Monitoring Requirements for Sodium and Corrosion
(Community systems only)
TEST
FREQUENCY
Sodium
Corrosivity includes those characteristics known to
indicate corrosivity:
• pH
• Calcium hardness
• Total dissolved solids (TDS)
• Temperature
• Langelier Index
Systems using surface water: annually
Systems using groundwater only: every 3 years
Once unless additional monitoring required by state or
EPA
Pharmaceutical Manufacturing
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Record-Keeping Requirements [§§141.33 and 141.91]
RECORDS PERTAINING TO
TIME PERIOD
Bacteriological analyses
Chemical analyses
Actions taken to correct violations
Sanitary survey reports
Variances or exemptions
Lead and copper control
At least 5 years
At least 10 years
At least 3 years after last action taken
At least 10 years
At least 5 years following expiration
At least 12 years
Lab Reports Summary Requirements [§141.33]
SAMPLING INFORMATION
ANALYSIS INFORMATION
Date, place, and time of sampling
Name of sample collector
Identification of sample:
• Routine or check sample
• Raw or treated water
Date of analysis
Laboratory conducting analysis
Name of person responsible for analysis
Analytical method used
Analysis results
Reporting Requirements for Check Sampling
CONTAMINANT
CHECK-SAMPLE REPORTING
Microbiological
Nitrate
All others
Must report to state within 48 hours when any check sample confirms the
presence of coliform bacteria.
Must report to state within 24 hours if check sampling confirms MCL has
been exceeded
Must be reported to the state within 10 days after the end of the month in
which the sample was received.
Pharmaceutical Manufacturing
SDWA-7
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MCL Violations
CONTAMINANT
VIOLATION
Inorganic chemicals (expect nitrate) and organic
chemicals (except THMs)
Nitrate
THMs
Radionuclides (natural and man-made)
Microbiological (coliform testing): membrane filter and
multiple-tube fermentation
If average of results from all samples taken in year
(if more than one sample) or average of initial
sample and check sample exceeds MCL
If average of results from initial sample plus the
check sample exceeds MCL
If average of results from present quarter plus
those of 3 preceding quarters exceeds MCL*
If average annual concentration exceeds MCL**
If any of the MCLs are exceeded
Quarter means a 3-month period. For convenience, calendar quarters are used.
Based on individual analyses of 4 consecutive quarterly samples or a single analysis of an annual composite
of 4 quarterly samples.
Public Notification Requirements, §141.32
VIOLATION OR CONDITION
Violation of an MCL, acute
Violation of an MCL, non-acute
Failure to monitor
Failure to follow compliance schedule
Failure to use approved testing procedure
System granted a variance or exemption
REQUIRED TIMING
72 HOURS
3,4,5
14 DAYS
2,4,5
2,4,5
45 DAYS
1,4,5
1,4,5
3 MONTHS
1,4,5
1,4,5
2,4,5
2,4,5
2,4,5
1,4,5
1 - Direct mail
4 - Hand delivery
2 - Local newspaper
5 - Continuous posting in conspicuous places
3 - By local radio and/or TV
Pharmaceutical Manufacturing
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Applicable Subparts:
These regulations are not
Federally enforceable but are
intended as guidelines for
States.
40 CFR Part 143
National Secondary Drinking Water
Regulations
40 CFR Part 143
Component
Regulatory Recommendation
Standards
Monitoring
Analytical Methods
Notification
Secondary MCLs exist for 15 contaminants
Conducted at least as frequently as the monitoring performed for
inorganic chemicals in the National Interim Primary Drinking
Water Regulations and more frequently for parameters such as
pH, color, and odor
pH, copper, and fluoride should be analyzed consistent with
methods described in 40 CFR Part 141. Other contaminants
should be analyzed using the procedures specified in 143.4(b).
Community water systems that exceed the secondary MCL for
fluoride, but do not exceed the primary MCL, should notify (using
the public notice provided in 143.5(b)) all billing units annually, all
new billing units at the time service begins, and the state public
health officer.
00
Pharmaceutical Manufacturing
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Pharmaceutical Manufacturing SDWA-10
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40 CFR Part 144
Underground Injection Control Program
Applicable Subparts:
Well classifications applicable
to pharmaceutical
manufacturers:
Class I - Wells used to inject hazardous or nonhazardous wastes beneath the lower most
formation containing within one-quarter mile of the well-bore, an underground source of
drinking water.
Class V - Injection wells not included in other classes.
40 CFR PART 144
REQUIREMENTS
Any underground injection is prohibited unless authorized
by permit or rule. Construction of any well required to
have a permit is prohibited until the permit has been
issued.
Injection activity may not allow movement of fluid
containing any contaminants into underground sources of
drinking water if the presence of that contaminant may
cause a violation of any primary drinking water regulation
or adversely affect human health 40 CFR 144.12.
Authorization by Rule Requirements:
• Inventory information as specified in 40 CFR 144.26
• 24-hour notification of noncompliance that may
endanger health or the environment (Class I wells)
as required in 40 CFR 144.28(b)
• Plugging and abandonment plan (Class I wells) as
required in .40 CFR 144.28(c).
• Reports containing the information required in 40
CFR 144.28(h)(l) (Class I wells)
• Notice of abandonment as required in 40 CFR
144.28Q
• Plugging and abandonment report as required in 40
CFR 144.28(k)
EFFECTIVE DATE
One year after the date of approval or effective
date of the UIC program for the State.
Orally within 24 hours and written five days
One year after the effective date of the UIC
program in the State (EPA administered
programs).
Quarterly
As specified by the Director
Existing wells: No later than 4 years from
approval or promulgation of UIC program.
New wells: Reasonable time before construction
is expected to begin
Pharmaceutical Manufacturing
SDWA-11
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40 CFR PART 144
REQUIREMENTS
EFFECTIVE DATE
Authorization by Permit
• All owners and operators (even those authorized by
rule, unless authorized for life of the well) are
required to submit a permit application containing
the information in 40 CFR 144.31.
Pharmaceutical Manufacturing
SDWA-12
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Resource Conservation
and Recovery Act (RCRA)
The Resource Conservation and Recovery Act (RCRA) of 1976, which amended the Solid
Waste Disposal Act of 1965, addresses hazardous (Subtitle C) and solid (Subtitle D) waste
management activities. The Hazardous and Solid Waste Amendments (HSWA) of 1984
strengthened RCRA's waste management provisions, including adding a Subtitle I which
governs Underground Storage Tanks (USTs). The goals and objectives of RCRA are to
protect human health and the environment and to conserve valuable materials and energy
resources. The applicable RCRA titles and the regulations and guidelines developed pursuant
to RCRA are illustrated in Exhibit RCRA-1 and are discussed below.
Regulations promulgated pursuant to Subtitle C of RCRA, at 40 CFR Parts 260-272, establish
a "cradle-to-grave" system that governs hazardous wastes from the point of generation to
treatment or disposal. As of 1996, 46 States are authorized to implement aspects of the
RCRA program and may include requirements more stringent than Federal regulations in
their authorized program. There are different levels of State authorization. States can be
authorized (i.e., approval to implement a State-administered program) for the base RCRA
program, or pre-HSWA RCRA requirements, for administering land disposal requirements,
and for administering the RCRA corrective action program. Non-RCRA authorized states or
territories (Alaska, Hawaii, Iowa, Puerto Rico and Wyoming) may also have state laws that
address hazardous waste management requirements.
Subtitle D of RCRA sets up a framework for regulating non-hazardous solid wastes. Impacts
from Subtitle D on a pharmaceutical facility may be direct, where the facility operates a solid
waste incinerator or manages an on-site solid waste landfill, or indirect, coming into play as a
result of a facility's use of an off-site solid waste disposal facility. Non-hazardous solid wastes
are regulated through state solid waste management programs and are specific to each state.
Typically, units such as solid waste landfills and non-hazardous waste indnerators are
regulated through state-issued
permits. Subtitle I regulates USTs
that contain petroleum and
hazardous substances. Regulations
for USTs are promulgated at 40 CFR
Part 280. Following is a summary of
RCRA regulations applicable to the
pharmaceutical manufacturing
industry.
Resource Conservation and Recovery Act Requirements
Hazardous Waste Generation RCRA-2
Hazardous Waste Transportation Regulations ... RCRA-7
Hazardous Waste Treatment, Storage, and
Disposal Regulations RCRA-7
Land Disposal Restrictions RCRA-8
Underground Storage Tank Regulations RCRA-9
RCRA Assessment Considerations RCRA-11
RCRA Regulatory Requirements RCRA-12
Pharmaceutical Manufacturing RCRA-1
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Exhibit RCRA-1. RCRA Statutes and Regulatory Requirements for
Pharmaceutical Manufacturing Facilities
Resource Conservation and Recovery Act
Subtitle C Hazardous Waste Management
Subtitle D State or Regional Solid Waste Plans
Subtitle I Regulation of Underground Storage Tanks
Subtitle C
40 CFR Part 261 Hazardous Waste
Identification
40 CFR Part 262 Hazardous Waste
Generators
40 CFR Part 263 Hazardous Waste
Transportation
40 CFR Part 264-265 Treatment,
Storage, Disposal
40 CFR Part 266 Specific Hazardous
Wastes/Specific Hazardous Waste
Management Facilities (Subpart H-
Boilers/Industrial Furnaces)
40 CFR Part 268 Land Disposal
Restrictions
40 CFR Part 270 RCRA Permit
Program
40 CFR Part 279 Used Oil
Management
Subtitle D
40 CFR Part 257 Solid
Waste Disposal Criteria
40 CFR Part 258
Municipal Waste Landfills
Subtitle I
40 CFR Part 280
Underground Storage
Tanks
Hazardous Waste Generation
Generators of hazardous waste are subject to requirements under 40 CFR Part 262. The
determination of what material is a hazardous waste is the starting point of any RCRA
compliance evaluation. Regulations for identification of hazardous wastes are detailed in 40
CFR Part 261. Under the Federal rules, to be a hazardous waste, a waste must: be a solid
waste (as defined in 40 CFR §261.2); not be excluded from regulation as a hazardous waste
under 40 CFR §261.4; and be a characteristic waste, a listed waste, a mixture of a solid waste
and a listed waste, or a mixture of a solid waste and a characteristic waste that still exhibits that
Pharmaceutical Manufacturing
RCRA-2
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characteristic. Also, a waste is hazardous if it is a mixture of soil or water and a listed waste,
or a mixture of soil or water and a characteristic waste that still exhibits that characteristic.
A solid waste, by definition, is any discarded material—solid, liquid, or containerized
gas—that is not excluded under the statute or regulations. Exclusions include hazardous
waste mixed with domestic sewage, discharged as point source discharges regulated under
the CWA and certain secondary materials that are reclaimed and reused in the original
process or processes in which they were generated.
If a waste meets the definition of solid waste, it is considered hazardous if it exhibits one or
more of four defined hazardous waste charactieristics (see Exhibit RCRA-2), or is listed as a
hazardous waste in 40 CFR Part 261 (see Exhibit RCRA-3). It is the generator's responsibility
to determine whether a waste is hazardous. This determination must be based on test results
or the generator's knowledge and familiarity with the waste. Generators may be subject to
enforcement penalties for improperly determining that a waste is not hazardous.
Exhibit RCRA-2. Characteristic Hazardous Wastes
Ignitability
Corrosivity
Reactivity
Toxicity
Flashpoint below 140°F §261.21
Liquids with a pH equal to or below 2 or equal to or above 12.5 or which corrode steel at a specified
rate §261.22
Reacts violently with water or other substances to create toxic gases §261.23
A waste that leaches specified amounts of metals, pesticides, or organic chemicals using the Toxicity
Characteristic Leaching Procedure (TCLP) §261.24
Exhibit RCRA-3. Listed Hazardous Wastes
"F" Wastes
"K" Wastes
"U" Wastes
"P" Wastes
Hazardous wastes from nonspecific sources §261.31
Hazardous wastes from specific sources §261.32
Hazardous wastes from discarded commercial chemical products, off-specification species, container
residues, and spill residues §261.34
Acutely hazardous wastes from discarded commercial chemical products, off-specification species,
container residues, and spill residues §261.33
If the waste is not found on any of these lists, it is not hazardous, although it may be listed on
a State hazardous waste list.
Secondary materials generated by the pharmaceutical industry may be classified as solid
wastes and potentially hazardous wastes where they are recycled in certain ways (e.g., used
in a manner constituting disposal, burned for energy recovery, reclaimed, or accumulated
speculatively). Such materials are considered accumulated speculatively where the material is
stored with less than 75 percent recycled within one calender year. Under 40 CFR
Pharmaceutical Manufacturing
RCRA-3
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261(c)(8), persons accumulating secondary materials prior to recycling must be able to show
1) the material is potentially recyclable; 2) they have a feasible means of recycling such
material; and 3) during the calendar year the amount of material recycled or transferred to a
different site for recycling equals at least 75 percent by weight or volume of the amount of
material accumulated at the beginning of the period. The 75 percent requirement is to be
applied to each material of the same type that is recycled in the same way. Materials
accumulating in units exempt from regulation under § 261.4(c) are not included in making the
calculation. And commercial chemical products being speculatively accumulated are not
regulated as solid wastes.
Hazardous wastes that are recycled are subject to the requirements for generators,
transporters, and storage facilities as identified in 40 CFR §261.6(b) and (c), except as
excluded in 40 CFR §261.6(a)(3). In addition, §261.6(a)(2) identifies recycled materials that
are only subject to Parts 266 (recycling regulations), 270 (permits), and 124 (NPDES
permits). This includes recyclable materials such as those that are used in a manner
constituting disposal, hazardous wastes burned for energy recovery in boilers and industrial
furnaces, and used oil burned for energy recovery. Any facility that stores recyclable materials
before they are recycled, except those materials excluded in 40 CFR §261.6(a), must comply
with applicable storage requirements of 40 CFR Parts 264 and 265.
The regulations also establish requirements for residues of hazardous waste in empty
containers. Specifically, 40 CFR §261.7 establishes that empty containers and inner liners
from an empty container are not subject to the hazardous waste regulations, provided that all
wastes have been removed using the practices commonly employed to remove materials
from that type of container, no more than one inch of residue remains in the container or
inner liner, or no more than 3 percent by weight of the total capadty (or 0.3 percent for
larger containers) remains in the container or inner liner. Containers that have held
compressed gas are considered empty when the pressure approaches atmospheric. For
acute hazardous wastes, additional measures are required.
Generators of hazardous wastes are the first link in the cradle-to-grave chain of hazardous
waste management. Under RCRA, there are three categories of hazardous waste
generators: large quantity generators (LQGs), small quantity generators (SQGs), and
conditionally exempt small quantity generators (CESQGs). The determination of a
generator's applicable categorylis summarized in Exhibit RCRA-4.
CESQGs must only comply with the Part 262 generator regulations as established at 40 CFR
§261.5. Specifically, CESQGs must identify the waste to determine if it is a hazardous waste,
accumulate less than 1,000 kilograms of hazardous waste at any time, treat or dispose of the
waste on-site, or ensure that the waste is sent to a permitted facility or a recycling facility.
The requirements CESQG are exempt from include, but are not limited to, the following:
Pharmaceutical Manufacturing RCRA-4
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> Manifest requirement
* Exception report—when generator does not receive a copy of the signed
manifest from the TSD facility
* Biennial/annual report
> Personnel training
* Contingency plan
> EPA ID number
* Storage requirements—no need to meet technical requirements under part
264 or 265 for containers or tanks.
However, many transporters will not accept wastes from a generator without an EPA ID
number or manifest.
CESQGs that exceed the 100 kilograms per month hazardous waste generation cutoff are
subject to SQG provisions. CESQGs that exceed the 1 kilogram per month of acutely
hazardous waste generation cutoff are subject to the LQG provisions. Note that some States
do not have CESQG exemptions (i.e., all generators must meet the same requirements).
All SQGs and LQGs must comply with requirements as described in 40 CFR Part 262.
Standards for generators establish responsibilities including obtaining an EPA identification
number, preparing hazardous waste manifests, ensuring proper packaging and labeling,
meeting standards for waste accumulation units, and recordkeeping and reporting
requirements. This Part also identifies requirements for generators that are importing or
exporting hazardous wastes into or out of the country.
Generators can accumulate hazardous waste for up to 90 days (180 days for SQGs) without
obtaining a storage permit provided that the facility complies with specific conditions in 40
CFR §262.34, including applicable management standards for containers, tanks, and drip
pads. Each accumulation container must include a "Hazardous Waste" label, identify the date
upon which accumulation began, and the facility must comply with 40 CFR Part 265, Subpart
C (Preparedness and Prevention). Additionally for LQGs, Subpart D (Contingency Plan and
Emergency Procedures), and with 40 CFR §265.16 (Personnel Training). SQGs have less
stringent requirements for accumulation than LQGs as identified in 40 CFR §262.34(d) and
(e).
Pharmaceutical Manufacturing RCRA-5
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Exhibit RCRA-4. Categories of Hazardous Waste Generators
KEY:
•
= 1 barrel = about 200 kilograms of hazardous
waste which is about 55 gallons
You ARE A LARGE QUANTITY GENERATOR IF ...
In one calendar month you ...
• generate 2,200 pounds or more of hazardous waste or
• generate 2,200 pounds or more of spill cleanup debris containing
hazardous waste or
• generate more than 2.2 pounds of acutely hazardous waste or
• generate more than 220 pounds of spill cleanup debris containing an
acutely hazardous waste or
At any time you ...
• accumulate more than 2.2 pounds of acutely hazardous waste on-site
You ARE A SMALL QUANTITY GENERATOR IF ...
221 Ibs.-
2,199lbs
In one calendar month you ...
• generate more than 220 pounds and less than 2,200 pounds of hazardous
waste or
^v,?, • generate more than 220 pounds and less than 2,200 pounds of spill
\ ^ cleanup debris containing hazardous waste or
v At any time you ...
• accumulate more than 2,200 pounds of acutely hazardous waste on-site
You ARE A CONDITIONALLY EXEMPT SMALL QUANTITY GENERATOR IF ...
In one calendar month you ...
• generate 2.2 pounds or less of acutely hazardous waste or
tS|" • generate 220 pounds or less of hazardous waste or
*~ l^f~~ ^ ' • generate 220 pounds or less of spill cleanup debris containing hazardous
£ s waste or
At any time you ...
• accumulate up to 2.2 pounds of hazardous waste on-site
Pharmaceutical Manufacturing
RCRA-6
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Hazardous Waste Transportation Regulations
Facilities that transport hazardous wastes off-site, where these wastes are required to be
manifested pursuant to 40 CFR Part 262, must comply with transporter requirements
established in 40 CFR Part 263. Hazardous waste transportation requirements, the middle
link in the "cradle-to-grave requirements of RCRA, require that the transporter obtain an EPA
identification number, and specify manifesting and recordkeeping requirements, including
specific conditions for shipment by rail or water. It is important to note that a transporter that
stores wastes at an off-site location for more than 10 days must comply with Parts 264, 265,
268, and 270 for storage of those wastes. Subpart C of Part 263 establishes response
requirements for discharges of hazardous wastes during transport.
Hazardous Waste Treatment, Storage, and Disposal Regulations
Any person owning or operating a fadlity that treats, stores, or disposes of hazardous waste is
considered to be an owner/operator of a treatment, storage, or disposal (TSD) fadlity and is
subject to requirements identified in 40 CFR Parts 264 and 265. Treatment, storage, and
disposal facilities (TSDFs) are the last link in the cradle-to-grave regulation of RCRA. All
TSDFs are required to obtain an operating permit and abide by TSD regulations. The TSD
regulations establish design and operating criteria as well as performance standards that
owners and operators must meet to protect human health and the environment. Because
TSDs involve many different types of units, these regulations are far more extensive than
those just described for generators and transporters.
The RCRA TSD regulations include both administrative and technical requirements. The
regulations identify administrative requirements such as the applicability of the requirements,
general fadlity standards, preparedness and prevention, contingency plans and emergency
procedures, and manifesting, reporting, and recordkeeping. Technical requirements may
address ground water monitoring, closure/post-closure, finandal requirements, and standards
related to the different types of waste management units. Specifically, the regulations identify
requirements for containers, tanks, surface impoundments, waste piles, land treatment,
landfills, indnerators, waste treatment, underground injection, and miscellaneous units. Also,
RCRA TSD regulations identify air emission requirements for process vents, equipment leaks,
and units that store hazardous wastes with high volatile organic concentrations from specific
operations related to the managing and recycling of hazardous waste.
EPA's hazardous waste permitting program is established at 40 CFR Part 270. New TSDFs
requiring a permit must submit a two part permit application. Part A is a short, standard form
that collects general information about the facility, while Part B of the application is much
more extensive and requires the facility to supply detailed and highly technical information.
This submission must be made at least 180 days prior to the date on which physical
construction is expected to start. Once issued, RCRA permits are valid for up to 10 years.
Pharmaceutical Manufacturing RCRA-7
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TSDFs fall into two categories: interim status facilities and permitted facilities. Interim status
regulations (40 CFR Part 265) apply to facilities that are operating under a Part A permit while
their Part B permit application is being reviewed. Any facility that is in existence on the
effective date of statutory or regulatory amendments under RCRA that render the facility
subject to permitting requirements qualifies for interim status, provided that the fadlity notifies
EPA of hazardous waste activity and complies with application requirements of 40 CFR
§270.10. Interim status standards must be met until a Part B permit is issued. TSDF permit
standards (40 CFR Part 264) are facility-specific performance standards and design and
operating requirements that are incorporated into a TSD permit. Permit writers use the
standard permit language established in 40 CFR Part 264 to set facility-specific conditions.
TSD permits can be extremely complex and may be several hundred pages in length. As
such, an evaluation of specific permit conditions must be made at pharmaceutical
manufacturing facilities operating under a RCRA TSD permit.
Land Disposal Restrictions
Under the Land Disposal Restriction (LDR) regulations (40 CFR Part 268), hazardous wastes
are largely prohibited from land disposal. Once prohibited, the statute provides two options:
comply with a specified treatment standard or dispose of the waste in a "no migration unit."
Land disposal includes any placement of hazardous waste into a landfill, land treatment unit,
waste pile, inject well, salt dome or salt bed formation, underground mine or cave or surface
impoundment. Restricted hazardous wastes may be land disposed only if certain treatment
standards are met or if waste extract or waste treatment residue concentrations are met, as
specified in 40 CFR §§268.41-43. Generators of wastes subject to the LDRs must provide
notification of such to the designated TSD facility to ensure proper treatment prior to
disposal. Facilities that generate less than 100 kilograms of non-acute hazardous waste or less
than one kilogram of acute hazardous waste per month are not subject to the LDRs. The
LDRs allow wastes which would otherwise be prohibited from land disposal to be treated in
surface impoundments, provided that specific conditions are met as outlined in 40 CFR
§268.4. Facilities may petition EPA for extensions to the effective date of LDRs in certain
instances as identified in 40 CFR §268.5.
The Land Disposal Restrictions also specify that for certain characteristic wastes managed in
non-Clean Water Act (CWA) wastewater treatment systems, non-CWA equivalent systems
or non-Class I injection wells, the underlying hazardous constituents reasonably expected to
be present in the waste at the point of generation should be treated as well as the hazardous
characteristic. For wastes that are characteristic for organics (i.e., D018-D043), this
requirement applies to both wastewaters and non-wastewaters. Underlying hazardous
constituents include all those constituents listed in 40 CFR 268.48 (Universal Treatment
Standards).
Pharmaceutical Manufacturing RCRA-8
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The LDRs prohibit the use of dilution as a substitute for treatment to meet the LDRs.
However, wastes that are hazardous only because they exhibit a characteristic and that are
treated in a treatment system which treats wastes and subsequently discharges these wastes
pursuant to a CWA permit are exempt from LDRs provided that the characteristic is
removed prior to management in a land based unfi. Exhibit RCRA-5 provides a decision
tree for making the determination as to whether dilution of a waste is permissible. Storage of
hazardous wastes restricted from land disposal under Part 268 Subpart C is prohibited, unless
certain conditions are met as identified in 40 CFR §268.50.
Underground Storage Tank Regulations
Underground storage tanks (USTs) containing petroleum and hazardous substances are
regulated under 40 CFR Part 280. Federal, state, and local agencies are or may be involved
in regulating USTs. The statute provides EPA with the authority to develop and enforce the
UST program, but states have discretionary authority to develop their own UST regulatory
program as long as the program is no less stringent than the Federal program. Local agendes
may also implement UST provisions through local ordinances.
An underground storage tank is one that stores "regulated substances" and that has at least 10
percent of its volume below the surface of the ground, including piping connected to the tank.
Regulated substances include hazardous substances regulated under CERCLA (above de
minimis concentrations) and any petroleum products that are liquid at standard conditions.
Regulated substances do not include hazardous wastes. As identified in 40 CFR
§280.10(b)(l), underground tanks containing hazardous waste are not subject to 40 CFR Part
280 requirements. Rather, underground tanks containing hazardous wastes are subject to
RCRA requirements, as appropriate.
Exclusions to the UST regulations include tanks such as for heating oil used primarily for space
heating on the premises where the tank is stored, flow-through process tanks, any
wastewater treatment tank system regulated under the CWA, tanks less than 110 gallons in
capadty, spill or overflow containment systems that are expeditiously emptied after use,
storm water and wastewater collection systems, and tanks situated on or above the floor of
underground areas such as basements, shafts, and tunnels.
The regulations at 40 CFR Part 280 include conditions for design, construction, operation,
installation, and notification; general operating requirements; release detection; release
response, investigation, and confirmation; release reporting and corrective action; out-of-
service UST systems and closures; and financial responsibility.
Pharmaceutical Manufacturing RCRA-9
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Exhibit RCRA-5. LDR Dilution Decision Tree
1
Dilution is
prohibited
"Toxic only includes: D001 (high
TOC NWW), D003 (cyanides and
sulfides), D004-17
Note: Dilution prohibition does not
apply to wastes with national
capacity extension or to wastes
going to no migration units
The UST program requires that by December 22, 1998, all existing USTs must add spill,
overfill, and corrosion protection, close the existing UST; or replace the existing UST with a
new UST. Spill protection is defined to include catchment basins to contain spills from
delivery hoses. Overfill protection requires either an automatic shutoff valve, overfill alarms,
or ball float valves. Corrosion protection requires that existing tanks match one of the
following tank conditions and one of the piping conditions:
Tanks
Steel tank has corrosion-resistant coating AND cathodic protection
Tank made of noncorrodible material
Steel tank clad with noncorrodible material or tank enclosed in
noncorrodible material
Uncoated steel tank has cathodic protection system
Uncoated steel tank has interior lined with noncorrodible material
Uncoated steel tank has cathodic protection AND interior lined with
noncorrodible material
Pharmaceutical Manufacturing
RCRA-10
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* Piping
Uncoated steel piping has cathodic protection
Steel piping has a corrosion-resistant coating AND cathodic protection
Piping made of (or enclosed in) noncorrodible material.
New USTs must have a suitable dielectric coating in addition to cathodic protection. Also,
new USTs must be installed in accordance with a code of practice and in accordance with the
manufacturer's instructions. Installation of new USTs must also be certified. Any facility which
brings an UST into use after May 8, 1986, must submit the Notification Form prescribed in
Appendix I of Part 280 (or a comparable state form) within 30 days of bringing the UST into
use. This form must be submitted to the state or local agency or department designated in
Appendix II of Part 280.
RCRA Compliance Assessment Considerations
The key components of a RCRA assessment are knowledge of the facility, a document
review, and an assessment plan.
A RCRA self-assessment requires familiarity with what hazardous wastes are generated at the
pharmaceutical manufacturing facility and how these wastes are managed. Pharmaceutical
manufacturing facility operations can be exceedingly complex and varied, so a knowledge of
each operation is necessary.
One source of information for determining compliance with RCRA requirements is a
document review. Useful documents to review include facility maps and blueprints; aerial
photographs; plant organization charts; piping and instrumentation diagrams (P&IDs);
operating or procedure manuals; information about emission points, waste streams, or
monitoring results; the daily operating log; company spill reports; permit applications; TRI
reports; annual/biannual operating reports; and documents prepared for environmental
activities such as siting a facility or remedial activity.
Before conducting an assessment, the assessor should draw up a Plan that traces material
flows through the plant. The Plan should indicate whether samples will be necessary to
determine if a particular waste stream is hazardous or if a release of hazardous material has
occurred. In addition, appropriate reports should be prepared as required, for example,
Quality Assurance/Quality Compliance Plans. Also, the Plan should reflect any special
considerations set forth in the facility permit or any consent decree or agency findings and
orders.
EPA has published various RCRA Inspection Checklists which are useful as guidance and as a
framework for a Plan. For example, checklists are available that list requirements from RCRA
Pharmaceutical Manufacturing RCRA-11
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regulations for generators of hazardous waste, closure and post-closure plans and
requirements, and land disposal requirements for generators.
Assessing compliance with RCRA paperwork and administrative requirements is as important
as assessing compliance with waste management requirements. Administrative and
paperwork requirements include keeping a daily log of facility operations, submitting an
annual/biannual operating report to the regulatory agency, manifest requirements, waste
analysis plans, certifications, having a contingency plan on file and procedures in place to
implement the plan, conducting an adequate training program, and implementing adequate
plant security.
During the actual assessment, the evaluation team should sit down with plant operations
personnel and discuss plant organization and site operations, identifying and verifying major
facility processes, preparedness and prevention measures, safety procedures that are
observed and that need to be observed during the visual inspection, descriptions and
locations of special equipment, and training programs.
RCRA Regulatory Requirements
The following sections provide summaries of the prindpal regulations developed pursuant to
RCRA that may apply to the pharmaceutical manufacturing industry. The section includes:
40 CFR §§261.5 and 262.34 - Generator Classifications and Requirements
• 40 CFR Part 262 - Hazardous Waste Generator Requirements
• 40 CFR Part 263 - Hazardous Waste Transporter Requirements
• 40 CFR Part 264 and 265 - Hazardous Waste Treatment Storage and Disposal
40 CFR Part 268 - Land Disposal Restrictions
40 CFR Part 280 - Underground Storage Tanks (UST)
Pharmaceutical Manufacturing RCRA-12
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40 CFR Part 261.5 and 262.34
Generator Classifications and Requirements
Conditionally Exempt Small Quantity Generators (CESQG)
REQUIREMENTS
AFFECTED FACILITY
Make hazardous waste determination under
§262.11
Waste must be managed and disposed in a
hazardous waste facility, or a landfull or
other facility approved by the State for
industrial or municipal wastes
Must comply with §261.5(g) to be excluded
from requirements under parts 262 through
266, 268, and 270.
Generate less than 100 kg/month (220
Ibs/month) of hazardous waste, or
Generate less than 1 kg/month (2.2
Ibs/month) of acute hazardous waste, or
Accumulate up to 1,000 kg (2,200 Ibs) of
hazardous waste onsite at any time
Small Quantity Generator (SQG)
REQUIREMENTS
AFFECTED FACILITY
Subject to regulation under parts 262
through 266, 268, and 270.
Special requirements under §265.201 for
accumulating hazardous waste in tanks.
May not accumulate more than 6,000 kg of
hazardous waste at any time.
May not accumulate hazardous waste onsite
for longer than 180 days (270 days if waste
must be transported over 200 miles to
hazardous waste facility), otherwise
hazardous waste storage permit required.
Generate more than 100 kg/month (220
Ibs/month) of hazardous waste and less than
1,000 kg/month (2,200 Ibs/month) of
hazardous waste, or
Accumulate more than 1,000 kg (2,200 Ibs),
but less than 6,000 kg of hazardous waste at
any time
10
Pharmaceutical Manufacturing
RCRA-13
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Large Quantity Generator (LQG)
REQUIREMENTS
AFFECTED FACILITY
Subject to regulation under parts 262
through 266, 268, and 270.
May not store hazardous waste onsite for
more than 90 days, otherwise hazardous
waste storage permit required.
Generate more than 1,000 kg/month (2,200
Ibs/month) of hazardous waste, or
Generate more than 1 kg/month (2.2
Ibs/month) of acutely hazardous waste, or
Generate more than 100 kg/month (220
Ibs/month) of spill cleanup debris containing
an acutely hazardous waste, or
Accumulate more than 1kg (2.2 Ibs) of
acutely hazardous waste at any time
Pharmaceutical Manufacturing
RCRA-14
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40 CFR Part 262
Hazardous Waste Generator Requirements
40 CFR PART 262 - HAZARDOUS WASTE GENERATOR REQUIREMENTS
REQUIREMENTS
DESCRIPTION
AFFECTED FACILITY
EPA ID Number §262.12
Subpart B - Manifest
Requirements §§262.20-
260.33
Subpart C - Pre-transport
Requirements §§262.30-
262.34
Cannot treat, store dispose of,
or transport hazardous waste
without EPA ID Number
Cannot offer hazardous
waste to transporter or to
treatment, storage, or
disposal facilities that do not
have an EPA ID Number
Must complete and sign EPA
form 8700-22 or 8700-22A
for each shipment of
hazardous waste
Must label and package
hazardous waste in
accordance with DOT
regulations (49 CFR parts
172,173, 178, 179) prior to
transport
Accumulation in units that
comply with Subpart I of 40
CFR 265 (containers), or
Subpart J of 40 CFR part 265
(tanks)
LQG or SQG that transports, or
offers for transportation,
hazardous waste for offsite
treatment, storage or disposal
SQGs allowed up to 180 (or
270) days for accumulating
hazardous waste without a
storage permit
Pharmaceutical Manufacturing
RCRA-15
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40 CFR PART 262 - HAZARDOUS WASTE GENERATOR REQUIREMENTS
REQUIREMENTS
Subpart D - Record keeping
and Reporting §§262.40-
262.44
Subpart E - Exports of
Hazardous Waste §§262.50-
262.57
Subpart F - Imports of
Hazardous Waste §262.60
DESCRIPTION
• Accumulation in units that
comply with air emission
standards identified in 40 CFR
265 Subparts AA (process
vents), BB (equipment leaks)
and CC (tanks, surface
impoundments and
containers) and with Subpart
DD (containment buildings)
• May accumulate wastes up to
90 days without storage
permit
• Must develop and maintain a
contingency plan for storing
wastes on-site
• Maintain copies of manifest
for three years
• Must prepare and submit
Biennial Report
• Must file exception report if
manifests not received by
designated facility within 35
days (LQG) or 60 days
(SQG)
• Notify EPA 60 days before
shipment
• Must confirm waste receipts
or file an exception report
• Must file a Summary Report
of Foreign Activity on March
1 of each year
• Must prepare manifest that
identifies foreign generator
and importer
AFFECTED FACILITY
SQG exempt from biennial
reporting requirements
Pharmaceutical Manufacturing
RCRA-16
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40 CFR PART 262 - HAZARDOUS WASTE GENERATOR REQUIREMENTS
REQUIREMENTS
DESCRIPTION
Must comply with all other
generator standards in 40
CFR Part 262
AFFECTED FACILITY
Pharmaceutical Manufacturing
RCRA-17
-------
Pharmaceutical Manufacturing RCRA-18
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40 CFR Part 263
Hazardous Waste Transporter Requirements
40 CFR PART 263 - HAZARDOUS WASTE TRANSPORTER REQUIREMENTS
REQUIREMENTS
DESCRIPTION
AFFECTED FACILITY
EPA ID Number §263.11
Transfer Facility Requirements
§263.12
Manifest and Record Keeping
Requirements §263.20
Hazardous Waste Discharges
§263.30
Must obtain an EPA ID
Number in order to
transport hazardous waste
May store manifested
shipments for ten days or
less, otherwise subject to
hazardous waste storage
requirements under parts
264, 265, 268, and 270
Cannot receive a waste
shipment unless
accompanied by a
hazardous waste manifest
Take appropriate action
Notify proper authorities
Persons who transport
hazardous waste within the
U.S. if manifest is required
under 40 CFR §262.
00
Pharmaceutical Manufacturing
RCRA-19
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Pharmaceutical Manufacturing RCRA-20
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40 CFR Part 264 and 265
Hazardous Waste Treatment, Storage, and
Disposal
40 CFR PART 264 - FACILITY REQUIREMENTS
(PART 265 INTERIM STATUS STANDARDS ARE SIMILAR BUT NOT IDENTICAL)
REQUIREMENTS
DESCRIPTION
AFFECTED FACILITY
General Facility Requirements
(Subpart B) Identification
Number §264.11
Required Notices §264.12
General Facility Management
Plans §§264.13-264.19
Must obtain an EPA ID Number
in order to treat, store, or dispose
of hazardous waste
Must notify Regional Administrator
of receipt of a hazardous waste
from foreign source
Must notify generator that the
facility receiving the waste has the
proper permits
General Waste Analysis §264.13
Security §264.14
General Inspection Requirements
§264.15
Personnel Training §264.16
General Requirements for I, C, R
wastes §264.17
Location Standards §264.18
Construction Quality Assurance
Program §264.19
Facilities that treat, store
or dispose of hazardous
waste
10
I
Pharmaceutical Manufacturing
RCRA-21
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40 CFR PART 264 - FACILITY REQUIREMENTS
(PART 265 INTERIM STATUS STANDARDS ARE SIMILAR BUT NOT IDENTICAL)
REQUIREMENTS
DESCRIPTION
AFFECTED FACILITY
Preparedness and Prevention
(Subpart C)
Contingency Plan and
Emergency Procedures
(Subpart D)
Manifest System, Record
keeping/Reporting (Subpart E)
Releases from Solid Waste
Management Units (Subpart F)
Must be equipped with
communications and alarm
systems, fire control equipment,
spill control equipment,
decontamination equipment,
adequate water supply and
distribution system
Must make arrangements with
local authorities for the event of
an emergency
Must develop and follow written
contingency plan to minimize
hazardous from fires, explosions
and releases
Must maintain a written operating
record
Must comply with hazardous
waste manifest requirements
Must submit a biennial report
Must submit Unmanifested Waste
Report within 15 days of receiving
hazardous waste without an
accompanying manifest
Must implement a groundwater
program capable of determining
the facility's impact on ground
water quality
Groundwater monitoring system
Develop and follow a ground-
water sampling and analysis plan
Owner/operator of a
surface impoundment,
landfull or land
treatment facility used to
manage hazardous
waste
Pharmaceutical Manufacturing
RCRA-22
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40 CFR PART 264 - FACILITY REQUIREMENTS
(PART 265 INTERIM STATUS STANDARDS ARE SIMILAR BUT NOT IDENTICAL)
REQUIREMENTS
DESCRIPTION
AFFECTED FACILITY
Closure and Post-Closure
(Subpart G)
Financial Requirements
(Subpart H)
Must develop and submit a
written closure plan as part of the
permit application under 40 CFR
Part 270
Must have detailed written
estimate of the cost of closing the
facility under the closure plan
Must establish financial assurance
by selecting appropriate options
Pharmaceutical Manufacturing
RCRA-23
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Pharmaceutical Manufacturing RCRA-24
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40 CFR Part 264 and 265
Hazardous Waste Treatment, Storage and
Disposal - Unit Specific Standards
40 CFR PART 264 AND 265 UNIT SPECIFIC STANDARDS
REQUIREMENTS
AFFECTED FACILITY
Containers (Subpart I)
Tank Systems (Subpart J)
Surface Impoundments
(Subpart K)
Waste Piles (Subpart L)
Land Treatment (Subpart M)
Landfills (Subpart N)
Incinerators (Subpart O)
Drip Pads (Subpart W)
Miscellaneous (Subpart X)
Air Emission Standards for
Process Vents (Subpart AA)
Air Emission Standards for
Equipment Leaks (Subpart BB)
Facilities that treat, store, or dispose of hazardous wastes in
containers
Facilities that treat, store or dispose of hazardous wastes in tanks
Facilities that treat, store, or dispose of hazardous wastes in
surface impoundments
Facilities that treat, store, or dispose of hazardous wastes in piles
Facilities that treat or dispose of hazardous wastes in land
treatment units
Facilities that dispose of hazardous waste in landfills
Facilities that treat or dispose of hazardous wastes in incinerators
Facilities that treat, store, or dispose of hazardous waste on drip
pads.
Facilities that treat, store or dispose of hazardous wastes in units
not identified in 40 CFR Parts 264/265
Facilities subject to RCRA permitting that have distillation,
fractionation, thin-film evaporation, solvent extraction, or
air/stream stripping operations that manage wastes with organic
concentrations of at least 10 ppmw. (See §264.1030)
Facilities with equipment, regardless of process, that manage
hazardous wastes in units which are subject to permitting under
40 CFR Part 270 and recycling units located at facilities subject to
permitting. (See §264.1050).
Units that manage less than ten percent organics by weight
require only record keeping.
*5
5
^h
Manufacturing
RCRA-25
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40 CFR PART 264 AND 265 UNIT SPECIFIC STANDARDS
REQUIREMENTS
AFFECTED FACILITY
Air Emissions Standards for
Tanks, Surface Impoundments,
and Containers (Subpart CC)
Containment Buildings
(Subpart DD)
Facilities that treat, store, or dispose of hazardous waste in tanks,
surface impoundments, or containers subject to subparts J, K, or
I, respectively.
Certain units may not be subject to subpart CC if criteria under
§§264.1080 and 264.1082 re met.
Facilities that treat or store hazardous wastes in containment
buildings are required to meet certain design and operating
standards.
Pharmaceutical Manufacturing
RCRA-26
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40 CFR Part 268
Land Disposal Restrictions - Certification and
Notification
40 CFR PART 268 - GENERATOR - CERTIFICATION AND NOTIFICATION
REQUIREMENTS
DESCRIPTION
AFFECTED FACILITY
Waste Analysis and Record
keeping for Generators
§268.7(a)
Must determine if waste is
restricted from land disposal
If waste does not meet
treatment standards in §268
Subpart D, must notify
treatment or storage facility
receiving waste
If waste meets treatment
standards §268 Subpart D,
must submit notification,
certification, and supporting
information to treatment,
storage, or disposal facility
receiving the waste
If accumulating and treating
restricted wastes onsite,
must develop waste analysis
plan and file with
Administrator or authorized
State
Maintain copies of records,
certifications, and notices for
five years
LQGs and SQGs
00
CO
Pharmaceutical Manufacturing
RCRA-27
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40 CFR 268 - TREATMENT AND DISPOSAL - CERTIFICATION AND NOTIFICATION
REQUIREMENTS
DESCRIPTION
AFFECTED FACILITY
Waste Analysis and Record
Keeping for Treatment
Facilities §268.7(b)
Waste Analysis and Record
Keeping for Disposal Facilities
§268.7(c)
Must test waste in
accordance with waste
analysis plan
Must submit notification and
certification to land disposal
facility receiving the waste
Must maintain copies of all
notices and certifications
specified in §268.7(a) and
(b)
Must test waste in
accordance with waste
analysis plan to determine if
the treatment standards
have been met
Facilities that treat hazardous
wastes subject to LDRs
Disposal Facilities
Pharmaceutical Manufacturing
RCRA-28
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40 CFR Part 280
Underground Storage Tanks (UST)
40 CFR PART 280 - UNDERGROUND STORAGE TANK REQUIREMENTS
REQUIREMENTS
DESCRIPTION
AFFECTED
FACILITY
Design,
Construction,
Installation, and
Notification (Subpart
B)
General Operating
Requirements
(Subpart C)
Release Detection
(Subpart D)
New USTs (installed after December 1988)
must meet performance standards detailed in
40 CFR §280.20
All existing UST systems (installed before
December 1988) must be upgraded to meet
standards detailed in 40 CFR §280.21 by
December 1998
Notify State and/or local agencies upon the
Installation and use of new UST systems (40
CFR §280.22)
Must ensure the prevention of releases through
spill and overfill control, proper corrosion
protection, use of compatible materials, and
proper and appropriate repairs to the UST
system
Reporting requirements include notification,
reports of all releases (suspected and
confirmed), corrective action, and permanent
change ins service or closure.
Record keeping requirements include
documentation of corrosion controls, UST
system repairs, release detection compliance
Must provide a method or combination of
methods to detect leaks and releases from the
UST system
Must comply with release detection
requirements according to the schedule set
forth in 40 CFR §280.40(c)
All owners and
operators of
underground storage
tank systems as
defined in 40 CFR
§280.12 (See
§280.10 (b-d) for
exceptions)
00
c\a
^h
Pharmaceutical Manufacturing
RCRA-29
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40 CFR PART 280 - UNDERGROUND STORAGE TANK REQUIREMENTS
REQUIREMENTS
DESCRIPTION
AFFECTED
FACILITY
Release Reporting,
Investigation, and
Confirmation
(Subpart E)
Release Response
and Corrective
Action for UST
Systems Containing
Petroleum or
Hazardous
Substances (Subpart
F)
Out-of-Service UST
Systems and
Closure (Subpart G)
• Petroleum USTs must comply with release
detection requirements under 40 CFR §280.41
• Hazardous substance USTs must comply with
release detection requirements under 40 CFR
§280.42
• Must maintain records demonstrating
compliance with release detection requirements
• Must report any suspected releases within 24
hours or another reasonable time period
specified by implementing agency
• Must investigate and confirm any suspected
releases
• Must contain and cleanup any release, and
report to implementing agency
In the event of a release
• Must notify implementing agency upon
confirmation of a release and take action to
prevent additional release
• Must submit report to implementing agency that
summarizes initial abatement activities within 20
days
• Must submit site characterization report
• Must develop and implement a corrective
action plan as directed by implementing agency
• For temporary closure, must maintain operating
practices to ensure prevention of releases
• Must notify within 30 days of permanent closure
• Must maintain records to demonstrate
compliance with closure requirements in
accordance with §280.34
UST systems that
manage petroleum
or hazardous
substances.
Pharmaceutical Manufacturing
RCRA-30
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40 CFR PART 280 - UNDERGROUND STORAGE TANK REQUIREMENTS
REQUIREMENTS
Financial
Responsibility
(Subpart H)
DESCRIPTION
• Must demonstrate financial responsibility for
taking corrective action and for compensating
third parties for bodily injury and property
damage caused by accidental releases
AFFECTED
FACILITY
Pharmaceutical Manufacturing
RCRA-31
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Pharmaceutical Manufacturing RCRA-32
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Emergency Planning and Community
Right-to-Know Act (EPCRA)
The Emergency Planning and Community Right-To-Know Act (EPCRA), also known as
Superfund Amendments Reauthorization Act (SARA) Title III, is designed to provide the
general public and emergency planning and response personnel with information regarding
the potential hazards in their community. EPCRA regulations identify emergency planning and
notification procedures for hazardous chemicals in the community. Pursuant to EPCRA, EPA
implements and enforces four regulatory programs applicable to pharmaceutical facilities.
These programs are described below. The detailed requirements included in the applicable
regulations are presented later in this section.
Hazardous Substance Notification
Pursuant to 40 CFR §302.6, facilities that release a hazardous substance in a quantity equal to
or exceeding the reportable quantity (RQ) established in 40 CFR §302.4 must immediately
notify the National Response Center at (800) 424-8802 and in the Washington, B.C. area at
(202) 426-2675. Depending on the hazardous substance, the RQ ranges from 1 to 5,000
pounds. For this regulation, "release" means any spilling, leaking, pumping, emitting,
emptying, discharging, injecting, escaping, leaching, dumping, or disposing into the
environment, but excludes any release that results in exposure to persons solely within a
workplace. Reporting procedures are similar to those required under 40 CFR Part 117
(CWA), but specify a different list of hazardous substances.
Emergency Planning and Notification
Pursuant to 40 CFR Part 355, any facility at which there is present an amount of any
extremely hazardous substance, as defined in 40 CFR Part 355, equal to or in excess of its
threshold planning quantity, shall notify the Commission (i.e., the State emergency response
commission (SERC) or the
Governor if there is no
commission) and the local
emergency planning
committee (LEPC) identified in
40 CFR §355.30. Any facility
producing, using, or storing a
hazardous chemical, as
defined in 40 CFR §355.20,
Emergency Planning and Community Right-to-Know Act
Hazardous Substance Notification EPCRA-1
Emergency Planning and Notification EPCRA-1
Hazardous Chemical Reporting: Community Right-to-Know EPCRA-2
Toxic Chemical Release Inventory EPCRA-2
EPCRA Assessment Considerations EPCRA-3
EPCRA Regulatory Requirements EPCRA-4
Pharmaceutical Manufacturing EPCRA-1
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that releases an RQ of an extremely hazardous substance or a CERCLA hazardous substance
must immediately notify the local emergency planning committee and the State emergency
planning commission as specified in 40 CFR §355.40.
Hazardous Chemical Reporting: Community Right-To-Know
As required in 40 CFR Part 370, pharmaceutical facilities are required to submit a Material
Safety Data Sheet (MSDS), as required in 29 CFR §1910.1200(c), or a list of hazardous
chemicals for which MSDSs are required (i.e., a minimum threshold of zero pounds), for
each hazardous chemical used as defined in 40 CFR §370.2 to the SERC, LEPC, and the fire
department.
All pharmaceutical facilities must also submit a Tier I or Tier II Form, as identified in 40 CFR
§§370.40 and 41, for all hazardous chemicals (above a threshold of 500 pounds) and all
extremely hazardous chemicals (above a threshold of zero pounds) indicating the aggregate
amount of these chemicals at their facilities classified by hazard category. All facilities must
submit a Tier I form (Aggregate Information by Hazard Type). If any agency requests a Tier II
report (Specific Information by Chemical), the pharmaceutical facility is required to submit this
information within 30 days of the request. Any facility may submit a Tier II form in lieu of a
Tier I form.
Information required in 40 CFR Part 370 must be submitted to the SERC, LEPC, and the fire
department.
Toxic Chemical Release Inventory
Section 313 of EPCRA requires submission of the Toxic Chemical Release Inventory (TRI)
Reporting Form (the Form R) as required in 40 CFR Part 372. Form R provides EPA with a
compilation of release information that supports future regulations and also provides the
public with information on releases of toxic chemicals in the community. Facilities subject to
the requirement must report the quantities of both routine and accidental releases of listed
toxic chemicals (40 CFR §372.65), the maximum amount of the listed toxic chemicals onsite
during the calendar year, and the amount contained in wastes transferred offsite.
A complete Form R is required annually for each toxic chemical manufactured, processed, or
otherwise used at each covered facility as described in 40 CFR Part 372. The form must be
filed on or before July 1 of the following year and submitted both to EPA and the State.
Included in the Form R reporting requirements are air releases that are not released through
any point source (stocks, vents, ducts, pipes, or any other combined air stream). These
releases include (1) fugitive equipment leaks from valves, pump seals, flanges, compressors,
sampling connections, etc.; (2) evaporative losses from surface impoundments and spills; (3)
Pharmaceutical Manufacturing EPCRA-2
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releases from building ventilation systems; and (4) any other fugitive or non-point air
emissions. Engineering estimates and mass balance equations may be useful in estimating
these fugitive emissions.
Pharmaceutical manufacturing facilities that have 10 or more employees are required to
submit a form for any Section 313 listed toxic chemical that is manufactured or processed at
the fadlity in excess of a 25,000 pound threshold during the course of a calendar year or is a
listed toxic chemical that is otherwise used at the facility in excess of a 10,000 pound
threshold during the course of the year. (Toxic chemicals contained in mixtures and trade
name products must also be accounted for when making threshold and release
determinations.) The facility should use the best information available to determine chemical
quantities. Section 313 listed toxic chemicals do not have to be considered if they are
present in a mixture at less than a de minimis total of 1.0 percent, or 0.1 percent combined
for toxic chemicals meeting the OSHA carcinogen standard. Uses that are exempt from
reporting requirements include, among others, use of toxic chemicals contained in intake
water (used for processing or non-contact cooling) or in intake air (used either as compressed
air or for combustion).
A supplier notification requirement exists at 40 CFR Part 372, Subpart C for facilities that
manufacture, import, or process a listed toxic chemical, and then sell or otherwise distribute a
mixture or trade name product containing the toxic chemical above de minimis levels to
either another manufacturing fadlity or another fadlity that then sells the same mixture or
trade name product to another manufacturing fadlity. Supplier notification is also required if a
waste mixture containing a toxic chemical is sold to a recycling or recovery facility. This
notification must be made to each customer with the first shipment of each calendar year.
Records of notifications must be kept for at least 3 years.
An alternative threshold of one million pounds per year applies to fadlities that calculate the
annual reportable amount of a toxic chemical to be less than 500 pounds for the combined
total of quantities released, disposed, treated, recovered, combusted, and transferred.
Facilities meeting these alternative reporting thresholds are not required to submit Form R for
these chemicals. Rather, the regulations at 40 CFR §372.95 identify certification procedures
that are to be followed.
EPCRA Assessment Considerations
When attempting to determine compliance with EPCRA at a pharmaceutical fadlity, activities
will focus primarily on reporting and recordkeeping. The Form R is the highest profile
reporting requirement under EPCRA. If the pharmaceutical fadlity meets the requirements
set out above for reporting, it must submit a Form R annually for every chemical it has on site
in excess of the threshold amounts. The Form R does not require specific studies or
analyses, the information submitted may be based on existing information and on estimates.
Pharmaceutical Manufacturing EPCRA-3
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However, EPA does consider data quality when reviewing the Form R and will question
numbers and data that do not appear to be reasonable.
The facility should pay particular attention to intermediate products it manufactures and then
uses in different products; it should also identify any chemicals it uses in waste treatment. The
facility is required to submit a Form R both for intermediates and treatment chemicals. A
facility should also be mindful of areas that are likely to have unreported spills, such as raw
materials handling areas, pumps, and pipe fittings and connections. In addition, a facility
should identify if (and where) volatile organic chemicals are used. VOC emissions in an open
area to the atmosphere do constitute a regulated release under EPCRA. These emissions
must be reported on the Form R.
EPCRA Regulatory Requirements
The following sections provide a summary of the principal regulations developed pursuant to
EPCRA that may apply to the pharmaceutical industry. The regulations included are:
* 40 CFR Part 302 - Designation, Reportable Quantities and Notification
* 40 CFR Part 355 - Emergency Planning and Notification
* 40 CFR Part 370 - Hazardous Chemical Reporting: Community Right-to-
Know
> 40 CFR Part 372 - Toxic Chemical Release Reporting, Community Right-to-
Know
Pharmaceutical Manufacturing EPCRA-4
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40 CFR Part 302
Designation, Reportable Quantities, and
Notification
Designation of Hazardous Substances, §302.4
REQUIREMENTS
REGULATORY THRESHOLD
Under Section 102(a) of CERCLA, these
regulations identify reportable quantities of
hazardous substances and set forth reporting
requirements of releases.
Listed hazardous substances are in Table
§302.4 and are designated as "hazardous under
Section 102 (a) of CERCLA." Also included are
"unlisted" hazardous substances which are
defined in 40 CFR 302.4(b) as characteristics of
hazardous waste.
The Table includes the reportable quantities of
these substances. Unlisted hazardous
substances have reportable quantity limit of 100
pounds (§302.5), except for unlisted hazardous
wastes that exhibit extraction procedure (EP)
toxicity as identified in Part 261 which vary
based on the reportable quantity of the
pollutant of concern and its lowest value in
Table §302.4. Appendix A of §302.4 contains a
sequential CAS number listing of chemicals and
Appendix B contains a listing of regulated
radionuclides.
Notification Requirements, §302.6
REQUIREMENTS
REGULATORY THRESHOLD
Facilities which release reportable quantities
established in Table §302.4 must immediately
notify the National Response Center at (800)
424-8802 or in the Washington D.C. area at
(202) 426-2675.
Table §302.4 is used to determine whether the
regulations apply to a specific facility based on
chemicals that are released.
Exposure to persons within a workplace is
excluded. Reportable quantities range from 1
to 5,000 pounds. Release means any spill, leak,
pumping, emitting, emptying, discharging,
injecting, escaping, leaching, dumping, or
disposing into the environment. Specific
requirements for various types of radionuclides,
including those which are exempt from
reporting to the National Response Center are
given in §302.6.
00
Pharmaceutical Manufacturing
EPCRA-5
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Pharmaceutical Manufacturing EPCRA-6
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40 CFR Part 355
Emergency Planning and Notification
Emergency Planning, §355.30
REQUIREMENTS
REGULATORY THRESHOLD
Facilities subject to emergency planning
requirements must notify the local and State
emergency planning commissions. They must
designate an emergency planning coordinator,
provide information to the local planning
committee, and calculate Threshold Planning
Quantities [§355.30(e)] for substances listed in
Appendices A and B of §355.
• §355.30(b) notification of planning
commission due May 17,1987, or within 60
days of becoming subject to the planning
requirements;
• §355.30(c) facility emergency coordinator
designated due September 17,1987, or 30
days after establishing a local emergency
planning committee;
• §355.30(d) information for planning must be
provided "promptly" upon request.
The facility has onsite an extremely hazardous
substance equal to or greater than its threshold
planning quantity.
10
10
00
Pharmaceutical Manufacturing
EPCRA-7
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Emergency Release Notification, §355.40
REQUIREMENTS
REGULATORY THRESHOLD
A facility must immediately notify the local
community emergency coordinator (or
emergency response personnel) and State
coordinator of reportable releases that will likely
affect the local area or state. Notice must
include chemical name or identity of any
substance released, indication of whether it is an
extremely hazardous substance, estimate of
quantity released, estimate of time and duration
of release, media into which release occurred,
known or expected acute or chronic health
risks including medical advice for exposed
individuals, precautions to be taken,
contact/phone numbers for further information.
A written follow up emergency notice must be
provided to update the information about the
release, and actions taken. For transportation-
related releases, this information can be
provided to the 911 operator.
The facility produces, uses, or stores a
hazardous chemical and there is a release of a
reportable quantity of any extremely hazardous
substance or CERCLA hazardous substance.
Pharmaceutical Manufacturing
EPCRA-8
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40 CFR Part 370
Hazardous Chemical Reporting: Community
Right-to-Know (EPCRA)
General Applicability:
Any facility that is required to
prepare or have available an
MSDS for a hazardous chemical
under OSHA (1970).
Reporting Requirements, §370.20
This part applies to any amount of onsite hazardous chemicals greater than or equal to
10,000 Ib and for all extremely hazardous substances present in an amount greater than or
equal to 500 pounds, or the Threshold Planning Quantity (TPQ), whichever is less.
Applicable facilities must submit Tier I forms by March 1, 1991, and annually thereafter. If
requested, they must also submit Tier II forms.
MSDS Reporting. §370.21
Applicable facilities must submit to the local emergency planning committee, state emergency
response commission and the local fire department (1) MSDSs for the facility for hazardous
chemicals as required in §370.20; or (2) similar information including a list of hazardous
chemicals by hazard category, the chemical or common name and components.
Reporting Upon Request. §370.21(d)
An MSDS must be provided for any changed chemicals within 3 months of the change.
Inventory Reporting, §370.25
The owner or operator must provide an inventory form to the emergency planning
commission, the committee and the fire department with jurisdiction over the facility. It
should contain Tier I information on hazardous chemicals present at the facility during the
preceding calendar year above the threshold levels in §370.20(b). It must be submitted
before March 1 each year. Tier II information may be submitted as an alternative per
§370.25(b).
Submission of Tier II Information, §370.25(c)
Upon request by the SERC, LEPC, or local fire department, the facility must submit Tier II
information.
Pharmaceutical Manufacturing EPCRA-9
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Fire Department Inspection, §370.25(d)
The facility must allow the fire department to conduct inspections and must provide specific
information on locations of hazardous chemicals upon request.
Mixtures. §370.28
Special reporting requirements apply for mixtures, including quantifying mixtures using
procedures in §370.28.
Public Access and Availability of Information (Subpart C), §370.30
The committee must provide any person with MSDS or Tier II information for a specific
facility, except upon request by the facility owner or operator, the commission or committee
can withhold information on the locations of chemicals identified on Tier II forms.
Inventory Forms, Tier I and Tier II (Subpart D), §370.40
The forms contain information on hazardous and extremely hazardous chemicals onsite at the
facility.
Pharmaceutical Manufacturing EPCRA-10
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40 CFR Part 372
Toxic Chemical Release Reporting,
Community Right-to-Know
Reporting Requirements, Subpart B
REQUIREMENTS
AFFECTED FACILITY
This section of the regulations sets forth
requirements for the submission of information
relating to the release of toxic chemicals under
§313 of EPCRA yearly on July 1. Date of
applicability: February 16, 1988.
Section §372.22 specifies the types of facilities
that are subject to the Form R reporting
requirements:
a) facilities with 10 or more full time employees;
b) facilities in SIC codes 20-39 (as of January 1,
1987). Criteria for the determination of SIC are
further explained in Section §372.22(b); and
(c) facilities which process, manufacture, or use
a toxic chemical in excess of the threshold
quantity set forth for the chemical in §§372.25
or 372.27.
Exemptions to the reporting of releases of toxic
chemicals are detailed in §372.38 (e.g., de
minimis concentrations, toxic chemicals
contained in articles, structural components,
routine janitorial uses, personal use by
employees, maintaining motor vehicles,
chemicals in process water or noncontact
cooling water, and laboratory activities).
Owners of industrial parks or similar real estate
owners are also exempt since the operators of
the facilities would hold this responsibility.
00
Pharmaceutical Manufacturing
EPCRA-11
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Record Keeping, §372.10
REQUIREMENTS
REGULATORY THRESHOLD
Facilities must retain copies of reports, supporting
documentation, including such items as data to show
how reportable quantities were determined, data to
calculate the quantity of a release, documentation of
offsite transfer or release of toxic chemicals, and
manifests or records for offsite transfer for a period of 3
years after each report is made. The reports must be
available for inspection by EPA.
All facilities subject to any reporting
requirements in Part 372.
Threshold in §372.25(a) applies to
chemicals manufactured, imported or
processed at a facility. The threshold is
25,000 Ib/yr for chemicals
manufactured or processed and 10,000
Ib/yr for chemicals used.
Reporting Requirements and Schedule for Reporting, §372.30
REQUIREMENTS
REGULATORY THRESHOLD
EPA Form 9350-1 (i.e. EPA Form R) is to be used to
report chemicals above thresholds for manufactured,
imported, processed, used or combined into a mixture
or trade name product. Details on characterizing
mixtures and trade name products are given in
§372.30(b). Reports are due annually on July 1.
A regulated facility may consist of more
than one establishment (defined as
economic unit) and separate forms may
be used for each establishment as long
as reporting is accomplished for the
entire facility.
Pharmaceutical Manufacturing
EPCRA-12
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Supplier Notification Requirement - Subpart C
REQUIREMENTS
REGULATORY THRESHOLD
Facilities must notify the person to whom toxic
chemicals, mixtures or trade name products containing
toxic chemicals, are sold. The notification must be in
writing and include specific information per §372.45(b):
product trade name, a statement that the product
contains a SARA Title III, Section 313 chemical and the
chemical name, the CAS number of the chemical, and
the percent by weight of each toxic chemical in the
mixture or product.
Notification must be with the first shipment of the
product in each calendar year. If the product is
renamed or changed, the notification must be initiated
over again.
Owners and operators of facilities
classified as SIC code 20-39 who
manufacture, import or process toxic
chemicals, and who sell or otherwise
distribute a mixture or trade name
product containing a toxic chemical to a
facility who uses or sells the product or
mixture. If an MSDS is required in
accordance with 29 CFR 1910.1200,
the notification must be attached or
incorporated into the MSDS.
Exceptions include mixtures or trade
name chemicals with de minimis
amounts (see §372.45(d) for others).
However, if the chemical is considered
proprietary (trade secret) under 29 CFR
1910.1200, the notification can be
written with generic language.
Specific Toxic Chemical Listings - Subpart D
Tables, with alphabetical and CAS number listings of chemicals and chemical categories, along
with the effective date of the regulation for each of the chemicals are provided in §372.65.
Forms and Instruction - Subpart E
Toxic Chemical Release Reporting Form and Instruction - §372.85
REQUIREMENTS
EPA Form R must be used and is available by writing to
the Section 313 Document Distribution Center, PO
Box 12505, Cincinnati, OH 45212.
REGULATORY THRESHOLD
Toxic chemicals, manufactured,
processed, or otherwise used in excess
of an applicable threshold in §372.25.
Pharmaceutical Manufacturing
EPCRA-13
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Pharmaceutical Manufacturing EPCRA-14
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Clean Water Act (CWA)
Regulatory Requirements
The primary objective of the Clean Water Act (CWA) is to restore and maintain the chemical,
physical, and biological integrity of the nation's waters. The CWA regulates both "direct"
discharges to waters of the United States and "indirect" discharges to publicly owned
treatment works (POTWs). Under the authority of the CWA, several types of regulations
have been developed to control discharges to the Nation's waters. Exhibit CWA-1 illustrates
how the following regulations and permits work to limit the wastewater discharged:
> Eiuent Limitation Guidelines and Categorical Pretreatment Standards
establishes limitations for direct and indirect discharges (40 CFR Part 405-471)
*• National Pollutant Discharge Elimination System (NPDES) Program controls
direct discharges (40 CFR Parts 122-125, 501, 503)
> National Pretreatment Program controls indirect discharges (40 CFR Parts 403)
> Spills of Oil and Hazardous Substances [CWA §311(b)(3)] prohibits oil
discharges (40 CFR Part 110)
* Oil Pollution Prevention establishes procedures to prevent discharge of oil (40
CFR Part 112)
> Reportable Quantities for Hazardous Substances designates hazardous
substances and the reportable volumes for each (40 CFR Parts 116 and 117).
The following sections address
each regulation individually and
identify the inspection
considerations for programs
implemented under the CWA.
The following sections emphasize
how the program is implemented
with the specific requirements and
compliance dates.
Clean Water Act
Effluents Limitations Guidelines and Categorical
Pretreatment Standards CWA-2
NPDES Program CWA-4
Pretreatment Program CWA-8
Policy on Effluent Trading in Watersheds CWA-9
Spills of Oil and Hazardous Substances CWA-10
Oil Pollution Prevention CWA-10
Reportable Quantities for Hazardous Substances ... CWA-11
CWA Assessment Considerations CWA-11
CWA Regulatory Requirements CWA-12
Pharmaceutical Manufacturing
CWA-1
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Exhibit CWA-1. CWA and Regulatory Requirements for Pharmaceutical Facilities
Clean Water Act
(Federal Water Pollution Control Act of 1972, as amended)
NPDES Program
40 CFR Part 122
Regulatory requirements to issue permits
controlling the discharge of pollutants to the
nation's waters
Regulates all industrial direct (point source)
discharges (e.g., process wastewater, cooling
water) discharged to the nation's waters.
> Storm water requirements
> Effluent Guidelines for Process Wastewater
Discharges
» Cooling water discharges
Oil and Hazardous Substances
40 CFR Part 110
40 CFR Part 112
40 CFR Part 116 and 117
Regulatory requirements that regulate the
discharges of oil into waters of the United States
and the designation of and reportable quantities of
hazardous substances
Regulates municipal wastewater treatment plant
discharges
*• Requires implementation of municipal
pretreatment programs
> Individual control mechanism (i.e., permit)
issued by municipality to all facilities regulated by
categorical pretreatment standards
Effluent Limitations Guidelines and Categorical Pretreatment Standards
For the CWA, industrial wastewater is regulated either by effluent limitations guidelines (direct
dischargers) or categorical pretreatment standards (indirect dischargers). Effluent guidelines
and categorical pretreatment standards apply only to industrial users with specific industrial
processes. Categorical pretreatment standards are technology-based limitations, requiring
compliance at the end-of-process. EPA has promulgated effluent guidelines (for direct
discharges) and existing source and new source pretreatment standards (for indirect
dischargers) for over 30 industrial categories, including Pharmaceutical Manufacturing (Part
439).
In most cases, the pharmaceutical fadlity will have a wastewater discharge permit issued
either by an EPA Regional office, the State, or the local sewer authority that incorporates
applicable guidelines and standards. Where a facility discharges to a POTW that is not
authorized to implement and enforce the pretreatment program, the fadlity will generally not
Pharmaceutical Manufacturing
CWA-2
-------
have a wastewater discharge permit unless it has been issued by the State. In these instances,
it is the facility's responsibility to comply with the applicable categorical pretreatment standards
and requirements. Specific applicability determinations are described in the appropriate
regulation and are summarized below.
Process wastewater flows are defined in the regulations (40 CFR §401.11) to include waste
waters resulting from manufacture of pharmaceutical products that come in direct contact
with raw materials, intermediate products, or final products, and surface runoff from the
immediate process area that has the potential to become contaminated. Non-contact cooling
waters, utility waste waters, general site runoff, ground waters, and other nonprocess waste
waters generated onsite are specifically excluded from the definition of process wastewater
discharges. As such, the composition of each waste stream that is being generated is not as
crucial as the amount of process and non-process wastewater, respectively.
Pharmaceutical Manufacturing
The existing Pharmaceutical Manufacturing regulations at 40 CFR Part 439 set effluent
limitation guidelines (for direct dischargers) based on required removal efficiencies for BOD,
COD, and TSS. In addition, the regulations specify cyanide limits according to the applicable
Subpart (except Subpart E - Research for which categorical pretreatment standards are not
specified) and set allowable pH ranges. Cyanide effluent limitation guidelines are not specified
for discharges from bench-scale pharmaceutical research operations and product
development activities under Subpart E. The existing regulations specify categorical
pretreatment standards (for indirect dischargers) for cyanide only.
On May 2, 1995, EPA proposed revisions to the Pharmaceutical Manufacturing regulations.
The proposed regulations set end-of-pipe effluent limitation guidelines (for direct dischargers)
for BOD, COD, TSS, pH, and the priority and nonconventional pollutants contained in the
applicable Subpart. EPA anticipates the rule to be finalized in early 1998. EPA may regulate
Air Pollutants (NESHAPs) for the pharmaceutical industry.
Centralized Waste Treatment
On April 27, 1995, EPA proposed 40 CFR Part 437, Effluent Limitations Guidelines,
Pretreatment Standards, and New Source Performance Standards: Centralized Waste
Treatment Category (60 FR 5463). This proposed regulation would establish technology-
based limits and standards for discharges by existing and new "centralized waste treatment
facilities." The facilities covered by the guideline include stand-alone waste treatment and
recovery facilities which treat waste received from offsite and also include treatment systems
which treat onsite generated process wastewater with wastes received from offsite.
Specifically, centralized waste treatment facilities include the following: (1) commercial
facilities that accept waste from offsite for treatment from facilities not under the same
ownership; (2) non-commercial facilities that accept waste from offsite for treatment only
from facilities under the same ownership (i.e., intra-company transfer); or (3) mixed
commercial/non-commercial facilities that accept some waste from offsite for treatment from
Pharmaceutical Manufacturing CWA-3
-------
facilities not under the same ownership and some waste from facilities under the same
ownership.
Pharmaceutical manufacturing facilities that might be covered by this rule should review the
proposed regulation and note any future rulemaking activities for 40 CFR Part 437.
NPDES Program
NPDES permits, issued by either EPA or an
authorized State (EPA has authorized 41
States and territories, as identified in Exhibit
CWA-2, to issue permits), contain industry-
specific technology-based (i.e., effluent
guidelines as discussed in the previous
section) and water quality-based effluent
discharge limitations, as well as monitoring,
record keeping, reporting, and other
requirements. All facilities discharging to
the Nation's waters must receive an
NPDES permit prior to initiating their
discharges. This covers both process and non-process (e.g., non-contact cooling) waste
waters, and storm water discharges associated with industrial activity that discharge either to a
municipal separate storm sewer or directly to waters of the United States. To regulate such
dischargers, EPA/States may issue NPDES permits to pharmaceutical facilities that include
process, non-process, and storm water conditions or these may be in separate permits.
The NPDES permit program is
implemented according to 40 CFR Part
122: EPA Administered Permit
Programs: The National Pollutant Dis-
charge Elimination System. These
regulations establish the general
program requirements, permit
application requirements, permit
conditions, and procedures for transfer,
modification, revocation, reissuance, and
termination of permits.
EPA issues two types of NPDES permits,
individual and general. An individual permit
is a permit tailored for a specific facility. A
general permit regulates a category of
similar dischargers within a geographical
area or within a State. There are few
exemptions to the requirement to obtain an
NPDES permit, as specified in 40 CFR §122.3.
instances where this exemption may apply:
The terms process, non-contact cooling
water, and industrial activity (as it applies
to the storm water regulations) are
defined in 40 CFR 40l.ll(q),
401.11(n), and 122.44(b) respectively.
For pharmaceutical facilities, there are four
Discharges to POTWs (these discharges will be regulated by a permit issued by
the POTW if the municipality has an approved pretreatment program and are
regulated by the National Pretreatment Program)
Discharges into privately owned treatment works, except as otherwise
required by EPA
Discharges of dredged or fill material (regulated by CWA §404)
Pharmaceutical Manufacturing
CWA-4
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Exhibit CWA-2. State NPDES Program Approval Status
State
Alabama
Arkansas
California
Colorado
Connecticut
Delaware
Florida
Georgia
Hawaii
Illinois
Indiana
Iowa
Kansas
Kentucky
Maryland
Michigan
Minnesota
Mississippi
Missouri
Montana
Nebraska
Nevada
New Jersey
New York
North Carolina
North Dakota
Ohio
Oregon
Pennsylvania
Rhode Island
South Carolina
South Dakota
Tennessee
Utah
Vermont
Virgin Islands
Virginia
Washington
West Virginia
Wisconsin
Wyoming
TOTALS
Approved State NPDES
Permit Program
10/19/79
11/01/86
05/14/73
03/27/75
09/26/73
04/01/74
05/01/95
06/28/74
11/28/74
10/23/77
01/01/75
08/10/78
06/28/74
09/30/83
09/05/74
10/17/73
06/30/74
05/01/74
10/30/74
06/10/74
06/12/74
09/19/75
04/13/82
10/28/75
10/19/75
06/13/75
03/11/74
09/26/73
06/30/78
09/17/84
06/10/75
12/30/93
12/28/77
07/07/87
03/11/74
06/30/76
03/30/75
11/14/73
05/10/82
02/04/74
01/30/75
41
Approved to Regulate
Federal Facilities
10/19/79
11/01/86
05/05/78
-
01/09/89
-
--
12/08/80
06/01/79
09/20/79
12/09/78
08/10/78
08/28/85
09/30/83
11/10/87
12/09/78
12/09/78
01/28/83
06/26/79
06/23/81
11/02/79
08/31/78
04/13/82
06/13/80
09/28/84
01/22/90
01/28/83
03/02/79
06/30/78
09/17/84
09/26/80
12/30/93
09/30/86
07/07/87
--
--
02/09/82
--
05/10/82
11/26/79
05/18/81
35
Approved State
Pretreatment Program
10/19/79
11/01/86
09/22/89
-
06/03/81
-
05/01/95
03/12/81
08/12/83
-
--
06/03/81
--
09/30/83
09/30/85
04/16/85
07/16/79
05/13/82
06/03/81
-
09/07/84
-
04/13/82
--
06/14/82
-
07/27/83
03/12/81
--
09/17/84
04/09/82
12/30/93
08/10/83
07/07/87
03/16/82
--
04/14/89
09/30/86
05/10/82
12/24/80
—
29
06/26/91
11/01/86
09/22/89
03/04/83
03/10/92
10/23/92
05/01/95*
01/28/91
09/30/91
01/04/84
04/02/91
08/12/92
11/24/93
09/30/83
09/30/91
11/29/93
12/15/87
09/27/91
12/12/85
04/29/83
07/20/89
07/27/92
04/13/82
10/15/92
09/06/91
01/22/90
08/17/92
02/23/82
08/02/91
09/17/84
09/03/92
12/30/93
04/18/91
07/07/87
08/26/93
--
05/20/91
09/26/89
05/10/82
12/19/86
09/24/91
40
Number of Fully Authorized Programs (Federal Facilities, Pretreatment, General Permits)
* New with phased Federal facilities & storm water programs by 2000.
= 26
Pharmaceutical Manufacturing
CWA-5
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> Any discharge in compliance with instructions from an on-scene coordinator
pursuant to 40 CFR Part 300 (i.e., The National Oil and Hazardous Substances
Pollution Contingency Plan) or 33 CFR §153.10(e) (i.e., Pollution by Oil and
Hazardous Substances).
[Note: Pollution by Oil and Hazardous Substances is enforced by the Coast
Guard and is not discussed herein.]
EPA or the State may terminate or modify a permit where it is determined that a permitted
activity endangers human health or the environment and can only be regulated to acceptable
levels by a permit modification or termination of the permit. Likewise, the permit may be
terminated or an application denied if the permittee fails to fully disclose all relevant facts or
misrepresents relevant facts at any time. EPA or the State may modify a permit as a minor
modification allowing for a change in
ownership or operational control of a facility
where the Director determines that no
other change in the permit is necessary,
provided that a written agreement
containing a specific date for transfer of
permit responsibility, coverage, and liability
between the current and new permittee has
been submitted to the Director as specified
in 40 CFR §122.61.
Specific permit applicability requirements
for storm water discharges are identified
in 40 CFR §122.26(a). Facilities
requesting to be covered under the
storm water general permitting program
are required to submit a Notice of Intent
(NO!) to be covered under the general
permit consistent with 40 CFR §122.28.
The evaluation team should be aware that
NPDES permits are issued with both an issuance and expiration date and the permits are
issued for a period of up to 5 years. In some instances, the NPDES permits issued by EPA or
the State remain in effect even after their expiration date, provided that the fadlity has
submitted a timely and complete application (pursuant to 40 CFR §122.21) and EPA or the
State, through no fault of the permittee, does not issue a new permit with an effective date on
or before the expiration date of the previous permit.
Pursuant to 40 CFR §122.21, new dischargers are required to apply at least 180 days before
commencing discharge while existing permittees are required to reapply at least 180 days
prior to the expiration date of the existing permit, unless a later date has been granted by the
Director. In no case may an application be submitted after the expiration date of an existing
permit. EPA has specific application forms that are to be used for NPDES permits.
Application forms that apply to a pharmaceutical fadlity include:
Pharmaceutical Manufacturing CWA-6
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Form Title
1 General Information
2C Existing manufacturers
2D New manufacturers
2E Manufacturers that only discharge non-process
wastewater
2F Storm water discharges associated with industrial
activity and consistent with the requirements of
122.26(c)
Regulation
Cite
122.21(1)
122.21(g)
122.21(k)
122.21(h)
122.26(d)
While specific permit conditions might vary from permit to permit, all NPDES permits must
contain the conditions specified in 40 CFR §122.41. In general, these include requirements
for:
> Reapplication
> Operation and maintenance
* Effluent limitations
> Monitoring and record keeping
* Reporting
> Bypass restrictions
* Upset provisions
> Other standard conditions.
For pharmaceutical facilities, both maximum
daily and average monthly discharge permit
limitations are set for each regulated
pollutant (i.e., technology-based limitations),
water quality considerations, and the permit
writer's best professional judgment.
Additionally, environmental laws (as identified in 40 CFR §122.49) may apply to the issuance
of NPDES permits. Specific laws that may apply include:
> Wild and Scenic Rivers Act
*• National Historic Preservation Act of 1966
> Endangered Species Act
*• Coastal Zone Management Act
> Fish and Wildlife Coordination Act
*• National Environmental Policy Act.
All pharmaceutical manufacturing facilities
are also required to notify the permitting
authority as soon as they know or have
reason to believe that any activity has
occurred or will occur which would
result in the discharge, on a routine,
non-routine, frequent, or infrequent
basis, of any toxic pollutant which is not
limited in the permit, if that discharge
will exceed the highest of specified
notification levels as identified in 40 CFR
§122.42(a).
Pharmaceutical Manufacturing
CWA-7
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It is the facility's responsibility to work with the EPA State NPDES permit writers to ensure
that these statutes are adequately addressed during the permitting process. The evaluation of
applicability for each of these statutes will occur as part of permit development.
Pretreatment Program
The goals of the pretreatment program are to: (1) prevent damage to municipal wastewater
treatment plants that may occur when hazardous, toxic or other wastes are discharged into a
sewer system (i.e., interference); (2) prevent pollutants from passing through the treatment
plant untreated and violating discharge limitations or causing exceedances of water quality
standards; and (3) encourage the reuse and recycling of municipal and industrial sludge (i.e.,
protect the quality of sludge generated by these plants). Nationwide, approximately 1,500
POTWs have been required to develop and implement local municipal pretreatment
programs. The requirement to develop and implement a program is included in the POTWs
NPDES permit. Through this program, the POTW is directly responsible for regulation of
certain significant industrial users discharging to the POTW wastewater treatment system,
including facilities regulated by categorical pretreatment standards. EPA's General
Pretreatment Regulations for Existing and New Sources of Pollution (40 CFR Part 403)
establish requirements for POTW programs to regulate discharges from industrial facilities to
POTWs and establishes certain requirements for industrial users (e.g., monitoring and record
keeping).
In most instances, pharmaceutical facilities discharge to POTWs that are authorized to
implement and enforce the pretreatment requirements through an approved pretreatment
program. Where this occurs, the fadlity is required to abide by the terms of a POTW-issued
control mechanism (e.g., permit) and the local sewer use ordinance (SUO). It is the POTWs
responsibility to appropriately implement and enforce these requirements and its
pretreatment program, that must be at least as stringent as the Federal pretreatment
requirements specified in 40 CFR Part 403, on its industrial users. However, even if a
POTW fails to properly apply Federal or State regulations, the pharmaceutical facility has an
independent obligation to comply with applicable Federal and State requirements.
Some pharmaceutical facilities are located in municipalities that do not have locally-run
pretreatment programs. In these areas, permits are generally not issued by EPA or the State;
rather these facilities are obligated to comply with Federal and/or State pretreatment
requirements as identified in the regulations. Both the general pretreatment regulations (40
CFR Part 403) and the pharmaceutical categorical pretreatment standards apply to the facility.
Currently, EPA has delegated pretreatment program authority to 29 States (as identified in
Exhibit CWA-2), in which the State directly controls those industries that discharge to
municipalities without locally-run pretreatment programs. In all remaining States, unless the
POTW is authorized to implement and enforce its own pretreatment program, EPA
implements and enforces the program.
Pharmaceutical Manufacturing CWA-8
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The 40 CFR Part 403 pretreatment regulations specify, among other things, requirements for
non-domestic sources discharging pollutants into POTWs. The regulations set out three
different types of effluent limitations for industrial discharges: prohibited discharge standards,
categorical pretreatment standards, and local discharge limitations.
Prohibited discharge standards forbid certain types of discharges to the POTW, including
POTWs without approved pretreatment programs. These standards include both general
and specific prohibitions. The general prohibitions are national prohibitions against pollutants
discharged to a POTW that cause pass through or interference, as defined in §403.3.
Specific prohibitions, at 40 CFR §403.5(b), are national prohibitions against pollutants that
cause problems at the POTW, such as fire or explosion, harm to worker health and safety,
corrosion, obstruction of flow, excessive heat, trucked or hauled waste or excessive mineral
or synthetic oil and grease.
As noted earlier effluent guidelines and categorical pretreatment standards apply to specific
process water waste streams from specific industrial processes, including pharmaceutical
manufacturing (40 CFR Part 439). The standards are technology-based and apply at the end
of the regulated industrial process.
Since National prohibited discharge standards and categorical standards are not POTW-
specific, these limitations may not necessarily protect a POTW from pass through or
interference. As such, all POTWs authorized to implement and enforce a local pretreatment
program, and many other POTWs that have received problematic discharges from their
industrial users, are required to develop local discharge limitations to address site-specific
concerns regarding interference with the POTW wastewater collection system or treatment
plant or pass through of pollutants to the receiving stream or sludge. In addition, local limits
translate prohibited discharge standards into numerical limitations that can be more readily
evaluated.
The General Pretreatment Regulations (40 CFR Part 403) also specify reporting requirements
applicable to industrial dischargers. POTWs may set more stringent requirements in their
local sewer use ordinance or in a wastewater discharge permit issued to the pharmaceutical
facility, but at a minimum, pharmaceutical facilities must submit semiannual monitoring reports
(403.12(e)), notices of potential problems, including slug loads (403.12(0), notification of
effluent violations (403.12(g)(2)), notification of changed discharge (403.12(j)); must keep
records as required (403.12(o)), and must notify of hazardous waste discharges (403.12(p)).
The regulations also include upset and bypass provisions, in §403.16 and §403.17,
respectively, that apply to industrial dischargers.
Policy on Effluent Trading in Watersheds
The evaluation team should be aware of EPA's draft Framework for Watershed-Based Effluent
Trading (May 1996). The fundamental principle of trading within the Clean Water Act
Pharmaceutical Manufacturing CWA-9
-------
framework is that water quality standards must be met and technology-based requirements
must remain in place.
Trading is a method to attain and/or maintain water quality standards, by allowing sources of
pollution to achieve pollutant reductions through substituting a cost-effective and enforceable
mix of controls on other sources of discharge. Effluent trading potentially offers a number of
economic, environmental, and social benefits. Proposed types of effluent trading approaches
are (1) intra-plant, (2) pretreatment, (3) point/point source, (4) point/nonpoint source, and (5)
nonpoint/nonpoint source.
Watershed-based trading will be implemented on a voluntary basis under existing CWA
authorities. There will be a substantial public outreach effort to obtain stakeholders' (e.g.,
regulated sources, non-regulated sources, regulatory agencies, and the public)
recommendations and insights on draft portions of the trading policy prior to implementation.
Facilities interested in this trading policy should initiate dialogue with their local permitting
authority.
Spills of Oil and Hazardous Substances
The regulations at 40 CFR Part 110 apply to the discharge of oil, which is prohibited by
Section 31 l(b)(3) of the CWA. For purposes of this regulation, "discharge" is defined as any
spilling, leaking, pumping, pouring, emitting, emptying, or dumping. Prohibited discharges
include those into or upon the navigable waters of the United States, adjoining shorelines, or
the contiguous zone or that which may affect natural resources under the jurisdiction of the
United States in such quantities that may be harmful to the public health or welfare of the
United States. EPA has determined that such harmful discharges of oil include those that
violate applicable water quality standards, or cause a film or sheen upon or discoloration of
the surface of the water or adjoining shorelines or cause a sludge or emulsion to be
deposited beneath the surface of the water or upon adjoining shorelines. Addition of
dispersants or emulsifiers to oil to be discharged that would circumvent these provisions is
prohibited. The National Response Center as described in 40 CFR §110.10 must be
immediately notified of any discharge in violation of these restrictions.
Oil Pollution Prevention
The regulations at 40 CFR Part 112 establish procedures, methods and equipment, and
other requirements for equipment to prevent the discharge of oil into or upon the navigable
waters of the United States or adjoining shorelines (i.e., preparation and implementation of
Spill Prevention Control and Countermeasure (SPCC) Plans). This part applies to owners or
operators of non-transportation related onshore and offshore facilities engaged in drilling,
producing, gathering, storing, processing, refining, transferring, distributing, or consuming oil
and oil products which could reasonably be expected to discharge oil in harmful quantities, as
defined in 40 CFR Part 110. Standards for the preparation and implementation of a SPCC
Plan are set out in 40 CFR §112.7, while specific requirements for these Plans are outlined in
40 CFR §112.3.
Pharmaceutical Manufacturing CWA-10
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This Part does not apply to facilities that both (1) have an underground buried storage
capacity for oil of 42,000 gallons of oil or less and (2) the storage capadty for oil, which is not
buried, is 1,320 gallons or less, provided that no single container has a capacity in excess of
660 gallons.
Reportable Quantities for Hazardous Substances
Under Section 311(b) the Federal Water Pollution Control Act, EPA promulgated rules which
designate hazardous substances and the reportable quantity (RQ) of hazardous substances,
respectively (40 CFR Parts 116 and 117). When an amount equal to or in excess of the RQ
is discharged into or upon the navigable waters of the United States, adjoining shorelines, or
into or upon the contiguous zone, the fadlity must provide notice to the Federal government
of the discharge, following Department of Transportation requirements set forth in 33 CFR
§153.203. For purposes of this regulation, "discharge" means any spilling, leaking, pumping,
pouring, emitting, emptying, or dumping. This requirement does not apply to facilities that
discharge the substance in compliance with an NPDES permit or a Part 404 Wetlands
(dredge and fill) permit. RQs for specific chemicals are listed in 40 CFR §117.3.
CWA Assessment Considerations
To evaluate compliance with effluent limitations and effluent monitoring, the assessor should
verify that the facility's operations are properly regulated by the permit and that monitoring
results are representative of the facility's operations. Pharmaceutical production may be either
a batch or continuous operation. For batch processes, the amount and frequency of
wastewater generated is potentially much higher than for continuous processes. The
investigator should verify that fadlity operations have not changed such that wastewater
characteristics changed significantly, but if so, that proper notification was given to the
permitting authority.
The assessor team should pay particular attention to treatment system performance at a
pharmaceutical fadlity. Where treatment systems are installed, the investigator needs to verify
that proper O&M practices are in place to ensure consistent treatment plant performance.
O&M should include documentation of all activities performed (e.g., calibrations, inspections,
repairs, chemical additions, etc.). Evaluation of trends in monitoring results can indicate
improper O&M. For example, steam strippers can lose efficiency due to fouling of the
packing material if the equipment is not cleaned at the proper frequency. The investigator
should verify that backup systems or procedures exist for the periods when system O&M is
being conducted. Also, the investigator should verify that the fadlity has adequate staff to
operate and maintain the treatment system. In many instances, this may require full-time,
around the clock staffing.
Because of the vast array of process equipment and piping, it is important that the facility's
operation and maintenance (O&M) program include regular facility assessments for leaks,
spills, and stressed equipment and a documented procedure for conducting these
assessments. In addition, areas that have a high potential for spills or leaks (e.g., pipes,
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pumps, fittings, etc.) should have spill containment installed to prevent major releases to the
environment, to the facility's onsite treatment system, or to the POTW.
Finally, when evaluating compliance with effluent limitations, the investigator should verify that
the monitoring results are representative of facility operations and consistent with 40 CFR Part
136 procedures. [Note that "EPA approved methods" does not indicate that proper
procedures were followed. EPA has approved methods for drinking water, wastewater, and
solid waste which can all be used to analyze pollutant concentrations in wastewater, but only
Part 136 regulations apply to CWA regulations.] Because of the potential variations in
production at pharmaceutical facilities, a wastewater sample collected on a given day may not
be a fair estimate of typical facility operations. Also, wastewater from pharmaceutical
manufacturers can be highly complex, causing matrix interferences that can hinder laboratory
analysis at the regulatory limitations. The assessor should verify that analytical results reported
as "Not Detected" have been analyzed down to the requisite quantification level. In June
1993, EPA published a guidance manual on laboratory protocol to improve analytical
performance due to matrix interference and other complications. The manual is called
Guidance on Evaluation, Resolution, and Documentation of Analytical Problems Associated with
Compliance Monitoring.
When evaluating compliance with the oil and hazardous substance regulations, the
investigator should inquire about past instances of spills (or leaks, pumping, etc.) and should
identify how the fadlity reacted to each circumstance. Specifically, the assessors should note:
what material was spilled; where did the discharge go; what quantity was spilled; what was
the reportable quantity; what was the facility's response for containment, clean-up, and
notification; any related health and safety issues for the plant, the community, or the
environment; and what are the facility's plans to prevent a recurrence of the situation. The
assessor should also review the SPCC Plan and any other spill or slug control plan onsite
applicable to the facility. As part of the pretreatment program, the facility may be required to
implement a spill and slug control plan concurrent with the SPCC plan and reportable
quantities regulation.
CWA Regulatory Requirements
The following section provides a summary of the principal regulations developed pursuant to
the CWA that are applicable to the pharmaceutical industry. The regulations included are:
> 40 CFR Part 439 - Pharmaceutical Manufacturing
> 40 CFR Part 110 - Discharge of Oil
> 40 CFR Part 112 - Oil Pollution Prevention
> 40 CFR Part 116 - Designation of Hazardous Substances
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> 40 CFR Part 117 - Determination of Reportable Quantities for Hazardous
Substances
The regulatory summaries for applicable effluent guidelines are provided for direct discharges
(i.e., facilities that discharge directly to waters of the U.S. and are regulated by an NPDES
permit) and those that discharge indirectly (i.e., discharge to a Publicly Owned Treatment
Works (POTW) which in turn discharges to waters in the U.S.)
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Applicability:
Any pharmaceutical
manufacturing fadlity discharging
process waste waters to water
of the United States.
Exemptions:
• None
Applicable Subparts:
Subpart A: Fermentation Products
Subpart B: Extraction Products
Subpart C: Chemical Synthesis Products
Subpart D: Mixing, Compounding, and Formulating
Subpart E: Research
40 CFR Part 439
Pharmaceutical Manufacturing as
Administered Through 40 CFR Part 122: EPA
Administered Permits Programs, The
National Pollutant Discharge Elimination
System
40 CFR PART 439 - DIRECT DISCHARGES
REQUIREMENTS
COMPLIANCE DATES
Discharge Limitations:
• Effluent limitations contained in 40 CFR Part 439 including:
- BOD, COD, and TSS limits based on required removal
efficiencies (Subparts A, B, C, D, E)
- Allowable pH range (Subparts A, B, C, D, E)
- BPT, BAT and NSPS cyanide limits (Subparts A, B, C, D)
Relate to May 2, 1995, proposed rule:
- BPT end-of-pipe limits for BOD, TSS, COD, and pH
(Subparts A, B, C, D)
- BPT, BAT, or NSPS cyanide limits at in-plant monitoring
points (Subparts A,C)
- BAT or NSPS end-of-pipe limits for priority and
nonconventional pollutants (Subparts A, B, C, D)
- BOD, COD and TSS limits based on required removal
efficiencies and allowable pH range (Subpart E)
Existing Sources: 10/27/86 (under current
regulations as required by permit
New Sources: Date source begins
operation, as required by permit
Compliance with specific permit limitations
upon effective date of the permit
a
0}
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40 CFR PART 439 - DIRECT DISCHARGES
REQUIREMENTS
COMPLIANCE DATES
• Any other effluent limitation contained in the NPDES permit
Monitoring and Reporting Requirements:
Note: All direct dischargers are required to obtain
an NPDES permit. The NPDES permit outlines the
dischargers specific monitoring and reporting
requirements.
• Permit Applications - containing the information required
under 122.21(0, (g), and (k) (application requirements for
new sources and new discharges) Permit applications are
to be submitted 180 days prior to the commencement of
discharge. Applications for permit renewal are required to
be submitted 180 days before the existing permit expires.
• Planned Changes - notification to the Director as soon as
possible of any planned physical alteration or addition that
meets the criteria in 122.41fl)(l). As soon as possible,
when applicable
• Anticipated Noncompliance - advance notification to the
Director of any planned changes that may result in permit
noncompliance
• Monitoring Reports - monitoring results must be submitted
as required by the NPDES permit (at least annually). All
monitoring must be conducted using 40 CFR Part 136
methods
Permittees not using or generating cyanide may certify in
lieu of monitoring
(Section 439.2 specifies required monitoring frequencies for
each regulated pollutant generated or used at a facility.)
• Compliance Schedules - reports of compliance or
noncompliance with compliance schedule requirements
• Anticipated and Unanticipated Bypass - notification as
required under 122.41(m)
• Discharge of Toxic Pollutants - notification to the Director
of activity that results in the discharge of toxic pollutants not
limited in the permit, if it exceeds the levels outlined in
122.42(a)(l)
• Storm Water Permit Applications - submission of either
individuals permit application, group permit applications, or
general permit applications
Permit applications are to be submitted 180
days prior to the commencement of
discharge
Applications for permit renewal are required
to be submitted 180 days before the existing
permit expires
As soon as possible, when applicable
In advance of changes, when needed
At least annually or more frequently by
permit
Within 14 days of each compliance schedule
date
At least 10 days prior to anticipated bypass.
Within 24 hours of unanticipated bypass
As soon as facility knows or has reason to
believe that levels will be exceeded
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40 CFR PART 439 - DIRECT DISCHARGES
REQUIREMENTS
COMPLIANCE DATES
Individual permit applications must include the
information in 122.26(c)(l)
Group permit applications requirements are identified in
122.26(c)(2)
Facilities to be covered under a general permit must file
a Notice of Intent (NOI)
• Other Storm Water Reports - submission of other reports
as required under a facility's storm water discharge permit.
These reports may include pollution prevention plans and
monitoring reports
Record Keeping Requirements:
• Records of monitoring information as required under
122.41(0 must be kept for at least three years
Individual permit applications for existing
facilities were due October 1, 1992. New
facilities must submit an application 180 days
prior to commencement of industrial activity
Part 1 applications were due on September
30, 1991, and Part 2 applications were due
on October 1, 1992
NOIs from existing facilities were due on
October 1, 1992
NOIs from new facilities are due 2 days
prior to the commencement of industrial
activities
Due dates as required by permits
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Applicability:
Any pharmaceutical
manufacturing facility discharging
process wastewater to a
POTW.
40 CFR Part 439
Pharmaceutical Manufacturing as
Administered Through 40 CFR Part 403:
General Pretreatment Regulations for Existing
and New Sources of Pollution
40 CFR PART 439 - INDIRECT DISCHARGES
REQUIREMENTS
COMPLIANCE DATES
Discharge limitations:
• Limitations contained in 40 CFR Part 439
including:
- Cyanide limits (Subparts A, B, C, D)
Relate to May 2, 1995, proposed rule:
- Priority and non-conventional pollutants limits
at in-plant and end-of-pipe monitoring points
(Subparts A, B, C, D)
• Prohibited discharge standards (general and
specific) in 40 CFR 403.5
• Applicable local limits
Monitoring and reporting requirements:
Note: Reports must be submitted
whether or not the facility has been issued
a permit
• Baseline Monitoring Reports (BMR) - containing
the information required under 40 CFR
403.12(b)
Compliance Schedule Progress Reports -
containing the information required under 40
CFR403.12(c)(3)
PSES: 10/27/86, as required by permit
PSNS: Date new source begins operation as
required by permit
a
BMRs from existing sources due within 180 days of
effective date of categorical pretreatment standard
(June 9, 1984, for current regulations)
BMRs from new sources are due 90 days prior to
commencement of discharge
Due within 14 days of completing compliance
schedule milestone or due date
0}
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40 CFR PART 439 - INDIRECT DISCHARGES
REQUIREMENTS
COMPLIANCE DATES
90-Day Compliance Report - containing the
information required under 40 CFR 403.12(d)
• Periodic Reports on Continued Compliance -
containing the information in 403.12(e) (including
monitoring data for all categorically regulated
pollutants). All monitoring must be conducted
using 40 CFR Part 136 methods.
Dischargers not using or generating cyanide may
certify in lieu of monitoring.
(Section 439.2 specifies required monitoring
frequencies for each regulated pollutant generated or
used at a facility.1)
• Notice of Potential Problems Including Slug
Loadings
• Notice of Changed Discharge - advanced
notification of any substantial change in the
volume or character of pollutants in the discharge
(including hazardous wastes)
• Notice of Violations and Resampling - notification
due to the Control Authority within 24 hours of
noting a violation; results of resampling must be
submitted within 30 days
• Notification of Hazardous Waste Discharge -
notification to the POTW, EPA, and the State of
the hazardous wastes discharged to the POTW
Record keeping requirements:
• Monitoring records including the information
listed in 403.12(o) must be maintained for at least
3 years
Due within 90 days following date for final
compliance (10/27/86 under current regulations) or
for new sources following the commencement of
introduction of wastewater to the POTW
Must be submitted at least semiannually
Due to the Control Authority immediately upon
identification of discharges that could cause problems
to the POTW
Prompt notification in advance of any substantial
change
Notice within 24 hours, results of resampling within
30 days
One time notification, unless changes to discharge
'The June 8, 1995 (Pesticide Chemicals) supplemental notice to the proposed April 1994 rule provides
a Pollution Prevention Alternative for facilities regulated under Subpart C and proposed Subpart E. In lieu of
meeting the zero discharge of process wastewater requirement, these facilities could demonstrate that the
requirements of the Pollution Prevention Alternative listed in Tables B-l and B-2 are met, notify the NPDES
permit writer or pretreatment authority, and keep necessary paperwork onsite.
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40 CFR Part 110
Discharge of Oil
Applicability:
Prohibited discharges include
certain discharges to U.S.
Navigable water, to adjoining
shorelines, or to waters of the contiguous zone, occurring in connection with activities under
the Outer Continental Shelf Lands Act or the Deepwater Port Act, or those that may affect
U.S. natural resources.
May be applicable to pharmaceutical facilities using oil and that are either located by a
municipal storm sewer that discharges to waters or near streams or bodies of water.
40 CFR PART 110
REQUIREMENTS
COMPLIANCE DATES
Discharge of oil is prohibited that:
- Violates applicable water quality standards, or
- Causes a film or sheen upon or discoloration
of the surface of the water or adjoining
shorelines or causes a sludge or emulsion to
be deposited beneath the surface of the water
or upon the adjoining shorelines
Notification must be provided immediately to the
National Response Center of any discharge of oil
in violation of the prohibition at (800) 424-8802
or (202) 426-2675 in the Washington, DC,
metropolitan area.
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40 CFR Part 112
Oil Pollution Prevention
Applicability:
Non-transportation related
onshore and off-shore facilities
engaged in drilling, producing,
gathering, storing, processing, refining, transferring, distributing, or consuming oil and oil
products that could reasonably discharge oil in harmful quantities, as defined in Part 110.
Exemptions:
• Facilities with underground buried oil storage capadty of < 42,000 gallons; and
• Storage capacity that is not buried < 1,320 gallons, with no single container capacity >
660 gallons
40 CFR PART 112
REQUIREMENTS
COMPLIANCE DATES
Reporting requirements:
• Prepare and implement Spill Prevention Control
and Countermeasure plans meeting the
requirements of 112.3 and 112.7
• Submit report as described in 112.4 when
discharged oil > 1,000 gallons in single spill event
or discharged oil in harmful quantities in two spill
events
• Review, evaluate, and update plan as required
under 112.5
Certain non-transportation related onshore facilities
which could reasonably be expected to cause
substantial harm to the environment may also be
required to implement the following provisions:
• Submit facility response plan as described in
112.20 and develop and implement facility
response training and drill exercise as described in
112.21
Existing sources:
New sources: Prepare plan within 6 months of
beginning operation and fully implement in no later
than 1 year
Within 60 days of becoming subject to reporting
requirements
Review plan once every 3 years, amend plan within 6
months, if needed
Existing sources: as described in 112.20
New source: prior to start of operations
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Applicability:
40 CFR Part 117 does not
apply to fadlities that discharge
the substance under an NPDES
permit or to a POTW, as long
as any applicable effluent limit
or pretreatment standard is
met.
40 CFR Part 116 and 117
Designation of Hazardous Substance and 40
CFR Part 117 Determination of Reportable
Quantities for Hazardous Substances
Requirements:
40 CFR 116.4 designates hazardous substances and 40 CFR 117.3 establishes the
Reportable Quantity (RQ) for each substance listed in Part 116. When an amount equal to
or in excess of the RQ is discharged, the facility must provide notice to the Federal
government following DOT requirements in 33 CFR 153.203.
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