STATE OF RHODE ISLAND AND PROVIDENCE PLANTATIONS

DEPARTMENT OF ENVIRONMENTAL MANAGEMENT

OFFICE OF AIR RESOURCES

AIR POLLUTION CONTROL REGULATION NO. 26

CONTROL OF ORGANIC SOLVENT EMISSIONS 

FROM MANUFACTURERS OF 

SYNTHESIZED PHARMACEUTICAL PRODUCTS

Effective 19 November1992

Last Amended   19 July 2007

AUTHORITY:	These regulations are authorized pursuant to R.I. Gen. Laws
§ 42-17.1-2(s) and 23-23, as amended, and have been promulgated
pursuant to the procedures set forth in the R.I. Administrative
Procedures Act, R.I. Gen. Laws Chapter 42-35.

RHODE ISLAND DEPARTMENT OF ENVIRONMENTAL MANAGEMENT

OFFICE OF AIR RESOURCES

AIR POLLUTION CONTROL REGULATION NO. 26 

CONTROL OF ORGANIC SOLVENT EMISSIONS FROM MANUFACTURE OF

 SYNTHESIZED PHARMACEUTICAL PRODUCTS

TABLE OF CONTENTS

  TOC \o "1-3" \h \z \u    HYPERLINK \l "_Toc168817300"  26.1
Definitions	  PAGEREF _Toc168817300 \h  1  

  HYPERLINK \l "_Toc168817301"  26.2	Applicability	  PAGEREF
_Toc168817301 \h  2  

  HYPERLINK \l "_Toc168817302"  26.3	Standards	  PAGEREF _Toc168817302
\h  3  

  HYPERLINK \l "_Toc168817303"  26.4	Test Methods and Compliance
Procedures	  PAGEREF _Toc168817303 \h  5  

  HYPERLINK \l "_Toc168817304"  26.5	Monitoring for Air Pollution
Control Equipment.	  PAGEREF _Toc168817304 \h  6  

  HYPERLINK \l "_Toc168817305"  26.6	Recordkeeping	  PAGEREF
_Toc168817305 \h  6  

  HYPERLINK \l "_Toc168817306"  26.7	Reporting	  PAGEREF _Toc168817306
\h  7  

  HYPERLINK \l "_Toc168817307"  26.8	General Provisions	  PAGEREF
_Toc168817307 \h  9  

 

RHODE ISLAND DEPARTMENT OF ENVIRONMENTAL MANAGEMENT

OFFICE OF AIR RESOURCES

AIR POLLUTION CONTROL REGULATION NO. 26 

CONTROL OF ORGANIC SOLVENT EMISSIONS FROM MANUFACTURE OF

 SYNTHESIZED PHARMACEUTICAL PRODUCTS

26.1	Definitions

	Unless otherwise expressly defined in this section, the terms used in
this regulation shall be defined by reference to the Rhode Island Air
Pollution Control General Definitions Regulation.  As used in this
regulation, the following terms shall, where the context permits, be
construed as follows:

	26.1.1	"Condenser" means any device which cools a gas stream to a
temperature which removes specific VOC by condensation.

	26.1.2	"Control System" means any number of control devices, including
condensers, which are designed and operated to reduce the quantity of
VOC emitted to the atmosphere.

	26.1.3	"Enclose" means to cover a volatile organic liquid surface in a
manner such that it is not exposed to the atmosphere.

	26.1.4	"Pharmaceutical Product and Intermediate" means any drug or
chemical substance or any intermediate used to make a drug or chemical
substance which is intended to be administered to a person or animal to
prevent or cure disease or otherwise enhance physical or mental welfare.

26.1.5	"Production equipment exhaust system" means a device for
collecting and directing out of the work area VOC fugitive emissions
from reactor openings, centrifuge openings, and other vessel openings
for the purpose of protecting workers from excessive VOC exposure.

	26.1.6	"Reactor" means a vat or vessel, which may be jacketed to permit
temperature control, designed to contain chemical reactions.

	26.1.7	"Separation operation" means a physical or chemical process that
separates a mixture of compounds and solvents into two or more
components.  Specific mechanisms include but are not limited to:
extraction, centrifugation, filtration, and crystallization.

	26.1.8	"Synthesized pharmaceutical manufacturing" means manufacture of
pharmaceutical products and intermediates by chemical synthesis.  The
production and recovery of materials produced via fermentation,
extraction of organic chemicals from vegetative materials or animal
tissues, and formulation and packaging of the product are not considered
synthesized pharmaceutical manufacturing.

26.2 Applicability

	26.2.1	This regulation applies to the following sources of volatile
organic compounds (VOC) at all synthesized pharmaceutical manufacturing
facilities:

		(a)	Reactors;

		(b)	Distillation operations;

		(c)	Crystallizers;

		(d)	Centrifuges;

		(e)	Vacuum dryers;

		(f)	Air dryers;

		(g)	Production equipment exhaust systems;

		(h)	Rotary vacuum filters and other filters;

		(i)	Storage tanks;

		(j)	In-process tanks; and

		(k)	Leaks.

	26.2.2	The owner or operator of a synthesized pharmaceutical
manufacturing facility subject to this regulation shall control the VOC
emissions from each vent which has the potential to emit 15 pounds per
day [lb/day] (6.8 kilograms per day (kg/day)) or more of VOC from
reactors, distillation operations, crystallizers, centrifuges, and
vacuum dryers.  VOC emissions shall be controlled in accordance with the
requirements in Section 26.3.

	26.2.3	Where ever the term "Volatile Organic Compound" or "VOC" is used
in Sections 26.2 through 26.7, this term should be read as "Volatile
Organic Compound and Halogenated Organic Compound" or "VOC and HOC".

	26.2.4	An owner or operator of a facility which has sources whose
emissions are below the  threshold in Subsection 26.2.2 shall comply
with the certification, recordkeeping, and reporting requirements in
Sections 26.6 and 26.7 for those sources.

	26.2.5	Any facility or source that becomes or is currently subject to
the provisions of this regulation by exceeding the applicability
threshold in Subsection 26.2.2 will remain subject to this regulation
even if the emissions later fall below the applicability threshold.

26.3	Standards

	By 19 November 1994 the following emissions limitations must be met. 
Any new source commencing operation after 19 November 1992 must meet the
following emission limitations upon commencing operations:

	26.3.1	Surface condensers or equivalent controls. 

		(a)	If surface condensers are used, the condenser outlet gas
temperature shall not exceed the allowable temperature limit described
for each associated vapor pressure in the following table; or

 PRIVATE  Allowable condenser outlet gas temperature, EC	VOC vapor
pressure at 20EC, kPa (psi)

-25	>40.01	(5.8)

-15	>20.0	(2.9)

0	>10.0	(1.5)

10	>7.0	(1.0)

25	>3.5	(0.5)



		(b)	If other controls such as carbon absorption or incineration are
used, the VOC emissions shall be reduced by at least as much as they
would be by using a surface condenser.  All such controls must be
approved by the Department.

	26.3.2	Air dryers and production equipment exhaust systems.

	The owner or operator of a synthesized pharmaceutical manufacturing
facility subject to this regulation shall reduce the VOC emissions from
all air dryers and production equipment exhaust systems:

		(a)	By at least 90 percent on an hourly basis if actual emissions
from all air dryers and production equipment exhaust are 150 kg/day
(330 lb/day) or more of VOC or

		(b)	To 15.0 kg/day (33 lb/day) or less if actual emissions from all
air dryers and production equipment exhaust are less than 150 kg/day
(330 lb/day) of VOC.

	26.3.3	Storage Tanks.

	The owner or operator of a synthesized pharmaceutical manufacturing
facility subject to this regulation shall reduce the VOC emissions from
storage tanks by:

		(a)	Providing a vapor balance system or equivalent control that is at
least 90 percent effective in reducing emissions from truck or railcar
deliveries to storage tanks with capacities greater than 7,500 liters
(L) (2,000 gallons [gal]) that store VOC with vapor pressures greater
than 28.0 kiloPascals (kPa) (4.1 pounds per square inch [psi]) at 20EC
(68EF); and

		(b)	Installing pressure/vacuum conservation vents set at a minimum
pressure of 0.2 kPa (0.03 pounds per square inch atmospheric [psia]) on
all storage tanks that store VOC with vapor pressures greater than
10.0 kPa (1.5 psi) at 20EC (68EF).

	26.3.4	Centrifuges, rotary vacuum filters, and other filters.

	The owner or operator of a synthesized pharmaceutical facility subject
to this regulation shall enclose all centrifuges, rotary vacuum filters,
and other filters having an exposed liquid surface if the liquid
contains VOC and exerts a total VOC vapor pressure of 3.50 kPa
(0.5 psi) or more at 20EC (68EF), as determined by ASTM D2879-83.

	26.3.5	In-process tanks.

	The owner or operator of a synthesized pharmaceutical facility subject
to this regulation shall install covers on all in-process tanks that
contain VOC at any time.  These covers shall be constructed of a
nonporous or nonabsorbent material and form a tight seal with the sides
of the tank and have no gaps or holes.  These covers shall remain closed
at all times except when production, sampling, maintenance, or
inspection procedures require operator access.

	26.3.6	Leaks.

	The owner or operator of a synthesized pharmaceutical manufacturing
facility subject to this regulation shall visually inspect for liquid
leaks once per week and use a portable VOC detector to inspect for vapor
leaks once per month to inspect all equipment listed in Subsections
26.2.1 (a) through (k).  All leaks repairs shall be completed as soon as
practicable but no later than 15 calendar days after the leak is found.

26.4	Test Methods and Compliance Procedures

	26.4.1	If a source uses air pollution control equipment to comply with
the requirements of this regulation, compliance shall be demonstrated in
accordance with 40 CFR Part 60, Appendix A,  Method 18, Method 25, or
Method 25A or any other EPA approved method which has been approved by
the Director.

	26.4.2	Selection of a method for testing compliance shall be based on
consideration of total concentration and speciation of the organics
present and on consideration of the potential presence of interfering
gases.  Only Method 25, which measures VOC as carbon, may be used for
determining destruction efficiency of incinerators or catalytic
incinerators.

	26.4.3	Except as indicated in Subsections (a) and (b), a test shall
consist of three separate runs, each lasting a minimum of 60 minutes,
unless the Director determines that process variables dictate shorter
sampling times.

		(a)	When the test is being done to determine the efficiency of a
fixed-bed carbon adsorption system with a common exhaust stack for all
of the individual adsorber vessels, the test shall consist of three
separate runs, each coinciding with one or more complete sequences
through the adsorption cycles of all the individual adsorber vessels.

		(b)	When the test is being done to determine the efficiency of a
fixed-bed carbon adsorption system with individual exhaust stacks for
each adsorber vessel, each adsorber vessel shall be tested individually.
 The test for each adsorber vessel shall consist of three separate runs.
 Each run shall coincide with one or more complete adsorption cycles.

	26.4.4	Method 1 or 1A of 40 CFR Part 60, Appendix A, shall be used
for velocity traverses.

	26.4.5	Method 2, 2A, 2C, or 2D of 40 CFR Part 60, Appendix A, shall
be used to measure velocity and volumetric flow rates.

	26.4.6	Method 3 or 3A of 40 CFR Part 60, Appendix A, shall be used
for O2 and CO2 analysis.

	26.4.7	Method 4 of 40 CFR Part 60, Appendix A, shall be used to
measure stack gas moisture.

	26.4.8	Methods 2, 2A, 2C, 2D, 3, 3A and 4 of 40 CFR Part 60,
Appendix A, shall be performed, as applicable, at least twice during
each test run.

	26.4.9	Use of modifications of any of the analytical methods specified
in Subsections 26.4.1 through 26.4.8 of this section shall be approved
or disapproved by the Director on a case-by-case basis.  An owner or
operator shall submit sufficient documentation for the Director to find
that the analytical methods specified in Subsections 26.4.1 through
26.4.7 will yield inaccurate results and that the proposed modification
is appropriate.

26.5	Monitoring for Air Pollution Control Equipment.

	26.5.1	At a minimum, continuous monitors measuring the following
parameters shall be installed on air pollution control equipment used to
control sources subject to this regulation by [the date two years after
the effective date of this regulation]:

		(a)	Destruction device combustion temperature;

		(b)	Temperature rise across a catalytic incinerator bed;

		(c)	VOC concentration at the outlet of a carbon adsorption unit at
breakthrough;

		(d)	Outlet gas temperature of a refrigerated condenser; and

		(e)	Outlet gas temperature of a non-refrigerated condenser coolant
supply system.

	26.5.2	Each monitor shall be:

		(a)	Equipped with a recording device,

		(b)	Calibrated quarterly, and

		(c)	Operated at all times that the associated control equipment is
operating.

26.6	Recordkeeping

	26.6.1	The owner or operator of a pharmaceutical manufacturing facility
subject to this  shall maintain the following records beginning [the
date two years after the effective date of this regulation]:

		(a)	Recording of parameters listed in Subsection				26.5.

		(b)	A record of the solvent true vapor pressure as determined by ASTM
D2879-86, for each VOC used in a source which is subject to this
regulation.  For a pure solvent, a record of published data reporting
the true vapor pressure of that solvent as determined using ASTM
D2879-86 is acceptable to fulfill this requirement.

	26.6.2	For any leak subject to Subsection 26.3.6(a), which cannot be
readily repaired within 24 hours after detection, the following shall
be recorded:

		(a)	The name of the leaking equipment;

		(b)	The date and time the leak is detected;

		(c)	The action taken to repair the leak; and

		(d)	The date and time the leak is repaired.

	26.6.3	All records required in this Subsection shall be maintained at
the facility for a minimum of five years.

26.7	Reporting

	26.7.1	Initial Compliance Certification Plan

		26.7.1.1	The owner or operator of any facility containing sources
subject to this regulation shall submit to the Director an initial
compliance certification plan by [the date one year after the effective
date of this regulation].  The owner or operator of any facility that
becomes subject to this regulation after [the date one year after the
effective date of this regulation] shall submit an initial compliance
certification for that source immediately upon start-up of the
operation.

		26.7.1.2	The initial compliance certification shall include as a
minimum the following information:

			(a)	The name and location of the facility;

			(b)	The name, address and telephone number of the person responsible
for the facility;

			(c)	An identification of subject sources at the facility;

			(d)	The information specified in Subsection 26.7.1.3 for each subject
source; and

			(e)	The time at which the facility's "day" begins if a time other
than midnight local time is used to define a "day".

		26.7.1.3	The initial compliance certification shall also include, as a
minimum, the following information for each subject source:

			(a)	Identification of the applicable emission limitation, equipment
specification, or work practice, as specified in Section 26.3;

			(b)	The method by which compliance has been or will be achieved;

			(c)	For each source subject to numerical emission limitations, the
estimated actual and potential emissions without control, and the basis
for the estimate;

	26.7.2	Final Compliance Certification 

		26.7.2.1	By 19 November 1994 or immediately upon startup for a
facility which becomes subject to this regulation after 19 November
1994, the owner or operator of any facility containing sources subject
to this regulation shall certify to the Director that the facility is in
compliance with the provisions of this regulation.  

		26.7.2.2	The final compliance certification shall include, at a
minimum, the following information:

			(a)	The method by which compliance has been achieved for each subject
source;

			(b)	For each source subject to numerical emission limitations, the
estimated actual and potential emissions without control, and the basis
for the estimate;

			(c)	Identification of the control system(s) in use for each subject
source;

			(d)	The design performance efficiency of the control system; 

			(e)	For each source subject to numerical emission limitations, the
estimated emissions after control;

			(f)	Certification that each subject source at the facility is in
compliance with the applicable emission limitation, equipment
specification, or work practice;

			(g)	An identification of any changes from the initial compliance
certification plan.

	26.7.3	Reports of Noncompliance with Standards

		(a)	The owner or operator of any facility containing sources subject
to this section shall, for each incidence of noncompliance with the
standards in Section 26.3, within 30 calendar days of becoming aware of
such occurrence, supply the Director with the following information:

			(i)	The name and location of the facility;

			(ii)	The subject source(s) that caused the noncompliance with the
standard;

			(iii)	The time and date of first observation of

				the incident of noncompliance;

			(iv)	The cause and expected duration of the incident of
noncompliance;

			(v)	For sources subject to numerical emission limitations, the
estimated

				rateof emissions (expressed in the units of the applicable emission
limitation) during the incident and the operating data and calculations
used in estimating the emission rate.

The proposed corrective actions and schedule to correct the conditions
causing the incidence of noncompliance.

General Provisions

Purpose

The purpose of this regulation is to limit volatile organic compound
emissions from the manufacture of synthesized pharmaceutical products

Authority

These regulations are authorized pursuant to R.I. Gen. Laws §
42-17.1-2(s) and 23-23, as amended, and have been promulgated pursuant
to the procedures set forth in the R.I. Administrative Procedures Act,
R.I. Gen. Laws Chapter 42-35

Application

The terms and provisions of this regulation shall be liberally construed
to permit the Department to effectuate the purposes of state law, goals
and policies.

Severability

If any provision of this regulation or the application thereof to any
person or circumstance, is held invalid by a court of competent
jurisdiction, the validity of the remainder of the regulation shall not
be affected thereby.

Effective Date

The foregoing regulation, "Control of Organic Solvent Emissions from
Manufacturers of Synthesized Pharmaceutical Products”, as amended,
after due notice, is hereby adopted and filed with the Secretary of
State this ____29th_ day of _June_, 2007_ to become effective twenty
(20) days thereafter, in accordance with the provisions of Chapters
23-23, 42-35, 42-17.1, 42-17.6, of the General Laws of Rhode Island of
1956, as amended.

W. Michael Sullivan, PhD., Director

Department of Environmental Management

Notice Given on:	February 21, 2007

Public Hearing held:	  March 23, 2007

Filing Date:	June 29, 2007

Effective Date:  July 19, 2007

 

 

Page   PAGE  2  of 10

