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Protection of the Stratospheric Ozone: De Minimis Exemption for Laboratory Essential Uses for Calendar Year 2001
Related Material
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: March 13, 2001 (Volume 66, Number 49)]
[Rules and Regulations]
[Page 14759-14770]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13mr01-13]
[[Page 14759]]
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Part III
Environmental Protection Agency
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40 CFR Part 82
Protection of the Stratospheric Ozone: De Minimis Exemption for
Laboratory Essential Uses for Calendar Year 2001; Final and Proposed
Rule
[[Page 14760]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 82
[FRL-6952-1]
RIN 2060-AJ15
Protection of the Stratospheric Ozone: De Minimis Exemption for
Laboratory Essential Uses for Calendar Year 2001
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
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SUMMARY: EPA is taking direct final action to provide an exemption for
laboratory and analytical essential uses for calendar year 2001. EPA
has determined that an allowance for laboratory and analytical
essential uses, which allows for the production and import of class I
stratospheric ozone depleting substances (ODSs) beyond the phase-out of
these substances, is allowable under the Clean Air Act as a de minimis
exemption. Based on specific findings, EPA is amending the regulations
on import and production of ODSs to reflect this determination and
allocating a general global exemption for class I ODSs for laboratory
and analytical essential uses for the year 2001. This action allows for
the continued import and production of class I ODSs for essential
laboratory uses necessary for protecting public health and the
environment. EPA is issuing a companion proposal to this direct final
rule elsewhere in this issue of the Federal Register.
DATES: This rule is effective on May 14, 2001 without further notice,
unless EPA receives adverse comment by April 12, 2001. If we receive
significant adverse comment on this rule, we will publish a timely
withdrawal in the Federal Register informing the public that this rule
will not take effect.
ADDRESSES: Should you have any comments on this direct final rule
submit them to: Margaret Sheppard, U.S. Environmental Protection Agency
(6205J), 1200 Pennsylvania Avenue, NW., Washington, DC 20460. If you
send your comments via overnight express mail, send them to: Margaret
Sheppard; 4th floor, 501 3rd Street NW; Washington, DC 20001. All
comments will be filed in EPA Air docket number A-93-39. If your
comments contain confidential business information, submit them
directly to Margaret Sheppard in two versions: one clearly marked
``Public'' to be filed in the public docket, and the other marked
``Confidential'' to be reviewed by authorized government personnel
only.
Materials relevant to this rulemaking are contained in Docket No.
A-93-39. The Docket is located in Waterside Mall Room M-1500, 401 M
Street, SW., Washington, DC. The materials may be inspected from 8 a.m.
until 5:30 p.m. Monday through Friday. A reasonable fee may be charged
by EPA for copying docket materials.
FOR FURTHER INFORMATION CONTACT: The Stratospheric Ozone Protection
Hotline at (800) 296-1996 or Margaret Sheppard, U.S. Environmental
Protection Agency, Global Programs Division, Office of Air and
Radiation (6205J), Ariel Rios Building, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460; sheppard.margaret@epa.gov; (202) 564-9163 phone
and (202) 565-2141 fax.
SUPPLEMENTARY INFORMATION: EPA is publishing this rule without specific
prior proposal for calendar year 2001; we view this as a
noncontroversial amendment and anticipate no adverse comment since we
have already received comment on this issue in response to the proposed
rule allocating essential use allowances for the year 2000 (64 FR
59144, November 2, 1999). With this action, EPA is taking the comments
received on the proposed rule allocating essential use allowances for
the year 2000 and applying them to a rulemaking determining a de
minimis exemption for laboratory and analytical uses (``laboratory
uses'') for the year 2001. This direct final amends 40 CFR 82.4. We are
publishing a separate document that will serve as the proposal to this
de minimis exemption for laboratory and analytical uses. This rule will
be effective on May 14, 2001. If EPA receives adverse comment on this
rule, we will publish a timely withdrawal in the Federal Register
informing the public that the rule will not take effect. We will
address any significant adverse comments in a subsequent final rule
based on the proposed rule. EPA will not institute a second comment
period on this action. Any parties interested in commenting must do so
at this time.
You may claim that information in your comments is confidential
business information, as allowed by 40 CFR part 2. If you submit
comments and include information that you claim as confidential
business information, we request that you submit them directly to
Margaret Sheppard in two versions: one clearly marked ``Public'' to be
filed in the public docket, and the other marked ``Confidential'' to be
reviewed by authorized government personnel only.
The regulated categories affected by this action include:
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Category SIC NAICS
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1. Medical and Diagnostic Laboratories.......... 8071................................................ 6215
2. Research and Development in the Physical, 8731 and 8733....................................... 54171
Engineering, and Life Sciences.
3. Environmental Consulting Services............ 8999................................................ 54162
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This table is not intended to be exhaustive but, rather, provides a
guide for readers likely to be interested in this direct final rule. If
you have any questions regarding the applicability of this direct final
rule please consult the person listed in the preceding FOR FURTHER
INFORMATION CONTACT section.
Table of Contents
I. Notice of Proposed Rulemaking Summary
II. Overview of Comments
III. De Minimis Exemption for Essential Laboratory and Analytical
Uses of Class I ODSs in 2001
IV. Criteria for Exempting Laboratory and Analytical Uses after
December 31, 2001
V. Administrative Requirements
VI. Judicial Review
VII. Submittal to Congress and General Accounting Office
I. Notice of Proposed Rulemaking Summary
The Notice of Proposed Rulemaking (NPRM) published on November 2,
1999 (64 FR 59141), proposed the allocation of essential use allowances
for class I stratospheric ozone depleting substances (ODSs) for
specific uses agreed to by the Parties to the Montreal Protocol.\1\ The
Montreal Protocol on Substances that Deplete the Ozone Layer (Protocol)
is an international
[[Page 14761]]
agreement to reduce and eventually eliminate production and consumption
\2\ of all stratospheric ozone depleting substances. Under both the
Protocol and the Clean Air Act (``the Act''), the elimination of
production and consumption is accomplished through adherence to phase-
out schedules for the production and consumption of specific ODSs
including chlorofluorocarbons (CFCs), halons, carbon tetrachloride,
methyl chloroform, hydrochlorofluorocarbons, and methyl bromide. Under
the Montreal Protocol and the Act, there was an original schedule for
phasing out class I ODSs by January 1, 2000. (Table 2 in section 604(a)
of the Act sets the amounts of class I ODSs that were allowed to be
produced under the original schedule.) Later actions by the Parties,
including the United States, accelerated the phase out of production
and import of class I ODSs so that all developed countries had phased
them out by January 1996. However, the Protocol and the Act provide
exemptions which allow for the continued import and/or production of
class I ODS for specific uses. Under the Montreal Protocol, exemptions
are granted for uses that are determined by the Parties to be
``essential.'' Decision IV/25, taken in 1992, established criteria for
determining whether a specific use should be approved as essential, and
set forth the international process for making such determinations.
Decision IV/25 states the following:
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\1\ This proposal addressed a number of ``essential uses'' of
ODSs allowed under the Montreal Protocol, including ODSs used in
metered dose inhalers, in the Space Shuttle and Titan Rockets, and
laboratory and analytical methods. EPA issued an interim final rule
for allowance allocations for the year 2000 for metered dose
inhalers, the Space Shuttle, and Titan Rockets on January 6, 2000
(65 FR 716) and later finalized that rule on June 30, 2000 (65 FR
40524). In those final rules, we stated that we would address
laboratory and analytical uses of ODSs in a separate final rule.
\2\ ``Consumption'' is defined as the amount of a substance
produced in the United States, plus the amount imported, minus the
amount exported to Parties to the Montreal Protocol (see section
601(6) of the Clean Air Act). Stockpiles of class I ODSs produced
prior to the 1996 phase-out can continue to be used for purposes not
expressly banned at 40 CFR part 82, subpart C-Ban on Nonessential
Products Containing Class I Substances and Ban on Nonessential
Products Containing or Manufactured with Class II Substances.
(1) That a use of a controlled substance should qualify as
`essential' only if:
(i) It is necessary for the health, safety or is critical for
the functioning of society (encompassing cultural and intellectual
aspects); and
(ii) There are no available technically and economically
feasible alternatives or substitutes that are acceptable from the
standpoint of environment and health;
(2) That production and consumption, if any, of a controlled
substance for essential uses should be permitted only if:
(i) All economically feasible steps have been taken to minimize
the essential use and any associated emission of the controlled
substance; and
(ii) The controlled substance is not available in sufficient
quantity and quality from existing stocks of banked or recycled
controlled substances, also bearing in mind the developing
countries' need for controlled substances.
For the year 2001, the parties to the Montreal Protocol granted the
U.S. essential use allowances for CFCs for use in metered dose inhalers
for the treatment of asthma and chronic obstructive pulmonary disease,
methyl chloroform for use in the Space Shuttle and Titan Rockets, and a
global essential use exemption for laboratory and analytical uses. Each
Party nominates or requests essential use allowances for specific
quantities of class I ODSs for medical devices and other essential
uses. For laboratory uses, the Protocol allows for a ``global
exemption''--that is, a general exemption for all laboratory and
analytical uses meeting established criteria \3\--rather than requiring
countries to nominate an amount to be used for laboratory and
analytical uses. This ``global exemption'' for laboratory essential
uses allows flexibility since it can be difficult to predict a nation's
needs for laboratory research in advance. In today's rulemaking, EPA is
implementing this ``global exemption'' as a general exemption for
laboratory and analytical uses in the U.S.
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\3\ EPA has previously adopted the United Nations Environment
Programme's recommendations for criteria for and conditions on the
exemption for laboratory and analytical uses in appendix G of
subpart A of 40 CFR part 82. Under these criteria, the following
laboratory purposes qualify for the exemption: equipment
calibration; use as extraction solvents, diluents, or carriers for
chemical analysis; biochemical research; inert solvents for chemical
reactions, as a carrier or laboratory chemical; and other critical
analytical and laboratory purposes.
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EPA is responsible for allocating essential use allowances in the
U.S. through rulemaking in accordance with provisions in the Act. From
1996 through 1999, EPA implemented the Montreal Protocol's laboratory
exemption under the authority of the original phase-out schedule
specified in the Act at section 604(a). Under section 604(a), Table 2,
EPA could authorize production and import of carbon tetrachloride and
other class I ODSs in amounts that did not exceed 15 percent of the
baseline amount for each substance (the amount of CFCs and halons
consumed in 1986 is the baseline amount for these chemicals, and the
amount of carbon tetrachloride consumed in 1989 is the baseline amount
for this chemical) through 2001 for methyl chloroform and through 1999
for all other class I ODSs. The actual amounts of class I ODSs
previously supplied to laboratories under this global essential use
exemption are listed in Table III below. These amounts were far below
15 percent of baseline for these substance (See Table III for the
quantities of class I ODSs supplied to laboratories under this previous
essential use exemption versus the baseline amount of each chemical as
defined at 40 CFR 82.6.) EPA implemented the laboratory use exemption
as part of the phase-out described in section 604(a) without granting a
specific allocation.
The original phase-out schedule specifies that production and
consumption of carbon tetrachloride and other class I substances should
be zero in the year 2000. While section 604(d) does provide explicit
exemptions to the ban on production and consumption of class I ODSs for
use in medical devices and various other uses such as halons for
aviation safety, and methyl chloroform for nondestructive testing of
metal fatigue, the Act does not explicitly provide or prohibit an
exemption for laboratory and analytical uses. Thus, in the November 2,
1999 proposed rule allocating essential use allowances for calendar
year 2000, we identified the possibility that in the year 2000 and
beyond, EPA might not be able to provide a laboratory essential use
exemption under section 604(d) for most class I ODSs, including CFCs,
halons, carbon tetrachloride, or hydrobromofluorocarbons (HBFCs).
We also explained in the proposal that the ban would apply only to
the import and production of class I ODSs for laboratory uses and would
not apply to their actual use in the laboratory. Thus, laboratories
could continue to use stockpiles of class I ODSs produced or imported
prior to January 1, 2000, and lab suppliers could continue to buy and
sell laboratory grade class I ODSs held in stock to laboratories. We
also stated that if EPA determined in the final rulemaking that
essential use exemptions for laboratory uses were no longer available,
the supply of this subset of class I ODSs would be finite, and once
domestic stockpiles were depleted, laboratories would cease to have
access to these chemicals. Finally, EPA solicited comment on the above
interpretation and other possible interpretations of the statutory
requirements related to EPA's ability to grant essential use exemptions
for laboratory and analytical uses.
II. Overview of Comments
EPA initially received three comments concerning laboratory uses in
response to the NPRM published on November 2, 1999.\4\ One commenter,
who represents research-based
[[Page 14762]]
pharmaceutical and biotechnology companies, stated that EPA can and
should continue to allow a laboratory use exemption for all ODSs in
order to ensure that research on new materials is as unrestricted as is
reasonably possible. The commenter said that the ability to purchase
and to import small quantities of various ODSs may be necessary in
early stages of research on new compounds since in synthesizing some
chemicals, it may be difficult to obtain the desired reaction product
if an ODS cannot be used as a reagent. According to the commenter,
while companies' efforts for developing compounds may devote the time
and resources necessary to redesign the approach for synthesizing a
chemical in the later stages, for the early stages of developing
compounds, the turnover and attrition rates are so high that an
inability to purchase a critical starting material may result in
leaving unexplored an entire category of potentially therapeutic
molecules. According to the commenter, a verbal survey of
pharmaceutical companies turned up only a few who had purchased any
ODSs for laboratory use in the last two or three years. These instances
were one-time purchases of a few grams of material for use in research.
In at least one case during 1999, the material had to be imported, as
it was not available for purchase within the United States. The
commenter believes that manufacture and importation at this rate of
usage represent a legitimate de minimis activity, especially when
contrasted with the ODS released by a single refrigerant leak from a
large chiller. The commenter believed that EPA should continue to allow
the manufacture and importation of all ODS for laboratory and
analytical use, subject to the limitations in 40 CFR part 82, subpart
A, appendix G.
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\4\ The three commenters were the Pharmaceutical Research and
Manufacturers of America, Hoffmann-La Roche, Inc., and Gardner,
Carton & Douglas, representing the CFC Consortium.
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The second commenter is a pharmaceutical company who also opposes
the deletion of EPA's previous essential use exemption for laboratory
and analytical uses, and asks that EPA provide a de minimis exemption
for class I ODSs for these uses. This commenter stated that the use of
carbon tetrachloride is critical as a laboratory solvent and co-reagent
in laboratory synthetic development procedures involving the reduction
and dehydration of certain intermediates that lead to derivatives used
in research and development programs for test drugs. They stated that
although it may be possible to substitute other solvents for these
uses, any transition would require a commitment of additional time and
resources, and success cannot be assured. This commenter also stated
that carbon tetrachloride is one of the only solvents for Nuclear
Magnetic Resonance (NMR) analytical chemical procedures used to
elucidate the molecular structure of certain complex organic chemicals.
Finally, this commenter stated that the total quantity of carbon
tetrachloride currently used in these laboratory synthetic and
analytical procedures is estimated to be 16 liters annually, most of
which is ultimately disposed for treatment as hazardous waste. This
commenter also stated that EPA can allow the laboratory use exemption
under the Act, which provides a basis for a de minimis exemption
according to the Court in Alabama Power Company v. Costle (636 F. 2d
323, 360-61 (D.C. Cir. 1979)), when the ``burdens of regulation yield a
gain of trivial or no value.''
Another commenter, a consortium that represents pharmaceutical
companies who produce metered dose inhalers, urged EPA to retain the
laboratory-use exemption at least for the narrow purpose of testing
those CFCs which are destined for use in metered dose inhalers (MDIs).
MDI manufacturers are required by the Food and Drug Administration
(FDA) to test each batch of CFC propellant used in MDIs to assure that
the CFCs conform to various specifications, including limits on
impurity levels. The commenter stated that removing the laboratory-use
exemption would substantially and unnecessarily complicate the process
of acceptance testing for MDIs for companies that manufacture the MDIs
in Europe and then import them to the U.S. The commenter believed that
under the proposal, such companies would need to request and receive a
special essential-use allowance allocation for a minuscule amount of
CFCs used to test the MDIs in the U.S., rather than relying upon the
laboratory use exemption.
This commenter stated that EPA is not restricted to granting
exemptions to those enumerated in section 604(d) of the Act, and that
the Agency could consider a de minimis exemption. The commenter also
suggested that CFCs imported to the U.S. to be analyzed as to whether
they meet the FDA specifications for use in metered dose inhalers could
be exempted using the authority at 604(d) of the Act. This section of
the Act provides an exemption for import and production of CFCs for use
in medical devices. In particular, the commenter stated that the use of
CFCs for use ``in'' a medical device, an exempt essential use under
section 604(d)(2), could include the CFCs used for laboratory testing
as part of the CFCs used in the manufacture of MDIs.
EPA agrees that a de minimis exemption for laboratory essential
uses is appropriate, for the reasons described below in section III.
Because we are addressing the wider issue for all laboratory uses of
class I ODSs, we do not believe it is necessary at this time to decide
whether CFCs (Class I ODSs) used to test MDIs fall under the medical
device essential use exemption of section 604(d)(2). Companies can rely
upon the laboratory use exemption to obtain CFCs for acceptance testing
of MDIs.
Because of the small number of initial comments, we felt it would
be important to gather additional stakeholder input on the laboratory
use portion of the rule while finalizing the year 2000 allocation of
essential use allowances for metered dose inhalers and the Space
Shuttle and Titan Rockets. The interim final rule allocating essential
use allowances for the year 2000 for use in metered dose inhalers and
the Space Shuttle and Titan Rockets was published on January 6, 2000
(65 FR 716), and the final rule was published on June 30, 2000 (65 FR
50524).
EPA solicited additional stakeholder input on the laboratory
essential use exemption by working with Sigma Aldrich, a major supplier
of class I ODSs for laboratory uses. Sigma Aldrich posted a notice on
their website stating that EPA was proposing to disallow the import and
production of class I ODSs for use in laboratory and analytical uses,
and that EPA would consider comments on this issue. In response to the
Sigma Aldrich announcement, EPA received over 70 comments requesting
that EPA continue to allow lab uses of class I ODSs in the year 2000
and beyond. (Comments are posted in docket # A-93-39.)
One group of commenters stated that an exemption for laboratory and
analytical uses for class I ODSs is critical because many regulatory
programs within the EPA and at the state level require that various
pollutants, including class I ODSs such as carbon tetrachloride and
certain CFCs, be monitored in water, air and soil. These programs
include those promulgated under the Clean Water Act, the Clean Air Act,
the Resource Conservation and Recovery Act (RCRA), and the
Comprehensive Environmental Response, Compensation, and Liability Act
(CERCLA or Superfund). In order to test for the presence and quantify
the amount of any chemical in water, soil, or air, the testing
equipment must be calibrated using high purity samples of
[[Page 14763]]
the chemical of interest as a standard. Then testers must analyze a
sample of water, soil, or air using the specific methodology for
identifying concentrations of the chemical established by various
public health agencies including EPA. As explained more fully in
section III below, EPA agrees that these types of monitoring tests do
require the use of certain CFCs and that it is appropriate to grant an
exemption for these types of essential laboratory uses.
Table I below contains EPA statutes and environmental testing
regulations which require testing for various class I ODSs. As such,
calibration standards of class I ODSs are necessary to determine
whether the contaminant is present in the sample, and it is not
possible to create an alternative test method that uses no class I
ODSs.
Table I.--Environmental Testing and Monitoring Methods Using Class I
ODSs as Calibration Standards
------------------------------------------------------------------------
Environmental
Authority testing programs Test Method
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Clean Water Act............. Volatile organic Methods 502.2,
compounds in water 524.2, 551.1, 601,
and surface water; 624, 5035 CLP for
National Pollutant volatile organic
Discharge compounds in water.
Elimination System;
National Primary
Drinking Water
Standards--Testing
for volatile
organic compounds
in water.
Clean Air Act............... Hazardous Air Methods TO-14 and TO-
Pollutants; Air 15 for volatile
Toxics; National organic compounds
Ambient Air Quality in air.
Standards--Photoche
mical Air
Monitoring Stations
(PAMS) program.
RCPA/CERCLA................. Solid waste......... Methods 8021B, 8260
for carbon
tetrachloride in
soil and solid
waste.
Occupational Safety and NIOSH/OSHA National Method 1020: for CFC-
Health Act. Institute for 112a and CFC-112 in
Occupational Safety air Method 1003:
and Health/ for halogenated
Occupational Safety hydrocarbons in
and Health air, including
Administration. carbon
tetrachloride
Method 1018: for
CFC-12 in air.
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Table II below contains statutes and the environmental testing
regulations which require testing methods that use class I ODSs as
extractants or solvents. In the future, the Agency believes it may be
possible to use alternatives to some of these testing methods that
would not require class I ODSs:
Table II.--Testing Methods That Require Class I ODSs as Extractants or
Solvents
------------------------------------------------------------------------
Environmental
Authority testing program Test method
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Occupational Safety and NIOSH/OSHA.......... Method 5026:
Health Administration. Measurement of
mineral oil mist in
air.
Clean Water Act............. National Pollutant Method 418.1
Discharge Petroleum
Elimination System. Hydrocarbons, Total
Recoverable; Method
413.1 \5\ and
413.2, Oil and
Greast, Total
Recoverable.
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\5\ Method 1664 Revision A does not use class I ODSs and is available as
an alternative to methods 413.1. Guidance documents on this test
method may be accessed at http://www.epa.gov/ost/methods/oil.htm1.
This alternative method has been available since mid-1999, a
relatively short time. EPA is still in the proces of informing testers
that this alternative method is available and that methods 413.1 and
413.2 are no longer the only acceptable tests to meet EPA
requirements. Testers require time to adjust to learning the new test
procedures, using new equipment and using up or replacing existing
stocks of CFC-113. Therefore, the Agency believes that it is
appropriate to continue to allow methods 413.1 and 413.2 as essential
laboratory uses for calendar year 2001. As discussed below in section
IV, this may no longer be true beginning with calendar year 2002.
The second group of comments that EPA received was from researchers
who utilize class I ODSs in small quantities in the laboratory for a
wide variety of basic science research applications. These commenters
stated that restricting the availability of carbon tetrachloride and
CFCs for laboratory use would be a major impediment to scientific
research, and would put U.S. academic and industrial researchers at a
great disadvantage. They also stated that carbon tetrachloride and CFCs
have long played central roles in a wide variety of investigations
involving these compounds as gas phase samples, solutes, or solvents,
and have been essential in developing a proper understanding of a broad
range of chemical properties and processes whose significance extends
throughout all basic and applied chemical sciences. A few commenters
noted that decreased availability of CFCs and carbon tetrachloride
would significantly restrict the range of compounds available for
pharmaceutical design and would restrict the development of potentially
life-saving therapies. Finally, many commenters stated that the amount
of class I ODSs used in research settings is very small. Some
commenters provided estimates of the amount of CFCs and carbon
tetrachloride used in their particular laboratory uses in a year. These
estimates ranged from as little as twenty-five milliliters or a few
grams, from estimates of some smaller, academic laboratories, to a
maximum of fifty-three liters, for a large pharmaceutical firm.
All commenters, with one exception, urged EPA to continue to
provide an essential use exemption allowing continued production and
import of class I ODSs for laboratory and analytical uses. Many stated
that the majority of responsible researchers store the chemical waste
in sealed bottles, so ODSs used in lab applications typically are not
emitted into the atmosphere. One commenter estimated that only 0.4% to
10% of carbon tetrachloride, the most commonly used ODS in
laboratories, was emitted to the atmosphere rather than recovered.
Again, for the reasons set forth below in section III, EPA has
determined that a de minimis exemption is appropriate for essential
laboratory uses in 2001. Part of the rationale for this determination
is that the controls in place, as noted by the commenters and as
required in appendix G, provides adequate
[[Page 14764]]
assurances that very little, if any, environmental damage will result
from the handling and disposal of the small amounts of class I ODSs
used in laboratory applications.
In summary, commenters stated there are no adequate alternatives
for class I ODS in the following applications:
1. Carbon tetrachloride:
(a) Liver toxicity research.
(b) Research into the functioning of enzymes related to
biodehalogenation, and the study of metabolic routes leading to toxic
effects.
(c) Low molecular weight halogenated compounds including some class
I ODSs are transformed into synthetic ``building blocks,'' a useful
strategy for the development of new medicinal and pharmacological
agents.
(d) As an extractant for organic synthesis and purification, as
well as unreactive solvents for carrying out fundamental chemical
studies.
(e) As a medium to carry out enzymatic reactions.
(f) As a solvent for procedures such as benzylic halogenation.
(g) For use in Nuclear Magnetic Resonance Spectroscopy (NMR)
(Carbon tetrachloride is critical for this use since it is necessary to
use a solvent containing no hydrogen atoms for testing certain
materials.)
(h) In the chemical separation of osmium for geological research
which is a critical step used in determining the absolute age of rocks,
minerals, and meteorites.
2. Various CFC compounds, including CFC-113:
(a) Preparation of kidney tissue for studying the pathogenesis of
kidney disease.
(b) In the study of electrostrictive stimulated Rayleigh scattering
using lasers.
(c) Preparation of antiproliferative glycolypids and analogs of
KRN7000, both of which have potential as anti-cancer agents.
(d) Preparation of adenoviral vectors for gene therapy.
(e) Biochemical investigations into the mechanism of enzyme action.
(f) Hydrologic age dating to determine the pathway and persistence
of ground water contamination by other synthetic chemicals.
The one commenter who believed no exemption was necessary stated
that there are alternatives available and that CFCs and carbon
tetrachloride do not need to be available for laboratory and analytical
uses. EPA disagrees. For nearly all laboratory uses identified, such as
class I ODSs used as calibration standards, there are no alternatives
available. Because the use of class I ODSs are necessary to provide the
public with important environmental and health testing, EPA believes
that an essential use exemption for laboratory uses is justified for
2001. For the one testing method where we are aware of an alternative
method that does not require class I ODS, the method for testing oil
and grease in water, the Agency believes that users should switch to
the alternative method as soon as is reasonably possible.
EPA received one comment stating that because environmental testing
laboratories are required to conduct testing using methods specified by
EPA using class I ODS, the taxes placed on these substances should be
waived since the laboratory has no alternative method available to
them. Under the Omnibus Budget Reconciliation Act of 1989, Public Law
101-239, section 7506, Congress imposed a new federal tax on CFCs and
other ODSs to encourage cuts in consumption of these chemicals and to
promote the development of alternatives. EPA does not have the
authority to waive this or any other tax.
III. De Minimis Exemption for Essential Laboratory and Analytical
Uses of Class I ODSs in 2001
With today's action, EPA is making the determination that continued
import and production of class I ODSs for laboratory and analytical
uses in 2001 is allowable as a de minimis use under the Act for the
following reasons:
1. The amount produced for this use is infinitesimal and trivial
when compared to the amount of class I ODSs produced prior to the
regulatory ban in 1996 when baseline production allowances of class I
ODS totaled 10,840 metric tons for carbon tetrachloride, and 322,558
metric tons for all CFCs. Furthermore, the amount of class I ODS used
for laboratory uses is approximately two orders of magnitude smaller
than the amount used for metered dose inhalers, and about the same
order of magnitude as the amount of methyl chloroform used in the Space
Shuttle and Titan Rockets, both of which receive an essential use
exemption. (For a comparison of the amounts, see Tables III and IV
below.)
2. The continued production of small amounts of class I ODSs is
essential for a number of analytical tests mandated by EPA and other
public health agencies as part of programs for protecting the
environment and human health.
3. The nature of these laboratory and analytical applications
involves extremely controlled use and disposal of all chemicals,
including any ODSs. As a result, emissions of the ODSs into the
atmosphere are negligible.
4. The class I ODSs, specifically carbon tetrachloride and CFCs,
are used in small quantities for a myriad of uses in basic science
research and medical research. Disallowing the essential use allowances
for these uses would inhibit important scientific innovations with
important public health benefits such as developing new drug therapies
and research into liver pathogenesis.
In addition to these reasons, EPA believes that a de minimis
essential use exemption for laboratory and analytical uses in calendar
year 2001 is appropriate because:
(A) EPA recognizes the limited grounds for the creation of a de
minimis exemption, but believes such grounds exist by the very nature
of the statutory language contained in Title VI of the Act,
specifically section 604. In addition to the general production phase
out in section 604(a), Congress, by operation of section 604(d), also
provides for exemptions where limited uses would serve an important
public need. EPA believes that the laboratory uses noted today are very
similar to the exemptions provided in 604(d) and serve similar public
purposes. It should be noted that section 604(d) provides for specific
exemptions, but by its express language it does not preclude other
exemptions. Courts have consistently held that where Congress has not
expressly prohibited an exemption there is likely to be a basis for the
justification of de minimis authority to provide an exemption when the
burdens of regulation yield a gain of trivial or no value. (See Alabama
Power Company v. Costle (636 F.2d 323, 360-61 (D.C. Cir. 1979);
Environmental Defense Fund v. EPA (82 F.3d 451, 465 (D.C. Cir. 1996)).
In addition to providing essential laboratory needs as noted above, EPA
also believes that the ban of ODSs for laboratory uses would produce
trivial environmental benefit.
(B) As noted below in Table III of this preamble, EPA expects there
to be very small quantities of ODSs actually consumed under this
exemption and such quantities are well below the cap for certain
exemptions contained in section 604(d). In light of the conditions
already applied to the global exemption by appendix G to subpart A of
40 CFR part 82, EPA believes that any additional controls on laboratory
uses would provide little, if any, benefit. Appendix G also sets forth
the limited laboratory uses for the import or new production of ODSs.
(C) EPA believes a de minimis exemption in this circumstance is
also consistent with the language and intent of section 614(b).
Although this section requires EPA to implement both the
[[Page 14765]]
Montreal Protocol and the Clean Air Act, and in cases of conflict to
implement that which is more stringent, it is believed that the
guidelines set forth in Decision IV/25 and in appendix G of subpart A
of 40 CFR part 82 provide stringent controls on how the categorical
exemption for laboratory uses shall be applied. Therefore, EPA believes
it is meeting its legal obligations and will continue to assess
annually whether such laboratory uses are indeed essential.
(D) As noted above, the use of ODSs are required in many
environmental and health tests mandated by the government. The
requirements of these tests would go unfulfilled should EPA implement
only the language contained within the Act. Therefore, EPA believes it
is appropriate to use the de minimis ``tool'' to avoid this otherwise
inherent conflict. The courts have held that the ``literal meaning of a
statute need not be followed where the precise terms lead to absurd or
futile results, or where failure to allow a de minimis exemption is
contrary to the primary legislative goal.'' (See State of Ohio v. EPA
(997 F.2d 1520, 1534 (D.C. Cir. 1993); Public Citizen v. Young (831
F.2d 1108 (D.C. Cir. 1987)). Given the number of environmental and
health statutes with laboratory tests which require the use of ODSs it
is likely that Congress did not intend for a ban on such uses by the
provisions set forth in the Clean Air Act.
Based on these considerations, EPA is allocating a de minimis
exemption for all laboratory and analytical uses for production and
import of class I ODSs for the year 2001. There is no cap on the amount
that may be produced or imported for the year 2001, consistent with the
Montreal Protocol's treatment of laboratory uses. Laboratory and
analytical uses must meet the conditions and criteria described in
appendix G of subpart A of 40 CFR part 82. We will continue the same
monitoring and reporting requirements for 2001 that we previously
finalized on August 5, 1998 as part of the regulations for the phase
out of class I ODSs at 40 CFR 82.13 (u) through (z) (63 FR 41625).
These requirements are described below.
Environmental Impact of the Laboratory Essential Use Exemption
As illustrated by Table III, the quantity of class I ODSs supplied
to various laboratories in the U.S. under the general essential use
exemptions in the year 1996 through 1999 have been extremely small.
These quantities are small even when contrasted with the relatively
small quantities of class I ODSs used in the U.S. in metered dose
inhalers and for the Space Shuttle and Titan Rocket, both essential
uses for which the Act provides a specific exemption (see Table IV).
The Act at section 604(d)(3) also provides an exemption for the use of
halon-1211, halon-1301, and halon-2402 for the purposes of aviation
safety.
Table III.--Amount of Class I ODSs Supplied to Laboratories in the U.S.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Baseline Amount of chemical supplied to labs by year \3\
consumption (metric tons)
Ozone allowance ------------------------------------------------------
Chemical depleting (metric tons)
potential as defined by 40 1999 1998 1997 1996
CFR 82.6
--------------------------------------------------------------------------------------------------------------------------------------------------------
CFC-11........................................................... 1 91,976 0.143 0.11 0.2 0.15
CFC-12........................................................... 1 148,398 0.001 0.001 0.001 0.001
CFC-112.......................................................... 1 5.9 0.001 0.001 0.001 0.001
CFC-113.......................................................... 0.8 71,072 2.761 7.052 11.478 4.478
CFC-114.......................................................... 1 5,171 0.007 0.002 0.006 0.007
CFC-115.......................................................... .001 5,935 0.001 0.001 0.001 0.001
Carbon tetrachloride............................................. 1.1 10,840 9.248 6.694 9.535 10.326
Methyl Chloroform................................................ 0.1 255,991 2.413 2.269 6.695 4.591
Methyl Bromide................................................... 0.7 109 0.014 0.031 0.007 0.023
Hydrobromo-fluorocarbons (Group VII Class I ODSs)................ (*) 40 0.003 0.008 0.004 0.014
--------------------------------------------------------------------------------------------------------------------------------------------------------
\3\ Data taken from U.S. EPA ODS Tracking System.
\*\ Varies with specific chemical.
Table IV.--Amount of Class I ODSs Used for Essential Uses Other Than Laboratory and Analytical Uses in the
U.S.\2\
----------------------------------------------------------------------------------------------------------------
Amount of CFCs (CFC-11, CFC-12, Amount of methyl chloroform used in
Year and CFC-114) used in MDIs the space shuttle and Titan rockets
----------------------------------------------------------------------------------------------------------------
1999.................................... 2630 metric tons............... 11 metric tons.
1998.................................... 2425 metric tons............... 6.4 metric tons.
1997.................................... 2255 metric tons............... 24.5 metric tons.
1996.................................... 2368 metric tons............... 0 metric tons.
----------------------------------------------------------------------------------------------------------------
The amounts of class I ODSs that have been used for laboratory uses is
approximately two orders of magnitude smaller than the amount used for
metered dose inhalers, and about the same order of magnitude as the
amount of methyl chloroform used in the Space Shuttle and Titan
Rockets. The amount of class I ODS used for laboratory uses is four to
six orders of magnitude smaller than the baseline amounts which
represent the amount of class I ODSs used prior to the complete ban
under the phase-out. EPA believes that Congress did not intend to
create a conflict between enforcing programs under the Clean Water Act,
the Resource Conservation and Recovery Act, the Clean Air Act, and the
Comprehensive Emergency Response, Compensation and Liability Act which
require the use
[[Page 14766]]
of class I ODSs as calibration standards, and enforcing a complete ban
on production of class I ODSs under Title VI of the Act. EPA believes
that preventing the use of ODSs to ensure compliance with environmental
statutes uses is contrary to the public welfare and is trivial in terms
of the total amount of ODS emitted into the atmosphere. In addition,
the Agency believes that the public benefit of allowing the continued
use of class I ODSs for basic science research far outweighs any
potential environmental damage by the very small amount of ODSs emitted
into the atmosphere through this use.
Environmental Benefits of Allowing a de Minimis Exemption for
Laboratory and Analytical Uses
As discussed above, EPA and other public health agencies require
testing for many different pollutants in the air, water, and soil,
including carbon tetrachloride and other class I ODSs. Many
environmental remediation and testing programs require monitoring of
carbon tetrachloride, a toxic chemical which causes liver damage and
which EPA classifies as a probable human carcinogen. Carbon
tetrachloride and other class I ODSs are often used in laboratories to
prepare standards to verify that testing and monitoring equipment reads
correctly. Comparison against the standard ensures that the testing
equipment accurately determines the presence of a particular class I
ODS and its concentration in a sample. The use of analytical standards
is critical to detecting the class I ODSs at a concentration near
permit limits.
Table I lists analytical methods requiring carbon tetrachloride or
other class I ODSs under wastewater discharge, waste management and air
permit programs. In addition to these analytical test method
requirements, identification of historical contamination sites often
includes sampling of soil and groundwater and analyses for chlorinated
compounds such as carbon tetrachloride or other class I ODSs. Ongoing
remediation programs, where a class I ODS may be a constituent of
concern, would be adversely affected by disallowing a laboratory
essential use exemption. Without high purity standards, it would be
impossible to analyze samples with the accuracy required to identify
and implement an appropriate remedy or to correctly monitor the
progress of the remediation program for these compounds.
CFCs and other class I ODSs are also required as a solvent or
extractant in tests for other pollutants in environmental and worker
safety programs. (See Table II for examples.) In some cases, the tests
themselves mandate the use of class I ODSs. Until and unless
alternative test methods can be developed and approved by the
applicable governing agencies, laboratories will continue to need class
I ODSs for these required test methods. It may take many years to
develop some of these alternative testing methods, and in some cases,
it may not be possible to find alternatives. The Technical and Economic
Assessment Panel for the Montreal Protocol periodically reviews the
need for specific analytical methods and seeks alternative testing
methods that do not require class I ODSs. In each case where an
alternative method becomes available, regulators will need time to
adopt the alternative method and testers will require time to learn
about and to switch to the alternative testing method. As discussed
below in section IV and above in section II, footnote 5, EPA expects
this to occur for one particular method used in the U.S. for testing
oil and grease in water.
Current EPA and Occupational Safety and Health Administration
(OSHA) regulations have put in place testing requirements to protect
the environment and human health. EPA believes that it would be
contrary to the public welfare to prevent testing that requires using
class I ODSs when those tests protect the environment and human health
unless the hazards of keeping the class I ODSs outweigh the benefits of
these environmental tests. Because of the small amounts of class I ODSs
required for this testing and because these uses emit little or no
ODSs, we believe that the benefits of health and environmental tests
significantly outweigh the potential damage to the ozone layer by
allowing the use of class I ODSs in these tests. The Montreal Protocol
currently allows for such testing through 2005. Also, the Agency
believes that until alternative test procedures are approved that do
not require class I ODSs, preventing use of the class I ODSs needed to
perform required environmental testing would create an untenable
situation for many laboratories and state and local environmental and
public health agencies.
Finally, calibration standards of class I ODSs are critical for
enforcement of Title VI, the portion of the Act which protects
stratospheric ozone. Calibration standards are necessary to calibrate
the chemical identification devices that customs agents use to test
whether imports of chemicals are properly labeled and are legal imports
of class I ODSs. Without calibration standards available, the ability
of the customs agents to properly identify class I ODSs would be
compromised as would the ability of the U.S. to enforce the Act and the
Montreal Protocol.
Benefits in Allowing Laboratory Essential Use Allowances for Medical
and Basic Science Research
Despite the very small quantities of class I ODSs used for basic
science research, the Agency believes that disallowing production and
import of class I ODSs would needlessly disadvantage scientists
pursuing important discoveries, for example:
(1) Investigating potential new drug therapies. A class I ODS
sometimes is necessary to synthesize various compounds to investigate
efficacy at an early stage of research on the new drug. Not allowing
access to class I ODSs by removing the exemption for laboratory uses
could slow the development of promising treatments for a variety of
medical problems.
(2) Carbon tetrachloride has been used for many years to induce
liver damage in rats as a model for liver disease in humans. Use of a
different chemical would yield non-comparable results to previous
studies, which would adversely affect research on this topic in the
U.S.
(3) Carbon tetrachloride is considered the ideal solvent in
analytical procedures using Nuclear Magnetic Resonance to determine the
molecular structure of organic substances. Organic compounds can be
potentially useful in a variety of applications, such as vitamins,
dietary supplements and flavorings.
(4) Carbon tetrachloride is essential in determining the age of
geologic formations. Such research is useful for understanding the
geology of an area.
Laboratory and Analytical Uses of Ozone Depleting Substances Considered
Essential Under the Global Exemption for 2001
The United Nations Environment Programme (UNEP) recommended
criteria for and conditions on the exemption for laboratory and
analytical uses. EPA adopted these recommendations in appendix G of
subpart A of 40 CFR part 82 as part of the regulations for phasing out
class I ODSs. Under the criteria of this appendix, the following
laboratory uses qualify for the exemption: Equipment calibration; use
as extraction solvents, diluents, or carriers for chemical analysis;
biochemical research; inert solvents for chemical reactions, as a
carrier or laboratory chemical; and other critical analytical and
laboratory
[[Page 14767]]
purposes. Class I ODSs used in manufacture of a product in a laboratory
do not qualify for this exemption.
Appendix G of subpart A of 40 CFR part 82 also specifies certain
conditions for laboratory uses of class I ODSs under the exemption. The
class I ODSs must meet standards of purity (at least 99.0 or 99.5
percent purity, depending on the substance). The class I ODSs may then
be mixed with other chemicals as they are customarily used in the
laboratory. The class I ODSs or mixtures must be supplied in particular
kinds of containers (re-closable containers or high pressure cylinders
smaller than three liters or in glass ampules of 10 mm or less). These
containers must be marked clearly as substances that deplete the ozone
layer which are restricted to laboratory use and analytical purposes.
In addition, there are requirements for recycling and disposal.
Finally, the Parties, including the U.S., have requirements for
reporting the purity, quantity, and test procedures required for each
class I ODSs, the efforts for eliminating its use, and regulations or
other requirements on controlled substances.
EPA believes that appendix G of subpart A of 40 CFR part 82
clarifies the allowable, essential uses of class I ODSs under the
global exemption for laboratory and analytical essential uses. We
continue to require that the conditions of this appendix apply to
today's exemption.
Reporting Requirements Related to Laboratory and Analytical Essential
Uses of Ozone Depleting Substances
Any person obtaining class I controlled substances after the phase-
out under the laboratory use exemption in today's action is subject to
all the restrictions and requirements in other sections of 40 CFR part
82, subpart A. Holders of essential-use allowances or persons obtaining
class I controlled substances under the essential-use exemptions must
comply with the record keeping and reporting requirements in 40 CFR
82.13 (u) through (z). In short, these regulations require the
following:
(a) Laboratory customers purchasing a controlled substances under
the global laboratory essential-use exemption must provide the
producer, importer or distributor with a one-time-per-year
certification for each controlled substance that the substance will
only be used for laboratory applications and will not be resold or used
in manufacturing. The certification must also include:
(1) The identity and address of the laboratory customer;
(2) The name and phone number of a contact person for the
laboratory customer; and
(3) The name and quantity of each controlled substance purchased,
and the estimated percent of the controlled substance that will be used
for each listed type of laboratory application (Sec. 82.13(y)).
(b) Any distributor of laboratory supplies receiving an essential
use exemption for sale to laboratory customers must:
(1) Report quarterly the quantity received of each controlled
substance from each producer or importer (Secs. 82.13(v) and 82.13
(u));
(2) Report quarterly the quantity of each controlled substance
purchased by each laboratory customer whose certification was
previously provided to the distributor (Sec. 82.13(x)); and
(3) Maintain as records copies of certifications from laboratory
customers provided (Sec. 82.13(w)).
(c) Distributors of laboratory supplies, who purchased class I
controlled substances under the global laboratory essential-use
exemption, and who only sell the class I substances as reference
standards for calibrating laboratory analytical equipment, may be
eligible to report annually instead of quarterly (Sec. 82.13(z)).
For guidance documents and reporting forms, please contact the
Stratospheric Protection Hotline at (800) 296-1996 or (301) 614-3390.
IV. Criteria for Exempting Laboratory and Analytical Uses After
December 31, 2001
Today's rule provides a de minimis exemption for essential
laboratory uses of class I ODSs for 2001 based on the criteria
mentioned in the previous section. These criteria for 2001 are
consistent with the Montreal Protocol and with the requirements for
laboratory uses of class I ODSs in appendix G of subpart A of 40 CFR
part 82. EPA expects to make rulings on laboratory uses of class I ODSs
for future years that will consider similar issues and criteria.
While EPA is making the determination that a de minimis exemption
applies to laboratory essential use allowances for the year 2001, it
should be noted that the Parties to the Montreal Protocol have not
extended the global laboratory and analytical essential-use exemptions
indefinitely. Decision X/19 taken at the tenth meeting of the Parties
in 1998 states that the global laboratory and analytical essential-use
exemption lasts until December 31, 2005 under the conditions set out in
annex II of the report of the Sixth Meeting of the Parties. Decision X/
19 also states that at the annual Meetings of the Parties, on the basis
of information reported by the Technology and Economic Assessment Panel
(TEAP), the Parties may decide on any uses of controlled substances
which should no longer be eligible under the exemption for laboratory
and analytical uses and the date from which any such restriction should
apply. (The full text Decision X/19 is posted in docket A-93-39, and
may also be reviewed at the UNEP website at http://www.unep.org/ozone/)
The Parties at the Eleventh Meeting of the Parties to the Protocol
took Decision XI/15. This decision eliminated the following uses from
the global exemption for laboratory and analytical uses for controlled
substances from the year 2002:
(a) Testing of oil, grease and total petroleum hydrocarbons in
water;
(b) Testing of tar in road-paving materials; and
(c) Forensic finger-printing.
EPA plans to issue a rule through notice and comment rulemaking
that would allocate a global exemption for essential laboratory uses
for the year 2002 in accordance with Decision XI/15. This means that
for the year 2002, EPA would provide a global exemption to the ban on
production and import of class I ODSs for laboratory uses, except for
use in those laboratory applications considered non-essential by the
Parties pursuant to Decision XI/15. Therefore, new production or import
of class I ODSs for non-essential uses would be prohibited beginning
January 1, 2002.
EPA notes that in the U.S., class I ODSs generally are not used for
testing of tar in road-paving materials and forensic finger-printing.
Thus, we expect that the major impact of decision XI/15 will be upon
testing of oil, grease and total petroleum hydrocarbons in water. The
Clean Water Act requires testing for the conventional pollutant ``oil
and greases'' in water. The analytical methods for measuring ``oil and
greases'' include EPA methods 413.1, 413.2 and 418.1, which use CFC-
113. Pursuant to Decision XI/15, EPA will however propose that methods
for testing oil and grease using class I ODSs will no longer be
considered ``essential'' in the year 2002 and thus newly produced CFC-
113 will not be available for those EPA test methods. However, this
should not cause a problem for laboratories. On May 14, 1999, EPA
published an alternative analytical method for these tests that does
not require using class I ODSs: Method 1664 Revision A: N-Hexane
Extractable Material (HEM; Oil and Grease) and Silica Gel Treated--
Hexane Extractable
[[Page 14768]]
Material (SGR-HEM; Nonpolar Material) by Extraction and Gravimetry. EPA
promulgated method 9071B to replace method 9070 and incorporates Method
1664 for use in EPA's Resource Conservation and Recovery Act programs.
For more information on method 1664, please reference EPA's Office of
Water website at http://www.epa.gov/ost/methods/oil.html. For technical
information regarding Resource Conservation and Recovery Act test
methods and regulations please call the Office of Solid Waste Methods
information and communication exchange at (703) 821-4690. For technical
information regarding testing methods required under the Clean Water
Act, call the Office of Water Resource Center at (202) 260-7786.
Pursuant to decision X/19, the TEAP will continue to make
recommendations for laboratory uses which no longer require class I
ODSs in the future. The Parties to the Protocol may disallow additional
uses from the global ban on essential use exemptions in the future.
Currently, there are no recommendations by the TEAP to disallow any
additional laboratory uses beyond those listed in decision XI/15. If
the Parties decide to disallow any other laboratory uses, EPA will
issue regulations to enforce those decisions. Further, EPA reserves the
right to determine that a particular test method is non-essential in
the United States, even if it continues to be considered essential by
the Parties.
V. Administrative Requirements
A. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector.
Under section 202 of the UMRA, EPA generally must prepare a written
statement, including a cost-benefit analysis, for proposed and final
rules with ``Federal mandates'' that may result in expenditures by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100 million or more in any one year. Before
promulgating an EPA rule for which a written statement is needed,
section 205 of the UMRA generally requires EPA to identify and consider
a reasonable number of regulatory alternatives and adopt the least
costly, most cost-effective or least burdensome alternative that
achieves the objectives of the rule. The provisions of section 205 do
not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective or least burdensome alternative if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted. Section 204 of the UMRA requires the
Agency to develop a process to allow elected state, local, and tribal
government officials to provide input in the development of any
proposal containing a significant Federal intergovernmental mandate.
Before EPA establishes any regulatory requirements that may
significantly or uniquely affect small governments, including tribal
governments, it must have developed under section 203 of the UMRA a
small government agency plan. The plan must provide for notifying
potentially affected small governments, enabling officials of affected
small governments to have meaningful and timely input in the
development of EPA regulatory proposals with significant Federal
intergovernmental mandates, and informing, educating, and advising
small governments on compliance with the regulatory requirements.
Today's rule contains no Federal mandates (under the regulatory
provisions of Title II of the UMRA) for State, local, or tribal
governments or the private sector. Because this rule imposes no
enforceable duty on any State, local or tribal government it is not
subject to the requirements of sections 202 and 205 of the UMRA. EPA
has also determined that this rule contains no regulatory requirements
that might significantly or uniquely affect small governments;
therefore, EPA is not required to develop a plan with regard to small
governments under section 203. Finally, because this rule does not
contain a significant intergovernmental mandate, the Agency is not
required to develop a process to obtain input from elected state,
local, and tribal officials under section 204.
B. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether this regulatory action is significant and
therefore subject to OMB review and the requirements of the Executive
Order. The Order defines significant regulatory action as one that is
likely to result in a rule that may:
(1) Have an annual effect on the economy of $100 million or more,
or adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities;
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlement, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
(4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
It has been determined by OMB and EPA that this action is not a
significant regulatory action under the terms of Executive Order 12866
and is therefore not subject to OMB review under the Executive Order.
C. Paperwork Reduction Act
This action does not add any information collection requirements or
increase burden under the provisions of the Paperwork Reduction Act, 44
U.S.C. 3501 et seq. The Office of Management and Budget (OMB)
previously approved the information collection requirements contained
in the final rule promulgated on May 10, 1995, and assigned OMB control
number 2060-0170 (EPA ICR No. 1432.16). The information collection
requirements were revised in a direct final rule on August 4, 1998 (EPA
ICR No. 1432.17).
Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements;
train personnel to be able to respond to a collection of information;
search data sources; complete and review the collection of information;
and transmit or otherwise disclose the information.
An Agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.
D. Executive Orders 13084 and 13175: Consultation and Coordination With
Indian Tribal Governments
On January 1, 2001, Executive Order 13084 was superseded by
Executive Order 13175. However, this rule was developed during the
period when Executive Order 13084 was still in force,
[[Page 14769]]
and so tribal considerations were addressed under Executive Order
13084.
Under Executive Order 13084, EPA may not issue a regulation that is
not required by statute, that significantly or uniquely affects the
communities of Indian tribal governments, and that imposes substantial
direct compliance costs on those communities, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by the tribal governments, or EPA consults with those
governments. If EPA complies by consulting, Executive Order 13084
requires EPA to provide to the Office of Management and Budget, in a
separately identified section of the preamble to the rule, a
description of the extent of EPA's prior consultation with
representatives of affected tribal governments, a summary of the nature
of their concerns, and a statement supporting the need to issue the
regulation. In addition, Executive Order 13084 requires EPA to develop
an effective process permitting elected officials and other
representatives of Indian tribal governments to provide meaningful and
timely input in the development of regulatory policies on matters that
significantly or uniquely affect their communities.'' Today's rule does
not significantly or uniquely affect the communities of Indian tribal
governments. Accordingly, the requirements of section 3(b) of Executive
Order 13084 do not apply to this rule.
E. Regulatory Flexibility Analysis
EPA has determined that it is not necessary to prepare a regulatory
flexibility analysis in connection with this final rule. EPA has also
determined that this rule will not have a significant economic impact
on a substantial number of small entities. For purposes of assessing
the impact of today's rule on small entities, small entities are
defined as (1) a small business that manufactures or sells chemicals
and has 500 or fewer employees; (2) a small governmental jurisdiction
that is a government of a city, county, town, school district or
special district with a population of less than 50,000; and (3) a small
organization that is any not-for-profit enterprise which is
independently owned and operated and is not dominant in its field.
After considering the economic impacts of today's final rule on
small entities, EPA has concluded that this action will not have a
significant economic impact on a substantial number of small entities.
Without today's direct final, manufacturers of ODSs for laboratory uses
would be subject to the general ban on the production and import of
class I ozone depleting substances under the Clean Air Act. This action
reduces regulatory burden by providing an exemption to the ban for the
production and import of class I ozone depleting substances
specifically for laboratory and analytic uses.
Although this final rule will not have a significant economic
impact on a substantial number of small entities, EPA nonetheless has
tried to reduce the impact of this rule on small entities. The rule
itself is an exemption which reduces the burden of the phase out of
ozone depleting substances. We requested comment from laboratory users,
some of whom work in small research laboratories, in the development of
today's rule and have issued an exemption from a ban otherwise
applicable.
F. Applicability of Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
Executive Order 13045: ``Protection of Children from Environmental
Health risks and Safety Risks'' (62 FR 19885, April 23, 1997) applies
to any rule that (1) is determined to be ``economically significant''
as defined under Executive Order 12866, and (2) concerns an
environmental health and safety risk that EPA has reason to believe may
have a disproportionate effect on children. If the regulatory action
meets both criteria, the Agency must evaluate the environmental health
or safety effects of the planned rule on children, and explain why the
planned regulation is preferable to other potentially effective and
reasonably feasible alternatives considered by the Agency. EPA
interprets Executive Order 13045 as applying only to those regulatory
actions that are based on health or safety risks, such that the
analysis required under section 5-501 of the Order has the potential to
influence the regulation. This rule is not subject to Executive Order
13045 because it implements the phase-out schedule and exemptions
established by Congress in Title VI of the Clean Air Act.
G. National Technology Transfer and Advancement Act
Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113, section12(d) (15 U.S.C.
272 note) directs EPA to use voluntary consensus standards in this
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus standards bodies. The NTTAA directs EPA
to provide Congress, through OMB, explanations when the Agency decides
not to use available and applicable voluntary consensus standards. This
rule does not involve changing any technical standards. Therefore, EPA
did not consider the use of any voluntary consensus standards.
H. Executive Order 13132 (Federalism)
Executive Order 13132, entitled ``Federalism'' (64 FR 432255,
August 10, 1999), requires EPA to develop an accountable process to
ensure ``meaningful and timely input by State and local officials in
the development of regulatory policies that have federalism
implications.'' ``Policies that have federalism implications'' is
defined in the Executive Order to include regulations that have
``substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government.'' Under
Executive Order 13132, EPA may not issue a regulation that has
federalism implications, that imposes substantial direct compliance
costs, and that is not required by State and local governments, or EPA
consults with State and local officials early in the process of
developing the proposed regulation. EPA also may not issue a regulation
that has federalism implications and that preempts State law unless the
Agency consults with State and local officials early in the process of
developing the proposed regulation.
If EPA complies by consulting, Executive Order 13132 requires EPA
to provide the Office of Management and Budget (OMB), in a separately
identified section of the preamble to the rule, a federalism summary
impact statement (FSIS). The FSIS must include a description of the
extent of EPA's prior consultation with State and local officials, a
summary of the nature of their concerns and the agency's position
supporting the need to issue the regulation, and a statement of the
extent to which the concerns of State and local officials have been
met. Also, when EPA transmits a draft final rule with federalism
implications to OMB for review pursuant to Executive Order 12866, EPA
must include a certification from the agency's Federalism Official
stating that EPA has met the requirements of Executive Order 13132
[[Page 14770]]
in a meaningful and timely manner. This final rule will not have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132. This final rule will affect only
the ability of private entities and the national government to request
production of controlled ozone-depleting substances for use in
laboratory and analytical applications. Thus, the requirements of
section 6 of the Executive Order to not apply to this rule.
VI. Judicial Review
Under section 307(b)(1) of the Act, EPA finds that these
regulations are of national applicability. Accordingly, judicial review
of the action is available only by the filing of a petition for review
in the United States Court of Appeals for the District of Columbia
Circuit within sixty days of publication of the action in the Federal
Register. Under section 307(b)(2), the requirements of this rule may
not be challenged later in the judicial proceedings brought to enforce
those requirements.
VII. Submittal To Congress and General Accounting Office
The Congressional Review Act (CRA), 5 U.S.C. 801 et seq., as added
by the Small Business Regulatory Enforcement Fairness Act of 1996,
generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. Section 808 allows the issuing agency to
make a rule effective sooner than otherwise provided by the CRA if the
agency makes a good cause finding that notice and public procedure is
impracticable, unnecessary or contrary to the public interest. This
determination must be supported by a brief statement. EPA has
determined that this regulation will become effective on May 14, 2001
and thus no good cause finding is necessary. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of the rule in the Federal Register.
This action is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 82
Environmental protection, Administrative practice and procedure,
Air pollution control, Chemicals, Chlorofluorocarbons, Exports,
Imports, Ozone layer, Reporting and recordkeeping requirements.
Dated: March 5, 2001.
Christine Todd Whitman,
Administrator.
40 CFR Part 82 is to be amended as follows:
PART 82--[AMENDED]
1. The authority citation for part 82 continues to read as follows:
Authority: 42 U.S.C. 7414, 7601, 7671-7671q.
Subpart A--Production and Consumption Controls
2. Section 82.4 is amended by revising the introductory text of
paragraph (t), by removing paragraph (t)(1)(iii), and by adding
paragraph (t)(3) to read as follows:
Sec. 82.4 Prohibitions.
* * * * *
(t) Effective January 1, 1996, essential-use allowances are
apportioned to a person under paragraph (t)(2) of this section for the
exempted production or importation of specified class I controlled
substances solely for the purposes listed in paragraphs (t)(1)(i) and
(ii) of this section. From October 5, 1998 through December 31, 1999
production and importation of class I controlled substances for
laboratory and analytical applications are exempted as an essential use
if conducted in accordance with requirements in Sec. 82.13 (u) through
(z) and appendix G to subpart A.
(1) * * *
(2) * * *
(3) A global exemption for class I ozone depleting substances for
laboratory and analytical uses shall be in effect for the year 2001
subject to the restrictions in appendix G of this subpart.
Laboratory and analytical applications are exempted as essential
uses for the year 2001 if conducted in accordance with the requirements
at Sec. 82.13(u) through (z) and appendix G of this subpart and in
accordance with the Montreal Protocol. There is no amount specified for
this exemption.
[FR Doc. 01-6084 Filed 3-12-01; 8:45am]
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