[Federal Register Volume 59, Number 176 (Tuesday, September 13, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-22586]
[[Page Unknown]]
[Federal Register: September 13, 1994]
_______________________________________________________________________
Part V
Environmental Protection Agency
_______________________________________________________________________
Protection of Stratospheric Ozone; Labeling; Petitions for Exemption;
Notice
ENVIRONMENTAL PROTECTION AGENCY
[FRL-5070-8]
Protection of Stratospheric Ozone; Labeling; Petitions for
Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice for proposed decision.
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SUMMARY: On February 11, 1993, the U.S. Environmental Protection Agency
(EPA) published the final labeling regulations implementing section 611
of the Clean Air Act (CAA), as amended by the Clean Air Act Amendments
(CAAA) of 1990. The regulations include a section which permits a
manufacturer to petition EPA to temporarily exempt a product
manufactured with a class I substance from the labeling requirements.
The company must prove that there are no substitutes that: do not rely
on the use of a class I substance; reduce the overall risk to human
health and the environment; and, are currently or potentially
available. Through this action, EPA proposes to grant petitions for
such exemptions for the two specific applications of products
manufactured with class I substances described below, because
substitutes that do not rely on the use of class I substances and
reduce the overall risk to human health and the environment are neither
potentially nor currently available. The effect of this action will be
to provide the extensions necessary for these two petitioners to
develop potentially available substitutes.
ADDRESSES: Copies of information relevant to these petitions are
available for inspection in public docket A-91-60 at the Air Docket
(LE-131) of the EPA, room M-1500, 401 M Street, SW., Washington, DC
20460 between the hours of 8:30 a.m. to noon and 1:30 p.m. to 3:30 p.m.
Monday through Friday.
Any comments, in duplicate, from interested parties should be
addressed to the docket with a copy forwarded to Mavis Sanders,
Stratospheric Protection Division (6205-J), Office of Air and
Radiation, U.S. Environmental Protection Agency, 401 M Street, SW.,
Washington, DC 20460. A reasonable fee may be charged for copying
services.
FOR FURTHER INFORMATION CONTACT: Mavis Sanders, Stratospheric
Protection Division (6205-J), Office of Air and Radiation, U.S.
Environmental Protection Agency, 401 M Street, SW., Washington, DC
20460, (202) 233-9737.
SUPPLEMENTARY INFORMATION:
I. Background
Section 611 of the Clean Air Act, as amended, requires EPA to
promulgate regulations requiring labeling of products manufactured
with, and products and containers containing, ozone-depleting
substances. On February 11, 1993 at 58 FR 8136, EPA published the final
regulations at 40 CFR part 82, subpart E (40 CFR 82.100 et seq).
Section 82.120 of the final labeling regulations (40 CFR 82.120),
states that a company may petition EPA to temporarily exempt a product
manufactured with a class I substance. To get the exemption, the
company must prove that there are no substitutes that: (1) Do not rely
on the use of a class I substance; (2) reduce the overall risk to human
health and the environment; and (3) are currently or potentially
available. In the regulations, EPA defines ``potentially available'' to
mean that adequate information exists to support a determination that a
substitute for a class I substance is environmentally acceptable,
economically viable, and technologically feasible.
The petition provision allows the Agency to exempt products
manufactured with class I substances from the labeling requirements
where a company shows that it has been unsuccessful in identifying a
commercially or potentially available alternative substance or
manufacturing process for its current use of the class I substance and
where the Agency finds that no such alternative substance or process is
``potentially available.'' The two petitions claimed that alternatives
were not ``potentially available'' at this time. In one case, the
argument was made that additional time is required in order to
accommodate an extensive evaluation and approval process required by
another Federal entity; and, in the other case, implementation of
possible substitutes/manufacturing processes remain uncertain,
requiring additional development of the possible alternative process
before full-scale construction of three new manufacturing facilities
can begin.
As part of the petition review process, EPA developed criteria by
which to evaluate the submissions. Unlike the Significant New
Alternatives Policy Program (SNAP) petitions naming acceptable
substitutes for eight sectors of industry submitted under section 612
of the CAA, the petitions submitted under section 611 are reviewed on a
case-by-case basis with careful attention given to each application of
a class I substance in a manufacturing process. The Agency considered
all of the factors below in determining whether to accept or reject a
petition with regard to the technological feasibility and the
environmental acceptability of a substitute.
In evaluating technological feasibility, EPA considers when the
company first began investigating alternative substances or processes
to replace their uses of class I substances; EPA's knowledge about the
product/manufacturing process and possible substitutes; whether
parallel manufacturers of similar products have come up with
substitutes; whether a timeline has been developed for implementation
of a substitute, including research and development of a substitute
process where applicable; and, whether the timeline seems reasonable
where no substitute is commercially available. In addition, the Agency
considers a company's constraints (technology, other Federal
requirements, etc.) in order to determine whether a change is within
the control of the company; whether a company is able to state what it
must specifically do to implement the substitute; whether training and
procurement of equipment and manufacturing materials are accessible;
what measures have been taken to understand and solve the ``unknowns;''
whether vendors exist that can meet the product's manufacturing needs;
and whether the company has discussed its manufacturing needs with
these vendors.
In evaluating environmental acceptability, EPA considers whether a
substitute is environmentally implementable in terms of the available
technology.
In general these criteria were considered collectively. However,
EPA believes that for most companies, implementation of an alternative,
whether it be a drop-in replacement or a complete overhaul of the
production process, often entails significant cost and time
constraints. EPA recognizes that companies need lead time in
establishing a labeling program or installing an alternative technology
where companies have chosen to switch from a class I substance to a
substitute in order to comply with the regulations. Companies that have
not implemented a substitute are required to label their products until
they have implemented a substitute. Therefore, where a company's early
efforts to replace its uses of controlled substances are prevented
through unavoidable obstacles beyond its control, such as a required
Federal review or permit program, or where a substitute requires
additional development through testing due to unknown or unavoidable
impediments, EPA has placed greater weight on such circumstances in
developing its determinations, because the ability of a company to
switch to an alternative is seriously hampered by circumstances outside
of its control.
EPA emphasizes that its process of evaluating a company's request
for exemption from the labeling requirements is a different review
process from the essential use exemption authorized by the Parties to
the Montreal Protocol on Substances that Deplete the Ozone Layer (the
Parties) and could well reach different conclusions. Under the Montreal
Protocol process, member countries can put forth nominations for
essential use exemptions that would allow for continued production of
ozone-depleting substances after the production phaseout, to be used in
an application for which there are no suitable substitutes. The Parties
receive and review these applications individually and may decide to
grant particular exemption requests. If the Parties agree that a
particular applications is essential, additional production of an
ozone-depleting substance will be authorized for that particular
application after the phaseout has taken effect.
EPA published a notice in the Federal Register on May 20, 1993 (58
FR 29410), requesting essential use nominations for CFCs, carbon
tetrachloride, methyl chloroform and HBFCs by July 19, 1993. The Agency
requested nominations for essential uses of halons on February 12, 1993
(58 FR 6788). Companies nominated their specific applications of a
controlled substance to receive an exemption from the production and
consumption phaseout schedule. These nominations are reviewed first by
EPA and then by the Montreal Protocol Parties. The Parties recognized
the need for such exemptions because of the accelerated phaseout dates.
Exemptions, if any, will be granted at the Sixth Meeting of the
Parties, which may be held as early as June 1994. Nominations for halon
essential uses will be considered earlier since halons are subject to
an even more rapid phaseout schedule. Nominations for essential uses
will continue to be considered each year at subsequent meetings of the
Parties; thus, companies will have additional opportunities to request
an essential use exemption in the future. The process will entail a
rigorous international review process, which is described in Decision
IV/25 of the Fourth Meeting of the Protocol. Therefore, if a company
requests a temporary exemption from the labeling requirements through
Sec. 82.120 of the labeling regulations, and also wishes to request an
exemption for use of controlled substances beyond the phaseout date,
the company must separately nominate its use for an essential use
exemption to EPA.
II. Petitions for Exemption
Today, EPA proposes to accept two petitions. The first petition,
submitted by the Upjohn Company (Upjohn), contends that Upjohn has a
substitute for its use of CFC-12 as a sterilant; however, a review and
evaluation period is required by the Food and Drug Administration (FDA)
before the alternative can be approved and then implemented. The
company therefore contends that a substitute is not potentially
available until the FDA review is completed. EPA is proposing to grant
this exemption until August 31, 1994.
The other petition, submitted by the E.I. DuPont de Nemours & Co.
(DuPont), is classified as confidential business information and thus,
EPA cannot disclose the name of its product. (Dupont has produced a
petition containing nonconfidential information that has been placed
into the docket). This product, which consists of certain fine
synthetic fibers, uses CFC-11 as a basic process solvent in the fiber
manufacturing process. Although Dupont has identified a possible
substitute, it must develop, implement and test a major process change
to replace the existing manufacturing facilities. Therefore, Dupont
contends that a substitute is not potentially available until this
process has been identified and current facilities have been
successfully modified to ensure that this alternative can in fact be
accommodated.
A. The Upjohn Company
The Upjohn Company (Upjohn) submitted a petition to exempt six of
its pharmaceutical products that are currently sterilized using CFC-12
from the labeling requirements. The products are Hydrocortisone,
Isoflupredone Acetate, Methylprednisolone acetate, Medroxyprogesterone
acetate, Neomycin Sulfate and Prednisolone Hydrous USP. The company has
submitted a request to the Food and Drug Administration (FDA) to accept
Spectinomycin Hydrochloride, a non-ozone-depleting substance, as a
replacement for CFC-12. The alternative is currently used by Upjohn to
sterilize some of its other products; however, FDA review and
evaluation is required before it can make a change. Therefore, Upjohn
is submitting this petition based on the premise that the above
mentioned products are not currently or potentially available until FDA
approval is obtained. There are no environmental concerns identified
with this substitution; the company clearly has an alternative which it
has instituted in other applications and requires additional time
before it can use the substitute in the above applications.
Without an exemption, the company asserts that it would be required
to label the five products until FDA concludes its review, which would
result in a substantial financial loss with little if any environmental
benefit. The company also maintains that by labeling its five products
while FDA reviews their submission, users could become confused by the
warning statement and could decide to discontinue use of the products
against the advice of their physicians. Upjohn indicates that such an
outcome could result in increased absenteeism from work and potentially
severe negative health effects and expenses incurred by society.
B. DuPont
DuPont currently manufactures a fine synthetic fiber using a
chlorofluorocarbon (CFC-11). DuPont began searching for an alternative
in 1987 and initiated a research and development (R&D) program to find
an alternative substance for the CFC-11. The R&D program was comprised
of the following activities: identifying all non-CFC candidates for
replacements; acquiring or fabricating (where none were commercially
available) all potential candidates for testing; conducting tests to
ascertain that each candidate possessed the desired properties; further
evaluating those which passed the initial tests in laboratory reviews;
performing additional examinations once the candidates passed the
laboratory tests; then performing testing to determine the
acceptability of the test product. For six years, DuPont has researched
over 100 potential candidates which hold specific properties required
for production of the fiber. This search has included all reasonable
chemical classes including (but not limited to): HCFCs, HFCs,
perfluorinated hydrocarbons, alcohols, and amines. After consideration
of these and other potential alternatives, Dupont determined that no
drop-in or replacement compound (i.e. a substitute that does not
require retrofitting of equipment) for the current manufacturing
process was possible. Dupont identified only one or two possible
replacement candidates, which will require complete testing and
development and which, even if successful, will require specially
designed and engineered new production facilities. All of the
unsuccessful replacement candidates failed to possess at least one of
the physical and chemical properties needed in the manufacturing
process. The critical properties include corrosion characteristics,
critical temperature, toxicity, boiling point and ozone depletion
potential. Moreover, use of the possible non-CFC replacement at the
current manufacturing facilities is not compatible with the existing
plant process and permits, as well as OSHA and other safety code
restrictions. Thus, testing of any non-CFC replacement must occur at
new specially designed and engineered facilities.
Although a candidate substance has been identified as a possible
substitute, Dupont continues to face various technical difficulties in
implementing a new process change. Once a substitute is identified as a
possible replacement, pilot testing of the candidate in a smaller
version of a large-scale production facility, the preparation of the
design of the larger facilities, and construction of the plants must
ensue in order for the alternative to be tested for large scale
production. DuPont has obtained the necessary local, state and Federal
operating permits and general approval from the appropriate
environmental authorities to design, construct and test the pilot plant
which will further verify the production technology and equipment, the
new process, and establish new procedures and practices for the
facility operators. In May 1993, this specially engineered and
constructed pilot plant was constructed.
DuPont indicates that it will spend millions of dollars over the
next several years for implementation and production trials in the new
facilities. Two years of development activities are planned for the
pilot facility in order to test and refine the manufacturing process.
The plant continues to be modified as the need for technical
adjustments arise from the trial runs. This occurs simultaneously with
the design of the first facility, selection of a contractor and
construction of the facility. There will be additional actions required
to prepare for the first round of commercial production trials once the
facility is built. DuPont will need to certify that each end use for
the new fiber product meets the standards of each customer base,
including industry, local, state, and Federal standards. The standards
vary, requiring distinct examinations in order to determine whether for
each end use, the product is capable of the same performance standards
as the product made with a CFC. In addition, personnel require
retraining, a new workforce is necessary to carry out the tests for
product standards and certifications, and process control systems need
monitoring.
DuPont contends that until all of the plants have been constructed,
fully evaluated for their productability, and full-scale production of
the saleable fiber product has been initiated following completion of
the standards testing, no substitute is potentially available. Because
of these various technical difficulties in design, and process changes
to accommodate further investigation of the potential alternative, the
Agency concurs that Dupont has subsequently shown that an alternative
is neither potentially nor currently available.
Although DuPont estimates it will be unable to meet the global
demand for its product by the end of 1996, the substitute would then be
considered to be potentially available, as some of the plants will have
undergone equipment quality checks and production tests and begun
producing the product.
III. Proposed Decisions
EPA proposes to accept these two petitions for temporary exemptions
from the labeling requirements until the dates specified by the
petitioners. No company may exceed its deadline without first obtaining
approval by the EPA. If the need for an additional extension is
required by either company, an addendum to the petition must be
submitted to the Agency requesting an extension.
A. Upjohn
EPA believes that in this case, the alternative identified in the
petition is neither potentially nor currently available, due to
additional Federal requirements regarding approval or disapproval of
the substitute, which preclude the company from implementing the change
until after a determination under such requirements is made. The
circumstances are outside of the company's control. Absent the FDA
requirements, Upjohn would be able to introduce the alternative
substance to its sterilizing operation. This proposed determination is
consistent with regulations implementing section 610 of the Clean Air
Act Amendments of 1990 which state that companies seeking Federal
approval of substitute chemicals or reformulations may receive a
temporary exemption (ninety days) from the product ban requirements (58
FR 69667). In those regulations, EPA recognized that other Federal
approval processes can be time-consuming and beyond the control of the
manufacturer. Until approval is obtained, a substitute is not
potentially available. EPA maintains that it would be inappropriate for
the federal government to deny a manufacturer a temporary exemption
from the labeling regulations while at the same time preventing them
from implementing a substitute pending receipt of a required Federal
approval for their alternative substance or process.
B. DuPont
EPA believes that DuPont's request for a temporary exemption from
the labeling requirements is appropriate given the task and the
uncertainties it has encountered and continues to face in developing a
substitute and implementing a major process change to replace an
existing system that currently depends on the use of a CFC. DuPont
contends that its alternative process is not potentially available
until the company is certain that the alternative process works in its
facilities. In order for the company to ensure that large scale
production is possible, it must first construct new facilities, test
the functioning of the new systems and perform full scale production
tests. Until production tests are completed in these facilities, due to
significant differences in technical design, no substitutes are
potentially available. DuPont indicates that current problems it is
experiencing with the pilot facility are due to unanticipated and
unknown factors, requiring delays in testing of the new design until
the problems are resolved and the necessary modifications are made to
the system. However, as the new system is undergoing the required
tests, DuPont is constructing its new facilities. The designs of the
facilities are based solely on the results of the trials at the pilot
facility, rather than on existing designs, thereby creating unknown
obstacles which can significantly impede the company's switch to an
alternative process.
EPA believes that a substitute process is not potentially available
for the fiber product, which currently depends on a process that uses a
CFC, until the company can be reasonably assured that its new systems
actually work with the candidate substitute and can produce a product
that meets the company's and its customers' quality standards in a
large scale production process. While EPA believes that this waiver
should be granted until January 1, 1996, EPA would like any information
on whether extending the waiver to this January 1, 1996 is appropriate.
IV. Changes to the Conditions of the Petition
EPA proposes to establish provisions to ensure that petitioners
meet the conditions agreed upon in a petition exemption. Companies that
receive a temporary exemption from the labeling requirements must
notify EPA if the agreed-upon conditions of the exemption change in any
way, such as a modification in a Federal entity's schedule for
evaluation, slippage in a company's implementation of an alternative
substance or process, or a shift in corporate priorities. Failure to
notify the Agency of such changes to the agreement will result in the
Agency's withdrawal of the exemption.
V. Statutory Authority
Authority for the action proposed in this notice is section
611(e) of the Clean Air Act, as amended (42 U.S.C. 7625-1(a)(1)).
VI. Administrative Designation and Regulatory Analysis
Under Executive Order (EO) 12866, the Agency must judge whether a
regulation is ``significant'' and thus subject to OMB review. The
decision proposed today is not a regulation, rule or significant
regulatory action, as defined in EO 12866; therefore, no OMB review is
necessary.
VII. Impact on Small Entities
Pursuant to the Regulatory Flexibility Act, 5 U.S.C. 601 through
612, whenever the Agency is required to publish a general notice of
rulemaking for any proposed or final rule, it must prepare and make
available for public comment a regulatory flexibility analysis which
describes the impact on small entities. Since today's proposed decision
does not have a significant impact on a substantial number of small
entities, no regulatory flexibility analysis has been prepared.
VIII. Paperwork Reduction Act
The Paperwork Reduction Act of 1980, 44 U.S.C. 3501 et seq. and
implementing regulations, 5 CFR part 1320, do not apply to this action
as it does not involve the collection of information as defined
therein.
Dated: September 6, 1994.
Mary D. Nichols,
Assistant Administrator.
[FR Doc. 94-22586 Filed 9-12-94; 8:45 am]
BILLING CODE 6560-50-P
