# Refractory Ceramic Fiber; Proposed Significant New Use of a Chemical Substance

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URL: https://www.frixlaw.com/law-library/documents/fr%3A94-6552

## Record

- **Collection:** Federal Register
- **Document type:** Uncategorized Document
- **Published:** March 21, 1994

## Text

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721

[OPPTS-50604; FRL-4075-2]
RIN 2070-AC37

Refractory Ceramic Fiber; Proposed Significant New Use of a
Chemical Substance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing a significant new use rule (SNUR) under
section 5(a)(2) of the Toxic Substances Control Act (TSCA) which would
require persons to notify EPA at least 90 days before commencing the
manufacture, import, or processing of refractory ceramic fiber (RCF) in
any new product form or any new application of an existing product
form. The proposed rule lists the existing product forms and ongoing
applications of existing product forms known to EPA. The required
notice would provide EPA with the opportunity to evaluate the intended
use and associated activities, and an opportunity to protect against
unreasonable risks, if any, from exposure that could result from the
significant new use. EPA is soliciting comments from the public on any
ongoing applications of the product forms of RCF which are not among
the applications listed in this proposed rule.
DATES: Written comments must be received by EPA no later than April 20,
1994.

ADDRESSES: All comments must be submitted in triplicate to: TSCA
Document Receipt Office (7407), Office of Pollution Prevention and
Toxics, Environmental Protection Agency, Rm. E-G99, 401 M St., SW.,
Washington, DC 20460. Comments that contain information claimed as
confidential must be clearly marked ``confidential business
information'' (CBI). If CBI is claimed, three additional sanitized
copies must also be submitted. Nonconfidential versions of comments on
this proposed rule will be placed in the rulemaking record and will be
available for public inspection. Comments should include the docket
control number. The docket control number for the chemical substance in
this SNUR is OPPTS-50604. Unit VI. of this preamble contains additional
information on submitting comments containing CBI claims.

FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 401 M St., SW.,
Rm. E-543B, Washington, DC 20460, Telephone: (202) 554-1404, TDD: (202)
554-0551.

SUPPLEMENTARY INFORMATION: This proposed SNUR for refractory ceramic
fiber (RCF) would require persons to notify EPA at least 90 days before
commencing the manufacture, import, or processing of RCF in any product
form not listed, or for any application of existing product forms not
listed in this proposed rule. The required notice is intended to
provide EPA with the information needed to evaluate new uses and their
associated activities, and an opportunity to protect against
potentially adverse exposure to RCF before it can occur.

I. Authority

Section 5(a)(2) of TSCA (15 U.S.C. 2605 (a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' The Agency must make this determination by rule after
considering all relevant factors, including those listed in section
5(a)(2). Section 5(a)(2) factors generally relate to the extent to
which a use changes the volume of a chemical's production or the type,
form, magnitude, or duration of exposure to it. Once EPA determines
that a use of a chemical substance is a significant new use, section
5(a)(1)(B) of TSCA requires persons to submit a notice to EPA at least
90 days before they manufacture, import, or process the chemical
substance for that use.
Persons subject to this SNUR would comply with the same notice
requirements and EPA regulatory procedures as submitters of
premanufacture notices (PMNs) under section 5(a)(1)(A) of TSCA. In
particular, these requirements include the information submission
requirements of section 5(b) and (d)(1), the exemptions authorized by
section 5(h)(1), (2), (3), and (5), and the regulations at 40 CFR part
720. EPA may take regulatory action under section 5(e), 5(f), 6, or 7
to control the activities for which it has received a SNUR notice. If
EPA does not take action, section 5(g) of TSCA requires EPA to explain
in the Federal Register its reasons for not taking action.
Persons who intend to export a chemical substance identified in a
proposed or final SNUR are subject to the export notification
provisions of TSCA section 12(b). The regulations that interpret
section 12(b) appear at 40 CFR part 707.

II. Applicability of General Provisions

General regulatory provisions applicable to SNURs are codified at
40 CFR part 721, subpart A. In the Federal Register of August 17, 1988
(53 FR 31252), EPA promulgated a ``User Fee Rule'' (40 CFR part 700)
under the authority of TSCA section 26(b). Provisions requiring persons
submitting significant new use notices to submit certain fees to EPA
are discussed in detail in that Federal Register document. Refer to the
CFR and the cited Federal Register notice for further information.

III. Summary of This Proposed Rule

EPA is proposing to designate the manufacture, import, or
processing of RCF in any product form not listed in this proposed rule,
or any application of listed product forms not listed in this proposed
rule, as a significant new use. RCF is defined by the Chemical Abstract
Service as follows:

An amorphous man-made fiber produced from the melting and
``blowing'' or ``spinning'' of calcined kaolin clay or a combination
of alumina (Al2O3) and silica (SiO2). Oxides such as
zirconia, ferric oxide, titanium oxide, magnesium oxide, calcium
oxide, and alkalies may also be added. Approximate percentages (by
weight) of components may vary as follows: Alumina, 20 to 80
percent; silica, 20 to 80 percent; and other oxides in lesser
amounts, approximately 1 to 5 percent (CAS number 142844-00-6).

This proposed rule would require persons who intend to manufacture,
import, or process RCF, as defined above, to submit a significant new
use notice to EPA at least 90 days before manufacturing, importing, or
processing RCF for use in any product form or any application of listed
product forms not included in the following lists. These lists include
all existing product forms and applications of RCF known to EPA.
Product forms
1. Bulk fibers.
2. Blankets, defined as high temperature insulation that is
produced from spun RCF and is in the form of a mat or blanket.
3. Boards, defined as high temperature insulation that is produced
from bulk fibers and is in the form of compressed rigid board, has a
higher density than blankets, and is used as core material, or as
sandwich assemblies.
4. Ropes and braids, defined as high temperature insulation that is
produced by textile operations and is used for packing, seals, and
wicking applications.
5. Woven textiles, defined as high temperature insulation that is
in the form of cloth, tape, or sleeve and is produced by textile
processes.
6. Papers and felts, defined as flexible high temperature
insulation that is produced by papermaking processes and is used for
seals, gaskets, and other automotive and aerospace applications.
7. Vacuum cast shapes, defined as high temperature insulation that
is produced by forming specialized shapes on prefabricated molds with
wet fibers, and then drying them by vacuum and heat, thereby
transforming the bulk fiber into rigid, shaped, products.
8. Specialties, defined as forms (i.e. mixes, cements, and caulking
compounds) that contain wet, inorganic binder and are used as
protective coating putties, as well as adhesives and heat and fire
barriers in high temperature applications.
9. Modules, defined as a packaged functional assembly of blanket
insulation with hardware for attaching to the surfaces of furnaces,
kilns, and other high temperature industrial equipment.
Applications
1. Insulation linings of high temperature industrial furnaces and
related equipment.
2. Hot spot repair of industrial furnace linings.
3. Industrial furnace curtains.
4. Industrial furnace gaskets and seals.
5. Insulation of pipes, ducts, and cables associated with high
temperature industrial furnaces.
6. Fire protection for industrial process equipment.
7. Aircraft/aerospace heat shields.
8. Commercial and consumer appliances consisting of prefabricated
chimneys, pizza ovens, self-cleaning ovens, and wood-burning stoves.
9. Automobile applications consisting of brake pads, clutch
facings, catalytic converters, air bags, shoulder belt controls, and
passenger compartment heat shields.
For purposes of the above listed product forms and applications,
high temperature refers to temperatures up to 3000 deg.F.
The product forms and applications listed in this proposed rule
were reported by the Thermal Insulation Manufacturers Association
(TIMA) in 1991 (Carborundum Company, Premier Refractories and
Chemicals, Inc., and Thermal Ceramics, Inc., March 7, 1991). The TIMA
submission did not include those applications which utilize less than
10 percent of any product form. Also, some miscellaneous applications
named in the TIMA submission could not be readily categorized for the
list in this proposal. For these reasons, EPA is soliciting comments
from the public concerning existing product forms and ongoing
applications of RCF not listed in this proposed rule. Anyone having
knowledge of such product forms and applications should notify EPA
during the comment period for the proposed rule. The notification to
EPA should include a brief description of the ongoing product form or
application, identification of the product forms involved, and
substantiation of the ongoing product forms or application (e.g.
invoices, shipping records). If no notices of additional ongoing
applications are received, for the purposes of the final rule, EPA will
assume the list in proposed Sec. 721.2090 is complete.

IV. Background Information on Refractory Ceramic Fiber

A. Production and Use Data

RCF is processed by two different methods: The ``spinning'' process
and the ``blowing'' process. The resultant fiber is vitreous and
noncrystalline. Fiber diameters vary within the product, ranging from
approximately 0.06 m (micrometers) to greater than 3
m. Lengths vary also in the final product and are dependent
upon the processing used.
RCFs are used primarily for high temperature industrial insulation
applications, most frequently as refractory lining in high temperature
furnaces, heaters, and kilns in industries such as ethylene, steel,
aluminum, ceramics, and glass production. RCFs are also used in
automotive applications, aerospace uses, and in certain commercial
appliances such as self-cleaning ovens, and prefabricated chimneys.
RCFs are currently produced by six companies in the United States
at eight locations. The Carborundum Company, Premier Refractories and
Chemicals, Inc., and Thermal Ceramics Inc., together account for the
bulk of U.S. production of RCFs. The three other domestic producers are
A.P. Green Industries, ELTECH Thermal Systems Corporation, and
Industrial Insulation, Inc. Approximately 80 million pounds of RCFs
were produced in the United States in 1990. The range of uses of RCF
has changed significantly over the last 15 to 20 years, with an
increasing number of industrial and consumer applications. Initially,
high production costs limited their uses to special high technology
applications and the aerospace industry. During the late 1960's the
increasing cost of other insulating refractories and of energy made the
use of RCF for furnace and kiln linings more economical. At the same
time, a gradual increase in the process operating temperatures was
being seen in the chemical processing industry, necessitating the
development of improved high temperature refractories. As an example,
ceramic fiber blanket linings have since been successfully utilized at
temperature up to 3000 deg.F (1650 deg.C).

B. Health Effects

EPA has classified RCF as a Category B2, probable human carcinogen,
based on sufficient evidence from animal studies, and in the absence of
human data. A single-dose chronic inhalation study using kaolin, a
common type of RCF, showed a high incidence of mesotheliomas in
hamsters. Several types of RCF, including kaolin RCF, have been shown
to cause increased incidence of lung tumors and pleural mesotheliomas
in rats following long-term inhalation exposure or direct application
of the fibers in the trachea. Administration of RCF by intraperitoneal
or intrapleural injection also caused increased incidence of peritoneal
and pleural mesotheliomas in several studies in rats. Results of
available chronic inhalation studies with RCF also showed the
development of pleural and lung fibrosis in exposed rats and hamsters
(IRIS (1992) Integrated Risk Information System. Refractory Ceramic
Fibers: Carcinogenicity assessment, September 1, 1992. EPA).
The University of Cincinnati is currently conducting a morbidity
study of workers to determine if occupational exposure to RCF is
associated with increased respiratory disease (Lockey, J. et al., 1990
Refractory Ceramic Fibers: Pulmonary Morbidity Study of Workers.
September 1985). Preliminary results indicate that RCF exposure is
associated with increased pleuritic chest pain, decreasing spirometric
function, and increased prevalence of pleural plaques that are also
known to be associated with asbestos fiber exposure.

V. Objectives and Rationale for This Proposed Rule

On November 21, 1991, the Agency concluded that, based on animal
inhalation data submitted to the Agency under section 8(e) of TSCA,
RCFs may present an unreasonable risk of cancer to human health. After
conducting an accelerated review of RCF under section 4(f), EPA
concluded there was not sufficient data available (particularly on
exposure to and substitutes for RCF) to determine whether or not RCFs
present an unreasonable risk. However, there was sufficient basis for
human health concerns to initiate a regulatory investigation of RCFs to
determine whether action under TSCA section 6 to control the use of
RCFs was appropriate. The regulatory investigation of RCFs includes a
thorough review of a recently completed multiple dose animal inhalation
study, an update of the findings from an ongoing worker epidemiology
study, an analysis of substitutes, and development of comprehensive
exposure data. (EPA and three of the six domestic manufacturers of RCF
have recently entered a consent agreement which provides for the
collection of exposure monitoring data from the facilities of the
participating companies and their customers.)
To determine what would constitute a significant new use, EPA
considered all relevant factors, including those listed in TSCA section
5(a)(2)(A) through (D). Data indicate that RCF may be carcinogenic and
fibrogenic. Considering the toxicity of RCF, and the fact that EPA
cannot predict with certainty what new forms or applications of RCF
might be developed in the future, EPA has serious concerns regarding
the potential projected volume of manufacturing and processing of RCF;
the potential methods and manner of manufacturing, processing,
distribution in commerce, and disposal of RCF; the extent to which a
new form or application might change the form or type of human exposure
to RCF; and the extent to which a new form or application might
increase the magnitude and duration of human exposure to RCF.
EPA believes that any new product form or application of RCF and
its related manufacture, import, or processing should be designated as
a significant new use. EPA consulted with TIMA to ascertain the full
extent of all existing uses of RCF. The resulting lists of product
forms and applications of product forms in this proposed rule represent
all uses of RCF known to EPA. Currently RCF is not subject to any other
Federal regulation that would provide a mechanism for preventing
potential exposures before they occur.
Based on these consideration, EPA wants to achieve the following
objectives with regard to the significant new use that is designated in
this proposed rule:
1. EPA wants to ensure that it would receive notice of any
company's intent to manufacture, import, or process RCF for the
significant new use designated in this proposed rule before that
activity begins.
2. EPA wants to ensure that it would have an opportunity to review
and evaluate data submitted in a significant new use notice before the
notice submitter begins manufacturing, importing, or processing RCF for
the significant new use designated in this proposed rule.
3. EPA wants to ensure that it would be able to regulate
prospective manufacturers, importers, or processors of RCF before a
significant new use of the substance occurs, provided that the degree
of potential health and/or environmental risk, or the uncertainty about
the risks, is sufficient to warrant such regulation.
If EPA receives a Significant New Use Notice (SNUN) in response to
this rule after it becomes final, EPA anticipates that a ``product
stewardship'' program would be critical to its evaluation of the
proposed significant new use. Based on the information available to EPA
at this time, EPA believes that a product stewardship program which
includes monitoring of workplace exposure and identifying means or
methods for reducing exposure, can represent an important step toward
reducing the risk of RCF to human health. Therefore, EPA would
encourage any SNUN submitter to provide information on ways the
submitter will limit or mitigate exposure to RCF.

VI. Applicability of Proposed Rule to Uses Occurring Before
Effective Date of the Final Rule

EPA believes that the intent of section 5(a)(1)(B) is best served
by designating a use as a significant new use as of the proposal date
of the SNUR rather than as of the effective date of the final rule. If
uses begun during the proposal period of a SNUR were considered ongoing
as of the effective date, it would be difficult for EPA to establish
SNUR notice requirements, because any person could defeat the SNUR by
initiating the proposed significant new use before the rule became
effective; this interpretation of section 5 would make it extremely
difficult for EPA to establish SNUR notice requirements.
Persons who begin commercial manufacture, importation, or
processing of RCF for any new use between publication of the proposal
and the effective dates of the SNUR may comply with this proposed SNUR
before it is promulgated. If a person were to meet the conditions of
advance compliance as codified at Sec. 721.45(h), the person will be
considered to have met the requirements of the final SNUR for those
activities. If persons who begin commercial manufacture, import, or
processing of RCF for a new use between publication of the proposal and
the effective date of the SNUR do not meet the conditions of advance
compliance, they must cease that activity before the effective date of
the rule. To resume their activities, these persons would have to
comply with all applicable SNUR notice requirements (Sec. 721.25) and
wait until the notice review period, including all extensions, expires.

VII. Economic Analysis

EPA has evaluated the potential costs of establishing SNUR
reporting requirements for RCFs. The costs to EPA of issuing a SNUR
range from $12,400 to $24,100. This estimated range assumes an
expenditure of 2.17 to 3.94 in-house worker-months between the time a
SNUR is proposed and when it is promulgated. Preproposal costs are not
included in the estimate because these costs are incurred even if the
Agency ultimately decides not to promulgate the SNUR. Additionally, the
costs to EPA of enforcement have not been estimated here.
If a SNUN is submitted, EPA would also incur estimated costs of
$9,800 to review the SNUN. EPA may also incur costs associated with
modification of the SNUR if such action is necessary. The uncertainty
of any such costs is too great to make a reasonable estimate in this
analysis possible.
Costs to the industry as a result of this SNUR could occur in two
ways. First, direct costs would be incurred by persons who intend to
manufacture, import, or process RCFs for a significant new use. The
costs incurred would be those involved in submitting a SNUN to the
Agency, which are estimated to be $2,200 to $10,000 per notice, as well
as the related costs due to delays in initiating the production and use
of the chemical. The firm would also be required to pay a $2,500 user
fee to EPA when submitting its notice. Second, costs associated with
regulatory follow-up could also be incurred by a submitter. The
uncertainty of such costs is too great to make a reasonable estimate
possible in this analysis.
The Agency's complete economic analysis for this proposed SNUR is
available in the public record for this proposed rule (OPPTS-50604).

VIII. Comments Containing Confidential Business Information

Any person who submits comments claimed as CBI must mark the
comments as ``confidential,'' ``trade secret,'' or other appropriate
designation. Comments not claimed as confidential at the time of
submission will be placed in the public file. Any comments marked as
confidential will be treated in accordance with the procedures in 40
CFR part 2. Any party submitting comments claimed to be confidential
must prepare and submit a nonconfidential version of the comments that
EPA can place in the public file.

IX. Rulemaking Record

EPA has established a record for this rulemaking (docket control
number OPPTS-50604). The record includes basic information considered
by EPA in developing this proposed rule. EPA will accept additional
materials for inclusion in the record at any time between this proposal
and designation of the complete record. EPA will identify the complete
rulemaking record by the date of promulgation.
A public version of the record, without any CBI, is available in
the OPPT Nonconfidential Information Center (NCIC), also known as, TSCA
Public Docket Office, from 8 a.m. to 12 noon and 1 p.m. to 4 p.m.,
Monday through Friday, except legal holidays. NCIC is located in Rm. E-
G102 (East Tower Tunnel), 401 M St., SW., Washington, DC 20460.

X. Regulatory Assessment Requirements

A. Executive Order 12866

Under Executive Order 12866, EPA must judge whether a rule is
``significant'' and therefore requires a Regulatory Impact Analysis.
EPA has determined that this proposed rule would not be a
``significant'' rule because it would not have an effect on the economy
of $100 million or more, and it would not have a significant effect on
competition, costs, or prices. While there is no precise way to
calculate the total annual cost of compliance with this proposed rule,
EPA estimates that the reporting cost for submitting a SNUN would be
approximately $2,200 to $10,000. Notice submitters would also have to
pay a $2,500 user fee to EPA to partially offset the costs of
processing the notice. EPA believes that, because of the nature of the
rule, and the chemical substance involved, there would be few SNUNs
submitted. Furthermore, while the expense of a notice and the
uncertainty of possible EPA regulation may discourage certain
innovation, that impact would be limited because such factors are
unlikely to discourage an innovation that has high potential value.
Pursuant to the terms of this Executive Order, it has been
determined that this rule is not ``significant'' and is therefore not
subject to review by the Office of Management and Budget (OMB).

B. Regulatory Flexibility Act

Under the Regulatory Flexibility Act (5 U.S.C. 605(b)), EPA has
determined that this proposed rule would not have a significant impact
on a substantial number of small businesses. EPA has not determined
whether parties affected by this proposed rule would likely be small
businesses. However, EPA expects to receive few SNUR notices for the
chemical substance. Therefore, EPA believes that the number of small
businesses affected by the rule would not be substantial, even if all
of the SNUR notice submitters were small firms.

C. Paperwork Reduction Act

OMB has approved the information collection requirements contained
in this proposed rule under the provisions of the Paperwork Reduction
Act (44 U.S.C. 3501 et seq.) and has assigned OMB control number 2070-
0038.
Public reporting burden for this collection of information is
estimated to be 118.6 hours per response, and includes time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information.
Send comments regarding the burden estimate or any other aspect of
this collection of information, including suggestions for reducing this
burden, to Chief, Information Policy Branch, (2131), U.S. Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460; and to Office
of Information and Regulatory Affairs, Office of Management and Budget,
Washington, DC 20530, marked ``Attention: Desk Officer for EPA.'' The
final rule will respond to any OMB or public comments on the
information requirements contained in this proposal.

List of Subjects in 40 CFR Part 721

Environmental protection, Chemicals, Hazardous materials,
Recordkeeping and reporting requirements, Significant new uses.

Dated: March 8, 1994.
Victor J. Kimm,
Acting Assistant Administrator for Prevention, Pesticides and Toxic
Substances.

Therefore, it is proposed that 40 CFR part 721 be amended as
follows:

PART 721--[AMENDED]-

1. The authority citation for part 721 will continue to read as
follows:

Authority: 15 U.S.C. 2604, 2607, and 2625(c).

2. By adding new Sec. 721.2090 to subpart E to read as follows:

Sec. 721.2090 Refractory ceramic fiber.

(a) Chemical substance and significant new use subject to
reporting. (1) The chemical substance, refractory ceramic fiber (RCF),
CAS No. 142844-00-6, is subject to reporting under this section for the
significant new use described in paragraph (a)(2) of this section. RCF
is defined as an amorphous man-made fiber produced from the melting and
blowing or spinning of calcined kaolin clay or a combination of alumina
(Al2O3) and silica (SiO2). Oxides such as zirconia,
ferric oxide, titanium oxide, magnesium oxide, calcium oxide, and
alkalies may be added. The percentage (by weight) of components is as
follows: Alumina, 20 to 80 percent; silica, 20 to 80 percent; and other
oxides in lesser amounts.
(2) The significant new use is: Use in any product form not listed
in paragraph (a)(2)(i) of this section, or any application of the
listed product forms not included in paragraph (a)(2)(ii) of this
section.
(i) Product forms: Bulk fibers; blankets, ``defined as high
temperature insulation that is produced from spun RCF and is in the
form of a mat or blanket''; boards, ``defined as high temperature
insulation that is produced from bulk fibers and is in the form of
compressed rigid board, has a higher density than blankets, and is used
as core material or as sandwich assemblies''; ropes and braids,
``defined as high temperature insulation that is produced by textile
operations and is used for packing, seals, and wicking applications'';
woven textiles, ``defined as high temperature insulation that is in the
form of cloth, tape, or sleeve and is produced by textile processes'';
papers and felts, ``defined as flexible high temperature insulation
that is produced by papermaking processes and is used for seals,
gaskets, and other automotive and aerospace applications''; vacuum cast
shapes, ``defined as high temperature insulation that is produced by
forming specialized shapes on prefabricated molds with wet fibers, and
then drying them by vacuum and heat, thereby transforming bulk fiber
into rigid, shaped products''; specialties, ``defined as forms (i.e.
mixes, cements, and caulking compounds) that contain wet, inorganic
binder and are used as protective coating putties, as well as adhesives
and heat and fire barriers in high temperature applications''; and
modules, ``defined as a packaged functional assembly of blanket
insulation with hardware for attaching to the surfaces of furnaces and
kilns.
(ii) Applications: Insulation linings of high temperature
industrial furnaces and related equipment; hot spot repair of
industrial furnace linings; industrial furnace curtains; industrial
furnace gaskets and seals; insulation of pipes, ducts, and cables
associated with high temperature industrial furnaces; fire protection
for industrial process equipment; aircraft/aerospace heat shields;
commercial and consumer appliances consisting of prefabricated
chimneys, pizza ovens, self-cleaning ovens, and wood-burning stoves;
and automobile applications consisting of brake pads, clutch facings,
catalytic converters, air bags, shoulder belt control, and passenger
compartment heat shields.
(b) [Reserved]
[FR Doc. 94-6552 Filed 3-18-94; 8:45 am]
BILLING CODE 6560-50-F

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A94-6552. Public record. Not legal advice.