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

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]

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