67466 Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Proposed Rules

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 799

[OPPTS–42187L; FRL–5742–2]

RIN 2070–AC76

Amended Proposed Test Rule for

Hazardous Air Pollutants; Extension of

Comment Period

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Amended proposed rule;

extension of comment period.

SUMMARY: EPA is amending the

proposed rule issued under section 4(a)

of the Toxic Substances Control Act

(TSCA) (61 FR 33178, June 26, 1996)

that would require manufacturers and

processors to test those hazardous air

pollutants (HAPs) specified in the

proposal for certain health effects.

Under this amended HAPs test rule

proposal (‘‘amended HAPs proposal’’),

EPA would require that testing be

conducted using eleven TSCA health

effects test guidelines issued by EPA on

August 15, 1997 (62 FR 43820), codified

at 40 CFR part 799, subpart H, instead

of the eleven OPPTS draft harmonized

test guidelines cross-referenced in the

June 26, 1996 proposed rule. The

Agency is soliciting comments on the

application of these part 799 test

guidelines to the amended proposed

HAPs test rule. In addition, the Agency

is amending the proposed HAPs test

rule by removing the testing

requirements for phenol; specifying

export notification requirements;

reviewing the status of the proposals for

enforceable consent agreements (ECAs)

for pharmacokinetics (PK) studies

submitted by industry; revising the

economic assessment; including

additional support documents in the

rulemaking record; and describing other

changes and clarifications to the

proposed test rule. In addition, EPA is

inviting ECA proposals for all of the

HAPs chemicals for which PK proposals

have not been received to provide for

alternative testing to meet the

requirements contained in the proposed

HAPs test rule, as amended in this

notice.

EPA is also extending the public

comment period in order to provide

interested individuals with sufficient

time to consider the effects of the newly

promulgated TSCA test guidelines

referenced in enforceable test standards

in this amended HAPs proposal, the

economic assessment for this

amendment, and other changes

described in this action, and to

comment accordingly.

DATES: Written comments on this

proposed rule must be received by EPA

on or before February 9, 1998. The

public comment period on the June 26,

1996 proposed rule is being extended

from January 9, 1998 to February 9,

1998.

ADDRESSES: Submit three copies of

written comments on the proposed

HAPs test rule, as amended, identified

by document control number (OPPTS–

42187A; FRL–4869–1) to: U.S.

Environmental Protection Agency,

Office of Pollution Prevention and

Toxics (OPPT), Document Control

Office (7407), Rm. G–099, 401 M St.,

SW., Washington, DC 20460. See Unit

V. of this preamble for further

instructions.

Comments and data may also be

submitted electronically to

oppt.ncic@epamail.epa.gov. Follow the

instructions under Unit V. of this

document. No confidential business

information (CBI) should be submitted

through e-mail.

FOR FURTHER INFORMATION CONTACT: For

general information: Susan B. Hazen,

Director, Environmental Assistance

Division (7408), Rm. ET–543B, Office of

Pollution Prevention and Toxics, U.S.

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460;

telephone: (202) 554–1404; TDD: (202)

554–0551; e–mail: TSCA–

Hotline@epamail.epa.gov. For technical

information contact: Richard W.

Leukroth, Jr. , Project Manager,

Chemical Control Division (7405),

Office of Pollution Prevention and

Toxics, U.S. Environmental Protection

Agency, 401 M St., SW., Washington,

DC, 20460; telephone: (202) 260–0321;

fax: (202) 260–8850; e-mail:

leukroth.rich@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of June 26, 1996 (61 FR

33178), EPA issued a proposed test rule

for the following hazardous air pollutant

chemicals that would require health

effects testing to be conducted using

eleven draft harmonized test guidelines

developed by EPA’s Office of

Prevention, Pesticides and Toxic

Substances (OPPTS): 1,1’-biphenyl (CAS

No. 92–52–4), carbonyl sulfide (CAS No.

463–58–1), chlorine (CAS No. 7782–50–

5), chlorobenzene CAS No. 108–90–7),

chloroprene (CAS No. 126–99–8), orthocresol (CAS No. 95–48–7), meta-cresol

(CAS No. 108–39–4), para-cresol (CAS

No. 106–44–5), diethanolamine (CAS

No. 111–42–2), ethylbenzene (CAS No.

100–41–4), ethylene dichloride (CAS

No. 107–06–2), ethylene glycol (CAS

No. 107–21–1), hydrochloric acid (CAS

No. 7647–01–0), hydrogen fluoride

(CAS No. 7664–39–3), maleic anhydride

(CAS No. 108–31–6), methyl isobutyl

ketone (CAS No. 108–10–1), methyl

methacrylate (CAS No. 80–62–6),

naphthalene (CAS No. 91–20–3), phenol

(CAS No. 108–95–2), phthalic

anhydride (CAS No. 85–44–9), 1,2,4–

trichlorobenzene (CAS No. 120–82–1),

1,1,2-trichloroethane (CAS No. 79–00–

5), and vinylidene chloride (CAS No.

75–35–4).

The Agency also offered to consider

the use of PK and other mechanistic

data as a means to permit route-to-route

extrapolation of data from the existing

chemical data base as an alternative to

conducting some or all of the testing

that would be required under the

proposed HAPs test rule. Since this

original proposal, EPA has promulgated

eleven new TSCA health effects test

guidelines, received eight ECA

proposals for PK studies and prepared

preliminary technical analyses for each

of these PK proposals, and updated the

economic assessment in light of the

changes to the guidelines that are

explained in this amended HAPs test

rule proposal. In addition, EPA has

identified needed changes and

clarifications to the proposed HAPs test

rule. This action amends the original

HAPs proposal to include these changes

and clarifications.

For all aspects of the original HAPs

test rule proposal that are not addressed

by this amended proposal, the

discussion in the preamble of the

original HAPs test rule proposal

continues to apply.

Table of Contents

I. Background

II. TSCA Test Guidelines for HAPs

Chemicals

A. Background to Test Guidelines Used in

this Amendment

B. Summary of Basic Testing Requirement

Changes Proposed by this Amendment

III. Changes and Clarifications

A. Phenol—Removal of Testing

Requirements

B. Export Notification Requirements

C. Persons Required to Test

D. Testing Subject to GLP Requirements

E. Cresols—Clarification of Test Substances

F. Use of Acute and Non-Acute Data in

Residual Risk Determinations

G. Submission of Equivalence Data

H. Other Changes to Regulatory Text

IV. Status of Proposals for

Pharmacokinetics Studies and Other

Proposals for Enforceable Consent

Agreements and Orders

A. Proposals for PK Studies

B. Other Proposals for ECAs

C. The ECA Negotiation Process

V. Public Record and Electronic

Submissions

VI. Regulatory Assessment Requirements

A. Economic Assessment
Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Proposed Rules 67467

B. Executive Order 12866 and Executive

Order 12898; Unfunded Mandates Reform

Act

C. Regulatory Flexibility Act

D. Paperwork Reduction Act

E. Executive Order 13045

I. Background

On June 26, 1996 (61 FR 33178), EPA

proposed, under TSCA section 4(a), 15

U.S.C. 2603(a), the testing of 21 HAPs

for certain health effects (the ‘‘original

HAPs test rule proposal’’). The proposal

also invited the submission of proposals

for enforceable consent agreements

(ECAs) for the HAPs chemicals which

would include pharmacokinetics (PK)

studies (61 FR 33178, 33189). On

September 11, 1996 (61 FR 47853)

(FRL–5395–9), EPA announced a public

meeting on the proposed HAPs test rule.

The public meeting was held on October

1, 1996; a transcript of the meeting is

included in the record for this

rulemaking. In response to requests

from industry, on October 2, 1996, EPA

held a meeting with potential submitters

of alternative testing proposals that

would include PK studies. At this

meeting, EPA clarified the types of

information the Agency was seeking in

the PK ECA proposals. A copy of the

meeting summary is included in the

record for this rulemaking.

The deadline for written comments on

the proposed HAPs test rule contained

in the June 26, 1996 Federal Register

proposal was December 23, 1996. EPA

has successively extended the comment

period on this proposed rule as follows:

On October 18, 1996 (61 FR 54383)

(FRL–5571–3), the comment period was

extended from December 23, 1996 to

January 31, 1997; on December 23, 1996

(61 FR 67516) (FRL–5580–6), it was

extended from January 31, 1997 to

March 31, 1997; on February 28, 1997

(62 FR 9142) (FRL–5592–1), it was

extended from March 31, 1997 to April

30, 1997; on March 28, 1997 (62 FR

14850) (FRL–5598–4), it was extended

from April 30, 1997 to June 30, 1997; on

May 30, 1997 (62 FR 29318) (FRL–5831–

6), it was extended from June 30, 1997

to August 15, 1997; on July 15, 1997 (62

FR 37833) (FRL–5732–2), it was

extended from August 15, 1997 to

September 30, 1997; on September 26,

1997 (62 FR 50546) (FRL–5748–8), it

was extended from September 30, 1997

to December 1, 1997; and on November

28, 1997 (62 FR 63299) (FRL–5759–2), it

was extended from December 1, 1997 to

January 9, 1998. These extensions to the

comment period were necessary to

allow the Agency more time to finalize

eleven TSCA health effects test

guidelines to be cross-referenced in this

amended HAPs test rule proposal, and

to respond to the PK ECA proposals

submitted by industry.

By this action, EPA is extending the

public comment period of the original

HAPs proposed rule from January 9,

1998 to February 9, 1998. This

extension of the comment period is

needed to provide commenters with

sufficient time to consider the effects of

the TSCA test guidelines, the economic

assessment for the amended HAPs

proposal and other changes described in

this action, and to comment

accordingly.

II. TSCA Test Guidelines for HAPs

Chemicals

A. Background to Test Guidelines Used

in this Amendment

The original proposed HAPs test rule

cross-referenced eleven draft

harmonized health effects test

guidelines developed by the Office of

Pollution Prevention and Toxic

Substances (OPPTS) of the EPA. These

draft OPPTS harmonized guidelines had

previously been made available for

public comment in the Federal Register

of June 20, 1996 (61 FR 31522 (FRL–

5367–7)). The draft harmonized

guidelines were designated as the

OPPTS draft Series 870 test guidelines

in the June 20, 1996 Federal Register

announcement. In the original HAPs

proposal, EPA stated that it was

considering one of three alternative

approaches for referencing test

guidelines in the test standards

proposed for HAPs testing (61 FR 33178,

33187). Deficiencies with each of the

three approaches led EPA to promulgate

eleven TSCA health effect guidelines on

August 15, 1997 (62 FR 43820), codified

at 40 CFR part 799, subpart H. EPA is

proposing to cross-reference these

guidelines in the test standards

proposed for HAPs testing, and intends

to cross-reference them, as appropriate,

in subsequent TSCA section 4(a) test

rules. Until the establishment of the

new TSCA test guidelines in subpart H,

EPA had been cross-referencing in test

rules an earlier set of TSCA test

guidelines in 40 CFR parts 795 through

798, originally promulgated in 1985 (50

FR 39252, September 27, 1985).

The Agency, in developing the TSCA

test guidelines established in part 799,

subpart H, adopted seven of the OPPTS

final harmonized test guidelines and

four guidelines developed by the

Organization for Economic Cooperation

and Development (OECD). The only

significant difference between the TSCA

test guidelines and the OPPTS final

harmonized test guidelines is that

certain recommended procedures in the

OPPTS final harmonized test guidelines

are made mandatory to provide for

enforceability. Table 1 in § 799.5053 of

this amended proposal shows how the

TSCA test guidelines would be

referenced in enforceable test standards

for the HAPs test rule.

An explanation of the process by

which the TSCA test guidelines were

developed from the OPPTS draft

harmonized test guidelines, along with

a discussion of the significant changes

made to the draft harmonized guidelines

in developing the TSCA guidelines, is

described in the final rule adding the

new TSCA test guidelines to 40 CFR

part 799, subpart H (62 FR 43820,

August 15, 1997) (FRL–5719–5). The

official record for the rulemaking for the

TSCA test guidelines has been

established under document control

number OPPTS–42193, and has been

included in the record for this

rulemaking. This record contains the

basic information considered by EPA in

developing the TSCA test guidelines.

The record includes the OPPTS draft

harmonized health effects test

guidelines, references contained in the

TSCA test guidelines, an explanation of

the process of developing OECD test

guidelines for genetic toxicity with

EPA’s role in this international process,

and the final report of the Scientific

Advisory Panel that provided peer

review comments to EPA which were

considered by the Agency in developing

the OPPTS final harmonized guidelines.

B. Summary of Basic Testing

Requirement Changes Proposed by this

Amendment

The eleven TSCA test guidelines

which are specified as basic testing

requirements in Table 1 of § 799.5053

that EPA is proposing to use for testing

the chemicals in the HAPs test rule are

as follows:

1. TSCA acute inhalation toxicity

with histopathology, 40 CFR 799.9135.

2. TSCA subchronic inhalation

toxicity, 40 CFR 799.9346.

3. TSCA prenatal developmental

toxicity, 40 CFR 799.9370.

4. TSCA reproduction and fertility

effects, 40 CFR 799.9380.

5. TSCA carcinogenicity, 40 CFR

799.9420.

6. TSCA bacterial reverse mutation

test, 40 CFR 799.9510.

7. TSCA in vitro mammalian cell gene

mutation test, 40 CFR 799.9530.

8. TSCA mammalian bone marrow

chromosomal aberration test, 40 CFR

799.9538.

9. TSCA mammalian erythrocyte

micronucleus test, 40 CFR 799.9539.

10. TSCA neurotoxicity screening

battery, 40 CFR 799.9620.
67468 Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Proposed Rules

11. TSCA immunotoxicity, 40 CFR

799.9780.

EPA is proposing to use the TSCA test

guideline § 799.9370 ‘‘TSCA prenatal

developmental toxicity’’ as the basic

testing requirement for developmental

toxicity testing in this amended

proposal. This guideline is based on the

OPPTS final harmonized 870.3700

guideline entitled ‘‘Prenatal

Developmental Toxicity Study’’ (to be

published when all OPPTS harmonized

health effects guidelines have been

finalized). The original HAPs proposal

cross-referenced OPPTS draft 870.3600

‘‘Inhalation Developmental Toxicity

Study’’ as the guideline for the

developmental toxicity endpoint. The

Agency prefers the approach taken by

the OPPTS final harmonized 870.3700

guideline (the basis for the TSCA

§ 799.9370 guideline) over that taken by

the OPPTS draft 870.3600 guideline

because the OPPTS final harmonized

870.3700 guideline provides a broader

testing approach. Furthermore, the

OPPTS final harmonized 870.3700

guideline incorporates the testing

specifications included in the OPPTS

draft 870.3600 guideline.

The original HAPs proposal crossreferenced four OPPTS draft Series 870

harmonized genotoxicity test guidelines:

870.5385 ‘‘In vivo Mammalian

Cytogenetics Tests: Bone Marrow

Chromosomal Analysis;’’ 870. 5395 ‘‘In

vivo Mammalian Cytogenetics Tests:

Erythrocyte Micronucleus Assay;’’

870.5100 ‘‘Escherichia coli WP2 and

WP2 uvrA Reverse Mutation Assays;’’

and 870.5300 ‘‘Detection of Gene

Mutations in Somatic Cells in Culture.’’

See Unit IV.C. ‘‘Test Guidelines’’ of the

original HAPs test rule proposal and

Table 1 in § 799.5053 of the original

HAPs proposal (61 FR 33178, 33187,

33197–33199). OPPTS later determined

that the above-referenced genotoxicity

test guidelines would not provide a

sufficient basis for developing OPPTS

final harmonized test guidelines for

genotoxicity and looked to international

efforts begun in 1989 by the OECD to

develop an internationally accepted set

of genotoxicity test guidelines. By

September 1996, four OECD

genotoxicity test guidelines had

undergone extensive peer review and

revision that included participation by

U.S. scientific experts in the area of

genotoxicity. The four OECD final

revision genotoxicity test guidelines

were approved by the member countries

of the OECD in September 1996. In

February 1997, these four genotoxicity

guidelines were read from the OECD

homepage (http://www.oecd.org/ehs/

test/testlist.htm). OPPTS reformatted

these documents and designated them

as OPPTS final Series 870 harmonized

test guidelines, to be published when all

OPPTS harmonized health effects

guidelines have been finalized. These

four Series 870 final OPPTS harmonized

test guidelines were adopted and

published as TSCA test guidelines at 40

CFR part 799, subpart H (62 FR 43820,

August 15, 1997).

In summary, the genotoxicity test

guidelines to be cross-referenced as

basic testing requirements by this

amended HAPs proposal were

developed based on the following

documents:

The OECD final revision test

guideline 471/472 ‘‘Bacterial reverse

mutation assay’’ was adopted as OPPTS

final harmonized test guideline,

870.5100 ‘‘Bacterial reverse mutation

test,’’ which in turn, provided the basis

for TSCA test guideline § 799.9510

‘‘TSCA bacterial reverse mutation test.’’

The OECD final revision test

guideline 476 ‘‘In vitro mammalian cell

gene mutation test’’ was adopted as

OPPTS final harmonized test guideline,

870.5300 ‘‘In vitro mammalian cell gene

mutation test,’’ which in turn, provided

the basis for TSCA test guideline

§ 799.9530 ‘‘TSCA in vitro mammalian

cell gene mutation test.’’

The OECD final revision guideline

475 ‘‘Mammalian bone marrow

chromosome aberration test’’ was

adopted as OPPTS final harmonized test

guideline, 870.5385 ‘‘Mammalian bone

marrow chromosomal aberration test,’’

which in turn, provided the basis for

TSCA test guideline § 799.9538 ‘‘TSCA

mammalian bone marrow chromosomal

aberration test.’’

The OECD final revision test

guideline 474 ‘‘Mammalian erythrocyte

micronucleus test’’ was adopted as

OPPTS final harmonized test guideline,

870.5395 ‘‘Mammalian erythrocyte

micronucleus test,’’ which in turn,

provided the basis for TSCA test

guideline § 799.9539 ‘‘TSCA

mammalian erythrocyte micronucleus

test.’’

EPA has documented the Agency’s

participation in the OECD revision

process for updating the genotoxicity

test guidelines (U.S. EPA Memorandum,

March 10, 1997 (a)), the relationship

among the OPPTS draft Series 870

harmonized genotoxicity test guidelines

cross-referenced in the original HAPs

test rule proposal, the OECD test

guidelines, and the OPPTS final Series

870 harmonized test guidelines (U.S.

EPA Memoranda, February 27, 1997;

and March 10, 1997(b)), and the

relationship between the TSCA 40 CFR

part 799 series test guidelines and the

OECD test guidelines in the record for

this rulemaking (see also 62 FR 43820,

August 15, 1997). Copies of these

documents are available as described in

Unit V. of this preamble.

These changes are summarized in the

following Table 1.

Table 1.—List of TSCA Test Guidelines Cross-referenced in the Proposed HAPs Test Rule, As Amended, and the

Corresponding OPPTS Draft Harmonized Test Guidelines

TSCA test guidelines cross-referenced in the amended HAPs

test rule proposal (40 CFR)

OPPTS draft harmonized test guidelines cross-referenced in

the original HAPs test rule proposal

799.9135 TSCA acute inhalation toxicity with histopathology 870.1350 Acute Inhalation Toxicity with Histopathology

799.9346 TSCA subchronic inhalation toxicity 870.3465 Subchronic Inhalation Toxicity

799.9370 TSCA prenatal developmental toxicity (derived from

870.3700)1

870.3600 Inhalation Developmental Toxicity Study

799.9380 TSCA reproduction and fertility effects 870.3800 Reproduction and Fertility Effects

799.9420 TSCA carcinogenicity 870.4200 Carcinogenicity

799.9510 TSCA bacterial reverse mutation test (derived from

OECD 471/472)1

870.5100 Escherichia coli WP2 and WP2uvrA Reverse

Mutation Assays

799.9530 TSCA in vitro mammalian cell gene mutation test

(derived from OECD 476)1

870.5300 Detection of Gene Mutations in Somatic Cells in

Culture

799.9538 TSCA mammalian bone marrow chromosomal

aberration test (derived from OECD 475)1

870.5385 In vivo Mammalian Cytogenetics Tests: Bone Marrow

Chromosomal Analysis
Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Proposed Rules 67469

Table 1.—List of TSCA Test Guidelines Cross-referenced in the Proposed HAPs Test Rule, As Amended, and the

Corresponding OPPTS Draft Harmonized Test Guidelines—Continued

TSCA test guidelines cross-referenced in the amended HAPs

test rule proposal (40 CFR)

OPPTS draft harmonized test guidelines cross-referenced in

the original HAPs test rule proposal

799.9539 TSCA mammalian erythrocyte micronucleus test

(derived from OECD 474)1

870.5395 In vivo Mammalian Cytogenetics Tests: Erythrocyte

Micrnucleus Assay

799.9620 TSCA neurotoxicity screening battery 870.6200 Neurotoxicity Screening Battery

799.9780 TSCA immunotoxicity 870.7800 Immunotoxicity

1 See explanation of derivation in Unit II.B. of this preamble.

A revised § 799.5053 ‘‘Chemical

testing requirements for hazardous air

pollutants,’’ based on the use of the

TSCA test guidelines for HAPs chemical

testing, is included as part of this

amended proposal.

The eleven TSCA test guidelines

described in Table 1 of this preamble

are included in the record for this

rulemaking. The Federal Register notice

containing the TSCA test guidelines is

available electronically from the EPA’s

World Wide Web site, http://

www.epa.gov/fedrgstr/, under the

heading: ‘‘Rules and Regulations;’’ by

internet e-mail:

guidelines@epamail.epa.gov; by mail;

or, from the TSCA Non-Confidential

Information Center, Rm. NE–B607, 401

M St., SW., Washington, DC 20460.

EPA is soliciting comments on the

eleven TSCA test guidelines to be

incorporated in enforceable test

standards under this amended HAPs

proposal. To be considered in this

rulemaking, comments must be

submitted in the manner specified in

the ‘‘ADDRESSES’’ section at the

beginning of this document.

III. Changes and Clarifications

In addition to cross-referencing the

TSCA test guidelines, this amended

HAPs proposal is making other changes

and clarifications to the original HAPs

proposal, which are set forth as follows:

A. Phenol—Removal of Testing

Requirements

The original HAPs proposal included

testing requirements for phenol (CAS

No. 108–95–2). On January 17, 1997,

EPA published a document (62 FR 2607)

which announced a testing consent

order (Order) under TSCA section 4 that

incorporated an ECA concluded

between EPA and fourteen specified

companies. In the ECA, the companies

agreed to perform certain health effects

tests on phenol. In addition, the January

17 document included a direct final rule

which added phenol to the list of

chemical substances in 40 CFR 799.5000

that are subject to testing consent orders

and hence subject to export notification

requirements under TSCA section 12(b).

EPA received adverse comment with

respect to making entities that are not

signatory to the ECA subject to export

notification requirements for phenol.

Because of those adverse comments, on

May 23, 1997 (62 FR 28368), EPA

removed the export notification rule.

EPA did not withdraw the Order or the

ECA, and signatories to the ECA remain

subject to export notification

requirements. EPA intends to propose a

phenol export notification rule at a

future time. Because EPA anticipates

receiving the necessary test data on

phenol pursuant to the ECA and Order,

EPA is amending the proposed HAPs

test rule to remove all phenol testing

requirements.

The documents entitled: ‘‘Economic

Assessment for the Amended Proposed

TSCA Section 4(a) Test Rule for 21

Hazardous Air Pollutants,’’ discussed in

Units VI.A. and VI.D. of this preamble,

and ‘‘Additional Information on Small

Entity Impacts of the Amended

Proposed TSCA Section 4(a) Test Rule

for 21 Hazardous Air Pollutants,’’

discussed in Unit VI.C. of this preamble,

have not yet been modified to reflect the

reductions in impact and burden

associated with the deletion of phenol

testing, but will be so modified by the

time the final rule is promulgated.

Unit VI. of this preamble contains

data from the above economic

assessment with all references to phenol

removed. Similarly, Table 1 in

§ 799.5053, which sets forth the testing

required for the chemicals in the

proposed HAPs test rule, as amended,

does not include phenol.

B. Export Notification Requirements

In the original HAPs proposal, EPA

did not state that export notification

under TSCA section 12(b), 15 U.S.C.

2611(b), would be required for the HAPs

chemicals in the final rule. Section 12(b)

of TSCA requires all persons who export

or intend to export a chemical substance

or mixture for which the submission of

data is required under TSCA section 4

to notify EPA of this export or intent to

export. Regulations interpreting the

requirements of TSCA section 12(b)

appear at 40 CFR part 707, subpart D.

In brief, as of the effective date of the

HAPs test rule, an exporter of any

subject HAP chemical would be

required to report to EPA the first export

or intended export of the chemical to

each foreign country of export. EPA

would then notify the foreign

government about the HAPs test rule as

it relates to that chemical.

Accordingly, EPA is amending the

original proposed HAPs test rule to

require export notification for all the

chemicals for which testing would be

required under the amended HAPs

proposal, and has changed § 799.5053

accordingly.

C. Persons Required to Test

1. General. In the original HAPs

proposal, EPA indicated that persons

who manufacture HAP chemicals

included in the proposed rule as

byproducts, as defined in 40 CFR

791.3(c), would be subject to the

requirements set forth in the proposed

rule. In addition, EPA proposed to

exempt those manufacturers and

processors that produce the HAP

chemicals included in the proposed rule

only as an impurity, as defined in 40

CFR 790.3, because it would be difficult

and prohibitively expensive for EPA,

manufacturers, and processors to

identify with complete assurance all

chemical substances that contain the

HAP chemicals included in the

proposed rule solely as an impurity and

EPA would find it difficult to apply

both the exemption and reimbursement

processes to those who manufacture

and/or process these HAP chemicals

solely as an impurity. Furthermore, the

Agency indicated that EPA’s data

reimbursement regulations established

under TSCA section 4(c) (40 CFR part

791) state that those persons who

manufacture or process chemical

substances as impurities are not subject

to test requirements unless a particular

test rule specifically states otherwise (40

CFR 791.48(b)) and that EPA found no

basis to propose such a requirement for
67470 Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Proposed Rules

the original HAPs proposal (61 FR

33178, 33189, 33190).

EPA has received inquiries from

industry seeking clarification of the

distinction between byproduct and

impurity in a variety of contexts in the

manufacture of products and in the

course of chemical processing (see

document numbers 3, 8, 9, 10, 11, 12,

and 14 referenced in Unit V.I. of this

preamble). EPA’s review has revealed

that certain HAP chemicals included in

this amended HAPs proposal are

manufactured or processed as

byproducts or impurities in quantities

large enough that they can be identified

in databases available to the Agency

(Chemical Update System (CUS), Toxic

Release Inventory (TRI), Aerometric

Information Retrieval System Facility

Subsystem (AFS)). Certain owners and

operators of facilities that have, during

the latest year prior to the publication

of the final HAPs rule in the Federal

Register, manufactured (including

imported) or processed HAP chemicals

included in this amended proposal in

amounts equal to or greater than 25,000

lb are required under section 313 of the

Emergency Planning and Community

Right-To-Know Act (EPCRA), 42 U.S.C.

11023, to report the TRI releases of these

substances and, accordingly, know or

should know whether they are

manufacturing or processing these HAP

chemicals. (EPCRA section 313 also

requires reporting by facilities that use

10,000 lb or more of a listed toxic

chemical during a calendar year). The

toxic chemicals release reporting

regulations promulgated pursuant to

EPCRA section 313 additionally provide

a de minimis exemption for chemicals

otherwise subject to TRI requirements

when the chemicals are present in

mixtures in concentrations of less than

one percent by weight (or 0.1% for

carcinogens) (40 CFR 372.38(a)).

Because chemical manufacturers and

processors are among the persons

required to report to TRI, manufacturers

and processors generally should know

the composition of chemicals that they

manufacture or process at least at or

above one percent by weight of

composition.

By this amendment, EPA is proposing

to modify criteria to determine when

persons subject to the HAPs test rule

must comply with the rule. The original

HAPs proposal did not provide a

volume cutoff beyond the provisions of

40 CFR 790.42(a) for manufacturers and

processors as a means for determining

when certain classes of persons would

be required to comply with the rule.

(The regulations cited above provide

that, while legally subject to a test rule,

processors, persons who manufacture

less than 500 kg (1,100 lb) of the

chemical annually, and persons who

manufacture small quantities of the

chemical solely for research and

development, are not required to

comply with the rule unless directed to

do so by EPA in a subsequent notice if

no manufacturer has submitted a notice

of its intent to conduct testing.) Under

the original HAPs proposal, all other

manufacturers were required to comply

with the rule when promulgated

(‘‘initially comply’’).

The criteria proposed in this amended

proposed rule provide an equitable

means for determining which entities

would be initially and secondarily

responsible for testing HAPs chemicals:

testing would be conducted primarily

by persons owning facilities at which

large volumes of HAPs chemicals are

manufactured, while persons owning

facilities at which smaller volumes of

HAPs chemicals are manufactured

would only be required to comply with

the rule if no manufacturer submits a

notice of its intent to conduct testing.

It is reasonable to expect that persons

who manufacture or process chemicals

containing HAPs should know the

composition of the chemicals they

manufacture or process at or above one

percent by weight, and should know if

they manufacture or process 25,000 lb

or more of a chemical per year at any

facility. Accordingly, EPA is amending

the proposal to specify those who must

initially comply with the HAPs rule: (1)

any person who during the last

complete corporate fiscal year prior to

the publication of the final rule in the

Federal Register, manufactured

(including imported) at a particular

facility any of the HAP chemicals

included in this amended HAPs

proposal in an amount equal to or in

excess of 25,000 lb (regardless of the

form of the HAP chemical, i.e., as a

Class 1 substance, as a component of a

mixture, as a byproduct, as an impurity,

as a component of a Class 2 substance,

or as an isolated intermediate), and (2)

any person who during the last

complete corporate fiscal year prior to

the publication of the final rule,

manufactured (including imported) at a

particular facility any of the HAP

chemicals as a component of a chemical

substance or mixture that comprises one

percent or more by weight of the

chemical substance or mixture, as long

as the amount of the HAP chemical is

equal to or in excess of 25,000 lb. EPA

is proposing to amend the ‘‘Persons

required to submit study plans, conduct

tests and submit data’’ text of § 799.5053

to reflect this change. (‘‘Naturally

occurring substances,’’ as described at

40 CFR 710.4(b), and non-isolated

intermediates, as defined at 40 CFR

704.3, are not to be considered in

determining whether a person is

responsible for HAP chemical testing.)

If, during the last complete corporte

fiscal year prior to the publication of the

final rule in the Federal Register, a

person manufactured 25,000 lb or more

of a HAP chemical, as such, or in

another substance or mixture at a

concentration of one percent or more (as

long as the amount of the HAP chemical

is equal to or in excess of 25,000 lb),

that person would be required to

comply initially with the rule.

This approach is consistent with the

policy of the United States, expressed

by Congress in section 2(b)(1) of TSCA,

15 U.S.C. 2601(b)(1), that development

of data regarding the effect of chemical

substances and mixtures on human

health and the environment should be

the responsibility of those who

manufacture and process such

chemicals. The following examples are

provided to guide companies in

determining whether they are subject to

the proposed HAPs test rule, as

amended:

a. Class 1 and Class 2 substances.

Under the amended HAPs proposal,

testing would be required for HAP

chemicals included in the proposed rule

that are manufactured (including

imported) or processed in the form of a

Class 1 substance or as a component of

a Class 2 substance. A Class 1 substance

is a chemical substance with a

composition that can be represented by

a specific, complete chemical structure

diagram. Examples of Class 1 substances

are 1,1,2-trichloroethane, 1,1’-biphenyl

and hydrochloric acid. A Class 2

substance is a complex combination of

substances that cannot be represented

by a specific, complete chemical

structure diagram. Examples of Class 2

substances are light paraffinic distillates

(petroleum), brominated soybean oil,

and propoxylated tall oil. Class 1 and

Class 2 substances that are in U.S.

commerce are listed on the TSCA

chemical substance inventory and have

Chemical Abstracts Service (CAS)

numbers. See 40 CFR 720.45(a)(1)(i) for

the distinction between Class 1

substances and Class 2 substances.

Example 1: Producer—Class 2 Substance

Containing a HAP Chemical

Company Z produces chemical substance

E. Chemical substance E has a Chemical

Abstract Service (CAS) number, includes

several different chemical species, and

cannot be represented by a specific, complete

chemical structure diagram, i.e., it is a Class

2 substance. Chemical substance E appears

on the TSCA Chemical Substance Inventory

and was reported as a Class 2 substance. The

composition of chemical substance E
Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Proposed Rules 67471

includes chemical B (which is a HAP

chemical that is included in the amended

HAPs proposal) that was produced in the

manufacture of chemical substance E.

Chemical B is normally present in

concentrations that range from 1 to 6 percent

by weight of chemical substance E.

Company Status: EPA considers Company

Z to be a producer of HAP chemical B.

Irrespective of whether it intended HAP

chemical B to be an integral part of chemical

substance E, Company Z is a producer of

HAP chemical B, if the amount of HAP

chemical B produced at a concentration of

one percent or greater at any facility during

the company’s last complete corporate fiscal

year were more than 25,000 lb, Company Z

would be required to comply initially with

the rule.

Example 2: Processor—Class 2 Substance

Containing a HAP Chemical

Company Z, which produces chemical

substance E as discussed in Example 1, also

applies chemical separation techniques on

chemical substance E (a Class 2 substance

that contains HAP chemical B) to produce

chemical substances F and G. The separation

proceeds without chemical reaction and no

additional amount of HAP chemical B is

produced. Chemical substance F, a Class 2

substance, contains some of the HAP

chemical B that was a component of

chemical substance E in concentrations that

exceed one percent by weight. Chemical

substance F has no separate commercial

purpose and is disposed of as waste.

Chemical substance G, a Class 1 substance,

also contains some HAP chemical B in

concentrations that exceed one percent by

weight of G.

Company Status: Company Z is considered

to be a processor of HAP chemical B with

respect to the production of chemical

substance F, a byproduct, and chemical

substance G, a commercial product.

However, Company Z remains responsible

for producing HAP chemical B because of its

original production of chemical substance E

(see Example 1 above). Therefore, as a

manufacturer and processor of HAP chemical

B, Company Z would be required to comply

initially with the amended HAPs test rule

proposal if the total amount of the HAP

chemical B component were 25,000 lb or

more at any facility during the company’s

last complete corporate fiscal year after the

publication of the rule. If another company

had purchased chemical substance E from

Company Z and had performed a similar

separation process resulting in the

production of chemical substances F and G,

both of which contain HAP chemical B as an

unintentionally present component, the

purchaser would be considered only to be a

processor of HAP chemical B as an impurity

and, therefore, as a processor, must comply

with the requirements of the rule only if

directed to do so by EPA in a subsequent

Federal Register notice because no

manufacturer has submitted a notice of its

intent to conduct testing. (Note that HAP

chemical B was present in chemical

substances F and G at greater than one

percent concentration). Additional

information regarding the status of processors

is provided in this Unit of the preamble.

b. HAPs present as part of mixtures.

Under the amended HAPs proposal,

testing would be required for HAP

chemicals included in the proposed rule

that are manufactured (including

imported) or processed as part of a

mixture, as that term is defined by

TSCA section 3(8). For example, a

combination of substances that is

manufactured as a result of a chemical

reaction, but that could have been

prepared without chemical reaction, is

considered a mixture under TSCA

section 3(8). If a HAP chemical is

produced as a result of this chemical

reaction, the person who manufactured

the mixture has also manufactured the

HAP chemical. A person who produced

the same mixture but without chemical

reaction would be considered to be a

HAP processor.

Example 3: Manufacturers of Mixtures

Two companies, Company Y and Company

Z, produce mixtures as commercial products

that have the same composition and that

contain HAP chemical B in concentrations

that exceed one percent by weight of the

mixture. Company Y purchases the

components of the mixture and combines

them without a chemical reaction occurring.

Company Z creates the mixture by reacting

chemicals. During the chemical reaction HAP

chemical B is formed.

Company Status: Company Z has

manufactured HAP chemical B and would be

required to comply initially with the

amended HAPs proposal if the total amount

of chemical B manufactured is 25,000 lb or

more at any facility during the company’s

last complete corporate fiscal year prior to

the publication of the test rule. Company Y

is a processor of HAP chemical B and,

therefore, must comply with the

requirements of the rule only if directed to

do so by EPA in a subsequent Federal

Register notice because no manufacturer has

submitted a notice of its intent to conduct

testing.

c. Isolated intermediates. Under the

amended HAPs proposal, testing would

be required for HAP chemicals included

in the proposed rule that are

manufactured (including imported) or

processed in the form of isolated

intermediates. HAP chemicals produced

in the form of non-isolated

intermediates (as defined at 40 CFR

704.3) are not subject to the amended

HAPs proposal.

Example 4: Producer—Non-isolated and

Isolated Intermediates

A company produces but does not isolate

chemical substance H, a Class 2 substance

that contains HAP chemical B in

concentrations that exceed one percent by

weight. Immediately following this

production in a continuous flow process,

chemical substance H is reacted with other

chemicals to form chemical substance I,

which the company isolates, packages and

distributes in commerce. Chemical substance

I does not contain any HAP chemical because

chemical B in chemical substance H

completely reacts in the formation of

chemical substance I.

Company Status: Chemical substance H is

a ‘‘non-isolated intermediate,’’ defined at 40

CFR 704.3. Although HAP chemical B is

formed as part of chemical substance H,

chemical B is reacted entirely in the

continuous flow process. Therefore, the

company would not be subject to the

requirements of the amended HAPs proposal

because the final product, chemical

substance I, does not contain HAP chemical

B.

If Class 2 chemical substance H had been

removed from the reaction vessel, stored, and

reacted later to form chemical substance I,

chemical substance H would have been an

isolated intermediate that contained HAP

chemical B. In this case, the company would

be required to comply initially with the

amended HAPs proposal, if the amount of

HAP chemical B that is manufactured during

the company’s last complete corporate fiscal

year prior to the publication of the rule in the

Federal Register were 25,000 lb or more at

any facility, due to the company’s production

of a HAP chemical as part of an isolated

intermediate.

2. Processors. The Agency has

proposed findings under TSCA sections

4(a)(1)(A) and 4(a)(1)(B) for the

manufacturing and processing of the

chemicals contained in the proposed

HAPs test rule. See Supporting

Documentation 3(a), (b) and (c) and

References 11, 12 and 16 as cited in

Unit III.C. ‘‘Review of Data and

Selection of HAPs’’ and Unit V.

‘‘Findings’’ of the original HAPs test

rule proposal (61 FR 33178, 3384,

33185, 33190). The terms ‘‘process’’ and

‘‘processor’’ are defined at TSCA

sections 3(10) and 3(11), respectively

Accordingly, in the preamble to the

original HAPs proposal (61 FR 33178,

33189), EPA stated that persons who

manufacture (including import) or

process, or intend to manufacture or

process, any of the HAPs chemicals

would be subject to the testing

requirements in the rule. The preamble

also explained that manufacturers

would be required to submit letters of

intent to conduct testing or exemption

applications under 40 CFR 790.45.

However, under 40 CFR 790.42,

processors, small-quantity

manufacturers, and manufacturers of

small quantities solely for research and

development purposes would not be

required to submit letters of intent or

exemption applications unless directed

to do so in a subsequent notice as

described in 40 CFR 790.48(b).

The text of § 799.5053 in the original

HAPs test rule proposal did not include
67472 Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Proposed Rules

processors in the class of persons

required to submit study plans, conduct

tests, and submit data. The text of

§ 799.5053, however, did reference the

fact that processors (and small-quantity

manufacturers and manufacturers of

small quantities solely for research and

development purposes) would become

subject to these requirements only after

notification in the Federal Register that

no manufacturer had notified EPA of its

intent to conduct testing.

The text of § 799.5053 of this

amended HAPs proposal makes it clear

that while processors would be

included in the class of persons subject

to the rule, processors, small quantity

manufacturers, manufacturers of small

quantities of HAP chemicals solely for

research and development purposes and

persons who, at any facility,

manufacture a HAP chemical subject to

this rule in an amount less than 25,000

lb or as a component of a chemical

substance or mixture and comprises less

than one percent by weight of the

chemical substance or mixture (as long

as the amount of the HAP chemical is

equal to or in excess of 25,000 lb) would

need to comply with the requirements

to submit study plans, conduct tests,

and submit data only if no manufacturer

submits a notice of its intent to conduct

testing and if these persons are directed

to do so in a subsequent notice

published in the Federal Register.

3. Carbonyl sulfide. The original

HAPs proposal identified carbonyl

sulfide as the first chemical substance to

be subject to a TSCA section 4 test rule

that is produced almost exclusively as a

byproduct (61 FR 33178, 33190). In the

original HAPs proposal, EPA noted that

persons who manufacture the subject

HAPs chemicals, including carbonyl

sulfide, as byproducts, as defined in 40

CFR 791.3(c), would be subject to the

testing requirements set forth in the

proposed rule. EPA also indicated that

all persons reporting the release of

carbonyl sulfide to the TRI pursuant to

section 313 of EPCRA would be

considered to be manufacturers of

carbonyl sulfide and would be subject to

the provisions of the HAPs test rule.

In preparing the economic analysis for

carbonyl sulfide for the amended HAPs

proposal, EPA utilized information from

1995 reports to both the TRI and AFS

databases. For 1995, all those reporting

release information to the TRI and AFS

databases on carbonyl sulfide are

manufacturers.

The Agency is hereby clarifying that

all persons who manufacture carbonyl

sulfide would be subject to the HAPs

testing requirements, whether or not

they report release information to the

TRI, or in EPA’s AIRS AFS database. As

explained in Appendix A of EPA’s

economic assessment and the additional

information document on small

business impacts prepared for this

assessment, EPA relied on information

taken from the TRI and AFS databases

to identify facilities releasing carbonyl

sulfide (see Units VI.A., VI.C., and VI.D.

of this preamble). EPA recognizes that

these facilities may not represent the

complete universe of facilities that

produce carbonyl sulfide and that the

information derived from these

databases is not exhaustive. To the

extent that there are additional

manufacturers not identified in the

Agency’s economic assessment, the

testing burden on any individual

manufacturer may be reduced.

D. Testing Subject to GLP Requirements

In this amended HAPs proposal, EPA

is clarifying the text of § 799.5053 to

indicate that the required testing under

the HAPs test rule shall be carried out

following TSCA Good Laboratory

Practice Standards (40 CFR part 792).

The text of § 799.5053 in the original

HAPs proposal stated that, among other

things, testing should be conducted as

specified in 40 CFR part 792 (see 61 FR

33178, 33197), but did not indicate that

GLPs are codified at 40 CFR part 792.

The text of § 799.5053 contained in this

amended HAPs proposal clarifies this

point.

E. Cresols—Clarification of Test

Substances

EPA is clarifying that the provision of

the HAPs test rule relating to cresols

requires separate testing of each cresol

isomer (i.e., ortho-isomer (CAS No. 95–

48–7), meta-isomer (CAS No.108–39–4),

and para-isomer (CAS No. 106–44–5)),

as indicated in Table 1 in § 799.5053 in

both the original HAPs proposal and

this amended HAPs proposal. Therefore,

each cresol isomer is subject to acute

toxicity, subchronic toxicity,

neurotoxicity, and immunotoxicity

testing (61 FR 33178, 33198).

Documentation supporting the findings

for each cresol isomer, and all other

subject HAPs chemicals, was previously

described in Unit III. C. ‘‘Review of Data

and Selection of HAPs’’ and Unit V.

‘‘Findings’’ of the original HAPs

proposal (61 FR 33178, 33184, 33185,

33190). See Unit X. A. ‘‘Supporting

Documentation,’’ Items (3)(a), (b), and (c

) and Unit X. B. ‘‘References,’’ Items

(11), (12), and (16) of the original HAPs

proposal (see 61 FR 33178, 33195).

Testing of cresols in particular is

discussed at Unit III. D. ‘‘Previous TSCA

Testing Actions Affecting These

Chemical Substances’’ and Unit IV. B.

‘‘Test Substance’’ of the original HAPs

proposal (61 FR 33178, 33185, 33186).

See Unit X. A. ‘‘Supporting

Documentation’’ of the original HAPs

proposal, Items (1)(g) and (j) (61 FR

33178, 33194). It should be noted that

the data for cresols summarized in the

table entitled ‘‘TSCA Section 4 (a)

Statutory Findings’’ (61 FR 33178,

33191) are based on the mixture of all

three cresol isomers. As previously

stated (61 FR 33178, 33186), EPA

believes that it would be very

burdensome to test every possible

variation of the cresol mixture and is

therefore proposing to test each isomer.

This approach follows that taken in the

final test rule for cresols (51 FR 15771,

15776, April 28, 1986).

Table 1 in § 799.5053, which sets

forth the testing required for the

chemicals in the proposed HAPs test

rule, as amended, has been changed to

clarify that testing is required for each

cresol isomer.

F. Use of Acute and Non-Acute Data in

Residual Risk Determinations

EPA is correcting an error in the

preamble to the original HAPs proposal.

In Unit II. ‘‘Uses of Data’’ (61 FR 33178,

33179 (third column)), the Agency

indicated that non-acute data will be

used by EPA to meet its statutory

obligation under section 112(f) of the

Clean Air Act (CAA), 42 U.S.C. 7412(f),

to assess residual risk after the

imposition of technology-based

emission standards (maximum

achievable control technology or MACT

standards) required by CAA section

112(d), 42 U.S.C. 7412(d). However, as

discussed at the public meeting held on

the proposed HAPs test rule on October

1, 1996, the Agency intends that the

residual risk determinations under the

Clean Air Act be based on both acute

and non-acute data. See pages 24 and 25

of the official transcript of the October

1, 1996 public meeting on the proposed

test rule, included as part of this

rulemaking record.

G. Submission of Equivalence Data

In Unit V. F. ‘‘Persons Required To

Test’’ of the original HAPs proposal (61

FR 33178, 33189–33190), EPA did not

indicate that those who file exemption

applications would not be required to

submit equivalence data, although this

was indicated in Unit VII.B. of the

original HAPs proposal. EPA is

clarifying that the Agency is not

proposing to require those who file

exemption applications to submit

equivalence data as a condition for

exemption from the testing for the

chemical substances subject to the HAPs

test rule.
Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Proposed Rules 67473

H. Other Changes to Regulatory Text

In addition to the changes made to the

text and table in § 799.5053 ‘‘Chemical

testing requirements for hazardous air

pollutants’’ of the amended HAPs

proposal that are set forth in previous

sections of Unit III. of this preamble, the

following changes have been made:

1. EPA has changed the titles of

columns 2, 3, and 4 in Table 1 of

§ 799.5053 of the original HAPs

proposal (61 FR 33178, 33197–33199)

from: ‘‘Chemical substance/required

testing,’’ ‘‘OPPTS harmonized

guidelines,’’ and ‘‘Specific requirements

under this section’’ to: ‘‘Chemical name/

types of testing,’’ ‘‘Basic testing

requirements (test guideline),’’ and

‘‘Changes from guideline.’’ The Agency

believes that this change of

nomenclature clarifies the meaning of

Table 1. The corresponding description

throughout the text of § 799.5053 has

been revised to incorporate these

changes.

2. In the original HAPs proposal at

§ 799.5053, EPA indicated that ‘‘E. coli

reverse mutation’’ and ‘‘gene mutation’’

tests would be required for the HAP

chemical carbonyl sulfide. The titles of

these tests have been changed in

§ 799.5053 of the amended HAPs

proposal to ‘‘Bacterial reverse mutation’’

and ‘‘Mammalian gene mutation,’’

respectively, to reflect corresponding

changes in the titles of the referenced

guidelines.

3. In the original HAPs proposal at

§ 799.5053, EPA designated paragraph

(b)(1)(ii)(C) in Table 1 to indicate an oral

route of exposure. No testing via an oral

route of exposure was required in Table

1. Consequently, paragraph (b)(1)(ii)(C)

has been changed. In the amended

HAPs proposal, this paragraph now

indicates a vapor-phase route of

exposure specifically for in vitro

cytogenetics testing.

4. In the original HAPs proposal, EPA

did not indicate the route of exposure

for the in vitro cytogenetics testing for

the HAP chemical carbonyl sulfide (61

FR 33178, 33199). EPA is indicating in

Table 1 of § 799.5053 that the route of

exposure for the Bacterial reverse

mutation and the Mammalian gene

mutation testing would be vapor-phase

as indicated in paragraph (b)(1)(ii)(C).

5. In the original HAPs proposal, EPA

omitted additional testing requirements

in the test standard for acute toxicity

testing for chlorobenzene in Table 1 of

§ 799.5053 (61 FR 33178, 33198).

Revised § 799.5053 corrects Table 1 to

include the additional testing

requirements specified in paragraph

(b)(2) ‘‘Modifications applicable to acute

testing’’ for chlorobenzene.

6. Paragraph (b)(5) ‘‘Reproductive

toxicity and fertility study test

modifications’’ of § 799.5053 in the

original HAPs proposal has been deleted

since it contains the same requirements

as paragraphs (b)(1)(ii)(A) and

(b)(1)(ii)(B), which specify that the route

of exposure would be either vaporphase inhalation or inhalation of

aerosol.

7. In the original HAPs proposal, the

guideline for developmental toxicity

testing (OPPTS draft 870.3600) cited in

Table 1 of § 799.5053 (61 FR 33178,

33197–33199) would have required

developmental testing to be conducted

using inhalation as the route of

exposure. The TSCA prenatal

developmental toxicity test guideline

(40 CFR 799.9370) specified for

developmental toxicity testing in this

amended HAPs proposal does not

indicate the route of exposure for

testing. Table 1 of § 799.5053 has been

changed to include specific references

to the route of exposure for each HAP

chemical substance for which

developmental toxicity testing is

proposed under this amended HAPs

proposal.

8. In this amended HAPs proposal,

EPA cites the TSCA immunotoxicity test

guideline (40 CFR 799.9780) in Table 1

of § 799.5053 (61 FR 33178, 33197–

33199). This test guideline contains four

different test methods. EPA is proposing

that immunotoxicity testing under the

HAPs test rule include only the

determination of antibody response to

the administration of sheep red blood

cell antigen. The Agency is further

proposing that either the antibody

plaque-forming cell assay

(§ 799.9780(g)(1)(i)) or the ELISA

immunoglobulin quantification assay

(§ 799.9780(g)(1)(ii)) shall be used to

meet the testing requirements. The

natural killer cell assay

(§ 799.9780(g)(1)(iii)) and the

enumeration of splenic or peripheral

blood cells (§ 799.9780(g)(2)) are not

being proposed for HAPs testing.

Accordingly, § 799.5053(b)(4) has been

changed to clarify the immunotoxicity

testing requirements and Table 1 of

§ 799.5053 includes notations to so

indicate.

IV. Status of Proposals for

Pharmacokinetics Studies and Other

Proposals for Enforceable Consent

Agreements and Orders

A. Proposals for PK Studies

1. EPA’s Invitation for Proposals

In the original HAPs proposal, EPA

invited proposals for pharmacokinetics

studies and other mechanistic data to

support route-to-route extrapolation of

data from existing studies for the subject

HAPs chemicals (61 FR 33178, 33188,

33189). The PK studies would be used

to inform the Agency about route-toroute extrapolation of toxicity data from

routes other than inhalation when it is

scientifically defensible in order to

empirically derive the inhalation risk.

The PK proposals could form the basis

for negotiation of enforceable consent

agreements (ECAs) that would provide

for testing in lieu of some or all of the

tests proposed in the HAPs test rule, as

amended.

The Agency has received alternative

testing proposals for eight HAPs

chemicals. These proposals are as

follows:

(1) Diethanolamine (CAS No. 111–42–

2), submitted by the Chemical

Manufacturers Association,

Alkanolamines Panel, and entitled

‘‘Proposal for Pharmacokinetics Studies

of Diethanolamine’’ (November 25,

1996).

(2) Ethylene dichloride (CAS No. 107–

06–2), submitted by the HAP Task

Force, and entitled ‘‘Proposal for

Pharmacokinetics Study of Ethylene

Dichloride’’ (November 22, 1996).

(3) Ethylene glycol (CAS No. 107–21–

1), submitted by the Chemical

Manufacturers Association, Ethylene

Glycol Panel, and entitled ‘‘Proposal for

Pharmacokinetic Studies of Ethylene

Glycol’’ (November 5, 1996).

(4) Hydrogen fluoride (CAS No. 7664–

39–3), submitted by the Chemical

Manufacturers Association, Hydrogen

Fluoride Panel, and entitled ‘‘Proposal

for a Physiologically-Based

Pharmacokinetic (PBPK) Model for

Hydrogen Fluoride’’ (November 22,

1996).

(5) Maleic anhydride (CAS No. 108–

31–6), submitted by the Chemical

Manufacturers Association, Maleic

Anhydride Panel, and entitled

‘‘Developing an Inhalation Testing

Program for Maleic Anhydride’’

(November 8, 1996).

(6) Phthalic anhydride (CAS No. 85–

44–9), submitted by the Chemical

Manufacturers Association, Phthalic

Anhydride Producers Task Group, and

entitled ‘‘Testing Proposal of the

Chemical Manufacturers Association,

Phthalic Anhydride Producers Task

Group in Response to EPA’s Proposed

Rule for Phthalic Anhydride’’

(November 22, 1996).

(7) 1,2,4-Trichlorobenzene (CAS No.

120–82–1), submitted by the

Chlorobenzene Producers Association

(CPA), and entitled ‘‘Proposal to Use the

Pharmacokinetics, Physical, and

Chemical Properties of 1,2,4-

Trichlorobenzene to Fill Data Gaps’’

(November 25, 1996).
67474 Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Proposed Rules

(8) 1,1,2-Trichloroethane (CAS No.

79–00–5), submitted by the HAP Task

Force, and entitled ‘‘Proposal for

Pharmacokinetics Study of 1,1,2-

Trichloroethane’’ (November 22, 1996).

Copies of the PK proposals and the

Agency’s preliminary technical analyses

of these proposals have been placed in

the public record for this action

(OPPTS–42187B, FRL–4869–1).

2. The Agency’s Evaluation of the

Proposals

The following provides a background

to EPA’s method of evaluating the PK

proposals. As the original HAPs

proposal indicated (61 FR 33178,

33189), EPA used the Gerrity and Henry

(1990) decision tree as an element in

evaluating the PK proposals and also

used mechanistic data in determining

the appropriateness of route-to-route

extrapolation from the existing data base

as an alternative to conducting some or

all of the testing required under the

proposed HAPs test rule.

Pharmacokinetics and mechanistic data

may be used to inform the Agency about

route-to-route extrapolation when EPA

determines that extrapolation from

existing studies may provide sufficient

data to substitute for required testing

under the proposed rule.

Pharmacokinetics and mechanistic data

alone may not be used to substitute for

proposed required testing when studies

by a route other than inhalation do not

exist or are deemed by EPA to be

inadequate. In such cases, however,

pharmacokinetics and mechanistic data

may be used to support a decision that

required testing could be conducted

using routes other than inhalation (see

document referenced in Unit V.J.2. of

this preamble).

In many cases, the proposals that EPA

received went beyond PK by including

alternate testing strategies to respond to

the testing identified in the proposed

HAPs test rule. EPA’s evaluations of

these proposals identify changes or

additions that provide for testing of

these HAP chemicals as an alternative to

the testing contained in the proposed

HAPs test rule. If this testing is

incorporated into ECAs, and if the data

resulting from testing under the ECAs

are acceptable to the Agency, such

testing will provide an alternative to

some or all of the testing proposed for

these substances in the HAPs test rule.

If testing under these ECAs does not

fulfill the Agency’s needs, EPA reserves

the right to meet these needs through

rulemaking.

The Agency has prepared preliminary

technical analyses of each PK proposal

(ethylene dichloride, hydrogen fluoride,

maleic anhydride, phthalic anhydride,

1,2,4-trichlorobenzene, ethylene glycol,

diethanolamine and 1,1,2-

trichloroethane) and sent each to the

appropriate submitter. EPA notes that,

as a result of unexpected complexities

arising in the review of the PK proposals

and contrary to the statement in the

preamble to the proposed HAPs test

rule, the Agency has not been able to

conclude ECAs relating to PK studies

within 12 months of the date of the

HAPs test rule proposal. EPA expects to

make further progress on these ECAs in

the next few months.

In each preliminary technical

response to a submitter of a PK

proposal, EPA requested the submitter

either to express a continued interest in

pursuing the ECA process as an activity

distinct from the test rule process, in

light of the Agency’s preliminary

technical analysis, or to submit a

revised proposal which takes into

consideration the Agency’s comments.

Depending on each submitter’s

response, EPA will determine whether

or not to proceed with the ECA process

for that particular PK proposal.

B. Other Proposals for ECAs

EPA has received a proposal to

develop a non-PK-related ECA for the

HAP chemical methyl isobutyl ketone

(CAS No. 108–10–1). This proposal was

submitted to the Agency by the

Chemical Manufacturers Association

Ketones Panel on December 11, 1996,

and is entitled ‘‘Alternative Testing

Proposal for Methyl Isobutyl Ketone.’’ In

addition, the EPA has received a

proposal to develop an ECA for the HAP

chemical 1,1’-biphenyl (CAS No. 92–

52–4). This proposal submitted by the

Biphenyl Workgroup on October 7,

1997, is entitled ‘‘Developing a Test

Plan for Assessing the Potential Risks of

Inhaled Biphenyl.’’ EPA has agreed to

review the contents of these proposals

and to provide comments on their

technical merit and relevance to the

proposed HAPs testing requirements.

EPA also received a proposal to enter

into an ECA from the Chemical

Manufacturers Association Cresols

Panel to develop an alternative to the

proposed HAPs testing for cresols. The

proposal was dated April 9, 1997 and

was accompanied by a document

entitled ‘‘Toxicological Profile for

Cresols.’’ The proposal focused on

testing for only the ortho-cresol isomer.

Subsequent telephone conversations

between EPA and the Panel

representative identified that the

proposal was not fully developed (see

documents referenced in Units V.G.3.

and V.G.4. of this preamble). The

proposal was later withdrawn by the

CMA Cresols Panel.

EPA is hereby inviting the submission

of proposals for ECAs on all the HAPs

chemicals for which ECA proposals

have not been received, but not for

phenol (see Unit III.A. of this preamble).

Such proposals must clearly describe

the rationale for proposing an

alternative testing program, detail the

full extent of the testing to be performed

under the proposal, and describe how

the proposed testing would meet the

testing requirements contained in the

proposed HAPs test rule, as amended.

ECA proposals to provide testing

alternative to that described in the

proposed HAPs test rule, as amended,

should be labeled: ‘‘ECA Proposal for

(HAP chemical name) to Provide

Alternative Testing to Meet HAPs Rule

Testing Requirements,’’ identified by

Document Control Number (OPPTS–

42187B; FRL–5742–2), and sent to U.S.

Environmental Protection Agency,

Office of Pollution Prevention and

Toxics, Document Control Office (7407),

Room G–099, 401 M St., SW.,

Washington, DC 20460. Proposals for

ECAs must be received no later than

February 9, 1998. EPA will also seek to

complete the development of any ECAs

expeditiously, and, whenever possible,

will work to complete such agreements

within 12 months from the date of the

Agency’s acceptance of the proposal.

EPA will review the submissions and

may select candidates for negotiation

based on the ability of the proposal to

fulfill the data requirements that are set

forth in this amended HAPs proposal. If

the Agency decides to proceed with the

ECA process, it will publish a notice in

the Federal Register soliciting persons

interested in participating in or

monitoring negotiations for the

development of ECAs for PK studies to

notify the Agency in writing.

C. The ECA Negotiation Process

Under its regulations, EPA is required

to provide the public with an

opportunity to comment on and

participate in the development of ECAs.

(The procedures for ECA negotiations

are described at 40 CFR 790.22(b).)

Under the ECA process, EPA will

publish a notice in the Federal Register

soliciting interested parties to

participate in or monitor negotiations

for ECAs on those HAPs chemicals for

which the Agency has decided to

proceed. The notice will also announce

a date for one or more public meetings

to negotiate the ECAs. At the meetings

to negotiate the PK ECAs, EPA may raise

issues, based on the Agency’s further

review of the PK proposals, that differ

from those contained in the Agency’s

preliminary technical analyses. If ECAs

are successfully concluded, they will be
Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Proposed Rules 67475

incorporated into testing consent orders,

by which means they become

enforceable.

It is important that all submitters of

ECA proposals—and potential

submitters—recognize the significance

of responding to the request for

comments on the proposed HAPs test

rule, as amended. The submission of a

proposal to develop an ECA to conduct

testing alternative to that contained in

the HAPs test rule is no guarantee that

the process will conclude with an

agreement. Comments on the proposed

HAPs test rule, as amended, should be

submitted as an activity separate from

the ECA process. To be considered in

this rulemaking, comments must be

submitted in the manner specified in

the ‘‘ADDRESSES’’ section at the

beginning of this document.

V. Public Record and Electronic

Submissions

The official record for this

rulemaking, including the public

version, which does not include any

information claimed as CBI, has been

established for this rulemaking under

document control number (OPPTS–

42187A; FRL–4869–1). This docket also

includes all material and submissions

filed under docket number OPPTS–

42193 (FRL–5719–5), the record for the

rulemaking for the TSCA test

guidelines, and all material and

submissions filed under docket number

OPPTS–42187B (FRL–4869–1), the

record for the receipt of proposals for

developing ECAs for alternative testing

of HAPs chemicals. This record contains

the basic information considered by

EPA in developing this proposed rule,

as amended, and appropriate Federal

Register notices. The public version of

this record, including printed, paper

versions of electronic comments, is

available for inspection from 12 noon to

4 p.m., Monday through Friday,

excluding legal holidays. The public

record is located in the TSCA

Nonconfidential Information Center,

Rm. NE–B607, 401 M St., SW.,

Washington, DC 20460.

Electronic comments can be sent

directly to EPA at:

oppt.ncic@epamail.epa.gov

Electronic comments must be submitted

as an ASCII file avoiding the use of

special characters and any form of

encryption. Comments and data will

also be accepted on disks in

WordPerfect 5.1 file format or ASCII file

format. All comments and data in

electronic form must be identified by

document control number (OPPTS–

42187A; FRL–4869–1). Electronic

comments on this proposed rule, as

amended, may be filed online at many

Federal Depository Libraries.

All comments which contain

information claimed as CBI must be

clearly marked as such. Three sanitized

copies of any comments containing

information claimed as CBI must also be

submitted and will be placed in the

public record for this rulemaking.

Persons submitting information any

portion of which they believe is entitled

to treatment as CBI by EPA must assert

a business confidentiality claim in

accordance with 40 CFR 2.203(b) for

each such portion. This claim must be

made at the time that the information is

submitted to EPA. If a submitter does

not assert a confidentiality claim at the

time of submission, EPA will make the

information available to the public

without further notice to the submitter.

No CBI should be submitted

electronically.

Electronic Availability: Internet:

Electronic copies of this document and

various support documents are available

from the EPA Home Page at the Federal

Register - Environmental Documents

entry for this document under

‘‘Regulations’’ (http://www.epa.gov/

fedrgstr/EPA-TOX/1997/). Fax-OnDemand: Using a faxphone call 202–

401–0527 and select item 4640 for an

index of available material and

corresponding item numbers related to

this document.

In addition to the documents listed in

Unit X. of the original HAPs proposal,

the record includes the following

documents that are referenced in this

amended HAPs proposal. Note that

certain documents are listed in both the

original HAPs proposal and the

amended HAPs proposal.

A. Federal Register notices pertaining

to this amended HAPs proposal

consisting of:

1. ‘‘Toxic Substances Control Act Test

Guidelines’’ (50 FR 39252, September

27, 1985).

2. ‘‘Cresols; Testing Requirements’’

(51 FR 15771, April 28, 1986).

3. ‘‘Small Business Size Standards’’

(61 FR 3280, January 31, 1996).

4. ‘‘Proposed Testing Guidelines;

Notice of Availability and Request for

Comments’’ (61 FR 31522, June 20,

1996).

5. ‘‘Proposed Test Rule for Hazardous

Air Pollutants; Proposed Rule’’ (61 FR

33178, June 26, 1996).

6. ‘‘Proposed Test Rule for Hazardous

Air Pollutants; Notice of Public

Meeting’’ (61 FR 47853, September 11,

1996).

7. ‘‘Proposed Test Rule for Hazardous

Air Pollutants; Extension of Comment

Period on Proposed Rule and Extension

of Period for Receipt of Proposals for

Enforceable Consent Agreements for

Pharmacokinetics Studies’’ (61 FR

54383, October 18, 1996).

8. ‘‘Proposed Test Rule for Hazardous

Air Pollutants; Extension of Comment

Period on Proposed Rule’’ (61 FR 67516,

December 23, 1996).

9. ‘‘Testing Consent Order for Phenol’’

(62 FR 2607, January 17, 1997).

10. ‘‘Proposed Test Rule for

Hazardous Air Pollutants; Extension of

Comment Period on Proposed Rule’’ (62

FR 9142, February 28, 1997).

11. ‘‘Proposed Test Rule for

Hazardous Air Pollutants; Extension of

Comment Period on Proposed Rule’’ (62

FR 14850, March 28, 1997).

12. ‘‘Testing Consent Order for

Phenol’’ (62 FR 28368, May 23, 1997).

13. ‘‘Proposed Test Rule for

Hazardous Air Pollutants; Extension of

Comment Period on Proposed Rule’’ (62

FR 29318, May 30, 1997).

14. ‘‘Proposed Test Rule for

Hazardous Air Pollutants; Extension of

Comment Period on Proposed Rule’’ (62

FR 37833, July 15, 1997).

15. ‘‘Toxic Substances Control Act

Test Guidelines’’ (62 FR 43820, August

15, 1997).

16. ‘‘Proposed Test Rule for

Hazardous Air Pollutants; Extension of

Comment Period on Proposed Rule’’ (62

FR 50546, September 26, 1997).

17. ‘‘Proposed Test Rule for

Hazardous Air Pollutants; Extension of

Comment Period on Proposed Rule’’ (62

FR 63299, November 28, 1997).

B. TSCA Test guidelines referenced in

this amended HAPs proposal consisting

of:

1. 799.9135 TSCA acute inhalation

toxicity with histopathology (62 FR

43820, 43824-43828, August 15, 1997).

2. 799.9346 TSCA subchronic

inhalation toxicity (62 FR 43820, 43828-

43832, August 15, 1997).

3. 799.9370 TSCA prenatal

developmental toxicity (62 FR 43820,

43832-43834, August 15, 1997).

4. 799.9380 TSCA reproduction and

fertility effects (62 FR 43820, 43834-

43838, August 15, 1997).

5. 799.9420 TSCA carcinogenicity (62

FR 43820, 43838-43842, August 15,

1997).

6. 799.9510 TSCA bacterial reverse

mutation test (62 FR 43820, 43842-

43846, August 15, 1997).

7. 799.9530 TSCA in vitro mammalian

cell gene mutation test (62 FR 43820,

43846-43850, August 15, 1997).

8. 799.9538 TSCA mammalian bone

marrow chromosomal aberration test (62

FR 43820, 43850-43853, August 15,

1997).

9. 799.9539 TSCA mammalian

erythrocyte micronucleus test (62 FR

43820, 43853-43857, August 15, 1997).
67476 Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Proposed Rules

10. 799.9620 TSCA neurotoxicity

screening battery (62 FR 43820, 43857-

43860, August 15, 1997).

11. 799.9780 TSCA immunotoxicity

(62 FR 43820, 43860-43864, August 15,

1997).

C. OPPTS draft harmonized test

guidelines cross-referenced in the

original HAPs proposal consisting of:

1. Acute Inhalation Toxicity with

Histopathology, OPPTS 870.1350, EPA

Pub. No. 712-C-96-291, June 1996.

2. Subchronic Inhalation Toxicity,

OPPTS 870.3465, EPA Pub. No. 712-C96-204, June 1996.

3. Inhalation Developmental Toxicity

Study, OPPTS 870-3600, EPA Pub. No.

712-C-96-206, June 1996.

4. Reproduction and Fertility Effects,

OPPTS 870.3800, EPA Pub. No. 712-C96-208, February 1996.

5. Carcinogenicity, OPPTS 870.4200,

EPA Pub. No. 712-C-96-211, June 1996.

6. Escherichia coli WP2 and WP2

uvrA Reverse Mutation Assays, OPPTS

870.5100, EPA Pub. No. 712-C-96-247,

June 1996.

7. Detection of Gene Mutations in

Somatic Cells in Culture, OPPTS

870.5300, EPA Pub. No. 712-C-96-221,

June 1996.

8. In Vivo Mammalian Cytogenetics

Tests: Bone Marrow Chromosomal

Analysis, OPPTS 870.5385, EPA Pub.

No. 712-C-96-225, June 1996.

9. In Vivo Mammalian Cytogenetics

Tests: Erythrocyte Micronucleus Assay,

OPPTS 870.5395, EPA Pub. No. 712-C96-226, June 1996.

10. Neurotoxicity Screening Battery,

OPPTS 870.6200, EPA Pub. No. 712-C96-238, June 1996.

11. Immunotoxicity, OPPTS 870.7800,

EPA Pub. No. 712-C-96-351, June 1996.

D. Other guidelines referenced in this

proposal:

1. OECD final revision test guideline

471 / 472 ‘‘Bacterial reverse mutation

assay,’’ as read from the OECD

homepage: http://www.oecd.org/ehs/

test/ testlist.htm (February 1997).

2. OECD final revision test guideline

476 ‘‘In vitro mammalian cell gene

mutation test,’’ as read from the OECD

homepage: http://www.oecd.org/ehs/

test/ testlist.htm (February 1997).

3. OECD final revision guideline 475

‘‘Mammalian bone marrow chromosome

aberration test,’’ as read from the OECD

homepage: http://www.oecd.org/ehs/

test/ testlist.htm (February 1997).

4. OECD final revision test guideline

474 ‘‘Mammalian erthyrocyte

micronucleus test,’’ as read from the

OECD homepage: http://www.oecd.org/

ehs/test/ testlist.htm (February 1997).

E. Test Guideline Support documents

referenced in this proposal:

1. USEPA. Memorandum, Angela

Auletta and Michael Cimino to Roger

Nelson. HAPs Rule: OECD Process for

Update of Genetic Toxicity Test

Guidelines, March 10, 1997(a).

2. USEPA. Memorandum, Michael C.

Cimino to Roger Nelson. Genotoxicity

Test Guidelines for the HAPs Rule,

February 27, 1997.

3. USEPA. Memorandum, Michael C.

Cimino to Richard Leukroth. HAPs

Rule: Adaptation of OECD Genotoxicity

Test Guidelines, March 10, 1997(b).

4. Final report of the FIFRA Scientific

Advisory Panel meeting, held October

29-30, 1996.

F. PK-related documents consisting

of:

1. Chemical Manufacturers

Association, Alkanolamines Panel,

‘‘Proposal for Pharmacokinetics Studies

of Diethanolamine’’ (November 25,

1996).

2. U.S. EPA, ‘‘Preliminary EPA

Technical Analysis of Proposed

Industry Pharmacokinetics (PK) Strategy

for Diethanolamine’’ (November 21,

1997).

3. HAP Task Force, ‘‘Proposal for

Pharmacokinetics Study of Ethylene

Dichloride’’ (November 22, 1996).

4. U.S. EPA, ‘‘Preliminary EPA

Technical Analysis of Proposed

Industry Pharmacokinetics (PK) Strategy

for Ethylene Dichloride,’’ with cover

letter (June 26, 1997).

5. Chemical Manufacturers

Association, Ethylene Glycol Panel,

‘‘Proposal for Pharmacokinetic Studies

of Ethylene Glycol’’ (November 5, 1996).

6. U.S. EPA, ‘‘Preliminary EPA

Technical Analysis of Proposed

Industry Pharmacokinetics (PK) Strategy

for Ethylene Glycol, with cover letter

(August 26, 1997).

7. Chemical Manufacturers

Association, Hydrogen Fluoride (HF)

Panel, ‘‘Proposal for a PhysiologicallyBased Pharmacokinetic (PBPK) Model

for Hydrogen Fluoride’’ (November 22,

1996).

8. U.S. EPA, ‘‘Preliminary EPA

Technical Analysis of Proposed

Industry Pharmacokinetics (PK) Strategy

for Hydrogen Fluoride’’ (June 26, 1997).

9. Chemical Manufacturers

Association, Maleic Anhydride Panel,

‘‘Developing an Inhalation Testing

Program for Maleic Anhydride’’

(November 8, 1996).

10. U.S. EPA, ‘‘Preliminary EPA

Technical Analysis of Proposed

Industry Pharmacokinetics (PK) Strategy

for Maleic Anhydride,’’ with cover letter

(July 10, 1997).

11. Chemical Manufacturers

Association, Phthalic Anhydride

Producers Task Group, ‘‘Testing

Proposal of the Chemical Manufacturers

Association, Phthalic Anhydride

Producers Task Group in Response to

EPA’s Proposed Rule for Phthalic

Anhydride’’ (November 22, 1996).

12. U.S. EPA. ‘‘Preliminary EPA

Technical Analysis of Proposed

Industry Pharmacokinetics (PK) Strategy

for Phthalic Anhydride,’’ with cover

letter (July 10, 1997).

13. Chlorobenzene Producers

Association, ‘‘Proposal to Use the

Pharmacokinetics, Physical, and

Chemical Properties of 1,2,4-

Trichlorobenzene to Fill Data Gaps’’

(November 25, 1996).

14. U.S. EPA, ‘‘Preliminary EPA

Technical Analysis of Proposed

Industry Pharmacokinetics (PK) Strategy

for 1,2,4-Trichlorobenzene,’’ with cover

letter (July 15, 1997).

15. HAP Task Force, ‘‘Proposal for

Pharmacokinetics Study of 1,1,2-

Trichloroethane’’ (November 22, 1996).

16. U.S. EPA, ‘‘Preliminary EPA

Technical Analysis of Proposed

Industry Pharmacokinetics (PK) Strategy

for 1,1,2-Trichloroethane,’’ with cover

letter (June 26, 1997).

G. Other ECA proposals and related

correspondence consisting of:

1. Chemical Manufacturers

Association, Ketones Panel,

‘‘Alternative Testing Proposal for

Methyl Isobutyl Ketone,’’ December 11,

1996 .

2. Letter from Charles M. Auer, EPA,

to Barbara Francis, Chemical

Manufacturers Association, March 3,

1997.

3. Letter from Carol R. Stack,

Chemical Manufacturers Association,

Cresols Panel to Charles M. Auer, EPA,

April 9, 1997 (with attachment).

4. Contact report by Richard W.

Leukroth, EPA, regarding discussion

with Leah Porter and Elizabeth Watson,

Chemical Manufacturers Association,

Cresols Panel, May 19, 1997.

5. Biphenyl Work Group, ‘‘Developing

a Test Plan for Assessing the Potential

Risk of Inhaled Biphenyl,’’ with cover

letter and attachment (October 7, 1997).

6. Letter from Charles Auer, EPA to

John Murray, Biphenyl Work Group,

November 4, 1997.

H. Technical support documents

consisting of:

1. U.S. EPA, ‘‘Economic Assessment

for the Amended Proposed TSCA

Section 4(a) Test Rule for 21 Hazardous

Air Pollutants,’’ OPPT/EETD/EPAB,

November 14, 1997.

2. U.S. EPA, ‘‘Section 4 Test Rule

Support for 21 Hazardous Air

Pollutants,’’ OPPT/EETD/EPAB, April 4,

1995 (economic analysis for the original

HAPs proposal).

3. U.S. EPA, ‘‘Additional Information

on Small Entity Impacts for the

Amended Proposed TSCA Section 4(a)

Test Rule for 21 Hazardous Air
Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Proposed Rules 67477

Pollutants,’’ OPPT/EETD/EPAB,

November 14, 1997.

4. U.S. EPA, ‘‘TSCA Test Guidelines:

Cost Estimates for Health Effects

Testing,’’ OPPT/EETD/RIB, various

dates.

5. U.S. EPA, ‘‘EPA Interim Guidance

for Implementing the Small Business

Regulatory Enforcement Fairness Act,’’

EPA SBREFA Task Force, February 5,

1997.

6. U.S. EPA, ‘‘Draft Review of

Economic Impact Methodology Applied

to TSCA Section 4 Test Rules,’’ OPPT/

ETD/RIB, September 23, 1988.

7. U.S. EPA, ‘‘Economic Analysis in

Support of the Final Rule to Amend

TSCA Section 12(b),’’ OPPT/ETD/RIB,

June 1992.

I. Letters, Facsimiles, electronic

correspondence, and contact reports

consisting of:

1. Letter from Gene P. Current,

Weirton Steel Corp., to Gary Timm,

EPA, August 26, 1996.

2. Letter from Marian K. Stanley,

Chemical Manufacturers Association, to

Gary Timm, EPA, August 28, 1996.

3. Electronic correspondence from Ed

J. Dulac, Air Products and Chemicals,

Inc., to Gary Timm, EPA, September 11,

1996.

4. Letter from Charles M. Auer, EPA,

to Kathleen Roberts, Chemical

Manufacturers Association, September

20, 1996.

5. Letter from Charles M. Auer, EPA,

to Elizabeth Watson, Chemical

Manufacturers Association, September

20, 1996.

6. Letter from Charles M. Auer, EPA,

to Jack Murray, Synthetic Organic

Chemical Manufacturers Association,

September 20, 1996.

7. Letter from Charles M. Auer, EPA,

to Caffey Norman, Halogenated Solvents

Industry Alliance, September 20, 1996.

8. Fax transmittal from Rudolph J.

Breglia, BP Oil, to Gary Timm, EPA,

September 26, 1996.

9. Electronic correspondence from

Steve Vasko, Eastalco Aluminum

Company, to Gary Timm, EPA, October

1, 1996.

10. Electronic correspondence from

Charlie Gjersvik, Goodwin & Broms,

Inc., to Gary Timm, EPA, October 25,

1996.

11. Fax transmittal from Rudolph J.

Breglia, BP Oil, to Dayton Eckerson,

EPA, November 21, 1996.

12. Letter from Charles M. Auer, EPA,

to Rudolph J. Breglia, BP Oil, July 29,

1997.

13. Note from Angela F. Hofmann,

EPA, to Kevin Bromberg, Small

Business Administration, September 9,

1997.

14. Contact report from Richard

Leukroth and George Semeniuk, EPA, of

phone call from Sharon Berryhill,

Samendon Oil Corp., October 17, 1997.

15. Contact report from Richard

Leukroth and Gary Timm, EPA, of

phone call from Ray Scholten, Union

Camp, October 20, 1997.

16. Letter from Charles M. Auer, EPA,

to Gene P. Current, Weirton Steel Corp.,

November 21, 1997.

17. Letter from Charles M. Auer, EPA,

to Ed J. Dulac, Air Products and

Chemicals, Inc., November 21, 1997.

18. Letter from Charles M. Auer, EPA,

to Steve Vasko, Eastalco Aluminum

Company, November 21, 1997.

19. Letter from Charles M. Auer, EPA,

to Charlie Gjersvik, Goodwin & Broms,

Inc., November 21, 1997.

20. Letter from Charles M. Auer, EPA,

to Rudolph J. Breglia, BP Oil, November

21, 1997.

21. Letter from Charles M. Auer, EPA,

to Sharon Berryhill, Samendon Oil

Corp., November 21, 1997.

22. Letter from Charles M. Auer, EPA,

to Roy Scholten, Union Camp,

November 21, 1997.

J. Meeting summaries consisting of:

1. Transcript of Public Meeting.

October 1, 1996. ‘‘Proposed Test Rule

for Hazardous Air Pollutants 40 CFR

Part 799.’’ Prepared by: Carol J. Thomas

Stenotype Reporting Services, Inc., 3162

Musket Court, Fairfax, VA 22030

2. Meeting Notes for the

Pharmacokinetics Enforceable Consent

Agreement Meeting. October 2, 1996.

Prepared by: Leah Freeman and Michael

Neal, Environmental Science Center,

Syracuse Research Corporation,

Syracuse, NY 13210.

3. Notes of EPA meeting with the

Hydrogen Fluoride Panel, November 4,

1996.

4. Summary of meeting with

Halogenated Solvents Industry Alliance

HAP Task Force on 1,1,2-

Trichloroethane and Ethylene

Dichloride, November 5, 1996.

5. Summary of meeting with Small

Business Administration on definition

of ‘‘small business’’ to be proposed in

the amended HAPs test rule, October 1,

1997.

VI. Regulatory Assessment

Requirements

A. Economic Assessment

EPA has prepared a revised economic

assessment entitled ‘‘Economic

Assessment for the Amended Proposed

TSCA Section 4(a) Test Rule for 21

Hazardous Air Pollutants.’’ This report

evaluates the potential for significant

economic impacts as a result of the

testing required by this amended HAPs

proposal. The costs estimated in the

economic assessment are based on the

use of the 11 TSCA test guidelines

cross-referenced in this amended

proposal. The total cost of providing test

data on the HAPs chemicals under this

amended proposal is estimated to range

from $22.6 million to $39.3 million.

These costs do not include data for

phenol, which, as explained in Unit

III.A. of this preamble, has been

removed from the amended HAPs

proposal. By comparison, the costs of

providing test data on the HAPs

chemicals under the original proposal

were estimated to range from $25.2

million to $41.4 million (as indicated in

the economic analysis for the original

proposal). The costs developed in the

economic assessment are based on test

cost estimates that have been placed in

the record for this rulemaking.

According to 40 CFR 790.42(a)(2),

while legally subject to the HAPs test

rule, processors of a HAP chemical

would be required to comply with the

requirements of the rule only if they are

directed to do so in a subsequent notice

as set forth in 40 CFR 790.48(b). EPA

would only issue such a notice if no

manufacturer or importer submits a

notice of its intent to conduct testing.

The Agency has never in fact notified

processors of their obligation to test

under such a notice, or applied the

reimbursement procedures of 40 CFR

part 791 to processors or even to

manufacturers. Since EPA has identified

at least one manufacturer or importer for

each HAP chemical, the Agency

presumes that at least one such

manufacturer or importer would submit

a notice of intent to conduct testing for

each chemical and would actually

conduct such testing, and thus that

processors would not, at least initially,

be burdened with the need to comply

with the rule. Thus, in the economic

assessment processors of the subject

chemicals are not included.

To evaluate the potential economic

effect of testing on HAP manufacturers

and importers, EPA estimated the

impact of the testing requirements as a

percentage of chemical sales price. This

measure compares annual revenues

from the sale of a chemical to the

annualized testing costs for that

chemical. Annualized testing costs

divide testing expenditures in the first

year into an equivalent, constant yearly

expenditure over a longer period of

time. To calculate the percent price

impact, testing costs (which include

both laboratory and administrative

expenditures) are annualized over 15

years using a 7 percent discount rate.

Annualized testing costs are then

divided by the total supply of the HAP

chemical to derive the annualized unit

test costs. The percent price impact is
67478 Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Proposed Rules

calculated by dividing the annualized

unit test costs by the sales price and

multiplying by 100.

The upper-bound estimated total costs

of testing (including both laboratory

costs and administrative costs),

annualized tests costs, price impact, and

public reporting burden hours for the

HAP chemicals in this amended HAPs

test rule proposal are presented in the

following Table 2. This table shows the

maximum test costs, maximum price

impacts (see Table 26 of the economic

assessment) and public reporting

burden hours (see Table C–3 of the

economic assessment) estimated by

EPA, which are presented in greater

detail in the revised economic

assessment document included in the

public record for this action.

Table 2.—Summary of Economic Analysis for the Amended HAPs Test Rule Proposal

Chemical substances1

Maximum test costs Maximum price

impact (%)

Public reporting

burden hours Total ($) Annualized ($)

1,1’-Biphenyl 2,518,183 276,483 0.7292 20,540

Carbonyl Sulfide 3,873,496 425,289 0.0424 35,560

Chlorine 105,186 11,549 0.0005 1,102

Chlorobenzene 1,218,931 133,832 0.1315 9,625

Chloroprene 1,592,388 174,836 0.0601 12,705

Cresol (3 isomers) 3,656,794 401,496 0.6069 28,875

Diethanolamine 2,518,183 276,483 0.2451 20,540

Ethylbenzene 1,934,638 212,413 0.0111 16,200

Ethylene Dichloride 2,397,668 263,251 0.0076 19,816

Ethylene Glycol 1,218,931 133,832 0.0068 9,625

Hydrochloric Acid 105,186 11,549 0.0048 1,102

Hydrogen Fluoride 2,518,183 276,483 0.1108 20,540

Maleic Anhydride 2,220,874 243,840 0.1258 22,755

Methyl Isobutyl Ketone 1,182,703 129,854 0.1384 9,247

Methyl Methacrylate 1,934,638 212,413 0.0200 16,200

Naphthalene 1,182,703 129,854 0.2081 9,247

Phthalic Anhydride 3,761,420 412,984 0.1174 34,513

1,2,4-Trichlorobenzene 977,636 107,339 0.8587 8,780

1,1,2-Trichloroethane 3,839,620 421,570 0.4138 35,275

Vinylidene Chloride 514,871 56,530 0.0853 4,561

Total 39,272,229 4,311,879 336,808

1 The requirement for phenol testing has been removed from the amended HAPs proposal (see Unit III.A. of this preamble).

EPA believes, on the basis of these

calculations, that the proposed testing of

the HAPs chemicals does not impose

any significant economic impact.

Because these chemical substances have

relatively large production volumes, the

annualized costs of testing, expressed as

a percentage of annual revenue, are very

small—ranging from 0.0005 to 0.86

percent. Costs of testing are therefore

found to be insignificant relative to

revenues for companies producing these

chemical substances. In addition, the

TSCA section 12(b) export notification

requirements that would be triggered by

the final rule are expected to have a

negligible impact on exporters—that of

less than 1 percent of sales revenue. As

discussed in more detail in the

economic assessment, the Agency

expects that the impact of the final

HAPs rule will be less than that

estimated in the original proposal.

Although not considered in the

economic assessment, EPA also

anticipates further reductions in the

estimated cost of the final rule

attributable to the conclusion of any

ECAs between EPA and industry.

While the rule imposes costs, it also

has significant benefits which were not

evaluated in the Agency’s economic

assessment. The data obtained from the

HAPs test rule will assist the Agency in

making regulatory decisions concerning

the protection of human health from

respiratory diseases such as asthma,

emphysema and respiratory cancer;

neurotoxicity; birth defects; and

reproductive malfunction that are

believed to be related to exposure to the

hazardous air pollutant chemicals

included in this rule. Specifically, data

from this test rule will be used for the

determination of significant residual

risk after the imposition of MACT

efforts to reduce human exposure to

these chemicals. The data will also

assist other agenices (e.g., Agency for

Toxic Substances and Disease Registry,

National Institute for Occupational

Safety and Health, Occupational Safety

and Health Administration, Consumer

Product Safety Commission) in

assessing chemical risks and in taking

appropriate action within their

programs.

EPA is seeking comment on the

revised economic assessment. To be

considered in this rulemaking,

comments must be submitted in the

manner specified in the ‘‘ADDRESSES’’

section at the beginning of his

document.

B. Executive Order 12866 and Executive

Order 12898; Unfunded Mandates

Reform Act

Because the overall costs associated

with testing under the amended HAPs

proposal are expected to decrease

relative to the original proposal, the

amended proposal does not contain any

provisions that would require additional

consideration by the Office of

Management and Budget (OMB) under

Executive Order 12866, entitled

Regulatory Planning and Review (58 FR

51735, October 4, 1993) or Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in
Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Proposed Rules 67479

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994). Similarly, the amended proposal

does not require any actions under Title

II of the Unfunded Mandates Reform

Act of 1995 (UMRA) (Pub. L. 104–4).

The Agency’s activities related to these

regulatory assessment requirements are

discussed in the original proposed rule.

C. Regulatory Flexibility Act

For the original proposed HAPs test

rule, EPA determined under section

605(b) of the Regulatory Flexibility Act

(RFA), 5 U.S.C. 601 et seq., that the

HAPs test rule, if finalized as proposed,

would not result in a significant

economic impact on small businesses.

See Unit XI.B. of the preamble to the

original HAPs proposal (61 FR 33178,

33196). In conjunction with this

amended proposal, EPA has prepared

and placed in the record for this action,

a document that gives additional

information on small entity impacts. As

presented in this additional analysis,

the new TSCA test guidelines crossreferenced in the amended HAPs

proposal do not affect the Agency’s

previous determination with regard to

small entity impacts. Since processors

would not, at least initially, be

burdened with the need to comply with

the rule, processors are not included in

the small entity analysis (see

explanation regarding processors in the

discussion of the economic assessment

in Unit VI.A. of this preamble).

EPA does not believe that the impacts

described in the analysis constitute a

significant economic impact on a

substantial number of small entities.

The analysis states that the worst-case

estimate shows that, on a HAP chemical

by HAP chemical basis, a total of 8

manufacturers/importers (out of 365

manufacturers/importers initially

burdened) may be affected by the rule.

No manufacturers/importers for whom

revenue data were available would be

impacted by test costs that exceed 1

percent of their sales. For 8

manufacturers/importers whose

revenues could not be determined, the

size of the testing burden could not be

determined and, therefore, the potential

for impacts at greater than 1 percent of

sales could not be ruled out.

Nevertheless, in this context the rule

would be unlikely to have a significant

economic impact on a substantial

number of small entities because the

impacts of 1 percent or greater would be

on fewer than 100 affected small

entities.

Therefore, the Agency certifies that

the HAPs test rule, if finalized according

to this amended proposal, will not have

a significant economic impact on a

substantial number of small entities.

In the small entity analysis, the

Agency has used the definition of a

‘‘small business’’ that is codified at 40

CFR 704.3 as ‘‘small manufacturer or

importer,’’ which has been used for the

general reporting and record keeping

provisions for TSCA section 8(a)

information gathering rules. According

to section 601(3) of the RFA, agencies

must use the definition of ‘‘small

business’’ that is provided under the

Small Business Act, 15 U.S.C. 631 et

seq., unless it establishes an alternative

definition. The Agency may use the

alternative definition for RFA purposes

only after it has consulted with the

Office of Advocacy of the Small

Business Administration (SBA) and

provided an opportunity for public

comment.

Under the TSCA-related definition

used by EPA, a manufacturer or

importer is considered to be a ‘‘small

business’’ if it meets either of the

following criteria: (1) total annual sales

of the company, combined with those of

any parent company, are below $40

million and annual production volume

or importation volume at the facility is

less than or equal to 100,000 pounds; or

(2) total annual sales of the company,

combined with those of any parent

company, are below $4 million (40 CFR

704.3). This definition also includes a

provision that allows EPA to adjust the

total annual sales values for inflation

whenever the Agency deems it

necessary to do so. EPA believes that

specified levels of total annual sales, in

conjunction with those for annual

production or import volume, indicate

the ability of a company to support

chemical testing without significant

costs or burden.

The small business size standards

promulgated by the SBA (61 FR 3280,

3289–3291, January 31, 1996) for

chemical manufacturers are based solely

on the number of employees. For

chemical manufacturing, however, the

number of employees may not be

closely related to the total annual sales

of a company. Since chemical testing

primarily requires a financial outlay,

EPA believes that the number of

employees is a less reliable measure of

a company’s ability to support testing

than is a company’s total annual sales.

Therefore, in this rulemaking, the

Agency is proposing to use the

definition that appears at 40 CFR 704.3.

This definition is discussed in the

document entitled, ‘‘Additional

Information on Small Entity Impacts of

the Amended Proposed TSCA section

4(a) Test Rule for 21 Hazardous Air

Pollutants’’ (see Unit V.H.3. of this

document).

EPA is seeking comment on the use of

the Agency’s definition of ‘‘small

business,’’ the ‘‘Additional Information

on Small Entity Impacts of the

Amended Proposed TSCA Section 4(a)

Test Rule for 21 Hazardous Air

Pollutants’’ document, as well as the

small entity impacts analysis in the

original proposal (61 FR 33178, 33196).

EPA has consulted with the Office of

Advocacy of the SBA concerning the

Agency’s use of the EPA definition. A

summary of the meeting is in the record

for this rulemaking (see document

referenced in Unit V.J.5. of this

preamble).

Any comments regarding the impacts

that this action may impose on small

entities should be submitted to the

Agency in the manner specified under

‘‘ADDRESSES’’ at the beginning of this

document.

D. Paperwork Reduction Act

The information collection

requirements associated with test rules

under TSCA section 4(a) in general,

have been approved by the Office of

Management and Budget (OMB)

pursuant to the Paperwork Reduction

Act, 44 U.S.C. 3501 et seq. (PRA) under

OMB control number 2070–0033 (EPA

ICR No. 1139). The information

collection requirements contained in

this amended proposed rule, however,

are not effective until the final rule, at

which point the total estimated burden

hours will be added to the total burden

approved by OMB under control

number 2070–0033. An Agency may not

conduct or sponsor, and a person is not

required to respond to a collection of

information subject to OMB approval

under the PRA, unless it has been

approved by OMB and displays a

currently valid OMB control number.

The OMB control numbers for EPA’s

regulations, after initial display in the

preamble of the final rules, are listed in

40 CFR part 9.

The list of public reporting burdens

for the collection of information for

chemical substances under the proposed

HAPs test rule, as amended, as well as

the numbers for the total public

reporting burden and the overall average

per chemical have changed from the

numbers used in Unit XI.C. of the

preamble to the original HAPs proposal

(see: ‘‘Paperwork Reduction Act’’ (61 FR

33178, 33196)). As described in Unit

VI.A. of this preamble, EPA has

prepared an economic assessment

which identifies the costs and burdens

associated with the testing of the HAPs

chemicals under the 11 TSCA test

guidelines referenced in this amended
67480 Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Proposed Rules

proposal. Table 3 compares the

estimated public reporting burden hours

for each of the HAPs chemicals in the

amended proposal with the burden

hours for each HAP chemical in the

original proposal.

Table 3.—Comparison of Estimated Public Reporting Burden for the Original and Amended HAPs Test Rule Proposals

HAPs chemical

Estimated public reporting burden

Original HAPs test rule proposal Amended HAPs test rule proposal

1,1’-Biphenyl 20,620 20,540

Carbonyl sulfide 47,644 35.560

Chlorine 693 1,102

Chlorobenzene 7,707 9,625

Chloroprene 13,039 12,705

ortho-Cresol 6,048 9,625

meta-Cresol 6,048 9,625

para-Cresol 6,048 9,625

Diethanolamine 21,826 20,540

Ethylbenzene 14,400 16,200

Ethylene dichloride 16,707 19,816

Ethylene glycol 7,816 9,625

Hydrochloric acid 693 1,102

Hydrogen fluoride 18,068 20,540

Maleic anhydride 35,849 22,755

Methyl isobutyl ketone 10,471 9,247

Methyl methacrylate 14,400 16,200

Naphthalene 10,580 9,247

Phenol1 693

Phthalic anhydride 51,032 34,513

1,2,4-Trichlorobenzene 8,091 8,780

1,1,2-Trichloroethane 33,133 35,275

Vinylidene chloride 5,439 4,561

Av. Per HAPs response: 15,524 15,309

Total (all HAPs): 357,045 336,808

1 The requirement for phenol testing has been removed from the amended HAPs proposal (see Unit III.A. of this preamble).

The total public reporting is now

estimated to be 336,808 burden hours

for all responses, as compared to the

357,045 burden hours indicated in the

original proposal. The overall average

public reporting burden for each HAP

chemical is 15,309 burden hours, as

compared to the 15,524 burden hours

estimated in the original proposal. The

overall average burden for each HAP

chemical that is presented in the table

in Unit XI.C. of the original HAPs

proposal was calculated based on a total

HAPs chemical count of 23 chemicals

(each cresol isomer was considered to

be a separate chemical moiety) (61 FR

33178, 33196). This method was also

used to calculate the overall average

public reporting burden for each HAP

chemical for the amended HAPs

proposal after the removal of data for

phenol (a count of 22 chemicals).

As defined by the PRA and 5 CFR

1320.3, ‘‘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. The burden

hours contained in the original

economic analysis and the table in Unit

XI.C. of the original HAPs proposal (61

FR 33178, 33196), however, were based

only on burdens associated with the

cost of laboratory testing and not the

other activities described in the PRA.

In addition, the total burden hours for

cresols that were presented in the

‘‘Paperwork Reduction Act’’ section of

the original HAPs proposal were not

reported correctly in the chemical-bychemical table at 61 FR 33196. The

reported 6,048 hours was the estimate

calculated for each cresol isomer, not all

three isomers as indicated in the table.

Nevertheless, the total burden of

357,045 hours for all responses that was

indicated in the original HAPs proposal

did include the burdens for all three

cresol isomers.

Comments are requested on the

Agency’s need for this information, the

accuracy of the provided burden

estimates, and any suggested methods

for minimizing respondent burden,

including through the use of automated

collection techniques. Send comments

to EPA as part of your overall comments

on this proposed action in the manner

specified in the ‘‘ADDRESSES’’ section

at the beginning of this document, or to

the Director, OPPE Regulatory

Information Division, U.S.

Environmental Protection Agency (Mail

Code 2137), 401 M Street, SW.,

Washington, DC 20460, with a copy to

the Office of Information and Regulatory

Affairs, Office of Management and

Budget, 725 17th St., N.W., Washington,

DC 20503, marked ‘‘Attention: Desk

Officer for EPA.’’ Please remember to

include the OMB control number in any

correspondence. In developing the final

rule, the Agency will address any

comments received regarding the

information collection requirements

contained in this proposal.

E. Executive Order 13045

Neither the original HAPs proposal

nor this amended proposal requires

special consideration by OMB pursuant
Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Proposed Rules 67481

to the terms of Executive Order 13045,

entitled ‘‘Protection of Children from

Environmental Health Risks and Safety

Risks’’ (62 FR 19885, April 23, 1997),

because the Executive Order does not

apply to rulemakings initiated prior to

the issuance of the Order, in this

instance, June 26, 1996, or actions

expected to have an economic impact of

less than $100 million.

List of Subjects in 40 CFR Part 799

Environmental protection, Chemicals,

Hazardous substances, Reporting and

recordkeeping requirements,

Incorporation by reference.

Dated: December 15, 1997.

Lynn R. Goldman,

Assistant Administrator for Prevention,

Pesticides and Toxic Substances.

Therefore, it is proposed that 40 CFR

chapter I, subchapter R, be amended as

follows:

PART 799—[AMENDED]

1. The authority citation for part 799

would continue to read as follows:

Authority: 15 U.S.C. 2603, 2611, 2625.

2. Section 799.5053 as proposed to be

added at 61 FR 33197, June 26, 1996, is

revised to read as follows:

§ 799.5053 Chemical testing requirements

for hazardous air pollutants.

(a) General testing provisions—(1)

Identification of test substance. Table 1

in paragraph (a)(6) of this section

identifies those chemical substances

that shall be tested in accordance with

this section. The purity of each test

substance shall be 97 percent or greater

unless otherwise specified.

(2) Persons required to submit study

plans, conduct tests, and submit data.

(i) For purposes of this section, the term

‘‘facility’’ is defined as ‘‘all buildings,

equipment, structures, and other

stationary items which are located on a

single site or on contiguous or adjacent

sites and which are owned or operated

by the same person (or by any person

which controls, is controlled by, or is

under common control with such

person). A facility may contain more

than one establishment.’’ The facility for

a person who imports a chemical

substance is the facility of the operating

unit within the person’s organization

which is directly responsible for

importing the substance and which

controls the import transaction, and

may in some cases be the organization’s

headquarters office in the United States.

(ii) All persons who, during the last

complete corporate fiscal year prior to

the effective date specified in Table 1 in

paragraph (a)(6) of this section,

manufacture (including import,

manufacture as a byproduct as defined

in 40 CFR 791.3(c), and manufacture,

including import, as an impurity as

defined in 40 CFR 790.3) or process any

chemical substance specified in Table 1

in the form of a Class 1 substance (as

described in 40 CFR 720.45(a)(1)(i)), or

a component of a Class 2 substance (as

described in 40 CFR 720.45(a)(1)(i)) or

mixture (as defined in TSCA section

3(8)), but not as a component of a

naturally-occurring substance (as

defined in 40 CFR 710.4(b)) or a nonisolated intermediate (as defined in 40

CFR 704.3), at a facility shall: submit

letters of intent to conduct testing,

submit study plans, conduct testing

under TSCA Good Laboratory Practice

Standards, and submit data, as specified

in this section and part 792 of this

chapter, or submit exemption

applications, as specified in part 790 of

this chapter.

(iii) As explained in part 790 of this

chapter, processors, small-quantity

manufacturers, and manufacturers of

small quantities of the chemical

substances specified in Table 1 solely

for research and development purposes

must comply with the requirements of

the rule only if directed to do so by EPA

in a subsequent notice because no

manufacturer has submitted a notice of

its intent to conduct testing.

(iv) Manufacturers of a chemical

substance specified in Table 1 who,

during the last complete corporate fiscal

year prior to the effective date specified

in Table 1, at no facility, manufacture

such substance in an amount equal to or

in excess of 25,000 lb must comply with

the requirements of the rule only if

directed to do so by EPA in a

subsequent notice because no

manufacturer has submitted a notice of

its intent to conduct testing.

(v) Manufacturers of a chemical

substance specified in Table 1 who,

during the last complete corporate fiscal

year prior to the effective date specified

in Table 1, at no facility, manufacture

such substance in an amount equal to or

in excess of 25,000 lb as a component

of another chemical substance or

mixture in which the proportion of the

substance specified in Table 1 is equal

to or in excess of one percent by weight

must comply with the requirements of

the rule only if directed to do so by EPA

in a subsequent notice because no

manufacturer has submitted a notice of

its intent to conduct testing.

(3) Export notification. All persons

who export or intend to export a

chemical substance listed in Table 1 in

paragraph (a)(6) of this section are

subject to part 707, subpart D, of this

chapter.

(4) Applicability of test guidelines.

The guidelines and test standards cited

in Table 1 in paragraph (a)(6) of this

section are referenced here as they exist

on the effective date listed in Table 1 for

that specific test. Testing shall be

conducted in accordance with test

standards specified in Table 1, which

references TSCA health effects test

guidelines codified at subpart H of this

part.

(5) Testing requirements. The

chemical substances identified by

Chemical Abstracts Service (CAS)

number and chemical name in Table 1

in paragraph (a)(6) of this section shall

be tested in accordance with the test

standards set forth in Table 1. The

column labeled ‘‘Basic testing

requirements (test guideline)’’

references the applicable TSCA test

guideline on which the test standard is

based, and the column entitled

‘‘Changes from guideline’’ lists the ways

in which the specific test standard

differs from the basic testing

requirement (test guideline), as

specified in paragraph (b) of this

section.

(6) Reporting requirements. Interim

progress reports for each test shall be

submitted every 6 months, beginning 6

months after the effective date of any

specific test listed in the following

Table 1. Final reports for any specific

test shall be submitted by the deadlines

indicated as the number of months after

the effective date shown in the

following Table 1.

TABLE 1

CAS No. Chemical name/types of

testing

Test standard

Final report Effective

Basic testing require- date

ments (test guideline) Changes from guideline

75–35–4 Vinylidene chloride:
67482 Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Proposed Rules

TABLE 1—Continued

CAS No. Chemical name/types of

testing

Test standard

Final report Effective

Basic testing require- date

ments (test guideline) Changes from guideline

Acute 799.9135 (b)(2) 21 mo

Neurotoxicity 799.9620 (b)(1)(ii)(A), (b)(1)(iii)(A),

(b)(1)(iii)(B)

21 mo

79–00–5 1,1,2-Trichloroethane:

Acute 799.9135 (b)(2) 21 mo

Subchronic 799.9346 (b)(3) 18 mo

Developmental 799.9370 (b)(1)(ii)(A) 12 mo

Reproductive 799.9380 (b)(1)(ii)(A) 29 mo

Neurotoxicity 799.9620 (b)(1)(ii)(A), (b)(1)(iii)(A),

(b)(1)(iii)(B)

21 mo

Carcinogenicity 799.9420 (b)(1)(i)(D), (b)(1)(ii)(A) 60 mo

In vivo cytogenetics 799.9538 or 799.9539 (b)(1)(ii)(A) 14 mo

Immunotoxicity 799.9780 (b)(1)(ii)(A), (b)(4) 18 mo

80–62–6 Methyl methacrylate:

Acute 799.9135 (b)(2) 21 mo

Developmental 799.9370 (b)(1)(i)(A), (b)(1)(ii)(A) 12 mo

Reproductive 799.9380 (b)(1)(ii)(A) 29 mo

Neurotoxicity 799.9620 (b)(1)(ii)(A), (b)(1)(iii)(A),

(b)(1)(iii)(B)

21 mo

Immunotoxicity 799.9780 (b)(1)(ii)(A), (b)(4) 21 mo

85–44–9 Phthalic anhydride:

Acute 799.9350 (b)(2) 21 mo

Subchronic 799.9346 (b)(1)(ii)(B), (b)(3) 18 mo

Developmental 799.9370 (b)(1)(ii)(B) 12 mo

Reproductive 799.9380 (b)(1)(ii)(B) 29 mo

Neurotoxicity 799.9620 (b)(1)(ii)(B), (b)(1)(iii)(A),

(b)(1)(iii)(B)

21 mo

Carcinogenicity 799.9420 (b)(1)(ii)(B) 60 mo

Immunotoxicity 799.9780 (b)(1)(ii)(B), (b)(4) 18 mo

91–20–3 Naphthalene:

Acute 799.9135 (b)(2) 21 mo

Reproductive 799.9380 (b)(1)(ii)(A) 29 mo

Immunotoxicity 799.9780 (b)(1)(ii)(A), (b)(4) 21 mo

92–52–4 1,1’-Biphenyl:

Acute 799.9135 (b)(2) 21 mo

Subchronic 799.9346 (b)(1)(ii)(B), (b)(3) 18 mo

Developmental 799.9370 (b)(1)(i)(A), (b)(1)(ii)(B) 12 mo

Reproductive 799.9380 (b)(1)(ii)(B) 29 mo

Neurotoxicity 799.9620 (b)(1)(ii)(B), (b)(1)(iii)(A),

(b)(1)(iii)(B)

21 mo

Immunotoxicity 799.9780 (b)(1)(ii)(B), (b)(4) 18 mo

95–48–7 ortho-Cresol:

Acute 799.9135 (b)(2) 21 mo

Subchronic 799.9346 (b)(3) 18 mo

Neurotoxicity 799.9620 (b)(1)(ii)(A), (b)(1)(iii)(A) 21 mo

Immunotoxicity 799.9780 (b)(1)(ii)(A), (b)(4) 18 mo

108–39–4 meta-Cresol:

Acute 799.9135 (b)(2) 21 mo

Subchronic 799.9346 (b)(3) 18 mo

Neurotoxicity 799.9620 (b)(1)(ii)(A), (b)(1)(iii)(A) 21 mo

Immunotoxicity 799.9780 (b)(1)(ii)(A), (b)(4) 18 mo

106–44–5 para-Cresol:

Acute 799.9135 (b)(2) 21 mo

Subchronic 799.9346 (b)(3) 18 mo

Neurotoxicity 799.9620 (b)(1)(ii)(A), (b)(1)(iii)(A) 21 mo

Immunotoxicity 799.9780 (b)(1)(ii)(A), (b)(4) 18 mo
Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Proposed Rules 67483

TABLE 1—Continued

CAS No. Chemical name/types of

testing

Test standard

Final report Effective

Basic testing require- date

ments (test guideline) Changes from guideline

100–41–4 Ethylbenzene:

Acute 799.9135 (b)(2) 21 mo

Developmental 799.9360 (b)(1)(i)(A), (b)(1)(ii)(A) 12 mo

Reproductive 799.9380 (b)(1)(ii)(A) 29 mo

Neurotoxicity 799.9620 (b)(1)(ii)(A), (b)(1)(iii)(A),

(b)(1)(iii)(B)

21 mo

Immunotoxicity 799.9780 (b)(1)(ii)(A), (b)(4) 21 mo

107–06–2 Ethylene dichloride:

Acute 799.9135 (b)(2) 21 mo

Subchronic 799.9346 (b)(3) 18 mo

Developmental 799.9370 (b)(1)(i)(C), (b)(1)(ii)(A) 12 mo

Reproductive 799.9380 (b)(1)(ii)(A) 29 mo

Neurotoxicity 799.9620 (b)(1)(ii)(A), (b)(1)(iii)(A),

(b)(1)(iii)(B)

21 mo

107–21–1 Ethylene glycol:

Acute 799.9135 (b)(2) 21 mo

Subchronic 799.9346 (b)(3) 18 mo

Neurotoxicity 799.9620 (b)(1)(ii)(A), (b)(1)(iii)(A),

(b)(1)(iii)(B)

21 mo

Immunotoxicity 799.9780 (b)(1)(ii)(A), (b)(4) 18 mo

108–10–1 Methyl isobutyl ketone:

Acute 799.9135 (b)(2) 21 mo

Reproductive 799.9380 (b)(1)(ii)(A) 29 mo

Immunotoxicity 799.9780 (b)(1)(ii)(A), (b)(4) 29 mo

108–31–6 Maleic anhydride:

Acute 799.9135 (b)(2) 21 mo

Developmental 799.9370 (b)(1)(i)(A), (b)(1)(ii)(A) 12 mo

Neurotoxicity 799.9620 (b)(1)(ii)(A), (b)(1)(iii)(A),

(b)(1)(iii)(B)

21 mo

Carcinogenicity 799.9420 (b)(1)(ii)(A) 60 mo

Immunotoxicity 799.9780 (b)(1)(ii)(A), (b)(4) 21 mo

108–90–7 Chlorobenzene:

Acute 799.9135 (b)(2) 21 mo

Subchronic 799.9346 (b)(3) 18 mo

Neurotoxicity 799.9620 (b)(1)(ii)(A), (b)(1)(iii)(A),

(b)(1)(iii)(B)

21 mo

Immunotoxicity 799.9780 (b)(1)(ii)(A), (b)(4) 18 mo

111–42–2 Diethanolamine:

Acute 799.9135 (b)(2) 21 mo

Subchronic 799.9346 (b)(1)(ii)(B), (b)(3) 18 mo

Developmental 799.9370 (b)(1)(ii)(B) 12 mo

Reproductive 799.9380 (b)(1)(ii)(B) 29 mo

Neurotoxicity 799.9620 (b)(1)(ii)(B), (b)(1)(iii)(A),

(b)(1)(iii)(B)

21 mo

Immunotoxicity 799.9780 (b)(1)(ii)(B), (b)(4) 18 mo

120–82–1 1,2,4-Trichlorobenzene:

Acute 799.9135 (b)(2) 21 mo

Developmental 799.9370 (b)(1)(ii)(A) 12 mo

Neurotoxicity 799.9620 (b)(1)(ii)(A), (b)(1)(iii)(A),

(b)(1)(iii)(B)

21 mo

Immunotoxicity 799.9780 (b)(1)(ii)(A), (b)(4) 21 mo

126–99–8 Chloroprene:

Acute 799.9135 (b)(2) 21 mo

Reproductive 799.9380 (b)(1)(ii)(A) 29 mo

Neurotoxicity 799.9620 (b)(1)(ii)(A), (b)(1)(iii)(A),

(b)(1)(iii)(B)

21 mo
67484 Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Proposed Rules

TABLE 1—Continued

CAS No. Chemical name/types of

testing

Test standard

Final report Effective

Basic testing require- date

ments (test guideline) Changes from guideline

Immunotoxicity 799.9780 (b)(1)(ii)(A), (b)(4) 21 mo

463–58–1 Carbonyl sulfide:

Acute 799.9135 (b)(2) 21 mo

Subchronic 799.9346 (b)(3) 18 mo

Developmental 799.9370 (b)(1)(ii)(A) 12 mo

Reproductive 799.9380 (b)(1)(ii)(A) 29 mo

Neurotoxicity 799.9620 (b)(1)(ii)(A), (b)(1)(iii)(A),

(b)(1)(iii)(B)

21 mo

Carcinogenicity 799.9420 (b)(1)(ii)(A) 60 mo

Bacterial reverse mutation 799.9510 (b)(1)(ii)(C) 6 mo

Mammalian gene mutation 799.9530 (b)(1)(ii)(C) 6 mo

In vivo cytogenetics 799.9538 or 799.9539 (b)(1)(ii)(A) 14 mo

Immunotoxicity 799.9780 (b)(1)(ii)(A), (b)(4) 18 mo

7647–01–0 Hydrochloric acid:

Acute 799.9135 (b)(2) 21 mo

7664–39–3 Hydrogen fluoride:

Acute 799.9135 (b)(2) 21 mo

Subchronic 799.9346 (b)(3) 18 mo

Developmental 799.9370 (b)(1)(ii)(A) 12 mo

Reproductive 799.9380 (b)(1)(ii)(A) 29 mo

Neurotoxicity 799.9620 (b)(1)(ii)(A), (b)(1)(iii)(A),

(b)(1)(iii)(B)

21 mo

Immunotoxicity 799.9780 (b)(1)(ii)(A), (b)(4) 18 mo

7782–50–5 Chlorine:

Acute 799.9135 (b)(2) 21 mo

(b) Changes from TSCA test

guidelines. The provisions in

paragraphs (b)(1) through (b)(4) of this

section when referenced in Table 1 in

paragraph (a)(6) of this section under

the column ‘‘Changes from guideline,’’

specify the manner in which the

specific test standard differs from the

TSCA test guideline upon which it is

based.

(1) Modifications applicable to all

testing. Only those provisions

specifically referenced in Table 1 in

paragraph (a)(6) of this section apply.

(i) Test species. The test animal shall

be:

(A) A mammalian species other than

the rat.

(B) A mammalian species other than

the mouse.

(C) A mammalian species other than

the rabbit.

(D) The male rat and the female

mouse.

(ii) Route of exposure. Animals shall

be exposed:

(A) Via vapor-phase inhalation.

(B) Via inhalation of aerosol.

(C) Via vapor-phase.

(iii) Duration and frequency of

exposure. The test animal shall be:

(A) Exposed for a 4-hour period in an

acute study.

(B) Exposed for 6 hours per day, 5

days per week for a 90-day period in a

subchronic study.

(2) Modifications applicable to acute

testing. When referenced in Table 1 in

paragraph (a)(6) of this section, all

provisions in this paragraph apply.

(i) The appraisal of pulmonary

irritation shall be evaluated during

exposure to the substance by the use of

the mouse respiratory sensory irritation

assay method as outlined in ASTM E–

981–84 (see paragraph (b)(2)(iii)(C) of

this section). This method assesses the

breathing patterns of test animals. This

incorporation by reference was

approved by the Director of the Federal

Register in accordance with 5 U.S.C.

552(a) and 1 CFR part 51. This material

is incorporated as it exists on the date

of approval and notice of any change in

this material will be published in the

Federal Register. Copies of the

incorporated material may be examined

at the TSCA Nonconfidential

Information Center, Rm. NE–B607, 401

M St., SW., Washington, DC, 20460 or

by contacting the American Society for

Testing and Materials (ASTM), 100 Bar

Harbor Drive, Conshohoken, PA 19428–

2959. Copies may be inspected at the

above address or at the Office of the

Federal Register, 800 North Capitol

Street, NW., Suite 700, Washington, DC.

For information on this test guideline,

the references in paragraph (b)(2)(iii) of

this section should be consulted.

(ii) Results of respiratory sensory

irritation assay. Results shall be

reported as follows:

(A) Data shall be included in the final

report and tabulated to show:

(1) The magnitude of change in

respiratory rate with exposure

concentration and with time for each

animal.

(2) A response concentration, which

indicates the concentration at which the

respiration rate is decreased by 50%

(RD50), will be calculated, along with

the 95% confidence limits.

(B) Time-effect curves shall be

included in the final report to evaluate

the onset and shape of the response.

(iii) References.

(A) Alarie, Y., and Luo, J.E. ‘‘Sensory

Irritation by Airborne Chemicals: A

basis to establish acceptable levels of

exposure.’’ Toxicology of the Nasal

Passages. Hemisphere Publishing

Corporation: New York pp. 91–100

(1986).
Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Proposed Rules 67485

(B) Alarie, Y., and Stokinger, H.E.

‘‘Sensory Irritation by Airborne

Chemicals.’’ CRC Critical Reviews in

Toxicology. pp. 299–363 (1973).

(C) ASTM. ‘‘Standard Test Method for

Estimating Sensory Irritancy of Airborne

Chemicals.’’ In: 1984 Annual Book of

ASTM Standards. Water and

Environmental Technology. Section 11.

Volume 11.04 Designation E 981–84 pp.

572–584 (1984).

(3) Modifications applicable to

subchronic testing. When referenced in

Table 1 of this section, all provisions in

this paragraph apply.

(i) Respiratory tract pathology.

Respiratory tract pathology shall be

performed as follows:

(A) Care shall be taken that the

method used to kill the animal does not

result in damage to the tissues of the

upper or lower respiratory tract. The

heart-lung, including the trachea, shall

be removed in bloc.

(B) Representative sections of the

lungs shall be examined histologically.

This shall include trachea, major

conducting airways, alveolar region,

terminal and respiratory bronchioles,

alveolar ducts and sacs, and interstitial

tissues.

(C) The nasopharyngeal tissue shall be

examined for histopathologic lesions.

This shall include sections through the

nasal cavity, and examination of the

squamous, transitional, respiratory, and

olfactory epithelia.

(D) The larynx mucosa shall be

examined for histopathologic changes.

Sections of the larynx to be examined

include the epithelium covering the

base of the epiglottis, the ventral pouch,

and the medial surfaces of the vocal

processes of the arytenoid cartilages.

(ii) Bronchoalveolar lavage.

Bronchoalveolor lavage shall be

performed as follows:

(A) The lungs shall be lavaged in situ

or after sacrifice. If the study will not be

compromised, one lobe of the lungs may

be used for lung lavage while the other

is fixed for histologic evaluation. The

lungs shall be lavaged using

physiological saline after cannulation of

the trachea. The lavages shall consist of

two washes each of which consists of

approximately 80 percent (e.g., 5 ml in

rats and 1 ml in mice) of total lung

volume. Additional washes merely tend

to reduce the concentrations of the

material collected. The lung lavage fluid

shall be stored on ice at approximately

5 deg. C until assayed.

(B) The following parameters shall be

determined in the lavage fluid as

indicators of cellular damage in the

lungs: total protein, cell count and

percent leukocytes. In addition, a

phagocytosis assay using the procedure

of Burleson or Gilmour and Selgrade

(Burleson et al., 1987; Gilmour and

Selgrade, 1993) shall be performed to

determine macrophage activity. This

incorporation by reference was

approved by the Director of the Federal

Register in accordance with 5 U.S.C.

552(a) and 1 CFR part 51. This material

is incorporated as it exists on the date

of approval and notice of any change in

this material will be published in the

Federal Register. Copies of the

incorporated material may be obtained

from the TSCA Nonconfidential

Information Center, Rm. NE–B607, 401

M St., SW., Washington, DC, 20460, for

the Burleson citation by contacting the

Society for Experimental Biology and

Medicine, at Blackwell Science Ltd.,

238 Main Street, Cambridge, MA 02142,

and for the Gilmour and Selgrade

citation by contacting Academic Press,

Inc., Toxicology and Applied

Pharmacology, 62777 Sea Harbor Drive,

Orlando, FL 32887. Copies may be

inspected at the above address or at the

Office of the Federal Register, 800 North

Capitol Street, NW., suite 700,

Washington, DC. The following

references may be consulted:

(1) Burleson, G.R. et al. ‘‘Poly (I): poly

(C)-enhanced alveolar peritoneal

macrophage phagocytosis:

Quantification by a new method

utilizing fluorescent beads.’’

Proceedings of the Society for

Experimental Biology and Medicine.

184:468–476 (1987).

(2) Gilmour, G.I., and Selgrade, M.K.

‘‘A Comparison of the Pulmonary

Defenses against Streptococcal Infection

in Rats and Mice Following O3

Exposure: Differences in Disease

Susceptibility and Neutrophil

Recruitment.’’ Toxicology and Applied

Pharmacology. 123:211–218 (1993).

(4) Modifications applicable to

immunotoxicity testing. The natural

killer cell assay and enumeration of

splenic or peripheral blood cells in

§ 799.9789 (g)(1)(iii) and (g)(2) are not

required.

[FR Doc. 97–33451 Filed 12–23–97; 8:45 am]

BILLING CODE 6560–50–F