Amended Proposed Test Rule for Hazardous Air Pollutants; 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

[email protected]. 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-

H[email protected]. 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:

[email protected].

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), ortho-cresol (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

[[Page 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 Sec. 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 Sec. 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.

[[Page 67468]]

11. TSCA immunotoxicity, 40 CFR 799.9780.

EPA is proposing to use the TSCA test guideline Sec. 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 Sec. 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 cross-referenced 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 Sec. 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 Sec. 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 Sec. 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

Sec. 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 Sec. 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

------------------------------------------------------------------------

OPPTS draft harmonized test

TSCA test guidelines cross-referenced guidelines cross-referenced in

in the amended HAPs test rule proposal the original HAPs test rule

(40 CFR) proposal

------------------------------------------------------------------------

799.9135 TSCA acute inhalation toxicity 870.1350 Acute Inhalation

with histopathology Toxicity with Histopathology

799.9346 TSCA subchronic inhalation 870.3465 Subchronic Inhalation

toxicity Toxicity

799.9370 TSCA prenatal developmental 870.3600 Inhalation

toxicity (derived from 870.3700)\1\ Developmental Toxicity Study

799.9380 TSCA reproduction and 870.3800 Reproduction and

fertility effects Fertility Effects

799.9420 TSCA carcinogenicity 870.4200 Carcinogenicity

799.9510 TSCA bacterial reverse 870.5100 Escherichia coli WP2

mutation test (derived from OECD 471/ and WP2uvrA Reverse

472)\1\ Mutation Assays

799.9530 TSCA in vitro mammalian cell 870.5300 Detection of Gene

gene mutation test (derived from Mutations in Somatic Cells in

OECD 476)\1\ Culture

799.9538 TSCA mammalian bone marrow 870.5385 In vivo Mammalian

chromosomal aberration test Cytogenetics Tests: Bone

(derived from OECD 475)\1\ Marrow Chromosomal Analysis

[[Page 67469]]

799.9539 TSCA mammalian erythrocyte 870.5395 In vivo Mammalian

micronucleus test (derived from Cytogenetics Tests:

OECD 474)\1\ Erythrocyte Micrnucleus Assay

799.9620 TSCA neurotoxicity screening 870.6200 Neurotoxicity

battery Screening Battery

799.9780 TSCA immunotoxicity 870.7800 Immunotoxicity

------------------------------------------------------------------------

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

A revised Sec. 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: [email protected]; 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

Sec. 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

Sec. 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

[[Page 67470]]

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

Sec. 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

[[Page 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 Sec. 799.5053 in the original HAPs test rule proposal

did not include

[[Page 67472]]

processors in the class of persons required to submit study plans,

conduct tests, and submit data. The text of Sec. 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 Sec. 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

Sec. 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 Sec. 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

Sec. 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

Sec. 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 Sec. 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.

[[Page 67473]]

H. Other Changes to Regulatory Text

In addition to the changes made to the text and table in

Sec. 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

Sec. 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 Sec. 799.5053 has been

revised to incorporate these changes.

2. In the original HAPs proposal at Sec. 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 Sec. 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 Sec. 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

Sec. 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 Sec. 799.5053 (61 FR 33178, 33198). Revised

Sec. 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 Sec. 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 vapor-phase 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

Sec. 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 Sec. 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 Sec. 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

(Sec. 799.9780(g)(1)(i)) or the ELISA immunoglobulin quantification

assay (Sec. 799.9780(g)(1)(ii)) shall be used to meet the testing

requirements. The natural killer cell assay (Sec. 799.9780(g)(1)(iii))

and the enumeration of splenic or peripheral blood cells

(Sec. 799.9780(g)(2)) are not being proposed for HAPs testing.

Accordingly, Sec. 799.5053(b)(4) has been changed to clarify the

immunotoxicity testing requirements and Table 1 of Sec. 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-to-route 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).

[[Page 67474]]

(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

[[Page 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:

[email protected]

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-On-Demand: 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).

[[Page 67476]]

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-C-96-204, 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-C-96-208, 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-C-96-226, June 1996.

10. Neurotoxicity Screening Battery, OPPTS 870.6200, EPA Pub. No.

712-C-96-238, 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 Physiologically-Based 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

[[Page 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

[[Page 67478]]

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

----------------------------------------------------------------------------------------------------------------

Maximum test costs

Chemical substances\1\ -------------------------------------- Maximum price Public reporting

Total ($) Annualized ($) impact (%) burden hours

----------------------------------------------------------------------------------------------------------------

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

[[Page 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 cross-referenced 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

[[Page 67480]]

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

----------------------------------------------------------------------------------------------------------------

Estimated public reporting burden

HAPs chemical -----------------------------------------------------------------------

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

Phenol\1\ 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-by-chemical 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

[[Page 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:

Sec. 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 non-

isolated 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

----------------------------------------------------------------------------------------------------------------

Test standard

--------------------------------------

CAS No. Chemical name/ Basic testing Final Effective

types of testing requirements Changes from report date

(test guideline) guideline

----------------------------------------------------------------------------------------------------------------

75-35-4-------------------------Vinylidene---------- ----------------- ----------------- ---------- --------

chloride:

[[Page 67482]]

Acute 799.9135 (b)(2) 21 mo

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

(b)(1)(iii)(A),

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

----------------------------------------------------------------------------------------------------------------

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), 21 mo

(b)(1)(iii)(A),

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

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

(b)(1)(ii)(A)

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

cytogenetics 799.9539

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

(b)(4)

----------------------------------------------------------------------------------------------------------------

80-62-6 Methyl

methacrylate:

Acute 799.9135 (b)(2) 21 mo

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

(b)(1)(ii)(A)

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

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

(b)(1)(iii)(A),

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

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

(b)(4)

----------------------------------------------------------------------------------------------------------------

85-44-9 Phthalic

anhydride:

Acute 799.9350 (b)(2) 21 mo

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

(b)(3)

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), 21 mo

(b)(1)(iii)(A),

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

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

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

(b)(4)

----------------------------------------------------------------------------------------------------------------

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), 21 mo

(b)(4)

----------------------------------------------------------------------------------------------------------------

92-52-4 1,1'-Biphenyl:

Acute 799.9135 (b)(2) 21 mo

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

(b)(3)

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

(b)(1)(ii)(B)

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

Neurotoxicity 799.9620 (b)(1)(ii)(B), 21 mo

(b)(1)(iii)(A),

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

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

(b)(4)

----------------------------------------------------------------------------------------------------------------

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), 21 mo

(b)(1)(iii)(A)

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

(b)(4)

----------------------------------------------------------------------------------------------------------------

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), 21 mo

(b)(1)(iii)(A)

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

(b)(4)

----------------------------------------------------------------------------------------------------------------

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), 21 mo

(b)(1)(iii)(A)

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

(b)(4)

----------------------------------------------------------------------------------------------------------------

[[Page 67483]]

100-41-4 Ethylbenzene:

Acute 799.9135 (b)(2) 21 mo

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

(b)(1)(ii)(A)

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

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

(b)(1)(iii)(A),

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

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

(b)(4)

----------------------------------------------------------------------------------------------------------------

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), 12 mo

(b)(1)(ii)(A)

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

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

(b)(1)(iii)(A),

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

----------------------------------------------------------------------------------------------------------------

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), 21 mo

(b)(1)(iii)(A),

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

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

(b)(4)

----------------------------------------------------------------------------------------------------------------

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), 29 mo

(b)(4)

----------------------------------------------------------------------------------------------------------------

108-31-6 Maleic anhydride:

Acute 799.9135 (b)(2) 21 mo

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

(b)(1)(ii)(A)

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

(b)(1)(iii)(A),

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

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

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

(b)(4)

----------------------------------------------------------------------------------------------------------------

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), 21 mo

(b)(1)(iii)(A),

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

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

(b)(4)

----------------------------------------------------------------------------------------------------------------

111-42-2 Diethanolamine:

Acute 799.9135 (b)(2) 21 mo

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

(b)(3)

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), 21 mo

(b)(1)(iii)(A),

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

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

(b)(4)

----------------------------------------------------------------------------------------------------------------

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), 21 mo

(b)(1)(iii)(A),

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

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

(b)(4)

----------------------------------------------------------------------------------------------------------------

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), 21 mo

(b)(1)(iii)(A),

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

[[Page 67484]]

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

(b)(4)

----------------------------------------------------------------------------------------------------------------

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), 21 mo

(b)(1)(iii)(A),

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

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

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

mutation

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

mutation

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

cytogenetics 799.9539

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

(b)(4)

----------------------------------------------------------------------------------------------------------------

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), 21 mo

(b)(1)(iii)(A),

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

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

(b)(4)

----------------------------------------------------------------------------------------------------------------

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).

[[Page 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 Sec. 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