Amended Proposed Test Rule for Hazardous Air Pollutants; Extension of Comment Period

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 799

[OPPTS-42187N; FRL-5780-6]

RIN 2070-AC76

Amended Proposed Test Rule for Hazardous Air Pollutants;

Extension of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Amended proposed rule; extension of comment period.

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SUMMARY: EPA is proposing additional amendments to the proposed test

rule (61 FR 33178, June 26, 1996, as amended at 62 FR 67466, December

24, 1997) that was issued under section 4(a) of the Toxic Substances

Control Act (TSCA) that would require manufacturers (including

importers) and processors to test the hazardous air pollutants (HAPs)

specified in the amended proposed test rule for certain health effects.

This second amended proposed test rule modifies the provisions

identifying the persons that would be required to test under the HAPs

rule, and provides additional guidance to persons in determining what

their responsibilities would be

[[Page 19695]]

under the rule. In addition, EPA is extending the public comment period

in order to provide interested persons with sufficient time to consider

the changes described in this proposed rule and to comment accordingly.

DATES: Written comments on this proposed rule must be received by EPA

on or before June 22, 1998. The public comment period on the June 26,

1996, proposed rule and the December 24, 1997, amended proposed rule is

being extended from May 11, 1998 to June 22, 1998.

ADDRESSES: Submit three copies of written comments on the second

amended proposed HAPs test rule, 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 IV. of this preamble for further instructions. The Document

Control Office telephone number is (202) 260-7093.

Comments and data may also be submitted electronically to

[email protected]. Follow the instructions under Unit IV. 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: 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) 260-1096; e-mail:

[email protected].

SUPPLEMENTARY INFORMATION:

I. Electronic Availability:

Internet: Electronic copies of this document and various support

documents are available from the EPA Home Page at the Federal

Register--Environmental Document service entry for this document under

``Laws and Regulations'' (http://www.epa.gov/fedrgstr/EPA-TOX/1998/).

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.

II. Background

On June 26, 1996 (61 FR 33178), EPA issued a proposed test rule

under TSCA section 4(a), 15 U.S.C. 2603(a), (the ``original HAPs

proposal'') to require health effects testing of the following

hazardous air pollutant chemicals: 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 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).

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; on November 28, 1997 (62 FR 63299) (FRL-5759-2), it was extended

from December 1, 1997 to January 9, 1998; and on February 5, 1998 (63

FR 5915)(FRL-5769-3), it was extended from January 9, 1998 to May 11,

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 the amended HAPs test rule

proposal, and to respond to the ECA proposals for PK studies submitted

by industry.

An amended proposed HAPs test rule was published on December 24,

1997 (62 FR 67466) (FRL-5742-2) (the ``first amended proposal'') that:

Used test guidelines codified at 40 CFR part 799, subpart H; removed

the testing requirements for phenol; specified export notification

requirements; reviewed the status of proposals for PK ECAs and invited

ECA proposals for all HAPs chemicals for which proposals had not yet

been received; discussed revisions to the economic assessment;

referenced additional support documents in the rulemaking record;

described modifications to the ``Persons Required To Test'' portion of

the proposed rule; and made other changes and clarifications to the

original proposal. The amended proposed HAPs test rule extended the

comment period from January 9, 1998 to February 9, 1998. On February 5,

1998 (63 FR 5915)(FRL-5769-3), the comment period was extended from

February 9, 1998 to May 11, 1998. This extension was granted by the

Agency in response to requests by the public for additional time in

which to fully consider the changes effected by the first amended

proposal and to adjust industry alliances. Also, in this document, the

Agency clarified the ``Persons Required To Test'' section of the

amended proposed HAPs preamble and the corresponding proposed

regulatory text.

In this second amended proposal, EPA is modifying the provision

regarding the persons that would be required to test under the HAPs

rule and is providing additional information to persons to assist them

in determining what their responsibilities would be under the rule. The

Agency is also extending the public comment period on the amended HAPs

proposed rule from May 11, 1998 to June 22, 1998. This extension is

needed to provide commenters with sufficient time to consider the

changes described in this proposed rule, and to comment accordingly.

For all aspects of the first amended HAPs test rule proposal that

are not addressed by this second amendment to the HAPs proposal, the

discussion in the preamble of the first amended HAPs test rule proposal

continues to apply.

[[Page 19696]]

III. Modifications and Clarifications

EPA is proposing to modify Unit III.C., the ``Persons Required To

Test'' portion of the preamble to the first amended proposed rule (62

FR 67466, 67469-72) and the corresponding section in the proposed

regulatory text at 40 CFR 799.5053(a)(2), ``Persons required to submit

study plans, conduct tests, and submit data'' (62 FR 67466, 67481). The

Agency is also proposing to modify the clarification contained in the

document published at 63 FR 5915, February 5, 1998, and is requesting

comment on the modification. In addition, EPA is making clarifications

concerning the physical states of the HAPs chemicals that are covered

under the proposal, as amended. The clarifications and modifications

are described in detail below.

A. Timeframe During Which Persons Would Be Subject to the Rule

The original HAPs proposal stated that persons who manufacture

(including import) or process, or who intend to manufacture (including

import) or process, any of the HAPs chemicals included in the rule,

other than as an impurity, would be subject to the rule (61 FR 33178,

33189). The original proposal did not distinguish among persons subject

to the rule based on low-volume production beyond the provisions of 40

CFR 790.42(a). The regulations at 40 CFR 790.42(a) provide that, while

legally subject to a test rule, processors, persons who manufacture

less than 500 kg (1,100 lbs) 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 Federal Register document if no

manufacturer has submitted a notice of its intent to conduct testing.

Under the original HAPs proposal, all other manufacturers (including

importers) of HAPs chemicals would have been required to comply with

the rule when promulgated (``initially comply'') (61 FR 33178, 33189-

33190).

In the first amended HAPs proposal, EPA specified the timeframe

during which manufacturing and processing volume calculations would be

made to determine who would be subject to the rule (both those who

would have to initially comply and others). EPA stated in the preamble

and in the proposed regulatory text (40 CFR 799.5053 (a)(2)(ii),

(a)(2)(iv), and (a)(2)(v)) that this timeframe consisted of the last

complete corporate fiscal year prior to the publication of the final

rule (62 FR 67466, 67470, 67481). EPA now proposes that the timeframe

be changed to the last complete calendar year prior to the publication

of the final rule or any successive complete calendar year prior to the

end of the reimbursement period, as defined in 40 CFR 791.3(h). The

Agency would base its determination concerning which persons would be

subject to the rule on the amount of manufacturing (including

importing) or processing of a HAP chemical at a facility during the

last complete calendar year prior to the publication of the final rule

or during any complete calendar year until the expiration of the rule

at the end of the reimbursement period. In the past, EPA has covered

persons under test rules where they manufactured (including imported)

or processed a test rule chemical between the effective date of the

rule and the end of the reimbursement period. See, e.g., 40 CFR

799.1053(b)(1); 40 CFR 799.1560(b); 40 CFR 799.1575(b); 40 CFR

799.1645(b); 40 CFR 799.1700(b); 40 CFR 799.2155(b). The Agency

believes that determining which persons would be subject to the test

rule based on the period during which the rule is in effect is more

appropriate for purposes of obtaining the needed testing and

reimbursement than restricting the timeframe to one year alone, as

would have been the result under the first amended proposal.

EPA is proposing to use the calendar year as the time period within

which to measure chemical manufacturing (including importing) and

processing rather than the corporate fiscal year as a more convenient

time period for potentially regulated persons to determine whether they

are subject to the rule. This approach would be consistent with

reporting requirements in other regulations, such as the Toxic Release

Inventory reporting regulations (40 CFR 372.30(a)), under the Emergency

Planning and Community Right-To-Know Act (EPCRA), 42 U.S.C. 11023. EPA

invites comment on this modification to the ``Persons Required To

Test'' provisions of the first amended proposed rule.

B. Threshold and De Minimis Provisions

As EPA discussed in its clarification of February 5, 1998 (63 FR

5915, 5917), the language in both the preamble and proposed regulatory

text of Sec. 799.5053 of the first amended proposal that indicates what

persons would be subject to the HAPs test rule and when they would have

to comply is ambiguous.

Those persons who would be required to initially comply with the

HAPs rule are: Any person who, during the last complete calendar year

prior to the publication of the final rule in the Federal Register, and

any person who, in any successive complete calendar year prior to the

end of the reimbursement period, manufactures (including imports) at a

particular facility any of the HAPs chemicals included in the first

amended proposed rule in an amount of 25,000 lbs or more (regardless of

the form of the HAP chemical, e.g., 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). ``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. In determining whether the 25,000 lbs threshold has

been met for a particular HAP chemical, persons are not to take into

account the amount of a HAP chemical that is manufactured (including

imported) as a component of a chemical substance or mixture at a

concentration of less than 1 percent by weight of the chemical

substance or mixture.

For example, if a person manufactures 9,000,000 lbs of a petroleum

refinery stream during a given calendar year at a particular facility,

30,000 lbs of which is a HAP chemical that is a component of the

stream, that person would not take into account this amount of HAP

chemical when determining whether the 25,000 lbs threshold has been met

for the year at that facility because the HAP chemical component

consists of less than 1 percent by weight of the total stream.

Similarly, if a person manufactures 500,000 lbs of a complex mixture

during a given calendar year at a facility, 10,000 lbs of which is a

HAP chemical byproduct that is a component of the complex mixture, that

person would not be required to initially comply with the rule on the

basis of its manufacture of the HAP chemical in the complex mixture

alone. This result is due to the fact that, although the HAP chemical

component consists of at least 1 percent by weight of the total complex

mixture, the total amount of HAP chemical manufactured at that facility

is less than 25,000 lbs. (Note that his answer assumes that the person

is not manufacturing the same HAP in other forms at the same facility.)

In this second amended proposal, EPA is proposing regulatory language

(40 CFR 799.5053 (a)(2)(ii) and (a)(2)(iv)) that would replace the

language that was proposed in the first amended proposed

[[Page 19697]]

rule at 40 CFR 799.5053 (a)(2)(ii), (a)(2)(iv) and (a)(2)(v) (62 FR

67466, 67481).

C. Physical State of Chemical

EPA is clarifying that the persons that would be subject to the

proposed HAPs test rule, as amended, are those who manufacture

(including import) or process a chemical included in the proposed rule,

as amended, in any physical state (i.e., solid, liquid, or gas).

Persons should refer to the Chemical Abstracts Service Registry Numbers

in the proposed rule, as amended, to determine which chemicals would be

covered under the rule.

IV. 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 second amended

proposed rule and appropriate Federal Register documents. 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 5.1/6.1 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 second amended proposal 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.

V. Regulatory Assessment Requirements

EPA's analysis in the first amended proposed rule of the regulatory

assessment requirements for the HAPs rulemaking (62 FR 67466, 67477-81)

is not altered by the amendments proposed in this second amended

proposed rule. The discussion provided in the first amended proposed

rule regarding the applicable regulatory assessment requirements is

still applicable. This second amended proposed rule includes new

sections to address the requirements of Executive Order 12875 and the

National Technology Transfer Advancement Act.

A. Economic Assessment

In conjunction with the issuance of the first amended HAPs

proposal, EPA prepared a revised economic assessment entitled

``Economic Assessment for the Amended Proposed TSCA Section 4(a) Test

Rule for 21 Hazardous Air Pollutants,'' OPPT/EETD/EPAB, November 14,

1997. (See document referenced in Unit V.H.1 of the preamble to the

first amended HAPs proposal (62 FR 67466, 67476), located in the docket

for this rulemaking). This report evaluates the potential for

significant economic impacts as a result of the testing on the HAPs

chemicals required under the first amended HAPs proposal, which is

identical to the testing required under this second amended HAPs

proposal. Although the number of manufacturers (including importers)

and processors subject to the HAPs test rule under the second amended

proposal may be greater than under the first amended proposal, the

conclusions of the economic assessment are not affected. The economic

assessment analyzes the economic effect of testing on a chemical-by-

chemical basis by comparing unit test costs to the chemical sales

price. (The analysis for carbonyl sulfide is similar, but uses the

sales price of a related chemical. See U.S. EPA, ``Economic Assessment

for the Amended Proposed TSCA Section 4(a) Test Rule for 21 Hazardous

Air Pollutants.'') This measure of economic impact depends on total

annualized test costs, total supply of the chemical, and the sales

price of the chemical (none of which is affected by the second amended

HAPs proposal). This measure is unrelated to the number of persons

subject to the rule. Therefore, the Agency continues to believe that

the HAPs test rule, if finalized according to this second amended

proposal, will not impose any significant economic impact.

B. Executive Order 12866 and Executive Order 12898; Unfunded Mandates

Reform Act; Executive Order 12875

Because the overall costs associated with testing under this second

amended HAPs proposal are expected to be the same as those associated

with testing under the first amended proposal, the second 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 Minority Populations and

Low-Income Populations'' (59 FR 7629, February 16, 1994). Similarly,

the second 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 (61 FR 33178, 33195-96). In

addition, the obligations imposed by Executive Order 12875, entitled

``Enhancing the Intergovernmental Partnership'' (58 FR 58093, October

28, 1993) are addressed in the discussion of UMRA in the original

proposed rule (61 FR 33178, 33196).

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 impact on small businesses. See Unit XI.B. of

the preamble to the original HAPs proposal (61 FR 33178, 33196). An

additional document was prepared under the first amended proposal to

provide information on small entity impacts. (See document referenced

at

[[Page 19698]]

Unit V.H.3 of the preamble to the first amended HAPs proposal (62 FR

67466, 67476-77)). The analysis contained in that document, which is in

the record for this proposed rule, also applies to this second amended

proposed rule. This analysis used the most recent single year of data

available at the time of the analysis to provide further information on

the potential economic impact of the proposed test rule on small

entities. EPA believes that these data are representative of the

universe of manufacturers and importers of the HAPs chemicals that

would be subject to the second amended proposed rule.

As indicated in the first amended proposal (62 FR 67466, 67479),

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 not likely have a significant economic impact on

a substantial number of small entities because any impacts of 1 percent

or greater would affect fewer than 100 small entities. While some small

entities not identified in EPA's analysis may become subject in

subsequent years as a result of the changes made in the second amended

HAPs proposal, EPA believes that it is unlikely that sufficient numbers

of small entities would begin manufacturing or importing the HAPs

chemicals in sufficient amounts to alter the conclusions of this

analysis.

Therefore, the Agency continues to certify that the HAPs test rule,

if finalized according to this second amended proposal, will not have a

significant economic impact on a substantial number of small entities.

Any comments regarding the impacts that this proposed rule may

impose on small entities should be transmitted 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 OMB pursuant

to the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. (PRA), under OMB

control number 2070-0033 (EPA Information Collection Request (ICR) No.

1139). The information collection requirements contained in this second

amended proposed rule, however, are not effective until the final rule

is published, 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 first amended proposed

HAPs test rule, as well as the figures for the total public reporting

burden and the overall average per chemical (see Unit VI.D. of the

preamble, ``Paperwork Reduction Act,'' 62 FR 67466, 67479-80), were

different from the figures used in the original HAPs proposal (see Unit

XI.C. of the preamble, ``Paperwork Reduction Act,'' 61 FR 33178,

33196). However, the public reporting burdens under the first amended

proposed HAPs test rule and the second amended proposed HAPs test rule

are anticipated by EPA to be the same. The burdens calculated for the

first amended proposal were based on the tests required for each

chemical. The testing requirements are not changed by the second

amended proposed rule.

Comments are requested on the Agency's need for the information set

out in the first amended HAPs proposal, 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

rule in the manner specified under ``ADDRESSES'' 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, as amended.

E. Executive Order 13045

As stated in the first amended HAPs proposal (62 FR 67466, 67480-

81), the proposed HAPs test rule does not require special consideration

by OMB pursuant to the terms of Executive Order 13045, entitled

``Protection of Children from Environmental Health Risks and Safety

Risks'' (62 FR 19885, April 23, 1997).

F. National Technology Transfer and Advancement Act

Section 12(d) of the National Technology Transfer and Advancement

Act of 1995 (NTTAA), Pub. L. No. 104-113, section 12(d) (15 U.S.C. 272

note), directs EPA to use voluntary consensus standards in its

regulatory activities unless to do so would be inconsistent with

applicable law or otherwise impractical. Voluntary consensus standards

are technical standards (e.g., materials specifications, test methods,

sampling procedures and business practices) that are developed or

adopted by voluntary consensus standards bodies. The NTTAA requires EPA

to provide Congress, through OMB, explanations when the Agency decides

not to use available and applicable voluntary consensus standards.

EPA is required under section 4 of TSCA to impose prescriptive test

requirements in test rules developed under section 4 and to review

their adequacy periodically. The testing that would be required under

this rulemaking would be conducted according to enforceable test

standards based on the health effects test guidelines (40 CFR part 799,

subpart H) that are cross-referenced in the first amended HAPs proposal

(62 FR 67466, 67467-67469, December 24, 1997). These guidelines are

based on harmonized guidelines that were developed through a process

that included informal opportunity for public input, and that are, in

some cases, internationally accepted. The guidelines were issued on

August 15, 1997 (62 FR 43820). Both the August 15, 1997 and the

December 24, 1997 Federal Register documents discuss the background to

the guidelines.

The acute testing guideline is modified in the proposed regulatory

text at Sec. 799.5053(b)(2) (62 FR 67466, 67484-

[[Page 19699]]

67485) to require the appraisal of pulmonary irritation during exposure

to a HAP chemical through the use of the mouse respiratory sensory

irritation assay method developed by the American Society for Testing

and Materials (ASTM), a voluntary consensus standard body (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)). This method assesses the breathing patterns of

test animals.

The testing of bronchoalveolar lavage fluid under the subchronic

testing guideline is modified as described in the proposed regulatory

text at Sec. 799.5053(b)(3)(ii) (62 FR 67466, 67485) to include a

phagocytosis assay using the procedure of Burleson (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)) or Gilmour and Selgrade (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)) to determine

macrophage activity.

EPA is not aware of any other potentially applicable voluntary

consensus standards which needed to be considered in lieu of the

guidelines at 40 CFR part 799, subpart H, that are cross-referenced in

this rulemaking. The Agency invites comment on the potential use of

voluntary consensus standards in this rulemaking, including the

identification of and information about other standards which the

Agency could consider.

List of Subjects in 40 CFR Part 799

Environmental protection, Chemicals, Hazardous substances,

Incorporation by reference, Reporting and recordkeeping requirements.

Dated: April 13, 1998.

Lynn R. Goldman,

Assistant Administrator for Prevention, Pesticides and Toxic

Substances.

Accordingly, EPA is extending the comment period on the proposed

rule and the first amended proposed rule from May 11, 1998 to June 22,

1998.

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 62 FR 67481-67485,

December 24, 1997, is amended by revising paragraphs (a)(2)(ii) and

(a)(2)(iv) and removing paragraph (a)(2)(v) as follows:

(Note: The regulatory text changes proposed in this second

amended proposal supersede the corresponding changes proposed in the

first amended proposal. All other regulatory text changes proposed

in the first amended proposal that are not changed by this second

amended proposal continue to apply to this rulemaking.)

Sec. 799.5053 Chemical testing requirements for hazardous air

pollutants.

(a) General testing provisions. * * *

* * * * *

(2) Persons required to submit study plans, conduct tests, and

submit data. * * *

* * * * *

(ii) All persons who, during the last complete calendar year prior

to the effective date specified in Table 1 in paragraph (a)(6) of this

section or in any successive complete calendar year prior to the end of

the reimbursement period, as defined at 40 CFR 791.3(h), 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 or intend to manufacture 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, with respect to such substance: 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.

* * * * *

(iv) Manufacturers (including importers) of a chemical substance

specified in Table 1 who, during the last complete calendar year prior

to the effective date specified in Table 1 or in any successive

complete calendar year prior to the end of the reimbursement period, at

no facility manufactured (including imported) such substance in an

amount equal to or in excess of 25,000 lbs must comply with the

requirements of the rule with regard to such substance only if directed

to do so by EPA in a subsequent notice if no manufacturer has submitted

a notice of its intent to conduct testing. A chemical substance

specified in Table 1 that is manufactured (including imported) as a

component of another chemical substance or mixture in which the

proportion of the substance specified in Table 1 is less than one

percent by weight is not to be taken into account in determining

whether the 25,000 lbs threshold specified in this paragraph has been

met.

* * * * *

[FR Doc. 98-10494 Filed 4-20-98; 8:45 am]

BILLING CODE 6560-50-F