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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 799

[OPPTS-42187M; FRL-5769-3]

RIN 2070-AC76

Amended Proposed Test Rule for Hazardous Air Pollutants;

Extension of Comment Period; Clarification

AGENCY: Environmental Protection Agency (EPA).

ACTION: Extension of comment period on amended proposed rule; extension

of deadline for receipt of alternative testing proposals;

clarification.

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SUMMARY: EPA is extending the public comment period from February 9,

1998 to May 11, 1998, on the proposed rule published in the Federal

Register of June 26, 1996 (61 FR 33178) (FRL-4869-1), amended December

24, 1997 (62 FR 67466) (FRL-5742-2), requiring the testing of certain

hazardous air pollutants (HAPs) for specific health effects. EPA is

also extending the deadline for the receipt of proposals for

enforceable consent agreements (ECAs) for HAPs test rule chemicals for

which proposals for ECAs have not been received from February 9, 1998

to March 11, 1998. In addition, EPA is clarifying Unit III.C. ``Persons

Required to Test'' of the amended proposed HAPs preamble and the

corresponding proposed regulatory text of the amendment to indicate

those persons who would be required to initially comply with the HAPs

rule.

DATES: Written comments on the proposed rule, as amended, must be

received by EPA on or before May 11, 1998. ECA proposals to provide

alternative testing to meet HAPs testing requirements must be received

by EPA on or before March 11, 1998.

ADDRESSES: Submit three copies of written comments on the proposed HAPs

test rule, as amended, identified by docket 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. The Document Control

Office telephone number is (202) 260-7093.

Submit three copies of ECA proposals 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. The Document Control Office telephone number is

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(202) 260-7093. ECA proposals 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).

Comments and data may also be submitted electronically to

[email protected]. Follow the instructions under Unit III. of

this document. No confidential business information (CBI) should be

submitted through electronic mail.

FOR FURTHER INFORMATION CONTACT: For additional information: Susan B.

Hazen, Director, Environmental Assistance Division (7408), Rm. ET-543B,

Office of Pollution Prevention and Toxics, 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-

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 Documents 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 proposed health effects

testing, under section 4(a) of TSCA, of the following hazardous air

pollutants (HAPs): 1,1'-biphenyl, carbonyl sulfide, chlorine,

chlorobenzene, chloroprene, cresols (3 isomers: ortho-, meta-, para-),

diethanolamine, ethylbenzene, ethylene dichloride, ethylene glycol,

hydrochloric acid, hydrogen fluoride, maleic anhydride, methyl isobutyl

ketone, methyl methacrylate, naphthalene, phenol, phthalic anhydride,

1,2,4-trichlorobenzene, 1,1,2-trichloroethane, and vinylidene chloride.

EPA would use the data generated under the rule to implement several

provisions of section 112 of the Clean Air Act and to meet other EPA

data needs and those of other Federal agencies (the Agency for Toxic

Substances and Disease Registry (ATSDR), the National Institute for

Occupational Safety and Health (NIOSH), the Occupational Safety and

Health Administration (OSHA), and the Consumer Product Safety

Commission (CPSC)).

On October 18, 1996, EPA extended the public comment period on the

proposed rule from December 23, 1996, to January 31, 1997 (61 FR 54383)

(FRL-5571-3). This extension was for the purpose of allowing more time

for the submission of proposals for pharmacokinetics (PK) studies and

adequate time for comments on the proposed rule to be submitted after

the Agency had responded to the proposals. Due to the complexity of the

issues raised by the eight proposals for PK studies that the Agency

received in response to the HAPs proposal, EPA successively extended

the public comment period (61 FR 67516, December 23, 1996 (FRL-5580-6);

62 FR 9142, February 28, 1997 (FRL-5592-1); 62 FR 14850, March 28, 1997

(FRL-5598-4); 62 FR 29318, May 30, 1997 (FRL-5722-1); 62 FR 37833, July

15, 1997 (FRL-5732-2) to allow the Agency more time to respond to the

PK proposals and to finalize the test guidelines to be referenced in

the proposed HAPs test rule. EPA extended the comment period again (62

FR 50546, September 26, 1997 (FRL-5748-8) and 62 FR 63299, November 28,

1997 (FRL-5759-2)) to allow the Agency more time to complete work on

amending the proposed HAPs test rule.

On December 24, 1997 (62 FR 67466) (FRL-5742-2) EPA amended the

proposed test rule to cross-reference new TSCA test guidelines

(codified at 40 CFR part 799, subpart H), remove the testing

requirements for phenol, specify export notification requirements,

revise the economic assessment, include additional support documents in

the rulemaking record, and describe other changes and clarifications to

the proposed test rule. In addition, the amendment invited ECA

proposals for all of the HAPs chemicals for which ECA proposals had not

been received to provide for alternative testing to meet the

requirements contained in the amended HAPs proposal.

In the proposed HAPs rule, EPA invited the submission of proposals

for pharmacokinetics (PK) studies for the HAPs chemicals, which could

provide the basis for negotiation of enforceable consent agreements

(ECAs). These PK studies would be used to conduct route-to-route

extrapolation of toxicity data from routes other than inhalation to

predict the effects of inhalation exposure, as an alternative to

testing proposed under the HAPs rule. The Agency received PK proposals

for eight HAPs chemicals: diethanolamine (CAS No. 111-42-2), ethylene

dichloride (CAS No. 107-06-2), ethylene glycol (CAS No. 107-21-1),

hydrogen fluoride (CAS No. 7664-39-3), maleic anhydride (CAS No. 108-

31-6), phthalic anhydride (CAS No. 85-44-9), 1,2,4-trichlorobenzene

(CAS No. 120-82-1), and 1,1,2-trichloroethane (CAS No. 79-00-5). By

notice in the Federal Register, EPA announced the date for a meeting to

conduct ECA negotiations on seven of these chemicals (diethanolamine

(63 FR 3109, January 21, 1998) (FRL-5766-7); ethylene glycol (63 FR

3111, January 21, 1998) (FRL-5766-6); phthalic anhydride (63 FR 1469,

January 9, 1998) (FRL-5765-3) ; hydrogen fluoride (63 FR 1467, January

9, 1998) (FRL-5765-5); maleic anhydride (63 FR 1464, January 9, 1998)

(FRL-5765-1); 1,1,2-trichloroethane (62 FR 66628, December 19, 1997)

(FRL-5763-2); and ethylene dichloride (62 FR 66626, December 19, 1997)

(FRL-5763-1)). Negotiating meetings on 1,1,2-trichloroethane and

ethylene dichloride were held on January 12, 1998. The PK ECA

negotiations will proceed on a separate but parallel track from the

HAPs rulemaking process. EPA urges all persons participating in ECA

negotiations to comment on the amended proposed HAPs rule as an

activity separate from the PK proposal/ECA process.

EPA has received requests for additional time to respond to the

amended HAPs proposal (see documents referenced in Unit III. of this

document). These requestors state that they would be unable to give

full consideration of, or respond appropriately to, Unit III. C., ``

Persons Required to Test`` (62 FR 67466, 67469-67472) of the amended

HAPs proposal before the current close of the comment period. These

persons assert that the Agency's proposed changes, that modify criteria

for determining persons who would be subject to the HAPs test rule and

when they would have to comply with the rule, form a new policy that

results in the need to adjust the composition of groups or alliances

previously formed to address testing under the HAPs proposal.

Furthermore, these persons indicate that changes in the composition of

testing alliances may result in the need to assess whether

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comments and positions developed previously in this rulemaking process

should be revised.

The Agency maintains that the proposed changes made in the

``Persons Required to Test'' section of the amended HAPs proposal would

provide an equitable means to determine which entities would be

responsible for testing HAPs chemicals. The amended proposal

distinguished those persons who, although subject to the rule, would

not be 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 from those persons who would be required to

comply with the requirements of the rule when promulgated (``initially

comply'').

It has been brought to the attention of the Agency that the

language (in both the preamble and the regulatory text) used to

determine what persons would be subject to the HAPs test rule and when

they would have to comply with the rule is ambiguous. The Agency is

therefore clarifying who would be required to initially comply with the

HAPs rule with regard to a particular HAP chemical, namely, any person

who has, during the last complete corporate fiscal year prior to the

publication of the final rule in the Federal Register, manufactured

(including imported) the HAP chemical at any facility 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). 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 one percent by

weight is not to be taken into account in determining whether the

25,000 lb threshold has been met. (``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.)

EPA requests that comments on the amended proposal be submitted

with this clarification in mind. Regulatory text which would be more

clear than that in the amended proposal might, rather than including

both paragraphs (iv) and (v) in Sec. 799.5053(a)(2) as published in the

amended proposal, include a single paragraph, Sec. 799.5053(a)(2)(iv),

that might read as follows:

(iv) Manufacturers (including importers) 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 manufactured such substance in an amount equal to or in

excess of 25,000 lb 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 because 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 lb

threshold specified in this paragraph has been met.

EPA acknowledges that some additional time may be required for

members of the public to give full consideration to the changes in the

amended HAPs proposal and the clarification contained in this document,

to adjust existing testing alliances, and to seek additional members of

groups or alliances to conduct testing. However, the Agency does not

believe that changes to existing testing alliances would likely result

in the need to make new comments regarding the testing requirements in

the amended proposal because these requirements have not changed

substantially from those originally proposed. The Agency emphasizes

that the data called for under the amended HAPs proposal are needed to

meet requirements under section 112 of the Clean Air Act, and that

these data are also needed for other government organizations (ATSDR,

NIOSH, OSHA, CPSC) to meet the needs of their programs. With this

general understanding, EPA has weighed these requests to extend the

comment period with the need to move forward with testing of these HAPs

chemicals and agrees to extend the comment period until May 11, 1998.

In the December 24, 1997 amended HAPs proposal, EPA invited the

submission of proposals for ECAs on all the HAPs chemicals for which

ECA proposals have not been received. The Agency indicated that 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 amended HAPs

proposal. EPA will review proposal submissions and may select

candidates for ECA negotiations based on the ability of the proposal to

fulfill the data requirements that are set forth in the 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 to notify the Agency in writing. EPA will 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. The deadline for

the receipt of alternative testing ECA proposals is being extended from

February 9, 1998 to March 11, 1998.

III. 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 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 proposed rule, as amended, may be filed

online at many Federal Depository Libraries.

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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.

In addition to the documents listed in Unit X. of the original HAPs

proposal and Unit V. of the amended HAPs proposal, the record includes

the following additional referenced documents:

1. Letter from M. L. Mullins, Chemical Manufacturers Association to

Charles M. Auer, EPA, January 5, 1998.

2. Letter from John F. Murray, Biphenyl Work Group to Charles M.

Auer, EPA, January 8, 1998.

3. Contact report from Richard W. Leukroth and Frank Kover, EPA, of

phone conversation with W. McLeod, American Petroleum Institute,

January 14, 1998.

4. Letter from A. Crane, North American Insulation Manufacturers

Association to C. Auer, EPA, January 9, 1998.

5. Letter from J. Rucker, American Petroleum Institute to C. Auer,

EPA, January 15, 1998.

List of Subjects in 40 CFR Part 799

Environmental protection, Chemicals, Hazardous substances,

Reporting and record keeping requirements.

Dated: January 30, 1998.

Ward Penberthy,

Acting Director, Chemical Control Division, Office of Pollution

Prevention and Toxics.

Accordingly, EPA is extending the comment period on the proposed

rule to May 11, 1998. EPA is also extending the period for the receipt

of ECA proposals to provide alternative testing to meet HAPs testing

requirements to March 11, 1998.

[FR Doc. 98-2877 Filed 2-4-98; 8:45 am]

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