[Federal Register Volume 62, Number 247 (Wednesday, December 24, 1997)]
[Proposed Rules]
[Pages 67466-67485]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33451]



[[Page 67465]]

_______________________________________________________________________

Part III





Environmental Protection Agency





_______________________________________________________________________



40 CFR Part 799



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

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

[[Page 67466]]



ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 799

[OPPTS-42187L; FRL-5742-2]
RIN 2070-AC76


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

AGENCY: Environmental Protection Agency (EPA).
ACTION: Amended proposed rule; extension of comment period.

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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