[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
oppt.ncic@epamail.epa.gov. Follow the instructions under Unit V. of
this document. No confidential business information (CBI) should be
submitted through e-mail.
FOR FURTHER INFORMATION CONTACT: For general information: Susan B.
Hazen, Director, Environmental Assistance Division (7408), Rm. ET-543B,
Office of Pollution Prevention and Toxics, U.S. Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone:
(202) 554-1404; TDD: (202) 554-0551; e-mail: TSCA-
Hotline@epamail.epa.gov. For technical information contact: Richard W.
Leukroth, Jr. , Project Manager, Chemical Control Division (7405),
Office of Pollution Prevention and Toxics, U.S. Environmental
Protection Agency, 401 M St., SW., Washington, DC, 20460; telephone:
(202) 260-0321; fax: (202) 260-8850; e-mail:
leukroth.rich@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of June 26, 1996 (61
FR 33178), EPA issued a proposed test rule for the following hazardous
air pollutant chemicals that would require health effects testing to be
conducted using eleven draft harmonized test guidelines developed by
EPA's Office of Prevention, Pesticides and Toxic Substances (OPPTS):
1,1'-biphenyl (CAS No. 92-52-4), carbonyl sulfide (CAS No. 463-58-1),
chlorine (CAS No. 7782-50-5), chlorobenzene CAS No. 108-90-7),
chloroprene (CAS No. 126-99-8), 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
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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: guidelines@epamail.epa.gov; by mail; or, from the TSCA Non-
Confidential Information Center, Rm. NE-B607, 401 M St., SW.,
Washington, DC 20460.
EPA is soliciting comments on the eleven TSCA test guidelines to be
incorporated in enforceable test standards under this amended HAPs
proposal. To be considered in this rulemaking, comments must be
submitted in the manner specified in the ``ADDRESSES'' section at the
beginning of this document.
III. Changes and Clarifications
In addition to cross-referencing the TSCA test guidelines, this
amended HAPs proposal is making other changes and clarifications to the
original HAPs proposal, which are set forth as follows:
A. Phenol--Removal of Testing Requirements
The original HAPs proposal included testing requirements for phenol
(CAS No. 108-95-2). On January 17, 1997, EPA published a document (62
FR 2607) which announced a testing consent order (Order) under TSCA
section 4 that incorporated an ECA concluded between EPA and fourteen
specified companies. In the ECA, the companies agreed to perform
certain health effects tests on phenol. In addition, the January 17
document included a direct final rule which added phenol to the list of
chemical substances in 40 CFR 799.5000 that are subject to testing
consent orders and hence subject to export notification requirements
under TSCA section 12(b). EPA received adverse comment with respect to
making entities that are not signatory to the ECA subject to export
notification requirements for phenol. Because of those adverse
comments, on May 23, 1997 (62 FR 28368), EPA removed the export
notification rule. EPA did not withdraw the Order or the ECA, and
signatories to the ECA remain subject to export notification
requirements. EPA intends to propose a phenol export notification rule
at a future time. Because EPA anticipates receiving the necessary test
data on phenol pursuant to the ECA and Order, EPA is amending the
proposed HAPs test rule to remove all phenol testing requirements.
The documents entitled: ``Economic Assessment for the Amended
Proposed TSCA Section 4(a) Test Rule for 21 Hazardous Air Pollutants,''
discussed in Units VI.A. and VI.D. of this preamble, and ``Additional
Information on Small Entity Impacts of the Amended Proposed TSCA
Section 4(a) Test Rule for 21 Hazardous Air Pollutants,'' discussed in
Unit VI.C. of this preamble, have not yet been modified to reflect the
reductions in impact and burden associated with the deletion of phenol
testing, but will be so modified by the time the final rule is
promulgated.
Unit VI. of this preamble contains data from the above economic
assessment with all references to phenol removed. Similarly, Table 1 in
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
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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
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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:
oppt.ncic@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the use
of special characters and any form of encryption. Comments and data
will also be accepted on disks in WordPerfect 5.1 file format or ASCII
file format. All comments and data in electronic form must be
identified by document control number (OPPTS-42187A; FRL-4869-1).
Electronic comments on this proposed rule, as amended, may be filed
online at many Federal Depository Libraries.
All comments which contain information claimed as CBI must be
clearly marked as such. Three sanitized copies of any comments
containing information claimed as CBI must also be submitted and will
be placed in the public record for this rulemaking. Persons submitting
information any portion of which they believe is entitled to treatment
as CBI by EPA must assert a business confidentiality claim in
accordance with 40 CFR 2.203(b) for each such portion. This claim must
be made at the time that the information is submitted to EPA. If a
submitter does not assert a confidentiality claim at the time of
submission, EPA will make the information available to the public
without further notice to the submitter. No CBI should be submitted
electronically.
Electronic Availability: Internet: Electronic copies of this
document and various support documents are available from the EPA Home
Page at the Federal Register - Environmental Documents entry for this
document under ``Regulations'' (http://www.epa.gov/fedrgstr/EPA-TOX/
1997/). Fax-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
