[Federal Register Volume 65, Number 116 (Thursday, June 15, 2000)]
[Notices]
[Pages 37550-37553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-15162]


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ENVIRONMENTAL PROTECTION AGENCY

[OPPTS-42198C; FRL-6494-5]


1,1,2-Trichloroethane (TCE); Final Enforceable Consent Agreement 
and Testing Consent Order

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: Under section 4 of the Toxic Substances Control Act (TSCA), 
EPA has issued a testing consent order (Order) that incorporates an 
enforceable consent agreement (ECA) with The Dow Chemical Company; 
Vulcan Materials Company; Occidental Chemical Corporation; Oxy Vinyls, 
LP; Georgia Gulf Corporation; Westlake Chemical Corporation; PPG 
Industries, Inc.; Borden Chemicals & Plastics Operating Limited 
Partnership; and Formosa Plastics Corporation, U.S.A. (``the 
Companies''). The Companies have agreed to perform toxicity testing and 
physiologically based pharmacokinetics (PBPK) and mechanistic (MECH) 
testing that is intended to satisfy the toxicological data needs 
identified in a proposed test rule for acute toxicity, subchronic 
toxicity, developmental toxicity, reproductive toxicity, neurotoxicity, 
carcinogenicity, in vivo cytogenetics, and immunotoxicity effects of 
1,1,2-trichloroethane (TCE). This notice announces the ECA and Order 
for TCE and summarizes the terms of the ECA.

DATES: The effective date of the ECA and Order is June 15, 2000.

FOR FURTHER INFORMATION CONTACT: For general information contact: 
Barbara Cunningham, Director, Office of Program Management and 
Evaluation, Office of Pollution Prevention and Toxics (7401), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (202) 554-1404; e-mail address: 
<a href="/cdn-cgi/l/email-protection#85d1d6c6c4a8cdeaf1e9ecebe0c5e0f5e4abe2eaf3"><span class="__cf_email__" data-cfemail="f7a3a4b4b6dabf98839b9e9992b7928796d9909881">[email protected]</span></a>.
    For specific information contact: John Schaeffer, Chemical Control 
Division (7405), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (202) 260-8130; fax: (202)260-
1096; e-mail address: <a href="/cdn-cgi/l/email-protection#d3b0b0b7fdb0baa7b193b6a3b2fdb4bca5"><span class="__cf_email__" data-cfemail="5a39393e7439332e381a3f2a3b743d352c">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: This notice announces the ECA and Order for 
TCE and summarizes the terms of the ECA.

I. General Information

A. Does this Action Apply to Me?

    The ECA and Order announced in this notice only affect those 
companies that signed the ECA for TCE: The Dow Chemical Company; Vulcan 
Materials Company; Occidental Chemical Corporation; Oxy Vinyls, LP; 
Georgia Gulf Corporation; Westlake Chemical Corporation; PPG 
Industries, Inc.; Borden Chemicals & Plastics Operating Limited 
Partnership; and Formosa Plastics Corporation, U.S.A. The Companies are 
members of the HAP Task Force, which is an association of manufacturers 
of TCE. However, as a result of the ECA and Order, EPA has initiated a 
rulemaking in the Federal Register of December 23, 1997 (62 FR 67036) 
(FRL-5762-9) under TSCA section 12(b)(1) which, when finalized, will 
require all persons who export or intend to export TCE to comply with 
the Agency's export notification regulations at 40 CFR part 707, 
subpart D.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register--Environmental Documents.'' You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPPTS-42198C. The official 
record consists of the documents specifically referenced in this 
action, any public comments received during an applicable comment 
period, and other information related to this action, including any 
information claimed as Confidential Business Information (CBI). This 
official record includes the documents that are physically located in 
the docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during

[[Page 37551]]

an applicable comment period, is available for inspection in the TSCA 
Nonconfidential Information Center, North East Mall Rm. B-607, 
Waterside Mall, 401 M St., SW., Washington, DC. The Center is open from 
noon to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Center is (202) 260-7099.

II. Background

A. What Is TCE?

    TCE is used as a feedstock intermediate in the production of 
vinylidene chloride and some tetrachloroethanes (Ref. 1). It is used as 
a solvent where its high solvency for chlorinated rubbers and other 
substances is needed, and for pharmaceuticals and electronic 
components. An estimated 1,036 workers are exposed to TCE. The Chemical 
Abstract Service (CAS) Registry number for TCE is 79-00-5.

B. Why is EPA Requiring Health Effects Testing on TCE?

    EPA proposed health effects testing under TSCA section 4(a) for a 
number of hazardous air pollutants (``HAPs'' or ``HAPs chemicals''), 
including TCE in the Federal Register of June 26, 1996 (61 FR 33178) 
(FRL-4869-1), as amended in the Federal Register of December 24, 1997 
(62 FR 67466) (FRL-5742-2) and April 21, 1998 (63 FR 19694) (FRL-5780-
6). In the HAPs proposal, the Agency made preliminary findings for TCE 
that:
    1. TCE may present an unreasonable risk of injury to health.
    2. TCE is or will be produced in substantial quantities, and there 
is or may be substantial human exposure to the chemical.
    3. There are insufficient data to determine or predict the effects 
of activities on human health involving TCE.
    4. Testing is necessary to develop health effects data for TCE.
    See the Federal Register of June 26, 1996 (61 FR 33178, 33190, and 
33193) (FRL-4869-1). See also Ref. 1.
    The HAPs rule proposed testing of TCE for acute toxicity, 
subchronic toxicity, developmental toxicity, reproductive toxicity, 
neurotoxicity, carcinogenicity, in vivo cytogenetics, and 
immunotoxicity. See the Federal Register of June 26, 1996 (61 FR 33178 
and 33197) (FRL-4869-1) and December 24, 1997 (62 FR 67466 and 67482) 
(FRL-5742-2).

III. ECA Development and Conclusion

A. How is EPA Going to Obtain Health Effects Testing on TCE?

    In the proposed HAPs test rule, as amended, EPA invited the 
submission of proposals for pharmacokinetics (PK) studies for the HAPs 
chemicals, which could provide the scientific basis for alternative 
testing to the testing proposed and could provide the basis for 
negotiation of ECAs. See the Federal Register of June 26, 1996 (61 FR 
33178 and 33189) (FRL-4869-1) and December 24, 1997 (62 FR 67466 and 
67474) (FRL-5742-2). EPA uses ECAs to accomplish testing where a 
consensus is reached concerning the need for and scope of testing. The 
procedures for ECA negotiations and the criteria for determining 
whether a consensus exists are described at 40 CFR 790.22 and 40 CFR 
790.24, respectively.
    In response to EPA's request for proposals for ECAs, the HAP Task 
Force submitted a proposal for alternative testing involving PK studies 
for TCE on November 22, 1996 (Ref. 2). EPA responded to this proposal 
by letter on June 26, 1997 (Ref. 3), indicating that this approach 
could offer sufficient merit to proceed with ECA negotiations. As a 
result of the response of the HAP Task Force on December 12, 1997 (Ref. 
4) to EPA's letter, EPA decided to proceed with ECA negotiations for 
TCE. Consequently, EPA published a document in the Federal Register of 
December 19, 1997 (62 FR 66628) (FRL-5763-2) soliciting interested 
parties to monitor or participate in these negotiations.
    EPA held a public meeting to negotiate an ECA for TCE on January 
12, 1998. The participants reached agreement on the general scope of 
the testing to be required under the ECA, and the HAP Task Force 
submitted a revised proposal for a testing program on February 27, 
1998, which EPA responded to on September 24, 1998 (Refs. 5,6). A final 
version of the ECA was circulated to the HAP Task Force and returned to 
EPA for signature. On June 7, 2000, EPA signed the ECA and accompanying 
Order (Ref. 7).

B. What Testing Does the ECA for TCE Require?

    As described in Table 1 of this unit, this ECA requires the 
following testing:
    1. Tier I HAPs Testing (taken from the proposed HAPs test rule, as 
amended): Acute and subchronic toxicity by the inhalation route of 
exposure.
    2. Tier I Program Review Testing: The development of PK/MECH data 
to inform route-to-route extrapolation of data from studies acceptable 
to EPA that were performed by a route other than inhalation and, also, 
the development and application of PBPK model simulations. The PK/MECH 
data and PBPK modeling will be subject to program review by EPA to 
confirm the validity of the oral-to-inhalation extrapolations. This 
testing relates to the following endpoints: Neurotoxicity, 
developmental toxicity, and reproductive toxicity (in the rat); and 
developmental toxicity, immunotoxicity, and carcinogenicity (in the 
mouse).
    3. Tier II Testing and/or Extrapolation Reporting:
    i. Acute neurotoxicity, subchronic neurotoxicity, developmental 
toxicity, and reproductive toxicity testing by the oral route of 
exposure.
    ii. Route-to-route extrapolation to the inhalation route for these 
acute neurotoxicity, subchronic neurotoxicity, developmental toxicity, 
and reproductive toxicity studies, as well as for the extant 
immunotoxicity and carcinogenicity studies which were also conducted by 
the oral route of administration (Refs. 8,9).
    This testing will allow EPA to characterize certain potential 
health hazards resulting from inhalation exposure to TCE. Table 1 of 
this unit sets forth the required testing, test standards, and 
reporting requirements under the ECA for TCE.
    In addition, EPA recognizes the concerns that have been expressed 
about animal testing. In this ECA, every effort is made to avoid 
unnecessary or duplicative testing. EPA supports the goals developed by 
the Interagency Coordinating Committee on the Validation of Alternative 
Methods (ICCVAM) (http://iccvam.niehs.nih.gov/home.htm) to:
    1. Encourage the reduction of the number of animals used in 
testing.
    2. Seek opportunities to replace test methods requiring animals 
with alternative test methods when acceptable alternative methods are 
available.
    3. Refine existing test methods to optimize animal use when there 
is no substitute for animal testing. EPA considers these goals to be 
important elements in developing health effects data for conducting 
scientifically sound chemical risk assessments. Thus, where testing 
must be conducted to develop adequate data, the Agency is committed to 
reducing the number of animals used for testing, including, whenever 
possible, by incorporating in vitro (non-animal) test methods or other 
alternative approaches that have been scientifically validated and have 
received regulatory acceptance. In addition, in this ECA,

[[Page 37552]]

which involves development of PBPK/MECH data, the subsequent route-to-
route extrapolations to existing data should result in the use of fewer 
test animals as compared to developing all new data by the inhalation 
route.

                 Table 1.--Required Testing, Test Standards, and Reporting Requirements for TCE
----------------------------------------------------------------------------------------------------------------
                                                                                            Deadline for final
           Testing segment                Required testing           Test standard          report\1\ (months)
----------------------------------------------------------------------------------------------------------------
Tier I HAPs Testing.................   Acute toxicity           40 CFR 799.9135 (as      15
                                       (inhalation).            annotated in ECA
                                                                Appendix D.1).
                                       Subchronic toxicity      40 CFR 799.9346 (as      24
                                       (inhalation).            annotated in ECA
                                                                Appendix D.2).
----------------------------------------------------------------------------------------------------------------
Tier I Program Review Testing.......  PK/MECH data to support   ECA Appendix C (1-3)...  15
                                       model validation and
                                       verification of oral-
                                       to-inhalation
                                       extrapolation for the
                                       following data needs
                                       in the F344 rat:
                                      a. Neurotoxicity.......
                                      b. Developmental
                                       toxicity.
                                      c. Reproductive
                                       toxicity.
                                      PK/MECH data to support   ECA Appendix C (1-3)...  15
                                       model development,
                                       validation, and
                                       verification of oral-
                                       to-inhalation
                                       extrapolation for the
                                       following data needs
                                       in the mouse:
                                      a. Developmental
                                       toxicity.
                                      b. Immunotoxicity......
                                      c. Carcinogenicity.....
                                       PBPK model simulations   ECA Appendix C (1-5)...  24
----------------------------------------------------------------------------------------------------------------
Tier II Testing and/or Extrapolation   Acute neurotoxicity      40 CFR 799.9620 (as      36
 Reporting.                            (oral).                  annotated in ECA
                                                                Appendix D.3).
                                       Acute neurotoxicity      ECA Appendix C.........  39
                                       extrapolation of oral
                                       data to inhalation.
                                       Subchronic               40 CFR 799.9620 (as      42
                                       neurotoxicity (oral).    annotated in ECA
                                                                Appendix D.3).
                                       Subchronic               ECA Appendix C.........  45
                                       neurotoxicity
                                       extrapolation of oral
                                       data to inhalation.
                                       Developmental toxicity   40 CFR 799.9370 (as      48
                                       (oral).                  annotated in ECA
                                                                Appendix D.4).
                                       Developmental toxicity   ECA Appendix C.........  51
                                       extrapolation of oral
                                       data to inhalation.
                                       Reproductive toxicity   40 CFR 799.9380 (as       54
                                       (oral).                  annotated in ECA
                                                                Appendix D.5).
                                       Reproductive toxicity    ECA Appendix C.........  57
                                       extrapolation of oral
                                       data to inhalation.
                                       Immunotoxicity           ECA Appendix C.........  33
                                       extrapolation of
                                       extant oral data in
                                       ECA Appendix E.2 to
                                       inhalation.
                                       Carcinogenicity          ECA Appendix C.........  30
                                       extrapolation of
                                       extant oral data in
                                       ECA Appendix E.3 to
                                       inhalation.
----------------------------------------------------------------------------------------------------------------
\1\Number of months after the effective date of the Order that incorporates this ECA when the final report is
  due. In addition, every 6 months from the effective date of the Order until the end of the ECA testing
  program, interim reports describing the status of all testing to be performed under this ECA must be submitted
  by the Companies to EPA.

C. What are the Uses for the Test Data for TCE?

    EPA will use the data obtained from testing to implement several 
provisions of section 112 of the Clean Air Act (CAA), including the 
determination of residual risk, the estimation of the risks associated 
with accidental releases of chemicals, and determinations whether 
substances should be removed from the CAA section 112(b)(1) list of 
hazardous air pollutants (delisting). The data will also be used by 
other Federal agencies (e.g., the Agency for Toxic Substances and 
Disease Registry (ATSDR), the National Institute for Occupational 
Safety and Health (NIOSH), the Occupational Safety and Health 
Administration (OSHA), and the Consumer Product Safety Commission 
(CPSC)) in assessing chemical risks and in taking appropriate actions 
within their programs. See the proposed HAPs test rule published in the 
Federal Register of June 26, 1996 (61 FR 33178, 33179) (FRL-4869-1).

D. Does the ECA for TCE Meet all the Testing Requirements for TCE that 
were Contained in the Proposed HAPs Test Rule, as Amended?

    In the proposed HAPs test rule, as amended, EPA required testing of 
TCE for acute toxicity, subchronic toxicity, developmental toxicity, 
reproductive toxicity, neurotoxicity, carcinogenicity, in vivo 
cytogenetics, and immunotoxicity by the inhalation route of exposure. 
The ECA for TCE requires testing for acute and subchronic toxicity by 
inhalation, and developmental and reproductive toxicity, and 
neurotoxicity by oral exposure. This ECA does not require testing for 
carcinogenicity, immunotoxicity, or in vivo cytogenetics. Instead, this 
ECA is requiring that PK/MECH data and PBPK modeling be developed in 
order to extrapolate exposure by the oral route to the inhalation 
route. These extrapolations will be performed on extant data for 
carcinogenicity and immunotoxicity that have been determined to be 
acceptable to EPA, as well as data which will be developed under this 
ECA for developmental and reproductive toxicity and neurotoxicity.
    The ECA does not require, and the final HAPs test rule will not 
require, in vivo cytogenetics testing because EPA

[[Page 37553]]

considers existing data to be sufficient to fill the testing need 
identified in the proposed HAPs test rule, as amended. These data 
include a study by Mazzulo, et al. (1986) demonstrating genotoxicity 
and a study by Doherty, et al. (1996) demonstrating cytogenicity, which 
are included as appendices to the ECA (Refs. 10,11). The Tier I HAPs 
Testing endpoints will not be included in the final HAPs test rule 
because such testing will be conducted under this ECA. Depending on the 
results of the EPA Program Review, the Agency anticipates that the 
balance of the testing for TCE that was identified in the proposed HAPs 
test rule, as amended, will also not be included in the final HAPs test 
rule because equivalent testing will be conducted as Tier II Testing 
and Extrapolation Reporting under this ECA.
    The issuance of the ECA and Order constitutes final EPA action for 
purposes of 5 U.S.C. 704.

E. What if EPA Should Require Additional Testing on TCE?

    If EPA decides in the future that it requires additional testing on 
TCE, the Agency will initiate a separate action.

IV. Other Impacts of the ECA for TCE

    The issuance of the ECA and Order under TSCA section 4 subjects the 
Companies that signed the ECA to export notification requirements under 
TSCA section 12(b)(1), as set forth at 40 CFR part 707, subpart D, if 
they export or intend to export TCE.
    In the Federal Register of December 23, 1997 (62 FR 67036) (FRL-
5762-9), EPA proposed to amend 40 CFR 799.5000 by adding TCE to the 
list of chemicals subject to testing consent orders. The listing of a 
chemical substance at 40 CFR 799.5000 serves as notification to all 
persons who export or intend to export the chemical substance that:
    1. The chemical substance is the subject of an ECA and Order.
    2. EPA's export notification regulations at 40 CFR part 707, 
subpart D, apply to those exporters who have signed the ECA, as well as 
those exporters who have not signed the ECA (40 CFR 799.19).
    When a final rule based on the proposed rule is published in the 
Federal Register, all persons who export or who intend to export TCE 
will be subject to export notification requirements.

V. Text of the Testing Consent Order

    As indicated in the ECA for TCE, EPA is publishing the text of the 
Order in this notice. The Order is entitled: ``United States 
Environmental Protection Agency; Testing Consent Order for 1,1,2-
Trichloroethane; Docket No. OPPTS-42198C,'' and reads as follows:
    ``Under the authority of section 4 of the Toxic Substances Control 
Act (TSCA), 15 U.S.C. 2603, the United States Environmental Protection 
Agency (EPA) issues this testing consent order (Order) to take effect 
on the date of publication of the notice in the Federal Register 
announcing the issuance of this Order. This Order incorporates the 
enforceable consent agreement (ECA) for 1,1,2-Trichloroethane (TCE).''
    The Order was signed by Susan H. Wayland, Acting Assistant 
Administrator for Prevention, Pesticides and Toxic Substances, on June 
7, 2000.

VI. Paperwork Reduction Act

    The ECA and Order announced in this notice do not contain any 
information collection requirements that require additional approval by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act (PRA), 44 U.S.C. 3501 et seq. The information collection 
requirements related to test rules and ECAs issued under TSCA section 4 
have already been approved by OMB under OMB control number 2070-0033 
(EPA ICR No. 1139). The one-time public burden for this collection of 
information is estimated to be approximately 5,323 hours total. Under 
the PRA, ``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. For this 
collection it includes the time needed to review instructions; complete 
and review the collection of information; and transmit or otherwise 
disclose the information. An agency may not conduct or sponsor, and a 
person is not required to respond to, a collection of information 
unless it displays a currently valid OMB control number. The OMB 
control numbers for EPA's regulations, after initial display in the 
final rule, are listed in 40 CFR part 9.

VII. References

    1. United States Environmental Protection Agency (USEPA), OPPT. 
TSCA Section 4 Findings for 21 Hazardous Air Pollutants: A Supporting 
Document for Proposed Hazardous Air Pollutants (HAPs) Test Rule. June 
25, 1996.
    2. The HAP Task Force. Letter from Peter E. Voytek to Charles M. 
Auer with attachment entitled: Proposal for Pharmacokinetics Study of 
1,1,2-Trichloroethane, November 22, 1996. November 22, 1996.
    3. USEPA. Letter from Charles M. Auer to Peter E. Voytek with 
attachment entitled: Preliminary EPA Technical Analysis of Proposed 
Industry Pharmacokinetics (PK) Strategy for 1,1,2-Trichloroethane, 
June, 1997. June 26, 1997.
    4. The HAP Task Force. Letter from Peter E. Voytek to Charles M. 
Auer, USEPA. December 12, 1997.
    5. The HAP Task Force. Letter from Peter E. Voytek to Charles M. 
Auer, USEPA, with enclosure entitled: Considerations for 1,1,2-TCE. 
February 27, 1998.
    6. USEPA. Letter from Charles M. Auer to Peter E. Voytek, HAP Task 
Force, re: EPA final Position for ECA Development of 1,1,2-
Trichloroethane (OPPTS -42198B), with attachment entitled: DRAFT--
1,1,2-TCE ECA--9/23/98. September 24, 1998.
    7. Final Enforceable Consent Agreement for 1,1,2-Trichloroethane 
and Accompanying Testing Consent Order, signed by EPA on June 7, 2000.
    8. Sanders, V. M., White, Jr., K. L., Shopp, Jr., G. M., and 
Musson, A.E. Humoral and cell-mediated immune status of mice exposed to 
1,1,2-trichloroethane. Drug and Chemical Toxicology. 8(5):357-372. 
1985.
    9. National Cancer Institute (NCI). Bioassay of 1,1,2-
Trichloroethane for Possible Carcinogenicity. Carcinogenesis: Technical 
Report Series No. 74. U.S. Department of Health, Education and Welfare, 
Public Health Service, National Institutes of Health. 1978.
    10. Mazzullo, M., Colaccai, A., Grilli, S., Prodi, G. and 
Arfellini, G. 1,1,2- trichloroethane: evidence of genotoxicity from 
short-term tests. Japanese Journal of Cancer Research. 77:532-539. 
1986.
    11. Doherty, A.T., Ellard, S., Parry, E.M., and Parry, J.M. An 
investigation into the activation and deactivation of chlorinated 
hydrocarbons to genotoxins in metabolically competent human cells. 
Mutagenesis. 11(3):247-274. 1996.

List of Subjects

    Environmental protection, Hazardous chemicals.

    Dated: June 7, 2000.
Susan H. Wayland,
Acting Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.
[FR Doc. 00-15162 Filed 6-14-00; 8:45 am]
BILLING CODE 6560-50-F


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