[Federal Register Volume 62, Number 246 (Tuesday, December 23, 1997)]
[Proposed Rules]
[Pages 67038-67041]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33448]


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 ENVIRONMENTAL PROTECTION AGENCY

 40 CFR Part 799

 [OPPTS-42197A; FRL-5762-8]
 RIN 2070-AC76


 Testing Consent Order and Export Notification Requirements for 
Ethylene Dichloride

  AGENCY: Environmental Protection Agency (EPA).

  ACTION: Proposed rule.

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  SUMMARY: On June 26, 1996, EPA proposed a test rule under section 
4(a) of the Toxic Substances Control Act (TSCA) to require 
manufacturers and processors of 21 hazardous air pollutants (HAPs) to 
test these substances for certain health effects. Included as one of 
these chemical substances was ethylene dichloride (CAS No. 107-06-2). 
EPA invited the submission of proposals for enforceable consent 
agreements (ECAs) for pharmacokinetics testing of the HAPs chemicals 
and received a proposal for testing ethylene dichloride from the HAP 
Task Force. In a previous document published EPA has solicited 
interested parties to monitor or participate in negotiations on an ECA 
for ethylene dichloride. EPA is proposing that if an ECA is 
successfully concluded for ethylene dichloride, then the subsequent 
publication of the TSCA section 4 testing consent order (Order) in the  
Federal Register would add ethylene dichloride to the table of testing 
consent orders for substances and mixtures with Chemical Abstract 
Service Registry Numbers. As a result of the proposed addition of 
ethylene dichloride, all exporters of ethylene dichloride, including 
persons who do not sign the ECA, would be subject to export 
notification requirements under section 12(b) of TSCA.

  DATES: Written comments on this proposed rule must be received by EPA 
on or before January 27, 1998.

  ADDRESSES: Each comment must bear the docket control number, OPPTS-
42197A. All comments should be sent in triplicate to: OPPT Document 
Control Officer (7407), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 401 M St., SW., Rm. G-099, East Tower, 
Washington, DC 20460.
     Comments and data may also be submitted electronically to: 
[email protected]. following the instructions under Unit IV. of 
this document. No Confidential Business Information (CBI) should be 
submitted through e-mail.
     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 document. 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.

  FOR FURTHER INFORMATION CONTACT:  For additional information: Susan 
B. Hazen, Director, Environmental Assistance Division (7408), Rm. ET-
543B, Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone: 
(202) 554-1404, TDD: (202)

[[Page 67039]]

554-0551; e-mail address: TSCA-H[email protected].
      For technical information : Richard W. Leukroth, Jr., Project 
Manager, Chemical Information and Testing Branch (7405), Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 401 M 
St., SW., Washington, DC 20460; telephone: (202) 260-0321; e-mail 
address: [email protected].

  SUPPLEMENTARY INFORMATION:

 I. Electronic Availability

      Internet: Electronic copies of this document and various support 
documents are available from the EPA Home Page at the  Federal Register 
--Environmental Documents entry for this document under ``Laws and 
Regulations'' (http://www.epa.gov/fedrgstr/EPA-TOX/1997/).

 II. Development of Enforceable Consent Agreement for Ethylene 
Dichloride

     Ethylene dichloride was one of the chemicals proposed for health 
effects testing in a proposed HAPs test rule under section 4(a) of TSCA 
in the  Federal Register of June 26, 1996 (61 FR 33178) (FRL-4869-1). 
In the proposed HAPs test rule, EPA invited the submission of proposals 
for pharmacokinetics (PK) testing for the chemicals included in the 
proposed HAPs test rule. These proposals could provide the basis for 
negotiation of ECAs, which, if successfully concluded, would be 
incorporated into Orders. The PK studies would be used to conduct 
route-to-route extrapolation of toxicity data from routes other than 
inhalation to predict the effects of inhalation exposure, as an 
alternative to testing proposed under the HAPs test rule. A proposal 
for PK testing for ethylene dichloride was submitted by the HAP Task 
Force to EPA on November 25, 1996. The Agency reviewed this alternative 
testing proposal and prepared a preliminary technical analysis of the 
proposal which it sent to the HAP Task Force on June 26, 1997. The HAP 
Task Force responded on July 31, 1997, that it has a continued interest 
in pursuing the ECA process for ethylene dichloride. EPA has decided to 
proceed with the ECA process for ethylene dichloride. EPA has published 
a document soliciting interested parties to monitor or participate in 
negotiations on an ECA for PK testing of ethylene dichloride in the 
Federal Register of December 19, 1997. The procedures for ECA 
negotiations are described at 40 CFR 790.22(b).
     If the ECA for ethylene dichloride is successfully concluded, and 
an Order is published in the  Federal Register, testing to develop 
needed data would be required of those persons that have signed the 
agreement. Section 12(b) of TSCA provides that if any person exports or 
intends to export to a foreign country a chemical substance or mixture 
for which the submission of data is required under section 4 of TSCA, 
that person shall notify EPA of this export or intent to export. This 
requirement applies to data obtained from either a test rule or an ECA 
and Order under the authority of section 4 of TSCA. EPA intends the ECA 
to include the export notification requirements of section 12(b) of 
TSCA, codified at 40 CFR part 707, subpart D.

 III. Publication of Testing Consent Order

     EPA is proposing that if an ECA is successfully concluded for 
ethylene dichloride, the publication of the Order in the  Federal 
Register would add ethylene dichloride to the table in 40 CFR 799.5000, 
Testing consent orders for substances and mixtures with Chemical 
Abstract Service Registry Numbers.
     Exporters of chemicals listed at 40 CFR 799.5000 are required 
under 40 CFR 799.19, Chemical imports and exports, to comply with the 
export notification requirements of 40 CFR part 707, subpart D. This 
proposed rule, when finalized, would amend Sec. 799.5000, and, in 
accordance with 40 CFR 799.19, all exporters of ethylene dichloride, 
including persons who do not sign the ECA, would be subject to export 
notification requirements under 40 CFR part 707, subpart D.
     Under 40 CFR 707.65(a)(2)(ii), a person who exports or intends to 
export for the first time to a particular foreign country a chemical 
subject to TSCA section 4 data requirements must submit a one-time 
notice to EPA identifying the chemical and country of import. A single 
notice can cover multiple chemicals and multiple countries. If 
additional importing countries are subsequently added, additional 
export notices must be submitted to EPA. Other procedures for 
submitting export notifications to EPA are described in 40 CFR 707.65.
     Under 40 CFR 707.67, the contents of the export notification from 
the exporter or intended exporter to EPA shall include:
     1. The name of the chemical (i.e., in this case, ethylene 
dichloride).
     2. The name and address of the exporter.
     3. The country(ies) of import.
     4. The date(s) of export or intended export.
     5. The section of TSCA under which EPA has taken action (i.e., in 
this case, section 4 of TSCA).
 Following receipt of the 12(b) notification from the exporter or 
intended exporter, under 40 CFR 707.70, EPA will provide notice of the 
export or intended export to the affected foreign government(s).

 IV. Public Record and Electronic Submissions

     The official record for this rulemaking, including the public 
version, that does not include any information claimed as CBI, has been 
established for this rulemaking under docket control number OPPTS-
42197A. The public version of this record 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 B-607, 401 M St., SW., Washington, DC 20460.
     Electronic comments can be sent directly to EPA at:
    [email protected].

     Electronic comments must be submitted as an ASCII file avoiding 
the use of special characters and any form of encryption. Comments and 
data will also be accepted on disks in WordPerfect 5.1/6.1 or ASCII 
file format. All comments and data in electronic form must be 
identified by the docket control number, OPPTS-42197A. Electronic 
comments on this proposed rule may be filed online at many Federal 
Depository Libraries.

 V. Regulatory Assessment Requirements

 A. Regulatory Flexibility Act

     Under the Regulatory Flexibility Act, 5 U.S.C. 601  et seq., EPA 
does not believe that the impacts of this proposed rule constitute a 
significant economic impact on small entities.
     Export regulations promulgated pursuant to section 12(b) of TSCA--
40 CFR part 707, subpart D--require only a one-time notification to 
each foreign country of export for each chemical for which data are 
required under section 4 of TSCA. In an analysis of the economic 
impacts of the July 27, 1993, amendment to the rules implementing 
section 12(b) of TSCA (58 FR 40238), EPA estimated that the one-time 
cost of preparing and submitting the TSCA section 12(b) notification 
was $62.60. See U.S. EPA, ``Economic Analysis in Support of the Final 
Rule to Amend Rule Promulgated Under TSCA Section 12(b),'' OPPT/ETD/
RIB, June 1992, contained in the record for the HAPs

[[Page 67040]]

rulemaking (OPPTS-42187). Inflated through the last quarter of 1996 
using the Consumer Price Index, the current cost is estimated to be 
$69.56. Although data available to EPA regarding export shipments of 
the HAPs chemicals are limited, a small exporter would have to have 
annual revenues below $6,956 per chemical/country combination in order 
to be impacted at a 1% or greater level. For example, a small exporter 
filing 3 notifications per year would have to have annual sales 
revenues below $20,868 (3 x $6,956) in order to be classified as 
impacted at the greater than 1% level. EPA believes that it is 
reasonable to assume that few, if any, small exporters would file 
sufficient export notifications to be impacted at or above the 1% 
level. Based on this, the export notification requirements triggered by 
the ECA for ethylene dichloride would be unlikely to have a significant 
economic impact on small exporters. Because EPA has concluded that 
there is no significant impact on small exporters, the Agency does not 
need to determine the number or size of the entities that would be 
impacted at a 1% or greater level.
     Therefore, the Agency certifies that this proposed rule, if 
finalized, would not have a significant economic impact on small 
entities.

 B. Executive Order 12866; Executive Order 12898; Executive Order 13045

     Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 
proposed rule is not a ``significant regulatory action'' subject to 
review by the Office of Management and Budget (OMB). It does not 
involve special considerations of environmental-justice related issues 
as required by Executive Order 12898 (59 FR 7629, February 16, 1994), 
nor raise any issues regarding children's environmental-health risks 
under Executive Order 13045 (62 FR 1985, April 23, 1997) because the 
Executive order does not apply to actions expected to have an economic 
impact of less than $100 million.

 C. Paperwork Reduction Act

     An agency may not conduct or sponsor, and a person is not required 
to respond to, an information collection request unless it displays a 
currently valid control number assigned by OMB. The OMB control numbers 
for EPA's regulations are listed in 40 CFR part 9. The information 
collection requirements related to this action have already been 
approved by OMB pursuant to the Paperwork Reduction Act, 44 U.S.C. 3501 
 et seq., under OMB control number 2070-0030 (EPA ICR No. 0795). The 
public reporting burden for the collection of information is estimated 
to average 0.55 hours per response.

 D. Unfunded Mandates Reform Act

     Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub. 
L. 104-4, establishes requirements for Federal agencies to assess the 
effects of certain regulatory actions on State, local, and tribal 
governments and the private sector, and to seek input from State, 
local, and tribal governments on certain regulatory actions. EPA has 
determined that this action does not contain a Federal mandate that may 
result in expenditures of $100 million or more for State, local, and 
tribal governments, in the aggregate, or the private sector in any 1 
year. Therefore, this action is not subject to the requirements of 
sections 202 and 205 of UMRA. The requirements of sections 203 and 204 
of UMRA which relate to regulatory requirements that might 
significantly or uniquely affect small governments and to regulatory 
proposals that contain a significant Federal intergovernmental mandate, 
respectively, also do not apply to this proposed rule because the rule 
would only affect the private sector, i.e., those companies that test 
chemicals.

 List of Subjects in 40 CFR Part 799

     Environmental protection, Chemicals, Exports, Hazardous 
substances, Health, Laboratories, Reporting and recordkeeping 
requirements.

    Dated: December 16, 1997.

Lynn R. Goldman,

 Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.
     Therefore, it is proposed that 40 CFR chapter I 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 799.5000 is amended by adding ethylene dichloride to 
the table in CAS number order to read as follows:


Sec. 799.5000   Testing consent orders for substances and mixtures with 
Chemical Abstract Service Registry Numbers.

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                                         Substance or mixture                                                   
              CAS Number                         name                    Testing            FR Publication Date 
----------------------------------------------------------------------------------------------------------------
                                                                                                                
 *                *                *                    *              *                    *                  *
107-06-2                               Ethylene dichloride....  Health effects.........  [Insert date of final  
                                                                                          rule].                
                                                                                                                
 *                *                *                    *              *                    *                  *
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 [FR Doc. 97-33448 Filed 12-22-97; 8:45 am]
 BILLING CODE 6560-50-F