[Federal Register Volume 63, Number 60 (Monday, March 30, 1998)]
[Proposed Rules]
[Pages 15128-15130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-8211]



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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 799

[OPPTS-42203A; FRL-5769-7]
RIN 2070-AC76


Testing Consent Order and Export Notification Requirements for 
Diethanolamine

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 diethanolamine (CAS No. 111-42-2). EPA invited 
the submission of proposals for enforceable consent agreements (ECAs) 
for pharmacokinetics testing of the HAPs chemicals and received a 
proposal for testing diethanolamine from the Chemical Manufacturers 
Association, Alkanolamines Panel (CMA Alkanolamines Panel). In a 
previous document EPA solicited interested parties to monitor or 
participate in negotiations on an ECA for diethanolamine. EPA is 
proposing that if an ECA is successfully concluded for diethanolamine, 
then the subsequent publication of the TSCA section 4 testing consent 
order (Order) in the Federal Register would add diethanolamine 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 diethanolamine, all exporters of diethanolamine, 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 on or 
before May 29, 1998.
ADDRESSES: Each comment must bear the docket control number, OPPTS-
42203A. 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-99, East Tower, 
Washington, DC 20460.
     Comments and data may also be submitted electronically to: 
[email protected]. following the instructions under Unit IV. of 
this preamble. 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 on 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) 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/1998/).

II. Development of Enforceable Consent Agreement for Diethanolamine

     Diethanolamine is 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). The 
proposed HAPs test rule was amended on December 24, 1997 (62 FR 67466) 
(FRL-5742-2). 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 diethanolamine was submitted by the 
CMA Alkanolamines Panel 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 CMA 
Alkanolamines Panel Panel on November 21, 1997. The CMA Alkanolamines 
Panel Panel responded on December 31, 1997 that it has a continued 
interest in pursuing the ECA process for diethanolamine. EPA has 
decided to proceed with the ECA process for diethanolamine. EPA has 
published a document soliciting interested parties to monitor or 
participate in negotiations on an ECA for PK testing of diethanolamine 
(63 FR 3109, January 21, 1998) (FRL-5766-7). The procedures for ECA 
negotiations are described at 40 CFR 790.22(b).
    If the ECA for diethanolamine 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 
diethanolamine, the publication of the Order in the Federal Register 
would add diethanolamine 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,

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when finalized, would amend Sec. 799.5000, and, in accordance with 40 
CFR 799.19, all exporters of diethanolamine, 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, diethanolamine).
    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 section 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 comments and 
data submitted electronically as described below), including the public 
version, that does not include any information claimed as CBI, has been 
established for this rulemaking under docket control number OPPTS-
42203A. The official record for this document also includes all 
material and submissions filed under docket control number [OPPTS-
42187A; FRL-4869-1], the record for the proposed HAPs test rule, as 
amended, and all materials and submissions filed under docket control 
number [OPPTS-42187B; FRL-4869-1], the record for the receipt of 
alternative testing proposals for developing ECAs for HAPs chemicals. 
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-42203A. 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 this rulemaking, and 
referenced in the amended proposed HAPs test rule (62 FR 67466, 
December 24, 1997). 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 
diethanolamine 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 hour 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

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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.

E. National Technology Transfer and Advancement Act

    This proposed regulatory action does not involve any technical 
standards that would require Agency consideration of voluntary 
consensus standards pursuant to section 12(d) of the National 
Technology Transfer and Advancement Act of 1995 (NTTAA), Pub. L. 104-
113, section 12(d) (15 U.S.C. 272 note). Section 12(d) directs EPA to 
use voluntary consensus standards in its regulatory activities unless 
to do so would be inconsistent with applicable law or otherwise 
impractical. Voluntary consensus standards are technical standards 
(e.g., materials specifications, test methods, sampling procedures, 
business practices, etc.) that are developed or adopted by voluntary 
consensus standards bodies. The NTTAA requires EPA to provide Congress, 
through OMB, explanations when the Agency decides not to use available 
and applicable voluntary consensus standards. EPA invites public 
comment on this conclusion.

List of Subjects in 40 CFR Part 799

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

    Dated: March 13, 1998.

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 diethanolamine 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  
----------------------------------------------------------------------------------------------------------------
                                                                                                                
*                        *                        *                        *                        *           
                                                  *                        *                                    
111-42-2                               Diethanolamine.........  Health effects.........  [insert date for final 
                                                                                          rule.]                
                                                                                                                
*                        *                        *                        *                        *           
                                                  *                        *                                    
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[FR Doc. 98-8211 Filed 3-27-98; 8:45 am]
BILLING CODE 6560-50-F