[Federal Register Volume 63, Number 59 (Friday, March 27, 1998)]
[Proposed Rules]
[Pages 14866-14869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-8071]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 799

[OPPTS-42199A; FRL-5764-9]
RIN 2070-AC76


Testing Consent Order and Export Notification Requirements for 
Maleic Anhydride

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 maleic anhydride (CAS No. 108-31-6). EPA 
invited the submission of proposals for enforceable consent agreements 
(ECAs) for pharmacokinetics (PK) testing of the HAPs chemicals and 
received a proposal for testing maleic anhydride from the Chemical 
Manufacturers Association, Maleic Anhydride Panel (CMA MA Panel). In a 
previous document, EPA solicited interested parties to monitor or 
participate in negotiations on an ECA for maleic anhydride. EPA is 
proposing that if an ECA is successfully concluded for maleic 
anhydride, then the subsequent publication of the TSCA section 4 
testing consent order (Order) in the Federal Register would add maleic 
anhydride 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 maleic anhydride, all exporters of maleic 
anhydride, 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 May 26, 1998.
ADDRESSES: Each comment must bear the docket control number, OPPTS-
42199A. 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. E-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 Maleic 
Anhydride

    Maleic anhydride 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 PK testing for the chemicals included in 
the proposed HAPs test rule. These proposals could provide the

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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 maleic anhydride was submitted by the CMA MA Panel 
to EPA on November 8, 1996. The Agency reviewed this alternative 
testing proposal and prepared a preliminary technical analysis of the 
proposal which it sent to the CMA MA Panel on July 10, 1997. The CMA MA 
Panel responded on September 3, 1997, that it has a continued interest 
in pursuing the ECA process for maleic anhydride. EPA has decided to 
proceed with the ECA process for maleic anhydride. EPA has published a 
document soliciting interested parties to monitor or participate in 
negotiations on an ECA for PK testing of maleic anhydride (63 FR 1464, 
January 9, 1998) (FRL-5765-1). The procedures for ECA negotiations are 
described at 40 CFR 790.22(b).
    If the ECA for maleic anhydride 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 
maleic anhydride, the publication of the Order in the Federal Register 
would add maleic anhydride 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 maleic anhydride, 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, maleic anhydride).
    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 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-
42199A. The official record for this document also includes all 
material and submissions filed under docket control number OPPTS-
42187A, the record for the proposed HAPs test rule, as amended, and all 
materials and submissions filed under docket control number OPPTS-
42187B, 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-42199A. 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 
three 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 maleic 
anhydride would be unlikely to have a significant economic impact on 
small

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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 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 maleic anhydride 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  
----------------------------------------------------------------------------------------------------------------
                                                                                                                
 *              *                  *                  *                  *                  *                  *
      108-31-6                         Maleic anhydride.......  Health effects.........  [date of final rule]   
                                                                                                                
 *              *                  *                  *                  *                  *                  *
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[FR Doc. 98-8071 Filed 3-26-98; 8:45 am]
BILLING CODE 6560-50-F