[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:
oppt.ncic@epamail.epa.gov 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-
Hotline@epamail.epa.gov.
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: leukroth.rich@epamail.epa.gov.
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:
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 5.1/6.1 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
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108-31-6 Maleic anhydride....... Health effects......... [date of final rule]
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[[Page 14869]]
[FR Doc. 98-8071 Filed 3-26-98; 8:45 am]
BILLING CODE 6560-50-F
