[Federal Register Volume 59, Number 170 (Friday, September 2, 1994)]
[Rules and Regulations]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-21692]
[[Page Unknown]]
[Federal Register: September 2, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 799
[OPPTS-42111D; FRL 4047-2]
Office of Water Chemicals, Final Test Rule; Clarification
AGENCY: Environmental Protection Agency (EPA).
ACTION: Clarification of final rule.
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SUMMARY: On November 10, 1993, EPA published a TSCA section 4 final
test rule requiring testing of 1,3,5-trimethylbenzene (TMB) (CAS No.
108-67-8). After EPA published the final rule, certain manufacturers
questioned the scope of the manufacturers, importers, and processors
subject to the test rule. EPA is now clarifying that only
manufacturers, importers, and processors of TMB as an isolated product,
and not persons who manufacture, import, or process the substance as
part of complex mixtures or substances, are subject to the final test
rule requiring certain health effects testing.
EFFECTIVE DATE: September 2, 1994.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxics, Rm. E-543B, 401 M St., SW., Washington, DC
20460, (202) 554-1404, TDD: (202) 544-0551.
SUPPLEMENTARY INFORMATION: On November 10, 1993, EPA issued a final
rule requiring manufacturers and processors of TMB to conduct oral 14-
day repeated dose and oral 90-day subchronic toxicity studies on TMB
(58 FR 59667). In the preamble to the final rule, EPA responded to a
comment from a manufacturer concerned that the proposed testing program
for TMB would cause substantial economic impact for its company that
would likely force it to discontinue sales of this chemical in the
United States. EPA stated in response that the impact will be less than
originally noted in the proposal because the cost of the testing
program required by the final rule is less than the testing program
proposed originally. In addition, EPA noted that it believed that the
commenter would not be the only company required to test because there
are other manufacturers that might be subject to the test rule,
including ``several manufacturers of C9 aromatic hydrocarbons, which
contain 1,3,5-trimethylbenzene.''
Manufacturers of the C9 aromatic hydrocarbons, petroleum refiners,
challenged EPA's final rule arguing that they had received inadequate
notice that they might be subject to the test rule. After reviewing the
record, EPA agrees that there is some question whether these
manufacturers received sufficient notice that they would be subject to
the test rule. As a result, EPA is issuing this Notice to clarify that
only manufacturers, importers, and processors of TMB as an isolated
product, and not persons who manufacture, import, or process the
substance as part of complex mixtures or substances, are subject to the
final test rule requiring certain health effects testing.
This then leaves open the issue of whether the testing requirements
would, if fulfilled, cause the original commenter to suffer a
substantial economic impact. EPA has revisited this issue with the
commenter and has been advised that this issue is no longer of concern
because the company has received voluntary contributions to cover some
of the testing costs (May 3, 1994 letter from Koch Industries to EPA).
EPA believes that public comment on this clarification is
unnecessary because: (1) Nothing in the actual regulation is being
changed and this merely aids in interpretation of the regulation; and
(2) to the extent that confusion has mistakenly led some persons to
believe that they are subject to the regulation, this provides relief
from that perceived requirement.
In summary, for persons who manufacture, import, and process TMB as
an isolated product, the test rule is valid and applicable to them. EPA
is now clarifying that persons, including relevant petroleum refiners,
who do not manufacture, import, or process TMB as an isolated product
are not required to submit test data, letters of intent to test,
applications for exemptions, import certifications, or any other item
that may be required pursuant to a final test rule under TSCA section
4. Additionally, only exporters of TMB as an isolated product or as
part of mixtures known to contain previously isolated TMB are subject
to the TSCA section 12(b) export notification requirements (40 CFR part
707).
A public docket has been established for this clarification (OPPTS-
42111D). This docket consists of support material for the
clarification.
List of Subjects in 40 CFR Part 799
Environmental protection, Chemicals, Hazardous substances,
Laboratories, Reporting and recordkeeping requirements, Testing.
Dated: August 24, 1994.
Susan H. Wayland,
Acting Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 94-21692 Filed 9-1-94; 8:45 am]
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