[Federal Register Volume 60, Number 96 (Thursday, May 18, 1995)]
[Rules and Regulations]
[Pages 26690-26691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-12142]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS-50611A; FRL-4953-7]
RIN 2070-AB27
1H,3H,5H-oxazolo [3,4-c] oxazole, Dihydro-7a-methyl-; Significant
New Use Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: EPA is promulgating a significant new use rule (SNUR) under
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the
chemical substance described as 1H,3H,5H-oxazolo [3,4-c] oxazole,
dihydro-7a-methyl-, which is the subject of premanufacture notice (PMN)
P-91-1324. This rule will require certain persons who intend to
manufacture, import, or process this substance for a significant new
use to notify EPA at least 90 days before commencing any manufacturing
or processing activities for a use designated by this SNUR as a
significant new use. The required notice would provide EPA with the
opportunity to evaluate the intended use and, if necessary, to prohibit
or limit that activity before it can occur.
DATES: The effective date of this rule is July 17, 1995. This rule
shall be promulgated for purposes of judicial review at 1 p.m. (e.s.t.)
on June 1, 1995.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, Rm. EB-543B,
401 M Street, SW., Washington, DC 20460, telephone: (202) 554-1404,
TDD: (202) 554-0551.
SUPPLEMENTARY INFORMATION:
I. Authority
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including those listed in section 5(a)(2). Once EPA
determines that a use of a chemical substance is a significant new use,
section 5(a)(1)(B) of TSCA requires persons to submit a notice to EPA
at least 90 days before they manufacture, import, or process the
chemical substance for that use. The mechanism for reporting under this
requirement is established under 40 CFR 721.25.
II. Applicability of General Provisions
General provisions for SNURs appear under subpart A of 40 CFR part
721. These provisions describe persons subject to the rule,
recordkeeping requirements, exemptions to reporting requirements, and
applicability of the rule to uses occurring before the effective date
of the final rule. Rules on user fees appear at 40 CFR part 700.
Persons subject to this SNUR would comply with the same notice
requirements and EPA regulatory procedures as submitter of PMNs under
section 5(a)(1)(A) of TSCA. In particular, these requirements include
the information submission requirements of section 5(b) and 5(d)(1),
the exemptions authorized by section 5 (h)(1), (2), (3), and (5), and
the regulations at 40 CFR part 720. Once EPA receives a SNUR, EPA may
take regulatory action under section 5(e), 5(f), 6, or 7 as appropriate
to control the activities for which it has received the SNUR. If EPA
does not take action, EPA is required under section 5(g) to explain in
the Federal Register its reasons for not taking action.
Persons who intend to export a substance identified in a proposed
or final SNUR are subject to the export notification provisions of TSCA
section 12(b). The regulations that interpret section 12(b) appear at
40 CFR part 707. Persons who intend to import a chemical substance
identified in a final SNUR are subject to the TSCA section 13 import
certification requirements, which are codified at 19 CFR 12.118 through
12.127 and 127.28. Such persons must certify that they are in
compliance with the SNUR requirements. The EPA policy in support of the
import certification appears at 40 CFR part 707.
III. Background
EPA published a proposed SNUR for the chemical 1H,3H,5H-oxazolo
[3,4-c] oxazole, dihydro-7a-methyl- in the Federal Register of November
2, 1994 at 59 FR 54874. The background and reasons for the SNUR are set
forth in the preamble to the proposed SNUR. The proposed SNUR
designated exposure to the PMN substance without ocular protection
(chemical goggles or equivalent eye protection) and any predictable or
purposeful release of the PMN substance to surface water above 500
parts per billion (ppb) as significant new uses. The Agency received no
public comment concerning the proposed SNUR. As a result, EPA is
promulgating this final SNUR.
IV. Determination of Proposed Significant New Uses
To determine what would constitute significant new uses of this
chemical substance, EPA considered relevant information about the
toxicity of the substance, likely exposures/releases associated with
possible uses, and the four factors listed in section 5(a)(2) of TSCA.
Section 5(a)(2) of TSCA provides that EPA's determination that a
chemical substance is a significant new use must be made after a
consideration of all relevant factors including:
A. The projected volume of manufacturing and processing of a
chemical substance.
B. The extent to which a use changes the type or form of exposure
of human beings or the environment to a chemical substance.
C. The extent to which a use increases the magnitude and duration
of exposure of human beings or the environment to a chemical substance.
D. The reasonably anticipated manner and methods of manufacturing,
processing, distribution in commerce, and disposal of a chemical
substance.
EPA construes the statute to allow consideration of any other
relevant factors, in addition to those enumerated in section 5(a)(2)(A)
through (D), because it is not an exclusive list.
V. Applicability of SNUR to Uses Occurring Before Effective Date of
the Final SNUR
EPA has decided that the intent of section 5(a)(1)(B) is best
served by designating a use as a significant new use as of the date of
proposal rather than as of the effective date of the final rule. If
uses which commence between the proposal date and the effective date of
the final rule were considered ongoing, rather than new, any person
could defeat the SNUR by initiating a significant new use before the
effective date. This would make it difficult for EPA to establish SNUR
notice requirements. Thus, persons who begin commercial manufacture,
import, or processing of the substance for uses identified in this SNUR
after the date of the proposed rule will have to cease any such
activity before the effective date of this rule. To resume their
activities, such persons would have to comply with all applicable SNUR
notice requirements and wait until the notice review period, including
all extensions, expires. EPA, not wishing to unnecessarily disrupt the
activities of [[Page 26691]] persons who begin commercial manufacture,
import, or processing of a significant new use before the effective
date of the SNUR, has promulgated provisions to allow such persons to
comply with this proposed SNUR before it is promulgated. If a person
were to meet the conditions of advance compliance as codified at
Sec. 721.45(h), the person would be considered to have met the
requirements of the final SNUR for those activities. If persons who
begin commercial manufacture, import, or processing of the substance
between proposal and the effective date of the final SNUR do not meet
the conditions of advance compliance, they must cease that activity
before the effective date of the rule. To resume their activities,
these persons would have to comply with all applicable SNUR notice
requirements and wait until the notice review period, including all
extensions, expires.
VI. Economic Analysis
EPA has evaluated the potential costs of establishing significant
new use notice requirements for potential manufacturers, importers, and
processors of the chemical substance subject to this rule. EPA's
complete economic analysis is available in the public record for this
final rule (OPPTS-50611).
VII. Rulemaking Record
EPA has established a record for this rulemaking (docket control
number OPPTS-50611) which includes information considered by the Agency
in developing this rule. The record includes the following information:
1. The economic analysis of this rule.
2. The environmental test data review support document.
3. Issue Summary Report.
4. The Federal Register notice pertaining to this rule.
A public version of the record, without any Confidential Business
Information, is available in the TSCA Nonconfidential Information
Center (NCIC) from 12 noon to 4 p.m., Monday through Friday, except
legal holidays. The TSCA NCIC is located in Rm. NE-B607, 401 M St.,
SW., Washington, DC.
VIII. Regulatory Assessment Requirements
A. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to all the requirements of the Executive Order
(i.e., Regulatory Impact Analysis, review by the Office of Management
and Budget (OMB)). Under section 3(f), the Executive Order defines a
``significant regulatory action'' as an action likely to lead to a
rule:
(1) Having an annual effect on the economy of $100 million or more,
or adversely and materially affecting a sector of the economy,
productivity, competition, jobs, the environment, public health of
safety, or State, local or tribal governments or communities (also
referred to as ``economically significant'').
(2) Creating serious inconsistency or otherwise interfering with an
action taken or planned by another agency.
(3) Materially altering the budgetary impacts of entitlement,
grants, user fees, or loan programs or the rights and obligations of
recipients thereof.
(4) Raising novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
this Executive Order.
Pursuant to the terms of Executive Order 12866, it has been
determined that this rule is not ``significant'' and is therefore not
subject to OMB review.
B. Regulatory Flexibility Act
Under the Regulatory Flexibility Act (5 U.S.C. 605(b)), EPA has
determined that this rule would not have a significant impact on a
substantial number of small businesses. EPA has determined that
approximately 10 percent of the parties affected by this rule could be
small businesses. However, EPA expects to receive few significant new
use notices for these substances. Therefore, EPA believes that the
number of small businesses affected by this rule will not be
substantial, even if all of the SNUR notice submitters were small
firms.
C. Paperwork Reduction Act
The information collection requirements contained in this rule have
been approved by OMB under the provisions of the Paperwork Reduction
Act (44 U.S.C. 3501 et seq.), and have been assigned OMB control number
2070-0012.
Public reporting burden for this collection of information is
estimated to vary from 30 to 170 hours per response, with an average of
100 hours per response, including time for reviewing instructions,
searching existing data sources, gathering and maintaining the data
needed, and completing and reviewing the collection of information.
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous materials, Reporting
and recordkeeping requirements, Significant new uses.
Dated: May 5, 1995.
Charles M. Auer,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Accordingly, 40 CFR part 721 is amended as set forth below:
PART 721--[AMENDED]
1. The authority citation for part 721 continues to read as
follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
2. By adding new Sec. 721.5540 to subpart E to read as follows:
Sec. 721.5540 1H,3H,5H-oxazolo [3,4-c] oxazole, dihydro-7a-methyl-.
(a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substance identified as 1H,3H,5H-oxazolo
[3,4-c] oxazole, dihydro-7a-methyl- (PMN P-91-1324) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(2)(iii) and (a)(3).
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (where N = 500 ppb).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping requirements. The following recordkeeping
requirements specified in Sec. 721.125 (a), (b), (c), (d), (e), and (k)
are applicable to manufacturers, importers, and processors of this
substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[FR Doc. 95-12142 Filed 5-17-95; 8:45 am]
BILLING CODE 6560-50-F
