[Federal Register Volume 59, Number 107 (Monday, June 6, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-13681]
[[Page Unknown]]
[Federal Register: June 6, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS-50612B; FRL-4750-4]
RIN 2070-AB27
Aromatic Amino Ether; Proposed Significant New Use Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing a significant new use rule (SNUR) under
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the
chemical substance described generically as an aromatic amino ether
which is the subject of premanufacture notice (PMN) P-90-1840 and which
is subject to a TSCA section 5(e) consent order issued by EPA. This
proposal would 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, importing, 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: Written comments must be received by EPA by July 6, 1994.
ADDRESSES: Each comment must bear the docket control number OPPTS-
50612B. All comments should be sent in triplicate to: TSCA Document
Receipt Office (7407), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, Rm. E-201, 401 M St., SW., Washington,
DC 20460. All comments which are claimed confidential must be clearly
marked as such. Three additional sanitized copies of any comments
containing confidential business information (CBI) must also be
submitted. Nonconfidential versions of comments on this proposed rule
will be placed in the rulemaking record and will be available for
public inspection.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, Rm. E-543B, 401
M St., SW., Washington, DC 20460, Telephone: (202) 554-1404, TDD: (202)
554-0551.
SUPPLEMENTARY INFORMATION: This proposed SNUR would require persons to
notify EPA at least 90 days before commencing the manufacture, import,
or processing of P-90-1840 for the significant new uses designated
herein. The required notice would provide EPA with information with
which to evaluate an intended use and associated activities.
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. Section 26(c) of TSCA authorizes EPA
to take action under section 5(a)(2) with respect to a category of
chemical substances.
Persons subject to this SNUR would comply with the same notice
requirements and EPA regulatory procedures as submitters of
premanufacture notices under section 5(a)(1) of TSCA. In particular,
these requirements include the information submission requirements of
section 5(b) and (d)(1), the exemptions authorized by section 5(h)(1),
(h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720.
Once EPA receives a SNUR notice, EPA may take regulatory action under
section 5(e), 5(f), 6, or 7 to control the activities for which it has
received a SNUR notice. If EPA does not take action, section 5(g) of
TSCA requires EPA 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.
II. Applicability of General Provisions
General regulatory provisions applicable to SNURs are codified at
40 CFR part 721, subpart A. On July 27, 1988 (53 FR 28354), and July
27, 1989 (54 FR 31298), EPA promulgated amendments to the general
provisions which apply to this SNUR. In the Federal Register of August
17, 1988 (53 FR 31252), EPA promulgated a ``User Fee Rule'' (40 CFR
part 700) under the authority of TSCA section 26(b). Provisions
requiring persons submitting significant new use notices to submit
certain fees to EPA are discussed in detail in that Federal Register
document. Interested persons should refer to these documents for
further information.
III. Background
EPA published a direct final SNUR for the chemical substance, which
was the subject of PMN P-90-1840 and a TSCA section 5(e) consent order
issued by EPA, in the Federal Register of October 4, 1993 (58 FR
51672). EPA received adverse comments following publication for this
chemical substance. Therefore, as required by Sec. 721.160, the final
SNUR for P-90-1840 is being withdrawn elsewhere in this issue of the
Federal Register and this proposed rule on the substance is being
issued.
EPA is not soliciting and will not respond to comments on any of
the other SNURs that were published in the October 4, 1993, Federal
Register because those rules became final effective rules on December
3, 1993, or are being withdrawn and proposed in a separate action. The
supporting rationale and background to this proposal are more fully set
out in the preamble to the direct final SNUR for this substance and in
the preamble to EPA's first direct final SNURs published in the Federal
Register of April 24, 1990 (55 FR 17376). Consult that preamble for
further information on the objectives, rationale, and procedures for
the proposal and on the basis for significant new use designations
including provisions for developing test data.
IV. Substance Subject to This Rule
EPA is proposing significant new use and recordkeeping requirements
for the following chemical substance under 40 CFR part 721.
PMN Number P-90-1840
Chemical name: (generic) Aromatic amino ether.
CAS number: Not available.
Effective date of section 5(e) consent order: November 5, 1992.
Basis for section 5(e) consent order: The order was issued under
section 5(e)(1)(A)(i) and (ii)(I) of TSCA based on a finding that this
substance may present an unreasonable risk of injury to health and the
environment.
Toxicity concern: The PMN substance and similar chemicals have been
shown to cause mutagenicity, carcinogenicity, neurotoxicity
(retinopathy), hepatotoxicity, reproductive effects, and aquatic
toxicity at concentrations as low as 1 ppb (part per billion) in test
animals.
Recommended testing: A 90-day subchronic rodent study (oral or
inhalation route) with special attention given to hepatotoxicity,
histopathological exam of the male and female reproductive organs, and
retinopathy is needed to help characterize the neurotoxic, hepatotoxic,
and reproductive effects of the PMN substance. The 90-day study must
also include for each treatment group a satellite group of exposed
animals to be retained for an additional 90-day recovery period to
evaluate the possible reversibility of retinopathy. Light and electron
microscopy should be utilized to examine the ocular tissue (40 CFR
798.2650, modified). A 2-year two-species bioassay (40 CFR 798.3300) is
also necessary to characterize the carcinogenic potential of the PMN
substance. The consent order contains two production volume limits. The
PMN submitter has agreed not to exceed the first production limit
without performing the 90-day subchronic study. The PMN submitter has
also agreed not to exceed the second, higher production volume limit
without performing the 2-year, two-species bioassay. In addition, an
early life stage toxicity study (40 CFR 797.1600), a Daphnia chronic
toxicity study (40 CFR 797.1330), an algal acute toxicity study (40 CFR
797.1050), and a coupled units test (40 CFR 796.3300) would
characterize the potential aquatic toxicity effects.
CFR citation: 40 CFR 721.3390.
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 rule. Because this
SNUR was first published on October 4, 1993, as a direct final rule,
that date will serve as the date after which uses will be considered to
be new uses. If uses which had commenced between that date and the
effective date of this rulemaking 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 regulated
through this SNUR after October 4, 1993, will have to cease any such
activity before the effective date of the 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 persons who begin commercial manufacture, import, or
processing for a proposed 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 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 at the time of the direct final
rule. The analysis is unchanged for the substance in this proposed
rule. The Agency's complete economic analysis is available in the
public record for this proposed rule (OPPTS-50612B).
VII. Comments Containing Confidential Business Information
Any person who submits comments claimed as CBI must mark the
comments as ``confidential,'' ``trade secret,'' or other appropriate
designation. Comments not claimed as confidential at the time of
submission will be placed in the public file. Any comments marked as
confidential will be treated in accordance with the procedures in 40
CFR part 2. Any party submitting comments claimed to be confidential
must prepare and submit a nonconfidential public version in triplicate
of the comments that EPA can place in the public file.
VIII. Rulemaking Record
EPA has established a record for this rulemaking (docket control
number OPPTS-50612B). The record includes basic information considered
by the Agency in developing this proposed rule. EPA will supplement the
record with additional information as it is received.
EPA will accept additional materials for inclusion in the record at
any time between this proposal and designation of the complete record.
EPA will identify the complete rulemaking record by the date of
promulgation.
A public version of the record, without any CBI, is available in
the TSCA Nonconfidential Information Center (NCIC), also known as, TSCA
Public Docket Office, from 12 noon to 4 p.m., Monday through Friday,
except legal holidays. NCIC is located in Rm. E-G102, 401 M St., SW.,
Washington, DC 20460.
IX. 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 order defines
``significant'' as those actions 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 or 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 (4) raising novel legal or
policy issues arising out of legal mandates, the President's
prioritities, or the principles set forth in this Executive Order.
Pursuant to the terms of this Executive Order, EPA has determined that
this proposed 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 proposed rule would not have a significant impact
on a substantial number of small businesses. EPA has not determined
whether parties affected by this proposed rule would likely be small
businesses. However, EPA expects to receive few SNUR notices for the
substance. Therefore, EPA believes that the number of small businesses
affected by the rule would not be substantial, even if all of the SNUR
notice submitters were small firms.
C. Paperwork Reduction Act
OMB has approved the information collection requirements contained
in this proposed rule under the provisions of the Paperwork Reduction
Act (44 U.S.C. 3501 et seq.), and has 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.
Send comments regarding the burden estimate or any other aspect of
this collection of information, including suggestions for reducing this
burden, to Chief, Information Policy Branch (2131), U.S. Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460; and to Office
of Information and Regulatory Affairs, Office of Management and Budget,
Washington, DC 20503, marked ``Attention: Desk Officer for EPA.'' The
final rule will respond to any OMB or public comments on the
information requirements contained in this proposed rule.
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous materials,
Recordkeeping and reporting requirements, Significant new uses.
Dated: May 24, 1994.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
Therefore, it is proposed that 40 CFR part 721 be amended as
follows:
PART 721--[AMENDED]
1. The authority citation for part 721 would continue to read as
follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
2. By adding new Sec. 721.1640 to subpart E to read as follows:
Sec. 721.1640 Aromatic amino ether.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic amino ether (PMN P-90-1840) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section. The requirements of this section do not apply once the
substance has been incorporated into a final product with residual
monomer 50 ppm (parts per million) by weight.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(2)(iii), (a)(3), (a)(4),
(a)(5)(i), (a)(6)(i), (b)(concentration set at 0.1 percent), and (c).
The demonstration of an impervious barrier for gloves required under
paragraph (a)(3) of this section will require testing of the gloves as
follows. There must be no permeation of the PMN substance greater than
2 ppm after 8 h of testing in accordance with the American Society for
Testing and Materials (ASTM) F739 ``Standard Test Method for Resistance
of Protective Clothing Materials to Permeation By Liquids and Gases''
and ASTM F1194 ``Guide for Documenting the Results of Chemical
Permeation Testing of Protective Clothing Materials.'' The employer
must submit all test data to the Agency and must receive the Agency's
written approval of the test results for each type of glove tested
prior to use of such gloves. Gloves may not be used for a time period
longer than they are actually tested and must be replaced at the end of
the work shift. As an alternative to the respiratory requirements in
this section, manufacturers, importers, and processors may use the new
chemical exposure limits provisions, including sampling and analytical
methods which have previously been approved by EPA for this substance,
found in the 5(e) consent order for this substance.
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72(a), (b), (c), (d), (e) (concentration set at 0.1 percent),
(f), (g)(1)(vi), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii),
(g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4), and (g)(5). The
following additional statements shall appear on each label and MSDS as
required by this paragraph: This substance may cause liver damage. This
substance may cause retinopathy.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(l) and (q).
(iv) Release to water. Requirements as specified in
Sec. 721.90(a)(4), (b)(4), and (c)(4) (where N = 1 ppb). When
calculating the surface water concentrations according to the
instructions in Sec. 721.91(a)(4), the statement that the amount of the
substance that will be released will be calculated before the substance
enters control technology does not apply. Instead, if the waste stream
containing the PMN substance will be treated before release, the amount
of the PMN substance reasonably likely to be removed from the waste
stream by treatment may be subtracted in calculating the number of
kilograms released. No more than 45 percent removal efficiency may be
attributed to such treatment.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping requirements. Recordkeeping requirements as
specified under Sec. 721.125(a) through (i) 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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
[FR Doc. 94-13681 Filed 6-3-94; 8:45 am]
BILLING CODE 6560-50-F