[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