[Federal Register Volume 62, Number 105 (Monday, June 2, 1997)]
[Proposed Rules]
[Pages 29684-29688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14297]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[OPPTS-50626, etc.; FRL-5597-1]


Proposed Modification of Significant New Use Rules For Certain 
Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to modify significant new use rules (SNURs) 
for six substances promulgated under section 5(a)(2) of the Toxic 
Substances Control Act (TSCA) for certain chemical substances based on 
new data. Based on the data the Agency determined that the SNURs should 
be modified.

DATES: Written comments must be received by July 2, 1997.

ADDRESSES: Each comment must bear the appropriate docket control number 
OPPTS-50626, etc. All comments should be sent in triplicate to: OPPT 
Document Control Officer (7407), Office of Pollution Prevention and 
Toxics, Environmental Protection Agency, 401 M Street, SW., Room G-099, 
East Tower, Washington, DC 20460.
    Comments and data may also be submitted electronically by following 
the instructions under Unit III of this preamble. No confidential 
business information (CBI) should be submitted through e-mail.
    All comments which are claimed confidential must be clearly marked 
as such. Three additional sanitized copies

[[Page 29685]]

of any comments containing CBI must also be submitted. Nonconfidential 
versions of comments on this rule will be placed in the rulemaking 
record and will be available for public inspection. Unit IV of this 
preamble contains additional information on submitting comments 
containing CBI.

FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director, 
Environmental Assistance Division (7408), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, Rm. E-543A, 401 
M St., SW., Washington, DC 20460; telephone: (202) 554-1404; TDD: (202) 
554-0551; e-mail: TSCA-H[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register referenced for each 
substance, OPPTS-50577, June 26, 1990 (55 FR 26110); OPPTS-50588, 
November 6, 1990 (55 FR 46774); OPPTS-50592, August 13, 1991 (56 FR 
40212); OPPTS-50601, September 23, 1992 (57 FR 44070); and OPPTS-50622, 
March 1, 1995 (60 FR 11042) (FRL-4868-4); EPA issued a SNUR 
establishing significant new uses for the substances listed in Unit I 
of this preamble. Because of additional data EPA has received for these 
substances, EPA is proposing to modify the SNURs.

I. Proposed Modifications

    EPA is proposing to modify the significant new use and 
recordkeeping requirements for the following chemical substances under 
40 CFR part 721, subpart E. In this unit, EPA provides a brief 
description for the substances, including its premanufacture notice 
(PMN) number, chemical name (generic name if the specific name is 
claimed as CBI), CAS number (if assigned), the proposed modification 
and basis, Federal Register reference, docket number, and the CFR 
citation in the regulatory text section of this proposed rule. Further 
background information for the substances is contained in the 
rulemaking record referenced in Unit III of this preamble.

PMN Number P-89-31

Chemical name: 2-propenoic acid, 7-oxabicyclo[4.1.0]hept-3-ylmethyl 
ester.
CAS number: Not available.
Federal Register publication date and reference: November 6, 1990 (55 
FR 46774).
Docket number: OPPTS-50588.
Basis for modification of SNUR: EPA received a second PMN for this 
substance. Based on analogy to acrylates and epoxides, EPA is concerned 
that toxicity to aquatic organisms may occur at a concentration as low 
as 80 parts per billion (ppb) of the PMN substance in surface waters. 
EPA determined that use of the substance as described in the PMN did 
not present an unreasonable risk because the substance would not be 
released to surface waters in significant quantities. Based on the 
information in the PMN, EPA has determined that other uses of the 
substance may result in releases to surface waters which exceed the 
concern concentration. Therefore, EPA has decided that a modification 
to the SNUR, requiring notification if the substance is released to 
water was necessary to prevent significant changes in environmental 
exposure. Based on this information the PMN substance meets the concern 
criteria at Sec. 721.170(b)(4)(ii).
CFR number: 40 CFR 721.8350.

PMN Number P-91-43

Chemical name: (generic) Fluorene substituted aromatic amine.
CAS number: Not available.
Federal Register publication date and reference: September 23, 1992 (57 
FR 44065). Amended on June 6, 1994 (59 FR 29204).
Docket number: Docket Number: OPPTS-50601.
Basis for modification of SNUR: The original PMN submitter submitted a 
90-day subchronic study on the PMN substance according to the terms of 
the section 5(e) consent order for the substance between EPA and the 
PMN submitter. The test results demonstrated liver effects at 50 and 
500 mg/kg/day dose levels and blood effects at the 500 mg/kg/day dose 
level. No adverse effects were seen at the lowest dose level of 5 mg/
kg/day. Based on the test results, EPA set a No Observed Adverse Effect 
Level (NOAEL) at 5/mg/kg/day. The PMN submitter requested that EPA 
revoke the consent order for the substance based on the 90-day study 
and mutagencity data it had developed and submitted for a similar 
substance, P-88-998. The mutagencity test results were negative in the 
Ames assay, negative in a mitotic recombination assay (S. Cerevisiae), 
weakly mutagenic in a mouse lymphoma assay, negative in a mouse 
micronucleus assay (intraperitoneal route), and was not a chromosome 
mutagen in human peripheral blood lymphocyte cells in culture during a 
human lymphocyte study. EPA chose to modify the order based on 
continued concerns for environmental effects from potential water 
releases and liver effects to unprotected workers. The modification 
eliminates hazard communication requirements for cancer and 
reproductive toxicity, requires less stringent respiratory protection, 
and eliminates triggered toxicity testing. The proposed modification of 
this SNUR is consistent with the modification to the consent order.
CFR number: 40 CFR 721.3764.

PMN Number P-85-1331

Chemical name: Naphthalene, 1,2,3,4-tetrahydro(1-phenylethyl).
CAS number: Not available.
Federal Register publication date and reference: June 26, 1990 (55 FR 
26110).
Docket number: OPPTS-50577.
Basis for modification of SNUR: A significant new use notice (SNUN) was 
submitted for this substance describing limited but measurable releases 
to water of the substance. After review of the SNUN, EPA determined 
that releases to water of less than 1 part per billion (ppb) would 
result in no significant environmental exposures. The Agency has 
determined, therefore, that modifying the SNUR by allowing releases to 
water of less than 1 ppb will not result in significant changes in 
environmental exposure.
CFR number: 40 CFR 721.5225.

PMN Number P-91-598

Chemical name: (generic) Epoxidized copolymer of phenol and substituted 
phenol.
CAS number: Not available.
Federal Register publication date and reference: September 23, 1992 (57 
FR 44071).
Docket number: OPPTS-50601.
Basis for modification of SNUR: A SNUN was submitted for this substance 
detailing its use as a densified tablet formulation of an epoxy molding 
compound. After review of the SNUN, EPA determined that use of the 
substance as a densified tablet formulation of an epoxy molding 
compound would result in no significant dermal or inhalation exposures. 
The Agency has determined, therefore, that modifying the SNUR by 
allowing use as a densified tablet formulation of an epoxy molding 
compound will not result in significant changes in human exposure.
CFR number: 40 CFR 721.7210.

PMN Number P-93-955

Chemical name: (generic) Formaldehyde, polymer with substituted 
phenols, glycidyl ether.
CAS number: Not available.
Federal Register publication date and reference: August 30, 1995 (60 FR 
45084).
Docket number: OPPTS-50622.
Basis for modification of SNUR: A SNUN was submitted for a similar 
substance (40 CFR 721.7210) detailing its use as a densified tablet 
formulation of an epoxy molding compound. The

[[Page 29686]]

SNUN submitter petitioned the Agency to modify the SNUR for this 
substance based on the data in that SNUN. After review of the SNUN and 
the SNUR for this substance, EPA determined that use of the substance 
as a densified tablet formulation of an epoxy molding compound would 
result in no significant dermal or inhalation exposures. The Agency has 
determined, therefore, that modifying the SNUR allowing use as a 
densified tablet formulation of an epoxy molding compound will not 
result in significant changes in human exposure.
CFR number: 40 CFR 721.7046.

PMN Number P-90-226

Chemical name: (generic) Titanate [Ti6013 (2-)] dipotassium.
CAS number: Not available.
Federal Register publication date and reference: August 13, 1991 (56 FR 
40215).
Docket number: OPPTS-50592.
Basis for modification of SNUR: A SNUN was submitted for the substance 
detailing an additional manufacturing process. In addition a 90-day 
subchronic inhalation study was submitted by the PMN submitter under 
the terms of the section 5(e) consent order. The study demonstrated no 
evidence of fibrosis to test animals. After review of the SNUN, EPA 
determined that the substance produced by that manufacturing process 
contained some fibers that are indicated in the development of 
fibrosis, but concluded that such levels would be unlikely to result in 
significant inhalation risk from exposure. After review of the test 
data, EPA determined that use of the substance without requiring hazard 
communication or a production volume trigger as described in the 
consent order and SNUR would result in no significant inhalation 
exposures. The Agency has determined, therefore, that modifying the 
SNUR allowing the manufacturing process described in the SNUN and 
removing the hazard communication and production volume limit 
requirements will not result in significant changes in human exposure.
CFR number: 40 CFR 721.9675.

II. Rationale for Modification of the Rules

    During review of the PMNs submitted for the chemical substances 
that are the subject of these modifications, EPA concluded that 
regulation was warranted based on the fact that activities not 
described in the section 5(e) consent order or the PMN may result in 
significant changes in human or environmental exposure. The basis for 
such findings is in the rulemaking records referenced in Unit III of 
this preamble. Based on these findings, a section 5(e) consent order 
was negotiated with the PMN submitter and/or a SNUR was promulgated.
    In light of the modification to a consent order, the data submitted 
in a PMN, or the data submitted in a SNUN, the Agency has determined 
that modifying these SNURs would not result in significant changes in 
human or environmental exposure. The modification of SNUR provisions 
for these substances designated herein is consistent with the 
provisions of the section 5(e) order or data submitted in the PMN/SNUN.

III. Rulemaking Record

     The official record for this rulemaking, as well as the public 
version, has been established for this rulemaking under docket number 
OPPTS-50626, etc. (including comments and data submitted electronically 
as described below). A public version of this record, including 
printed, paper versions of electronic comments, which does not include 
any information claimed as confidential business information (CBI), is 
available for inspection from 12 noon to 4 p.m., Monday through Friday, 
excluding legal holidays. The official rulemaking record is located in 
the TSCA Nonconfidential Information Center, Rm. NE-B607, 401 M St. 
SW., Washington, DC.
    Electronic comments can be sent directly to EPA at:
    [email protected]

    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 file format or ASCII 
file format. All comments and data in electronic form must be 
identified by the docket number OPPTS-50626, etc. Electronic comments 
on this proposed rule may be filed online at many Federal Depository 
Libraries.

IV. 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 must prepare and submit a public version of the comments 
that EPA can place in the public file.

V. Regulatory Assessment

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 
action is not a ``significant regulatory action'' subject to review by 
the Office of Management and Budget (OMB). In addition, this action 
does not impose any enforceable duty or contain any unfunded mandate as 
described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), 
or require prior consultation with State officials as specified by 
Executive Order 12875 (58 FR 58093, October 28, 1993), or involve 
special considerations of environmental justice related issues as 
required by Executive Order 12898 (59 FR 7629, February 16, 1994).
    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.), the Agency hereby certifies that any 
promulgation of a SNUR, including this rule, will not have a 
significant adverse economic impact on a substantial number of small 
entities. Because this certification is applicable to all SNURs, it 
will also serve as the generic certification for the promulgation of 
any SNUR and EPA will incorporate it by reference in future individual 
SNUR actions. In addition, this certification and rationale presented 
below will be provided to the Chief Counsel for Advocacy of the Small 
Business Administration.
    The certification presented above is based on the following 
rationale. A SNUR applies to any person (including small or large 
entities) who intends to engage in any activity described in the rule 
as a ``significant new use.'' By definition of the word ``new,'' and 
based on all information currently available to EPA, it appears that no 
small or large entities presently engage in such activity. Since a SNUR 
only requires that any person who intends to engage in such activity in 
the future must first notify EPA (by submitting a Significant New Use 
Notice (SNUN)), no economic impact will even occur until someone 
decides to engage in those activities. Although some small entities may 
decide to conduct such activities in the future, EPA cannot presently 
determine how many, if any, there may be. However, EPA's experience to 
date is that, in response to the promulgation of over 530 SNURs, the 
Agency has received fewer than 15 SNUNs. Of those SNUNs submitted, none 
appear to be from small entities. In fact, EPA expects to receive few, 
if any, SNUNs from either large or small entities in response to any 
SNUR. Therefore, EPA believes that, the economic impact of complying 
with a SNUR is not expected to be

[[Page 29687]]

significant or adversely impact a substantial number of small entities.
    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 OMB control number. The information collection 
requirements related to this action have already been approved by OMB 
pursuant to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., 
under OMB control number 2070-0012 (EPA ICR No. 574). This action does 
not impose any burdens requiring additional OMB approval. The public 
reporting burden for this collection of information is estimated to 
average 100 hours per response. The burden estimate includes the time 
needed to review instructions, search existing data sources, gather and 
maintain the data needed, and complete and review the collection of 
information.

VI. Submission to Congress and the General Accounting Office

    Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business 
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted a 
report containing this rule and other required information to the U.S. 
Senate, the U.S. House ofRepresentatives, and the Comptroller General 
of the General Accounting Office prior to publication of this rule in 
today's Federal Register. This is not a major rule as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous materials, 
Recordkeeping and reporting requirements.

    Dated: May 20, 1997.

William H. Sanders, III
Director, Office of Pollution Prevention and Toxics.

    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 revising Sec. 721.3764 to read as follows:


Sec. 721.3764  Fluorene substituted aromatic amine.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
fluorene substituted aromatic amine (PMN P-91-43) 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)(1), (a)(2)(iii), (a)(3), (a)(4), (a)(5)(iii), 
(a)(5)(iv), (a)(5)(v), (a)(5)(vi), (a)(6)(i), (b) (concentration set at 
1.0 percent) and (c). However, these requirements do not apply after 
the PMN substance is adhered onto film or incorporated into prepreg 
form (resin impregnated substrate).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 during manufacture (a), (b), (c), (d), (e) (concentration 
set at 1.0 percent), (f), (g)(1)(iv), (g)(2)(i), (g)(2)(ii), 
(g)(2)(iii), (g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(iii) 
and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(l).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
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. In Sec. 721.5225 by revising paragraph (a)(2)(v) to read as 
follows:


Sec. 721.5225  Naphthalene, 1,2,3,4-tetrahydro(1-phenylethyl) (specific 
name).

    (a) Chemical substance and significant new uses subject to 
reporting. * * *
    (2) * * *
    (v) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where n = 1).
      *      *      *      *      *
    4. In Sec. 721.7046 by revising paragraph (a)(1) to read as 
follows:


Sec. 721.7046  Formaldehyde, polymer with substituted phenols, glycidyl 
ether.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as formaldehyde, 
polymer with substituted phenols, glycidyl ether (PMN P-93-955) 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 is a component of a highly 
densified tablet formulation of an epoxy molding compound.
      *      *      *      *      *
    5. In Sec. 721.7210 by revising paragraph (a)(1) to read as 
follows:


Sec. 721.7210  Epoxidized copolymer of phenol and substituted phenol.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as epoxidized 
copolymer of phenol and substituted phenol (PMN P-91-598) 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 is a component of a highly densified 
tablet formulation of an epoxy molding compound.
      *      *      *      *      *
    6. In Sec. 721.8350 by adding paragraph (a)(2)(iv) to read as 
follows:


Sec. 721.8350  2-Propenoic acid, 7-oxabicyclo[4.1.0]hept-3-ylmethyl 
ester .

    (a) Chemical substance and significant new uses subject to 
reporting. * * *
    (2) * * *
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
      *      *      *      *      *
    7. In Sec. 721.9675 by removing and reserving paragraph (a)(2)(i) 
and revising paragraphs (a)(2)(ii) introductory text, (a)(2)(ii)(A), 
and (b)(1) to read as follows:


Sec. 721.9675  Titanate [Ti6013 (2-)] dipotassium.

    (a) Chemical substance and significant new uses subject to 
reporting. * * *
    (2) * * *
    (i) [Reserved]
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (f) and (l). In addition, a significant new 
use of the substance is importation of the PMN substance if:
    (A) Manufactured by other than the method described in 
premanufacture notice P-90-226 or significant new use notice P-96-1408. 
If manufactured by the method described in significant new use notice 
P-96-1408 then notification requirements for the bulk density 
measurements in paragraph (a)(2)(i)(B) of this section do not apply.
      *      *      *      *      *
    (b) Specific requirements. * * *
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to

[[Page 29688]]

manufacturers, importers, and processors of this substance. In 
addition, records shall be kept identifying the foreign supplier and 
documenting, by lot, for each shipment, the method of manufacture and 
bulk density measurements. Records of bulk density measurements are 
required only when notification requirements are applicable.
      *      *      *      *      *

[FR Doc. 97-14297 Filed 5-30-97; 8:45 am]
BILLING CODE 6560-50-F