[Federal Register Volume 62, Number 156 (Wednesday, August 13, 1997)]
[Proposed Rules]
[Pages 43297-43301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21412]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS-50627; FRL-5720-2]
RIN 2070-AB27
Significant New Uses of Certain Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing significant new use rules (SNURs) under
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for four
chemical substances which are the subject of premanufacture notices
(PMNs) P-95-1584, P-96-1674/1675, and P-97-267. This proposal would
require certain persons who intend to manufacture, import, or process
these substances 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 September 12, 1997.
ADDRESSES: Each comment must bear the docket control number OPPTS-50627
and the name(s) of the chemical substance(s) subject to the comment.
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
instructions under Unit IX of this document. 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 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.
FOR FURTHER INFORMATION CONTACT: Susan Hazen, Director, Environmental
Assistance Division (7408), Office of Toxic Substances, Environmental
Protection Agency, Rm. E-543B, 401 M St., SW., Washington, DC 20460,
telephone: (202) 554-1404, TDD: (202) 554-0551; e-mail: TSCA-
Hotline@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: This proposed SNUR would require persons to
notify EPA at least 90 days before commencing the manufacture, import,
or processing of P-95-1584, P-96-1674/1675, and P-97-267 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
[[Page 43298]]
``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 substance for that use. The mechanism for
reporting under this requirement is established under 40 CFR 721.10.
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. Provisions relating to user fees appear at 40 CFR
part 700. Persons subject to this SNUR must comply with the same notice
requirements and EPA regulatory procedures as submitters 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), (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 on which it has received the SNUR
notice. 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 SNUR requirements. The EPA policy in support of the
import certification appears at 40 CFR part 707.
III. Substances Subject to This Rule
EPA is proposing 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 each substance,
including its PMN number, chemical name (generic name if the specific
name is claimed as CBI), CAS number (if assigned), basis for the action
taken by EPA for the substance (including the statutory citation and
specific finding), toxicity concern, recommended testing, and the CFR
citation assigned in the regulatory text section of this rule. The
specific uses which are designated as significant new uses are cited in
the regulatory text section of this document by reference to 40 CFR
part 721, subpart E where the significant new uses are described in
detail. Certain new uses are claimed as CBI. The procedure for
obtaining confidential information is set out in Unit VI of this
preamble.
Data on potential exposures or releases of the substances, testing
other than that specified in the section 5(e) order for the substances,
or studies on analogous substances, which may demonstrate that the
significant new uses being reported do not present an unreasonable
risk, may be included with significant new use notification. Persons
submitting a SNUN must comply with the same notice requirements and EPA
regulatory procedures as submitters of PMNs, as stated in 40 CFR
721.1(c), including submission of test data on health and environmental
effects as described in 40 CFR 720.50.
PMN Number P-95-1584
Chemical name: Organosolv lignin.
CAS number: 8068-03-9.
Basis for action: The PMN substance will have the following uses: (1)
As a phenolic resin substitute for wood adhesives, rubber trackifer and
brake pads; (2) an additive to enhance degradability of polymer blends;
and (3) as a moisture barrier for paper lamination. Based on structural
activity relationships derived from test data on structurally similar
phenols and aldehydes, EPA expects toxicity to aquatic organisms to
occur at a concentration of 10 parts per billion (ppb) PMN substance in
surface waters. Use of the PMN substance could result in releases that
significantly exceeded the concern level. However if the PMN substance
is manufactured, processed or used with a number average molecular
weight greater than or equal to 1000 daltons (an oligomer content less
than 10 percent below molecular weight 500 and less than 25 percent
below molecular weight 1000), EPA does not have environmental concerns
for aquatic toxicity. EPA determined that uses of the substance as
described in the PMN did not present an unreasonable risk to the
environment because the submitter would manufacture, process, and use
the PMN substance with a number average molecular weight greater than
or equal to 1000 daltons (an oligomer content less than 10 percent
below molecular weight 500 and less than 25 percent below molecular
weight 1000). EPA has determined that uses of the substance in any
other molecular weight form may result in toxicity to the aquatic
environment. Based on this information the PMN substance meets the
concern criteria at Sec. 721.170(b)(3)(iii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400), a daphnid acute toxicity study (40 CFR
797.1300), an algal acute toxicity study (40 CFR 797.1050), a ready
biodegradability study (OPPTS 835.3110 test guideline (public draft))
and an anaerobic biodegradation study (OPPTS 835.3400 test guideline
(public draft)) would help characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.5460.
PMN Numbers P-96-1674/1675
Chemical name: Alkyl amino nitriles.
CAS number: Not available.
Basis for action: The PMN substances will be used as intermediates.
Based on submitted test data and test data for analogous substances,
EPA is concerned that workers exposed via the ocular route may be at
risk of death. There is also concern for acute oral and dermal
toxicity. EPA determined that use of the substances as described in the
PMN did not present an unreasonable risk because workers would not be
subject to significant exposures. EPA has determined that use other
than as an intermediate, in non-industrial uses, and use of the
substances without appropriate protective equipment and adequate hazard
communication may result in significant exposure to workers. Based on
this information the PMN substances meet the concern critera at
Sec. 721.170(b)(3)(i) and (b)(3)(ii).
Recommended testing: EPA has determined that an acute dermal toxicity
study in rabbits (OPPTS 870.1200 test guideline (public draft)) would
help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.555.
PMN Number P-97-267
Chemical name: (generic) Substituted carbazate.
CAS number: Not available.
Basis for action: The PMN substance will be used in an enclosed
process. Based on analogy to hydrazines there are concerns for liver
toxicity, developmental toxicity, oncogenicity, and mutagenicity. Based
on submitted toxicity data there are concerns for lethality via the
oral, dermal, inhalation,
[[Page 43299]]
and eye routes and for neurotoxicity. EPA determined that use of the
substance as described in the PMN did not present an unreasonable risk
because workers would not be subject to significant exposures. EPA has
determined that uses of the substance in a non-enclosed process,
without appropriate hazard communication, and other than for the
specific use designated in the PMN may result in significant exposures
to workers. Based on this information the PMN substance meets the
concern criteria at Sec. 721.170 (b)(1)(i)(c), (b)(3)(i), and
(b)(3)(ii).
Recommended testing: None.
CFR citation: 40 CFR 721.2077.
IV. Objectives and Rationale of the Rule
During review of the PMNs submitted for the chemical substances
that are subject to this SNUR, EPA determined that one or more of the
criteria of concern established at 40 CFR 721.170 were met. EPA is
proposing this SNUR for specific chemical substances which have
undergone premanufacture review to ensure that:
(1) EPA will receive notice of any company's intent to manufacture,
import, or process a listed chemical substance for a significant new
use before that activity begins.
(2) EPA will have an opportunity to review and evaluate data
submitted in a SNUR notice before the notice submitter begins
manufacturing, importing, or processing a listed chemical substance for
a significant new use.
(3) When necessary to prevent unreasonable risks EPA will be able
to regulate prospective manufacturers, importers, or processors of a
listed chemical substance before a significant new use of that
substance occurs. Issuance of a SNUR for a chemical substance does not
signify that the substance is listed on the TSCA Inventory.
Manufacturers, importers, and processors are responsible for ensuring
that a new chemical substance subject to a final SNUR is listed on the
TSCA Inventory.
V. Test Data and Other Information
EPA recognizes that section 5 of TSCA does not require developing
any particular test data before submission of a SNUN. Persons are
required only to submit test data in their possession or control and to
describe any other data known to or reasonably ascertainable by them.
Unit III of this preamble lists recommended tests (if any) that would
address the potential risks of the substances.
The recommended studies may not be the only means of addressing the
potential risks of the substance. However, SNUNs submitted for
significant new uses without any test data may increase the likelihood
that EPA will take action under section 5(e), particularly if
satisfactory test results have not been obtained from a prior
submitter. EPA recommends that potential SNUN submitters contact EPA
early enough so that they will be able to conduct the appropriate
tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on:
(1) Human exposure and environmental release that may result from
the significant new use of the chemical substances.
(2) Potential benefits of the substances.
(3) Information on risks posed by the substances compared to risks
posed by potential substitutes.
VI. Procedural Determinations
EPA is establishing through this rule some significant new uses
which have been claimed as CBI. EPA is required to keep this
information confidential to protect the CBI of the original PMN
submitter. EPA promulgated a procedure to deal with the situation where
a specific significant new use is CBI. This procedure appears in 40 CFR
721.1725(b)(1) and is similar to that in Sec. 721.11 for situations
where the chemical identity of the substance subject to a SNUR is CBI.
This procedure is cross-referenced in each of these SNURs.
A manufacturer or importer may request EPA to determine whether a
proposed use would be a significant new use under this rule. Under the
procedure incorporated from Sec. 721.1725(b)(1), a manufacturer or
importer must show that it has a bona fide intent to manufacture or
import the substance and must identify the specific use for which it
intends to manufacture or import the substance. If EPA concludes that
the person has shown a bona fide intent to manufacture or import the
substance, EPA will tell the person whether the use identified in the
bona fide submission would be a significant new use under the rule.
Since most of the chemical identities of the substances subject to
these SNURs are also CBI, manufacturers and processors can combine the
bona fide submission under the procedure in Sec. 721.1725(b)(1) with
that under Sec. 721.11 into a single step.
VII. Applicability of Rule to Uses Occurring Before Effective Date
of the Final Rule
To establish a significant ``new'' use, EPA must determine that the
use is not ongoing. The chemical substances subject to this rule have
recently undergone premanufacture review. In cases where EPA has not
received a notice of commencement (NOC) and the substance has not been
added to the Inventory, no other person may commence such activities
without first submitting a PMN. For substances for which an NOC has not
been submitted at this time, EPA has concluded that the uses are not
ongoing. However, EPA recognizes in cases when chemical substances
identified in this SNUR are added to the Inventory prior to the
effective date of the rule, the substances may be manufactured,
imported, or processed by other persons for a significant new use as
defined in this rule before the effective date of the rule. However,
all four of the substances contained in this rule have CBI chemical
identities, and since EPA has received a limited number of post-PMN
bona fide submissions, the Agency believes that it is highly unlikely
that any of the significant new uses described in the following
regulatory text are ongoing.
As discussed in the Federal Register of April 24, 1990 (55 FR
17376), 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. Thus,
persons who begin commercial manufacture, import, or processing of the
substances regulated through this SNUR will have to cease any such
activity before the effective date of this 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.
EPA has promulgated provisions to allow persons to comply with this
SNUR before the effective date. If a person were to meet the conditions
of advance compliance under 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 publication 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
[[Page 43300]]
requirements and wait until the notice review period, including all
extensions, expires.
VIII. 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 proposed rule.
EPA's complete economic analysis is available in the public record for
this proposed rule (OPPTS-50627).
IX. Rulemaking Record
The official record for this rulemaking, as well as the public
version, has been established for this rulemaking under docket number
OPPTS-50627 (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 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:
oppt-ncic@epamail.epa.gov
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-50627. Electronic comments on
this proposed rule may be filed online at many Federal Depository
Libraries.
The OPPTS harmonized test guidelines referenced in this document
are available on EPA's World Wide Web site under ``Researchers and
Scientists,'' ``Environmental Test Methods & Guidelines'' (http://
www.epa.gov/epahome/research.htm).
X. Regulatory Assessment Requirements
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).
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.
In addition, pursuant to section 605(b) of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency has determined
that the promulgation of a SNUR does not have a significant adverse
economic impact on a substantial number of small entities. The Agency's
generic certification for promulgation of new SNURs appears on June 2,
1997 (62 FR 29684) (FRL-5597-1), and was provided to the Chief Counsel
for Advocacy of the Small Business Administration.
XI. 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 proposed rule and other required information to
the U.S. Senate, the U.S. House of Representatives, and the Comptroller
General of the General Accounting Office prior to publication of this
proposed 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: August 4, 1997.
Ward Penberthy,
Acting Director, Chemical Control Division, 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 adding new Sec. 721.555 to subpart E to read as follows:
Sec. 721.555 Alkyl amino nitriles.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified as alkyl amino
nitriles (PMNs P-96-1674 and P-96-1675) are 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), (a)(4), (a)(5)(i), (a)(6)(ii),(a)(6)(v), and
(c). A full face shield is required if splashing or spraying occurs.
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (c)(1) and (c)(2)(iv). The MSDS required by this paragraph
shall include the following statement: Ocular exposure may cause death.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (g) and (l).
(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), (b), (c), (d), (h), and (i) 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. By adding new Sec. 721.2077 to subpart E to read as follows:
Sec. 721.2077 Substituted carbazate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
substituted carbazate (PMN P-97-267) 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) Hazard communication program. Requirements as specified in
Sec. 721.72
[[Page 43301]]
(c)(1) and (c)(2)(iv). The MSDS required by this paragraph shall
include the following statements: Overexposure to this material may
cause severe acute toxicity including death. This concern is
particularly true with respect to direct contact to the eyes. Exposure
to the eyes may cause severe acute toxicity including death.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (a), (b), (c), and (j).
(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), (b), (c), (h), and (i) 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.
4. By adding new Sec. 721.5460 to subpart E to read as follows:
Sec. 721.5460 Organosolv lignin.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as an organosolv
lignin (PMN P-95-1584; CAS No. 8068-03-9) is subject to reporting under
this section for the significant new use described in paragraph (a)(2)
of this section.
(2) The significant new use is any manufacture, processing or use
of the substance with a number average molecular weight less than 1000
daltons or greater than or equal to 1000 daltons with an oligomer
content greater than 10 percent below molecular weight 500 and greater
than 25 percent below molecular weight 1000.
(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), (b), (c), and records documenting compliance with the
designated molecular weight requirements 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. 97-21412 Filed 8-12-97; 8:45 am]
BILLING CODE 6560-50-F
