[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]


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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.

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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-
H[email protected].

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:
    [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-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