[Federal Register Volume 63, Number 229 (Monday, November 30, 1998)]
[Rules and Regulations]
[Pages 65705-65710]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31680]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS-50627A; FRL-6033-6]
RIN 2070-AB27
Significant New Uses of Certain Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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[[Page 65706]]
SUMMARY: EPA is issuing significant new use rules (SNURs) under section
5(a)(2) of the Toxic Substances Control Act (TSCA) for four chemical
substances which were the subject of premanufacture notices (PMNs).
Today's action requires persons who intend to manufacture, import, or
process these substances for a significant new use to notify EPA at
least 90 days before commencing the manufacturing or processing of the
substance for a use designated by this SNUR as a significant new use.
The required notice will provide EPA with the opportunity to evaluate
the intended use, and if necessary, to prohibit or limit that activity
before it occurs.
DATES: This rule is effective December 30, 1998.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, Rm. E-531, 401
M St., SW., Washington, DC 20460, Telephone: (202) 554-1404, TDD: (202)
554-0551; e-mail: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
Electronic Availability: Electronic copies of this document are
available from the EPA Home Page at the Federal Register-Environmental
Documents entry for this document under ``Laws and Regulations''
(http://www.epa.gov/fedrgstr/).
This SNUR will require persons to notify EPA at least 90 days
before commencing manufacturing or processing of a substance for any
activity designated by this SNUR as a significant new use. The
supporting rationale and background to this rule are more fully set out
in the preamble to EPA's first direct final SNUR 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 rules and on the basis for significant new use designations
including provisions for developing test data.
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
substance for that use. The mechanism for reporting under this
requirement is established under Sec. 721.10.
II. Applicability of General Provisions
General provisions for SNURs appear under 40 CFR part 721, subpart
A. 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 TSCA section 5(b) and
5(d)(1), the exemptions authorized by section 5 (h)(1), (2), (3), and
(5) of TSCA, 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 of TSCA to control the activities on which it has
received the SNUR notice. If EPA does not take action, EPA is required
under TSCA 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 TSCA 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. Background
EPA proposed SNURs for four chemical substances, which were the
subject of PMNs P-95-1584, P-96-1674/1675, and P-97-267 in the Federal
Register of August 13, 1997 (62 FR 43297) (FRL-5720-2). The background
and reasons for the SNURs are set forth in the preamble to the proposed
rule. EPA received no comments regarding P-96-1674/1675 and will issue
the rules as proposed. EPA received comments concerning P-97-267 and P-
95-1584. EPA's response to the comments is discussed in this unit. EPA
is issuing P-97-267 as proposed and is issuing P-95-1584 as a modified
final rule.
The submitter of P-97-267 was the only commenter for the proposed
SNUR. While the commenter did not object to the specific language
required in the material safety data sheet (MSDS) in the proposed SNUR,
the commenter did object to EPA's requiring any language in an MSDS
under TSCA such as those requirements for SNURs at Sec. 721.72. The
commenter's position is that development and preparation of MSDS's fall
under the criteria set forth under the Occupational Safety and Health
Administration's (OSHA) Hazard Communication Standard, 29 CFR part
1910.1200. The commenter stated that requiring specific language on an
MSDS under TSCA would interfere with the ongoing process of developing
the MSDS under OSHA's Hazard Communication Standard as new
toxicological information is developed.
EPA strongly disagrees with this position for several reasons. The
hazard communication requirements at Sec. 721.72 were designed to
parallel OSHA's hazard communication standard as closely as possible.
For further background consult the preamble to EPA's General Provisions
for New Chemical Follow-Up, published July 27, 1989 (54 FR 31298). The
language dictated by this SNUR does not affect the ongoing process of
modifying or updating an MSDS with other statements as new information
is received.
In the unlikely event that the commenter develops new toxicological
data contradicting the acute toxicity studies already conducted on the
substance demonstrating potential lethality via the oral, dermal,
inhalation, and ocular routes of exposure, the submitter may submit a
significant new use notice or can petition for modification of the SNUR
based on the new toxicity data.
In order to prevent potential unreasonable risks or significant
changes in exposure under TSCA, EPA will require specific hazard
communication warnings in TSCA 5(e) consent orders and SNURs. EPA
thinks it is especially important in this case to warn workers of the
potentially lethal hazard. It is EPA's position that any delay in
updating the specific MSDS language mandated by the SNUR is far
outweighed by the potential change in exposure by not adequately
warning potentially exposed workers of the lethality of this compound.
The submitter of P-95-1584 was the only commenter for the proposed
SNUR. The commenter objected to the molecular weight designation in the
proposed SNUR, stating that commencement of manufacture or
[[Page 65707]]
import of the PMN substance with a number average molecular weight in
the range from 707-1051 daltons as described in the PMN had already
occurred. As this is an existing use, EPA concurs that it is unable to
finalize the SNUR as proposed. However, in order to prevent potential
exposures to low molecular weight forms of this PMN substance, EPA is
issuing a final SNUR requiring 90-day notification before any
manufacture, processing, or use of the substance with a number average
molecular weight less than 700 daltons.
The commenter stated that EPA's concerns for the PMN substance
arose solely from the low molecular weight species (LMWS) and EPA had
no objection to importation of the high molecular weight species
(HMWS).
EPA disagrees with this statement. Based on the existing toxicity
and exposure data, EPA was unable to make an unreasonable risk finding
for the HMWS of the PMN substance. While it is true that the potential
toxicity of the HMWS decreases as the molecular weight increases, EPA
would have preferred significant new use notification at the molecular
weight stated in the proposed SNUR to ensure that no significant new
exposures occurred. The HMWS can have a number average molecular weight
as low as 700 daltons. As the molecular weight approaches 700 daltons
the potential toxicity of the PMN substance becomes more like that of
the LMWS.
The commenter stated that the specific uses referenced in the
proposed SNUR, a phenolic resin substitute for wood adhesives, rubber
tackifier, and brake pads; an additive to enhance degradibility of
polymer blends; and a moisture barrier for paper lamination were
projected uses for the HMWS of the PMN substance and should not be
considered when estimating potential exposures to the LMWS. The
commenter also noted that after substantially lowering its estimated
production volume of the HMWS of the PMN substance and eliminating
completely its production volume estimate of the LMWS, EPA's risk
assessment remained the same and stated that any exposure estimates
should be based on the revised production volume limit of the HMWS. The
commenter also stated that information based on existing uses of the
HMWS of the PMN substance cannot be used as a basis for a SNUR applying
to the LMWS of the PMN substance.
Before addressing each comment specifically, EPA is reiterating the
following considerations it made when deciding to issue a SNUR for the
PMN substance:
1. As a polymeric substance that is already on the TSCA Inventory,
the PMN substance may be manufactured or imported at any molecular
weight or range of molecular weights without further notification even
when the different molecular weight species can and do exhibit
different physical and toxicological properties.
2. The stated purpose of the SNUR was to require 90-day
notification before any release of the LMWS of the PMN substance to the
environment.
3. When considering the potential change in exposures and
production volumes for a SNUR, EPA must consider all potential
manufacturers, importers, and processors and not just the PMN
submitter.
The commenter questioned the applicability of the specific uses
cited in the proposed SNUR to the LMWS of the PMN substance. It is
EPA's finding that any use of the LMWS warrants notification in order
to evaluate potential releases. The original PMN submitted for the LMWS
and the uses of the HMWS are merely evidence that usage of the LMWS is
possible.
The commenter also questioned why, when the estimated production
volume was reduced, that the risk assessment remained the same. EPA did
not change its risk assessment because its analysis of the potential
market for the PMN substance did not agree with the submitter's revised
estimate. In addition, when notifying the Agency of its reduced
estimated production volume, the commenter also informed EPA of the
estimated production volume of its potential customers who would import
the PMN substance directly. The estimated production volume of the PMN
substance imported directly by customers was high enough that EPA's
original risk assessment was not changed.
The commenter stated that information, such as use and production
volume information, specific to a chemical substance for an existing
use cannot be used as a basis for a SNUR for another substance. EPA
strongly disagrees with this statement. While it is true that a
significant new use cannot be designated when the use is ongoing, EPA
can and does use information regarding existing use of similar
chemicals as a basis for a SNUR for other chemicals. When evaluating
new chemical substances under section 5(a)2 or 5(e) of TSCA, reasonable
estimates of production volume, use, and exposure can only be based on
past experience with other chemicals and their existing uses.
This paragraph summarizes and reiterates EPA's findings for P-95-
1584. Based on a structure-activity relationship analogy to similar
phenols and aldehydes, EPA is concerned for environmental toxicity
effects at concentrations as low as 10 parts per billion (ppb) in
surface waters, especially the LMWS of the PMN substance. Because the
substance is a polymer, once it is placed on the TSCA Inventory, any
manufacturer, importer, or processor may use the PMN substance of any
molecular weight. This is true even if different molecular weights have
different physical and toxicological properties. Based on the potential
uses and production volume of the PMN substance, EPA finds that
exposures may result in toxicity to the aquatic environment. To prevent
any significant change in exposures, EPA is designating any
manufacture, import, or processing of the PMN substance at a number
average molecular weight less than 700 daltons as a significant new
use. This designation of molecular weight is different from the
proposed rule because existing use of the PMN substance occurred at a
number average molecular weight no lower than 707 daltons.
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 Sec. 721.170 were met. EPA is
issuing 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.
[[Page 65708]]
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.
The preamble to the proposed SNUR 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 TSCA 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 Confidential Business Information (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 Sec. 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) of TSCA
is best served by designating a use as a significant new use as of the
date of publication 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 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 rule. EPA's
complete economic analysis is available in the public record for this
rule (OPPTS-50627A).
IX. Public Record
The official record for this rulemaking, as well as the public
version, has been established for this rulemaking under docket control
number OPPTS-50627A (including comments and data submitted
electronically). 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.
X. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
Under Executive Order 12866, entitled Regulatory Planning and
Review (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), nor does it
involve special considerations of environmental justice related issues
as required by Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), or additional OMB review
in accordance with Executive Order 13045, entitled Protection of
[[Page 65709]]
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This regulatory action does not involve any technical
standards that would require Agency consideration of voluntary
consensus standards pursuant to section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (NTTAA), Pub. L. 104-
113, section 12(d) (15 U.S.C. 272 note).
According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., an agency may not conduct or sponsor, and a person is not
required to respond to a collection of information that requires OMB
approval under the PRA, unless it has been approved by OMB and displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations, after initial display in the preamble of the final rules,
are listed in 40 CFR part 9. The information collection requirements
related to this action have already been approved by OMB pursuant to
the PRA under OMB control number 2070-0012 (EPA ICR No. 574). This
action does not impose any burden requiring additional OMB approval.
If an entity were to submit a significant new use notice to the
Agency, the annual burden is estimated to average between 30 and 170
hours per response. This burden estimate includes the time needed to
review instructions, search existing data sources, gather and maintain
the data needed, and complete, review and submit the required
significant new use notice.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
OPPE Regulatory Information Division, U.S. Environmental Protection
Agency (Mail Code 2137), 401 M St., SW., Washington, DC 20460, with a
copy to the Office of Information and Regulatory Affairs, Office of
Management and Budget, 725 17th St., NW., Washington, DC 20503, marked
``Attention: Desk Officer for EPA.'' Please remember to include the OMB
control number in any correspondence, but do not submit any completed
forms to these addresses.
In addition, pursuant to section 605(b) of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency has previously
certified, as a generic matter, 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.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local, or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an effective process permitting
elected officials and other representatives of Indian tribal
governments ``to provide meaningful and timely input in the development
of regulatory policies on matters that significantly or uniquely affect
their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This rule does not involve or
impose any requirements that affect Indian Tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
XI. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this rule in the Federal Register. This rule 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 substances,
Reporting and recordkeeping requirements.
Dated: November 16, 1998.
Charles M. Auer,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Therefore, 40 CFR part 721 is amended as follows:
PART 721--[AMENDED]
1. The authority citation for part 721 continues 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 (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically 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
[[Page 65710]]
(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 (generic).
(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 (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 700
daltons.
(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. 98-31680 Filed 11-27-98; 8:45 am]
BILLING CODE 6560-50-F
