[Federal Register Volume 67, Number 54 (Wednesday, March 20, 2002)]
[Rules and Regulations]
[Pages 12882-12885]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-6725]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[OPPTS-50642A; FRL-6819-5]
RIN 2070-AB27


Modification of Significant New Uses of Certain Chemical 
Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: Under section 5(a)(2) of the Toxic Substances Control Act 
(TSCA) and 40 CFR 721.185, EPA is amending two significant new use 
rules (SNURs) to allow certain uses without requiring a significant new 
use notice (SNUN). EPA is amending these rules based on review of new 
toxicity and exposure data. The amended SNURs would continue to require 
a SNUN for new uses that may involve significant changes in human or 
environmental exposure

DATES: This final rule is effective on May 20, 2002.

FOR FURTHER INFORMATION CONTACT: For general information contact: 
Barbara Cunningham, Acting Director, Environmental Assistance Division 
(7408M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (202) 554-1404; e-mail address: [email protected].
    For technical information contact: James Alwood, Chemical Control 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (202) 564-8974; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture, 
import, process, or use the chemical substances contained in this rule. 
Potentially

[[Page 12883]]

affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Chemical manufacturers            325                 Manufacturers,
                                                       importers,
                                                       processors, and
                                                       users of
                                                       chemicals
Petroleum and coal product        324                 Manufacturers,
 industries                                            importers,
                                                       processors, and
                                                       users of
                                                       chemicals
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table in this unit 
could also be affected. The North American Industrial Classification 
System (NAICS) codes have been provided to assist you and others in 
determining whether or not this action applies to certain entities. To 
determine whether you or your business is affected by this action, you 
should carefully examine the applicability provisions in title 40 of 
the Code of Federal Regulations (CFR) at 40 CFR 721.5. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the technical person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document or Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. A frequently updated electronic 
version of 40 CFR part 721 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr721_00.html, a beta site currently 
under development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPPTS-50642A. The official 
record consists of the documents specifically referenced in this 
action, any public comments received during an applicable comment 
period, and other information related to this action, including any 
information claimed as Confidential Business Information (CBI). This 
official record includes the documents that are physically located in 
the docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period, is available 
for inspection in the TSCA Nonconfidential Information Center, North 
East Mall Rm. B-607, Waterside Mall, 401 M St., SW., Washington, DC. 
The Center is open from noon to 4 p.m., Monday through Friday, 
excluding legal holidays. The telephone number for the Center is (202) 
260-7099.

II. Background

A. What Action is the Agency Taking?

    The Agency proposed the modification of these SNURs in the Federal 
Register of August 16, 2001 (66 FR 42978) (FRL-6557-8). The background 
and reasons for the modification of each individual SNUR are set forth 
in the preamble to the proposed SNUR modification. The comment period 
closed on September 17, 2001. EPA received no comments regarding the 
SNUR for P-89-769 codified at 721.9480. Therefore EPA is issuing the 
modified SNUR.
    EPA received one comment from the PMN submitter of P-95-4, who 
provided particle size data that was the basis for the proposed 
elimination of reporting requirements for respiratory protection when 
the particle size of the PMN substance is 250 microns or greater. The 
commenter stated that when the particle size of the substance is 250 
microns or greater, exposed workers are not reasonably likely to be 
exposed to significant amounts of the PMN substance and that SNUR 
reporting provisions should not apply. EPA reviewed the available 
dermal toxicity data and determined that when the particle size of the 
substance is 250 microns or greater dermal exposures would not result 
in significant changes in human exposure. This determination was based 
on the fact that the dermal LD50 of the substance is greater 
than 2,000 milligram/kilogram (mg/kg), the skin irritation study in 
rabbits for the substance showed no skin irritation and had a Draize 
irritation score of 0, indicative of a compound with no irritation 
potential to the skin, the skin sensitization study for the substance 
showed no reactions, and no dermal absorption of particles greater than 
250 microns is expected. Therefore, EPA is issuing a modified final 
SNUR where no SNUR reporting requirements apply when the particle size 
of the substance is greater than 250 microns.

B. What is the Agency's Authority for Taking this Action?

    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) of TSCA. 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 721.5.
    During review of the PMNs submitted for the chemical substances 
that are the subject of this rule, EPA concluded that regulation was 
warranted based on available information that indicated activities not 
described in the TSCA section 5(e) consent order might result in 
significant changes in human or environmental exposure as described in 
section 5(a)(2) of TSCA. Based on these findings, SNURs were 
promulgated.
    EPA has revoked the TSCA section 5(e) consent order for P-89-769 
and 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 TSCA section 5(e) consent 
order.

C. 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 TSCA section 5(b) and 
5(d)(1), the exemptions authorized by TSCA 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 TSCA 
section 5(e), 5(f), 6, or 7 to control the

[[Page 12884]]

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. Regulatory Assessment Requirements

    Under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993), the Office of Management and 
Budget (OMB) has determined that proposed or final SNURs are not a 
``significant regulatory action'' subject to review by OMB, because 
they do not meet the criteria in section 3(f) of the Executive Order.
    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reasons to believe that any 
State, local, or tribal government will be impacted by this rulemaking. 
As such, EPA has determined that this regulatory action does not impose 
any enforceable duty, contain any unfunded mandate, or otherwise have 
any affect on small governments subject to the requirements of sections 
202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Public Law 104-4).
    This rule does not have tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes. This rule 
does not significantly or uniquely affect the communities of Indian 
tribal governments, nor does it involve or impose any requirements that 
affect Indian Tribes. Accordingly, the requirements of Executive Order 
13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000), which took effect on 
January 6, 2001 do not apply to this rule. Nor will this action have a 
substantial direct effect on States, on the relationship between the 
national government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 
1999).
    In issuing this rule, EPA has taken the necessary steps to 
eliminate drafting errors and ambiguity, minimize potential litigation, 
and provide a clear legal standard for affected conduct, as required by 
section 3 of Executive Order 12988, entitled Civil Justice Reform (61 
FR 4729, February 7, 1996).
    EPA has complied with Executive Order 12630, entitled Governmental 
Actions and Interference with Constitutionally Protected Property 
Rights (53 FR 8859, March 15, 1988), by examining the takings 
implications of this rule in accordance with the ``Attorney General's 
Supplemental Guidelines for the Evaluation of Risk and Avoidance of 
Unanticipated Takings'' issued under the Executive Order.
    This action does not entail special considerations of environmental 
justice related issues as delineated by Executive Order 12898, entitled 
Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
    This action is not subject to Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997), because this is not an economically 
significant regulatory action as defined by Executive Order 12866, and 
this action does not address environmental health or safety risks 
disproportionately affecting children.
    In addition, since this action does not involve any technical 
standards, section 12(d) of the National Technology Transfer and 
Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 
U.S.C. 272 note), does not apply to this action.
    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation 
of this SNUR will not have a significant adverse economic impact on a 
substantial number of small entities. The rationale supporting this 
conclusion is as follows. 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 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 response to any SNUR. In addition, 
the estimated reporting cost for submission of a SNUN are minimal 
regardless of the size of the firm. Therefore, EPA believes that the 
potential economic impact of complying with this SNUR are not expected 
to be significant or adversely impact a substantial number of small 
entities. In a SNUR that published on June 2, 1997 (62 FR 29684) (FRL-
5597-1), the Agency presented it's general determination that proposed 
and final SNURs are not expected to have a significant economic impact 
on a substantial number of small entities, which was provided to the 
Chief Counsel for Advocacy of the Small Business Administration.
    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 rule 
and in addition to its display on any related collection instrument, 
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 SNUN.
    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

[[Page 12885]]

techniques, to the Director, OP Regulatory Information Division (2137), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. Please remember to include the OMB control number 
in any correspondence, but do not submit any completed forms to this 
address.
    This rule is not subject to Executive Order 13211, ``Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use'' (66 FR 28355, May 22, 2001) because it is not a 
significant regulatory action under Executive Order 12866.

IV. 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 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 the rule in the Federal Register. This rule is 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: March 1, 2002.
William H. Sanders, III
Office Director, 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. Section 721.1925 is amended as follows:
    a. By revising the section heading.
    b. By revising paragraphs (a)(1) and (a)(2)(iii).
    c. By removing paragraph (b)(3).


Sec. 721.1925  Substituted carboheterocyclic butane tetracarboxylate 
(generic).

    (a) *  *  * (1) The chemical substance identified generically as 
substituted carboheterocyclic butane tetracarboxylate (PMNs P-90-440 
and P-95-4) 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 when particle sizes of the 
chemical substance is greater than 250 microns.
    (2) *  *  *
* * * * *
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(f).
* * * * *

    3. Section 721.9480 is amended as follows:
    a. By revising the section heading.
    b. By revising paragraphs (a)(1), (a)(2)(i), and (b)(1).
    c. By removing and reserving paragraph (a)(2)(ii).
    d. By removing paragraphs (a)(2)(iii), (a)(2)(iv), (a)(2)(v), and 
(b)(3).


Sec. 721.9480  Resorcinol, formaldehyde substituted carbomonocycle 
resin (generic).

    (a) *  *  * (1) The chemical substance identified generically as 
resorcinol, formaldehyde substituted carbomonocycle resin (PMN P-89-
769) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) *  *  *
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) *  *  *
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
* * * * *

[FR Doc. 02-6725 Filed 3-19-02; 8:45 am]
BILLING CODE 6560-50-S