[Federal Register Volume 66, Number 159 (Thursday, August 16, 2001)]
[Proposed Rules]
[Pages 42978-42982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20664]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[OPPTS-50642; FRL-6557-8]
RIN 2070-AB27


Proposed Modification of Significant New Uses of Certain Chemical 
Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to modify significant new use rules (SNURs) 
for 2 substances promulgated under section 5(a)(2) of the Toxic 
Substances Control Act (TSCA) based on new data. Based on the new data 
the Agency finds that activities not described in the corresponding 
TSCA section 5(e) consent orders for the chemical substances may result 
in significant changes in human or environmental exposure.

DATES: Comments, identified by docket control number OPPTS-50642, must 
be received on or before September 17, 2001.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number OPPTS-50642 in the subject line on the first page of 
your response.

FOR FURTHER INFORMATION CONTACT: For general information contact: 
Barbara Cunningham, Director, Office of Program Management and 
Evaluation, Office of Pollution Prevention and Toxics (7401), 
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, Office of Pollution Prevention and Toxics (7405), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (202) 260-1857; 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 
proposed rule. Potentially 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.

[[Page 42979]]

B. How Can I Get Additional Information, Including Copies of this 
Document and 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-50642. 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.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number OPPTS-50642 in the subject line on 
the first page of your response.
    1. By mail. Submit your comments to: Document Control Office 
(7407), Office of Pollution Prevention and Toxics (OPPT), Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: OPPT Document 
Control Office (DCO) in East Tower Rm. G-099, Waterside Mall, 401 M 
St., SW., Washington, DC. The DCO is open from 8 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The telephone number for the 
DCO is (202) 260-7093.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or mail your computer disk to the address 
identified above. Do not submit any information electronically that you 
consider to be CBI. Electronic comments must be submitted as an ASCII 
file avoiding the use of special characters and any form of encryption. 
Comments will also be accepted on standard disks in WordPerfect 6.1/8.0 
or ASCII file format. All comments in electronic form must be 
identified by docket control number OPPTS-50642. Electronic comments 
may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI by marking any part or all of that information as 
CBI. Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the technical person listed under FOR FURTHER 
INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    We invite you to provide your views on the various options we 
propose, new approaches we haven't considered, the potential impacts of 
the various options (including possible unintended consequences), and 
any data or information that you would like the Agency to consider 
during the development of the final action. You may find the following 
suggestions helpful for preparing your comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the proposed rule.
    7. Make sure to submit your comments by the deadline in this 
document.
    8. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

II. Background

A. What Action is the Agency Taking?

    In the Federal Register of September 28, 1990, OPPTS-50585 (55 FR 
39905) EPA issued a SNUR for P-89-769. In the Federal Register of April 
25, 1991, OPPTS-50591 (56 FR 19228) EPA issued a SNUR for P-90-440. 
Because of additional data EPA has received for these substances, EPA 
is proposing to modify the significant new use and recordkeeping 
requirements under 40 CFR part 721, subpart E. In this unit, EPA 
provides a brief description for each substance, including its 
premanufacture notice (PMN) number, chemical name (generic name if the 
specific name is claimed as CBI), CAS number (if assigned), basis for 
the modification of the TSCA section 5(e) consent order for the 
substance, and the CFR citation. Further background information for the 
substance is contained in Unit I.B.2 of this document.

PMN Number P-89-769
Chemical name: Resorcinol, formaldehyde substituted carbomonocycle 
resin (generic).
CAS number: Not available.
Federal Register publication date and reference: September 28, 1990 (55 
FR 39905).
Docket number: OPPTS-50585.
Basis for modification: Based on an absorption study demonstrating that 
approximately 4 percent PMN substance will be absorbed following oral 
intake, EPA no longer concluded that the PMN substance may present an 
unreasonable risk of injury to human health, and consequently revoked 
the consent order. EPA is eliminating the SNUR provisions for worker 
protection, hazard communication, and disposal by

[[Page 42980]]

incineration as it no longer finds these provisions necessary to 
prevent significant changes in human exposure. The SNUR provisions for 
release to water will remain as EPA still finds that releases to water 
could result in significant changes in environmental exposure.
CFR citation: 40 CFR 721.9480 (Formerly 40 CFR 721.1889).

PMN Number P-90-440 and P-95-4
Chemical name: Substituted carboheterocyclic butane tetracarboxylate 
(generic).
CAS number: Not available.
Federal Register publication date and reference: April 25, 1991 (56 FR 
19228).
Docket number: OPPTS-50591.
Basis for modification: A PMN submitter conducted a 90-day subchronic 
oral study in rats. The study demonstrated toxicity at all test doses 
(5, 20, and 75 milligram/kilogram/day (mg/kg/day)). The PMN submitter 
also conducted a particle size analysis of the PMN substance using 
vibration testing. The analysis indicated that a pellet form of the PMN 
substance would have a particle size greater than 250 microns. Workers 
exposed to the pellet form of the PMN substance having a particle size 
greater than 250 microns are not reasonably likely to be exposed to 
significant amounts of the PMN substance through inhalation. Therefore, 
EPA has determined that the proposed manufacturing, processing, and use 
of the pellet form of the PMN substance would not result in significant 
changes in human exposure. EPA is modifying the existing SNUR to state 
that the SNUR provisions for respiratory protection do not apply when 
the particle size of the PMN substance is 250 microns or greater. If, 
however, the particle size is less than 250 microns, then the SNUR 
provisions for respiratory protection will still apply. EPA is also 
eliminating the production volume limit from the SNUR as the 90-day 
subchronic test required by the TSCA section 5(e) consent order at the 
same production volume limit has already been conducted. In addition, 
EPA has noted in the preamble and added to the PMN heading a second PMN 
number for this substance as EPA had received an additional PMN 
submission for the same substance.
CFR citation: 40 CFR 721.1925 (Formerly 40 CFR 721.2094).

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 proposed 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 proposed rule, 
recordkeeping requirements, exemptions to reporting requirements, and 
applicability of the proposed 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 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) (Pub. L. 104-4).
    This proposed rule does not have tribal implications because it is 
not expected to have substantial direct effects on Indian Tribes. This 
does not significantly or uniquely affect the communities of Indian 
trial governments, nor does it involve or impose any requirements that 
affect Indian Tribes. Accordingly, the requirements of section 3(b) of 
Executive Order 13084, entitled Consultation and Coordination with 
Indian Tribal Governments (63 FR 276755, May 19, 1998), do not apply to 
this proposed rule. Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000), which took effect on January 6, 2001, revokes Executive Order 
13084 as of that date. EPA developed this rulemaking, however, during 
the period when Executive Order 13084 was in effect; thus, EPA 
addressed tribal considerations under Executive Order 13084. For the 
same reasons stated for Executive Order 13084, the requirements of 
Executive Order 10175

[[Page 42981]]

do not apply to this proposed rule either. 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 proposed 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 proposed 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) Pub. L. 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 proposed rule as a ``significant new use.'' By definition of the 
word ``new,'' and based on all information currently available to EPA, 
it appears that no small or large entities presently engage in such 
activity. Since a SNUR only requires that any person who intends to 
engage in such activity in the future must first notify EPA by 
submitting a Significant New Use Notice (SNUN), no economic impact will 
even occur until someone decides to engage in those activities. 
Although some small entities may decide to conduct such activities in 
the future, EPA cannot presently determine how many, if any, there may 
be. However, EPA's experience to date is that, in response to the 
promulgation of over 530 SNURs, the Agency has received fewer than 15 
SNUNs. Of those SNUNs submitted, none appear to be from small entities 
in response to any SNUR. In addition, the estimated reporting cost for 
submission of a SNUN is 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 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, 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 proposed 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.

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.


    Dated: July 18, 2001.
William H. Sanders, III
Office Director, Office of Pollution Prevention and Toxics.

    Therefore, it is proposed that 40 CFR part 721 be amended as 
follows:

PART 721--[AMENDED]

    1. The authority citation for part 721 would continue to read as 
follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).

    2. Section 721.1925 is amended as follows:
    a. By revising the section heading.
    b. By revising paragraphs (a)(1), (a)(2)(i), 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.
    (2) *  *  *
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), 
(a)(6)(i), (b) (concentration set at 1.0 percent), and (c). Sections 
721.63 (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), and (a)(6)(i) do not 
apply when particle sizes of the chemical substance is greater than 250 
microns.
* * * * *

[[Page 42982]]

    (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. 01-20664 Filed 8-15-01: 8:45 am]
BILLING CODE 6560-50-S