[Federal Register Volume 76, Number 103 (Friday, May 27, 2011)]
[Rules and Regulations]
[Pages 30835-30837]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-13250]



40 CFR Part 721

[EPA-HQ-OPPT-2008-0296; FRL-8858-1]
RIN 2070-AJ41

Requests for Modification or Revocation of Toxic Substances 
Control Act Section 5 Significant New Use Notice Requirements; Revision 
to Notification Regulations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.


SUMMARY: This direct final rule amends the procedures for requests for 
modification or revocation of Toxic Substances Control Act (TSCA) 
section 5 significant new use notification (SNUN) requirements by 
establishing electronic submission requirements. EPA issued a final 
rule in the Federal Register of January 6, 2010, introducing electronic 
reporting requirements for TSCA section 5 submissions and supporting 
documents. However, the regulatory text inadvertently did not include 
amendments to the reporting requirements for submissions of requests 
for modifications or revocations of SNUN requirements. This direct 
final rule includes the amendment that was originally intended by EPA.

DATES: This direct final rule is effective July 26, 2011 without 
further notice, unless EPA receives adverse comment on or before June 
27, 2011. If EPA receives adverse comments on this action, EPA will 
withdraw the direct final rule before its effective date. EPA will then 
issue a proposed rule, providing a 30-day period for public comment.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPPT-2008-0296. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket 
Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., 
NW., Washington, DC. The EPA/DC Public Reading Room hours of operation 
are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number of the EPA/DC Public Reading Room is 
(202) 566-1744, and the telephone number for the OPPT Docket is (202) 
566-0280. Docket visitors are required to show photographic 
identification, pass through a metal detector, and sign the EPA visitor 
log. All visitor bags are processed through an X-ray machine and 
subject to search. Visitors will be provided an EPA/DC badge that must 
be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Greg Schweer, Chemical Control Division (7405M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 
(202) 564-8469; e-mail address: schweer.greg@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; e-mail address: TSCA-Hotline@epa.gov.


I. Does this action apply to me?

    You may be affected by this action if you manufacture, import, or 
process chemicals for commercial purposes. Potentially affected 
entities may include, but are not limited to:
     Manufacturers, importers, and processors of chemical 
substances or mixtures, e.g., chemical manufacturing and processing and 
petroleum refineries (NAICS codes 325 and 324110).
    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 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 this action might apply to certain entities. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in 40 CFR part 721 for 
TSCA section 5-related obligations. 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.

II. Background

A. What action is the agency taking?

    This action amends 40 CFR 721.185(b)(1), which sets forth 
requirements for requesting modification or revocation of SNUN 
requirements. This provision requires persons who request modification 
of SNUN requirements for a particular chemical substance to send the 
request in writing to EPA. When developing the TSCA section 5 
electronic reporting requirements published in the Federal Register 
issue of January 6, 2010 (75 FR 773) (FRL-8794-5), EPA had intended to 
include these modification requests. In the document proposing 
electronic reporting of TSCA section 5 submissions published in the 
Federal Register issue of December 22, 2008 (73 FR 78261) (FRL-8395-8), 
EPA included regulatory text to require electronic reporting for 
modification and revocation requests regarding significant new use 
reporting requirements for microorganisms under 40 CFR 725.984(b)(1), 
containing language almost identical to the regulatory language 
included in this direct final rule. Discussion in the preamble of the 
final rule regarding types of submissions that would continue to be 
required in hard copy did not include modification and revocation 
requests under Sec.  721.185(b)(1). No comments were received regarding 
40 CFR 725.984(b)(1), and EPA finalized this change. However, the 
corresponding change to the analogous provision in Sec.  721.185(b)(1) 
was inadvertently omitted from both the proposed and final rule. This 
direct final rule includes this change.

B. What is the agency's authority for taking this action?

    Section 5(a)(1)(A) of TSCA requires persons to notify EPA at least 
90 days before manufacturing a new chemical substance for commercial 
purposes (under TSCA manufacture includes import). Section 3(9) of TSCA 
defines a ``new chemical substance'' as any substance that is not on 
the TSCA Inventory of Chemical Substances compiled by EPA under section 
8(b) of TSCA. Section 5(a)(2) of TSCA 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 TSCA section 5(a)(2). Once EPA determines 
that a use of a chemical

[[Page 30836]]

substance is a significant new use, TSCA section 5(a)(1)(B) requires 
persons to submit a notice to EPA at least 90 days before manufacturing 
or processing the chemical substance for that use.
    The Government Paperwork Elimination Act (GPEA) requires Federal 
agencies to provide for the:
    1. Option of electronic maintenance, submission, or disclosure of 
information, when practicable as a substitute for paper.
    2. Use and acceptance of electronic signatures, when practicable. 
EPA's Cross-Media Electronic Reporting Regulation (CROMERR) (40 CFR 
part 3), published in the Federal Register issue of October 13, 2005 
(70 FR 59848) (FRL-7977-1), provides that any requirement in title 40 
of the CFR to submit a report directly to EPA can be satisfied with an 
electronic submission that meets certain conditions once the Agency 
publishes a document that electronic document submission is available 
for that requirement.

C. Why is this notice issued as a final rule?

    Section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 
553(b)(3)(B), provides that, when an agency for good cause finds that 
notice and public procedure are impracticable, unnecessary, or contrary 
to the public interest, the agency may issue a final rule without 
providing notice and an opportunity for public comment. EPA has 
determined that there is good cause for making this rule final without 
prior proposal and opportunity for comment, for the reasons mentioned 
in Unit II.A. EPA finds that this constitutes good cause under 5 U.S.C. 

III. Statutory and Executive Order Reviews

    This action amends an existing regulation to correct an omission in 
the final rule published in the Federal Register of January 6, 2010, 
introducing electronic reporting of TSCA section 5 submissions and 
supporting documents; it does not otherwise amend or impose any other 
requirements. This action is not a ``significant regulatory action'' 
under Executive Order 12866, entitled Regulatory Planning and Review 
(58 FR 51735, October 4, 1993). Further, this direct final rule does 
not impose new or change any information collection burden that 
requires additional review by the Office of Management and Budget (OMB) 
under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501 et seq.). The information collection activities contained in the 
regulations are already approved under OMB control numbers 2070-0012 
and 2070-0038. An agency may not conduct or sponsor, and a person is 
not required to respond to a collection of information unless it 
displays a currently valid OMB control number. The OMB control numbers 
for EPA's regulations in 40 CFR are listed in 40 CFR part 9 and on 
corresponding collection instruments, as applicable.
    Pursuant to section 605(b) of the Regulatory Flexibility Act (5 
U.S.C. 601 et seq.), the Agency hereby certifies that this direct final 
rule will not have a significant adverse economic impact on a 
substantial number of small entities. The correction is not expected to 
have any adverse economic impacts on affected entities, regardless of 
their size. This determination is consistent with that made for the 
final rule, which appears in Unit VII.C. of the preamble to the January 
6, 2010 final rule.
    State, local, and tribal governments were not expected to be 
affected by the January 6, 2010 final rule (see Unit VII.D. through F. 
of the preamble to that action), and, similarly, this direct final rule 
is not expected to affect these governments. Accordingly, pursuant to 
Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1531-
1538), EPA has determined that this action is not subject to the 
requirements in UMRA sections 202 and 205 because it does not contain a 
Federal mandate that may result in expenditures of $100 million or more 
for State, local, and tribal governments, in the aggregate, or for the 
private sector in any 1 year. In addition, this action does not 
significantly or uniquely affect small governments or impose a 
significant intergovernmental mandate, as described in UMRA sections 
203 and 204. For the same reasons, EPA has determined that this direct 
final rule does not have ``federalism implications'' as specified in 
Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 
1999), because it would not have substantial direct effects on the 
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 the Order. Thus, 
Executive Order 13132 does not apply to this direct final rule. Nor 
does it have ``tribal implications'' as specified in Executive Order 
13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 22951, November 9, 2000). Thus, Executive Order 
13175 does not apply to this action.
    Since this action is not economically significant under Executive 
Order 12866, it is not subject to Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997), and Executive Order 13211, entitled 
Actions Concerning Regulations that Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). In addition, EPA 
interprets Executive Order 13045 as applying only to those regulatory 
actions that concern health or safety risks, which is not the case in 
this direct final rule.
    This action does not involve technical standards that would require 
the consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act (NTTAA) 
(15 U.S.C. 272).
    This action does not have an adverse impact on the environmental 
and health conditions in low-income and minority communities. 
Therefore, this action does not involve special consideration of 
environmental justice related issues as specified in Executive Order 
12898, entitled Federal Actions to Address Environmental Justice in 
Minority Populations and Low-Income Populations (59 FR 7629, February 
16, 1994).

IV. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the Agency promulgating 
the rule must submit a rule report 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 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: May 12, 2011.
Stephen A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution 

    Therefore, 40 CFR chapter I is amended as follows:


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

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

2. Revise paragraph (b)(1) of Sec.  721.185 to read as follows:

[[Page 30837]]

Sec.  721.185  Limitation or revocation of certain notification 

* * * * *
    (b) * * *
    (1) Any affected person may request modification or revocation of 
significant new use notification requirements for a substance that has 
been added to subpart E of this part using the procedures described in 
Sec.  721.160 or Sec.  721.170 by writing to the Director of the Office 
of Pollution Prevention and Toxics, and stating the basis for such 
request. The request must be accompanied by the information sufficient 
to support the request. Persons submitting a request to EPA under this 
part, unless allowed by 40 CFR 720.40(a)(2)(i), (ii), or (iii), must 
submit the request to EPA via EPA's Central Data Exchange (CDX) using 
EPA-provided e-PMN reporting software in the manner set forth in 40 CFR 
720.40(a)(2). See 40 CFR 720.40(a)(2)(iv) for information on how to 
obtain the e-PMN software. Support documents related to these requests 
must also be submitted to EPA in the manner set forth in 40 CFR 
720.40(a)(2)(i), (ii), or (iii). Paper requests must be submitted 
either via U.S. mail to the Document Control Office (DCO) (7407M), 
Office of Pollution Prevention and Toxics, Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; ATTN: 
Request to Amend SNUR or submitted via courier to the Environmental 
Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 
1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004; ATTN: 
Request to Amend SNUR. Optical discs containing electronic requests 
must be submitted by courier to the Environmental Protection Agency, 
OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution 
Ave., NW., Rm. 6428, Washington, DC 20004; ATTN: Request to Amend SNUR.
* * * * *
[FR Doc. 2011-13250 Filed 5-26-11; 8:45 am]