[Federal Register Volume 77, Number 114 (Wednesday, June 13, 2012)]
[Proposed Rules]
[Pages 35331-35336]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14242]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 725
[EPA-HQ-OPPT-2010-0994; FRL-9350-6]
RIN 2070-AD43
Trichoderma reesei; Proposed Significant New Use Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing a significant new use rule (SNUR) under the
Toxic Substances Control Act (TSCA) for the genetically modified
microorganism identified generically as Trichoderma reesei (T. reesei).
This microorganism was the subject of a Microbial Commercial Activity
Notice (MCAN). EPA believes this action is necessary because the use of
this genetically modified T. reesei under certain conditions may be
hazardous to human health and the environment. This proposed rule would
also establish a mechanism to allow EPA to evaluate an intended use and
its conditions, and to prohibit or limit that activity before it
occurs, if EPA determines it may be hazardous.
DATES: Comments must be received on or before July 13, 2012.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2010-0994, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave. NW., Washington, DC.
Attention: Docket ID Number EPA-HQ-OPPT-2010-0994. 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) 564-8930. Such deliveries are
only accepted during the DCO's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2010-0994. EPA's policy is that all comments received will be included
in the docket without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or email. The
regulations.gov Web site is an ``anonymous access'' system, which means
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: 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., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically 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:
Kenneth Moss, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-9232; email address: moss.kenneth@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
[[Page 35332]]
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 products that contain living microorganisms
subject to TSCA, especially if you know that your products contain or
may contain T. reesei. Potentially affected entities may include, but
are not limited to:
Manufacturers, importers, or processors of chemical
substances (NAICS codes 325 and 324110), e.g., chemical manufacturing
and petroleum refineries.
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 list of chemical substances excluded by TSCA
section 3(2)(B) and the applicability provisions in Sec. 725.105(c)
for SNUR 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.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR 12.118 through 12.127;
see also 19 CFR 127.28. Chemical importers must certify that the
shipment of the chemical substance complies with all applicable rules
and orders under TSCA. Importers of chemical substances subject to
these SNURs must certify their compliance with the SNUR requirements.
The EPA policy in support of import certification appears at 40 CFR
part 707, subpart B. In addition, any persons who export or intend to
export a chemical substance that is the subject of a proposed or final
SNUR are subject to the export notification provisions of TSCA section
12(b) (15 U.S.C. 2611(b)) (see Sec. [emsp14]725.920), and must comply
with the export notification requirements in 40 CFR part 707, subpart
D.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes 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 docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. What action is the agency taking?
EPA is proposing this SNUR for the genetically modified
microorganism identified generically as T. reesei (MCAN J-10-2). This
proposed rule would require persons to notify EPA at least 90 days
before commencing the manufacture, import, or processing of the
microorganism for any activity designated as a significant new use.
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.'' (see 40 CFR part 725, subparts L and M). EPA must make this
determination by rule after considering all relevant factors, including
the TSCA section 5(a)(2) factors, listed in Unit III. Once EPA
determines that a use of a chemical substance is a significant new use,
TSCA section 5(a)(1)(B) requires persons to submit a significant new
use notice (SNUN) to EPA at least 90 days before they manufacture,
import, or process the chemical substance for that use. Persons who
must report are described in Sec. 725.105(c).
EPA has interpreted the TSCA section 3(2) definition of ``chemical
substance'' as authorizing EPA to regulate microorganisms under TSCA.
See the Federal Register issue of April 11, 1997 (62 FR 17910) (FRL-
5577-2).
C. Applicability of General Provisions
General provisions for SNURs for microorganisms appear in 40 CFR
part 725, subpart L. These provisions describe persons subject to the
proposed rule, recordkeeping requirements, exemptions to reporting
requirements, and applicability 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 notice
requirements under TSCA section 5(a)(1)(A) and must submit a MCAN,
using the procedures set out in 40 CFR part 725, subpart D, and
additional ``Significant New Uses of Microorganisms'' procedures at 40
CFR part 725, subpart L.
Under 40 CFR part 725, EPA has adopted a more narrow interpretation
of the TSCA section 5(h)(3) exemption for small quantities used in
research than it has for other chemical substances under 40 CFR part
721. Under Sec. 725.3, EPA has defined small quantities solely for
research and development as ``quantities of a microorganism
manufactured, imported, or processed or proposed to be manufactured,
imported, or processed solely for research and development that meet
the requirements of Sec. 725.234.'' Any other research and development
activity of a microorganism subject to a SNUR must comply with the TSCA
section 5(a)(1)(A) notification requirements unless that activity has
been excluded from coverage under the SNUR. See Sec. 725.3, subparts E
and F of 40 CFR part 725, and the April 11, 1997 Federal Register
document. Once EPA receives a SNUN, EPA may take regulatory action
under TSCA section 5(e), 5(f), 6, or 7 to control the activities for
which it has received the SNUN. If EPA does not take action, EPA is
required under TSCA section 5(g) to explain in the
[[Page 35333]]
Federal Register its reasons for not taking action.
III. Significant New Use Determination
Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In addition to these factors specifically enumerated in TSCA section
5(a)(2), the statute authorizes EPA to consider any other relevant
factors.
To determine what would constitute a significant new use for the
chemical substance that is the subject of this proposed SNUR, EPA
considered the available information relating to the four bulleted
factors listed in TSCA section 5(a)(2) factors listed in this unit, and
other relevant factors. This includes relevant information about the
toxicity of the chemical substance and likely human exposures and
environmental releases associated with possible uses. See the risk
assessment in the docket under docket ID number EPA-HQ-OPPT-2010-0994
for this information and other relevant factors.
IV. Substance Subject to This Proposed Rule
EPA is proposing to establish significant new use and recordkeeping
requirements for only the microorganism identified generically as T.
reesei, genetically modified as described in MCAN J-10-2. This will be
codified in 40 CFR part 725, subpart M. Any T. reesei microorganism
with genetic modifications other than those described in MCAN J-10-2
would not be subject to this SNUR and will require submission and EPA
review of a separate MCAN.
MCAN Number J-10-2
Chemical name: Trichoderma reesei (MCAN J-10-2) (generic).
Chemical Abstracts Service (CAS) Registry Number: Not available.
Use: The MCAN states that the generic (non-confidential) use of the
microorganism will be to produce enzymes for ethanol production.
Basis for action: When used to produce enzymes that can release
sugars from de-lignified plant materials, human and environmental
exposures to live T. reesei cells are low, due to the containment and
inactivation procedures specified in the MCAN. These containment and
inactivation procedures are consistent with standard industry practices
and those delineated in 40 CFR 725.422(d). These procedures include the
use of equipment to minimize aerosol releases from the facility, and
the use of inactivation methods that reduce the number of viable cells
by at least 6 logs (i.e., 10\6\) in the liquid and solid waste streams.
More importantly, the manufacturing process described in the MCAN
relies on the typical submerged standard industrial fermentation
process for enzyme production, wherein the microorganism is grown in
liquid broth culture in the absence of solid materials or solid
surfaces, the fermentation is terminated prior to the microorganism
entering the stationary phase of growth, and the enzyme is separated
from the microbial biomass which is inactivated prior to disposal.
Therefore, EPA determined that the proposed manufacturing, processing,
or use of the microorganism as described in the MCAN is not expected to
present an unreasonable risk. However, EPA has determined that use of
the microorganism under other conditions may result in adverse human
health and environmental effects. Specifically, where growth on solid
plant material or insoluble substrate occurs, T. reesei has been shown
to produce a secondary metabolite known as paracelsin, which is a
peptaibol. Peptaibols are small linear peptides of 1,000-2,000 Daltons
characterized by a high content of the non-proteinogenic amino acid
alpha-amino-isobutyric acid (Aib), with a N-terminus that is typically
acetylated, and a C-terminus that is linked to an amino alcohol, which
is usually phenylalaninol, or sometimes valinol, leucinol, isoleucinol,
or tryptophanol. Peptaibols are associated with a wide variety of
biological activities and have antifungal, antibacterial, sometimes
antiviral, antiparasitic, and neurotoxic activity. Paracelsin has been
shown to have toxicity toward mammalian cells such as hemolytic
activity on human erythrocytes and cytotoxicity to rat adrenal medulla
PC12 (pheochromocytoma) cells. Paracelsin has also been shown to
exhibit cytotoxicity to Gram-positive bacteria, to human erythrocytes,
and to other mammals such as aquatic indicator species. Additional
information relating to the assessment of this chemical substance and
paracelsin, including a sanitized EPA risk assessment and a list of
references used, is available in the docket under docket ID number EPA-
HQ-OPPT-2010-0994.
Recommended testing: EPA has determined that the results of the
following studies would help characterize any potential human health
and environmental effects of the MCAN substance:
1. Investigation of whether paracelsin will be produced, and at
what levels if the genetically modified T. reesei is grown on various
plant biomass materials for different durations under various
fermentation conditions in cellulosic biomass facilities.
2. If paracelsin is produced, a study of whether paracelsin would
be denatured/inactivated during production and processing.
3. If paracelsin is released from the facility, a study of whether
paracelsin would be degraded/inactivated during wastewater treatment.
4. If released to the environment, studies on the persistence,
stability, dissemination, accumulation, and the potential resulting
biological activity of paracelsin with exposure to aquatic and
terrestrial organisms in the environment.
5. Studies to determine the ability of the MCAN microorganism to
survive in the environment relative to the survival of the unmodified
parent or recipient strain, and to assess its competitiveness with
other fungi in the environment. This study may require some
supplementation with one or more carbon sources and the use of various
soil types.
6. A study to determine survival of the fungus during an anaerobic
fermentation for production of ethanol by an ethanologen, and survival
of the fungus during ethanol distillation or at the distillation
temperature for ethanol.
CFR citation: 40 CFR 725.1077.
V. Rationale and Objectives of the Proposed Rule
A. Rationale
During review of the specific T. reesei, modified as described in
MCAN J-10-2, EPA determined that certain fermentation conditions, other
than the typical submerged standard industrial fermentation process for
enzyme production described in Unit IV., could result in increased
exposures thereby constituting a ``significant new use.'' Specifically,
EPA is concerned that where growth on solid plant material or
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insoluble substrate occurs, T. reesei has been shown to produce a
secondary metabolite known as paracelsin, which is associated with a
variety of toxic effects to mammalian and bacterial cells. Use of the
MCAN microorganism without the specific containment or inactivation
controls listed in the MCAN, described in Unit IV., may result in
adverse human health and environmental effects. Based on the
descriptions of manufacturing, processing, and use in the MCAN J-10-2,
the Agency believes that uses of the organism covered by the proposed
definition of a significant new use are not currently ongoing.
B. Objectives
EPA is proposing this SNUR for a chemical substance that has
undergone review to achieve the following objectives with regard to the
significant new uses designated in this proposed rule:
EPA would receive notice of any person's intent to
manufacture, import, or process a listed chemical substance for the
described significant new use before that activity begins.
EPA would have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing,
importing, or processing a listed chemical substance for the described
significant new use.
EPA would be able to determine whether regulation of
prospective manufacturers, importers, or processors of a listed
chemical substance is warranted pursuant to TSCA sections 5(e), 5(f),
6, or 7, and impose any necessary requirements before the described
significant new use of that chemical substance occurs.
Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Chemical Substance
Inventory (TSCA Inventory). Guidance on how to determine if a chemical
substance is on the TSCA Inventory is available electronically at
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.
VI. Applicability of Proposed 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. EPA solicits comments on whether any of the uses
proposed as significant new uses are ongoing.
As discussed in the Federal Register issue of April 24, 1990 (55 FR
17376), EPA has decided that the intent of TSCA section 5(a)(1)(B) is
best served by designating a use as a significant new use as of the
date of publication of the proposed rule rather than as of the
effective date of the final rule. If uses begun after publication of
the proposed rule were considered ongoing rather than new, it would be
difficult for EPA to establish SNUR notice requirements because a
person could defeat the SNUR by initiating the significant new use
before the proposed rule became final, and then argue that the use was
ongoing before the effective date of the final rule. Thus, any persons
who begin commercial manufacture, import, or processing activities with
the microorganism that would be regulated through this proposed rule
will have to cease any such activity before the effective date of the
final rule, if and when finalized. 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
proposed SNUR before the effective date. If a person were to meet the
conditions of advance compliance under 40 CFR 725.912(a), the person
would be considered exempt from the requirements of the SNUR.
VII. Test Data and Other Information
EPA recognizes that TSCA section 5 does not require developing any
particular test data before submission of a SNUN. There are two
exceptions:
1. Development of test data is required where the chemical
substance subject to the SNUR is also subject to a test rule under TSCA
section 4 (see TSCA section 5(b)(1)).
2. Development of test data may be necessary where the chemical
substance has been listed under TSCA section 5(b)(4) (see TSCA section
5(b)(2)).
In the absence of a TSCA section 4 test rule or a TSCA section
5(b)(4) listing covering the chemical substance, 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 (see 40 CFR
725.25(a)(2)). However, upon review of MCANs and SNUNs, the Agency has
the authority to require appropriate testing. In this case, EPA
recommends persons, before performing any testing, to consult with the
Agency pertaining to protocol selection.
The recommended testing specified in Unit IV. may not be the only
means of addressing the potential risks for the chemical substance.
However, SNUNs submitted without any test data may increase the
likelihood that EPA will respond by taking action under TSCA section
5(e), particularly if satisfactory test results have not been obtained
from a prior submission. 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 the following:
Human exposure and environmental release that may result
from the significant new use of the chemical substance.
Potential benefits of the chemical substance.
Information on risks posed by the chemical substance
compared to risks posed by potential substitutes.
VIII. SNUN Submissions
Persons subject to this SNUR must comply with the notice
requirements under TSCA section 5(a)(1)(A) and must submit a MCAN,
using the procedures set out in 40 CFR part 725, subpart D, and
additional ``Significant New Uses of Microorganisms'' procedures at 40
CFR part 725, subpart L. SNUNs must be submitted to EPA on EPA Form No.
6300-07, generated using e-PMN software, and submitted to the Agency in
accordance with the procedures set forth in 40 CFR 725.25 and 40 CFR
725.27. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems.
IX. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers, importers, and processors of
the chemical substance subject to this proposed rule. EPA's complete
Economic Analysis is available in the docket under docket ID number
EPA-HQ-OPPT-2010-0994.
X. Statutory and Executive Order Reviews
A. Executive Order 12866
This proposed rule would establish a SNUR for a chemical substance
that was the subject of a MCAN. The Office of Management and Budget
(OMB) has exempted these types of actions from review under Executive
Order 12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993).
B. Paperwork Reduction Act
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 PRA, unless it has been approved by OMB and displays a
currently valid OMB
[[Page 35335]]
control number. The OMB control numbers for EPA's regulations in title
40 of the CFR, after appearing in the Federal Register, are listed in
40 CFR part 9, and included on the related collection instrument or
form, if applicable. EPA would amend the table in 40 CFR part 9 to list
the OMB approval number for the information collection requirements
contained in this proposed rule. This listing of the OMB control
numbers and their subsequent codification in the CFR satisfies the
display requirements of PRA and OMB's implementing regulations at 5 CFR
part 1320.
The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action would not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
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 techniques, to the Director,
Collection Strategies Division, Office of Environmental Information
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001. Please remember to include the OMB control
number in any correspondence, but do not submit any completed forms to
this address.
C. Regulatory Flexibility Act
On February 18, 2012, EPA certified pursuant to section 605(b) of
the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), that
promulgation of a SNUR would not have a significant economic impact on
a substantial number of small entities where the following are true:
1. A significant number of SNUNs would not be submitted by small
entities in response to the SNUR.
2. The SNUN submitted by any small entity would not cost
significantly more than $8,300.
A copy of that certification is available in the docket for this
proposed rule.
This proposed rule is within the scope of the February 18, 2012
certification. Based on the Economic Analysis discussed in Unit IX. and
EPA's experience promulgating SNURs (discussed in the certification),
EPA believes that the following are true:
A significant number of SNUNs would not be submitted by
small entities in response to the SNUR.
Submission of the SNUN would not cost any small entity
significantly more than $8,300. Therefore, the promulgation of the SNUR
would not have a significant economic impact on a substantial number of
small entities.
D. Unfunded Mandates Reform Act
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 reason to believe that any
State, local, or Tribal government would be impacted by this proposed
rule. As such, EPA has determined that this proposed rule would not
impose any enforceable duty, contain any unfunded mandate, or otherwise
have any effect 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).
E. Executive Order 13132
This action would not 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).
F. Executive Order 13175
This proposed rule would not have Tribal implications because it is
not expected to have substantial direct effects on Indian Tribes. This
proposed rule would not significantly nor uniquely affect the
communities of Indian Tribal governments, nor would 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 9,
2000), do not apply to this proposed rule.
G. Executive Order 13045
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.
H. Executive Order 13211
This proposed rule is not subject to Executive Order 13211,
entitled ``Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001),
because this action is not expected to affect energy supply,
distribution, or use and because this action is not a significant
regulatory action under Executive Order 12866.
I. National Technology Transfer and Advancement Act
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.
J. Executive Order 12898
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).
List of Subjects in 40 CFR Part 725
Chemicals, Environmental protection, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: June 1, 2012.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 725--[AMENDED]
1. The authority citation for part 725 continues to read as
follows:
Authority: 15 U.S.C. 2604, 2607, 2613, and 2625.
2. Add Sec. 725.1077 to subpart M to read as follows:
Sec. 725.1077 Trichoderma reesei (generic).
(a) Microorganism and significant new uses subject to reporting.
(1) The genetically modified microorganism identified generically as
Trichoderma reesei (MCAN J-10-2) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2)(i) The significant new use is any manufacturing, processing, or
use of the microorganism other than in a
[[Page 35336]]
fermentation system that meets all of the following conditions:
(A) Submerged fermentation (i.e., growth of the microorganism
occurs beneath the surface of the liquid growth medium).
(B) No solid plant material or insoluble substrate is included with
the microorganism for fermentation.
(C) Any fermentation of solid plant material or insoluble
substrate, to which fermentation broth is added, is initiated only
after the inactivation of the microorganism as delineated in 40 CFR
725.422(d).
(ii) [Reserved]
(b) [Reserved]
[FR Doc. 2012-14242 Filed 6-12-12; 8:45 am]
BILLING CODE 6560-50-P