Document ID: EPA-HQ-OPPT-2010-0994-0001
Agency: epa
Document Type: Proposed Rule
Title: Significant New Use Rules: Trichoderma reesei
Posted Date: 2012-06-13T04:00Z

[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

[[Page 35334]]

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]
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