Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 35331 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Public Law 104–4); 

• Does not have Federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the Clean Air Act; 

and 

• Does not provide EPA with the 

discretionary authority to address 

disproportionate human health or 

environmental effects with practical, 

appropriate, and legally permissible 

methods under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, this proposed action does 

not have tribal implications as specified 

by Executive Order 13175 (65 FR 67249, 

November 9, 2000), because the SIP is 

not approved to apply in Indian country 

located in the State, and EPA notes that 

it will not impose substantial direct 

costs on tribal governments or preempt 

tribal law. 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Intergovernmental 

relations, Ozone, Reporting and 

recordkeeping requirements, Volatile 

organic compounds. 

Authority: 42 U.S.C. 7401 et seq. 

Dated: May 25, 2012. 

Jared Blumenfeld, 

Regional Administrator, Region IX. 

[FR Doc. 2012–14410 Filed 6–12–12; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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: TSCAHotline@epa.gov. 

SUPPLEMENTARY INFORMATION: 


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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 

§ 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 

§ 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 

§ 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 § 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 § 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 

§ 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 


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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., 106) 

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 alphaamino-isobutyric acid (Aib), with a Nterminus 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 


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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 § 725.1077 to subpart M to 

read as follows: 

§ 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 


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35336 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 

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 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 64 

[CC Docket No. 96–115; DA 12–818] 

Privacy and Security of Information 

Stored on Mobile Communications 

Devices 

AGENCY: Federal Communications 

Commission. 

ACTION: Proposed rule. 

SUMMARY: This document seeks 

comment on the privacy and data 

security practices of mobile wireless 

services providers with respect to 

customer information stored on their 

users’ mobile communications devices. 

In addition, the document seeks 

comment on the application of existing 

privacy and security requirements to 

such information. 

DATES: Comments may be filed on or 

before July 13, 2012, and reply 

comments may be filed on or before July 

30, 2012. 

ADDRESSES: You may submit comments, 

identified by CC Docket No. 96–115, by 

any of the following methods: 

D Federal Communications 

Commission’s Web Site: http:// 

fjallfoss.fcc.gov/ecfs2/. Follow the 

instructions for submitting comments. 

D Mail: See the SUPPLEMENTARY

INFORMATION section of this document. 

D People with Disabilities: Contact the 

FCC to request reasonable 

accommodations (accessible format 

documents, sign language interpreters, 

CART, etc.) by email: FCC504@fcc.gov 

or phone: 202–418–0530 or TTY: 202– 

418–0432. For detailed instructions for 

submitting comments and additional 

information, see the SUPPLEMENTARY

INFORMATION section of this document. 

FOR FURTHER INFORMATION CONTACT: For 

further information regarding this 

proceeding, contact Douglas Klein, 

Office of General Counsel, (202) 418– 

1720. 

SUPPLEMENTARY INFORMATION: This is a 

summary of a Public Notice released by 

the Wireline Competition Bureau, the 

Wireless Telecommunications Bureau, 

and the Office of General Counsel on 

May 25, 2012. The full text of this 

document is available for public 

inspection and copying during regular 

business hours in the Commission’s 

Reference Information Center, Portals II, 

445 12th Street SW., Room CY–A257, 

Washington, DC 20554. The complete 

text of this document also may be 

purchased from the Commission’s copy 

contractor, Best Copy and Printing, Inc., 

Portals II, 445 12th Street SW., Room 

CY–B402, Washington, DC 20554, 

telephone (202) 488–5300, facsimile 

(202) 488–5563 or via email 

FCC@BCPIWEB.com. The full text may 

also be downloaded at http:// 

www.fcc.gov. Pursuant to §§ 1.415 and 

1.419 of the Commission’s rules, 47 CFR 

1.415, 1.419, interested parties may file 

comments and reply comments on or 

before the dates indicated on the first 

page of this document. Comments may 

be filed using the Commission’s 

Electronic Comment Filing System 

(ECFS). See Electronic Filing of 

Documents in Rulemaking Proceedings, 

63 FR 24121 (1998). 

D Electronic Filers: Comments may be 

filed electronically using the Internet by 

accessing the ECFS: http:// 

fjallfoss.fcc.gov/ecfs2/. 

D Paper Filers: Parties who choose to 

file by paper must file an original and 

one copy of each filing. If more than one 

docket or rulemaking number appears in 

the caption of this proceeding, filers 

must submit two additional copies for 

each additional docket or rulemaking 

number. 

Filings can be sent by hand or 

messenger delivery, by commercial 

overnight courier, or by first-class or 

overnight U.S. Postal Service mail. All 

filings must be addressed to the 

Commission’s Secretary, Office of the 

Secretary, Federal Communications 

Commission. 

D All hand-delivered or messengerdelivered paper filings for the 

Commission’s Secretary must be 

delivered to FCC Headquarters at 445 

12th St. SW., Room TW–A325, 

Washington, DC 20554. The filing hours 

are 8:00 a.m. to 7:00 p.m. All hand 

deliveries must be held together with 

rubber bands or fasteners. Any 

envelopes and boxes must be disposed 

of before entering the building. 

D Commercial overnight mail (other 

than U.S. Postal Service Express Mail 

and Priority Mail) must be sent to 9300 

East Hampton Drive, Capitol Heights, 

MD 20743. 

D U.S. Postal Service first-class, 

Express, and Priority mail must be 

addressed to 445 12th Street SW., 

Washington, DC 20554. 

Documents will be available for 

public inspection and copying during 

business hours at the FCC Reference 

Information Center, Portals II, Room 

CY–A257, 445 12th Street SW., 

Washington, DC 20554. The documents 

may also be purchased from BCPI, 

telephone (202) 488–5300, facsimile 

(202) 488–5563, TTY (202) 488–5562, 

email fcc@bcpiweb.com. 

People with Disabilities: To request 

materials in accessible formats for 

people with disabilities (Braille, large 

print, electronic files, audio format), 

send an email to fcc504@fcc.gov or call 

the Consumer & Governmental Affairs 

Bureau at 202–418–0530 (voice), 202– 

418–0432 (tty). 

The Commission has designated this 

proceeding as a ‘‘permit-but-disclose’’ 

proceeding in accordance with the 

Commission’s ex parte rules. 47 CFR 

1.1200 et seq.; Amendment of Certain of 

the Commission’s Part 1 Rules of 

Practice and Procedure and Part 0 Rules 

of Commission Organization, Notice of 

Proposed Rulemaking, 25 FCC Rcd 

2430, 2439–40 (2010). Persons making 

ex parte presentations must file a copy 

of any written presentation or a 

memorandum summarizing any oral 

presentation within two business days 

after the presentation (unless a different 

deadline applicable to the Sunshine 

period applies). Persons making oral ex 

parte presentations are reminded that 

memoranda summarizing the 

presentation must (1) list all persons 

attending or otherwise participating in 

the meeting at which the ex parte 

presentation was made, and (2) 

summarize all data presented and 

arguments made during the 

presentation. If the presentation 

consisted in whole or in part of the 

presentation of data or arguments 

already reflected in the presenter’s 

written comments, memoranda or other 

filings in the proceeding, the presenter 

may provide citations to such data or 

arguments in his or her prior comments, 

memoranda, or other filings (specifying 

the relevant page and/or paragraph 

numbers where such data or arguments 

can be found) in lieu of summarizing 

them in the memorandum. Documents 

shown or given to Commission staff 

during ex parte meetings are deemed to 

be written ex parte presentations and 

must be filed consistent with § 1.1206(b) 


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