### 41359 Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices

1 To view the notice, go to http://www. regulations.gov/#!docketDetail;D=APHIS-2011-

0129. Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests,’’ regulate, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. Such genetically engineered organisms and products are considered ‘‘regulated
articles.’’

The regulations in § 340.6(a) provide that any person may submit a petition
to the Animal and Plant Health Inspection Service (APHIS) seeking a
determination that an article should not be regulated under 7 CFR part 340. Paragraphs (b) and (c) of § 340.6 describe the form that a petition for a determination of nonregulated status
must take and the information that must be included in the petition.

APHIS has received a petition (APHIS Petition Number 09–328–01p) from Bayer CropScience LP (Bayer), seeking a determination of nonregulated status of soybean designated as event FG72, which has been genetically engineered to tolerate the herbicides glyphosate and isoxaflutole. The petition states that this soybean is unlikely to pose a plant pest risk and, therefore, should not be a regulated article under APHIS’ regulations in 7 CFR part 340.

As described in the petition, soybean event FG72 contains the stably integrated 2mepsps gene, which confers tolerance to the herbicide glyphosate,
and the hppdPfW336 gene, which
confers tolerance to HPPD inhibitors
such as the herbicide isoxaflutole.

Field tests conducted under APHIS oversight allowed for evaluation in a natural agricultural setting while imposing measures to minimize the risk of persistence in the environment after completion of the test. Data are gathered on multiple parameters and used by the applicant to evaluate agronomic characteristics and product performance. These and other data are used by APHIS to determine if the new variety poses a plant pest risk.

In section 403 of the Plant Protection Act, ‘‘plant pest’’ is defined as any living stage of any of the following that can directly or indirectly injure, cause damage to, or cause disease in any plant or plant product: A protozoan, a nonhuman animal, a parasitic plant, a bacterium, a fungus, a virus or viroid, an infectious agent or other pathogen, or any article similar to or allied with any of the foregoing. APHIS has prepared a plant pest risk assessment to determine if soybean event FG72 is unlikely to pose a plant pest risk. APHIS has also prepared a draft Environmental Assessment (EA) in which it presents two alternatives based on its analyses of data submitted by Bayer, a review of other scientific data,
and field tests conducted under APHIS oversight. APHIS is considering the following alternatives: (1) Take no action, i.e., APHIS would not change the regulatory status of soybean event FG72 and it would continue to be a regulated article, or (2) make a determination of nonregulated status for soybean event

FG72.

The draft EA has been prepared to provide the APHIS decisionmaker with a review and analysis of any potential environmental impacts associated with the proposed determination of nonregulated status for soybean event FG72. The draft EA was prepared in accordance with (1) the National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et

seq. ), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500–1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) APHIS’ NEPA Implementing Procedures (7 CFR part 372).

Paragraph (d) of § 340.6 provides that APHIS will publish a notice in the Federal Register providing 60 days for public comment for petitions for a determination of nonregulated status. On March 6, 2012, we published in the Federal Register (77 FR 13258–13260, Docket No. APHIS–2011–0129) a

notice 1 describing our updated process for soliciting public comment when considering such petitions. As described in the notice, all petitions received by APHIS on or after March 6, 2012, will be handled using the updated process, whereby APHIS will publish two separate notices in the Federal Register for petitions for which APHIS prepares
an environmental assessment. For petitions received before this date, however, we indicated that petitions may follow our previous process, i.e., the petition, draft EA, and PPRA will be made available in a single Federal Register notice for a 60-day comment period. For this petition, APHIS will follow our previous process.

In accordance with § 340.6(d) of the regulations, we are publishing this notice to inform the public that APHIS will accept written comments regarding the petition for a determination of nonregulated status from interested or affected persons for a period of 60 days from the date of this notice. We are also soliciting written comments from interested or affected persons on the plant pest risk assessment and the draft EA prepared to examine any potential environmental impacts of the proposed determination of nonregulated status of the subject soybean line. The petition, draft EA, and plant pest risk assessment are available for public review, and copies of the petition, draft EA, and plant pest risk assessment are available
as indicated under **ADDRESSES** and **FOR**

**FURTHER INFORMATION CONTACT** above.

After the comment period closes,
APHIS will review all written comments received during the comment period and any other relevant information. All comments received regarding the petition, draft EA, and plant pest risk assessment will be available for public review. After reviewing and evaluating the comments on the petition, the draft EA, plant pest risk assessment, and other data, APHIS will furnish a response to the petitioner, either approving or denying the petition. APHIS will also publish a notice in the Federal Register announcing the regulatory status of soybean event FG72 and the availability of APHIS’ written environmental decision and regulatory
determination.

Authority: 7 U.S.C. 7701–7772 and 7781– 7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and

371.3.

Done in Washington, DC, this 9th day of July 2012.

Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 2012–17136 Filed 7–12–12; 8:45 am]

**BILLING CODE 3410–34–P**

**DEPARTMENT OF AGRICULTURE**

**Animal and Plant Health Inspection**
**Service**

**[Docket No. APHIS–2012–0027]**

**Monsanto Co.; Availability of Petition for Determination of Nonregulated**  **Status of Maize Genetically Engineered With Tissue-Selective Glyphosate**  **Tolerance Facilitating the Production of Hybrid Maize Seed** 

**AGENCY :**  Animal and Plant Health Inspection Service, USDA.

**ACTION :**  Notice.

**SUMMARY :**  We are advising the public
that the Animal and Plant Health Inspection Service (APHIS) has received a petition from the Monsanto Company seeking a determination of nonregulated status of maize designated as MON 87427, which has been genetically


### 41360 Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices

1 To view the notice, go to http://www.regulations.gov/#!docketDetail;D=APHIS2011-0129

. engineered with tissue-selective tolerance to glyphosate in order to facilitate the production of hybrid maize seed. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. We are making the Monsanto petition available for review and comment to help us identify potential
environmental and interrelated economic issues and impacts that APHIS may determine should be
considered in our evaluation of the petition.

**DATES :**  We will consider all comments that we receive on or before September

11, 2012.

**ADDRESSES :**  You may submit comments by either of the following methods:

• Federal eRulemaking Portal: Go to http://www.regulations.gov/ #!documentDetail;D=APHIS-2012-0027-

0001

.

• Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2012–0027, Regulatory Analysis and Development, PPD, APHIS, Station 3A–03.8, 4700 River Road Unit 118, Riverdale, MD 20737–1238.

Supporting documents and any
comments we receive on this docket may be viewed at http:// www.regulations.gov/ #!docketDetail;D=APHIS-2012-0027 or in our reading room, which is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799–7039 before coming.

The petition is also available on the
APHIS Web site at http:// www.aphis.usda.gov/brs/aphisdocs/

10

_28101p.pdf

.

**FOR FURTHER INFORMATION CONTACT :**  Dr. John Turner, Director, Environmental Risk Analysis Programs, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737– 1236; (301) 851–3954, email: john.t.turner@aphis.usda.gov. To obtain copies of the petition, contact Ms. Cindy Eck at (301) 851–3892, email: cynthia.a.eck@aphis.usda.gov

.

**SUPPLEMENTARY INFORMATION :** 
Background

Under the authority of the plant pest provisions of the Plant Protection Act (7

U.S.C. 7701 et seq. ), the regulations in 7 CFR part 340, ‘‘Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests,’’ regulate, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. Such genetically engineered (GE) organisms and products are considered ‘‘regulated articles.’’

The regulations in § 340.6(a) provide that any person may submit a petition
to the Animal and Plant Health Inspection Service (APHIS) seeking a
determination that an article should not be regulated under 7 CFR part 340. Paragraphs (b) and (c) of § 340.6 describe the form that a petition for a determination of nonregulated status
must take and the information that must be included in the petition.

APHIS has received a petition (APHIS Petition Number 10–281–01p) from the Monsanto Company (Monsanto) of St. Louis, MO, seeking a determination of nonregulated status of maize ( Zea mays L.) designated as event MON 87427, which has been genetically engineered
for tissue-selective tolerance to glyphosate in order to facilitate the production of hybrid maize seed, stating that this maize is unlikely to pose a plant pest risk and, therefore, should not be a regulated article under APHIS’ regulations in 7 CFR part 340.

As described in the petition, maize event MON 87427 has been genetically engineered to facilitate the production of hybrid maize seed through the incorporation of a cp4 epsps coding sequence. The CP4 EPSPS protein
confers tolerance to the herbicide glyphosate, and tissue-selective expression of this protein in MON
87427 enables an extension of the use of glyphosate-tolerant maize as a tool in hybrid maize seed production. Maize event MON 87427 is currently regulated under 7 CFR part 340. Interstate
movements and field tests of maize
event MON 87427 have been conducted under permits issued or notifications acknowledged by APHIS.

Field tests conducted under APHIS oversight allowed for evaluation in a natural agricultural setting while imposing measures to minimize the risk of persistence in the environment after completion of the test. Data are gathered on multiple parameters and used by the applicant to evaluate agronomic characteristics and product performance. These and other data are used by APHIS to determine if the new variety poses a plant pest risk.

Paragraph (d) of § 340.6 provides that APHIS will publish a notice in the Federal Register providing 60 days for public comment for petitions for a determination of nonregulated status. On March 6, 2012, we published in the Federal Register (77 FR 13258–13260, Docket No. APHIS–2011–0129) a

notice 1 describing our process for soliciting public comment when considering petitions for determinations of nonregulated status for GE organisms.
In that notice we indicated that APHIS would accept written comments regarding a petition once APHIS deemed it complete.

In accordance with § 340.6(d) of the regulations and our process for soliciting public input when considering petitions for determinations of nonregulated status for GE organisms, we are publishing this notice to inform the public that APHIS will accept written comments regarding the petition for a determination of nonregulated
status from interested or affected persons for a period of 60 days from the date of this notice. The petition is available for public review, and copies
are available as indicated under

**ADDRESSES** and **FOR FURTHER**

**INFORMATION CONTACT** above.

We are interested in receiving comments regarding potential
environmental and interrelated economic issues and impacts that APHIS may determine should be
considered in our evaluation of the petition. We are particularly interested in receiving comments regarding biological, cultural, or ecological issues, and we encourage the submission of scientific data, studies, or research to support your comments. We also request that, when possible, commenters provide relevant information regarding specific localities or regions as maize growth, crop management, and crop utilization may vary considerably by geographic region.

After the comment period closes,
APHIS will review all written comments received during the comment period and any other relevant information; any substantive issues identified by APHIS based on our review of the petition and our evaluation and analysis of
comments will be considered in the development of our decisionmaking
documents.

As part of our decisionmaking process regarding a GE organism’s regulatory status, APHIS prepares a plant pest risk assessment to assess its plant pest risk and the appropriate environmental
documentation—either an Environmental Assessment (EA) or an


### 41361 Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices

1 To view the notice, go to http://www.regulations.gov/#!docketDetail;D=APHIS2011-0129. Environmental Impact Statement (EIS)—
in accordance with the National Environmental Policy Act (NEPA), to provide the Agency with a review and analysis of any potential environmental impacts associated with the petition request. For petitions for which APHIS prepares an EA, APHIS will follow our published process for soliciting public comment (see footnote 1) and publish a separate notice in the Federal Register announcing the availability of APHIS’ EA and plant pest risk assessment.
Should APHIS determine that an EIS is necessary, APHIS will complete the NEPA EIS process in accordance with Council on Environmental Quality regulations (40 CFR part 1500–1508) and APHIS’ NEPA implementing regulations (7 CFR part 372).

Authority: 7 U.S.C. 7701–7772 and 7781– 7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and

371.3.

Done in Washington, DC, this 9th day of July 2012.

Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 2012–17142 Filed 7–12–12; 8:45 am]

**BILLING CODE 3410–34–P**

**DEPARTMENT OF AGRICULTURE**

**Animal and Plant Health Inspection**
**Service**

**[Docket No. APHIS–2012–0032]**

**Dow AgroSciences LLC; Availability of**
**Petition for Determination of Nonregulated Status of Soybean**  **Genetically Engineered for Herbicide**

**Tolerance**

**AGENCY :**  Animal and Plant Health Inspection Service, USDA.

**ACTION :**  Notice.

**SUMMARY :**  We are advising the public
that the Animal and Plant Health Inspection Service (APHIS) has received a petition from Dow AgroSciences LLC (DAS) seeking a determination of nonregulated status of soybean designated as DAS–44406–6, which has been genetically engineered for
tolerance to broadleaf herbicides in the phenoxy auxin group (such as the herbicide 2,4-D) and the herbicides glyphosate and glufosinate. The petition
has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. We are making the DAS petition available for review and comment to help us identify potential environmental and
interrelated economic issues and impacts that APHIS may determine should be considered in our evaluation of the petition.

**DATES :**  We will consider all comments that we receive on or before September

11, 2012.

**ADDRESSES :**  You may submit comments by either of the following methods:

• Federal eRulemaking Portal: Go to http://www.regulations.gov/ #!documentDetail;D=APHIS-2012-0032-

0001.

• Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2012–0032, Regulatory Analysis and Development, PPD, APHIS, Station 3A–03.8, 4700 River Road Unit 118, Riverdale, MD 20737–1238.

Supporting documents and any
comments we receive on this docket may be viewed at http:// www.regulations.gov/ #!docketDetail;D=APHIS-2012-0032 or in our reading room, which is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799–7039 before coming.

The petition is also available on the
APHIS Web site at http:// www.aphis.usda.gov/brs/aphisdocs/

11

_23401p.pdf

.

**FOR FURTHER INFORMATION CONTACT :**  Dr. John Turner, Director, Environmental Risk Analysis Programs, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737– 1236; (301) 851–3954, email: john.t.turner@aphis.usda.gov. To obtain copies of the petition, contact Ms. Cindy Eck at (301) 851–3892, email: cynthia.a.eck@aphis.usda.gov.

**SUPPLEMENTARY INFORMATION :** 
Background

Under the authority of the plant pest provisions of the Plant Protection Act (7

U.S.C. 7701 et seq. ), the regulations in 7 CFR part 340, ‘‘Introduction of Organisms and Products Altered or Produced Through Genetic Engineering
Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests,’’ regulate, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. Such genetically engineered (GE) organisms and products are considered ‘‘regulated articles.’’

The regulations in § 340.6(a) provide that any person may submit a petition to the Animal and Plant Health Inspection Service (APHIS) seeking a
determination that an article should not be regulated under 7 CFR part 340. Paragraphs (b) and (c) of § 340.6 describe the form that a petition for a determination of nonregulated status
must take and the information that must be included in the petition.

APHIS has received a petition (APHIS Petition Number 11–234–01p) from Dow AgroSciences LLC of Indianapolis, IN, seeking a determination of nonregulated status of soybean ( Glycine max) designated as event DAS–44406–6, which has been genetically engineered
for tolerance to broadleaf herbicides in the phenoxy auxin group (such as the herbicide 2,4-D) and the herbicides glyphosate and glufosinate, stating that this soybean is unlikely to pose a plant pest risk and, therefore, should not be a regulated article under APHIS’ regulations in 7 CFR part 340.

As described in the petition, soybean
event DAS–44406–6 has been genetically engineered to express the aryloxyalkanoate dioxygenase-12 (AAD– 12), the double mutant 5- enolpyruvylshikimate-3-phosphate synthase (2mEPSPS), and phosphinothricin acetyltransferase (PAT) proteins. Soybean event DAS– 44406–6 is currently regulated under 7 CFR part 340. Interstate movements and field tests of soybean event DAS–44406– 6 have been conducted under permits issued or notifications acknowledged by

APHIS.

Field tests conducted under APHIS oversight allowed for evaluation in a natural agricultural setting while imposing measures to minimize the risk of persistence in the environment after completion of the test. Data are gathered on multiple parameters and used by the applicant to evaluate agronomic characteristics and product performance. These and other data are used by APHIS to determine if the new variety poses a plant pest risk.

Paragraph (d) of § 340.6 provides that APHIS will publish a notice in the Federal Register providing 60 days for public comment for petitions for a determination of nonregulated status. On March 6, 2012, we published in the Federal Register (77 FR 13258–13260, Docket No. APHIS–2011–0129) a

notice 1 describing our process for soliciting public comment when considering petitions for determinations of nonregulated status for GE organisms.
In that notice we indicated that APHIS would accept written comments