### 41356 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. **DEPARTMENT OF AGRICULTURE**

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

**[Docket No. APHIS–2012–0047]**

**Monsanto Co.; 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 the Monsanto Company (Monsanto) seeking a determination of nonregulated status of soybean designated as MON 87708, which has been genetically engineered for
tolerance to the herbicide dicamba. 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-2012-0047-

0001.

• Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2012–0047, 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-2012-0047 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

_ 18801p.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 10–188–01p) from the Monsanto Company (Monsanto) of St. Louis, MO, seeking a determination of nonregulated status of soybean ( Glycine max) designated as event MON 87708, which has been genetically engineered for tolerance to the herbicide dicamba, 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 MON 87708 has been genetically engineered to contain a gene from the
bacteria Stenotrophomonas maltophilia that expresses a monooxygenase enzyme that rapidly demethylates dicamba rendering it inactive, thereby conferring
tolerance to the herbicide dicamba. Soybean event MON 87708 is currently regulated under 7 CFR part 340.
Interstate movements and field tests of soybean event MON 87708 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 soybean growth, crop management, and crop utilization may vary considerably by geographic region.

After the comment period closes,
APHIS will review all written comments


### 41357 Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices

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 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. 2012–17129 Filed 7–12–12; 8:45 am]

**BILLING CODE 3410–34–P**

**DEPARTMENT OF AGRICULTURE**

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

**[Docket No. APHIS–2012–0035]**

**Monsanto Co.; Availability of Petition for Determination of Nonregulated**  **Status of Canola 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 the Monsanto Company (Monsanto) seeking a determination of nonregulated status of canola designated as MON 88302, which has been genetically engineered for tolerance to the herbicide glyphosate with more flexibility in the timing of herbicide application. 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-2012-0035-

0001

.

• Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2012–0035, 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-2012-0035 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

_ 18801p.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 11–188–01p) from the Monsanto Company of St. Louis, MO, seeking a determination of nonregulated status of canola ( Brassica napus) designated as event MON 88302, which has been genetically engineered for tolerance to the herbicide glyphosate with more flexibility in the timing of herbicide application, stating that this canola 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, canola event MON 88302 has been genetically engineered for tolerance to the herbicide glyphosate via the incorporation of a cp4 epsps coding sequence, producing the same 5-enolpyruvylshikimate-3- phosphate synthase (CP4 EPSPS) protein that is produced in commercial Roundup Ready ® crop products. MON 88302 utilizes an improved promoter sequence to enhance CP4 EPSPS expression in male reproductive tissues (i.e., pollen). Enhanced CP4 EPSPS expression in the male reproductive tissues of MON 88302 allows the greater flexibility of glyphosate herbicide applications as MON 88302 plants can be sprayed with higher rates of glyphosate and at later stages of development with no detectable impact to male fertility. Canola event MON 88302 is currently regulated under 7 CFR part 340. Interstate movements and
field tests of canola event MON 88302
have been conducted under 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