Federal Register / Vol. 76, No. 197 / Wednesday, October 12, 2011 / Notices 63279 

1To view the notice, petition, draft EA, the PPRA, 

and the comments we received, go to http:// 

www.regulations.gov/#!docketDetail;D=APHIS2011-0038. 

longer subject to our regulations 

governing the introduction of certain 

genetically engineered organisms. 

Copies of the signed determination 

document, as well as copies of the 

petition, PPRA, EA, and finding of no 

significant impact are available as 

indicated in the ADDRESSES and FOR

FURTHER INFORMATION CONTACT sections 

of this notice. 

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 5th day of 

October 2011. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2011–26349 Filed 10–11–11; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2011–0038] 

Monsanto Co.; Determination of 

Nonregulated Status for Soybean 

Genetically Engineered for Insect 

Resistance 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice. 

SUMMARY: We are advising the public of 

our determination that a soybean line 

developed by the Monsanto Co., 

designated as event MON 87701, which 

has been genetically engineered for 

insect resistance, is no longer 

considered a regulated article under our 

regulations governing the introduction 

of certain genetically engineered 

organisms. Our determination is based 

on our evaluation of data submitted by 

the Monsanto Company in its petition 

for a determination of nonregulated 

status, our analysis of available 

scientific data, and comments received 

from the public in response to our 

previous notice announcing the 

availability of the petition for 

nonregulated status and its associated 

environmental assessment and plant 

pest risk assessment. This notice also 

announces the availability of our 

written determination and finding of no 

significant impact. 

DATES: Effective Date: October 12, 2011. 

ADDRESSES: You may read the 

documents referenced in this notice and 

the comments we received in our 

reading room. The reading room 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) 690–2817 before 

coming. Those documents are also 

available on the Internet at http:// 

www.aphis.usda.gov/biotechnology/ 

not_reg.html and are posted with the 

previous notice and the comments we 

received on the Regulations.gov Web 

site at http://www.regulations.gov/ 

#!docketDetail;D=APHIS–2011–0038. 

FOR FURTHER INFORMATION CONTACT: 

Mr. Evan Chestnut, Policy Analyst, 

Biotechnology Regulatory Services, 

APHIS, 4700 River Road Unit 147, 

Riverdale, MD 20737–1236; (301) 734– 

0942, e-mail: 

evan.a.chestnut@aphis.usda.gov. To 

obtain copies of the documents 

referenced in this notice, contact Ms. 

Cindy Eck at (301) 734–0667, e-mail: 

cynthia.a.eck@aphis.usda.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

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 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 received a petition (APHIS 

Petition Number 09–082–01p) from the 

Monsanto Company (Monsanto) of St. 

Louis, MO, seeking a determination of 

nonregulated status for soybean (Glycine 

max) designated as event MON 87701, 

which has been genetically engineered 

for insect resistance, 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. 

In a notice1 published in the Federal 

Register on June 28, 2011 (76 FR 37770– 

37771, Docket No. APHIS–2011–0038), 

APHIS announced the availability of the 

Monsanto petition, a plant pest risk 

assessment (PPRA), and a draft 

environmental assessment (EA) for 

public comment. APHIS solicited 

comments on the petition, whether the 

subject soybeans are likely to pose a 

plant pest risk, the draft EA, and the 

PPRA for 60 days ending on August 29, 

2011. 

APHIS received four comments 

during the comment period. Two 

commenters referenced a different 

soybean line. One commenter expressed 

general opposition to genetically 

engineered crops but did not provide 

any specific comments on the petition, 

draft EA, or PPRA. One commenter 

suggested that APHIS should analyze 

the impacts of MON 87701 on bees and 

groundwater. APHIS has addressed the 

issues raised by this commenter in an 

attachment to the finding of no 

significant impact, and impacts to nontarget insects and impacts on water are 

both addressed in the EA. 

National Environmental Policy Act 

To provide the public with 

documentation of APHIS’ review and 

analysis of any potential environmental 

impacts associated with the 

determination of nonregulated status for 

Monsanto’s soybean event MON 87701, 

an EA has been prepared. The 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). Based on our EA, the response to 

public comments, and other pertinent 

scientific data, APHIS has reached a 

finding of no significant impact with 

regard to the preferred alternative 

identified in the EA. 

Determination 

Based on APHIS’ analysis of field and 

laboratory data submitted by Monsanto, 

references provided in the petition, 

peer-reviewed publications, information 

analyzed in the EA, the PPRA, 

comments provided by the public, and 

information provided in APHIS’ 

response to those public comments, 

APHIS has determined that Monsanto’s 


jlentini on DSK4TPTVN1PROD with NOTICES
63280 Federal Register / Vol. 76, No. 197 / Wednesday, October 12, 2011 / Notices 

soybean event MON 87701 is unlikely to 

pose a plant pest risk and therefore is no 

longer subject to our regulations 

governing the introduction of certain 

genetically engineered organisms. 

Copies of the signed determination 

document, as well as copies of the 

petition, PPRA, EA, finding of no 

significant impact, and response to 

comments are available as indicated in 

the ADDRESSES and FOR FURTHER

INFORMATION CONTACT sections of this 

notice. 

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 5th day of 

October 2011. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2011–26351 Filed 10–11–11; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

[Docket No. FSIS–2011–0022] 

Codex Alimentarius Commission: 

Meeting of the Codex Committee on 

Nutrition and Foods for Special Dietary 

Uses 

AGENCY: Office of the Under Secretary 

for Food Safety, USDA. 

ACTION: Notice of public meeting and 

request for comments. 

SUMMARY: The Office of the Under 

Secretary for Food Safety, U.S. 

Department of Agriculture (USDA), and 

the Food and Drug Administration 

(FDA), are sponsoring a public meeting 

on October 20, 2011. The objective of 

the public meeting is to provide 

information and receive public 

comments on agenda items and draft 

United States (U.S.) positions that will 

be discussed at the 33rd Session of the 

Codex Committee on Nutrition and 

Foods for Special Dietary Uses 

(CCNFSDU)of the Codex Alimentarius 

Commission (Codex), which will be 

held in Bad Soden am Taunus, Germany 

from November 14–18, 2011. In 

addition, two working groups will meet 

on November 12 from 9 a.m. to 5:30 

p.m. to discuss the Proposed Draft 

Revision of the Guidelines on 

Formulated Supplementary Foods for 

Older Infants and Young Children, and 

the Proposed Draft Revision of the 

Codex General Principles for the 

Addition of Essential Nutrients to 

Foods. 

The Under Secretary for Food Safety 

and the FDA recognize the importance 

of providing interested parties the 

opportunity to obtain background 

information on the 33rd Session of the 

CCNFSDU and to address items on the 

agenda. 

DATES: The public meeting is scheduled 

for October 20, 2011 from 1 p.m.–4 p.m. 

ADDRESSES: The public meeting will be 

held in the Harvey Wiley Building, 

FDA, Center for Food Safety and 

Applied Nutrition, (CFSAN), 5100 Paint 

Branch Parkway, Room (1A–003) 

College Park, MD 20740. Parking is 

adjacent to this building and will be 

available at no charge to individuals 

who preregister by the date below (See 

Pre-Registration). In addition, the 

College Park metro station is across the 

street. 

Documents related to the 33rd Session 

of the CCNFSDU will be accessible via 

the World Wide Web at the following 

address: http:// 

www.codexalimentarius.net/ 

current.asp. 

Barbara Schneeman, U.S. Delegate to 

the 33rd Session of the CCNFSDU, 

invites U.S. interested parties to submit 

their comments electronically to the 

following e-mail address: 

CCNFSDU@fda.hhs.gov. 

Pre-Registration: To pre-register for 

this meeting, please send the following 

information to this e-mail address 

(nancy.crane@fda.hhs.gov) by October 

13, 2011. 

—Your name 

—Organization 

—Mailing Address 

—Phone number 

—E-mail address 

Call-In Number 

If you wish to participate in the 

public meeting for the 33rd Session of 

the CCNFSDU by conference call, please 

use call-in number and participant code 

listed below. 

Call-in Number: 1–866–859–5767 

Participant Code: 2225276 

For Further Information About the 

33rd Session of the CCNFSDU Contact: 

Nancy Crane, Senior Advisor to the U.S. 

CCNFSDU Delegate, Office of Nutrition, 

Labeling and Dietary Supplements, 

CFSAN (HFS–830), FDA, 5100 Paint 

Branch Parkway, College Park, MD 

20740, telephone: (240) 402–1450, fax: 

(301) 436–2636, e-mail: 

Nancy.Crane@fda.hhs.gov. 

For Further Information About the 

Public Meeting Contact: Paulo Almeida, 

U.S. Codex Office, 1400 Independence 

Avenue, SW., Room 4861, Washington, 

DC 20250, telephone: (202) 205–7760, 

fax: (202) 720–3157, e-mail: 

Paulo.Almeida@fsis.usda.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

Codex was established in 1963 by two 

United Nations organizations, the Food 

and Agriculture Organization (FAO) and 

the World Health Organization (WHO). 

Through adoption of food standards, 

codes of practice, and other guidelines 

developed by its committees, and by 

promoting their implementation by 

governments, Codex seeks to protect the 

health of consumers and ensure that fair 

practices are used in trade. 

The CCNFSDU is responsible for: 

(a) Studying specific nutritional 

problems assigned to it by Codex and 

advising Codex on general nutrition 

issues; 

(b) Drafting general provisions as 

appropriate, concerning the nutritional 

aspects of all foods; 

(c) Developing standards, guidelines, 

or related texts for foods for special 

dietary uses, in cooperation with other 

committees where necessary; and 

(d) Considering, amending if 

necessary, and endorsing provisions on 

nutritional aspects proposed for 

inclusion in Codex standards, 

guidelines, and related texts. 

Issues To Be Discussed at the Public 

Meeting 

The following items on the agenda for 

the 33rd Session of the CCNFSDU will 

be discussed during the public meeting: 

• Matters Referred to the CCNFSDU 

by Codex and/or Other Codex 

Committees. 

• Matters of Interest Arising from the 

FAO and WHO. 

• Proposed Draft Additional or 

Revised Nutrient Reference Values (for 

Labeling Purposes in the Codex 

Guidelines on Nutrition Labeling at Step 

4). 

• Report from FAO and WHO on 

Nutrient Reference Values. 

• Revised Draft of the General 

Principles for Establishing Nutrient 

Reference Values for labeling purposes 

for Nutrients Associated with Risk of 

Diet-Related Noncommunicable 

Diseases for the General Population at 

Step 4 (in light of comments at Step 3). 

• Proposed Draft Nutrient Reference 

Values for Nutrients Associated with 

Risk of Diet-Related Noncommunicable 

Diseases. 

• Proposed Draft Revision of the 

Codex General Principles for the 

Addition of Essential Nutrients to Foods 

at Step 4. 

• Proposed Draft Revision of the 

Guidelines on Formulated 

Supplementary Foods for Older Infants 

and Young Children at Step 4. 

• Proposed Draft Amendment of the 

Standard for Processed Cereal-Based 


jlentini on DSK4TPTVN1PROD with NOTICES