Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices 13305 

1To view the notice, the PRA, and the comments 

we received, go to http://www.regulations.gov/ 

#!docketDetail;D=APHIS-2012-0009. 

APHIS may begin issuing permits for 

importation of the fruit or vegetable 

subject to the identified designated 

measures if: (1) No comments were 

received on the PRA; (2) the comments 

on the PRA revealed that no changes to 

the PRA were necessary; or (3) changes 

to the PRA were made in response to 

public comments, but the changes did 

not affect the overall conclusions of the 

analysis and the Administrator’s 

determination of risk. 

In accordance with that process, we 

published a notice 1 in the Federal 

Register on April 16, 2012 (77 FR 

22557–22558, Docket No. APHIS–2012– 

0009), in which we announced the 

availability, for review and comment, of 

a PRA that evaluates the risks associated 

with the importation into the 

continental United States of fresh 

strawberry (Fragaria spp.) fruit with 

calyx and short stalk from Egypt. We 

solicited comments on the notice for 60 

days ending on June 15, 2012. We 

received three comments by that date. 

They were from a State department of 

agriculture, an agricultural research 

center, and a non-profit industry 

representative. 

In the PRA, APHIS determined that 

three plant pests have a high risk 

potential of being introduced into the 

United States via the pathway of fresh 

strawberry fruit from Egypt. Those pests 

are: Chrysodeixis chalcites, 

Eutetranychus orientalis, and 

Spodoptera littoralis. The PRA notes 

that Eutetranychus orientalis could 

potentially avoid detection beneath the 

calyx of the strawberries due to its small 

size. One commenter cited this potential 

risk as a phytosanitary concern. The 

commenter stated that they would be 

willing to revisit this issue if current 

mitigation procedures are proven to be 

effective and without any detections of 

this mite. 

We acknowledge the risk that this 

plant pest could potentially evade 

detection and be introduced into the 

United States in the manner referred to 

by the commenter. However, while the 

pest itself may potentially evade 

detection by its small size, its presence 

can be detected by visible signs of 

discoloration and damage to fruits and 

leaves. Additionally, good agricultural 

practices can effectively suppress or 

eliminate this pest from fields or 

prevent infestation. Successful control 

programs typically include monitoring, 

cultural, biological, and chemical 

components, all of which are used as 

part of Egypt’s standard pre- and postharvest practices for the production of 

export strawberries. Moreover, APHIS 

has permitted the entry of commercial 

strawberries from several countries in 

Asia, Europe, and South America where 

this pest of concern occurs. Over several 

decades, there has only been one 

interception of Eutetranychus orientalis 

in strawberry consignments. 

Another commenter stated that the 

PRA does not provide for adequate 

phytosanitary security against any 

tetranychid mite. 

In the risk assessment portion of the 

PRA, the only tetranychid species 

identified as likely to follow the 

importation pathway was Eutetranychus 

orientalis. For the reasons detailed 

above, we have determined that the 

application of certain phytosanitary 

measures coupled with standard 

industry practices will be adequate to 

mitigate the risk posed by this pest. 

Other tetranychid species identified as 

pests of fresh strawberry were: 

Tetranychus cinnabarinus (Boisduval), 

Tetranychus ludeni Zacher, 

Tetranychus neocalendonicus Andre ́, 

and Tetranychus urticae Koch, which 

are reported as being present in Egypt, 

but do not meet the definition of 

quarantine pests, and Tetranychus 

turkestani, which has been reported as 

being present in the region, but APHIS 

did not find sufficient evidence the pest 

is present in Egypt. The commenter did 

not discuss any particular species of 

tetranychid which they believe to be of 

concern, nor did they present evidence 

contradicting the information presented 

in the risk assessment. 

The third commenter recommended 

that we adopt specific phytosanitary 

measures to address the pest risks 

discussed in the PRA. 

APHIS has permitted the entry of 

commercial strawberries from several 

countries in Asia, Europe, and South 

America with similar lists of pests of 

concern (e.g., Jordan and Israel). Based 

on our knowledge and experience in 

relation to importation of fresh 

strawberry fruit from these countries 

with similar pest lists, we are confident 

of the efficacy of the designated 

measures in mitigating the 

phytosanitary risks posed by the 

importation of strawberry from Egypt. 

Finally, the commenter added that we 

should intensively monitor fresh 

strawberry from Egypt at the port of 

entry. 

An integral part of standard APHIS 

phytosanitary practices is inspection at 

the port of entry. 

For these reasons, together with 

Egypt’s use of integrated pest 

management practices in the production 

of commercial strawberries, APHIS has 

concluded that commercial strawberries 

for export from Egypt are unlikely to 

contain the identified quarantine pests. 

Accordingly, we have determined that 

no changes to the PRA are necessary 

based on these comments. 

Therefore, in accordance with the 

regulations in § 319.56–4(c)(2)(ii), we 

are announcing our decision to begin 

issuing permits for the importation into 

the continental United States of fresh 

strawberry fruit from Egypt subject to 

the following phytosanitary measures: 

• The fresh strawberry fruit may be 

imported into the continental United 

States in commercial consignments 

only; 

• Each consignment of fresh 

strawberry fruit must be inspected by 

the national plant protection 

organization of Egypt and accompanied 

by a phytosanitary certificate that 

includes an additional declaration 

stating that the consignment was 

inspected and found free of 

Chrysodeixis chalcites, Eutetrancychus 

orientalis, and Spodoptera littoralis; and 

• The fresh strawberry fruit is subject 

to inspection upon arrival at the U.S. 

port of entry. 

These conditions will be listed in the 

Fruits and Vegetables Import 

Requirements database (available at 

http://www.aphis.usda.gov/favir). In 

addition to these specific measures, 

fresh strawberry fruit from Egypt will be 

subject to the general requirements 

listed in § 319.56–3 that are applicable 

to the importation of all fruits and 

vegetables. 

Authority: 7 U.S.C. 450, 7701–7772, and 

7781–7786; 21 U.S.C. 136 and 136a; 7 CFR 

2.22, 2.80, and 371.3. 

Done in Washington, DC, this 20th day of 

February 2013. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2013–04475 Filed 2–26–13; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2012–0090] 

Syngenta Seeds, Inc., and Bayer 

CropScience AG; 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. 


erowe on DSK2VPTVN1PROD with NOTICES
13306 Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices 

1To view the notice, go to http:// 

www.regulations.gov/#!docketDetail;D=APHIS2011-0129. 

SUMMARY: We are advising the public 

that the Animal and Plant Health 

Inspection Service (APHIS) has received 

a petition from Syngenta Seeds, Inc., 

and Bayer CropScience AG seeking a 

determination of nonregulated status of 

soybean designated as event SYHTOH2, 

which has been genetically engineered 

for tolerance to the herbicides 

glufosinate and mesotrione. The petition 

has been submitted in accordance with 

our regulations concerning the 

introduction of certain genetically 

engineered organisms and products. We 

are making the Syngenta Seeds, Inc., 

and Bayer CropScience AG 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 April 29, 

2013. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/ 

#!documentDetail;D=APHIS-2012-0090- 

0001. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2012–0090, 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-2012-0090 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/ 

12_21501p.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 12–215–01p) from 

Syngenta Seeds, Inc., and Bayer 

CropScience (BCS) AG of Research 

Triangle Park, NC, seeking a 

determination of nonregulated status of 

soybean designated as event SYHTOH2, 

which has been genetically engineered 

to tolerate exposure to the herbicides 

glufosinate and mesotrione. Glufosinate 

tolerance is not a new engineered trait 

in GE soybean, while mesotrione 

tolerance is a new trait. The petition 

states that this soybean event 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 SYHTOH2 has been genetically 

engineered for tolerance to herbicides 

that inhibit p-hydroxyphenylpyruvate 

dioxygenase (HPPD), such as 

mesotrione, and tolerance to 

applications of glufosinate-ammonium 

herbicide. Soybean derived from 

transformation event SYHTOH2 was 

developed through Agrobacteriummediated transoformation to stably 

incorporate the genes avhppd-03 and 

pat into the soybean genome. The gene 

avhppd-03 encodes the enzyme phydroxyphenylpyruvate dioxygenase 

(AvHPPD–03) derived from oat (Avena 

sativa). AvHPPD–03 has lower binding 

affinity to mesotrione than does native 

soybean HPPD. When expressed in 

soybean, avhppd-03 conveys pre-and 

post-emergence tolerance to mesotrione. 

The gene pat encodes the enzyme 

phosphinothricin acetyltransferase 

(PAT) which, when produced in plants, 

acetylates L-phosphinothricin, the 

active form of glufosinate-ammonium 

herbicide, resulting in post-emergence 

tolerance. Soybean event SYHTOH2 is 

currently regulated under 7 CFR part 

340. Interstate movement and field tests 

of soybean event SYHTOH2 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 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, 


erowe on DSK2VPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices 13307 

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 

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 22nd day of 

February 2013. 

Michael Gregoire, 

Deputy Administrator, Biotechnology 

Regulatory Services, Animal and Plant Health 

Inspection Service. 

[FR Doc. 2013–04521 Filed 2–26–13; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2012–0110] 

Dow AgroSciences LLC; Availability of 

Petition for Determination of 

Nonregulated Status of Soybean 

Genetically Engineered for Insect 

Resistance 

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–81419–2, which has 

been genetically engineered for 

resistance to certain lepidopteran pests. 

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 April 29, 

2013. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/ 

#!documentDetail;D=APHIS-2012-0110- 

0001. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2012–0110, 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-2012-0110 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/ 

12_27201p.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 12–272–01p) from Dow 

AgroSciences LLC of Indianapolis, IN, 

seeking a determination of nonregulated 

status of soybean (Glycine max) 

designated as event DAS–81419–2, 

which has been genetically engineered 

for resistance to certain lepidopteran 

pests. 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 DAS–81419–2 has been 

genetically engineered to express two 

insecticidal proteins, Cry1Ac and 

Cry1F, and phosphinothricin 

acetyltransferase, or PAT, protein. 

Soybean event DAS–81419–2 is 

currently regulated under 7 CFR part 

340. Interstate movements and field 

tests of soybean event DAS–81419–2 


erowe on DSK2VPTVN1PROD with NOTICES