Federal Register / Vol. 62, No. 189 / Tuesday, September 30, 1997 / Notices 51081

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

[Docket No. 97–091–1]

AgrEvo USA Co.; Receipt of Petition

for Determination of Nonregulated

Status for Canola Genetically

Engineered for Glufosinate 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 has received a

petition from AgrEvo USA Company

seeking a determination of nonregulated

status for canola designated as

Transformation Event T45, which has

been genetically engineered for

tolerance to the herbicide glufosinate.

The petition has been submitted in

accordance with our regulations

concerning the introduction of certain

genetically engineered organisms and

products. In accordance with those

regulations, we are soliciting public

comments on whether this canola

presents a plant pest risk.

DATES: Written comments must be

received on or before December 1, 1997.

ADDRESSES: Please send an original and

three copies of your comments to

Docket No. 97–091–1, Regulatory

Analysis and Development, PPD,

APHIS, Suite 3C03, 4700 River Road

Unit 118, Riverdale, MD 20737–1238.

Please state that your comments refer to

Docket No. 97–091–1. A copy of the

petition and any comments received

may be inspected at USDA, room 1141,

South Building, 14th Street and

Independence Avenue SW.,

Washington, DC, between 8 a.m. and

4:30 p.m., Monday through Friday,

except holidays. Persons wishing access

to that room to inspect the petition or

comments are asked to call in advance

of visiting at (202) 690–2817 to facilitate

entry into the reading room.

FOR FURTHER INFORMATION CONTACT: Dr.

James Lackey, Biotechnology

Evaluation, BSS, PPQ, APHIS, Suite

5B05, 4700 River Road Unit 147,

Riverdale, MD 20737-1236; (301) 734–

7612. To obtain a copy of the petition,

contact Ms. Kay Peterson at (301) 734–

4885; e-mail:

mkpeterson@aphis.usda.gov.

SUPPLEMENTARY INFORMATION: 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

determination of nonregulated status

must take and the information that must

be included in the petition.

On July 24, 1997, APHIS received a

petition (APHIS Petition No. 97–205–

01p) from AgrEvo USA Company

(AgrEvo) of Wilmington, DE, requesting

a determination of nonregulated status

under 7 CFR part 340 for canola

(Brassica napus L.) designated as

Transformation Event T45 (event T45),

which has been genetically engineered

for tolerance to the herbicide

glufosinate. The AgrEvo petition states

that the subject canola should not be

regulated by APHIS because it does not

present a plant pest risk.

As described in the petition, event

T45 canola has been genetically

engineered to contain the pat gene

derived from Streptomyces

viridochromogenes. The pat gene

encodes the enzyme phosphinothricinN-acetyltransferase (PAT), which

confers tolerance to the herbicide

glufosinate. Expression of the pat gene

is controlled by the 35S promoter and

terminator derived from the plant

pathogen cauliflower mosaic virus. The

Agrobacterium tumefaciens method was

used to transfer the added genes into the

parental cultivar B. napus var. AC

EXCEL.

Event T45 canola has been considered

a regulated article under the regulations

in 7 CFR part 340 because it contains

gene sequences from plant pests. The

subject canola has been field tested in

Canada since 1995, and in the U.S. since

1996 under APHIS permits. In the

process of reviewing the permit

applications for field trials of this

canola, APHIS determined that the

vectors and other elements were

disarmed and that the trials, which were

conducted under conditions of

reproductive and physical containment

or isolation, would not present a risk of

plant pest introduction or

dissemination. Event T45 canola has

been approved for commercial sale in

Canada.

In the Federal Plant Pest Act, as

amended (7 U.S.C. 150aa et seq.), ‘‘plant

pest’’ is defined as ‘‘any living stage of:

Any insects, mites, nematodes, slugs,

snails, protozoa, or other invertebrate

animals, bacteria, fungi, other parasitic

plants or reproductive parts thereof,

viruses, or any organisms similar to or

allied with any of the foregoing, or any

infectious substances, which can

directly or indirectly injure or cause

disease or damage in any plants or parts

thereof, or any processed, manufactured

or other products of plants.’’ APHIS

views this definition very broadly. The

definition covers direct or indirect

injury, disease, or damage not just to

agricultural crops, but also to plants in

general, for example, native species, as

well as to organisms that may be

beneficial to plants, for example,

honeybees, rhizobia, etc.

The U. S. Environmental Protection

Agency (EPA) is responsible for the

regulation of pesticides under the

Federal Insecticide, Fungicide, and

Rodenticide Act (FIFRA), as amended (7

U.S.C. 136 et seq.). FIFRA requires that

all pesticides, including herbicides, be

registered prior to distribution or sale,

unless exempt by EPA regulation. In

cases in which genetically modified

plants allow for a new use of an

herbicide or involve a different use

pattern for the herbicide, EPA must

approve the new or different use. When

the use of the herbicide on the

genetically modified plant would result

in an increase in the residues of the

herbicide in a food or feed crop for

which the herbicide is currently

registered, or in new residues in a crop

for which the herbicide is not currently

registered, establishment of a new

tolerance or a revision of the existing

tolerance would be required. Residue

tolerances for pesticides are established

by EPA under the Federal Food, Drug

and Cosmetic Act (FFDCA), as amended

(21 U.S.C. 301 et seq.), and the Food and

Drug Administration (FDA) enforces

tolerances set by EPA under the FFDCA.

FDA published a statement of policy

on foods derived from new plant

varieties in the Federal Register on May

29, 1992 (57 FR 22984–23005). The FDA

statement of policy includes a

discussion of FDA’s authority for

ensuring food safety under the FFDCA,

and provides guidance to industry on

the scientific considerations associated

with the development of foods derived

from new plant varieties, including

those plants developed through the

techniques of genetic engineering.

AgrEvo has begun consultation with

FDA on the subject canola.
51082 Federal Register / Vol. 62, No. 189 / Tuesday, September 30, 1997 / Notices

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 Determination of

Nonregulated Status from any interested

person for a period of 60 days from the

date of this notice. The petition and any

comments received are available for

public review, and copies of the petition

may be ordered (see the ADDRESSES

section of this notice).

After the comment period closes,

APHIS will review the data submitted

by the petitioner, all written comments

received during the comment period,

and any other relevant information.

Based on the available information,

APHIS will furnish a response to the

petitioner, either approving the petition

in whole or in part, or denying the

petition. APHIS will then publish a

notice in the Federal Register

announcing the regulatory status of

AgrEvo’s event T45 canola, and the

availability of APHIS’ written decision.

Authority: 7 U.S.C. 150aa–150jj, 151–167,

and 1622n; 31 U.S.C. 9701; 7 CFR 2.22, 2.80,

and 371.2(c).

Done in Washington, DC, this 24th day of

September 1997.

Terry L. Medley,

Aministrator, Animal and Plant Health

Inspection Service.

[FR Doc. 97–25858 Filed 9–29–97; 8:45 am]

BILLING CODE 3410–34–P

DEPARTMENT OF COMMERCE

International Trade Administration

[A–570–831]

Fresh Garlic From the People’s

Republic of China; Final Results of

Antidumping Duty Administrative

Review and Partial Termination of

Administrative Review

AGENCY: Import Administration,

International Trade Administration,

Department of Commerce.

ACTION: Notice of Final Results of

Antidumping Duty Administrative

Review.

SUMMARY: On June 20, 1997, the

Department of Commerce published the

preliminary results of administrative

review of the antidumping duty order

on fresh garlic from the People’s

Republic of China. The review covers

nine producers/exporters of subject

merchandise. The period of review is

November 1, 1995, through October 31,

1996.

We gave interested parties an

opportunity to comment on the

preliminary results. Since we received

no comments from interested parties,

the final results are the same as our

preliminary results. The final dumping

margin is listed below the section

entitled ‘‘Final Results of the Review.’’

EFFECTIVE DATE: September 30, 1997.

FOR FURTHER INFORMATION CONTACT:

Andrea Chu or Robin Gray, Office of

AD/CVD Enforcement, Import

Administration, International Trade

Administration, U.S. Department of

Commerce, 14th Street and Constitution

Avenue, N.W., Washington, D.C. 20230;

telephone (202) 482–4733.

SUPPLEMENTARY INFORMATION:

Applicable Statute

Unless otherwise indicated, all

citations to the Tariff Act of 1930, as

amended (the Tariff Act), are references

to the provisions effective January 1,

1995, the effective date of the

amendments made to the Tariff Act by

the Uruguay Round Agreements Act

(URAA). In addition, unless otherwise

indicated, all citations to the

Department’s regulations are to19 CFR

Part 353 (April 1997).

Background

On June 20, 1997, the Department

published the preliminary results of

administrative review (62 FR 33601) of

the antidumping duty order on fresh

garlic from the PRC (November 16,

1994, 59 FR 59209). Because we

determined that one named respondent,

Rizhao Hanxi Fisheries &

Comprehensive Development Co., Ltd.,

failed to submit a complete response to

our questionnaire and the remaining

named respondents failed to respond at

all to our questionnaires, we

preliminarily determined to use facts

otherwise available for cash deposit and

assessment purposes for all PRC

producers/exporters of the subject

merchandise. We received no comments

from interested parties on our

preliminary results.

We have conducted this

administrative review in accordance

with section 751 of the Tariff Act.

Scope of the Review

The products subject to this

antidumping duty order are all grades of

garlic, whole or separated into

constituent cloves, whether or not

peeled, fresh, chilled, frozen,

provisionally preserved, or packed in

water or other neutral substance, but not

prepared or preserved by the addition of

other ingredients or heat processing.

The differences between grades are

based on color, size, sheathing and level

of decay.

The scope of this order does not

include: (a) garlic that has been

mechanically harvested and that is

primarily, but not exclusively, destined

for non-fresh use; or (b) garlic that has

been specially prepared and cultivated

prior to planting and then harvested and

otherwise prepared for use as seed.

The subject merchandise is used

principally as a food product and for

seasoning. The subject garlic is

currently classifiable under subheadings

0703.20.0000, 0710.80.7060,

0710.80.9750, 0711.90.6000, and

2005.90.9500 of the Harmonized Tariff

Schedule of the United States (HTSUS).

Although the HTSUS subheadings are

provided for convenience and customs

purposes, our written description of the

scope of this proceeding is dispositive.

In order to be excluded from the

antidumping duty order, garlic entered

under the HTSUS subheadings listed

above that is (1) mechanically harvested

and primarily, but not exclusively,

destined for non-fresh use or (2)

specially prepared and cultivated prior

to planting and then harvested and

otherwise prepared for use as seed must

be accompanied by declarations to the

Customs Service to that effect.

Final Results of the Review

As a result of our review, we

determine that a margin of 376.67

percent exists for all producers/

exporters of the subject merchandise

from the PRC for the period November

1, 1995 through October 31, 1996.

The Department shall determine, and

the Customs Service shall assess,

antidumping duties on all appropriate

entries. The Department will issue

appraisement instructions directly to

the Customs Service.

Furthermore, the following cash

deposit requirements will be effective

upon publication of these final results

for all shipments of the subject

merchandise entered, or withdrawn

from warehouse, for consumption on or

after the publication date, as provided

for by section 751(a)(1) of the Tariff Act:

(1) for all PRC exporters, all of which

were found not to be entitled to separate

rates, the cash deposit will be 376.67

percent; and (2) for other non-PRC

exporters of subject merchandise from

the PRC, the cash deposit rate will be

the rate applicable to the PRC supplier

of that exporter. These deposit

requirements shall remain in effect until

publication of the final results of the

next administrative review.

This notice serves as a reminder to

importers of their responsibility under

19 CFR 353.26 to file a certificate

regarding the reimbursement of

antidumping duties prior to liquidation