This section of the FEDERAL REGISTER

contains documents other than rules or

proposed rules that are applicable to the

public. Notices of hearings and investigations,

committee meetings, agency decisions and

rulings, delegations of authority, filing of

petitions and applications and agency

statements of organization and functions are

examples of documents appearing in this

section.

Notices Federal Register

13108

Vol. 60, No. 47

Friday, March 10, 1995

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

[Docket No. 94–121–2]

Availability of Determination of

Nonregulated Status for Gentically

Engineered Potato Lines

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Notice.

SUMMARY: We are advising the public of

our determination that certain potato

lines genetically engineered for

resistance to the Colorado potato beetle

by the Monsanto Company are no longer

considered regulated articles 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, an analysis of other scientific

data, and our review of comments

received from the public in response to

a previous notice announcing our

receipt of the Monsanto Company

petition. This notice also announces the

availability of our written determination

document and its associated

environmental assessment and finding

of no significant impact.

EFFECTIVE DATE: March 2, 1995.

ADDRESSES: The determination, an

environmental assessment and finding

of no significant impact, the petition,

and all written comments received

regarding the petition 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 to

inspect those documents are asked to

call in advance of visiting at (202) 690–

2817.

FOR FURTHER INFORMATION CONTACT: Dr.

Susan Koehler, Biotechnologist, Animal

and Plant Health Inspection Service,

Biotechnology, Biologics, and

Environmental Protection,

Biotechnology Permits, 4700 River Road

Unit 147, Riverdale, MD 20737–1228;

(301) 734–7612. To obtain a copy of the

determination or the environmental

assessment and finding of no significant

impact, contact Ms. Kay Peterson at

(301) 734–7612.

SUPPLEMENTARY INFORMATION:

Background

On September 14, 1994, the Animal

and Plant Health Inspection Service

(APHIS) received a petition from the

Monsanto Company (Monsanto) of St.

Louis, MO, seeking a determination that

seven Russet Burbank potato lines

designed at BT6, BT10, BT12, BT16,

BT17, BT18, and BT23, that have been

genetically engineered for resistance to

the Colorado potato (CPB) (hereinafter

CPB-resistant potato lines) do not

present a plant pest risk and, therefore,

are not regulated articles under APHIS’

regulations in 7 CFR part 340.

On December 2, 1994, APHIS

published a notice in the Federal

Register (59 FR 61866–61867, Docket

No. 94–121–1) announcing receipt of

the Monsanto petition and announcing

that the petition was available for public

review. The notice also discussed the

role of APHIS, the Environmental

Protection Agency, and the Food and

Drug Administration in regulating the

subject potato lines and food products

derived from them. In the notice, APHIS

solicted written comments from the

public as to whether the subject potato

lines posed a plant pest risk. The

comments were to have been received

by APHIS on or before January 31, 1995.

APHIS received a total of 61

comments on the Monsanto petition.

Comments were received from the

following categories of respondents,

with the categories containing the larger

number of respondents listed first:

potato farmers; universities; registered

dietitians; regional and national potato

growers’ association, councils, and

boards; cooperative extension service

offices; State departments of agriculture;

high school educators; individuals;

potato marketing services; a potato

research company; an agricultural

experiment station; the department of

agriculture of a foreign government; a

food company; an international

technology transfer agency; a potato

processor; and a member of the U.S.

House of Representatives. Fifty-eight of

the commenters urged approval of the

petition or provided information in

support of nonregulated status for the

subject potato lines. Three of the 61

commenters did not directly or

indirectly support approval of the

petition: one of the three did not

address the APHIS approval process;

another endorsed the concept of the

development of a CPB-resistant patato

but expressed certain concerns; and one

commenter asked that APHIS deny the

petition. APHIS has provided a

summary and discussion of the

comments in the determination

document, which is available upon

request from the individual listed under

FOR FURTHER INFORMATION CONTACT.

Analysis

The Monsanto CPB-resistant potato

lines have been genetically engineered

to express a gene from the common soil

bacterium Bacillus thuringiensis subsp.

tenebrionis (Btt) the encodes a highly

selective insecticidal delta-endotoxin

crystalline protein, CryIIIA. This insect

control protein is identical in amino

acid sequence to one of the proteins

naturally produced by Btt and found in

commercial microbial Btt formulations.

According to Monsanto, the protein is

highly selective in controlling CPB and

is expressed at an effective level in the

potato foliage throughout the growing

season. The expression of the insect

control protein in the subject potato

lines is regulated by an enhanced 35S

promoter derived from the plant

pathogen cauliflower mosaic virus and

by the nontranslated region of the small

subunit of ribulose-1,5-bisphosphate

carboxylase referred to as E9 3′ derived

from pea plants. The CPB-resistant

patato lines also express a selectable

marker gene derived from the

prokaryotic transposon Tn5 encoding

the enzyme neomycin

phosphotransferase II (nptII). The

expression of the nptII gene in the

subject potato lines is regulated by the

35S promoter and the nontranslated 3′

region of the nopaline synthase gene

derived from the plant pathogen

Agrobacterium tumefaciens. The

expression of nptII in the subject potato

lines allows for selective growth of

transgenic plant cells on the antibiotic
Federal Register / Vol. 60, No. 47 / Friday, March 10, 1995 / Notices 13109

kanamycin during plant tissue culture.

These genes were stably transferred into

the genome of potato plants through an

A. tumefaciens-mediated

transformation.

The subject potato lines have been

considered ‘‘regulated articles’’ under

APHIS’ regulations in 7 CFR part 340

because their noncoding regulatory

sequences were derived from the plant

pathogens A. tumefaciens and

cauliflower mosaic virus. However,

evaluation of field data reports from

field tests of the subject potato lines

conducted since 1991 in the major

potato-growing areas of the country

indicate that there were no deleterious

effects on plants, nontarget organisms,

or the environment as a result of the

subject patato lines’ release into the

environment.

Determination

Based on its analysis of the data

submitted by Monsanto, a review of

other scientific data, the comments

received from the public, and a review

of field tests of the subject potato lines,

APHIS has determined that the subject

patio lines: (1) Exhibit no plant

pathogenic properties; (2) are no more

likely to become weeds than CPBresistant potato lines that could

potentially be developed by traditional

breading techniques; (3) are unlikely to

increase the weediness potential of any

other cultivated plant or native wild

species with which the organisms can

interbreed; (4) will not cause damage to

processed agricultural commodities; (5)

are unlikely to harm other organisms,

such as bees or earthworms, that are

beneficial to agriculture; and (6) should

pose no greater threat to the ability to

control CPB in potatoes and other crops

than that posed by the widely-practiced

method of applying insecticides to

control CPB on potatoes. APHIS has also

concluded that there is a reasonable

certainty that new varieties developed

from the subject potato lines will not

exhibit new plant pest properties, i.e.,

properties substantially different from

any observed in the field-tested potato

lines, or those observed in standard

potatoes in traditional breeding

programs.

The effect of this determination is that

the seven Russet Burbank potato lines

designated as BT6, BT10, BT12, BT16,

BT17, BT18, and BT23 and all other

lines developed from them are no longer

considered regulated articles under

APHIS’ regulations in 7 CFR part 340.

Therefore, the permit and notification

requirements pertaining to regulated

articles under those regulations no

longer apply to the field testing,

importation, or interstate movement of

the subject potato lines or their progeny.

However, the importation of the subject

potato lines and any potato nursery

stock or seeds capable of propagation is

still subject to the restrictions from in

APHIS’ foreign quarantine notices in 7

CFR part 319.

National Environmental Policy Act

An environmental assessment (EA)

has been prepared to examine the

potential environmental impacts

associated with this determination. The

EA was prepared in accordance with: (1)

The National Environmental Policy Act

(NEPA) of 1969 (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

Procedures. Based on that EA, APHIS

has reached a finding of no significant

impact (FONSI) with regard to its

determination that the subject potato

lines and other lines developed from

those lines are no longer regulated

articles under its regulations in 7 CFR

part 340. Copies of the EA and the

FONSI are available upon request from

the individual listed under FOR FURTHER

INFORMATION CONTACT.

Done in Washington, DC, this 6th day of

March 1995.

Terry L. Medley,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 95–5993 Filed 3–9–95; 8:45 am]

BILLING CODE 3410–34–M

Commodity Credit Corporation

Uniform Grain and Rice Storage

Agreement Fees

AGENCY: Commodity Credit Corporation,

USDA.

ACTION: Notice of fees.

SUMMARY: The purpose of this notice is

to publish, in accordance with 7 CFR

1421.5558(b), a schedule of fees to be

paid to Commodity Credit Corporation

(CCC) by grain and rice warehouse

operators requesting to: (a) enter into a

storage agreement; or (b) renew an

existing storage agreement.

EFFECTIVE DATE: April 1, 1995.

FOR FURTHER INFORMATION CONTACT: Mr.

Steven Closson, Warehouse and

Inventory Division, Consolidated Farm

Service Agency, United States

Department of Agriculture, Room

5968—South Building. P.O. Box 2415,

Washington, DC 20013, (202) 720–4018.

SUPPLEMENTARY INFORMATION:

Executive Order 12372

The Uniform Grain and Rice Storage

Agreements are not subject to the

provisions of Executive Order 12372

which requires intergovernmental

consultation with State and local

officials. See the notice related to 7 CFR

part 3015, subpart V, published at 48 FR

29115 (June 24, 1983).

Paperwork Reduction Act

The fees set forth in this Notice do not

generate any new or revised information

collection or recordkeeping

requirements on the public.

Regulatory Flexibility Act

It has been determined that this

Notice will not significantly impact a

substantial number of small entities.

Contracting with CCC under the

Uniform Storage Agreements is strictly

voluntary. CCC is also not required by

5 U.S.C. 553 or any other provision of

law to publish a Notice of proposed

rulemaking with respect to the subject

matter of this Notice. Therefore the

Regulatory Flexibility Act is not

applicable to this notice, and a

Regulatory Flexibility Analysis was not

prepared.

Executive Order 12612

It has been determined that the

policies contained in this Notice will

not have substantial direct effects on

States or their political subdivisions, or

on the distribution of power and

responsibilities among the various

levels of Government.

Background

In accordance with the provisions of

CCC’s Charter Act (15 U.S.C. 714 et seq),

CCC enters into storage agreements with

private grain and rice warehouse

operators to provide for the storage of

commodities owned by CCC or pledged

as security to CCC for price support

loans.

The regulation, 7 CFR 1421.5558

requires that all non-federally licensed

grain and rice warehouse operators in

States that do not have a cooperative

agreement with CCC for warehouse

examinations and who do not have an

existing agreement with CCC for storage

and handling of CCC-owned

commodities or commodities pledged to

CCC as loan collateral, but who desire

such an agreement, must pay an

application and inspection fee prior to

CCC conducting the original warehouse

examination. Such grain or rice

warehouse operator who is already a

party to a storage agreement with CCC

must pay the annual contract fee in