Federal Register / Vol. 79, No. 68 / Wednesday, April 9, 2014 / Notices 19611 

Inquiry from private citizens affected by 

the use of Ge-68 in Ge-68/Ga-68 

generators critical in medical imaging 

for certain cancers, and from some 

private companies involved in the 

manufacture of products for medical 

purposes. Responses from commenters 

focused on concerns such as pricing, 

monopolies, and discontinuation of 

isotope availability in the event of 

foreign or domestic supply disruption. 

A private U.S. company, Mallinckrodt 

Pharmaceuticals Inc., supplied a 

substantial amount of information in 

support of the Department’s withdrawal 

from commercial production and 

distribution of Ge-68. The concerns and 

interests expressed by private citizens 

and affected industry are precisely those 

which comprise the factors the 

Department has evaluated to ensure 

there would be no adverse impacts in 

the event of DOE withdrawal from 

production. 

While DOE is currently the only 

domestic producer of Ge-68, there are 

foreign producers of Ge-68 that 

distribute the radioisotope in the U.S. 

through U.S. distributors. Mallinckrodt 

has an existing facility in the U.S. that 

currently produces radioisotopes, with 

the capability to produce Ge-68 for 

domestic distribution. The information 

supplied by Mallinckrodt indicates it 

has a long history as a strong market 

participant in the production and sales 

of radioisotopes. Further, Mallinckrodt 

was judged to have the facilities, 

expertise, and management and 

financial resources necessary to produce 

sufficient quantities of Ge-68 to meet 

domestic demand. Production and 

distribution of radioisotopes is the core 

of the Mallinckrodt’s business and Ge68 is the latest product that they have 

developed to generate near-term sales 

and capture a share of a long-term 

growth market. Mallinckrodt has 

demonstrated capability to 

commercially produce Ge-68. 

The Department has determined that 

there is sufficient evidence to conclude 

that, upon the Department’s withdrawal 

from the production and distribution of 

Ge-68, Mallinckrodt would continue 

production of Ge-68, based upon the 

investments it’s made in developing 

production capability, the fact that it 

has built a worldwide capability to 

engage in isotope production and 

distribution, and that such activities are 

at the core of their business. The 

Department has further concluded that 

if it were to withdraw from the market, 

Mallinckrodt would establish the price 

for the Ge-68 isotope on a fair and 

reasonable basis and within a range of 

the prices the Department currently 

charges. While Mallinckrodt did not 

explicitly state the price it would 

charge, its intention to maintain pricing 

consistent with the market suggests that 

there would not be catastrophic price 

changes if the Department withdraws 

from the market. With multiple private 

sector suppliers, pricing more likely 

than not would be controlled by market 

forces obviating the need for any 

Department mandate. 

In light of the information provided 

by Mallinckrodt, input from private 

industry, and other information 

available to the Department, the 

Department intends to withdraw from 

the market for Ge-68 for the 

manufacture of PET calibration sources. 

The Department has concluded that 

Mallinckrodt has the capability and 

intent to meet market demand, and 

because there are multiple suppliers of 

Ge-68 suitable for use in the 

manufacturing of PET calibration 

sources (as well as multiple companies 

engaging in source fabrication), the 

Department has further concluded that 

the demand for the Ge-68 for calibration 

source manufacturing will be met and 

maintained at reasonable market-based 

pricing. 

The Department has concluded that it 

will not withdraw from the market for 

Ge-68 for the manufacture of generators, 

however, because it has determined that 

there are no suppliers of bulk Ge-68 

qualified for use in Ge-68/Ga-68 

generators. This issue involves several 

concerns. First, if the Department were 

to exit the market, it appears that there 

would be no domestic producers of Ge68 presently qualified for use in Ge-68/ 

Ga-68 generators. These generators 

provide Ga-68 which is incorporated as 

a positron source in 

radiopharmaceuticals used in PET 

imaging medical applications currently 

under development. Qualification of 

other Ge-68 suppliers to serve the 

generator market would take time (in 

addition to potentially lengthy product 

testing, producers may have to change 

their production processes to provide 

Ge-68 that can be used on a generator 

for Ga-68 use in humans) and could 

impact researchers’ achievement of 

Food and Drug Administration (FDA) 

approval for Ga-68-based medical 

imaging. Second, there is only one 

known foreign supplier of Ge-68/Ga-68 

generators, which the Department does 

not believe is a dependable supply 

source for the U.S. market. The foreign 

supplier’s production data does not 

provide adequate assurance the U.S. 

generator market would be adequately 

supplied by foreign suppliers. In the 

absence of a Department supply of Ge68 for the manufacture of generators, 

Mallinckrodt would be the only 

immediate domestic source for 

generators, but only when or if the 

Mallinckrodt develops its own generator 

or its Ge-68 is qualified for use by other 

generator manufacturers. A single 

foreign supplier represents a risk that 

one domestic company, Mallinckrodt, 

could be the sole reliable domestic 

supplier of Ge-68 for generators and this 

could be problematic for the U.S. market 

for generators. If generator 

manufacturers were able to qualify 

Mallinckrodt’s Ge-68 for use in 

generators, the Department’s withdrawal 

from production would provide 

Mallinckrodt with a monopoly position 

in the marketplace for Ge-68 use in the 

manufacture of generators and other 

generator manufacturers would 

eventually be in a position of having to 

buy Ge-68 from their competitor. 

In light of these circumstances, the 

Department has concluded that there is 

not effective competition in the market 

for Ge-68 for use in Ge-68/Ga-68 

generators, and therefore it will 

continue to serve that segment of the 

Ge-68 market to provide competition. 

The Department’s participation in that 

segment of the market will serve to 

reduce the potential for impediments to 

research and development leading to 

FDA approval of Ga-68 

radiopharmaceuticals. 

To help provide assurance of supply 

of Ge-68 for calibration source purposes, 

DOE proposes to maintain production 

capability, but not engage in sales to the 

marketplace, such that production 

would resume in a timely manner if 

Mallinckrodt and other suppliers are not 

be able to adequately serve the market 

or if private supplier pricing 

substantially increases and has a 

negative impact on the development 

and utilization of Ge-68 products. 

Issued in Washington, DC, on April 2, 

2014. 

Jehanne Gillo, 

Director, Facilities and Project Management 

Division, Office of Nuclear Physics, Office 

of Science. 

[FR Doc. 2014–07865 Filed 4–8–14; 8:45 am] 

BILLING CODE 6450–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPP–2014–0212; FRL–9908–82] 

Pesticide Experimental Use Permit; 

Receipt of Application, Comment 

Request 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 


TKELLEY on DSK3SPTVN1PROD with NOTICES
19612 Federal Register / Vol. 79, No. 68 / Wednesday, April 9, 2014 / Notices 

SUMMARY: This notice announces EPA’s 

receipt of an application 8917–EUP–R 

from J.R. Simplot Company requesting 

an experimental use permit (EUP) for 

the Rpi-vnt1 gene that expresses the 

VNT1 protein in InnateTM 2.0 branded 

potato varieties. The Agency has 

determined that the permit may be of 

regional and national significance. 

Therefore, because of the potential 

significance, EPA is seeking comments 

on this application. 

DATES: Comments must be received on 

or before May 9, 2014. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2014–0212, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC) (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery of boxed 

information, please follow the 

instructions at http://www.epa.gov/

dockets/contacts.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at 

http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Shanaz Bacchus, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8097; email address: 

bacchus.shanaz@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

This action is directed to the public 

in general. Although this action may be 

of particular interest to those persons 

who conduct or sponsor research on 

pesticides, the Agency has not 

attempted to describe all the specific 

entities that may be affected by this 

action. 

B. What should I consider as I prepare 

my comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or email. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD–ROM that 

you mail to EPA, mark the outside of the 

disk or CD–ROM as CBI and then 

identify electronically within the disk or 

CD–ROM the specific information that 

is claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When submitting comments, remember 

to: 

i. Identify the document by docket ID 

number and other identifying 

information (subject heading, Federal 

Register date and page number). 

ii. Follow directions. The Agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number. 

iii. Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes. 

iv. Describe any assumptions and 

provide any technical information and/ 

or data that you used. 

v. If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

vi. Provide specific examples to 

illustrate your concerns and suggest 

alternatives. 

vii. Explain your views as clearly as 

possible, avoiding the use of profanity 

or personal threats. 

viii. Make sure to submit your 

comments by the comment period 

deadline identified. 

3. Environmental justice. EPA seeks to 

achieve environmental justice, the fair 

treatment and meaningful involvement 

of any group, including minority and/or 

low income populations, in the 

development, implementation, and 

enforcement of environmental laws, 

regulations, and policies. To help 

address potential environmental justice 

issues, the Agency seeks information on 

any groups or segments of the 

population who, as a result of their 

location, cultural practices, or other 

factors, may have atypical or 

disproportionately high and adverse 

human health impacts or environmental 

effects from exposure to the pesticide(s) 

discussed in this document, compared 

to the general population. 

II. What action is the Agency taking? 

Under section 5 of the Federal 

Insecticide, Fungicide and Rodenticide 

Act (FIFRA), 7 U.S.C. 136c, EPA can 

allow manufacturers to field test 

pesticides under development. 

Manufacturers are required to obtain an 

EUP before testing new pesticides or 

new uses of pesticides if they conduct 

experimental field tests on 10 acres or 

more of land, or one acre or more of 

water. 

Pursuant to 40 CFR 172.11(a), the 

Agency has determined that the 

following EUP application may be of 

regional and national significance, and 

therefore is seeking public comment on 

the EUP application: 

Submitter: J.R. Simplot Company, 

5369 West Irving Street, Boise, ID 

83706, (8917–EUP–R). 

Pesticide Chemical: Rpi-vnt1 gene 

that expresses the VNT1 protein in 

InnateTM 2.0 branded potato varieties. 

Summary of Request: Simplot is 

proposing an experimental program to 

allow planting for the evaluation of the 

plant-incorporated protectant (PIP) Rpivnt1 gene that expresses the VNT1 

protein in InnateTM 2.0 branded potato 

varieties. Simplot asserts that this plant 

trait confers resistance to the plant 

pathogen Phytophthora infestans 

(commonly known as late blight). 

Planting is expected to occur from 

spring 2014 through October 2014 on a 

total of 96.75 acres; testing will occur in 

10 states: Idaho, Michigan, Nebraska, 

New York, North Carolina, North 

Dakota, Oregon, Pennsylvania, 

Washington, and Wisconsin. The total 

amount of material expected to be used 

is 0.0088 pounds of VNT1 protein in 

239,375 pounds of potatoes. 

A copy of the application and any 

information submitted is available for 

public review in the docket established 

for this EUP application. 

Following the review of the 

application and any comments and data 

received in response to this solicitation, 

EPA will decide whether to issue or 

deny the EUP request, and if issued, the 

conditions under which it is to be 

conducted. Any issuance of an EUP will 

be announced in the Federal Register. 

List of Subjects 

Environmental protection, 

Experimental use permits. 

Dated: March 27, 2014. 

Robert McNally, 

Director, Biopesticides and Pollution 

Prevention Division, Office of Pesticide 

Programs. 

[FR Doc. 2014–07819 Filed 4–8–14; 8:45 am] 

BILLING CODE 6560–50–P 


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