Federal Register / Vol. 65, No. 128 / Monday, July 3, 2000 / Proposed Rules 41029

5. In § 55.45, paragraph (b) is revised

to read as follows:

§ 55.45 Operating tests.

* * * * *

(b) Implementation— (1)

Administration. The operating test will

be administered in a plant walkthrough

and in either—

(i) A simulation facility which the

Commission has approved for use after

application has been made by the

facility licensee; or

(ii) A plant-referenced simulator as

defined in § 55.4.

(2) Commission-approved simulation

facilities. (i) Facility licensees who

propose to use a simulation facility in

the administration of the operating test

in accordance with paragraph (b)(1)(i) of

this section, shall submit an application

for approval of the simulation facility to

the Commission. This application must

include:

(A) A description of the components

of the simulation facility that are

intended to be used for each part of the

operating test, unless previously

approved;

(B) A description of the performance

tests as part of the application, and the

results of these tests; and

(C) A description of the procedures

for maintaining examination and test

integrity consistent with the

requirements of § 55.49.

(ii) The Commission will approve a

simulation facility if it finds that the

simulation facility and its proposed use

are suitable for the conduct of operating

tests for the facility licensee’s reference

plant under paragraph (a) of this

section.

(3) Plant-referenced simulators. (i)

Facility licensees which propose to use

a plant-referenced simulator to meet the

experience requirements in § 55.31(a)(5)

must ensure that:

(A) The plant-referenced simulator

uses models relating to nuclear and

thermal-hydraulic characteristics that

replicate the core load that exists in the

nuclear power unit for which a license

is being sought at the time of the

applicant’s operating test; and

(B) Simulator fidelity has been

demonstrated so that significant control

manipulations are completed without

procedural exceptions, simulator

performance exceptions, or deviation

from the approved training scenario

sequence.

(ii) If the Commission determines that

a simulation facility consisting solely of

a plant-referenced simulator does not

meet either the definition of a plantreferenced simulator as defined in

§ 55.4, or the criteria in § 55.45(b)(4)(A)

and (D), the Commission will not accept

the plant-referenced simulator for

conducting operating tests as described

in § 55.45(b)(1) of this part,

requalification training as described in

§ 55.59(c)(3) of this part, or performing

control manipulations that affect

reactivity to establish eligibility for an

operator’s license as described in

§ 55.31(a)(5).

(4) Continued assurance of simulator

fidelity. Facility licensees that maintain

a simulation facility shall:

(A) Conduct performance testing

throughout the life of the simulation

facility in a manner sufficient to assure

that the criteria of paragraphs

55.45(b)(4)(C) and 55.45(b)(3)(i)(B) as

applicable, are met. The results of

performance tests must be retained for

four years after the completion of each

performance test or until superseded by

updated test results;

(B) Correct scenario validation,

performance test, modeling , and

hardware discrepancies;

(C) Make available for NRC review,

before or concurrent with preparations

for each operator licensing operating

test or requalification program

inspection, results of any uncorrected

performance test failures that may exist

at the time of the operating test or

requalification program inspection; and

(D) Maintain the provisions for

examination and test integrity

consistent with § 55.49.

* * * * *

6. In § 55.59, paragraph (c)(4)(iv) is

revised to read as follows:

§ 55.59 Requalification.

* * * * *

(c) * * *

(4) * * *

(iv) Simulation of emergency or

abnormal conditions that may be

accomplished by using the control panel

of the facility involved or by using a

simulator. Where the control panel of

the facility is used for simulation, the

actions taken or to be taken for the

emergency or abnormal condition must

be discussed; actual manipulation of the

plant controls is not required. If a

simulator is used in meeting the

requirements of paragraph (c)(4)(iii) of

this section, it must accurately

reproduce the operating characteristics

of the facility involved and the

arrangement of the instrumentation and

controls of the simulator must closely

parallel that of the facility involved.

After the provisions of § 55.45(b) have

been implemented at a facility, the

simulation facility must be used to

comply with this paragraph.

* * * * *

Dated at Rockville, Maryland, this 27th day

of June, 2000.

For the Nuclear Regulatory Commission.

Annette L. Vietti-Cook,

Secretary of the Commission.

[FR Doc. 00–16751 Filed 6–30–00; 8:45 am]

BILLING CODE 7590–01–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 00N–1351]

Food Labeling; Use of the Term

‘‘Fresh’’ for Foods Processed With

Alternative Nonthermal Technologies;

Public Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Announcement of meeting.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

public meeting to discuss the use of the

term ‘‘fresh’’ in the labeling of foods

processed with alternative nonthermal

technologies. The purpose of the

meeting is to determine whether the use

of the term ‘‘fresh’’ is truthful and not

misleading on foods processed with

these alternative technologies and to

determine what type of criteria FDA

should use when considering the use of

the term with future technologies.

DATES: The public meeting will be held

on July 21, 2000, from 8:30 a.m. to 4

p.m. Please preregister by July 14, 2000.

Late registrations will be accepted

contingent on space availability.

Comments must be submitted no later

than August 21, 2000.

ADDRESSES: The meeting will be held at

the Holiday Inn City Centre, 300 East

Ohio St., Chicago, IL, 312–787–6100.

Submit written comments to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1061, 5630 Fishers Lane, Rockville,

MD 20852. You may also send

comments to the Dockets Management

Branch at the following e-mail address:

FDADockets@oc.fda.gov or on the FDA

website at http://

www.accessdata.fda.gov/scripts/oc/

dockets/comments/commentdocket.cfm.

FOR FURTHER INFORMATION CONTACT:

For registration: Kimberly Phillips or

Darlene M. Bailey, Office of Public

Affairs (HFR–CE645), Food and

Drug Administration, 300 South

Riverside Plaza, suite 550 South,

Chicago, IL 60606, 312–353–7126 or

FAX 312–886–3280.

41030 Federal Register / Vol. 65, No. 128 / Monday, July 3, 2000 / Proposed Rules

For general information: Geraldine A.

June, Center for Food Safety and

Nutrition, Food and Drug

Administration (HFS–822), 200 C

St. SW., Washington, DC 20204,

202–205–4168 or FAX 202–205–

5295.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of January 6,

1993 (58 FR 2302 at 2401), FDA

published a final rule that established

labeling regulations that govern the use

of the terms ‘‘fresh,’’ ‘‘freshlylll’’

(e.g., ‘‘freshly baked’’) and ‘‘fresh

frozen’’ as they appear on the labeling

of foods, including the use of these

terms in brand names and as sensory

modifiers. As discussed in the final rule,

we issued this regulation because of the

continued misuse of the term ‘‘fresh’’

and related terms in the marketplace.

We concluded at that time that it was

necessary to establish a definition for

‘‘fresh’’ to preclude the type of misuse

that we encountered most often, i.e., use

of the term to imply that a food is

unprocessed, when in fact it has been

processed. Thus, provisions in § 101.95

(21 CFR 101.95) govern the use of the

term ‘‘fresh’’ when used on the labels or

in labeling of foods to suggest or imply

that the food is unprocessed. Generally,

the appearance of the term ‘‘fresh’’ on a

label or in labeling means that the food

in its raw state or finished form has not

been frozen or subjected to any form of

thermal processing or any other form of

preservation. However, we provided

that the following treatments do not

preclude the food from bearing the term

‘‘fresh’’: (1) The addition of approved

waxes or coatings, (2) the post-harvest

use of approved pesticides, (3) the

application of a mild chlorine wash or

mild acid wash on produce, or (4) the

treatment of raw foods with ionizing

radiation not to exceed the maximum

dose of 1 kiloGray.

The regulation also notes that use of

the term ‘‘fresh’’ is not precluded when

it does not imply that the food is

unprocessed, e.g., ‘‘fresh’’ may be used

to describe pasteurized whole milk

because consumers understand that

almost all milk is pasteurized and,

therefore, there is no misleading

implication.

Recently, manufacturers have

developed new alternative food

processing technologies to control

pathogens in foods while minimizing

the thermal component of the process.

Such processes include, but are not

limited to, high pressure processing,

pulsed electric field, pulsed light,

submerged arc, and filtration.

FDA contracted with the Institute of

Food Technologists (IFT) to review and

evaluate the scientific information

available on these new alternative

technologies and to assist us in

evaluating each technology’s

effectiveness in reducing and

inactivating pathogens of public health

concern. Where information on these

technologies was too limited for a

thorough evaluation and conclusion,

IFT identified research needs. The final

report of this work, entitled ‘‘Kinetics of

Microbial Inactivation for Alternative

Food Processing Technologies’’ (Ref. 1),

is available on FDA’s website at

www.cfsan.fda.gov.

Manufacturers using these processes

contend that their products maintain the

same ‘‘fresh’’ characteristics as

unprocessed products. Thus, these

manufacturers have asked FDA if they

may label these products with the term

‘‘fresh.’’ We are interested in obtaining

the views of interested parties on the

use of the term ‘‘fresh’’ for foods

processed with these technologies.

Thus, we have decided to hold a public

meeting to engage interested parties in

discussion on this issue. We will use

information gathered at this meeting, as

well as other information available to

FDA, in considering whether to initiate

rulemaking to amend § 101.95.

In this notice, we are announcing a

public meeting to discuss the use of the

term ‘‘fresh’’ in the labeling of foods

processed with the alternative

technologies. We are soliciting public

comment on whether the use of the term

‘‘fresh’’ is truthful and not misleading

on foods processed with these

alternative technologies and on what

type of criteria FDA should use when

considering the use of the term with

future technologies. Specifically, we

invite comment on the following

questions:

1. Do consumers associate the term

‘‘fresh’’ with organoleptic

characteristics, nutritional

characteristics, or some other

characteristics?

2. Do consumers want a way to

identify foods that taste and look fresh

but have been processed to control

pathogens?

3. What does industry think the term

‘‘fresh’’ means?

4. Is the term ‘‘fresh’’ when applied to

foods processed with the new

technologies misleading to consumers?

5. Do the new technologies preserve

the foods?

6. Are the new technologies truly

nonthermal?

7. Are there quantifiable parameters,

e.g., level of nutrients, vitamins etc.,

that could be measured to determine if

a food is ‘‘fresh?’’

8. Is there a term other than ‘‘fresh’’

that can be used for foods processed

with the new technologies?

9. Would consumers understand a

new term?

10. What is the economic impact of

allowing use of the term ‘‘fresh’’ for

foods processed with the new

technologies?

11. Would allowing the term ‘‘fresh’’

on foods processed with new

technologies place small firms not able

to use these technologies at an economic

disadvantage?

At the public meeting, we will be

addressing whether the use of

alternative processing technologies

should preclude the use of the term

‘‘fresh.’’ Therefore, the public meeting

will be restricted to the discussion of

whether these processes fit the criteria

for the use of the term ‘‘fresh’’ and not

whether other aspects of the provisions

in § 101.95 should be reopened.

II. Registration and Requests to Make

Oral Presentations

If you would like to attend the

meeting, you must preregister in writing

with the contact person for registration

(address above) by July 14, 2000, by

providing your name, title, business

affiliation, address, telephone and fax

number. Preregistered persons should

check in before the meeting between 8

a.m. and 8:30 a.m. Persons who have

not preregistered may register before the

meeting between 8 a.m. and 8:30 a.m.,

dependent on space availability. To

expedite processing, this registration

information also may be sent to the

contact person by FAX to 312–886–

3280. If you need special

accommodations due to disability (e.g.,

sign language interpreter), please inform

the contact person when you register.

If, in addition to attending, you wish

to make an oral presentation during the

meeting, you must so inform the contact

person and submit: (1) A brief written

statement of the general nature of the

views you wish to present and (2) the

names and addresses of the persons who

will give the presentation. Depending

on the number of people who register to

make presentations, we will limit the

time allotted for each presentation. We

anticipate that, if time permits, those

attending the meeting will have the

opportunity to ask questions during the

meeting.

III. Comments

Interested persons may, on or before

August 21, 2000, submit written

comments to the Dockets Management

Branch (address above). You may also

Federal Register / Vol. 65, No. 128 / Monday, July 3, 2000 / Proposed Rules 41031

send comments to the Dockets

Management Branch at the following email address: FDADockets@oc.fda.gov

or to the FDA website at http://

www.accessdata.fda.gov/scripts/oc/

dockets/comments/commentdocket.cfm.

Please address your comments to the

docket number given at the beginning of

this notice. You must submit two copies

of comments, identified with the docket

number found in brackets in the

heading of this document, except that

you may submit one copy if you are an

individual. You may review received

comments in the Dockets Management

Branch between 9 a.m. and 4 p.m.

Monday through Friday.

IV. Transcripts

You may request a transcript of the

meeting from the Freedom of

Information Office (HFI–35), Food and

Drug Administration, rm. 12A–16, 5600

Fishers Lane, Rockville, MD 20857,

approximately 15 working days after the

meeting, at a cost of 10 cents per page.

You may also examine the transcript of

the meeting after August 11, 2000, at the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday, as well as on the FDA website

at http://www.fda.gov.

V. Reference

We have placed the following

reference on display in the Dockets

Management Branch. You may see it at

that office between 9 a.m. and 4 p.m.,

Monday through Friday.

1. Institute of Food Technologists,

‘‘Kinetics of Microbial Inactivation for

Alternative Food Processing Technologies,’’

A report of the Institute of Food

Technologists for the Food and Drug

Administration of the United States

Department of Health and Human Services,

June 2, 2000.

REGISTRATION FORM

Public Meeting on Use of the Term ‘‘Fresh’’ on Foods

Processed with Alternative Nonthermal Technologies

Instructions: To register, complete this form and mail it to the

address of the contact person(s) for registration or fax it to

312–886–3280 by July 14, 2000.

Name, llllllllll

Title, llllllllll

Company, lllllllllll

Address, llllllllll

Telephone, lllllllllll

Fax, llllllllllll

E-mail, lllllllllll

Please indicate the type of

organization that you represent:

Industry ll

Government ll

Consumer Organization ll

Media ll

Law Firm ll

Educational Organization ll

Other (specify) ll

Do you wish to make an oral

presentation?

Yesll

No ll

If yes, you must also submit the

following:

1. A brief statement of the general

nature of the views you wish to present,

2. The names and addresses of all

persons who will participate in the

presentation, and depending on the

number of people who register to make

presentations, we will limit the time

allotted for each presentation.

Dated: June 27, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–16716 Filed 6–28–00; 1:38 pm]

BILLING CODE 4160–01–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 141 and 142

[FRL–6728–2]

Announcement of Stakeholders

Meeting on Arsenic in Drinking Water

Proposed Rule

AGENCY: . Environmental Protection

Agency.

ACTION: Notice of stakeholders meeting.

SUMMARY: The Environmental Protection

Agency (EPA) will be holding a one-day

Stakeholders meeting on August 9, 2000

in Reno, Nevada. The purpose of this

meeting is to present information and to

answer questions on the proposed rule.

EPA is encouraging people to attend

from State and Tribal drinking water

programs, the regulated community

(water systems), public health

organizations, academia, environmental

and public interest groups, engineering

firms, and other interested stakeholders.

DATES: The stakeholder meeting on

arsenic in drinking water will be held

on Wednesday, August 9, 2000 from 8

a.m. to 12 pm and 1 p.m. to 5 p.m. PDT.

ADDRESSES: The meeting will be held at

the Reno Hilton [(800) 648–5080],

which is located at 2500 E. Second

Street, Reno, NV 89595.

To register for the meeting, please

contact the Safe Drinking Water Hotline

at 1–800–426–4791 between 9 am and

5:30 p.m. EST. Those registered for the

meeting by Friday, July 28, 2000 will

receive an agenda, logistics sheet, and a

copy of the Federal Register notice prior

to the meeting. There will be a limited

number of conference lines available.

These lines will be allocated on a firstreserved, first served basis. Members of

the public who cannot attend the

meeting in person should register with

the Safe Drinking Water Hotline by July

28 to receive copies of the overheads in

advance. Please provide your name,

organization, title, mailing address,

telephone number, facsimile number, email address and telephone number for

EPA to connect the caller via conference

call [if applicable] for the ‘‘Arsenic

Meeting.’’

FOR FURTHER INFORMATION CONTACT: For

general information on meeting

logistics, please contact the Safe

Drinking Water Hotline at 1–800–426–

4791. For information on the activities

related to the proposed arsenic rule,

contact the Safe Drinking Water Hotline

at 1–800–426–4791, or visit the EPA

Office of Ground Water and Drinking

Water arsenic webpage at http://

www.epa.gov/OGWDW/ars/

arsenic.html, which contains electronic

copies of two fact sheets, the proposed

rule, and the discussion papers and

executive meeting summaries from

previous stakeholders meetings.

Registrants must make their own room

reservations for the Reno Hilton by July

7, 2000 by calling (800) 648–5080 and

mention ‘‘EPA Arsenic in Drinking

Water Meeting’’ to guarantee the room

rate of $55 plus tax.

SUPPLEMENTARY INFORMATION:

A. Background

Arsenic (As) is a naturally occurring

element found in the human body and

is present in food, water, and air.

Arsenic in drinking water occurs in

ground water and surface water and is

associated with certain natural geologic

conditions, as well as with

contamination from human activities.

Arsenic ingestion is linked to skin

cancer and arsenic inhalation to lung

cancer. In addition, arsenic ingestion

seems to be associated with vascular

effects, gastrointestinal irritation, and

cancers of the kidney, bladder, liver,

lung, and other organs. Water primarily

contains inorganic arsenic species

(AsV+ and AsIII+).

On August 6, 1996, Congress

amended the SDWA, adding section

1412(b)(12)(A) which requires, in part,

that EPA propose a NPDWR for arsenic

by January 1, 2000 and issue a final

regulation by January 1, 2001. The

current maximum contaminant level

(MCL) of 50 μg/L remains in effect until

the effective date of the revised rule.

The National Primary Drinking Water

regulation for arsenic proposes a

Maximum Contaminant Level Goal

(MCLG) of zero, an MCL of 5 μg/L, and

lists best available technologies and

small system compliance technologies.

In addition, the proposed rule,