38182 Federal Register / Vol. 65, No. 119 / Tuesday, June 20, 2000 / Rules and Regulations

Done in Washington, DC, this 14th day of

June 2000.

Richard L. Dunkle,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 00–15494 Filed 6–19–00; 8:45 am]

BILLING CODE 3410–34–U

NUCLEAR REGULATORY

COMMISSION

10 CFR Part 50

RIN 3150–AG22

Elimination of the Requirement for

Noncombustible Fire Barrier

Penetration Seal Materials and Other

Minor Changes

AGENCY: Nuclear Regulatory

Commission.

ACTION: Final rule.

SUMMARY: The Nuclear Regulatory

Commission (NRC) is amending its fire

protection regulations to remove the

requirement that fire barrier penetration

seal materials be noncombustible, and

to make other minor changes. The final

rule removes a requirement that has a

negligible contribution to safety and

includes editorial changes designed to

meet the intent of the Presidential

memorandum dated June 1, 1998,

entitled, ‘‘Plain Language in

Government Writing.’’

EFFECTIVE DATE: July 20, 2000.

FOR FURTHER INFORMATION CONTACT:

Daniele Oudinot, Office of Nuclear

Reactor Regulation, U.S. Nuclear

Regulatory Commission, Washington,

DC 20555–0001, telephone 301–415–

3731; e-mail DHO@nrc.gov.

SUPPLEMENTARY INFORMATION:

I. Background

The NRC conducted a technical

assessment of fire barrier penetration

seals. The NRC documented the results

of its assessment in SECY–96–146,

‘‘Technical Assessment of Fire Barrier

Penetration Seals in Nuclear Power

Plants,’’ July 1, 1996; in NUREG–1552,

‘‘Fire Barrier Penetration Seals in

Nuclear Power Plants,’’ July 1996; and

in NUREG–1552, Supplement 1, January

1999. On the basis of its findings, the

NRC concluded that the

noncombustibility criterion for

penetration seal materials that is

specified in the NRC fire protection

regulation and review guidance had a

negligible contribution to safety, and

recommended that this

noncombustibility criterion be deleted.

Copies of NUREG–1552 and NUREG–

1552, Supplement 1, may be purchased

from the Superintendent of Documents,

U.S. Government Printing Office, P.O.

Box 37082, Washington, DC 20402–

9328. Copies are also available from the

National Technical Information Service,

5285 Port Royal Road, Springfield, VA

22161. A copy of each document is also

available for inspection and/or copying

at the NRC Public Document Room,

2120 L Street, NW. (Lower Level),

Washington, DC. NUREG–1552,

Supplement 1, is also available through

the Technical Reports area of the NRC

Reference Library accessed through the

NRC Website: http://www.nrc.gov/NRC/

NUREGS/index.html.

II. Analysis of Public Comments and

Staff Response

The proposed rule was published for

public comment in the Federal Register

on August 18, 1999 (64 FR 44860). The

comment period ended on November 1,

1999. The NRC received eight comment

letters. Six commenters supported the

proposed amendment; two commenters

objected to the changes. This section

discusses the comments received, how

the NRC staff was able to incorporate

some comments into the final rule and,

if not, why a comment was not

accepted. This section addresses all

comments, but specific commenters are

not identified.

A commenter suggested that footnote

1 to Section I, ‘‘Introduction and

Scope,’’ of Appendix R to 10 CFR Part

50, be deleted because its wording is

identical to footnote 4 to § 50. 48(b).

This commenter stated that the basis for

deleting footnote 4 to § 50.48 also

applies to footnote 1 to Section I of

Appendix R. The NRC agrees with this

comment and footnote 1 to Section I of

Appendix R is deleted.

One of the commenters who endorsed

the proposed rule stated that, in

particular, (1) There are no reports of

fire that have challenged the ability of

fire-rated penetration seals to confine a

fire; (2) numerous fire endurance tests

have confirmed the fire-resistive

capabilities of the penetration seal

materials, designs, and configurations

installed in nuclear power plants; and

(3) if penetration seals are properly

designed, installed, and maintained,

there is reasonable assurance that they

will provide the fire-resistive integrity

of the fire barriers in which they are

installed, and confine a fire to its area

of origin.

A commenter objected to the rule

change, but did not identify any specific

technical or safety information for NRC

staff consideration. Therefore, the

comment did not result in changes to

the rule.

One commenter provided multiple

comments in opposition to the proposed

rule. Each of these comments are

discussed below. None of the comments

resulted in any changes from the

proposed rule.

1. Comment. The non-combustibility

requirement for fire seals is key in

providing a high level of confidence in

the operability determination for a fire

seal.

Response. The Commission disagrees.

10 CFR Part 50, Appendix A, General

Design Criteria (GDC), Criterion 3—Fire

Protection states: ‘‘Noncombustible and

heat resistant materials shall be used

wherever practical throughout the

unit. * * *’’ Thus, the Commission’s

most fundamental requirements with

respect to fire protection do not

mandate the exclusive use of

noncombustible materials. The

Commission’s implementing

requirements on fire protection in 10

CFR 50.48 and 10 CFR Part 50,

Appendix R, require the use of fire

barriers that meet 1-hour or 3-hour fire

ratings; while the current regulation

requires the use of noncombustible

materials it is also clear that the 1-hour

and 3-hour ratings can be achieved with

the use of properly tested, rated and

qualified material that is ‘‘combustible.’’

Penetration seals used as a part of the

rated fire barrier assembly are required

to meet the acceptance criteria of

Nationally Recognized Testing

Standards that are specifically designed

to test these components. Examples of

these standards include American

Society for Testing and Materials

(ASTM) E–814, ‘‘Standard Test Method

for Fire Tests of Through-Penetration

Fire Stops,’’ and Institute of Electrical

and Electronics Engineers (IEEE) 634,

‘‘Standard Cable Penetration Fire Stop

Qualification Test.’’ These nationally

recognized testing standards do not

require the penetration seal material to

be noncombustible, but rather focus on

the penetration seals ability to prevent

flame travel through the opening and

limit the heat transfer through the

penetration seal assembly by measuring

the cold-side temperature. As such,

‘‘noncombustibility,’’ as defined in

ASTM–136, ‘‘Standard Test Method for

Behavior of Materials in a Vertical Tube

Furnace at 750 °C,’’ is not a necessary

requirement for an adequate fire barrier

or a penetration seal that is part of this

barrier. Penetration seal assemblies,

when properly tested, qualified, and

installed, meet this requirement as a fire

(heat) resistant material. In fire

protection engineering design, this can

be thought of as analogous to the

National Fire Protection Association

(NFPA) Life Safety Code, NFPA 101,

Federal Register / Vol. 65, No. 119 / Tuesday, June 20, 2000 / Rules and Regulations 38183

which allows certain wooden doors to

be used as 20-minute fire protectionrated doors. (See NFPA 101, Section 6–

2.3.2.3.2.) The NFPA Code recognizes

that even though the wooden door

assembly is unquestionably

combustible, as long as that fire door

assembly can provide the required level

of protection (20 minutes in this

example) the wooden door assembly is

acceptable. In sum, the current

Appendix R requirement for

noncombustible fire barrier penetration

seals is not an inherent part of the

NRC’s overall regulatory approach on

fire protection, and is not necessary to

provide reasonable assurance of

adequate protection against fire spread

in nuclear power plants.

2. Comment. The NRC has not

analyzed the risk associated with the

use of combustible fire seal material as

it provides a fuel supported pathway or

‘‘wick’’ for flame and hot gas to burn

through wall penetrations into adjacent

fire zones that contain vital safety

systems, structures or components.

Response. As discussed in NUREG–

1552 and its supplement, the NRC has

evaluated fire barrier penetration seals

and concluded that properly tested,

configured, installed, and maintained

penetration seal assemblies will not

provide a fuel supported pathway or

‘‘wick’’ for flame and hot gas to burn

through wall penetrations. Hundreds of

fire endurance qualification tests have

been performed by materials

manufacturers, installation contractors,

test laboratories, research organizations,

licensees, and others. These

qualification tests involved a wide

variety of penetration seal designs and

materials, in configurations which are

found at nuclear power plants,

including the actual cables that run

through the fire barrier penetration seal.

These tests also maximize the fire

severity by subjecting the penetration

seals to a rapidly rising temperature in

a relatively small and confined space.

Note that with few exceptions, nuclear

power plant fire loads are not great

enough to produce a fire approaching

the severity of the Standard Time/

Temperature test curve. In the unlikely

event that a large fire exposes a

qualified combustible or

noncombustible penetration seal to high

temperatures for an extended period of

time, the seal will perform as rated. For

the case of a silicone-based material, the

silicone will ablate by design and be

replaced with char or ash. The silicone

foam material is sacrificial by design in

preserving the integrity of the fire

barrier. This sacrificial behavior and

charing has been observed during fullscale qualification fire endurance tests

of a wide variety of silicone-based

penetration seal configurations. Other

combustible penetration seal materials

have also been qualified. For example,

Minnesota Mining and Manufacturing

Company (3M) has over 25 years of

experience with combustible

penetration seal designs using their

intumescent materials (caulks, putty,

wrap strips, and composite sheets). The

intumescent material swells when

heated, which causes the seal to expand

and protect the penetration.

Underwriters Laboratories, Inc. (UL),

has qualified dozens of combustible

penetration seal designs and lists and

classifies these designs in a full volume

of their Fire Resistance Directory

(Volume 2). The NRC concludes that

these tests have demonstrated that

combustible, limited combustible or

noncombustible penetration seals can

provide the necessary fire resistance and

provide reasonable assurance that a fire

will not spread from one side of the fire

barrier to the other side of the barrier

within the 1- or 3-hour time period

required by the NRC.

3. Comment. The NRC’s technical

assessment does not offer any

evaluation or analysis regarding the

contribution to severe accident risk

evolving from a quick burn-through of

fire seals resulting from the use of

combustible penetration sealant

material and other generic problems

widely experienced with the Dow

Corning product.

Response. As stated above, a large

body of fire test results have proven the

capabilities and effectiveness of

penetration seals in maintaining the

fire-resistive integrity of the barriers in

which they are installed, typically for 1

or 3 hours, which precludes a quick

burn-through scenario, i.e., if the

penetration seal assembly has passed

the testing criteria to be rated, it could

not experience a ‘‘quick burn-through’’.

Further, the nature of combustible

penetration seal materials and the

limited air supply in penetration seals

preclude a ‘‘quick burn-through,’’ and

an analysis of the contribution to severe

accident risk evolving from a quick

burn-through of fire seals resulting from

the use of combustible penetration

sealant material is not relevant. For

instance, silicone-based penetration seal

materials are relatively difficult to ignite

and ablate slowly at a rate of about 3

inches per hour when exposed to the

Standard Time/Temperature fire curve

of ASTM E–119.

Fire barrier penetration seals are not

considered in the assessment of

postulated fire scenarios that are the

major contributors to core damage for

most plants, because the major

contributors are those in which the

redundant divisions of post-fire safeshutdown components and systems are

located in the fire affected area.

Scenarios involving the spread of fire

from one area of a plant to another and

evolving to core damage (scenarios that

could potentially involve penetration

seals) are also of low frequency. It is the

NRC’s judgment that considering the

probability of failure of a plant’s passive

fire barrier penetration seals would not

significantly alter the overall

contribution of fire risk to the plant’s

total calculated core damage frequency.

4. Comment. Given the combustibility

of the silicone material, the industry has

also widely documented improperly

installed seals (less than sufficient

sealant material, varying size voids

created by problematic installation

procedures and cracks). By providing

for the acceptance of combustible

penetration seals, the NRC is reducing

the level of defense-in-depth without

fully analyzing the risks associated with

accelerated burn-through of seals from

the combination of these widely

documented factors.

Response. The NRC disagrees with the

commenter’s implication that there are

widespread and numerous instances of

improperly-installed silicone fire barrier

seals. First, while plant-specific

deficiencies of fire barrier penetration

seals have been and will likely continue

to be found, they have been isolated and

not tied to any installation problems

generic to this material. Installation

deficiencies that have been identified to

date have been or are in the process of

being corrected by licensees.

Second, the NRC disagrees with the

commenter’s apparent argument that

combustible fire seals that meet the

NRC’s 1- and 3-hour fire rating

significantly decreases the safety of a

nuclear power plant as compared to fire

seals which are ‘‘noncombustible’’ as

defined by ASTM E–136. Fire seals are

one passive sub-component of fire

protection provided by the defense-indepth concept, the others being fire

prevention, detection, suppression and

plant-design features. As discussed in

the response to Comment 2, the NRC

also believes that it is highly unlikely

that fire barriers in a nuclear power

plant would be exposed to fires of

sufficient temperature and duration

such that the silicone fire seals that fail

before their rated 1- or 3-hours. Thus,

consideration of the probability of

failure of properly-qualified penetration

seals that meet the NRC’s requirements

for 1- or 3-hour protection would not

significantly alter the overall

contribution of fire risk to the plant’s

total calculated core damage frequency.

38184 Federal Register / Vol. 65, No. 119 / Tuesday, June 20, 2000 / Rules and Regulations

Finally, the practical benefits of the

silicone-based penetration seal materials

(e.g., easy installation, compatibility

around safety-related cables, and

reasonable cost) far outweigh concerns

regarding material combustibility. Thus,

the NRC concludes that properly

qualified fire barriers will provide

reasonable assurance of adequate

protection to public health and safety.

5. Comment. The NRC does not offer

any analysis and evaluation of how a

combustible penetration sealant could

also harbor a fire as it moves through a

penetration seal. The fire could leave a

protective barrier of insulating ash in its

trail making it difficult to identify,

locate and extinguish. Accordingly, it is

inappropriate to move forward with this

rule change without analysis on the

quick burn-through of seals under the

above stated conditions.

Response. A properly designed,

tested, and installed penetration seal

will maintain the fire resistive integrity

of the wall/ceiling/floor assembly in

which it is installed. During this time,

automatic and/or manual fire

suppression activities will be used to

control and extinguish the fire. After the

fire is extinguished, standard fire

fighting procedures would require that

the fire brigade perform the ‘‘overhaul’’

firefighting function of ensuring all

combustibles have been extinguished.

During this firefighting, if the fire

brigade were to identify ash or swelled

material in a penetration seal,

procedures would require that the fire

brigade take appropriate action either to

identify whether the seal is continuing

to combust (by removal), or to promptly

implement extinguishing activities. This

is a standard firefighting operation to

check for any possible fire extension.

Therefore, the NRC concludes that it is

not inordinately difficult to identify and

extinguish fires in combustible fire

barrier penetration seals.

6. Comment. The basic premise of the

NRC rule change fails to address

industry experience in properly

bounding fire tests for the myriad of fire

seal configurations deployed throughout

nuclear power stations. In one case, the

licensee improperly used a single test to

bound 2000 fire barrier penetration seals

in many different fire seal

configurations. This omission does not

lend to the credibility of the agency’s

argument. Such evidence documents

improperly tested seal configurations.

Response. The Browns Ferry fire of

March 22, 1975, demonstrated the

weakness in penetration seals to the

nuclear and general building industry.

After the fire, specific testing methods

were developed by nationally

recognized testing organizations to test

and qualify penetration seals. The

American Society for Testing and

Materials (ASTM) first issued their

standard E–814, ‘‘Standard Test Method

for Fire Tests of Through-Penetration

Fire Stops,’’ in 1981. The Institute of

Electrical and Electronics Engineers

(IEEE) first issued their standard IEEE

634, ‘‘Standard Cable Penetration Fire

Stop Qualification Test,’’ in 1978. In

regard to the commenter’s assertions

regarding ‘‘a single test to bound 2000

fire barrier penetration seals * * *,’’ the

first penetration seal fire tests were

often used to bound numerous

configurations. This issue of bounding

fire tests was addressed in Information

Notice (IN) 88–04, ‘‘Inadequate

qualification and documentation of fire

barrier penetration seals,’’ dated

February 5, 1988. Since that time,

decades of experience with the test

standards by the nuclear and general

building industries have provided

adequate assurance that such standards

are appropriate for qualifying fire barrier

penetration seals. Hundreds of

qualification-type fire endurance tests of

a wide variety of penetration seal

designs and materials have been

performed by material manufacturers,

installation contractors, test

laboratories, research organizations,

licensee, and others. Underwriters

Laboratories, Inc. (UL) alone publishes a

complete volume of Listed and

Classified rated through-penetration fire

stop systems. Additionally, the NRC

staff has observed fire endurance tests of

fire barrier penetration seals, and

reviewed fire test reports during

licensing reviews and inspections. On

the basis of these eyewitness accounts

and reviews, the NRC staff has

concluded that fire endurance tests have

established the fire-resistive capabilities

of numerous penetration seal materials,

designs, and configurations as installed

in the nuclear power plants. The NRC

staff provided guidance on the bounding

of plant-installed configurations with

tested configurations in Generic Letter

86–10, ‘‘Implementation of Fire

Protection Requirements,’’ dated April

24, 1986. Subsequently, the industry

used this guidance in inspecting plant

designs. As licensees identified

potential penetration seal issues, the

staff informed the industry through

numerous INs, including: (1) IN 88–04,

and Supplement 1, dated August 9,

1988; (2) IN 88–56, ‘‘Potential Problems

with Silicone Foam Fire Barrier

Penetration Seals,’’ dated August 4,

1988; (3) IN 94–28, ‘‘Potential Problems

with Fire-Barrier Penetration Seals,’’

dated April 5, 1994; and (4) IN 97–70,

‘‘Potential Problems with Fire Barrier

Penetration Seals,’’ dated September 19,

1997. These potential problems were

brought forward by licensee inspections

and NRC staff observed weaknesses

discovered during some of its

inspections.

7. Comment. The basic premise of the

NRC rule change fails to take into

account ongoing industry-wide

discovery of insufficient material fill,

large voids and cracking in seals as the

result of the problematic installation of

the silicone foam penetration seal

material in the field. In numerous cases,

licensees have reported universal fire

seal installation problems involving the

silicone foam material. Such evidence

documents improperly installed

silicone-based penetration seals. The

NRC also fails to take into account that

licensees are using the same

problematic material to replace

inoperable fire seals. Given these

recurring and what appears to be

ongoing failures, the NRC does not offer

any method for determining how it is

achieving properly tested, configured,

installed and maintained silicone-based

penetration seals. Given the apparent

lack of reasonable assurance that fire

barrier seals are adequately inspected to

determine that they have been properly

tested, configured, installed and

maintained, it is inappropriate to reduce

the fire protection standard by removing

the non-combustibility standard.

Similarly, it is inappropriate to maintain

a policy of enforcement discretion for

the same noncombustibility standard.

Response. The NRC disagrees with the

commenter’s implicit argument that

historical problems with installation of

silicone fire barrier penetration seals

have not been rectified, and, as a result,

the Appendix R non-combustibility

requirement should be retained.

The NRC disagrees with the

commenter’s assertion that improper

installation and maintenance of fire

barrier penetration seals is a reasonable

basis for retaining the current

noncombustibility requirement. First,

proper installation of fire barrier

penetration seals is necessary in order

for the seals to perform their intended

safety function, regardless of whether

the seals are made of combustible or

noncombustible materials. Licensees

must have appropriate procedures for

installation of Appendix R-required fire

barrier penetration seals and implement

corrective action if improperly installed

seals are discovered, regardless of the

combustibility of the fire barrier

penetration seal material. Thus, while

improperly installed fire barrier

penetration seals raise valid concerns

with respect to their functionality, these

concerns are not relevant to the issue of

Federal Register / Vol. 65, No. 119 / Tuesday, June 20, 2000 / Rules and Regulations 38185

the need for a noncombustibility

requirement.

Second, the NRC disagrees with the

commenter’s implicit argument that

there are widespread problems with the

installation, inspection, and

maintenance of fire barrier penetration

seals that remain uncorrected. While

there have been historical problems

with the installation of silicone fire

barrier penetration seals, the NRC has

taken a series of regulatory actions in

response to instances of improper fire

barrier penetration seal installation.

These actions include the issuance of

the information notices discussed above

to alert nuclear power plant licensees of

potential problems with silicone fire

barrier penetration seal installation and

inspection, changes to the NRC resident

inspector inspection program to include

fire barrier penetration seals as part of

the NRC’s inspection program, and

continued NRC review and oversight of

licensees’ corrective actions. The NRC

has confirmed that licensees have taken

appropriate action to identify and

correct improperly installed siliconebased fire barrier penetration’s seals, as

discussed in NUREG–1522 and its

supplement. Based upon NRC

inspections and audits, the NRC

believes that licensees and vendors

understand the fire-resistive capabilities

and limitations of the penetration seal

materials, and that existing licensee and

vendor seal installation programs are

adequate to prevent potential

penetration seal installation problems.

Potential penetration seal problems are

understood; industry standards are

available and licensees are complying

with them. In regard to installation,

maintenance, and in-service inspection,

the NRC’s comprehensive reassessment

of fire barrier penetration seals included

the review of procedures, specifications,

and training programs for installation,

surveillance, maintenance, and repair of

penetration seals at both nuclear power

plants and the facilities where seals are

manufactured. Overall, the NRC

concluded that licensees and vendors

are aware of the importance of proper

design, installation, surveillance,

maintenance, and repair of penetration

seals, including training of installers

and inspectors. Therefore, based on

inspections and review of the licensees’

corrective action programs, the NRC

concludes that historical problems with

the installation of silicone-based fire

barrier penetration seals have been

corrected. Many plants include fire

barrier penetration seals that are

required by Appendix R in their

Maintenance Rule’s requirements

program (10 CFR 50.65). This requires

monitoring of the performance or

condition of relevant structures, systems

and components (SSCs) unless there is

a continuing basis for concluding that

the performance or condition of the

SSCs is being effectively controlled.

This provides additional regulatory

assurance that fire barrier penetration

seals are being properly installed,

inspected, and maintained. For these

reasons, the NRC concludes that

historical problems with fire barrier

penetration seal installation and

inspection does not provide an

appropriate basis for retaining the

current noncombustibility requirement

in Appendix R.

8. Comment. Visual industry reliance

upon walk-downs of fire barrier

penetration seals installed in walls,

ceilings and floors, in many cases

behind a series of obstacles, is not

sufficient in determining the reliability

and operability of a silicone foam fire

barrier penetration seal. Non-destructive

examination of installed seals (e.g.,

ultrasound techniques) can provide a

greater measure of confidence in

determining if a seal has been properly

installed.

Response. The NRC believes that

existing inspection techniques

developed by the manufacturers of

silicone fire barrier penetration seals for

evaluating the adequacy of installation

of seals are adequate. The vendor

requirements for physical parameters for

the installation of seals include

attributes such as density of the mixed

material, cell structure, texture, and

color. These are the same parameters

used in the construction of the

penetration seals for testing and, as

such, ensure that the seals installed in

the plant are representative of those

qualified during testing. The installed

penetration seals are passive fire

barriers and remain unchanged after

proper installation. The commenter did

not provide any credible information

showing that the manufacturerdeveloped installation inspection

methodology (which may include visual

examinations) is inadequate to detect

improper installation. In the absence of

such information, the NRC does not

believe that any consideration should be

given to requiring non-destructive

examination, which is outside of the

scope of the rule change. When the NRC

discovers a problem with penetration

seals, such as can occur in the area of

surveillances, the NRC alerts licensees

and advises them to evaluate whether

the potential problem exists at their

plants. Licensees typically evaluate this

information for applicability to their

plants as a part of their Nuclear

Experience Review Program and take

corrective actions when necessary. For

example, fire penetration seal

surveillance problems were discussed in

IN 88–56 which examines in detail

visual inspection information regarding

voids, gaps, and splits in the material.

9. Comment. Because of the evidence

of recurring non-compliance with

testing, configuration, installation and

maintenance, retaining and enforcing

the non-combustibility standard is an

essential component in establishing

confidence in fire barrier penetration

seal operability at nuclear power

stations.

Response. As discussed above, the

NRC does not agree that there are

recurring, generic problems with fire

barrier penetration seal qualification,

configuration and installation

throughout the nuclear power plant

industry. The NRC believes that the

proper amount of attention is being

provided by licensees and will be

provided for in the future. Additionally,

to prevent any possible deficiencies in

the penetration seal program, the NRC

will continue to provide regulatory

oversight.

10. Comment. In making the claim

that combustible materials are already

used in nuclear power stations, NRC

attempts to circumlocate (sic.) the

significant safety issue on how

combustible cable jacketing installed

through a penetration surrounded in a

combustible fire barrier material with

additional documented problems can

contribute to an accelerated burn

through thus failing as a rated fire

barrier.

Response. As discussed in the

response to Comment 2, the fire

endurance tests for qualifying fire

barrier penetration seals were

conducted using the cable which would

be used in the actual plant

configurations. Thus, the contribution of

the cable jacketing to combustion of the

fire barrier penetration seal was an

inherent part of the fire endurance

qualification tests.

11. Comment. NRC provides no

reference to what degree staff and

Commission went to arrive at the

determination that no technical

argument exists for the fire barrier

penetration seals non-combustible

materials requirement.

Response. The primary documents

reviewed by the NRC in attempting to

identify the basis for the current

noncombustibility requirement were the

statements of consideration for the

proposed and final Fire Protection rules,

May 29, 1980; 45 FR 36082, and

November 19, 1980; 45 FR 76608 and

the Commission papers that led to these

proposed and final rules. The primary

38186 Federal Register / Vol. 65, No. 119 / Tuesday, June 20, 2000 / Rules and Regulations

technical documents and rationales for

the Commission’s determination that no

technical basis exists for the

noncombustibility requirement are

contained in NUREG–1552 and

Supplement 1 to that document.

III. Summary of Changes

This final rule amends Section III.M

in Appendix R to 10 CFR Part 50

(Appendix R), removes footnotes 3 and

4 from § 50.48, removes footnote 1 from

Section I in Appendix R, removes

§ 50.48 (c), (d), and (e), corrects a

grammatical error in footnote 2 to

Section III.G. 3 in Appendix R, and

makes editorial changes.

1. In Appendix R, Section III.M, the

words ‘‘shall utilize only

noncombustible materials and * * *’’

are removed.

The technical basis for removing the

noncombustibility requirement for fire

barrier penetration seal materials is

documented in NUREG–1552 and

NUREG–1552, Supplement 1. A

summary of the technical basis for this

action follows.

NRC requirements and guidelines for

penetration seals appear in a number of

documents. In 1971, the NRC

promulgated General Design Criterion

(GDC) 3, ‘‘Fire protection,’’ and

subsequently developed specific

guidance for implementing GDC 3;

Branch Technical Position (BTP)

Auxiliary Power Conversion Systems

Branch (APCSB) 9.5–1, ‘‘Guidelines for

Fire Protection for Nuclear Power

Plants,’’ May 1, 1976; and Appendix A

to BTP APCSB 9.5–1, ‘‘Guidelines for

Fire Protection for Nuclear Power Plants

Docketed Prior to July 1, 1976,’’

February 24, 1977. Most licensees

complied with most of the

implementing guidance. To resolve the

contested issues, the NRC published the

final fire protection rule (10 CFR 50.48)

and Appendix R to 10 CFR Part 50 on

November 10, 1980 (45 FR 76602). It is

important to note that Appendix R is

not a set of generically applicable fire

protection requirements and applies

only to plants that were operating before

January 1, 1979.

The record for Appendix R does not

disclose the technical basis for

including the noncombustibility

criterion in Appendix R. The

noncombustibility criterion is not

included in BTP APCSB 9.5–1,

Appendix A to BTP APCSB 9.5–1, or in

the industry fire endurance test

standards. Section 50.48 does not

address the use of combustible

materials. Although GDC 3 states that

noncombustible and heat-resistant

materials must be used wherever

practical, GDC 3 does not preclude the

use of combustible materials. In general,

when these materials are incorporated

as integral components of the plant fire

protection program, including the fire

hazard analysis, they are acceptable.

Fire barrier penetration seals are one

element of the defense-in-depth concept

at nuclear power plants. The objectives

of the defense-in-depth concept as

applied to fire protection are to:

(1) Prevent fires from starting;

(2) Promptly detect, control, and

extinguish those fires that do occur; and

c. Protect structures, systems, and

components important to safety so that

a fire that is not extinguished promptly

will not prevent the safe shutdown of

the plant.

To achieve defense in depth, each

operating reactor maintains an NRCapproved fire protection program.

Nuclear power plants are divided into

separate areas by structural fire barriers,

such as walls and floor-ceiling

assemblies whose fire-resistance rating,

typically 1, 2, or 3 hours, is determined

by testing. The function of these

structural barriers is to prevent a fire

that starts in one area from spreading to

another area. Penetration seals are used

to close openings through the structural

fire barriers. The intended design

function of the penetration seal is to

confine a fire to the area in which it

started and to protect important

equipment within an area from a fire

outside the area. As for other fire

barriers, the fire-resistance rating of the

penetration seals is determined by

testing.

The ability of a particular penetration

seal to achieve its intended design

function (i.e., to contain a fire), as

determined by a fire endurance test

conducted in accordance with an

industry standard, is the foremost

design consideration. In NUREG–1552

and NUREG–1552, Supplement 1, the

NRC concluded:

(1) There are no reports of fires where

fire-rated penetration seals failed to

confine a fire at a nuclear power plant;

(2) A large body of fire endurance

tests has confirmed the fire-resistive

capabilities of the penetration seal

materials, designs, and configurations

installed in nuclear power plants; and

(3) If penetration seals are properly

designed, tested, installed, inspected,

and maintained, there is reasonable

assurance that they will provide the fire

resistance of the tested design, maintain

the fire-resistive integrity of the fire

barriers in which they are installed, and

confine a fire to its area of origin.

The NRC evaluated silicone-based

penetration seal materials that are

combustible and are the most widely

used materials for penetration seals

throughout the commercial nuclear

power industry. In presenting the

results of its evaluation in NUREG–1552

and in NUREG–1552, Supplement 1, the

NRC concluded:

(1) Properly designed, tested,

installed, and maintained silicone-based

penetration seals are not credible fire

hazards;

(2) Despite the fact that a siliconebased penetration seal could contribute

some fuel to a fire, its relative

contribution to overall fire severity

would be negligible;

(3) Qualified silicone-based fire

barrier penetration seals can accomplish

their intended design function; and

(4) The benefits of combustible or

limited combustible penetration seal

materials outweigh any potential

concerns regarding material

combustibility. For example, the

penetration seal material must be

compatible with the penetrating item

material. In the case of electrical cables,

the 3M intumescent material or the Dow

Corning Silicone will not damage the

cable jacket and flows between the

individual cables during installation.

Likewise, the flexible combustible seal

materials allow for normal pipe

movement due to heating and cooling of

the pipe. The combustible seal materials

are economical to install and remove/

replace during plant modifications. In

short, silicone foam and silicone

elastomer can fill complex irregular

openings and adhere to the penetration

and the penetrants; cure rapidly; have

high-temperature stability; are flexible;

and resist the effects of radiation

exposure and aging.

2. In § 50.48, footnotes 3 and 4 are

removed.

Footnote 3 to § 50.48(a) stated that

basic fire protection guidance for

nuclear power plants is contained in

two NRC documents: Branch Technical

Position (BTP) Auxiliary Power

Conversion System Branch (APCSB)

9.5–1, ‘‘Guidelines for Fire Protection

for Nuclear Power Plants’’ (for new

plants docketed after July 1, 1976),

dated May 1976, and Appendix A to

BTP APCSB 9,5–1, ‘‘Guidelines for Fire

Protection for Nuclear Power Plants

Docketed Prior to July 1, 1976’’ (for

plants that were operating or in various

stages of design or construction before

July 1, 1976), dated August 23, 1976.

Footnote 3 also referred to footnote 4 to

§ 50.48(b), that lists four additional

documents related to permissible

alternatives to satisfy Appendix A to

BTP APCSB 9.5–1. The documents

listed in footnote 4 were:

‘‘Supplementary Guidance on

Information Needed for Fire Protection

Evaluation,’’ dated October 21, 1976;

Federal Register / Vol. 65, No. 119 / Tuesday, June 20, 2000 / Rules and Regulations 38187

1The removed paragraphs read as follows:

(c) All fire protection modifications required to

satisfy the provisions of appendix R to this part or

directly affected by such requirements shall be

completed on the following schedule:

(1) Those fire protection features that involve

revisions of administrative controls, manpower

changes, and training, shall be implemented within

30 days after the effective date of this section and

appendix R to this part.

(2) Those fire protection features that involve

installation of modifications that do not require

prior NRC approval or plant shutdown shall be

implemented within 9 months after the effective

date of this section and appendix R to this part.

(3) Those fire protection features, except for those

requiring prior NRC approval by paragraph (c)(5) of

this section, that involve installation of

modifications that do require plant shutdown, the

need for which is justified in the plans and

schedules required by the provisions of paragraph

(c)(5) of this section, shall be implemented before

startup after the earliest of the following events

commencing 180 days or more after the effective

date of this section and appendix R to this part:

(i) The first refueling outage;

(ii) Another planned outage that lasts for at least

60 days; or

(iii) An unplanned outage that lasts for at least

120 days.

(4) Those fire protection features that require

prior NRC approval by paragraph (c)(5) of this

section, shall be implemented within the following

schedule: Dedicated shutdown systems — 30

months after NRC approval; modifications requiring

plant shutdown—before startup after the earliest of

the events given in paragraph (c)(3) commencing

180 days after NRC approval; modifications not

requiring plant shutdown—6 months after NRC

approval.

(5) Licensees shall make any modifications

necessary to comply with these requirements in

accordance with the above schedule without prior

review and approval by NRC except for

modifications required by section III.G.3 of

appendix R to this part. Licensees shall submit

plans and schedules for meeting the provisions of

paragraphs (c)(2), (c)(3), and (c)(4) within 30 days

after the effective date of this section and appendix

R to this part. Licensees shall submit design

descriptions of modifications needed to satisfy

section III.G.3 of appendix R to this part within 30

days after the effective date of this section and

appendix R to this part.

(6) In the event that a request for exemption from

a requirement to comply with one or more of the

provisions of Appendix R filed within 30 days of

the effective date of this rule is based on an

assertion by the licensee that such required

modifications would not enhance fire protection

safety in the facility or that such modifications may

be detrimental to overall facility safety, the

schedule requirements of paragraph (c) shall be

tolled until final Commission action on the

exemption request upon a determination by the

Director of Nuclear Reactor Regulation that the

licensee has provided a sound technical basis for

such assertion that warrants further staff review of

the request.

(d) Fire protection features accepted by the NRC

staff in Fire Protection Safety Evaluation Reports

referred to in paragraph (b) of this section and

supplements to such reports, other than features

covered by paragraph (c), shall be completed as

soon as practicable but no later than the completion

date currently specified in license conditions or

technical specifications for such facility, or the date

determined by paragraphs (d)(1) through (d)(4) of

this section, whichever is sooner, unless the

Director of Nuclear Reactor Regulation determines,

upon a showing by the licensee, that there is good

cause for extending such date and that the public

health and safety is not adversely affected by such

extension. Extensions of such date shall not exceed

the dates determined by paragraphs (c)(1) through

(c)(4) of this section.

(1) Those fire protection features that involve

revisions of administrative controls, manpower

changes, and training shall be implemented within

4 months after the date of the NRC staff Fire

Protection Evaluation Report accepting or requiring

such features.

(2) Those fire protection features involving

installation of modifications not requiring prior

approval or plant shutdown shall be implemented

within 12 months after the date of the NRC staff

Fire Protection Safety Evaluation Report accepting

or requiring such features.

(3) Those fire protection features, including

alternative shutdown capability, involving

installation of modifications requiring plant

shutdown shall be implemented before the startup

after the earliest of the following events

commencing 9 months or more after the date of the

NRC staff Fire Protection Safety Evaluation Report

accepting or requiring such features:

(i) The first refueling outage;

(ii) Another planned outage that lasts for at least

60 days; or

(iii) An unplanned outage that lasts for at least

120 days.

(4) Those fire protection features involving

dedicated shutdown capability requiring new

buildings and systems shall be implemented within

30 months of NRC approval. Other modifications

requiring NRC approval prior to installation shall be

implemented within 6 months after NRC approval.

(e) Nuclear power plants licensed to operate after

January 17, 1979, shall complete all fire protection

modifications needed to satisfy Criterion 3 of

appendix A to this part in accordance with the

provisions of their licensees.

‘‘Sample Technical Specification,’’

dated May 12, 1977; ‘‘Nuclear Plant Fire

Protection Functional Responsibilities,

Administrative Control and Quality

Assurance,’’ dated June 14, 1997; and

‘‘Manpower Requirements for Operating

Reactors,’’ dated May 11, 1978. The six

documents that were referred to in

footnotes 3 and 4 no longer reflect

accurately the current NRC guidance.

Footnotes 3 and 4 were not intended

to be rulemaking requirements but

rather statements of fact. The footnotes

reflected the Commission’s approval of

the NRC staff’s practice, as reflected in

Branch Technical Position (BTP) APCSB

9.5–1 and in its Appendix A, that the

date of the docketing of the construction

permit would determine the NRC staff’s

review criteria for verifying compliance

with General Design Criterion (GDC) 3,

and that compliance with the guidance

of BTP APCSB 9.5–1 or its Appendix A

and the other listed guidance

documents would establish compliance

with GDC 3. The NRC has completed its

review of the fire protection programs at

all operating reactors and has issued

license conditions that establish the

licensing bases for each reactor. The

licensing bases may include the

documents listed in footnotes 3 and 4,

but typically include a number of other

guidance documents that the NRC

issued after it promulgated § 50.48. In

addition, the licensees included the fire

protection licensing basis for each

reactor in the Updated Final Safety

Analysis Report for the facility.

Footnotes 3 and 4 have served their

purpose and are not needed by the NRC

or the licensees to maintain the fire

protection licensing bases for the

reactors.

The change does not affect or change

the licensing basis for any plant.

However, it makes 10 CFR 50.48

consistent with other reactor regulations

that do not identify guidance

documents. It also eliminates the need

to update the footnotes to include the

large number of guidance documents

that the NRC has issued since it

promulgated § 50.48 and to conduct

future rulemakings to add new guidance

documents as they are issued. The

change also resolves an inconsistency

between the information in footnote 3 to

§ 50.48 and the regulatory requirements

of § 50.34(g)(1)(ii). Specifically

§ 50.34(g)(1)(ii) states, in part, that

‘‘Applications for light water cooled

nuclear power plant construction

permits, manufacturing licenses, and

preliminary or final design approvals for

standard plants docketed after May 17,

1982, shall include an evaluation of the

facility against the SRP * * *,’’

whereas, footnote 3 indicated that the

fire protection portions of these

applications would be reviewed against

BTP APCSB 9.5–1.

3. In Section I of Appendix R,

footnote 1 is removed.

Footnote 1 to Section I in Appendix

R is identical to footnote 4 to § 50.48(b).

The reasons given above for the removal

of footnote 4 to § 50.48(b) also apply to

footnote 1 to Section I in Appendix R.

4. In § 50.48, paragraphs (c), (d), and

(e) are removed.

Paragraphs (c) and (d) of § 50.48

contained schedule requirements that

were added to the Code of Federal

Regulations when Appendix R became

effective on February 17, 1981. These

requirements applied to nuclear power

plants licensed before January 1, 1979,

and involved fire protection installation

modifications, revisions of

administrative controls, manpower

changes, and training. These

requirements were to be completed on

a schedule determined by the provisions

specified in § 50.48 (c) and (d). All

scheduler requirements of § 50.48 (c)

and (d) have been implemented and

need not be retained.1

Paragraph (e) of § 50.48 specified that

nuclear power plants licensed after

January 1, 1979, were to complete all

fire protection modifications needed to

satisfy GDC 3 of Appendix A to 10 CFR

Part 50 in accordance with the

provisions of their licenses. License

38188 Federal Register / Vol. 65, No. 119 / Tuesday, June 20, 2000 / Rules and Regulations

conditions pertaining to fire protection

have been implemented at all plants.

Therefore, § 50.48(e) has been

implemented and need not be retained.

5. In Section III.G.3 of Appendix R, a

grammatical error is corrected.

Footnote 2 to Section III.G.3 of

Appendix R read, ‘‘Alternative

shutdown capability is provided by

rerouting, relocating, or modificating of

existing systems; dedicated shutdown

capability is provided by installing new

structures and systems for the function

of post-fire shutdown.’’ This final rule

replaces the words ‘‘modificating of’’

with ‘‘modifying.’’

IV. Plain Language

The Presidential memorandum dated

June 1, 1998, entitled, ‘‘Plain Language

in Government Writing,’’ directed that

the Federal Government’s writing be in

plain language (63 FR 31883, June 10,

1998). In compliance with this directive,

editorial changes have been made in

these amendments to improve the

readability of the existing language of

the provisions being revised. These

types of changes are not discussed

further in this document.

V. Compatibility of Agreement State

Regulations

Under the ‘‘Policy Statement on

Adequacy and Compatibility of

Agreement State Programs’’ approved by

the Commission on June 30, 1997, and

published in the Federal Register

September 3, 1997 (62 FR 46517), Part

50 is classified as compatibility

Category ‘‘NRC.’’ The NRC program

elements in this category are those that

relate directly to areas of regulation

reserved to the NRC by the AEA or

provisions of Title 10 of the Code of

Federal Regulations.

VI. Voluntary Consensus Standards

The National Technology Transfer Act

of 1995, Public Law 104–113, requires

that Federal agencies use technical

standards that are developed or adopted

by voluntary consensus standards that

are developed or adopted by voluntary

consensus standards bodies unless the

use of such a standard is inconsistent

with applicable law or otherwise

impractical. The NRC is deleting the

Government-unique standard in 10 CFR

Part 50, Appendix R, Section III.M,

which requires that fire barrier

penetration seals utilize only

noncombustible materials. The NRC is

not aware that deletion of this

requirement is inconsistent with any

voluntary consensus standard.

VII. Finding of No Significant

Environmental Impact

Environmental Assessment

The NRC has determined, in

accordance with the National

Environmental Policy Act of 1969, as

amended, and the Commission’s

regulations in Subpart A of 10 CFR Part

51, that the amendments are not a major

Federal action significantly affecting the

quality of the human environment;

therefore, an environmental impact

statement is not required.

1. The Action

The NRC is amending its regulations

that require fire barrier penetration seal

materials to be noncombustible and

making minor changes to § 50.48 and to

Appendix R to Part 50.

These minor changes are to remove

footnote 3 from § 50.48(a), footnote 4

from § 50.48(b), and footnote 1 from

Section I in Appendix R; remove

paragraphs (c), (d), and (e) from § 50.48;

correct a grammatical error in footnote

2 to Section III.G.3 of Appendix R; and

make editorial changes.

2. Need for the Rulemaking Action

The technical basis for removing the

noncombustibility requirement for fire

barrier penetration seal materials is

documented in NUREG–1552, ‘‘Fire

Barrier Penetration Seals in Nuclear

Power Plants,’’ July 1996; and in

NUREG–1552, Supplement 1, January

1999. In these reports, the NRC staff

documented the results of a technical

assessment of fire barrier penetration

seals. On the basis of its findings, the

NRC concluded that the

noncombustibility criterion for

penetration seal materials specified in

the NRC fire protection regulations and

review guidance has a negligible

contribution to safety and recommended

that this noncombustibility criterion be

deleted. In a staff requirements

memorandum dated June 30, 1998, the

Commission directed the NRC staff to

amend Section III.M of Appendix R to

10 CFR Part 50 (Appendix R) to

eliminate the noncombustibility

requirement for penetration seal

material and to make other minor

changes to the fire protection

regulations. These minor changes

include the deletion of references that

no longer reflect accurately the guidance

documents published by the NRC in

footnotes 3 and 4 of § 50.48 and in

footnote 1 to Section I of Appendix R,

the deletion of schedular requirements

that have been implemented in

§ 50.48(c) and (d), and a grammatical

correction in footnote 2 to Section

III.G.3 of Appendix R. The NRC also

took advantage of this rulemaking to

make editorial changes to comply with

the Presidential memorandum dated

June 1, 1998, entitled, ‘‘Plain Language

in Government Writing.’’ The deletion

of the noncombustibility criterion

removes a requirement that has a

negligible contribution to safety. It

constitutes a burden reduction for the

NRC and for the licensees.

3. ‘‘No Regulatory Action’’ Alternative

No regulatory action would have

continued the regulatory burden on

licensees and on the NRC. Siliconebased material is currently the material

of choice for fire barrier penetration

seals and is combustible. The NRC has

performed an assessment of siliconebased penetration seal materials and

concluded that the benefits of the

silicone-based materials in penetration

seals, such as high-temperature stability,

flexibility, and resistance to the effects

of radiation exposure and aging,

outweigh any potential concerns

regarding material combustibility. In the

past, licensees using silicone-based

penetration seal materials have

requested and been granted exemptions

from the requirement of Section III.M of

Appendix R to Part 50, regarding the use

of noncombustible materials, provided

the seals are qualified by fire endurance

tests conducted in accordance with an

industry standard. Under the previous

rule, a licensee that chose penetration

seals made of silicone-based materials to

replace existing seals or to install new

seals would have had to request an

exemption from the requirement of

Section III.M of Appendix R to the

extent that the silicone-based material is

combustible. This request for an

exemption would have increased the

regulatory burden on both the NRC and

the licensees, and would have presented

no safety benefit. No regulatory action

regarding the removal of footnote 3 to

§ 50.48(a), footnote 4 to § 50.48 (b),

footnote 1 to Section I of Appendix R,

and § 50.48 (c), (d), and (e) would have

had a negative regulatory impact for the

following reasons. Footnotes 3 and 4 in

§ 50.48 and footnote 1 to Section I of

Appendix R were inaccurate and

incomplete. In addition, the information

in footnote 3 was inconsistent with the

regulatory requirements contained in

§ 50.34(g)(1)(ii). The requirements in

§ 50.48 (c), (d), and (e) had been

implemented and need not be retained.

No regulatory action regarding the

correction of a grammatical error in

footnote 2 to Section III.G.3 of Appendix

R to Part 50, which was administrative

in nature, would not have had any

regulatory impact.

Federal Register / Vol. 65, No. 119 / Tuesday, June 20, 2000 / Rules and Regulations 38189

4. Environmental Impacts of the

Proposed Amendment and the

Alternative

The environmental impacts of this

amendment, as well as the alternative,

are considered negligible by the NRC.

The NRC has determined that the ability

of a particular penetration seal to

achieve its intended design function

(i.e., to contain a fire), as determined by

a fire endurance test conducted in

accordance with an industry standard,

is the foremost design consideration.

The amendment will not impact the

ability to shut down the plant safely in

the event of a fire and will provide a

level of safety equivalent to that attained

by compliance with Section III.M of

Appendix R to 10 CFR Part 50. There is

no environmental impact associated

with the other changes which are

administrative in nature. On this basis,

the NRC concludes that there are no

radiological environmental impacts

associated with this amendment. If no

regulatory action had been taken in

regard to the noncombustibility

requirement of Section III.M of

Appendix R there would have been no

radiological environmental impact, the

same as the action. No regulatory action

regarding the changes in § 50.48 and in

Appendix R (and the correction of an

error in footnote 2 to Section III.G.3 of

Appendix R, which is administrative in

nature) would have had no radiological

impact on the environment.

With regard to potential

nonradiological impacts, the

amendment does not affect

nonradiological plant effluents and has

no other environmental impact.

Therefore, the NRC concludes that there

are no significant nonradiological

environmental impacts associated with

the amendment.

5. List of Agencies and Persons

Consulted

Much of the technical information

required for this rulemaking was

obtained directly from technical experts

within the NRC. No other agencies were

consulted in preparing this

environmental assessment.

VIII. Paperwork Reduction Act

Statement

This final rule does not contain a new

or amended information collection

requirement subject to the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501

et seq.). Existing requirements were

approved by the Office of Management

and Budget, approval number 3150–

0011.

Public Protection Notification

If a means used to impose an

information collection does not display

a currently valid OMB control number,

the NRC may not conduct or sponsor,

and a person is not required to respond

to, the information collection.

IX. Regulatory Analysis

The NRC has prepared the following

regulatory analysis for the rule.

1. Statement of the Problem

The NRC is amending its regulations

regarding the requirement for fire barrier

penetration seal materials to be

noncombustible and is also making

minor changes to § 50.48 and to

Appendix R to 10 CFR Part 50. The

changes remove footnote 3 from

§ 50.48(a), footnote 4 from § 50.48(b),

and footnote 1 from Sect. I. of Appendix

R; remove paragraphs (c), (d), and (e)

from § 50.48; correct a grammatical error

in footnote 2 to Section III.G.3 of

Appendix R; and make editorial changes

to comply with the Presidential

memorandum dated June 1, 1998,

entitled, ‘‘Plain Language in

Government Writing.’’

2. Objectives of the Rulemaking

The main objective of the rule is to

remove the requirement of Section III.M

of Appendix R to 10 CFR Part 50 that

fire barrier penetration seal materials be

noncombustible. In addition, this rule

removes certain parts of § 50.48 and of

Appendix R, corrects a grammatical

error in Appendix R, and makes

editorial changes.

3. Alternative

The alternative of no regulatory action

would have continued the unnecessary

regulatory burden on licensees and on

the NRC.

4. Consequences

Removing the requirement that fire

barrier penetration seal materials be

noncombustible from Section III.M of

Appendix R to Part 50 lessens the

unnecessary regulatory burden on

licensees and on the NRC staff. It allows

licensees to use combustible materials

in penetration seals without requesting

an exemption from the requirement in

Section III.M of Appendix R regarding

the noncombustibility of penetration

seal materials, provided the seals are

qualified by fire endurance tests

comparable to those used to rate fire

barriers and conducted in accordance

with an industry standard. The other

minor changes are administrative and

do not affect the regulatory burden on

licensees.

5. Value Impact Analysis.

The value (benefit) and impact (cost)

of the changes are estimated below.

Section III.M of Appendix R to 10 CFR

Part 50 applies to the plants that were

operating before January 1, 1979, and

had open items when Appendix R was

published. As detailed in NUREG–1552,

Supplement 1, Section III.M of

Appendix R applies to 5 operating

reactors. In order to estimate the benefit

of the change, the NRC assumes that the

licensees for these plants may want to

replace some of their penetration seals

with penetration seals made of siliconebased combustible material and that

these licensees would request an

exemption from the technical

requirements of Section III.M of

Appendix R. Labor cost is $145/hr for a

power reactor licensee and $75/hr for

NRC. The change to Section III.M of

Appendix R would save licensees the

cost of preparing an exemption request

and would save the NRC the cost of

preparing a safety evaluation and

processing the request. Assuming a cost

saving of approximately $7500 for

licensees and approximately $2500 for

NRC for each exemption request, the

total cost saving from the change to

Section III.M would be approximately

$50,000. There would be no benefit or

cost associated with the other proposed

changes.

6. Decision Rationale

The NRC reviewed the requirement of

Section III.M of Appendix R during its

reassessment of fire barrier penetration

seals and determined that this

requirement has a negligible

contribution to safety. The removal of

the requirement of Section III.M reduces

the regulatory burden on the licensee

without reducing safety. In addition, the

rule makes the following minor changes:

removes footnote 3 from § 50.48(a),

footnote 4 from § 50.48(b), and footnote

1 from Section I of Appendix R;

removes paragraphs (c), (d), and (e) from

§ 50.48; corrects an error in footnote 2

to Section III.G.3 of Appendix R; and

makes editorial changes to comply with

the Presidential memorandum dated

June 1, 1998, entitled, ‘‘Plain Language

in Government Writing.’’ The other

changes as discussed above do not

change the regulatory burden on the

licensees and do not affect safety.

X. Regulatory Flexibility Act

Certification

As required by the Regulatory

Flexibility Act of 1980 (5 U.S.C. 605(b)),

the Commission certifies that this rule

does not have a significant impact on a

substantial number of small entities.

38190 Federal Register / Vol. 65, No. 119 / Tuesday, June 20, 2000 / Rules and Regulations

Nuclear power plant licensees do not

fall within the definition of small

businesses as defined in Sect. 3 of the

Small Business Act (15 U.S.C. 632) or

the Commission’s size standards at 10

CFR 2.810 (60 FR 18344; April 11,

1995).

XI. Backfit Analysis

The NRC has determined that these

amendments do not involve any

provisions that impose backfits because

it does not meet the definition of backfit

contained in § 50.109(a)(1) for the

following reasons. The removal of the

requirement that fire barrier penetration

seals be noncombustible is a permissive

relaxation of an existing requirement

and does not constitute imposition of a

new requirement. The removal of

footnotes 3 and 4 from § 50.48 and of

footnote 1 from Section I of Appendix

R does not affect the licensing basis for

existing plants, does not constitute a

change in design requirements for

existing plants, and is not applicable to

future plants. The schedular

requirements contained in paragraphs

(c) and (d) of § 50.48 apply to plants

licensed before February 17, 1981, and

have been implemented at these plants.

The requirements contained in

paragraph (e) of § 50.48 apply to existing

plants and have been implemented at all

applicable plants. Therefore, the

removal of paragraphs (c), (d), and (e)

from § 50.48 does not affect the

licensing basis and does not constitute

a change in design or optional

requirements for these plants. The

correction of a grammatical error in

footnote 2 to Section III.G.3 of Appendix

R and the changes in the language of

§ 50.48 in accordance with the

Presidential memorandum entitled

‘‘Plain Language in Government

Writing,’’ are administrative changes

that do not change any requirement and

need not be considered in this backfit

determination. For the reasons stated

above, a backfit analysis has not been

prepared for this rulemaking.

XII. Small Business Regulatory

Enforcement Fairness Act

In accordance with the Small

Business Regulatory Enforcement

Fairness Act of 1996, the NRC has

determined that this action is not a

major rule and has verified this

determination with the Office of

Information and Regulatory Affairs of

OMB.

List of Subjects in 10 CFR Part 50

Antitrust, Classified information,

Criminal penalties, Fire prevention,

Intergovernmental relations, Nuclear

power plants and reactors, Radiation

protection, Reactor siting criteria,

Reporting and recordkeeping

requirements.

For the reasons given in the preamble

and under the authority for the Atomic

Energy Act of 1954, as amended, the

Energy Reorganization Act of 1974, as

amended, and 5 U.S.C. 552 and 553, the

NRC is adopting the following

amendments to 10 CFR Part 50.

PART 50—DOMESTIC LICENSING OF

PRODUCTION AND UTILIZATION

FACILITIES

1. The authority citation for Part 50

continues to read as follows:

Authority: Secs. 102, 103, 104, 105, 161,

182, 183, 186, 189, 68 Stat. 936, 937, 938,

948, 953, 954, 955, 956, as amended, sec.

234, 83 Stat. 444, as amended, (42 U.S.C.

2132, 2133, 2134, 2135, 2201, 2232, 2233,

2236, 2239, 2282); secs. 201, as amended,

202, 206, 88 Stat. 1242, as amended, 1244,

1246 (42 U.S.C. 5841, 5842, 5846).

Section 50.7 also issued under Pub. L. 95–

601, sec. 10, 92 Stat. 2951 (42 U.S.C. 5851).

Section 50.10 also issued under secs. 101,

185, 68 Stat. 955 as amended (42 U.S.C. 2131,

2235), sec. 102, Pub. L. 91–190, 83 Stat. 853

(42 U.S.C. 4332). Sections 50.13, 50.54(dd),

and 50.103 also issued under sec. 108, 68

Stat. 939, as amended (42 U.S.C. 2138).

Section 50.23, 50.35, 50.55, and 50.56 also

issued under sec. 185, 68 Stat. 955 (42 U.S.C.

2235). Sections 50.33a, 50.55a, and Appendix

Q also issued under sec. 102, Pub. L. 91–190,

83 Stat. 853 (42 U.S.Q. 4332). Sections 50.34

and 50.54 also issued under sec. 204, 88 Stat.

1245 (42 U.S.Q. 5844). Sections 50.58, 50.91,

and 50.92 also issued under Pub. L. 97–415,

96 Stat. 2073 (42 U.S.Q. 2239). Section 50.78

also issued under sec. 122, 68 Stat. 939 (42

U.S.Q. 2152). Sections 50.80–50.81 also

issued under sec. 184, 68 Stat. 954, as

amended (42 U.S.Q. 2234). Appendix F also

issued under sec. 187, 68 Stat. 954 (42 U.S.Q.

2237).

2. Section 50.48 is revised to read as

follows:

§ 50.48 Fire protection.

(a)(1) Each operating nuclear power

plant must have a fire protection plan

that satisfies Criterion 3 of appendix A

to this part. This fire protection plan

must:

(i) Describe the overall fire protection

program for the facility;

(ii) Identify the various positions

within the licensee’s organization that

are responsible for the program;

(iii) State the authorities that are

delegated to each of these positions to

implement those responsibilities; and

(iv) Outline the plans for fire

protection, fire detection and

suppression capability, and limitation of

fire damage.

(2) The plan must also describe

specific features necessary to implement

the program described in paragraph

(a)(1) of this section such as—

(i) Administrative controls and

personnel requirements for fire

prevention and manual fire suppression

activities;

(ii) Automatic and manually operated

fire detection and suppression systems;

and

(iii) The means to limit fire damage to

structures, systems, or components

important to safety so that the capability

to shut down the plant safely is ensured.

(3) The licensee shall retain the fire

protection plan and each change to the

plan as a record until the Commission

terminates the reactor license. The

licensee shall retain each superseded

revision of the procedures for 3 years

from the date it was superseded.

(b) Appendix R to this part establishes

fire protection features required to

satisfy Criterion 3 of appendix A to this

part with respect to certain generic

issues for nuclear power plants licensed

to operate before January 1, 1979.

(1) Except for the requirements of

Sections III.G, III.J, and III.O, the

provisions of Appendix R to this part do

not apply to nuclear power plants

licensed to operate before January 1,

1979, to the extent that—

(i) Fire protection features proposed

or implemented by the licensee have

been accepted by the NRC staff as

satisfying the provisions of Appendix A

to Branch Technical Position (BTP)

APCSB 9.5–1 reflected in NRC fire

protection safety evaluation reports

issued before the effective date of

February 19, 1981; or

(ii) Fire protection features were

accepted by the NRC staff in

comprehensive fire protection safety

evaluation reports issued before

Appendix A to Branch Technical

Position (BTP) APCSB 9.5–1 was

published in August 1976.

(2) With respect to all other fire

protection features covered by

Appendix R, all nuclear power plants

licensed to operate before January 1,

1979, must satisfy the applicable

requirements of Appendix R to this part,

including specifically the requirements

of Sections III.G, III.J, and III.O.

(c) [Reserved].

(d) [Reserved].

(e) [Reserved].

(f) Licensees that have submitted the

certifications required under

§ 50.82(a)(1) shall maintain a fire

protection program to address the

potential for fires that could cause the

release or spread of radioactive

materials (i.e., that could result in a

radiological hazard).

(1) The objectives of the fire

protection program are to—

Federal Register / Vol. 65, No. 119 / Tuesday, June 20, 2000 / Rules and Regulations 38191

1Alternative shutdown capability is provided by

rerouting, relocating, or modifying existing systems;

dedicated shutdown capability is provided by

installing new structures and systems for the

function of post-fire shutdown.

(i) Reasonably prevent these fires from

occurring;

(ii) Rapidly detect, control, and

extinguish those fires that do occur and

that could result in a radiological

hazard; and

(iii) Ensure that the risk of fireinduced radiological hazards to the

public, environment and plant

personnel is minimized.

(2) The licensee shall assess the fire

protection program on a regular basis.

The licensee shall revise the plan as

appropriate throughout the various

stages of facility decommissioning.

(3) The licensee may make changes to

the fire protection program without NRC

approval if these changes do not reduce

the effectiveness of fire protection for

facilities, systems, and equipment that

could result in a radiological hazard,

taking into account the

decommissioning plant conditions and

activities.

3. In Appendix R, Section I, footnote

1 is removed and footnotes 2 through 5

are redesignated as footnotes 1 through

4, respectively. New footnote 1 to

Section III.G.3, and Section III.M are

revised to read as follows:

Appendix R to Part 50—Fire Protection

Program for Nuclear Power Facilities

Operating Before January 1, 1979

* * * * *

III. Specific Requirements * * *

G. * * *

3. Alternative of dedicated shutdown

capability and its associated circuits,1

independent of cables, systems or

components in the area, room, zone under

consideration should be provided: * * *

* * * * *

M. Fire barrier cable penetration seal

qualification. Penetration seal designs must

be qualified by tests that are comparable to

tests used to rate fire barriers. The acceptance

criteria for the test must include the

following:

1. The cable fire barrier penetration seal

has withstood the fire endurance test without

passage of flame or ignition of cables on the

unexposed side for a period of time

equivalent to the fire resistance rating

required of the barrier;

2. The temperature levels recorded for the

unexposed side are analyzed and

demonstrate that the maximum temperature

is sufficiently below the cable insulation

ignition temperature; and

3. The fire barrier penetration seal remains

intact and does not allow projection of water

beyond the unexposed surface during the

hose stream test.

* * * * *

Dated at Rockville, Maryland, this 14th day

of June, 2000.

For the Nuclear Regulatory Commission.

Annette Vietti-Cook,

Secretary of the Commission.

[FR Doc. 00–15544 Filed 6–19–00; 8:45 am]

BILLING CODE 7590–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201, 330, 331, 341, 346,

355, 358, 369, and 701

[Docket Nos. 98N–0337, 96N–0420, 95N–

0259, and 90P–0201]

RIN 0910–AA79

Over-the-Counter Human Drugs;

Labeling Requirements; Partial

Extension of Compliance Dates

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; partial extension of

compliance dates.

SUMMARY: The Food and Drug

Administration (FDA) is providing a

partial extension of the compliance

dates for its final rule that appeared in

the Federal Register of March 17, 1999.

The final rule established a

standardized format and standardized

content requirements for the labeling of

over-the-counter (OTC) drug products.

That final rule requires all OTC drug

products to have the new, easy-to-read

format and the revised labeling

requirements within prescribed

implementation periods. This partial

extension provides 1 additional year for

implementation for specific types of

OTC drug products to be in compliance

with the final rule.

DATES:

Effective Date: This rule is effective

July 20, 2000.

Compliance Dates: For compliance

dates, see section III of the

SUPPLEMENTARY INFORMATION section of

this document. Submit written

comments by September 18, 2000.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Gerald M. Rachanow, Center for Drug

Evaluation and Research (HFD–560),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–2307.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of March 17,

1999 (64 FR 13254), FDA published a

final rule establishing standardized

format and standardized content

requirements for the labeling of OTC

drug products. Those requirements are

codified in § 201.66 (21 CFR 201.66).

Section 201.66(a) states that the

content and format requirements in

§ 201.66 apply to the labeling of all OTC

drug products. This includes products

marketed under a final OTC drug

monograph, an approved new drug

application (NDA) or abbreviated new

drug application (ANDA) under section

505 of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C. 355),

and OTC drug products for which there

is no final OTC drug monograph or

approved drug application.

The agency provided different

implementation dates by which OTC

drug products had to be in compliance

with the new requirements. These dates

varied according to the regulatory status

of the products (64 FR 13254 at 13273

and 13274).

A. Products in the OTC Drug Review

Products marketed under final OTC

drug monographs had to comply with

the final rule by April 16, 2001.

Products for which a final monograph

became effective on or after April 16,

1999, had to comply as of: (1) The

applicable implementation date for that

final monograph; (2) the next major

revision to any part of the label or

labeling after April 16, 2001; or (3) April

18, 2005, whichever occurs first.

Combination drug products in which

all of the active ingredients are the

subject of a final monograph or

monographs had to comply with the

final rule as of April 16, 2001.

Combination products in which one or

more active ingredients are the subject

of a final monograph, and one or more

ingredients are still under review as of

the effective date of the final rule, had

to comply as of the implementation date

for the last applicable final monograph

for the combination, or as of April 16,

2001, whichever is earlier. Combination

products in which none of the active

ingredients is the subject of a final

monograph or monographs as of the

effective date of the final rule had to

comply as of: (1) The implementation

date of the last applicable final

monograph for the combination; (2) the

next major revision to any part of the

label or labeling after April 16, 2001; or

(3) April 18, 2005, whichever comes

first.