60658 Federal Register / Vol. 62, No. 218 / Wednesday, November 12, 1997 / Rules and Regulations

36.3 g/t with bacitracin zinc 10 g/t and

roxarsone 30 to 45.4 g/t is used as an aid

in the prevention of coccidiosis where

severe exposure to coccidiosis from E.

acervulina, E. maxima, and E. brunetti

is likely to occur, and for improved feed

efficiency and improved pigmentation.

Alpharma Inc.’s ANADA 200–214

provides for combining approved

AMPROL HI–E (Merck Research

Laboratories’ amprolium and ethopabate

NADA 13–461), ALBAC (Alpharma

Inc.’s bacitracin zinc ANADA 200–223),

and 3–NITRO (Alpharma Inc.’s

roxarsone NADA 7–891) Type A

medicated articles to make the

combination drug Type C medicated

feeds.

Alpharma Inc.’s ANADA 200–214 is

approved as a generic copy of

Hoffmann-LaRoche, Inc.’s NADA 105–

758. The ANADA is approved as of

November 12, 1997, and the regulations

are amended in 21 CFR 558.58(d)(1)(iii)

to reflect the approval. The basis for

approval is discussed in the freedom of

information summary.

In accordance with the freedom of

information provisions of 21 CFR part

20 and 514.11(e)(2)(ii), a summary of

safety and effectiveness data and

information submitted to support

approval of this application may be seen

in the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857, between

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

Friday.

The agency has determined under 21

CFR 25.33 that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

List of Subjects in 21 CFR Part 558

Animal drugs, Animal feeds.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR part 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR

part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.

§ 558.58 [Amended]

2. Section 558.58 Amprolium and

ethopabate is amended in the table in

paragraph (d)(1)(iii) in the entry for

‘‘Bacitracin 10 to 50 plus roxarsone 15.4

to 45.4 (0.0017% to 0.005%)’’ under

‘‘Limitations’’ by removing ‘‘No.

000004’’ both times it appears and

adding in their place ‘‘Nos. 000004 and

046573’’, and under ‘‘Sponsor’’ by

removing ‘‘000004’’ and adding in its

place ‘‘000004, 046573’’.

Dated: October 22, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–29653 Filed 11-10-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Office of Surface Mining Reclamation

and Enforcement

30 CFR Part 946

[VA–106–FOR]

Virginia Regulatory Program

AGENCY: Office of Surface Mining

Reclamation and Enforcement (OSM),

Interior.

ACTION: Final rule; correction.

SUMMARY: This document corrects and

explains an OSM decision on a

provision of a proposed amendment

submitted by the State of Virginia as a

modification to its permanent regulatory

program (hereinafter referred to as the

Virginia program) under the Surface

Mining Control and Reclamation Act of

1977 (SMCRA). OSM published its

decision on the provision in a

September 17, 1997, final rule Federal

Register document. The provision

concerns an exemption from the

requirement to conduct mitigation

measures to prevent or lessen the

impact of subsidence damage, when

planned subsidence mining methods are

used, when the structure owners deny

the permittee access to implement the

measures to minimize material damage.

DATES: Effective: November 12, 1997.

FOR FURTHER INFORMATION CONTACT: Mr.

Robert A. Penn, Director, Big Stone Gap

Field Office, Office of Surface Mining

Reclamation and Enforcement, 1941

Neeley Road, Suite 201, Compartment

116, Big Stone Gap, Virginia 24219,

Telephone: (540) 523–4303.

SUPPLEMENTARY INFORMATION: By letter

dated May 21, 1996 (Administrative

Record No. VA–882), Virginia submitted

amendments to the Virginia program

concerning subsidence damage. The

amendments are intended to make the

Virginia program consistent with the

Federal regulations as amended on

March 31, 1995 (60 FR 16722). Virginia

stated that the proposed amendments

implement the standards of the Federal

Energy Policy Act of 1992, and sections

45.1–243 and 45.1–258 of the Code of

Virginia.

On September 17, 1997, OSM

approved, with certain exceptions, the

amendment submitted by Virginia (62

FR 48758). This document revises and

explains one of OSM’s decisions.

Subsidence Control

In the September 17, 1997, final rule,

Federal Register document, OSM stated

that it was approving, for longwall

mining permittees, Virginia’s proposed

language at 480–03–19.817.121(a)(2)(iii)

concerning an exemption from the

requirement to conduct mitigation

measures to minimize material damage

from subsidence. The exemption would

apply when the structure owners deny

the permittee access to implement the

measures to minimize material damage.

(See Finding No. 5 of the September 17,

1997, final rule, 62 FR 48760.

In that finding, OSM excluded room

and pillar retreat mining from qualifying

for the proposed exemption. Upon

further consideration of Virginia’s

proposed provision at 480–03–

19.817.121(a)(2)(iii), OSM is changing is

previous finding and decision. The

rational for the revised decision is

discussed below. The following finding

replaces the preamble discussion for

that part of Finding 5 that concerns

amendments to subsection (a) of 480–

03–19.817.121, in the final rule (62 FR

48758, second and third columns on

page 48760).

5. § 480–03–13.817.121 Subsidence

Control

Subsection (a) concerning measures to

prevent or minimize damage is

amended by adding new language (at

new subsection (a)(2)) to provide that

planned subsidence must include

measures to minimize material damage

to protected structures, except if the

permittee has written consent of the

structure owners, the costs of such

measures exceed the anticipated costs of

repair (unless the anticipated damage

would constitute a threat to health or

safety), or the structure owners deny the

permittee access to implement the

measures to minimize material damage

and the permittee provides written

evidence of good faith efforts to obtain

access.

The proposed language is

substantively identical to and no less

effective than the counterpart Federal

language at 30 CFR 817.121(a)(2) with

one exception. 30 CFR 817.121(a)(2)

contains no counterpart to the proposed

language that provides an exception to

the requirement to include measures to

minimize material damage to protected
Federal Register / Vol. 62, No. 218 / Wednesday, November 12, 1997 / Rules and Regulations 60659

structures if the structure owners deny

the permittee access to implement the

measures to minimize material damage.

‘‘Planned subsidence in a predictable

and controlled manner’’ includes

longwall mining and pillar retreat

mining. Mitigation efforts performed on

the surface to minimize material damage

from planned subsidence include

trenching, bracing, or jacking of the

structures to be protected. These

mitigation measures remain in place

while the ground underneath the

structures subsides, keeping the

structures level and, thereby, helping to

minimizing damage to the structures.

It is possible to prevent or minimize

damage to the surface and surface

structures by leaving coal in place (for

example, by leaving support pillars or

reducing the width of a longwall

extraction panel). Such underground

measures are not undertaken, however,

if the approved mining method involves

planned subsidence in a predictable and

controlled manner as with longwall and

pillar retreat mining, ‘‘because they are

not normally consistent with longwall

technology.’’ (60 FR at 16731) As stated

in the final rule preamble to 30 CFR

784.20(b), ‘‘OSM does not intend to

require anything other than surface

measures to minimize material damage

from longwall mining where

conventional underground measures

may not be practicable.’’ (60 FR at

16731) Note that in the preamble, OSM

used the term ‘‘longwall mining’’ to

refer to the ‘‘longwall mining and pillar

recovery technologies.’’ (60 FR at 16731)

Subsidence is a natural and common

result of underground mining. However,

there is a clear distinction between the

mining methods that produce planned

subsidence and those that produce

unplanned subsidence. The following is

a brief explanation of planned and

unplanned subsidence and the mining

methods that produce them.

Unplanned subsidence. The standard

method of room and pillar mining

produces unplanned subsidence.

Standard room and pillar mining is

accomplished as follows. First, a series

of parallel paths are cut through the

coal. These cuts are called entries. As

the entries are increased in length, they

are connected together by cutting a

series of cross cuts through the coal

from one entry to the next. These cross

cuts produce a series of coal pillars

surrounded by mined-out spaces (called

rooms). Room and pillar mining

produces a pattern much like a common

checkerboard: on a checkerboard, each

black square is surrounded by red

squares. In a room and pillar

underground mine, a pillar of coal is

surrounded by mined-out coal. In

standard room and pillar mining, the

pillars are left in place to support the

rock (roof) above the coal layer.

The size of the pillar that is left to

support the roof is determined by the

strength of the coal, depth of the coal,

the characteristics of the rock (above the

coal) that is being supported, and the

width of the entry system. The pillars in

place support the roof of an

underground coal mine for an

undetermined length of time. It is

possible that, sometime in the future,

roof and/or pillar failure may occur and

surface subsidence may take place.

Normally, the extraction of coal from

this type of mine development is less

than 70 percent.

Planned subsidence. Planned

subsidence is achieved by both retreat

mining of the pillars of a room and

pillar system, and by longwall mining.

In retreat mining, the pillars of a room

and pillar system are reduced in size

(robbed) as the miners retreat back out

of the room and pillar system. In retreat

mining, the pillars are reduced in size

to the point of allowing a controlled

failure of the roof (roof fall) to occur.

Total extraction of coal within the area

defined for retreat mining is usually

greater than 75 percent. It is important

to note that in pillar retreat mining, it

is essential that the roof fall take place

in order to reduce the forces on the

remaining pillars. If the load forces on

the remaining pillars aren’t reduced by

roof fall, the mining equipment can’t

properly and safely mine the remaining

pillars.

A longwall mining operation is first

developed by using room and pillar

methods to develop entries,

haulageways, paths for ventilation, and

to define the blocks of coal to be

removed by the longwall cutter. the

blocks of coal to be removed are often

quite large (for example, 500 to 1,000

feet wide by thousands of feet long).

Since all the coal is removed in these

large blocks, the unsupported roof falls

shortly following passage of the

longwall cutter. The amount of surface

subsidence that is expected to take place

is determined from the thickness of the

coal, width of the block of coal

removed, and the characteristics and

thickness of the overburden.

The Federal regulations at 30 CFR

817.121(a)(1) provide that a permittee

must either adopt measures to prevent

subsidence from causing material

damage, or adopt mining technology

that provides for planned subsidence in

a predictable and controlled manner.

Room and pillar retreat mining and

longwall mining are examples of mining

technology that provides for planned

subsidence in a predictable and

controlled manner. Thus, Virginia’s

proposal with regard to longwall mining

operations and room and pillar retreat

mining operations is consistent with the

Federal rule at 30 CFR 817.121(a)(2)

which requires measures to minimize

subsidence damage only when such

measures are ‘‘consistent with the

mining method employed’’ and they are

‘‘technologically feasible.’’

Section 516(b)(1) of SMCRA provides

a special exemption for planned

subsidence methods of mining from the

requirement to adopt measures

consistent with known technology in

order to prevent subsidence from

causing material damage. Section

720(a)(2) of SMCRA, which concerns

subsidence related to underground

mining operations, provides that

nothing in section 720(a)(2) ‘‘shall be

construed to prohibit or interrupt

underground coal mining operations.’’

Additionally, the preamble to 30 CFR

817.121(a)(2) states that the damage

minimization requirements for planned

subsidence operations are based on both

sections of SMCRA. (60 FR at 16734, 1st

column; March 31, 1995)

OSM was also concerned about

whether or not the structure owner

would be notified by the longwall

permittee of the consequences of failing

to allow access for the placement of

mitigation measures. Since Virginia’s

proposal had no direct Federal

counterpart, there was no direct Federal

notice counterpart. The Federal

regulations at 30 CFR 784.20(a)(3)

provide a relevant comparison. 30 CFR

784.20(a)(3) provides that, if an owner

denies access for a pre-mining survey,

the permittee must provide certain

information to the landowner

concerning the potential negative effect

of their actions, but the lack of access

does not prevent the permittee from

mining. Virginia, by a letter dated

January 3, 1997 (Administrative Record

Number VA–902) clarified that under

480–03–19.817.121(a)(2)(iii), the

permittee must provide a written

document to the structure owner

informing the owner of the

consequences of denying access.

Further, the permittee must provide

Virginia with evidence documenting

such notice.

The Director finds, therefore, that

Virginia’s proposal is reasonable and

not inconsistent with SMCRA, since it

would facilitate both the use of planned

subsidence mining methods and the

continuation of underground mining in

situations in which surface owners

refuse to allow implementation of

surface measures approved by the

regulatory authority.
60660 Federal Register / Vol. 62, No. 218 / Wednesday, November 12, 1997 / Rules and Regulations

In addition, the preamble to the

Federal regulation at 30 CFR

817.121(a)(2) does not address the

question of what happens when a

landowner denies access. Therefore, it is

reasonable to presume that OSM never

envisioned this situation, thus creating

the regulatory gap that Virginia is

endeavoring to fill.

Subsection (c) has been revised by

deleting the existing language and

replacing new language.

* * * * *

The Federal regulations at 30 CFR

part 946 codifying decisions concerning

the Virginia program are being amended

to implement this revised finding.

Section 946.15 Approval of Virginia

regulatory program amendments is

being amended in the table (third

column on page 48765, 62 FR 48758) to

show both the September 17, 1997, final

publication of this amendment, and the

date of the revision discussed in this

notice.

Dated: November 3, 1997.

Tim L. Dieringer,

Acting Regional Director, Appalachian

Regional Coordinating Center.

PART 946—VIRGINIA

1. The authority citation for part 946

continues to read as follows:

Authority: 30 U.S.C. 1201 et seq.

2. Section 946.15 is amended in the

table by revising the entry having the

original amendment submission date of

May 21, 1996, to read as follows:

§ 946.15 Approval of Virginia regulatory

program amendments.

* * * * *

Original amendment submission date Date of final publication Citation/description

* * * * * * *

May 21, 1996 ...................... September 17, 1997, and November 12, 1997 ............... VA Code §§ 480–03–19.700.5; 784.14, 20; 817.41, 121.

[FR Doc. 97–29724 Filed 11–10–97; 8:45 am]

BILLING CODE 4310–05–M

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–300505A; FRL–5750–3]

40 CFR Part 180

RIN 2070–AB78

Corn Gluten; Exemption from the

Requirement of a Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This document establishes an

exemption from the requirement of a

tolerance for residues of corn gluten also

known as corn gluten meal, when used

as an herbicide in or on all food

commodities, when applied in

accordance with good agricultural

practice. This exemption from

requirement of a tolerance is being

established by the Agency on its own

initiative, under the Federal Food, Drug,

and Cosmetic Act (FFDCA) as amended

by the Food Quality Protection Act

(FQPA) of 1996.

DATES: This regulation becomes

effective November 12, 1997. Written

objections and requests for hearings

must be received by January 12, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number [OPP–300505A],

must be submitted to: Hearing Clerk

(1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk identified

by the docket control number, [OPP–

300505A], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of

electronic objections and hearing

requests must be submitted as an ASCII

file avoiding the use of special

characters and any form of encryption.

Copies of electronic objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1/6.1 or

ASCII file format. All copies of

electronic objections and hearing

requests must be identified by the

docket control number [OPP–300505A].

No Confidential Business Information

(CBI) should be submitted through email. Copies of electronic objections and

hearing requests on this rule may be

filed online at many Federal Depository

Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Freshteh Toghrol, Biopesticides

and Pollution Prevention Division

(7511W), Office of Pesticide Programs,

Environmental Protection Agency, 401

M St. SW., Washington, DC 20460.

Office location, telephone number, and

e-mail address: 5th Floor, Crystal

Station 1, 2805 Crystal Drive, Arlington,

VA; (703) 308–7014, e-mail:

toghrol.freshteh@epamail.epa.gov..

SUPPLEMENTARY INFORMATION: In the

Federal Register of July 18, 1997 (62 FR

38513) [OPP–300505; FRL–5717–8],

EPA proposed, pursuant to section

408(e) of the FFDCA, 21 U.S.C. 346a(d)

to amend 40 CFR 180.1164 by

establishing an exemption from the

requirement of a tolerance for corn

gluten in or on all food commodities,

when applied in accordance with good

agricultural practice.

There were no comments received in

response to the proposed rule.

Based on the reasons set forth in the

preamble to the proposed rule, EPA

esablishes an exemption from tolerance

for corn gluten as provided below.

I. Objections and Hearing Requests

The new FFDCA section 408(g)

provides essentially the same process

for persons to ‘‘object’’ to a regulation

for an exemption from the requirement

of a tolerance issued by EPA under new

section 408(e) as was provided in the

old section 408 and in section 409.

However, the period for filing objections

is 60 days, rather than 30 days. EPA

currently has procedural regulations

which governs the submission of

objections and hearing requests. These