This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

20770

Vol. 65, No. 75

Tuesday, April 18, 2000

DEPARTMENT OF AGRICULTURE

Office of the Secretary

7 CFR Part 6

RIN 0551–AA59

Licensing for Certain Sugar-Containing

Products Under Tariff-Rate Quota

AGENCY: Office of the Secretary, USDA.

ACTION: Proposed rule: Extension of

comment period.

SUMMARY: The proposed rule, published

in the Federal Register on March 17,

2000, (65 FR 14478–14484) provides for

licensing of imports of sugar-containing

products which enter under the tariffrate quota (TRQ) provided for in

Additional U.S. Note 8 to chapter 17 of

the Harmonized Tariff Schedule of the

United States (HTS). Public comments

were requested by April 17, 2000. The

Department is extending the public

comment period to May 17, 2000.

DATES: The comment period has been

extended and will expire on May 17,

2000. Comments should be received on

or before this date to be assured of

consideration.

ADDRESSES: Comments should be

mailed or delivered to Diana

Wanamaker, Import Policies and

Programs Division, Foreign Agricultural

Service, 1400 Independence Avenue

SW, STOP 1021, U.S. Department of

Agriculture, Washington, DC 20250–

1021. Comments received may be

inspected between 10:00 a.m. and 4:00

p.m. at room 5541–S, 1400

Independence Avenue SW, Washington,

DC 20250–1021.

FOR FURTHER INFORMATION CONTACT:

Diana Wanamaker at the address above,

or telephone at 202–720–2916, or e-mail

at Wanamaker@fas.usda.gov.

SUPPLEMENTARY INFORMATION: The

proposed rule was published in the

Federal Register on March 17, 2000 (65

FR 14478–14484) and public comments

were requested on or before April 17,

2000, to be assured of consideration. In

view of private sector and foreign

government requests that the comment

period be extended in order to more

fully assess the proposed import

licensing requirement and its effects on

business operations, the Department has

decided that a 30-day extension of the

comment period to May 17, 2000 would

be reasonable.

Signed at Washington, D.C. on April 13,

2000.

Timothy J. Galvin,

Administrator, Foreign Agricultural Service.

[FR Doc. 00–9728 Filed 4–17–00; 8:45 am]

BILLING CODE 3410–10–P

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

7 CFR Part 301

[Docket No. 99–077–1]

RIN 0579–AB17

Karnal Bunt; Regulated Areas

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Proposed rule.

SUMMARY: We propose to amend the

Karnal bunt regulations by removing

from regulated areas any noninfected

acreage that is more than 3 miles from

a field or area associated with a bunted

wheat kernel. This action would reduce

the size of the areas that are regulated

because of Karnal bunt in La Paz,

Maricopa, and Pinal Counties of

Arizona. We also propose to specify that

mechanized harvesting equipment must

be cleaned and disinfected before

leaving a regulated area only if it has

been used to harvest host crops that test

positive for Karnal bunt. This action

would relieve restrictions on the

movement of mechanized harvesting

equipment from all areas regulated

because of Karnal bunt. We believe

these actions would not result in a

significant risk of spreading Karnal

bunt.

DATES: We invite you to comment on

this docket. We will consider all

comments that we receive by June 19,

2000.

ADDRESSES: Please send your comment

and three copies to: Docket No. 99–077–

1, Regulatory Analysis and

Development, PPD, APHIS, Suite 3C03,

4700 River Road, Unit 118, Riverdale,

MD 20737–1238.

Please state that your comment refers

to Docket No. 99–077–1.

You may read any comments that we

receive on this docket in our reading

room. The reading room is located in

room 1141 of the USDA South Building,

14th Street and Independence Avenue,

SW., Washington, DC. Normal reading

room hours are 8 a.m. to 4:30 p.m.,

Monday through Friday, except

holidays. To be sure someone is there to

help you, please call (202) 690–2817

before coming.

APHIS documents published in the

Federal Register, and related

information, including the names of

organizations and individuals who have

commented on APHIS rules, are

available on the Internet at http://

www.aphis.usda.gov/ppd/rad/

webrepor.html.

FOR FURTHER INFORMATION CONTACT: Dr.

Vedpal S. Malik, National Karnal Bunt

Coordinator, PPQ, APHIS, 4700 River

Road Unit 134, Riverdale, MD 20737–

1236; (301)734–6774.

SUPPLEMENTARY INFORMATION:

Background

Karnal bunt is a fungal disease of

wheat (Triticum aestivum), durum

wheat (Triticum durum), and triticale

(Triticum aestivum X Secale cereale), a

hybrid of wheat and rye. Karnal bunt is

caused by the fungus Tilletia indica

(Mitra) Mundkur and is spread through

the movement of infected seed. In the

absence of measures taken by the U.S.

Department of Agriculture (USDA) to

prevent its spread, the establishment of

Karnal bunt in the United States could

have significant consequences with

regard to the export of wheat to

international markets. The regulations

regarding Karnal bunt are set forth in 7

CFR 301.89–1 through 301.89–14

(referred to below as the regulations).

Regulated Areas in Arizona

The regulations in § 301.89–3(e)

provide the criteria for classifying a

field or area as a regulated area for

Karnal bunt. Under those criteria, a field

or area would be classified as a

regulated area when it is:

• A field planted with seed from a lot

found to contain a bunted wheat kernel;

• A distinct definable area that

contains at least one field that was

found during survey to contain a bunted

Federal Register / Vol. 65, No. 75 / Tuesday, April 18, 2000 / Proposed Rules 20771

wheat kernel (the distinct definable area

may include an area where Karnal bunt

is not known to exist but where

intensive surveys are required because

of the area’s proximity to a field found

during survey to contain a bunted

kernel); or

• A distinct definable area that

contains at least one field that was

found during survey to contain spores

consistent with Karnal bunt and has

been determined to be associated with

grain at a handling facility containing a

bunted wheat kernel (the distinct

definable area may include an area

where Karnal bunt is not known to exist

but where intensive surveys are

required because of the area’s proximity

to a field that has been associated with

grain at a handling facility containing a

bunted kernel).

The boundaries of distinct definable

areas are determined using the criteria

in paragraphs (b) through (d) of

§ 301.89–3, which provide for the

regulation of less than an entire State,

the inclusion of noninfected acreage in

a regulated area, and the temporary

designation of nonregulated areas as

regulated areas. Paragraph (c) of

§ 301.89 states that the Administrator

may include noninfected acreage within

a regulated area due to its proximity to

an infestation or inseparability from the

infected locality for regulatory purposes,

as determined by:

• Projections of the spread of Karnal

bunt along the periphery of the

infestation;

• The availability of natural habitats

and host materials within the

noninfected acreage that are suitable for

establishment and survival of Karnal

bunt; and

• The necessity of including

noninfected acreage within the

regulated area in order to establish

readily identifiable boundaries.

When we include noninfected acreage

in a regulated area for one or more of

these reasons, the noninfected acreage,

along with the rest of the acreage in the

regulated area, is intensively surveyed.

Negative results from surveys of the

noninfected acreage provide assurance

that all infected acreage is within the

regulated area. In effect, the noninfected

acreage serves as a buffer zone between

fields or areas associated with a bunted

kernel and areas outside of the regulated

area.

Based on 4 years of experience

surveying noninfected acreage included

in regulated areas, we have determined

that a buffer zone of no more than 3

miles around a field or area associated

with a bunted kernel is sufficient.

The regulations at § 301.89–3(f) set

the boundaries for regulated areas in

Arizona, California, New Mexico, and

Texas. Certain regulated areas in

Arizona, California, and Texas include

noninfected acreage. In those regulated

areas in California and Texas, the buffer

zone does not extend more than 3 miles.

However, in Arizona, regulated areas

include additional noninfected

acreage—in some cases up to 6 miles

from a field or area associated with a

bunted kernel—when the area is within

contiguous agricultural acreage.

We propose to reduce the size of the

regulated areas in Arizona by removing

noninfected acreage that is more than 3

miles from a field or area associated

with a bunted wheat kernel. This action

would reduce the size of the areas in La

Paz, Maricopa, and Pinal Counties of

Arizona that are regulated because of

Karnal bunt and would create a uniform

and consistent standard for setting the

boundaries of regulated areas in all

affected States.

As a result of our proposal to reduce

the size of the regulated areas in

Maricopa and Pinal Counties so that

they include only a 3-mile buffer zone

around a field or area associated with a

bunted kernel, we also propose to add

10 fields in Maricopa County and 5

fields in Pinal County to the respective

county lists of individual fields

classified as regulated areas. These 15

fields are currently part of larger

regulated areas in Pinal and Maricopa

Counties that would be broken up by

our removing some noninfected acreage

from regulation. These fields were

planted in 1995 with lots of seed that

contained bunted wheat kernels, so we

believe it necessary to continue to

regulate these fields. However, because

crops from these fields have never

tested positive for Karnal bunt, we see

no need to establish a buffer zone

around these fields.

The areas in La Paz, Maricopa, and

Pinal Counties of Arizona that we

propose to designate as regulated areas

are described in § 301.89(f) in the rule

portion of this document.

Mechanized Harvesting Equipment

Section 301.89–12 of the regulations

requires cleaning and disinfection of

mechanized harvesting equipment and

seed conditioning equipment. Currently,

mechanized harvesting equipment and

seed conditioning equipment must be

cleaned and disinfected before leaving a

regulated area after harvesting any

Karnal bunt host crops in regulated

areas.

We propose to amend the regulations

to require that mechanized harvesting

equipment be cleaned and disinfected

before leaving a regulated area only if it

has been used to harvest host crops that

test positive for Karnal bunt.

Our regulations concerning the testing

of Karnal bunt host crops (see § 301.89–

6) require that harvested host crops be

tested for the presence of Karnal bunt

prior to movement from the field or

before commingling with other grains.

This testing occurs before, or while,

harvesting equipment is in the field.

Harvesting equipment presents a risk

only if contaminated by positive host

crops. Therefore, instead of requiring all

mechanized harvesting equipment to be

cleaned and disinfected before leaving

the regulated area, we can focus

requirements on that equipment that

presents a risk of spreading Karnal bunt

without causing delays for the operators

of mechanized harvesting equipment.

This action would reduce the use of

corrosive chemicals for cleaning and

disinfection in regulated areas and

relieve restrictions on the movement of

mechanized harvesting equipment from

areas regulated because of Karnal bunt.

In connection with this change, we

also propose to amend § 301.89–2(i),

which lists mechanized harvesting

equipment as a regulated article. We

would specify that mechanized

harvesting equipment is a regulated

article only if it has been used to harvest

host crops that test positive for Karnal

bunt.

The cleaning and disinfection

requirements for seed conditioning

equipment would remain unchanged

because that equipment handles only

seed, which presents a greater risk for

the artificial spread of Karnal bunt.

Executive Order 12866 and Regulatory

Flexibility Act

This proposed rule has been reviewed

under Executive Order 12866. The rule

has been determined to be significant

for the purposes of Executive Order

12866 and, therefore, has been reviewed

by the Office of Management and

Budget.

We have prepared an economic

analysis for this action, which is set

forth below. The analysis addresses the

effects on small entities, as required by

the Regulatory Flexibility Act, and

serves as the cost-benefit analysis

required by Executive Order 12866.

We propose to amend the Karnal bunt

regulations by removing from regulated

areas any noninfected acreage that is

more than 3 miles from a field or area

associated with a bunted wheat kernel.

This action would reduce the size of the

areas that are regulated because of

Karnal bunt in La Paz, Maricopa, and

Pinal Counties of Arizona. We also

propose to specify that mechanized

harvesting equipment must be cleaned

20772 Federal Register / Vol. 65, No. 75 / Tuesday, April 18, 2000 / Proposed Rules

and disinfected before leaving a

regulated area only if it has been used

to harvest host crops that test positive

for Karnal bunt. This action would

relieve restrictions on the movement of

mechanized harvesting equipment from

all areas regulated because of Karnal

bunt.

Regulated Areas in Arizona

As a result of the proposed reduction

of regulated areas in La Paz, Maricopa,

and Pinal Counties of Arizona, the

regulated agricultural acreage in central

Arizona would decline by about 131,000

acres, reducing the regulated acreage in

Arizona as a whole by about one-third,

from 389,000 acres to 258,000 acres. The

total regulated agricultural acreage in

Arizona, California, New Mexico, and

Texas would decline by about 25

percent, from approximately 484,000

acres to 353,000 acres.

This change would benefit an

estimated five wheat producers

operating in the areas that would no

longer be regulated. These five

producers would benefit because they

would be able to move their wheat

without restriction. Currently, wheat

grain may be moved from a regulated

area only if it tests negative for bunted

kernels, and commercial wheat seed

may not be moved from a regulated area.

However, the benefits for these

producers are not likely to be significant

for two reasons. First, grain is tested for

Karnal bunt at no cost to producers in

all regulated areas. For producers who

would be affected by this change, the

elimination of the current testing

requirement would remove an

inconvenience only, not a financial

burden. Second, very little commercial

wheat seed is, or is expected to be,

grown in the areas that would be

removed from regulation. Because of

that, the elimination of the current

restriction on moving commercial seed

would have only a minimal economic

effect on producers in the affected areas.

It is possible that, by giving affected

producers new status as deregulated

growers, the rule could serve to enhance

the perception of the quality of the

producers’ wheat crop. This could, in

turn, lead to higher wheat prices.

However, even if producers were to

benefit from higher prices for their

wheat, those prices are not likely to

increase significantly.

Mechanized Harvesting Equipment

The proposed change to the

requirements for cleaning and

disinfecting mechanized harvesting

equipment would primarily benefit

custom combine harvesters, who

routinely move their machines into and

out of regulated areas in the course of

harvesting wheat for multiple

producers. They would benefit because

they would no longer be required to

clean and disinfect their combines prior

to moving them out of the regulated

area, as long as the machines had not

been used to harvest host crops that

tested positive for Karnal bunt.

Currently, there are about 67

harvesters, including both custom

operators and producers who use their

own combines, operating 124 combines

in regulated areas. Many of these 67

harvesters could benefit from this rule.

However, the exact number who would

benefit—and the extent to which each

would benefit—is unknown, since the

information needed to make that

determination (i.e., the operating

characteristics for each of the

harvesters) is not available. It is not

uncommon, for example, for custom

harvesters to move the same combine

into and out of the regulated area

several times in the same crop season,

a situation that occurs when cutting

wheat that matures at different times.

The regulations allow for several

different cleaning methods, but most

combine operators choose a steam

treatment, which takes a minimum of 8

hours and costs from about $500 to $600

per cleaning. In addition to the cost of

cleaning itself, combine operators also

incur an indirect cost of approximately

$2,000 for each steam cleaning,

representing lost income associated

with the cleaning down time. For a

combine harvester, therefore, each

steam cleaning can cost up to about

$2,600.

The economic effect of the proposed

change to the regulations would vary

depending on the operator’s business

practices and other factors. Incurring the

cost of five cleanings per year for certain

individual operators is not uncommon,

although some operators must clean

their equipment more than five times

and some fewer than five times. Certain

operators in the regulated area would

not benefit at all from this proposed rule

because they do not move their

equipment from regulated areas.

However, if a custom harvester avoided

the cost of five cleanings per year as a

result of this proposed rule, the savings

would amount to approximately

$13,000.

Effects on Small Entities

Virtually all of the wheat producers

and firms that would be affected by this

proposed rule are likely to be

categorized as small according to the

Small Business Administration (SBA)

size classification. Economic impacts

resulting from this proposed rule would

therefore largely affect small entities.

The wheat producers that could be

affected by the proposed changes to the

regulations are all assumed to be small

entities. This assumption is based on

composite data for providers of the same

and similar services. There were a total

of 6,135 farms in Arizona in 1997. Of

those 6,135 farms, which include wheat

farms, 89 percent had annual sales of

less than $0.5 million, the SBA’s small

entity threshold for wheat farms.

However, for the reasons discussed

above, we do not expect this proposed

rule to have a significant economic

effect on these entities.

The combine operators that could be

affected by the proposed changes to the

regulations are also all assumed to be

small entities. In 1996, there were 282

U.S. firms primarily engaged in

mechanical harvesting and related

activities (SIC 0722), including

combining of crops. Of the 282 firms, 95

percent (or 268) had less than $5.0

million in annual sales, the SBA’s small

entity threshold for businesses in that

SIC category. Further, in 1996, the per

firm average sales for all of the 268 firms

in SIC 0722 that met the SBA’s

definition of a small entity was

$551,571. Therefore, based on our

calculation of $13,000 in potential

savings for many of these firms, the

economic benefits of this proposal

would represent 2 percent of annual

sales, which would not amount to a

significant economic effect on these

firms.

Under these circumstances, the

Administrator of the Animal and Plant

Health Inspection Service has

determined that this action would not

have a significant economic impact on

a substantial number of small entities.

Executive Order 12372

This program/activity is listed in the

Catalog of Federal Domestic Assistance

under No. 10.025 and is subject to

Executive Order 12372, which requires

intergovernmental consultation with

State and local officials. (See 7 CFR part

3015, subpart V.)

Executive Order 12988

This proposed rule has been reviewed

under Executive Order 12988, Civil

Justice Reform. If this proposed rule is

adopted: (1) All State and local laws and

regulations that are inconsistent with

this rule will be preempted; (2) no

retroactive effect will be given to this

rule; and (3) administrative proceedings

will not be required before parties may

file suit in court challenging this rule.

Federal Register / Vol. 65, No. 75 / Tuesday, April 18, 2000 / Proposed Rules 20773

Paperwork Reduction Act

This proposed rule contains no new

information collection or recordkeeping

requirements under the Paperwork

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

et seq.).

Lists of Subjects in Part 301

Agricultural commodities, Plant

diseases and pests, Quarantine,

Reporting and recordkeeping

requirements, Transportation.

Accordingly, we propose to amend 7

CFR part 301 as follows:

PART 301—DOMESTIC QUARANTINE

NOTICES

1. The authority citation for part 301

would continue to read as follows:

Authority: 7 U.S.C. 147a, 150bb, 150dd,

150ee, 150ff, 161, 162, and 164–167; 7 CFR

2.22, 2.80, and 371.2(c).

2. In § 301.89–2, paragraph (i) would

be revised to read as follows:

§ 301.89–2 Regulated articles.

* * * * *

(i) Mechanized harvesting equipment

used in the production of wheat, durum

wheat, and triticale that test positive

from Karnal bunt;

* * * * *

3. In § 301.89–3, paragraph (f), the

entry for Arizona would be revised to

read as follows:

§ 301.89–3 Regulated areas.

* * * * *

(f) * * *

ARIZONA

La Paz County. Beginning at the

southeast corner of sec. 33, T. 5 N., R.

21 W.; then west to the Colorado River;

then north along the Colorado River to

the west edge of sec. 26, T. 6 N., R. 22

W.; then north to the northwest corner

of sec. 26, T. 6 N., R. 22 W.; then east

to the northeast corner of sec. 27, T. 6

N., R. 21 W.; then south to the southeast

corner of sec. 10, T. 5 N., R. 21 W.; then

west to the southwest corner of sec. 10,

T. 5 N., R. 21 W.; then south to the point

of beginning; and

Beginning at the southeast corner of

sec. 36, T. 7 N., R. 21 W.; then west to

the southwest corner of sec. 31, T. 7 N.,

R. 21 W.; then north to the northwest

corner of sec. 7, T. 7 N., R. 21 W.; then

east to the northwest corner of sec. 8, T.

7 N., R. 21 W.; then north to the

northwest corner of sec. 5, T. 7 N., R.

21 W.; then east to the northwest corner

of sec. 4, T. 7 N., R. 21 W.; then north

to the northwest corner of sec. 33, T. 8

N., R. 21 W.; then east to the northeast

corner of sec. 34, T. 8 N., R. 21 W.; then

south to the northeast corner of sec. 3,

T. 7 N., R. 21 W.; then east to the

northeast corner of sec. 2, T. 7 N., R. 21

W.; then south to the northeast corner

of sec. 11, T. 7 N., R. 21 W.; then east

to the northeast corner of sec. 12, T. 7

N., R. 21 W.; then south to the point of

beginning.

Maricopa County. Beginning at the

southeast corner of sec. 12, T. 6 S., R.

6 W.; then west to the southwest corner

of sec. 7, T. 6 S., R. 6 W.; then north to

the northwest corner of sec. 7, T. 6 S.,

R. 6 W.; then west to the southwest

corner of sec. 2, T. 6 S., R. 7 W.; then

north to the northwest corner of sec. 14,

T. 5 S., R. 7 W.; then east to the

northeast corner of sec. 18, T. 5 S., R.

6 W.; then south to the southeast corner

of sec. 19, T. 5 S., R. 6 W.; then east to

the northeast corner of sec. 25, T. 5 S.,

R. 6 W.; then south to the point of

beginning; and

Beginning at the southeast corner of

sec. 14, T. 1 S., R. 4 W.; then west to

the southwest corner of sec. 14, T. 1 S.,

R. 5 W.; then north to the northwest

corner of sec. 14, T. 1 N., R. 5 W.; then

east to the northeast corner of sec. 14,

T. 1 N., R. 4 W.; then south to the point

of beginning; and

Beginning at the southeast corner of

sec. 6, T. 1 S., R. 2 W.; then west to the

southwest corner of sec. 5, T. 1 S., R. 3

W.; then north to the northwest corner

of sec. 17, T. 1 N., R. 3 W.; then east to

the northeast corner of sec. 18, T. 1 N.,

R. 2 W.; then north to the northwest

corner of sec. 8, T. 1 N., R. 2 W.; then

east to the northeast corner of sec. 8, T.

1 N., R. 2 W.; then south to the

southeast corner of sec. 32, T. 1 N., R.

2 W.; then west to the northeast corner

of sec. 6, T. 1 S., R. 2 W.; then south

to the point of beginning; and

Beginning at the southeast corner of

sec. 28, T. 1 S., R. 2 E.; then west to the

southwest corner of sec. 30, T. 1 S., R.

2 E.; then north to the southwest corner

of sec. 18, T. 1 S., R. 2 E.; then west to

the southwest corner of sec. 14, T. 1 S.,

R. 1 E.; then north to the southwest

corner of sec. 2, T. 1 S., R. 1 E.; then

west to the southwest corner of sec. 4,

T. 1 S., R. 1 E.; then north to the

northwest corner of sec. 4, T. 1 S., R. 1

E., then west to the southwest corner of

sec. 33, T. 1 N., R. 1 W.; then north to

the southwest corner of sec. 9, T. 1 N.,

R. 1 W.; then west to the southwest

corner of sec. 12, T. 1 N., R. 2 W.; then

north to the southwest corner of sec. 25,

T. 2 N., R. 2 W.; then west to the

southwest corner of sec. 27, T. 2 N., R.

2 W.; then north to the northwest corner

of sec. 3, T. 3 N., R. 2 W.; then east to

the northeast corner of sec. 1, T. 3 N.,

R. 1 W.; then south to the northwest

corner of sec. 19, T. 3 N., R. 1 E.; then

east to the northeast corner of sec. 23,

T. 3 N., R. 1 E.; then south to the

southeast corner of sec. 35, T. 3 N., R.

1 E.; then east to the northeast corner of

sec. 1, T. 2 N., R. 1 E.; then south to the

northwest corner of sec. 18, T. 1 N., R.

2 E.; then east to the northeast corner of

sec. 13, T. 1 N., R. 2 E.; then south to

the southeast corner of sec. 12, T. 1 S.,

R. 2 E.; then west to the southeast corner

of sec. 9, T. 1 S., R. 2 E.; then south to

the point of beginning; and

Beginning at the southeast corner of

sec. 34, T. 2 N., R. 5 E.; then west to the

southwest corner of sec. 31, T. 2 N., R.

5 E.; then north to the northwest corner

of sec. 7, T. 2 N., R. 5 E.; then east to

the northeast corner of sec. 10, T. 2 N.,

R. 5 E.; then south to the point of

beginning; and

Beginning at the intersection of the

Maricopa/Pinal County line and the

southwest corner of sec. 31, T. 2 S., R.

5 E.; then north to the northwest corner

of sec. 31, T. 2 S., R. 5 E.; then west to

the southwest corner of sec. 25, T. 2 S.,

R. 4 E.; then north to the southwest

corner of sec. 13, T. 2 S., R. 4 E.; then

west to the southwest corner of sec. 15,

T. 2 S., R. 4 E.; then north to the

northwest corner of sec. 3, T. 2 S., R. 4

E.; then east to the southwest corner of

sec. 35, T. 1 S., R. 4 E.; then north to

the northwest corner of sec. 35, T. 1 S.,

R. 4 E.; then east to the northwest corner

of sec. 34, T. 1 S., R. 5 E.; then north

to the northwest corner of sec. 22, T. 1

S., R. 5 E.; then east to the northwest

corner of sec. 20, T. 1 S., R. 6 E.; then

north to the northwest corner of sec. 8,

T. 1 S., R. 6 E.; then east to the northeast

corner of sec. 7, T. 1 S., R. 7 E.; then

south to the southeast corner of sec. 31,

T. 1 S., R. 7 E.; then east to the northeast

corner of sec. 5, T. 2 S., R. 7 E.; then

south to the southeast corner of sec. 5,

T. 2 S., R. 7 E.; then east to the

Maricopa/Pinal County line; then south

and west along the Maricopa/Pinal

County line to the point of beginning.

The following individual fields in

Maricopa County are regulated areas:

301060505 304073005 306013222

301060506 304073010 306013231

301060601 304081410 306020404

301060602 304081413 306020501

301060603 304081415 306020601

301060604 304081417 306020623

301102505 304081505 316123301

301102506 304081506 316123302

303111502 304082202 316123303

303111503 304082302 316131901

303113002 304082303 316131904

304031904 304082607 316132302

304031906 304082703 316132604

304073004

Pinal County. Beginning at the

intersection of the Maricopa/Pinal

County line and the northwest corner of

sec. 7, T. 2 S., R. 8 E.; then east to the

20774 Federal Register / Vol. 65, No. 75 / Tuesday, April 18, 2000 / Proposed Rules

northeast corner of sec. 8, T. 2 S., R. 8

E.; then south to the southeast corner of

sec. 8, T. 2 S., R. 8 E.; then east to the

northeast corner of sec. 16, T. 2 S., R.

8 E.; then south to the southeast corner

of sec. 28, T. 2 S., R. 8 E.; then west to

the southeast corner of sec. 29, T. 2 S.,

R. 8 E.; then south to the southeast

corner of sec. 32, T. 2 S., R. 8 E.; then

west to the Maricopa/Pinal County line;

then north along the Maricopa/Pinal

County line to the point of beginning;

and

Beginning at the intersection of the

Maricopa/Pinal County line and the

northeast corner of sec. 5, T. 3 S., R. 6

E.; then south to the southeast corner of

sec. 32, T. 3 S., R. 6 E.; then west to the

southwest corner of sec. 34, T. 3 S., R.

5 E.; then north to the southwest corner

of sec. 3, T. 3 S., R. 5 E.; then west to

the southwest corner of sec. 6, T. 3 S.,

R. 5 E.; then north to the Maricopa/Pinal

County line; then east along the

Maricopa/Pinal County line to the point

of beginning; and

Beginning at the southeast corner of

sec. 5, T. 6 S., R. 4 E.; then west to the

southwest corner of sec. 5, T. 6 S., R. 3

E.; then north to the southwest corner of

sec. 28, T. 5 S., R. 3 E.; then west to the

southwest corner of sec. 25, T. 5 S., R.

2 E.; then north to the southwest corner

of sec. 24, T. 5 S., R. 2 E.; then west to

the southwest corner of sec. 23, T. 5 S.,

R. 2 E.; then north to the northwest

corner of sec. 35, T. 4 S., R. 2 E.; then

east to the northwest corner of sec. 36,

T. 4 S., R. 2 E.; then north to the

northwest corner of sec. 25, T. 4 S., R.

2 E.; then east to the northwest corner

of sec. 29, T. 4 S., R. 3 E.; then north

to the northwest corner of sec. 20, T. 4

S., R. 3 E.; then east to the northeast

corner of sec. 21, T. 4 S., R. 4 E.; then

south to the northeast corner of sec. 4,

T. 5 S., R. 4 E.; then east to the northeast

corner of sec. 3, T. 5 S., R. 4 E.; then

south to the southeast corner of sec. 22,

T. 5 S., R. 4 E.; then west to the

southeast corner of sec. 21, T. 5 S., R.

4 E.; then south to the point of

beginning.

The following individual fields in

Pinal County are regulated areas:

307012207 309033507 309042621

308102604 309042544 309050104

308102605 309042545 309050109

309021801 309042601 309050122

309021804 309042607 309050207

309021812 309042619 309050209

309031304 309042620

Yuma County. The following

individual fields in Yuma County are

regulated areas:

321010208 321040405 323030401

321010210 321040911 323030402

321010211 321040912 323030403

321010224 321040915 323030404

321010301 321040917 323030405

321010302 321040918 323030406

321011103 321040921 323030501

321033501 321040922 323030502

321033502 321041903 323030512

321033503 321041904 323030513

321033516 321041908 323030514

321033517 321041919 323030515

321033518 321042903 323030521

321033519

* * * * *

4. In § 301.89–12, paragraph (a) would

be revised to read as follows:

§ 301.89–12 Cleaning and disinfection.

(a) Mechanized harvesting equipment

that has been used to harvest host crops

that test positive for Karnal bunt and

seed conditioning equipment that has

been used in the production of any host

crops must be cleaned and disinfected

in accordance with § 301.89–13(a) prior

to movement from a regulated area.

* * * * *

Done in Washington, DC, this 12th day of

April 2000.

Bobby R. Acord,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 00–9670 Filed 4–17–00; 8:45 am]

BILLING CODE 3410–34–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 210, 211, 820, and 1271

[Docket No. 97N–484S]

Suitability Determination for Donors of

Human Cellular and Tissue-Based

Products

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule; reopening of

comment period.

SUMMARY: The Food and Drug

Administration (FDA) is reopening for

90 days the comment period for the

proposed rule concerning suitability

determinations for donors of human

cellular and tissue-based products. The

proposed rule was published in the

Federal Register of September 30, 1999

(64 FR 52696). This action is being

taken in response to requests for an

extension to allow interested parties,

including State and local officials,

additional time for review and to submit

comments.

DATES: Submit written comments on the

proposed rule by July 17, 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:

Paula S. McKeever, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–6210.

SUPPLEMENTARY INFORMATION: In the

Federal Register of September 30, 1999

(64 FR 52696), FDA published a

proposed rule to require manufacturers

of human cellular and tissue-based

products to screen and test the donors

of cells and tissue used in those

products for risk factors for and clinical

evidence of relevant communicable

disease agents and diseases. As part of

that regulatory action, the agency

proposed to amend the current good

manufacturing practice regulations that

apply to human cellular and tissuebased products regulated as drugs,

medical devices, and/or biological

products to incorporate the new donorsuitability procedures into existing good

manufacturing practice regulations.

Interested persons were given until

December 29, 1999, to submit written

comments on the proposed rule.

On November 19, 1999, a comment

was submitted to the docket by a

professional association requesting a 60-

day extension of the comment period on

the proposed rule. The comment

requests additional time to allow an ad

hoc group of experts assembled by the

organization to complete the collection

and analysis of scientific data on

transmissible spongiform

encephalopathies and Creutzfeld-Jakob

Disease. The association also noted the

recent publication of the proposed rule

entitled ‘‘Standards for Privacy of

Individually Identifiable Health

Information’’ by the Department of

Health and Human Services (64 FR

59918, November 3, 1999), and

requested an opportunity to evaluate the

potential impact of that proposed rule in

relation to the September 30, 1999,

proposed rule. On December 1, 1999, a

second comment requested an extension

to at least January 31, 2000.

In addition, FDA has learned that the

State of California and other

jurisdictions have enacted legislation

and issued regulations governing tissue

donor suitability. Because those laws

might conflict with provisions in the

September 30, 1999, proposed rule, FDA

has invited State officials to participate

in this rulemaking. The agency would

appreciate comment on: (1) The need for

uniform national standards for donor

suitability determinations to prevent

communicable disease transmission