Karnal Bunt

SUMMARY: We are establishing criteria for levels of risk for areas with

regard to Karnal bunt and for the movement of regulated articles based

on those risk levels, and are establishing criteria for the planting of

seed from Karnal bunt host crops. These actions are warranted because

they relieve unnecessary restrictions on areas regulated because of

Karnal bunt, while guarding against the artificial spread of that

disease. We are also making final, with some changes, the Karnal Bunt

regulations established in a series of interim rules, and are removing

some areas from the list of areas regulated because of Karnal bunt.

EFFECTIVE DATE: November 4, 1996.

FOR FURTHER INFORMATION CONTACT:

Mr. Mike Stefan, Operations Officer, Domestic and Emergency Operations,

PPQ, APHIS, 4700 River Road Unit 134, Riverdale, MD 20737-1236, (301)

734-8247.

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. The establishment of Karnal bunt

in the United States would have significant consequences with regard to

the export of wheat to international markets. Karnal bunt is caused by

the smut fungus Tilletia indica (Mitra) Mundkur and is spread by

spores. The regulations regarding Karnal bunt are set forth in 7 CFR

301.89-1 through 301.89-14.

On March 8, 1996, Karnal bunt was detected in Arizona during a seed

certification inspection done by the Arizona Department of Agriculture.

On March 20, 1996, the Secretary of Agriculture signed a ``Declaration

of Extraordinary Emergency'' authorizing the Secretary to take

emergency action under 7 U.S.C. 150dd with regard to Karnal bunt within

the States of Arizona, New Mexico, and Texas. In an interim rule

effective on March 25, 1996, and published in the Federal Register on

March 28, 1996 (61 FR 13649-13655, Docket No. 96-016-3), the Animal and

Plant Health Inspection Service (APHIS) established the Karnal bunt

regulations (7 CFR 301.89-1 through 301.89-11), and quarantined all of

Arizona and portions of New Mexico and Texas because of Karnal bunt.

The regulations define regulated articles and restrict the movement of

these regulated articles from the quarantined areas.

After the establishment of the regulations, Karnal bunt was

detected in seed lots that were either planted or stored in California.

On April 12, 1996, the Secretary of Agriculture signed a ``Declaration

of Extraordinary Emergency'' authorizing the Secretary to take

emergency action under 7 U.S.C. 150dd with regard to Karnal bunt within

California. In an interim rule effective on April 19, 1996, and

published in the Federal Register on April 25, 1996, APHIS also

quarantined portions of California because of Karnal bunt (61 FR 18233-

18235, Docket No. 96-016-5). In an interim rule effective on June 27,

1996, and published in the Federal Register on July 5, 1996, we removed

certain areas in Arizona, New Mexico, and Texas from the list of areas

quarantined because of Karnal bunt (61 FR 35107-35109, Docket No. 96-

016-6). That list was amended in a technical amendment effective on

July 9, 1996, and published in the Federal Register on July 15, 1996

(61 FR 36812-36813, Docket No. 96-016-8). In an interim rule effective

June 27, 1996, and published in the Federal Register on July 5, 1996,

we amended the regulations to provide compensation for certain growers

and handlers, owners of grain storage facilities, and flour millers in

order to mitigate losses and expenses incurred because of actions taken

by the Secretary to prevent the spread of Karnal bunt (61 FR 35102-

35107, Docket No. 96-016-7).

In a proposed rule published in the Federal Register on August 2,

1996 (61 FR 40354-40361, Docket No. 96-016-10), we proposed to

establish criteria for levels of risk for areas with regard to Karnal

bunt and the movement of regulated articles based on those risk levels,

and to establish criteria for seed planting.

Comments from the public regarding the interim rules and the

proposed rule were required to be received by APHIS by September 3,

1996. During the comment period, public forums were conducted in

Washington, D.C.; Kansas City, MO; Phoenix, AZ; Imperial, CA; and Las

Cruces, NM, to accept public comment on the regulations.

We received a total of 178 comments on the interim rules and the

proposed rule by September 3, 1996. The commenters included members of

Congress, State departments of agriculture, agricultural associations

and councils, local governments, the wheat industry, academia, and

other members of the public. The information we received from

commenters was a valuable resource in formulating this final rule. We

consider refinement and improvement of the Karnal bunt program an

ongoing process, and welcome data that will enable us to protect wheat-

growing areas of the United States, while causing the least possible

disruption to affected areas.

We discuss below each of the issues raised by the commenters. We

first discuss those comments addressing the Karnal bunt regulations

that were established by the series of interim rules. These regulations

were established on an emergency basis and are currently in effect. We

then discuss those comments that address our August 2, 1996, proposal

to amend the Karnal bunt regulations. Based on the comments received,

we have made a number of changes to the existing Karnal bunt

regulations, as well as to the regulatory revisions we proposed. In

most cases, changes that were prompted by a specific comment

recommendation are identified with our discussion of that comment.

Additionally, as part of our discussion of our proposed rule in this

document, we set forth a summary of the broad changes we are making to

the way we will classify regulated areas, and the practical

implications of falling into a particular classification category.

It is important to note that this final rule does not change or

make final the interim rule made effective June 27, 1996, and published

in the Federal Register on July 5, 1996, in which we amended the

regulations to provide compensation for certain growers and handlers,

owners of grain storage facilities, and flour millers in order to

mitigate losses and expenses incurred because of Karnal bunt. We are

still considering issues related to compensation.

Comments Addressing the Interim Rules

Several commenters supported the provisions of the interim rules. A

number of these, however, recommended certain additions to the

regulations. Each of these recommendations is discussed below.

Control and Eradication of Karnal Bunt

A number of commenters stated that, although it is possible to

control the spread of Karnal bunt, it is impossible to eradicate it

from the United States,

[[Page 52191]]

that no bunt or smut disease of grain crops has been eradicated, that

Karnal bunt has likely existed in the United States for a number of

years now, and that a program of management should be substituted for

the current eradication program. Several commenters stated that

focusing on the artificial spread of Karnal bunt ignores the natural

spread of the disease, particularly from Mexico into the United States.

As a regulatory agency, we consider eradication a reasonable first

objective in dealing with a new quarantine pest. This position has been

supported by various industry groups, State departments of agriculture,

and officials involved in international trade. The Karnal bunt

regulations are intended to prevent the artificial spread of the

disease by minimizing the risk of spread of the causal agent to other

wheat production areas.

Tolerance Levels for Karnal Bunt

A number of commenters stated that the tolerance level for spores

in grain should be a biological zero, not an absolute zero, and that

scientists need to determine the number of spores and the conditions

necessary to perpetuate the disease. Several commenters stated that the

emphasis of the quarantine should be on the risk of spreading Karnal

bunt and not on control of the spore, that non-bunted wheat should be

certified ``free from'' Karnal bunt if no bunted kernels or only low

levels of spores are present, and that ``free from'' status should be

accorded to areas where no evidence exists that fields are likely to

manifest the disease. One commenter recommended that all fields in

which bunted kernels are not found should be released from quarantine.

Another commenter stated that infestation should be defined in

Sec. 301.89-1 as the presence of bunted kernels caused by Karnal bunt,

and not include any stage of development of the fungus Tilletia indica

(Mitra) Mundkur. One commenter stated that APHIS should remove the

Karnal bunt quarantine, establish a commercial tolerance for Karnal

bunt, and allow the market to provide incentive to the industry to

minimize disease spread through price adjustments. Another commenter

stated that APHIS should assume that any test that discovers fewer than

ten spores is a coincidental contamination.

We are making no changes based on these comments. APHIS does not

use a zero tolerance approach to survey and railcar testing. Our test

procedures, which were developed in concert with State and industry

representatives, provide a reasonable assurance that detecting a spore

count of 1 or more in a 50-gram sample will identify levels of Karnal

bunt that present a risk of spreading the disease. Because it is the

objective of the regulatory measures to prevent the further spread of

the pathogen, it is APHIS' policy to accept the limited risk posed by

spore counts that might be lower than this level. Although tolerance

levels have been established as a quality factor for various fungal

toxins that are widespread in the United States, these toxins are of

concern only when they reach levels at which they might adversely

affect the health of humans or animals. Therefore, their presence below

a certain level, while detectable, is not of concern. This is not the

case for Karnal bunt, where detectable levels present a risk of

spreading the disease.

Characterization of Karnal Bunt

A number of commenters disagreed with our description of Karnal

bunt as a ``serious fungal disease.'' One commenter stated that Karnal

bunt, at its previous worst known rates of infection of grain in the

world, is not strong enough to do any damage to the resultant flour

taste, smell, or color. A number of commenters stated that several

other grain-related diseases have a greater economic impact than Karnal

bunt, and that these diseases are allowed tolerances and are handled by

grading techniques within the grain industry. The commenters

recommended that such an approach be allowed for Karnal bunt. One

commenter stated that the Biological Assessment group in APHIS, Plant

Protection and Quarantine, has concluded that Tilletia indica

represents a high ``Pest Risk Potential'' in the United States, as

estimated by internationally recognized pest risk analysis procedures.

The commenter stated that other evaluators, using the same standard as

that used by APHIS, have judged the pest risk potential of Tilletia

indica to be low. According to international guidelines, Pest Risk

Assessment consists of evaluating the likelihood of a pest's

introduction and the consequences of such an introduction. We rate the

consequences by calculating the Pest Risk Potential according to five

elements that rate a pest's climatic range, host range, dispersal

potential, and economic and environmental impacts. As part of a 1995

Karnal bunt Pest Risk Assessment, APHIS concluded that, for the United

States, the Pest Risk Potential of the Karnal bunt fungus was high.

This rating was objectively based on the determinations that: (1) The

Karnal bunt fungus is able to survive in four or more hardiness zones;

(2) the Karnal bunt fungus attacks multiple species within a single

plant family; (3) the Karnal bunt fungus produces many spores that may

be distributed over long distances; (4) the Karnal bunt fungus has the

potential to cause yield loss, lower commodity values and result in

loss of markets; and (5) the presence of the fungus might trigger

control programs with environmental impacts.

We acknowledge that the use of the word ``serious'' in describing

Karnal bunt can be open to several interpretations. We believe that the

greatest impact of the establishment of Karnal bunt is on the export of

U.S. wheat to foreign markets, a $5 billion industry annually. Karnal

bunt is a pest of quarantine significance throughout the world and

jeopardizes the continued trade of U.S. wheat. However, because we

agree that our use of the word ``serious'' has caused some confusion,

we do not refer to Karnal bunt as a serious disease in this final rule.

One commenter questioned why the description of Karnal bunt in the

definitions in Sec. 301.89-1 did not describe the disease as one

``which is new to or not widely prevalent or distributed within and

throughout the United States.'' The commenter said such a description

of Karnal bunt appears in the definition of Karnal bunt in Sec. 319.59,

as established on October 13, 1983. The commenter stated that the

modifying phrase implies that the Department acknowledged that Karnal

bunt existed in the United States as early as 1983. We do not agree

with the commenter's conclusion. It is true that Karnal bunt is

described in Sec. 319.59-1 as a disease that is ``new to or not widely

prevalent or distributed in and throughout the United States.''

However, that reference to Karnal bunt is included in the ``Foreign

Quarantine Notice'' section of title 7 of the Code of Federal

Regulations. The wording there is consistent with the statutory

language in the United States Code (7 U.S.C. 160) which states that

``in order to prevent the introduction into the United States of any

tree, plant, or fruit disease or of any injurious insect, new to or not

theretofore widely distributed throughout the United States,'' the

Secretary of Agriculture may establish importation regulations to

prevent such introduction. The modifying phrase ``new to and not

heretofore widely prevalent or distributed within and throughout the

United States'' is used in other importation regulations in 7 CFR part

319, and it does not imply that the disease in question already exists

in the United States.

[[Page 52192]]

Regulated Articles

Several commenters recommended that the list of regulated articles

in Sec. 301.89-2 be expanded. The items recommended for inclusion, the

commenters' rationale for the additions, and our responses are as

follows:

Rye: One commenter stated that the 1991 APHIS Pest Risk Analysis on

Karnal bunt includes rye (Secale cereale) as a host of the disease. We

are making no changes based on this comment. The 1991 Pest Risk

Analysis included rye and several species of grasses that are reported

to demonstrate a degree of susceptibility to infection when inoculated

(or forced) in the laboratory. Karnal bunt has not been reported on

these species under natural conditions.

Seeds and grain of crops other than wheat, durum wheat, and

triticale that pass through contaminated facilities or that move out of

a regulated area: One commenter stated that seed crops are of

particular concern because they may be planted in fields that are

subsequently planted with a host crop. Several other commenters stated

that stringent restrictions should be placed on the movement of all

seed out of quarantined areas. We are making no changes based on these

comments. We consider the possible contamination of seed other than

wheat, durum wheat, and triticale to pose a negligible risk. The amount

of inoculum on non-host seed and the opportunity to infest a host would

be small. For non-host seed moving out of a regulated area, the

inoculum moving with the seed would originate from a field where a non-

host crop was planted and that was destined to be planted with a non-

host crop.

Seed crops other than host crops harvested from fields infested

with teliospores: One commenter stated that seed crops, especially

those seed crops where soil contaminates the harvested seed, could

become contaminated with teliospores. The commenter additionally stated

that crops such as dry edible beans and soybeans are particularly prone

to soil contact and contamination. We are making no changes based on

this comment, for the same reasons cited immediately above.

Seed crops other than host crops planted near an infected crop: One

commenter recommended that a buffer be required to minimize the risk of

contamination from airborne teliospores, especially if any infested

fields will be harvested, which creates dusty conditions. Again, we

consider the risk of the movement of the Karnal bunt causal agent with

seed other than wheat, durum wheat, and triticale to be negligible.

Apiary equipment placed in fields contaminated with teliospores:

Several commenters stated that such equipment can carry contaminated

soil, and that, additionally, there may be a risk of the bees'

disseminating teliospores. We are making no changes based on this

comment. We not do not consider the movement of apiaries to present a

significant risk of spreading Karnal bunt. Hives are usually not set in

the fields.

Animals fed crops susceptible to Karnal bunt: Several commenters

noted that animals that have fed on susceptible crops may not have

passed all of the feed through their systems when moved, or may

transport soil from infected areas. We are making no changes based on

this comment. We consider the risk of possible contamination due to

animal movement to be negligible. The amount of inoculum moving with

the animal would be small, and would have little opportunity to infect

a suitable host. In most cases, the animals would be moved to a

stockyard, and it is not likely that the manure from the animals at the

stockyard would be collected and distributed on a field to be planted

with wheat. However, soil from areas where field crops are produced and

manure from animals that have fed on untreated or raw wheat, durum

wheat, and triticale are regulated articles.

Nursery stock accompanied by soil from contaminated fields: One

commenter stated that nursery stock accompanied by soil from

contaminated fields should be regulated. We do not consider it

necessary to make any changes based on this comment. Soil from areas

where field crops are produced is already regulated and, under the

Karnal bunt program, is not allowed to be moved.

Any machinery, farm equipment, or means of conveyance that could

move soil from areas where field crops are produced: One commenter

cited spray and fertilizer equipment used in contaminated fields as

potentially contaminated equipment. In establishing the list of

regulated articles, it was our intent that any farm equipment that

could move soil within or from the regulated area should be regulated.

We are therefore revising the list of regulated articles at

Sec. 301.89-2(j) of the regulations to refer to used farm tools and

equipment.

One commenter stated that the listing in Sec. 301.89-2 of ``soil

from areas where field crops are produced'' as a regulated article

should be interpreted strictly to include soil that adheres to

propagative plant parts, including seeds. We agree with the commenter,

and consider the regulations as written adequate to effect such

enforcement.

One commenter stated that ``soil'' should not be interpreted to

include such materials as dust or road film. We believe the definition

of soil as set forth in Sec. 301.89-1 of this final rule addresses the

commenter's concerns and clarifies our intent. Soil is defined in the

final rule as ``the loose surface material of the earth in which plants

grow, in most cases consisting of disintegrated rock with an admixture

of organic material.'' Under this definition, we do not consider dust

or road film to be ``soil.''

One commenter recommended that the list of regulated articles in

Sec. 301.89-2 be modified as follows: The current listing of ``manure

from animals that have fed on wheat, durum wheat, or triticale'' should

be changed to ``manure from animals which have been fed untreated or

raw wheat, durum wheat, triticale, or byproducts thereof which have

tested positive for Karnal bunt;'' ``soil from areas where field crops

are produced'' should be changed to ``soil from crop production fields

proven to contain Karnal bunt;'' and ``any other product, article, or

means of conveyance when an inspector determines that it presents a

risk of spreading Karnal bunt due to its proximity to an infestation of

Karnal bunt * * *.'' should be changed to ``any contaminated product,

article, or means of conveyance when an inspector determines that

Karnal bunt contamination exists and the conveyance presents a risk of

spreading Karnal bunt* * *.'' We are making no changes based on this

comment. We consider a risk to exist in the movement of each of the

categories of the regulated articles the commenter suggested relaxing,

and that appropriate safeguards are needed based on the level of risk.

We do recognize that there is little risk from ``manure from animals

that have been fed treated millfeed,'' and are adding this exemption to

the regulations.

The list of regulated articles in Sec. 301.89-2 includes soil from

areas where field crops are produced. One commenter stated that this

listing would unfairly apply to soil from areas where suspect wheat

seed was planted, but then was destroyed and not grown to harvest. The

commenter stated that the risk from such soil is very significantly

less than for soil where the wheat crop was allowed to mature. In this

final rule, we continue to consider as a regulated article the soil

described by the commenter. We consider it necessary to regulate any

article that presents a risk of spreading the causal agent of Karnal

[[Page 52193]]

bunt. However, we base the extent of regulation on the level of risk.

This rule categorizes areas based on risk and imposes appropriate

regulatory actions for each. These risk categories are discussed in

this SUPPLEMENTARY INFORMATION under the heading ``Regulated Areas.''

One commenter stated that quarantines imposed because of Karnal

bunt should affect no crops other than wheat. In conducting the Karnal

bunt program, we have focused our regulatory efforts on wheat

production activities. However, in some cases, as with the movement of

root crops with soil, we consider there to be sufficient risk to

warrant regulatory activity.

One commenter stated a connection should be made in the regulations

between all regulated articles and Karnal bunt host crops. We do not

agree that the rationale for regulating an article should rest solely

on whether it had direct contact with Karnal bunt host crops. A number

of the articles we are regulating pose a risk of spreading Karnal bunt

because of the danger that soil on the article from the regulated area

might transmit the Karnal bunt causal agent.

One commenter recommended, without explanation, that several

articles be removed from our list of regulated articles. We are not

certain of the commenter's rationale for recommending the removal of

the articles in question, and continue to consider it necessary to

regulate those articles listed in Sec. 301.89-2.

Actions of Individual States

One commenter stated that the regulations should specifically

provide that infested articles moving under limited permit may do so

only after concurrence by the destination State and other States

through which the regulated article would traverse. We are making no

changes based on this comment. As part of the Karnal bunt program, we

are not allowing grain that tests positive for Karnal bunt to move out

of the quarantined area. Other contaminated articles must be cleaned

and sanitized before such movement. We are notifying destination States

of grain that has tested negative and is moving under limited permit to

approved mills. We do not believe there is sufficient risk involved

with the controlled movement of these articles to warrant additional

restrictions on their movement.

Several commenters recommended that the Department prohibit

individual States from imposing restrictions on Arizona agricultural

products that, in effect, preempt APHIS standards. State regulations

cannot preempt APHIS' regulations. While, as a practical matter, the

Department cannot prohibit States from imposing restrictions on

agricultural products, affected persons could assert Federal preemption

as a legal basis for seeking relief from any State regulation that is

inconsistent with APHIS' regulations.

Restrictions on Movement

One commenter stated that the provisions in Sec. 301.89-5 regarding

the issuance of a certificate or limited permit should specifically

state that any Karnal bunt potential host crop grown on land with a

history of infestation with Karnal bunt teliospores is not eligible for

certification. We are making no changes based on this comment. In

Sec. 301.89-4 of this final rule, we prohibit the planting of host

crops in fields that tested positive and in fields planted in 1995 with

seed known to be contaminated with Karnal bunt.

Several commenters recommended that no commercial seed be allowed

to leave a quarantined area under any conditions. We are making no

changes based on this comment. The regulations already prohibit the

movement of commercial wheat, durum wheat, and triticale seed from the

quarantined area. We consider risk from the possible contamination of

seed other than from host crops to be negligible. With regard to

commercial seed, the regulations in Sec. 301.89-6 of this final rule

set forth the criteria under which a regulated article may move from a

regulated area, accompanied either by a certificate or a limited

permit. Commercial seed does not meet the criteria for movement outside

the regulated area either with a certificate or a limited permit, in

that the commercial seed would, among other things, need to: (1) Be

tested free of Karnal bunt; (2) have been grown, produced,

manufactured, stored, or handled in a manner that would prevent

infestation or destroy all live stages of Karnal bunt; or (3) have been

treated in accordance with approved methods. Current testing and

treatment procedures do not exist for large quantities of commercial

seed intended for planting outside the regulated area that would ensure

such seed could be certified free of Karnal bunt. To be eligible for a

limited permit, the risk of the seed spreading Karnal bunt would have

to be eliminated by the destruction of the pathogen of Karnal bunt, or

be mitigated by specified handling, utilization, or processing.

Commercial seed to be used for planting would not meet these criteria.

One commenter recommended that the regulations require that any

wheat that is to be used for seed be harvested with a fumigated combine

and be transported in vehicles that have been fumigated, and that the

grain be thoroughly tested for spores prior to being certified for

planting. We are making no changes based on this comment. We have

developed sanitization and testing protocols for seed moving within the

area. Additionally, this final rule requires that all wheat seed to be

planted within the regulated area be sampled and tested for Karnal

bunt, and, for seed originating in a regulated area, treated prior to

planting.

A number of commenters opposed what they called a ``strict''

quarantine regarding Karnal bunt in the southwest United States due to

its potential impact on the movement of germplasm, winter nurseries,

and ``off-season'' increases for spring and winter cereals used in many

northern States. We understand the importance of the southwest United

States in wheat breeder research. However, we consider the movement of

seed for planting a high risk activity and currently do not allow its

movement outside the regulated area, except for limited quantities of

research seed. We are allowing germplasm and research seed to move

under conditions involving testing, treatment (described below), and

subsequent monitoring. We will continue to work with researchers and

industry to develop protocols and treatments that will allow movement

of seed to resume.

In this final rule, we are setting forth an approved treatment for

seed used as germplasm or for research purposes. To be eligible for

movement, the seed must be treated with a 1.5 percent aqueous solution

of sodium hypochlorite (=30 percent household bleach) containing 2 ml.

of Tween 20TM per liter agitated for 10 minutes at room

temperature followed by a 15-minute rinse with clean, running water and

then by drying, and either: (1) With 6.8 fl. oz. of Carboxin thiram (10

percent+10 percent, 0.91+0.91 lb. ai./gal.) flowable liquid and 3 fluid

ounces of pentachloronitrobenzene (2.23 lb. ai./gal.) per 100 pounds of

seed; or (2) with 4.0 fluid ounces of Carboxin thiram (1.67 + 1.67 lb.

ai./gal.) flowable liquid and 3 fluid ounces of pentachloronitrobenzene

(2.23 lb. ai./gal.) per 100 pounds of seed.

Several commenters urged the Department to develop specific

protocols to outline procedures for shipment of seed within and outside

of quarantined areas, seed treatment requirements, certification

requirements, and the movement of germ plasm. One commenter stated that

[[Page 52194]]

this protocol should address germ plasm, foundation, registered,

certified, and uncertified seed. We have developed protocols for

testing, treatment, and movement of commercial seed within the

regulated area and limited quantities of research seed out of the

regulated area. (For more information regarding these protocols, please

contact the individual listed in this final rule under FOR FURTHER

INFORMATION CONTACT.) Currently, however, movement of commercial seed

to destinations outside the regulated area is considered a high risk

and adequate treatment and safeguard conditions have not been

developed.

One commenter recommended that the regulations allow seed infected

with Karnal bunt that is not to be used for propagation to be used for

feed, milling, or other non-propagative purposes. We agree with the

commenter that the seed described can be safely used under certain

conditions. We are continuing to cooperate with the industry, States,

and export partners to develop additional options for grain testing

positive.

One commenter stated that because movement of grain to mills and/or

export destinations is always to expedite the end use of the grain,

such transport of byproducts and grain with low spore numbers should

not be an issue. Another commenter stated that as long as wheat and

wheat byproducts infected with Karnal bunt are segregated from other

wheat, and the identity of the wheat and wheat byproducts is preserved

through the marketing chain, such wheat and byproducts should be

allowed to move to end users willing to comply with specified sanitary

precautions. During the 1996 harvest, we were able to provide a means

to move wheat from regulated areas with appropriate safeguards and to

minimize the risk to other wheat producing areas. Based on survey

information from the 1996 harvest, we are removing requirements for the

treatment of millfeed and the sanitization of equipment for some parts

of the regulated areas.

One commenter stated that APHIS should in some way encourage grain

ports to handle wheat grown in quarantined areas. Another commenter

requested that a procedure be developed to allow wheat from Arizona to

move to international ports. Currently, APHIS, the State of Texas, and

the wheat industry are cooperating to move grain from quarantined areas

to ports for export.

Treatments

Several commenters said that no treatment for Karnal bunt should be

listed in the regulations until efficacy data has been compiled on

``real-life'' applications. One commenter expressed concern that the

regulations include a treatment for millfeed when, according to the

commenter, efficacy data for heat treatment for millfeed does not

exist. We agree with the commenters that approval of treatments should

be based on empirical data. The treatment options set forth in our

regulations are based on the latest scientific literature and efficacy

data available.

One commenter recommended that the sodium hypochlorite treatment

provided for in the regulations specify that the treatment solution

must remain in contact for 15 minutes with the surface to be

decontaminated. We are making no changes based on this comment. The

treatment set forth in the regulations requires that the equipment or

site not be washed down until 15 minutes have passed.

Several commenters stated that treatment of equipment with sodium

hypochlorite should not be included as an approved treatment, due to

the likelihood of corrosion of the equipment being disinfected. Because

this treatment may be corrosive to the equipment being disinfected, we

advise in the treatment instructions to wash the equipment thoroughly

after application in order to minimize corrosion. We are testing

alternative, less potentially corrosive, treatments for their

effectiveness on the pathogen. However, we have not found any less

corrosive, effective treatment to date.

The regulations regarding the treatment with sodium hypochlorite

call for ``a solution of sodium hypochlorite mixed with water applied

at the rate of 1 gallon of commercial chlorine bleach (5.2 percent

sodium hypochlorite) mixed with 2.5 gallons of water.'' One commenter

stated that it is possible that not all commercial chlorine bleaches

are 5.2 percent sodium hypochlorite and that, therefore, only the final

necessary treatment solution strength should be set forth. We agree

with the commenter that it is the final percentage of sodium

hypochlorite, after being mixed with water, that is important. We are

therefore specifying in this final rule that the treatment in question

requires wetting all surfaces to the point of runoff with a solution of

1.5 percent sodium hypochlorite. Because we believe that most users

will disinfect with household bleach with 5.2 percent sodium

hypochlorite, we are retaining in the treatment description, as an

example, the suggested mix of ``1 gallon of household chlorine bleach

(5.2 percent sodium hypochlorite) mixed with 2.5 gallons of water.''

One commenter recommended that a critical temperature be specified

for treatment with sodium hypochlorite or steam, and that it be

required that the surfaces treated be thoroughly wetted. The commenter

also stated that the fumigation treatment in Sec. 301.89-11(a)(4) be

revised by adding tarpaulin fumigation for small acreages. With regard

to both the sodium hypochlorite and steam treatments, the regulations

require the surfaces treated to be wetted thoroughly to the point of

runoff. With regard to the sodium hypochlorite treatment, the

temperature is not critical. However, we agree that a critical

temperature at the point of contact should be specified for treatment

with steam. Therefore, we are requiring in Sec. 301.89-13 of this final

rule that, for steam treatment, a critical temperature of 170 deg.F be

reached at the point of contact. With regard to tarpaulin fumigation,

we are making no changes based on the comment. We are still developing

a soil treatment with methyl bromide for the regulated area.

One commenter recommended as a treatment for used bags, sacks, and

containers soaking for 15 minutes in 30 percent chlorine bleach (5.2

percent hypochlorite). We have been unable to find any literature on

this treatment and are not endorsing it at this time. However, we do

consider effective, and are setting forth in Sec. 301.89-14 as an

approved treatment for bags, sacks, and containers used for infected

grain or seed fumigation with methyl bromide at the dosage of 15

pounds/1000 cubic feet for 96 hours.

One commenter stated that only storage bins that have held bunted

kernels and only combines and other equipment and means of conveyance

found to be infested with bunted kernels should have to be sanitized.

We disagree with the commenter, due to the risk of the spread of Karnal

bunt by spores.

One commenter stated that efficacy data for treatment methods

applicable to custom harvest equipment has not been provided and,

therefore, that custom combines used in fields infected with Karnal

bunt should be prohibited from moving out of the quarantined area.

Several other commenters also recommended such a prohibition, due to

what the commenters described as the impossibility of ensuring that all

spores on custom combines have been destroyed by the currently approved

treatment. Several commenters recommended that the Department purchase

a number of combines to be used, then left, in the regulated area. We

are making no changes based on these comments. We have specified

procedures for cleaning and sanitizing

[[Page 52195]]

equipment such as combines and consider the treatment, when properly

monitored, to be effective.

Several commenters stated that, although the regulations allow for

several methods of disinfecting equipment with regard to Karnal bunt,

fumigation with methyl bromide is the only completely effective way to

sanitize a combine. We are making no changes based on these comments.

We have specified procedures for cleaning and sanitizing combines, and

believe that the treatment with sodium hypochlorite, when properly

monitored, to be effective.

Several commenters stated in general that available methods for

``sanitizing'' equipment for Karnal bunt are costly and not totally

effective. One commenter described the hot detergent solution treatment

as ``essentially worthless.'' The commenter also stated that the need

to moisten areas treated with methyl bromide in some cases makes such

treatment impractical, such as in the treatment of grain elevators and

grain augers. We are making no changes based on these comments. We set

forth treatment options based on the best information available from

scientists familiar with Karnal bunt control. Procedures were developed

to facilitate the application of treatments. However, we agree that not

all treatments are equally effective in all situations. Therefore, we

are adding language to Sec. 301.89-13 of this final rule to provide

that the treatment option chosen must be the one specified by an

inspector if that treatment is deemed most effective in a given

situation.

One commenter stated that treatment dosage of methyl bromide

specified in the regulations is greater than that allowed by the

Environmental Protection Agency. The commenter urged APHIS to request

the necessary waivers to allow the use of methyl bromide as a fumigant

for the duration of the quarantine. We have obtained the appropriate

exemptions and permits for all the chemicals and treatments used in the

Karnal bunt program.

Section 301.89-11(b) of the Karnal bunt regulations set forth as an

approved treatment for straw/stalks/seed heads for decorative purposes

fumigation with methyl bromide at the dosage of 15 pounds/1,000 cubic

feet for 96 hours. One commenter stated that APHIS' import regulations

for wheat diseases in 7 CFR 319.59 exempts from regulation ``straw

without heads that has been processed or manufactured.'' The commenter

stated that, for consistency and because no pest risk has been

identified with this material, the Karnal bunt regulations should be

revised to include this exemption. We consider the commenter's point a

valid one. Section 319.59 exempts from regulation straw, with or

without heads, that has been processed or manufactured for use indoors,

such as for decorative purposes, or for use as toys. In Sec. 301.89-14

of this final rule, we provide that straw need not be treated for

movement outside the regulated area if it has been processed or

manufactured prior to movement, and is intended for use indoors.

Another commenter recommended that the dosage of methyl bromide be 5

pounds/1,000 cubic feet, rather than 15 pounds. We have no data

indicating that 5 pounds is an effective dosage and are making no

changes based on this comment.

One commenter recommended that equipment moved from a regulated

area be allowed to do so only under limited permit, rather than under a

certificate. Another commenter stated that, because of the difficulty

in assuring effective decontamination of conveyances carrying infected

articles, movement of such conveyances from quarantined areas should be

prohibited. We are making no changes based on this comment. We have

developed specific procedures for cleaning and sanitizing equipment and

conveyances, and believe that, when properly monitored, the treatments

are effective.

Several commenters recommended that all requirements for the

sanitization of farm equipment, conveyances, and grain elevators be

removed from the regulations. Another commenter recommended that

equipment coming from quarantined fields be required to be cleaned but

not sanitized. One commenter recommended that only those articles that

have come in contact with wheat or soil that has tested positive for

Karnal bunt be required to be sanitized. One commenter stated that it

was unrealistic and unachievable to restrict the movement of any

equipment or materials that come into contact with the soil on

contaminated fields. One commenter questioned the requirement to wash

soil from equipment in light of what he perceived as the greater risk

presented by windborne teliospores. Several commenters stated that, due

to what the commenters considered the impossibility of the eradication

of Karnal bunt, equipment moving within a quarantined area from a

contaminated field should be required to be cleaned free of soil, but

not be required to be sanitized. We acknowledge that the possibility of

the windborne spread of teliospores within the regulated area can

counteract the beneficial effects of sanitizing equipment. Because of

the potential windborne spread of Karnal bunt, and also because of the

possibility that equipment and means of conveyance may have been moved

from infected fields prior to the initial detection of Karnal bunt, we

are removing cleaning and sanitization requirements for movement within

the regulated area, except for movement from fields that test positive

for Karnal bunt during the 1996-97 crop season. Equipment moving

outside the regulated area must still be cleaned and sanitized prior to

movement. Additionally, we are still requiring the cleaning and

sanitization of contaminated elevators, so that grain testing negative

that is moving into the elevator remains uncontaminated.

Several commenters recommended that custom harvesting equipment be

prohibited from movement from a quarantined area, or, at the least,

that an effective monitoring program be implemented to assure that only

properly certified equipment leaves the quarantined area. We agree with

the commenter that the movement of custom harvesting equipment must be

closely monitored, and we have developed a system to monitor the

sanitization and movement of equipment from the regulated area.

In Sec. 301.89-11 of the regulations (Sec. 301.89-13 of the August

2, 1996, proposed rule), paragraph (a)(2) lists as an approved

treatment ``applying steam to all surfaces to the point of runoff.''

One commenter stated that the effectiveness of this treatment would be

doubtful, because the regulations set forth no requirement for the

``removal of material'' or for a minimum surface temperature. We

disagree that the regulations do not require cleaning. Section 301.89-

11 of the regulations (301.89-13 of this final rule) requires cleaning

by removing all soil and plant debris, followed by disinfection with

one of the required treatments.

In Sec. 301.89-11 of the regulations (Sec. 301.89-13 of the

proposed rule), paragraph (a)(3) lists as an approved treatment

``cleaning with a solution of hot water and detergent, under high

pressure (at least 30 pounds per square inch), at a minimum temperature

of 180 deg.F.'' One commenter stated that 30 pounds per square inch is

not considered high pressure and that 300 pounds per square inch would

be more appropriate. The commenter also expressed reservations about

the effectiveness of the treatment without the use of a fungicide. We

consider the treatment to be effective when used and monitored

appropriately. However, in order to avoid confusion as to the meaning

of ``high pressure,'' we are specifying only that the cleaning

[[Page 52196]]

solution must be applied with pressure of at least 30 pounds per square

inch.

One commenter recommended that requirements for the sanitization of

equipment be made gradually less stringent over the 5-year period

following the establishment of a quarantine. In our August 2, 1996,

proposed rule, we proposed to make less stringent the cleaning and

sanitization requirements within regulated areas, and to require

cleaning and sanitization of equipment only when moving from a

regulated area. In this final rule, we are requiring cleaning and

sanitization of equipment only when moving from a regulated area, and

in those cases where equipment is moved from a field that tests

positive for Karnal bunt during the 1996-1997 crop season. As we obtain

more data, we will consider other modifications to the sanitization

requirements.

Recommended Regulatory Actions

One commenter stated that allowing a Karnal bunt host crop to be

mature and harvested from a field known to be infested with Karnal bunt

teliospores or from a field planted with seed infected with Karnal bunt

allows for the possibility of teliospores being produced in the

resulting crop that would re-infest the soil in the field and

potentially be blown to other fields. This commenter and several other

commenters recommended that crops from infested fields be destroyed. We

are making no changes based on these comments. Due to currently

available survey techniques, we cannot determine whether a field is

infested until the crop is sampled and tested at harvest. In this final

rule, we are prohibiting the planting for the 1996-97 crop season of

host crops in fields that are known to be infested.

One commenter stated that once wheat shown to be infected is

destroyed in the field, the field should be burned and plowed to

destroy the spores. Then, the field should immediately undergo a soil

test for the presence of live spores. If no live spores are found, the

field should be considered clean and no further action should be

necessary. We are making no changes based on this comment. There are

scientific reports indicating that teliospores are carried on wind

currents caused by burning, and that the eradicative measure may

actually promote the spread of Karnal bunt. Also, we do not have an

effective methodology for testing soil at this time.

One commenter stated that the regulations should not allow the

burning of sacks, bags, and containers used for infected grain or seed

as a treatment option, due to the possibility of teliospores being

spread by the burning. As discussed above, we agree that burning is not

an appropriate treatment measure, and such an option is not set forth

in the regulations.

Several commenters stated that the ideal eradication scenario would

be to prohibit host crop production in the regulated area for a minimum

of 5 years. We are making no changes based on this comment. Although we

agree that the prohibition suggested by the commenter would be an

effective eradication technique, we believe there are other effective

measures that are less disruptive to farmers and the wheat industry

within the regulated area.

One commenter requested that, in order to restore the integrity of

grain produced in Arizona, APHIS assure the domestic industry and

international markets that the 1996 Arizona wheat crop would be

thoroughly tested prior to shipment. Several commenters recommended

that no preharvest testing be done, except for the most suspicious

fields. We consider adequate testing integral to the Karnal bunt

program. In 1996, all grain in the Karnal bunt program areas was tested

twice prior to movement. In 1997, under Sec. 301.89-6 of this final

rule, all grain in regulated areas must again test negative twice

before being moved from a regulated area, and one of these tests must

occur at the means of conveyance or storage facility immediately prior

to movement. We consider it necessary to test all grain moving from a

regulated area, because some fields that will be planted with wheat in

the 1996-97 crop season were not tested in 1996.

One commenter recommended that, due to the possibility of spillage,

open trucks or trailers transporting infected grain, even those covered

with a tarpaulin, be prohibited from leaving a quarantined area. We are

making no changes based on this comment. As noted, only grain that has

tested negative for Karnal bunt twice is eligible for movement out of

the regulated area. Additionally, the provisions of Sec. 301.89-6 this

final rule regarding movement from the regulated area provide that an

article to be moved under limited permit must be moved to a specified

destination for specified handling, utilization, or processing. In the

case of grain from where infested fields may occur, this means movement

only to approved mills under specific sanitation and safeguard

conditions.

One commenter objected to the provision in Sec. 301.89-5(c) that

states that an inspector shall issue blank certificates and limited

permits to a person operating under a compliance agreement. The

commenter requested that such documents be issued only by Federal or

approved State plant regulatory officials. We are making no changes

based on this comment. APHIS and State cooperators do not have the

resources to be present when each shipment or regulated article is

moved. However, the compliance of persons operating under compliance

agreement is monitored through inspections of facilities and equipment,

observation of procedures, and review and accounting of documents.

Calculation of Spore Prevalence

One commenter stated that APHIS is incorrect in concluding that the

detection of one spore in a railcar sample represents the presence of

close to 2 million spores in the railcar. The commenter stated that

subsequent tests of the railcar sometimes detect no further spores. Our

wheat testing program is basic to determining the actions appropriate

to controlling the spread of the Karnal bunt pathogen. We view the

detection of Karnal bunt teliospores in a sample from a qualitative,

not a quantitative, standpoint. We recognize that spores may not be

evenly distributed in a railcar. Nonetheless, we consider the detection

of teliospores as an adequate method to determine whether there is a

risk of spread of Karnal bunt.

Management of Karnal Bunt

Several commenters recommended that an eradication program be

replaced with a management program to potentially include the

following: (1) Planting clean, fungicide-treated seed; (2) requiring

crop rotations that include non-host crops; (3) using a later planting

date to force crop heading in central Arizona into a drier period of

the winter; (4) applying foliar fungicides on seed fields if conditions

indicate a risk of Karnal bunt infection; (5) implementing post-harvest

testing of seed to detect field infections of Karnal bunt; and (6)

using varieties of grains resistant to Karnal bunt. At this time, we

will continue to contain and control this disease to attain our goals

of (1) protecting other wheat producing areas of the United States, (2)

protecting and maintaining export markets, and (3) providing as many

options as possible to wheat producers within the impacted areas.

However, we consider the recommendations of the commenter good

management techniques. We are requiring in this final rule the use of

fungicide-treated seed for planting if the seed originated in a

regulated area and post-harvest testing. We are also examining the

feasibility of foliar

[[Page 52197]]

fungicides and are exploring the use of more resistant varieties of

wheat.

One commenter stated that if widely scattered areas in the United

States are found to have incidental Karnal bunt spores, such areas may

need to be put under ``observation,'' ``investigation,'' or

``restriction,'' but that ``quarantine'' may be counterproductive.

APHIS is currently conducting activities to control and contain the

disease within the regulated area. In addition, we are conducting a

national survey to determine if the disease exists in other portions of

the United States. If we find Karnal bunt in additional areas, we will

review the available data and take the most appropriate actions

consistent with our goals to protect other wheat growing areas, protect

export markets, and provide as many options as possible to growers and

industry impacted by our actions.

Non-Host Crops

One commenter stated that the small amount of soil present on

lettuce, cabbage, and onions poses a minimal threat of spreading spores

to other fields. Several commenters opposed the quarantining of crops

other than wheat, rye, and triticale. Several commenters stated that

the production of non-host crops such as root crops, onions, and

ornamentals should not be regulated merely because of the possibility

of the movement of soil or soil residues. The commenter stated that the

production of these crops poses a negligible risk of spreading Karnal

bunt. Another commenter recommended that standards for ``free from

soil'' be developed for the unrestricted movement of low risk crops

from quarantine areas. We are making no changes based on these

comments. We consider the risk of the spread of Karnal bunt through

soil to be sufficient to require cleaning of non-host crops prior to

movement outside the regulated area, or, alternatively, to require

movement under limited permit to facilities that will remove the soil

from the crops. Because cleaning root crops and other commodities is a

normal practice prior to sale, we do not believe that handling and

disposal of the soil in an appropriate manner will cause undue burden.

One commenter expressed concern that the sanitization treatments

provided will in most cases damage the fruit or vegetable crop beyond

marketability. We are making no changes based on this comment. Under

the regulations, fruits and vegetables need only to be free of soil.

Typically, fruits and vegetables are cleaned at harvest or at a packing

facility. There should be no additional damage as a result of the

requirement to remove soil from root crops and other vegetables and

fruit.

One commenter stated that the regulations should state that soil

associated with certain commodities (i.e., nursery stock, turf, etc.)

from a positive field in which a host crop has been grown, may not be

moved from that field unless it has been treated, tested, and found to

be negative. However, the commenter recommended that other types of

soil, such as soil attached to fruits or vegetables growing on top of

the ground and soil adhering to equipment, boxes, bags, etc, as a

result of their being set on the ground should not be regulated. We are

making no changes based on this comment. We consider the risk

associated with soil from a quarantined area merits regulation and

appropriate mitigative measures.

One commenter stated that in the case of New Mexico, where the

commenter said growers plowed down all known wheat acreage planted with

contaminated seed, and no Karnal bunt was detected on mature wheat,

establishing requirements to prevent the movement of soil and plant

debris on equipment and vegetable crops is excessive. We are making no

changes based on this comment. We consider a risk to exist with the

movement of soil on equipment and vegetable crops out of the regulated

area.

Calculation of Risk

One commenter stated that the Department should conduct a risk

analysis on each regulated article to determine if the risk is

``significant,'' and regulate only those articles posing a significant

risk. Several commenters said the Department's analysis of the risk of

a Karnal bunt outbreak from untreated millfeed showed the risk to be

negligible. One commenter said that the Department had stated that the

chance of Karnal bunt spreading from a quarantined area through Karnal-

bunt-negative millfeed was approximately 1 in 5,556 years, that the

Department considers this a ``moderate'' rather than a ``significant''

risk, and, therefore, that millfeed should not be a regulated article.

We are making no changes based on this comment. APHIS' estimate that

one outbreak might occur every 5,556 years was specific to the

situation where grain is shipped from anywhere in the quarantine area

to a mill outside the quarantine area and the millfeed is not treated.

This scenario was one of 17 scenarios presented by APHIS in formal risk

assessments on Karnal bunt. According to APHIS' current guidelines,

this constitutes a ``medium likelihood of spread'' (as opposed to a

moderate risk). The estimate of 5,556 years--and estimates for the

likelihood of an event in general--do not constitute a measure of

``risk''; 5,556 years was APHIS' estimate for the likelihood that

Karnal bunt would spread under these conditions. By definition,

estimates of the risk incorporate both the likelihood of an event (in

this case, spread of Karnal bunt) and the severity of the consequences

should Karnal bunt spread (e.g., economic and environmental impacts).

When a decision is made about what is an acceptable level of risk, both

the likelihood of an event (e.g., spread of Karnal bunt once every

5,556 years as a result of this particular type of shipment) and the

severity of the consequences (e.g., loss of export markets for United

States wheat) must be considered. The risk of each type of proposed

action must then be considered along with (e.g., added to) the risk

posed by other proposed or planned actions. The risk posed by these

shipments was determined to present a level of risk that was

unacceptable.

One commenter stated that the potential establishment of Karnal

bunt in an area outside the infested area from wheat grain intended for

milling for human consumption or processing for animal consumption was

judged by APHIS and the University of California to be remote--i.e., in

the order of magnitude of 1 in 1 million to 1 in 5 million. We believe

it is misleading to simplify the results of the analyses cited. The

estimate made by the University of California (UC) was compared with

the analogous estimate made by APHIS (i.e., Scenario No. 2C, Table 4a,

USDA, May 28, 1996). The methodology used by UC and APHIS were similar

in some respects but significantly different in other respects. Most

notably, APHIS performed a probabilistic risk assessment with a

probabilistic result (i.e., the estimate provided by the assessment was

a probabilistic range of values for the likelihood of spread). Because

the UC assessment was not a probabilistic assessment, only a single

number was reported (i.e., the spread of Karnal bunt once every 1.05

million years) and the scientific uncertainty about the biology and

movement of Karnal bunt was not considered. APHIS' assessment accounted

for the uncertainty regarding the biology of Karnal bunt. The estimate

used by APHIS to make decisions regarding regulation for this type of

shipment was, and continues to be, once

[[Page 52198]]

every 2,119 years (the 95th percentile of the estimated likelihood of

spread). Because the UC and APHIS methodologies were different, the

results could not be compared directly. However, UC and APHIS

essentially reached the same conclusion using different means, and

APHIS has not changed its estimate for the likelihood of spread.

One commenter recommended that APHIS conduct an evaluation of the

risk posed by Karnal bunt to the U.S. wheat industry and its

international markets. APHIS completed a risk analysis in 1991 that

addresses the consequences of the establishment of Karnal bunt.

Information regarding the analysis can be obtained from the person

listed in this final rule under FOR FURTHER INFORMATION CONTACT.

Definitions

One commenter stated that the definition of soil in Sec. 301.89-1

should be consistent with the definition established in the 1994

``North American Plant Protection Organization Position Paper on Soil

Movement.'' In that paper, soil is defined to mean ``the loose surface

material of the earth in which plants grow, in most cases consisting of

disintegrated rock with an admixture of organic material.'' We agree

with the commenter and have revised the definition of soil in this

final rule.

One commenter stated that Sec. 301.89-1, ``Definitions,'' defines

the terms farm tools, mechanized cultivating and mechanized harvesting

equipment, movement, soil, and soil moving equipment in their generic

sense, i.e., without reference to the connection they might have to

host crops. The commenter stated that by using such definitions, the

terms become all inclusive, even though, according to the commenter,

equipment such as harvesting equipment specific to commodities other

than wheat pose little risk of bearing spores of Karnal bunt. The

commenter recommended that the definitions be revised to make such a

connection to host crops, or, alternatively, that the term ``used''

that modifies certain regulated equipment in Sec. 301.89-2 be tied to

the risk associated with host crops for Karnal bunt. We are making no

changes based on this comment. We consider there to be a risk that the

pathogen will be moved with soil adhering to farm equipment and tools.

We consider cleaning and sanitization of these articles to be necessary

prior to movement from the regulated area, and prior to movement from

fields that test positive for Karnal bunt during the 1996-97 crop

season.

Scientific Resources

Several commenters stated that, in establishing the Karnal bunt

regulations, APHIS did not sufficiently enlist the expertise of

specialized scientific personnel. One commenter recommended that a

representative scientific panel be appointed to advise the Department

on modification of the quarantined areas. We disagree with the

commenters' contention. In developing program procedures, the

Department has solicited input from all interested parties. In

addition, APHIS has requested that informally structured groups such as

the Karnal bunt Science Panel meet to review and clarify technical

issues. Also, APHIS is exploring the possibility of establishing a

formal Karnal bunt advisory committee.

Regulated Areas

Section 301.89-3(c) provides 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. One commenter stated in general that this provision gives the

Administrator unnecessarily broad powers, and in particular that the

maximum regulated area in New Mexico should be those fields previously

planted with contaminated wheat seed. We disagree. Due to the movement

of equipment, the potential natural movement of the causal agent by

wind, and incomplete information on seed distribution for planting, we

consider the regulation of larger areas appropriate until additional

survey information is available.

Several commenters stated that areas such as Yuma County, AZ,

should not be quarantined. One of these commenters stated that natural

conditions in that area do not favor the establishment of Karnal bunt.

Several commenters stated that, as of the date the comments were

written, extensive testing in Yuma County had shown no Karnal bunt

infestation. Several commenters questioned why Arizona was the only

State to be quarantined in its entirety for Karnal bunt. One commenter

requested that the quarantine of Hudspeth County in Texas be reduced to

``more accurately reflect the affected areas.'' APHIS has revised the

quarantine boundaries in Arizona, California, New Mexico, and Texas,

including Hudspeth County, to include only those areas that contain

wheat fields that are associated with contaminated wheat seed or that

have tested positive. The Yuma area will remain within the regulated

area because it contains fields that tested positive during the

preharvest survey.

Several commenters stated that the same quarantine restrictions

have not been applied to areas with similar Karnal bunt conditions in

different States, requested that the specific scientific standards for

quarantine be publicly stated and applied equally, and that an

explanation be provided of why certain areas where Karnal bunt has been

determined to exist or that are suspect for the existence of Karnal

bunt have not been quarantined. At any indication of Karnal bunt, APHIS

and State cooperators respond immediately to identify potential

infestations. APHIS has traced contaminated seed to several locations

outside the regulated areas. In some cases, the seed had not been

planted but was still in storage. In those cases, the seed was

destroyed and the facilities were cleaned and sanitized. Contaminated

seed was traced to several small research plots, where the fields were

plowed down and fumigated. In some instances, despite extensive testing

and traceback efforts, we have not been able to confirm that

contaminated seed was either distributed or planted in the area in

question. We are continuing additional monitoring activities in those

areas. We consider such measures sufficient to ensure that Karnal bunt

is eliminated from the site without the unnecessary imposition of a

geographical quarantine.

Several commenters recommended a reduction or modification of the

quarantined area in California. According to the commenters, as of the

date the comment was written, no samples of grain produced in the

Imperial Valley of Imperial County, CA, had been proven to have Karnal

bunt. The commenters recommended that the Imperial Valley be removed

from the list of quarantined areas (with the possible exception of

those fields known to be planted with infected seed). One commenter

recommended that the current quarantine in Imperial County be replaced

with a program of wheat seed inspections, fungicidal treatment of wheat

seed, testing of outgoing shipments of wheat, and preharvest sampling.

One commenter recommended that those townships in Imperial County where

Karnal bunt has been found to be present be monitored during the coming

year. The commenter stated that a formal quarantine was unnecessary

because Karnal bunt can be dealt with in crop production and in

marketing in the same fashion as with other smut and bunt diseases that

occur in California. We disagree with the commenters that the Imperial

Valley should be released from regulation. This

[[Page 52199]]

area received seed that was contaminated with Karnal bunt. In addition,

composite samples taken from grain originating in the Imperial Valley

have tested positive. However, we acknowledge that no individual field

in the Imperial Valley has tested positive and are, therefore,

categorizing the Imperial Valley as a surveillance area in this final

rule. (Surveillance areas are discussed in more detail in this

SUPPLEMENTARY INFORMATION under the heading ``Regulated Areas.'')

One commenter recommended that APHIS quarantine wheat lots, rather

than quarantine States or counties according to geographical

boundaries. We are making no changes based on this comment. However, in

APHIS' current program, eligibility for movement is determined by test

results of grain from either individual fields or means of conveyance.

One commenter recommended that the Department take responsibility

for the movement of regulated articles out of the regulated area, and

that States be responsible for movement within regulated areas. We are

making no changes based on this comment. APHIS and State cooperators

work together to provide an integrated program, because movement

outside the regulated area is dependent on program activities conducted

within the regulated area.

One commenter recommended that growing areas be removed from

regulation if they show less than 1 percent positive results in the

pre-harvest survey. The commenter also recommended that regulated areas

be delineated using geographic boundaries, i.e., highways, roads, and

rivers, rather than county boundaries. We do not agree that regulation

of an area should be dependent on whether Karnal bunt is detected in

some specified percentage of fields tested. However, in this final

rule, based on 1996 survey data, we have modified the regulations by

categorizing areas based on the presence or not of fields that tested

positive for the pathogen. The areas are regulated based on their

relative risks. Areas with positive fields are of greater risk because

the pathogen has been shown to exist and may be spread locally by wind

or the movement of equipment. This would occur independently of

whatever percentage of the fields are positive. We are using boundaries

other than county lines to describe the regulated areas.

Several commenters stated that, in those areas where only several

fields have been found to be infected with Karnal bunt, only those

fields testing positive should be quarantined, not the entire area.

Another commenter recommended that, using traceback survey and pre-

harvest sampling results, only those areas where an infestation has

been found should be subject to quarantine. One commenter stated that

negative preharvest testing of seed produced in a quarantined area

should be grounds for allowing that seed to move from the quarantined

area. One commenter recommended that quarantined areas be limited to

those wheat-growing areas where Karnal bunt is suspected and projected

by APHIS. We agree with the commenters that, based on survey data,

certain areas present a greater risk than others, and, in this final

rule, we have created criteria for two categories of areas within the

regulated area: (1) Restricted areas which include fields testing

positive, and (2) surveillance areas where no fields testing positive

are located. We discuss these areas in greater detail in this

Supplementary Information under the heading ``Regulated Areas.'' Grain

moving from restricted areas will continue to move under limited permit

with safeguard conditions. Grain from surveillance areas may move under

certificate without restriction.

Services of Inspectors

Section 301.89-8 of the regulations sets out the procedures for

requesting the services of an inspector by persons requiring

certification or other services. Paragraph (a) of that section requires

that 48 hours notice be given to the inspector before the services are

needed. One commenter suggested that, instead of the mandated 48 hours

notice, provisions for assembly and inspection of regulated articles be

set through compliance agreements. We do not believe that specifics

concerning requirements for APHIS lead-time notification are

appropriate for a compliance agreement. However, we recognize the need

for a quicker response time during harvest, and, therefore, are

revising the regulations by reducing from 48 hours to 24 hours the time

required for notification prior to the provision of APHIS services.

Section 301.89-10 provides that the services of an inspector during

normal business hours will be furnished by APHIS without cost, but that

the user will be responsible for all costs and charges arising from

services provided outside of normal business hours. One commenter

stated that, during harvest season, ``normal business hours'' are

virtually around the clock, and that the Department should be

responsible for all costs and charges arising from inspection and other

services provided at any time. During the 1996 harvest, APHIS did not

charge for services conducted outside ``normal'' business hours. We

expect to continue this policy for most activities in the 1997 crop

season.

Import Requirements

Several commenters stated that the restrictions regarding produce

from Mexico because of Karnal bunt are less stringent than those

established by the domestic quarantine regulations, and inquired

whether the two sets of restrictions would be made consistent. We

disagree with the commenters' statement. Wheat products and soil from

Mexico are restricted entry into the United States to prevent the

introduction of insect pests and plant diseases such as Karnal bunt.

Analysis of Economic Impact

Several commenters stated that the Department has not published an

assessment of the economic impact of the Karnal bunt quarantine.

Another commenter stated that the long-term economic costs of

maintaining the current Karnal bunt quarantine would outweigh the

amount of foreign export business that might be temporarily lost if the

Karnal bunt regulations were removed. We are currently in the process

of assessing the economic impact of the Karnal bunt quarantine, and

will publish this assessment in the Federal Register upon its

completion.

Comment Period

One commenter stated that the 60-day comment period provided for

our interim rule establishing the Karnal bunt regulations allowed

insufficient time for interested parties to compile sufficient

information to comment. Although the comment period for the interim

rule establishing the regulations was initially to end on May 28, 1996,

that period was extended until September 3, 1996. We consider this

sufficient time for interested parties to have commented on the interim

rule.

Comments on Proposed Rule, Docket No. 96-016-10

Several commenters supported our August 2, 1996, proposal.

One commenter requested that APHIS explain the sound science upon

which it based each provision of the proposed rule. We acknowledge the

need to base regulatory actions on the latest scientific data

available. The provisions of the Karnal bunt regulations are based on a

combination of scientific data and recommendations of the Karnal bunt

Science Panel, APHIS' experience as a regulatory agency, and standard

regulatory procedures and systems that have proven effective in

previous

[[Page 52200]]

programs. Sound science, coupled with environmental considerations,

forms the basis for a risk-based, flexible regulatory system to

accomplish APHIS' goals to (1) protect other wheat-producing areas of

the United States, (2) protect and maintain export markets, and (3)

provide as many options as possible for wheat producers within the

impacted area.

One commenter disagreed with the statement in our proposed rule

that the purpose of the proposal was to relieve unnecessary restriction

on areas regulated because of Karnal bunt, while guarding against the

artificial spread of the disease. The commenter stated that the

proposal actually expands the restriction on movement. For example,

stated the commenter, where the regulations required the removal of

soil from equipment that entered a field that is positive for Karnal

bunt or that had been planted with contaminated seed, the proposed rule

expands the cleaning requirement to any field known to be planted in

the past 5 years with seed contaminated with Karnal bunt, and fields

adjacent to fields in which preharvest samples tested positive. We

agree with the commenter that, in many cases, such cleaning is

unnecessary within the regulated area. In this final rule, we have

modified the cleaning and sanitization requirements to require these

measures only when equipment or conveyances are moved out of the

regulated area, or are moved from fields that tested positive for

Karnal bunt during the 1996-97 crop season.

Several commenters stated that APHIS should publish in the

regulations the terms of compliance agreements under which regulated

articles may be moved out of regulated areas. In general, the terms of

compliance agreements follow the provisions and treatments set forth in

the regulations. Additional information is often provided to the

regulated establishment concerning recordkeeping, handling of limited

permits and certificates, local contacts, and any special instructions

specific to the operations of the establishment. When the interim rule

establishing the Karnal bunt regulations was promulgated, its

provisions were general and flexible. This was because we were

regulating a new outbreak of a disease with which we had minimal past

experience. In this final rule, we are publishing a table of conditions

under which areas of differing risk levels will be regulated, to inform

growers and other members of the industry of how they will be impacted.

Compliance agreements will be based on these regulatory conditions.

One commenter stated that, where possible, the use of compliance

agreements for such actions as the movement of grain, disposition of

millfeed, and movement of equipment should be avoided. The commenter

said that being required to sign a compliance agreement in order to

handle a product discourages potential buyers from handling the product

in question. We consider the use of compliance agreements to be

beneficial to both APHIS and the person operating under the compliance

agreement. The use of compliance agreements allows APHIS to better use

its resources, and allows the person to handle and move regulated

articles without the constant presence of an inspector. We believe that

the necessity for on-site monitoring during operations and at movement

would be more discouraging to buyers and handlers.

Risk Categories for Areas and Fields

In Sec. 301.89-3(f) of our proposed rule, we proposed criteria by

which fields in regulated areas would be classified into various risk

class levels. We proposed that the Administrator would classify fields

in regulated areas according to the following categories, and would

notify the owner or person in possession of the field of the field's

classification:

1. Fields in which preharvest samples tested positive for Karnal

bunt;

2. Fields known to be planted in the past 5 years with seed

contaminated with Karnal bunt;

3. Fields adjacent to fields in which preharvest samples tested

positive;

4. Fields associated only through ownership, management, the

movement of equipment, or proximity within a distinct definable area

with fields in which preharvest samples tested positive; and

5. Fields within a regulated area that are not fields described in

``2'' and ``4,'' and that are part of a distinct definable area that

includes no fields in which preharvest samples tested positive.

A number of commenters commented on these proposed categories. Some

of the commenters addressed the proposed categories in general; other

commenters addressed individual categories. After reviewing the

recommendations made by the commenters, we believe that we should

revise our categorization of risk areas to simplify them and to make it

easier for the owner of specific fields to know the status of those

fields. For purposes of clarity, in the following paragraphs we will

first explain what this revised system of categorization will consist

of, then we will discuss comments on the system of categorization that

we set forth in our proposed rule. We believe conducting the discussion

of the comments in this way will allow us to respond to the comments in

the context of the regulatory scheme that we are adopting in this final

rule.

Regulated Areas

In Sec. 301.89-3 of this final rule, we set forth the criteria for

designating an area as a regulated area. These criteria are the same as

that set forth in the proposal. Under these criteria, the Administrator

will regulate each State or portion of a State that is infected. In

Sec. 301.89-1 of both the proposal and this final rule, infestation

(infected) is defined as the ``presence of Karnal bunt, or any stage of

development of the fungus Tilletia indica (Mitra) Mundkur, or the

existence of circumstances that make it reasonable to believe that

Karnal bunt is present.'' In Sec. 301.89-2 of this final rule, we set

forth a list of regulated areas.

Restricted Areas and Surveillance Areas

In this final rule, we then divide each regulated area into two

sub-categories. In each regulated area, all or a portion of that

regulated area will be designated as either a ``restricted area'' or a

``surveillance area.'' In Sec. 301.89-1 of this final rule, we define a

restricted area as a ``distinct definable commercial wheat production

area that includes at least one field that tested positive for Karnal

bunt.'' A distinct definable area is defined as ``a commercial wheat

production area of contiguous fields that is separated from other wheat

production areas by desert, mountains, or other nonagricultural terrain

as determined by an inspector, or, in the case of restricted areas, as

determined by an inspector based on survey results, including the

number of positive fields and the relative spore count of the fields

within the area.'' In Sec. 301.89-1, we define surveillance area as a

``distinct definable commercial wheat production area in which no

fields have tested positive for Karnal bunt, but in which movement of

contaminated seed has occurred.'' In Sec. 301.89-2 of this final rule,

we set forth a list of each restricted area and each surveillance area.

There are several practical differences between being designated a

restricted area and being designated a surveillance area. First, grain

from a restricted area that tests negative for Karnal bunt may move

under limited permit from the regulated area to designated facilities

under safeguard and sanitation conditions; grain from a surveillance

area that tests negative for Karnal bunt may move under certificate to

any destination without restriction.

[[Page 52201]]

Additionally, under Sec. 301.89-13(c) of this final rule, millfeed from

grain produced in a restricted area is required to be treated, whereas

millfeed from grain produced in a surveillance area is not required to

be treated. However, as explained below, only certain types of fields

will be permitted to be planted with host crops; therefore only those

fields will be capable of producing grain to be sent for milling.

In this final rule, each restricted area and each surveillance area

is further divided into individual fields within those areas, as

described in the following paragraph. Each field in a restricted area

will fall into one of three categories. Each field in a surveillance

area will fall into one of two categories.

In a restricted area, each field will be designated either as (1) a

field in which preharvest samples tested positive; (2) a field planted

with known contaminated seed in 1995; or (3) any other field within the

restricted area. In a surveillance area, each field will be designated

either as (1) a field planted with known contaminated seed in 1995; or

(2) any other field in the surveillance area.

There is a practical effect to being designated a certain risk

level of field. In a restricted area, in fields in which preharvest

samples tested positive, no Karnal bunt host crops may be planted in

the 1996-97 crop season. This same prohibition applies to fields in

both restricted areas and surveillance areas which were planted with

known contaminated seed in 1995. Also, as noted above, millfeed from

grain from a field in the ``any other field'' category in a restricted

area must be treated; millfeed from a surveillance area need not be

treated.

In order to help clarify our system of categorization, we have set

forth each category we are establishing in this final rule, and the

practical ramifications of being classified in that category, in a

table in this final rule, as follows:

Conditions for Wheat Production and Utilization in a Regulated Area

--------------------------------------------------------------------------------------------------------------------------------------------------------

Definition Host planting Seed Decontamination Millfeed Survey Disposition of grain

--------------------------------------------------------------------------------------------------------------------------------------------------------

Restricted

area

Category:

1............ Fields in which No host planting Not applicable... Equipment movement Not applicable... Not applicable... Not applicable.

preharvest in 1996-97 crop outside regulated

samples tested season. area: cleaned and

positive. sanitized. Movement

within: no

restrictions.

2............ Fields planted No host planting Not applicable... Equipment movement Not applicable... Not applicable... Not applicable.

with known in 1996-97 crop outside regulated

contaminated season. area: cleaned and

seed in 1995. sanitized. Movement

within: no

restrictions.

3............ All other fields No restrictions.. Tested and, if Equipment movement Required, unless Double-tested: Movement of grain

within from regulated outside regulated destination Sampled in field testing positive

restricted area. area, treated area: cleaned and State controls at harvest; restricted; grain

prior to sanitized. Movement disposition/ composite sample testing negative

planting. within: no movement. prior to may move under

restrictions. movement. limited permit to

designated

facilities under

safeguard and

sanitation

conditions.

Surveillance

area

4............ Fields planted No host planting Not applicable... Equipment movement Not applicable... Not applicable... Not applicable.

with known in 1996-97 crop outside regulated

contaminated season. area: cleaned and

seed in 1995. sanitized. Movement

within: no

restrictions.

5............ All other fields No restrictions.. Tested and, if Equipment movement Not required..... Double-tested: Movement of grain

located in from regulated outside regulated Sampled in field testing positive

definable area area, treated area: cleaned and at harvest; restricted; grain

where no fields prior to sanitized. Movement composite sample testing negative

in risk level 1 planting. within: no prior to may move under

are located. restrictions. movement. certificate.

Safeguard and

sanitation of

railcars not

required.

--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 52202]]

Comments On Proposed Risk Categories

We will now discuss the comments that addressed the risk categories

we set forth in our proposal. We will first discuss those comments that

addressed our proposed system of categorization in general. We will

then discuss those comments that addressed specific categories set

forth in our proposal.

Comments on Proposed Categorization in General

The definitions in proposed Sec. 301.89-1 include a definition of

distinct definable area. This definition reads ``a commercial wheat

production area of contiguous fields that is separated from other wheat

production areas by desert, mountains, or other nonagricultural terrain

as determined by an inspector.'' One commenter stated that this

definition does not accurately describe wheat production in the

proposed regulated area of New Mexico, where less than 4 percent of the

agricultural acreage is planted in wheat, and the fields are small and

randomly dispersed. We believe we can identify distinct definable areas

in New Mexico when appropriate. Under the criteria for classification

set forth in this final rule, all regulated portions of New Mexico will

at this time be classified as surveillance areas.

One commenter stated that although the proposed rule stated that

regulated areas would be classified according to specific risk

categories, such classifications were not included in the proposed

regulations. Another commenter requested that APHIS publish a map

showing the location of fields in Arizona and the level of risk

classification for those fields. Another commenter stated that the

regulations should explain how risk levels are determined. As noted

above, in this final rule, we have simplified the proposed rule by

categorizing areas into two types--restricted and surveillance, and we

describe the criteria for and the boundaries of each type of area. We

have identified the location of fields that have tested positive and

will notify growers in those areas. We are preparing maps and will

distribute them when they are completed.

One commenter stated that the criteria for the different risk

levels is broad and arbitrary, and that, consequently, lenders will not

be able to assess the risk a field presents. One commenter stated that

the proposed rule did not make clear what practical impact

classification of fields into different risk categories would have. As

noted, in this final rule, we have simplified the provisions that were

proposed by setting forth criteria for two categories of fields--

restricted and surveillance. We are also providing a table in the

regulations that outlines the effects of being classified as a

particular area.

One commenter inquired whether a process would be established by

which a field classification could be appealed. The commenter also

inquired whether the risk classification of a field would be subject to

change after initial classification. No appeal process has been

established. After initial classification, changes would occur only

when positive survey results indicate that it is appropriate.

Several commenters expressed concern that the ``regulated'' areas

in the proposed rule were identical to the ``quarantined'' areas in the

current regulations, and recommended that the regulated areas be

reduced. In this final rule, we are making certain changes to the

existing quarantined areas. Additionally, there are significant

differences between restricted areas as defined in this final rule, and

surveillance areas.

One commenter questioned whether the Department has the resources

to regulate the different field classifications, rather than simply on

an ``area'' level. We are confident we have sufficient resources to

enforce the regulations. Operationally, we consider the regulatory

scheme in this final rule to be simpler than that in our proposed rule.

One commenter inquired whether currently quarantined areas that do

not fit into one of the classifications described above would be

considered not to be quarantined. As noted above, in this final rule,

we are removing from regulation additional wheat growing areas that

have no association with contaminated seed, We believe the remaining

areas can be categorized.

Several commenters recommended that only four categories of fields

be established, as follows:

1. Fields in which 1996 preharvest samples tested positive;

2. Fields known positively to have been planted with contaminated

seed since 1995;

3. Fields in which 1996 preharvest samples tested negative; and

4. Fields outside the 1996 regulated area. We are not adopting the

commenter's recommended scheme, which we consider to require

regulations essentially the same as those in effect during the 1996

harvest. We believe that, based on survey data, we can relax

restrictions in the coming crop year in some areas, while we gather

more data on the extent of the infestation.

As part of this scheme of four categories, the commenters

recommended the following:

Host Planting: Prohibited for 1 year in categories ``1'' and ``2;''

unrestricted in categories ``3'' and ``4.''

Seed: No seed should be present in categories ``1'' and ``2;'' test

and treat in category ``3;'' recommend treatment in category ``4.''

Disposition of Grain: No grain should be present in categories

``1'' and ``2;'' unrestricted disposition from categories ``3'' and

``4.''

Decontamination: Decontaminate equipment with soil in categories

``1'' and ``2;'' decontaminate only equipment that came into contact

with contaminated wheat in categories ``3'' and ``4''

Millfeed Treatment: No requirements.

With regard to the restrictions and requirements recommended by the

commenters, we believe that due to the potential natural and artificial

movement of the Karnal bunt pathogen, areas that include fields that

test positive are a high risk, and that different levels of regulatory

activity within areas, not only fields, is appropriate.

One commenter recommended that the current quarantine be replaced

with a program of ``monitored grain exchange,'' to contain three key

elements:

1. Require that all seed, feed, and grain be twice tested negative

before leaving areas where there is a risk of contamination, and

require source labeling for all grain shipped from these areas.

2. Within the current quarantined area, classify zones according to

three levels of risk, as follows:

a. Zone 1: Bunted kernels have been confirmed. No grain may leave

area, except for use as feed. All grain exceeding a specified tolerance

is removed from distribution.

b. Zone 2: No contamination has been found, but a risk of

contamination exists. Allow grain to move to designated end-use sites,

such as research facilities, certain seed replication sites, and flour

mills.

c. Zone 3: No contamination has been found. Allow unlimited grain

movement once samples have been twice tested negative.

3. Establish a multi-level tolerance based on end use. As noted

above, we have modified the regulatory scheme we proposed. We have

included several elements similar to those suggested by the commenter,

including the testing twice of all grain, restricted movement of grain

from areas that tested positive or presented a risk

[[Page 52203]]

of contamination, and unrestricted movement from areas of minimal risk.

The provisions in Sec. 301.89-4 of the current regulations set

forth conditions for the movement of regulated articles from

quarantined areas. These provisions are similar to those set forth in

Sec. 301.89-5 of the proposed rule, ``Movement of regulated articles

from or within regulated areas.''

Comments on Specific Categories

We now discuss comments that addressed specific categories of

fields as set forth in our proposal.

1. Fields in Which Preharvest Samples Tested Positive for Karnal Bunt

One commenter specifically supported this risk classification.

Another commenter recommended that future plantings in this category be

limited for 5 years to crops that are not hosts of Karnal bunt. Another

commenter recommended that the regulations require that wheat be

planted no more often than every third year in a field testing positive

for Karnal bunt. During the 1996-97 crop season, we are prohibiting the

planting of host crops in fields that tested positive in the 1996

harvest testing. We will reassess this prohibition on an annual basis

after considering new survey and scientific information.

Several commenters stated that the proposed requirements for the

treatment of millfeed from wheat from fields of this category are

unnecessary, because fields that tested positive in 1996 would have no

wheat grown on them in 1997. To eliminate any confusion, we have

reworded the regulations to clarify that this applies only to fields

that test positive in the future. However, we expect to find additional

fields that test positive. Millfeed produced from grain originating

from such positive fields will require appropriate treatment and

handling.

One commenter stated that if a new field tested positive for Karnal

bunt in 1997, the grain would be heat treated, sent to a feedlot within

the quarantined area, or handled in some other fashion that would not

spread the disease, and there would be no millfeed. We are cooperating

with the industry and States to develop additional options for positive

grain, such as milling or export.

One commenter inquired how APHIS would classify a field that tested

positive during preharvest testing, then was harvested and tested

negative at harvest. In such a situation, the field would be classified

as positive for Karnal bunt.

Several commenters objected to the proposed requirement that

vegetable crops that are not moved to an approved processing facility

must be cleaned of all soil and plant debris prior to movement from

fields in this category, and also from fields in categories ``2'' and

``3,'' as described below. The commenters stated that fresh fruits and

vegetables are in a ``consumer market'' upon harvest and packaging, and

therefore present no risk of spreading Karnal bunt. Most fruit and

vegetables are cleaned prior to being sold. We are concerned with the

handling of the soil resulting from this cleaning when the fruits and

vegetables are moved outside the regulated area.

2. Fields Known to be Planted in the Past 5 Years With Seed

Contaminated With Karnal Bunt

One commenter stated that the 5-year period may be too long, based

on a report from India that, according to the commenter, indicated that

Karnal bunt spores can survive in the soil for only 27-45 months. One

commenter objected to having to disinfect equipment because seed known

to be contaminated was planted in 1994, if all lots of seed in 1995

tested negative. Several commenters recommended that this category

include only fields known to be planted with contaminated seed within

the last year. We agree that the issue of spore viability requires

further review, and are conducting such review. Due to the need for

such review, and the absence of historical records regarding many

fields, in this final rule, we have changed the description of fields

of this type to include only fields planted with contaminated seed in

1995. In addition, in the final rule, we are not requiring cleaning and

sanitization of equipment moving within the regulated area, except from

fields testing positive for Karnal bunt during the 1996-97 crop season.

One commenter recommended that future plantings in this category of

field be limited for 5 years to crops that are not hosts of Karnal

bunt. During the 1996-97 crop season, we are prohibiting the planting

of host crops in fields that were planted with contaminated seed in

1995. We will reassess this prohibition on an annual basis after

considering new survey and scientific information.

One commenter questioned the need to clean and disinfect equipment

moving out of the regulated area from fields of this category, stating

that wind erosion can relocate more spores in 12 hours than equipment

could carry in years. In order to protect other wheat growing areas of

the United States, we consider it necessary to require cleaning and

sanitization of equipment and conveyances moving out of a regulated

area. However, as discussed earlier in this document, we acknowledge

the role of wind in the local movement of the pathogen and have removed

the requirement for cleaning and sanitization for movement within the

regulated area, except from fields testing positive for Karnal bunt

during the 1996-97 crop season.

Several commenters recommended that future planting restrictions

for fields of this category be applied only if there is direct evidence

that the seed planted was from a contaminated source and the specific

location of the site where it was planted can be identified. We agree

with the commenters' recommendation and, as noted above, have redefined

this category as fields planted in 1995 with known contaminated seed.

This categorization will be applied only if there is direct evidence

that the seed planted was from a contaminated source and if the

specific location of the site where it was planted can be identified.

Several commenters recommended that no planting restrictions be

applied to fields in this category, and one commenter described this

category as unrealistic. The commenter stated that unless the seeds are

checked by DNA analysis and tested for germination, there is no

certainty that the spores are Karnal bunt. The commenter also stated

that the presence of a relatively small number of spores in soil may

not mean there is significant risk when moving wheat from the area. We

are making no changes based on these comments. The lots in question

that were planted in 1995 were determined to be contaminated by the

presence of bunted kernels, by standard microscopic diagnostic

techniques involving morphometric characteristics, and/or by DNA

analysis. We consider it necessary to prohibit planting of host crops

in fields where contaminated seed was planted. Planting of host crops

would allow multiplication and probable spread of the disease.

Several commenters stated that the requirement to clean soil and

plant debris from vegetables from this category of fields is excessive

and should be removed. We are making no changes based on these

comments. We consider it necessary to require that vegetable crops

moving outside the regulated area be cleaned of all soil and plant

debris prior to movement, or be moved under limited permit to

processing facilities for cleaning.

One commenter stated that if there is a prohibition against

planting in a field in which a preharvest sample has tested positive or

a field that has been planted within the last 5 years with

[[Page 52204]]

contaminated seed, it should also apply to such fields outside the

regulated area. If it does not, said the commenter, the scientific

basis for such a decision should be published. We consider our response

to the comment discussed earlier regarding varying restrictions on

different areas to be applicable here. As noted, APHIS has traced

contaminated seed to several locations outside the regulated areas. In

some cases, the seed had not been planted but was still in storage. In

those cases, the seed was destroyed and the facilities were cleaned and

sanitized. Contaminated seed was traced to several small research

plots, where the fields were plowed down and fumigated. In some

instances, despite extensive testing and traceback efforts, we have not

been able to confirm that contaminated seed was either distributed or

planted in the area in question. We are continuing additional

monitoring activities in those areas. We consider such measures

sufficient to ensure that Karnal bunt is eliminated from the site

without the unnecessary imposition of a geographic quarantine.

3. Fields Adjacent to Fields in Which Preharvest Samples Tested

Positive

Several commenters recommended that this category be deleted,

stating that no scientific justification exists for presuming that

Karnal bunt can be easily spread from field to field due only to

physical proximity. Alternatively, the commenters recommended that

``adjacent'' be defined, and not mean fields separated by main roads,

main canals, agricultural drains, and other large landmarks. Several

commenters opposed restrictions on movement from this category of

fields, as well as requirements for cleaning and disinfection and the

treatment of millfeed. The proposed category of fields referred to by

the commenters is not set forth in this final rule. All fields in an

area that includes a field that tests positive are now classified as

being part of a restricted area. There is a higher risk in these areas

that the pathogen is present due to windborne spread and movement of

equipment and means of conveyance prior to regulation.

4. Fields Associated Only Through Ownership, Management, the Movement

of Equipment, or Proximity Within a Distinct Definable Area With Fields

in Which Preharvest Samples Tested Positive

Several commenters recommended that this category be deleted,

because, according to the commenters, there is no evidence that Karnal

bunt has been spread among fields associated as described. The

commenters opposed the proposed requirement for the treating of

millfeed from fields of this category. One commenter stated that APHIS

should either state the scientific basis for regulating these fields,

or consider these fields outside the regulated area. Although this

category of fields is not specifically set forth in this final rule, we

consider our response to the previous comment applicable here.

One commenter recommended that this category should also include

fields that are possibly associated with contaminated seed, but for

which direct evidence is not available. The commenter cited the

situation where a specific field in which contaminated wheat was

planted cannot be identified because the grower did not keep records.

In such a case, said the commenter, all fields planted to the same

variety as the contaminated seed are suspect. The commenter stated

that, because of the elevated risk of fields in this category, farm

equipment, farm tools, and soil moving equipment should be required to

be cleaned and disinfected prior to movement from fields in this

category to locations outside the regulated area. In this final rule,

we have modified our decontamination requirements to require cleaning

and sanitization of farm equipment, tools, and soil-moving equipment

prior to movement out of the regulated area, and prior to movement from

fields testing positive for Karnal bunt during the 1996-97 growing

seasons.

One commenter stated that the cleaning and disinfection

requirements for fields in categories ``1,'' ``2,'' and ``3'' should

also apply to regulated articles from fields in categories ``4'' and

``5.'' The commenter stated that 1996 pre-harvest testing did not

detect the presence of Karnal bunt in all infected or contaminated

fields, that there were reported cases where positive post-harvest

testing followed negative pre-harvest testing, and that, because all

fields with a history of wheat production in years prior to the 1995-96

crop were not planted to wheat in 1995-96, there are no pre-harvest

test results from these fields to provide evidence of area freedom from

Karnal bunt. We agree with the commenter. This final rule requires that

equipment and means of conveyance moved out of any regulated area be

cleaned and sanitized. As noted above, however, we are not requiring

cleaning for movement within the regulated area, except from fields

testing positive for Karnal bunt during the 1996-97 crop season.

5. Fields Within a Regulated Area That are Not Fields Described in

``2'' and ``4,'' and That are Part of a Distinct Definable Area That

Includes No Fields in Which Preharvest Samples Tested Positive

One commenter supported the proposed provision that millfeed from

wheat from fields of this category need not be treated to be moved from

a regulated area. Several commenters recommended that fields meeting

this classification be removed from the regulated area. We are making

no changes based on these comments. We consider it necessary to

regulate these fields and areas because of the movement of contaminated

equipment and seed, composite samples that tested positive in the

areas, and the fact that many fields that were planted to wheat in

years prior have not been sampled.

Seed For Planting

One commenter stated that the requirements regarding planting seed

in Sec. 301.89-4 as proposed should make clear that seed to be planted

must first be sampled and tested negative for Karnal bunt, then be

treated with a fungicide. The regulations as proposed set forth the

fungicide requirement first, then the sampling and testing requirement.

We agree that the recommended change would clarify our intent and have

made the change in this final rule.

One commenter stated that it would be helpful to the wheat industry

if APHIS specified which fungicides are acceptable. We agree with the

commenter, and have added to Sec. 301.89-13 of this final rule the

provision that the treatment for seed must consist of either: (1) 6.8

fl. oz. of Carboxin thiram (10 percent + 10 percent, 0.91 + 0.91 lb.

ai./gal.) flowable liquid and 3 fluid ounces of pentachloronitrobenzene

(2.23 lb. ai./gal.) per 100 pounds of seed; or (2) 4.0 fluid ounces of

carboxin-thiram (1.67 + 1.67 lb. ai./gal.) flowable liquid and 3 fluid

ounces of pentachloronitrobenzene (2.23 lb. ai./gal.) per 100 pounds of

seed.

One commenter asked APHIS to specify whom the Agency would allow to

conduct the required sampling and testing. APHIS and State

representatives conduct the sampling and testing.

One commenter stated that the requirement in Sec. 301.89-4 for

sampling and negative testing of seed to be planted should apply only

to wheat seed originating within a regulated area. We disagree. We

consider it necessary to ensure that all seed planted in the regulated

area is free of Karnal bunt, and to be able to identify any sources of

[[Page 52205]]

contamination outside the regulated area.

One commenter recommended that no seed be planted within a

quarantined area unless it has been certified as having undergone the

necessary phytosanitary requirements, and has been treated with

antifungicides. We are making no changes based on this comment. In this

final rule, we require that all seed to be planted within a regulated

area be tested for the causal agent of Karnal bunt and be treated with

a fungicide.

Millfeed

Section 301.89-13 of the proposed rule set forth requirements for

approved treatments for regulated articles, including millfeed. Several

commenters stated that requirements for treatment of millfeed should

apply only to millfeed from wheat grown in fields that have tested

positive for Karnal bunt. APHIS is requiring millfeed to be treated if

from grain originating in restricted areas. There is a risk of movement

of the pathogen with wind or equipment and means of conveyance from

fields that test positive. Many fields that will be planted in wheat in

the 1996-97 crop season have not been tested.

One commenter requested that the requirement that millfeed from

quarantined areas be treated be reviewed, especially if it can be shown

that its final destination and disposition does not present a

significant risk for re-infection or disease spread to new areas. One

commenter stated that APHIS should continue its policy of allowing

States to govern millfeed movement, and should continue its policy of

not inspecting or quarantining flour mills. We agree that final

destination and disposition of millfeed is important in determining

risk. During the 1996 harvest, we allowed the destination State to

determine appropriate treatment and handling based on the intended use

within their State. Interstate movement was still monitored and treated

when appropriate. This final rule requires special treatment and

handling of millfeed only when the grain originates from distinct

definable areas that have fields that test positive. We are not

conducting detection surveys in flour mills.

Several commenters recommended that millfeed that results from the

milling of wheat from clean areas within the quarantined area and/or

wheat that has been tested and found free of teliospores should be

allowed to move freely in commerce, and that treatment of the millfeed

should be required only when teliospores have been detected. One

commenter stated that it appeared that millfeed from grain from all

areas of Arizona would have to be treated. In this final rule, we are

not requiring millfeed to be treated if from grain originating in

surveillance areas. The regulated areas in Arizona include several

surveillance areas. As discussed above, we consider grain from

restricted areas to pose a higher risk. APHIS will continue to allow

destination States willing to accept responsibility to determine the

appropriate treatment and handling based on the intended use within

their States.

One commenter objected to the requirement that millfeed be heat

treated at 170 oF for at least 1 minute, and recommended instead

that the treatment require only instantaneous heating to 170 oF.

The commenter stated that the 1-minute requirement would require

substantial capital investment and would have a negative effect on

mills, which the commenter stated rely on high throughput rates. We are

making no changes based on this comment. The ``1-minute'' requirement

ensures that all surface areas are exposed to a temperature that will

devitalize any spores present.

One commenter stated that the requirement for heat treatment of

millfeed should be maintained unless other effective mitigating

measures can be identified. We agree and are retaining the heat

treatment requirement in this final rule. However, as noted, under this

final rule we are reducing the amount of millfeed that would have to be

treated.

Several commenters recommended that APHIS review the millfeed

treatment requirements, and consider all options that reduce the risk

of further contamination, but that may be more easily incorporated in

existing milling processes. APHIS has reduced the millfeed treatment

requirement and has provided alternatives for disposition in States

willing to accept the responsibility for monitoring. We are continually

looking for other options that are effective and less intrusive, and

are willing to explore any ideas that may be more easily incorporated

into existing milling processes.

Additional Comments

One commenter requested that no areas in New Mexico be classified

as regulated areas. The commenter recommended that no quarantines be

placed on a field in that State unless preharvest sampling shows the

existence of Karnal bunt. We disagree with the commenter's

recommendation. We consider it necessary to continue to regulate these

fields and areas because of the potential movement of contaminated

equipment and seed prior to regulation, and the fact that many fields

that were planted to wheat in years prior have not yet been sampled.

However, under this final rule, all regulated areas in New Mexico will

at this time be classified as surveillance areas, rather than as

restricted areas.

Section 301.89-12(b) of our proposed rule provided that vegetable

crops be cleaned of all soil and plant debris prior to movement outside

the regulated area, or be moved under limited permit to processing

facilities approved by the Administrator. One commenter expressed

concern that this requirement might be applied to fields that have not

been contaminated with Karnal bunt. We believe that requiring that

vegetable crops moving outside the regulated area meet the conditions

for freedom from soil described above is necessary to protect other

wheat production areas.

Section 301.89-12(a) of the proposed rule sets forth cleaning and

disinfection requirements for used mechanized cultivating equipment,

used mechanized harvesting equipment, used farm tools, and used

mechanized soil-moving equipment. One commenter recommended that the

cleaning and disinfection requirements also apply to used seed

conditioning equipment. We agree and are making the appropriate

addition in this final rule.

A number of commenters submitted comments that expressed general

concerns about the economic impact of the Karnal bunt program, without

addressing specific issues. Others expressed general criticisms of the

way the Karnal bunt regulations were being carried out, expressed

concern regarding the effect of the Karnal bunt regulations on

international trade, or expressed an opinion regarding APHIS' role in

research regarding the disease. Although we are not specifically

addressing these comments in this final rule, we have reviewed each one

of them carefully, and share their concerns that the Karnal bunt

program must remain a risk-based program to prevent the artificial

spread of Karnal bunt.

Changes to Areas Regulated Because of Karnal Bunt

A number of commenters recommended that the areas quarantined

because of Karnal bunt be reduced as evidence indicates which areas do

not pose a risk of having the disease. We agree with the commenters.

When the initial quarantined areas were established, they were

deliberately broadly drawn due to the lack of data available at that

time as to the extent of the infestation. Based on sampling and testing

during the past months, we have been able to shrink the areas

designated

[[Page 52206]]

as quarantined areas. In this final rule, we are further reducing areas

regulated because of Karnal bunt.

We are amending Sec. 301.89-3(e) of the regulations by removing the

following portions of the States of Arizona, New Mexico and Texas from

the list of quarantined areas: The entire county of Mohave, AZ,

portions of Dona Ana and Sierra Counties, NM, and portions of El Paso

and Hudspeth Counties, TX. These areas do not produce wheat, durum

wheat, or triticale, or do produce wheat but we have been able to

determine that they have no association with Karnal bunt contaminated

seed, and, therefore, do not present a risk of being, or becoming,

infested with Karnal bunt. In addition, we are making editorial changes

to the description of the quarantined area in Luna County, NM, for

clarity and consistency. The remainder of the counties listed in

Sec. 301.89-3(e) will remain under regulation because of potential

infestation with Karnal bunt.

The area of Dona Ana County, NM, that will remain under regulation

is that portion of the county bounded as follows: Beginning at the

intersection of the Sierra/Dona Ana County line and Interstate 25; then

south along Interstate 25 to the Texas State line; then west and south

along the New Mexico/Texas State line to the United States/Mexico

boundary; then west along the United States/Mexico boundary to the

Luna/Dona Ana County line; then north and east along the Dona Ana

County line to the point of beginning.

The areas of Sierra County, NM, that will remain under regulation

are those portions of the county bounded as follows: (1) Beginning at

intersection of the Luna/Sierra County line and State Route 27; then

north along State Route 27 to State Route 152; then east along State

Route 152 to Interstate 25; then south along Interstate 25 to the Dona

Ana County line; then west and south to the Luna County line; then west

along the Luna/Sierra County line to the point of beginning; and (2)

Beginning at the intersection of the Socorro/Sierra County line and

State Route 142; then southeast along State Route 142 to State Route

52; then south along State Route 52 to Interstate 25; then north along

Interstate 25 to the Socorro/Sierra County line; then west along the

Socorro/Sierra County line to the point of beginning.

The area of El Paso County, TX, that will remain under regulation

is that portion of the county bounded as follows: Beginning at a point

on the Rio Grande River due east from the intersection of County Route

659 and County Route 375; then due east along an imaginary line to

County Route 659; then north along County Route 659 to Interstate 10;

then southeast along Interstate 10 to the El Paso/Hudspeth County line;

then southwest along the El Paso/Hudspeth County line to the Rio Grande

River; then north along the Rio Grande River to the point of beginning.

The area of Hudspeth County, TX, that will remain under regulation

is that portion of the county bounded as follows: Beginning at the

intersection of the El Paso/Hudspeth County line and Interstate 10;

then southeast along Interstate 10 to County Route 34; then south along

County Route 34 to County Route 192; then due south along an imaginary

line to the Rio Grande River; then northwest along the Rio Grande River

to the El Paso/Hudspeth County line; then north along the El Paso/

Hudspeth County line to the point of beginning.

This action relieves unnecessary regulatory restrictions on the

public while continuing to prevent the artificial spread of Karnal bunt

into noninfested areas of the United States. Additionally, in this

final rule as discussed above in this Supplementary Information, the

areas designated as regulated areas in Sec. 301.89-3 of this final rule

are divided into ``restricted areas'' and ``surveillance areas,'' as

set forth in Sec. 301.89-3.

Executive Order 12866 and Regulatory Flexibility Act

This rule has been reviewed under Executive Order 12866. This rule

has been determined to be economically significant for purposes of

Executive Order 12866 and, therefore, has been reviewed by the Office

of Management and Budget.

This action makes final with certain changes a series of interim

rules establishing and amending regulations regarding a program to

control and eradicate Karnal bunt in the United States, and a proposed

rule establishing criteria for levels of risk for areas with regard to

Karnal bunt, and criteria for seed planting and movement of regulated

articles based on those risk levels. It does not make final an interim

rule establishing compensation for certain growers and handlers, owners

of grain storage facilities, and flour millers in order to mitigate

losses and expenses incurred because of Karnal bunt. We are still

considering issues related to compensation. This rule is being

published on an emergency basis in order to give affected growers the

opportunity to make planting decisions for the 1996-97 crop season on a

timely basis. This emergency situation makes timely compliance with

section 6, subsections (3)(B)(ii) and (3)(C), of Executive Order 12866

impracticable. We will complete the required cost-benefit analysis as

soon as possible and make this information available to the public.

Further, this emergency situation makes compliance with section 603 and

timely compliance with section 604 of the Regulatory Flexibility Act (5

U.S.C. 603 and 604) impracticable. This rule may have a significant

economic impact on a substantial number of small entities. If we

determine this is so, then we will discuss the issues raised by section

604 of the Regulatory Flexibility Act in our Final Regulatory

Flexibility Analysis, which we will publish in a future Federal

Register.

Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L.

104-121, 5 U.S.C. Secs. 801-808)

This rule has been designated by the Administrator, Office of

Information and Regulatory Affairs, Office of Management and Budget, as

a major rule under the Small Business Regulatory Enforcement Fairness

Act of 1996 (Act). The Administrator of the Animal and Plant Health

Inspection Service has determined, however, that there is good cause

for making this rule effective less than 60 days after submission of

the rule to each House of Congress and to the Comptroller General

because a delay in the implementation of this rule would be contrary to

the public interest. It is necessary to make this rule effective 30

days after publication in the Federal Register in order that affected

growers and other regulated parties can make critical planning

decisions for the 1996-1997 crop year. Obviously, it is also essential

to remove, as soon as possible, many other restrictions affecting

growers and other regulated parties that are deemed unnecessary in this

final rule. Section 808 of the Act provides that rules which would be

exempted from the notice and comment provisions of the Administrative

Procedure Act may be excepted from section 801(a)(1)(A), and the delay

in the effective date for major rules under section 801(a)(3). Such

rules may be made effective as the agency promulgating the rule

determines.

A 60-day or longer delay of the effective date for this final rule

would clearly be contrary to the public interest, since it would result

in unnecessary burdens on affected growers and other regulated parties

who would otherwise be released from regulation or be subjected to

lesser regulatory requirements than under the current rules. This is a

critical time for growers in the regulated areas. These growers

[[Page 52207]]

must make their planting decisions promptly for the 1996-1997 crop

season.

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 rule has been reviewed under Executive Order 12988, Civil

Justice Reform. This rule: (1) Preempts all State and local laws and

regulations that are inconsistent with this rule will be preempted; (2)

has no retroactive effect; and (3) does not require administrative

proceedings before parties may file suit in court challenging this

rule.

National Environmental Policy Act

An environmental assessment and finding of no significant impact

have been prepared for this rule. The assessment provides a basis for

the conclusion that the anti-fungicide and other sanitization

treatments required under the Karnal bunt regulations do not present a

risk of introducing or disseminating plant pests and will not have a

significant impact on the quality of the human environment. Based on

the finding of no significant impact, the Administrator of the Animal

and Plant Health Inspection Service has determined that an

environmental impact statement need not be prepared.

The environmental assessment and finding of no significant impact

were prepared in accordance with: (1) The National Environmental Policy

Act of 1969 (NEPA) (42 U.S.C. 4321 et seq.), (2) Regulations of the

Council on Environmental Quality for implementing the procedural

provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations

implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing

Procedures (7 CFR part 372).

Copies of the environmental assessment and finding of no

significant impact are available for public inspection at USDA, room

1141, South Building, 14th Street and Independence Avenue SW.,

Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday,

except holidays. Persons wishing to inspect copies are requested to

call ahead on (202) 690-2817 to facilitate entry into the reading room.

In addition, copies may be obtained by writing to the individual listed

under FOR FURTHER INFORMATION CONTACT.

Paperwork Reduction Act

This rule contains no new information collection or recordkeeping

requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501

et seq.).

Unfunded Mandates Reform Act of 1995

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub.

L. 104-4, establishes requirements for Federal agencies to assess the

effects of their regulatory actions on State, local, and tribal

governments and the private sector. Under section 202 of the UMRA,

APHIS generally must prepare a written statement, including a cost-

benefit analysis, for proposed and final rules with ``Federal

mandates'' that may result in expenditures to State, local, or tribal

governments, in the aggregate, or to the private sector, of $100

million or more in any one year. When such a statement is needed for a

rule, section 205 of the UMRA generally requires APHIS to identify and

consider a reasonable number of regulatory alternatives and adopt the

least costly, more cost-effective or least burdensome alternative that

achieves the objectives of the rule.

This rule contains no Federal mandates (under the regulatory

provisions of Title II of the UMRA) that may result in expenditures to

State, local, and tribal government, in the aggregate, or to the

private sector, of $100 million or more in any one year. Thus, this

rule is not subject to the requirements of sections 202 and 205 of the

UMRA.

List of subjects in 7 CFR Part 301

Agricultural commodities, Plant diseases and pests, Quarantine,

Reporting and recordkeeping requirements, Transportation.

PART 301--DOMESTIC QUARANTINE NOTICES

Accordingly, 7 CFR part 301 is amended as follows:

1. The authority citation for part 301 continues to read as

follows:

Authority: 7 U.S.C. 150bb, 150dd, 150ee, 150ff, 161, 162, and

164-167; 7 CFR 2.22, 2.80, and 371.2(c).

2. In part 301, ``Subpart--Karnal Bunt,'' Secs. 301.89-1 through

301.89-12, is amended by revising the table of contents and

Secs. 301.89-1 through 301.89-11, by redesignating Sec. 301.89-12 as

Sec. 301.89-14, by and by adding new Secs. 301.89-13 and adding an

Appendix to read as follows:

Subpart--Karnal Bunt

Sec.

301.89-1 Definitions.

301.89-2 Regulated articles.

301.89-3 Regulated areas.

301.89-4 Planting.

301.89-5 Movement of regulated articles from regulated areas.

301.89-6 Issuance of a certificate or limited permit.

301.89-7 Compliance agreements.

301.89-8 Cancellation of a certificate, limited permit, or

compliance agreement.

301.89-9 Assembly and inspection of regulated articles.

301.89-10 Attachment and disposition of certificates and limited

permits.

301.89-11 Costs and charges.

301.89-12 Cleaning and disinfection.

301.89-13 Treatments.

301.89-14 Compensation.

Appendix to Subpart--Karnal Bunt

Sec. 301.89-1 Definitions.

Administrator. The Administrator, Animal and Plant Health

Inspection Service, or any person authorized to act for the

Administrator.

Animal and Plant Health Inspection Service (APHIS). The Animal and

Plant Health Inspection Service of the U.S. Department of Agriculture.

Certificate. A document in which an inspector or a person operating

under a compliance agreement affirms that a specified regulated article

meets the requirements of this subpart and may be moved to any

destination.

Compliance agreement. A written agreement between APHIS and a

person engaged in growing, handling, or moving regulated articles, in

which the person agrees to comply with the provisions of this subpart

and any conditions imposed under this subpart.

Contaminated seed. Seed from sources in which the Karnal bunt

pathogen (Tilletia indica (Mitra) Mundkur) has been determined to

exist.

Conveyances. Containers used to move wheat, durum wheat, or

triticale, or their products, including trucks, trailers, railroad

cars, bins, and hoppers.

Distinct definable area. A commercial wheat production area of

contiguous fields that is separated from other wheat production areas

by desert, mountains, or other nonagricultural terrain as determined by

an inspector, or, in the case of restricted areas, as determined by an

inspector based on survey results, including the number of positive

fields and the relative spore count of the fields within the area.

Farm tools. An instrument worked or used by hand, e.g., hoes,

rakes, shovels, and axes.

Infestation (infected). The presence of Karnal bunt, or any stage

of development of the fungus Tilletia

[[Page 52208]]

indica (Mitra) Mundkur, or the existence of circumstances that make it

reasonable to believe that Karnal bunt is present.

Inspector. An APHIS employee or designated cooperator/collaborator

authorized by the Administrator to enforce the provisions of this

subpart.

Karnal bunt. A plant disease caused by the fungus Tilletia indica

(Mitra) Mundkur.

Limited permit. A document in which an inspector affirms that a

specified regulated article not eligible for a certificate is eligible

for movement only to a specified destination and in accordance with

conditions specified on the permit.

Mechanized cultivating equipment and mechanized harvesting

equipment. Mechanized equipment used for soil tillage, including

tillage attachments for farm tractors--e.g., tractors, disks, plows,

harrows, planters, and subsoilers; mechanized equipment used for

harvesting purposes--e.g., combines, cotton harvesters, and hay balers.

Milling products and byproducts. Products and byproducts resulting

from processing wheat, durum wheat, or triticale, including animal

feed, waste and debris.

Movement (moved). The act of shipping, transporting, delivering, or

receiving for movement, or otherwise aiding, abetting, inducing or

causing to be moved.

Person. Any association, company, corporation, firm, individual,

joint stock company, partnership, society, or any other legal entity.

Premises. All structures, conveyances, or materials associated with

a grain storage facility at a single location.

Soil. The loose surface material of the earth in which plants grow,

in most cases consisting of disintegrated rock with an admixture of

organic material.

Soil-moving equipment. Equipment used for moving or transporting

soil, including, but not limited to, bulldozers, dump trucks, or road

scrapers.

State. The District of Columbia, Puerto Rico, the Northern Mariana

Islands, or any State, territory, or possession of the United States.

Sec. 301.89-2 Regulated articles.

The following are regulated articles:

(a) Conveyances, including trucks, railroad cars, and other

containers used to move wheat, durum wheat, or triticale;

(b) Grain elevators/equipment/structures used for storing and

handling wheat, durum wheat, and triticale;

(c) Milling products or byproducts, except flour;

(d) Plants, or plant parts, including grain, seed, or straw of all

varieties of the following species:

Wheat: Triticum aestivum;

Durum wheat: Triticum durum; and

Triticale: Triticum aestivum X Secale cereale;

(e) Tilletia indica (Mitra) Mundkur;

(f) Root crops with soil;

(g) Soil from areas where field crops are produced;

(h) Manure from animals that have fed on untreated or raw wheat,

durum wheat, or triticale;

(i) Used bags, sacks and containers;

(j) Used farm tools and equipment;

(k) Used mechanized cultivating equipment;

(l) Used mechanized harvesting equipment;

(m) Used seed conditioning equipment;

(n) Used mechanized soil-moving equipment; and

(o) Any other product, article or means of conveyance when:

(1) An inspector determines that it presents a risk of spreading

Karnal bunt due to its proximity to an infestation of Karnal bunt; and

(2) The person in possession of the product, article, or means of

conveyance has been notified that it is regulated under this subpart.

Sec. 301.89-3 Regulated areas.

(a) The Administrator will regulate each State or each portion of a

State that is infected.

(b) Less than an entire State will be listed as a regulated area

only if the Administrator:

(1)(i) Determines that the State has adopted and is enforcing

restrictions on the intrastate movement of the regulated articles

listed in Sec. 301.89-2 that are equivalent to the movement

restrictions imposed by this subpart; and

(ii) Determines that designating less than the entire State as a

regulated area will prevent the spread of Karnal bunt; or

(2) Exercises his or her extraordinary emergency authority under 7

U.S.C. 150dd.

(c) 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:

(1) Projections of the spread of Karnal bunt along the periphery of

the infestation;

(2) The availability of natural habitats and host materials within

the noninfected acreage that are suitable for establishment and

survival of Karnal bunt; and

(3) The necessity of including uninfected acreage within the

regulated area in order to establish readily identifiable boundaries.

(d) The Administrator or an inspector may temporarily designate any

nonregulated area as a regulated area in accordance with the criteria

specified in paragraphs (a), (b), and (c) of this section. The

Administrator will give written notice of this designation to the owner

or person in possession of the nonregulated area, or, in the case of

publicly owned land, to the person responsible for the management of

the nonregulated area. Thereafter, the movement of any regulated

article from an area temporarily designated as a regulated area is

subject to this subpart. As soon as practicable, this area either will

be added to the list of designated regulated areas in paragraph (e) of

this section, or the Administrator will terminate the designation. The

owner or person in possession of, or, in the case of publicly owned

land, the person responsible for the management of, an area for which

the designation is terminated will be given written notice of the

termination as soon as practicable.

(e) The Administrator will classify areas within the regulated

boundaries as either restricted areas or surveillance areas. Fields

within each restricted area and surveillance area will be classified

according to the following categories:

(1) Restricted areas: A restricted area is a distinct definable

commercial wheat production area that includes at least one field that

tested positive for Karnal bunt. Fields within a restricted area fall

into one of three categories:

(i) Fields in which preharvest samples tested positive for Karnal

bunt;

(ii) Fields known to be planted in the 1995 with seed contaminated

with Karnal bunt; or

(iii) All other fields within a distinct definable area with fields

in which preharvest samples tested positive.

(2) Surveillance areas: A surveillance area is a distinct definable

commercial wheat production area in which no fields have tested

positive for Karnal bunt, but in which movement of contaminated seed

has occurred. Fields within a surveillance area fall into one of three

categories:

(i) Fields known to be planted in 1995 with seed contaminated with

Karnal bunt; or

(ii) All other fields within a distinct definable area that

includes no fields in which preharvest samples tested positive.

(3) Fields in a regulated area for which the Administrator has

given no notification of classification to the

[[Page 52209]]

owner or the person in possession of the field shall be considered to

be fields as described in paragraph (e)(2)(ii) of this section.

(f) The following areas are designated as regulated areas, and

those areas are divided into restricted areas or surveillance areas as

indicated below:

Arizona

Cochise County. The entire county.

(1) Restricted areas. None.

(2) Surveillance areas. The entire regulated area.

Graham County. The entire county.

(1) Restricted areas. Beginning at the intersection of Highway

70 and Black Rock Road; then due east 5 miles along an imaginary

line to the northeast corner of Section 4 in T 5S R24E; then south 9

miles along an imaginary line to the southeast corner of Section 16

in T 6S R24E; then west 8 miles along an imaginary line to the

southwest corner of Section 17 in T 6S R23E; then north 9 miles

along an imaginary line to the northwest corner of Section 5 in T 5S

R23E; then east along an imaginary line to the point of beginning.

(2) Surveillance areas. All other areas within the regulated

area.

LaPaz County. The entire county.

(1) Restricted areas. Beginning at the intersection of Cibola

Road and Baseline Road; then south 2.5 miles on Cibola Road; then

west to Cibola Lake Road; then north along Cibola Lake Road to its

intersection with Cibola Road; then south on Cibola Road to the

point of beginning;

T 3N R11W; T 2N R11W, Sections 1-24;

T 7N R11W, Sections 1-3, Sections 10-15, Sections 22-27, and

Sections 34-36; T 7N R10W; and

The Colorado River Indian Reservation.

(2) Surveillance areas. All other areas within the regulated

area.

Maricopa County. The entire county.

(1) Restricted areas. Beginning at the intersection of the

northeast corner of T 4S R1E and the Maricopa/Pinal County line;

then west along an imaginary line to the northwest corner of T 4S

R3W; then due north along an imaginary line to the northeast corner

of Section 24 in T 2S R4W; then due west along an imaginary line to

the northwest corner of Section 19 in T 2S R5W; then due north along

an imaginary line to the northwest corner of Section 19 in T 4N R5W;

then due east along an imaginary line following Beardsley Road to

its intersection with 40th Street; then due south on 40th Street to

its intersection with Broadway Road; then 12 miles from this

intersection along an imaginary line to the intersection of the

northeast corner of section 25 in T 1S R1E and the Maricopa/Pinal

County line; then south along this county line to the point of

beginning;

T 7N R10W; T 7N R9W; T 8N R9W; T 7N R8W; T 6N R8W;

T 3N R10W; T 2N R10W, Sections 1-24;

T 5S R10W, Sections 25-36; T 6S R10W, Sections 1-18; and

Beginning at the intersection of Baseline Road and the Maricopa/

Pinal County line; then west along Baseline Road to its intersection

with Bush Road; then north along Bush Road to its intersection with

McDowell Road; then west along McDowell Road to its intersection

with Pima Road; then south along Pima Road to its intersection with

Price Road; then south along Price Road to its intersection with

Baseline Road; then west along Baseline Road to its intersection

with 40th Street; then south from this intersection along an

imaginary line to its intersection with the Maricopa/Pinal County

line; then south, west, and north along this county line to the

point of beginning.

(2) Surveillance areas. All other areas within the regulated

area.

Pima County. Beginning at the intersection of the Pima County

line, the Pinal County line, and the Papago Indian Reservation

boundary; then east along the Pima County line to its easternmost

point; then south along the Pima County line to the Cochise and

Santa Cruz County lines; then west along the Pima County line to the

United States/Mexico boundary; then west along the United States/

Mexico boundary to the Papago Indian Reservation boundary; then

north along the Papago Indian Reservation boundary to the point of

beginning.

(1) Restricted areas. None.

(2) Surveillance areas. All other areas in the regulated area.

Pinal County. The entire county.

(1) Restricted areas. T 4S R2E; T 4S R3E; T 4S R4E; T 5S R2E; T

5S R3E; T 5S R 4E; T 6S R2E; T 6S R3E; T 6S R 4E; T 4S R14E;

Beginning at the Toltec junction of the Southern Pacific

Railroad adjacent to Highway 84; then north along Signal Peak Road

to its intersection with Kleck Road; then west on Kleck Road, which

becomes Korsten Road; then west on Korsten Road to its intersection

with Treckell Road; then south on Treckell Road to its intersection

with Shedd Road; then east on Shedd Road to the point of beginning;

Beginning at the intersection of Shay Road and Fast Track Road;

then north 7 miles on Fast Track Road to its intersection with Arica

Road; then west on Arica Road to its intersection with Tweedy Road;

then south on Tweedy Road to its intersection with Shay Road; then

east on Shay Road to the point of beginning;

(2) Surveillance areas. All other areas within the regulated

area.

Yuma County. The entire county.

(1) Restricted areas. Beginning at the intersection of 14th

Street and Avenue 2E; then west on 14th Street to its intersection

with Somerton Avenue; then north on Somerton Avenue to the Arizona/

California State line; then east along the State line to a point

directly north of the intersection of Avenue 2E and County 8th

Street; then south from this intersection along an imaginary line to

the intersection of Avenue 2E and 8th Street; then south on Avenue

2E to the point of beginning;

Beginning at the intersection of I-8 and Foothill Boulevard;

then south on Foothill Boulevard to its intersection with 12th

Street; then west on 12th Street to its intersection with Araby

Road; then north 6 miles on Araby Road to the southern edge of

Section 16 of T 8S R 22W; then east to the California/Arizona State

line; then north along the State line to Laguna Dam; then east along

the southern shore of Mittry Lake and continue to the Yuma Proving

Grounds boundary line; then south and then east along this boundary

line to its intersection with Highway 95; then south along an

imaginary line to the point of beginning; and

Beginning on 5th Street at the Kofa junction of the Southern

Pacific Railroad; then northwest along 5th Street to the Yuma

Proving Grounds boundary line; then west along this boundary line to

the intersection of Highway 95; then south along the Gila Mountains

Range until it intersects the Barry Goldwater Air Force Range; then

east along the Barry Goldwater Air Force Range boundary to its

intersection with the southwest corner of Section 6 in T 8S R 13W;

then north from that point to the point of beginning.

(2) Surveillance areas. All other areas within the regulated

area.

California

Imperial County. The entire county.

(1) Restricted areas. That portion of Imperial County known as

the Bard-Winterhaven area bounded by a line drawn as follows:

Beginning at the intersection of the west boundary line of Range 22

East and the California-Arizona State line; then, north along this

boundary line to its intersection with the All American Canal; then

northeasterly along this canal to its intersection with the south

boundary line of Section 25, Township 15 South, Range 23 East; then

east along this line to its intersection with the California-Arizona

State line; the southerly and westerly along this State line to the

point of beginning; and

That portion of Imperial County known as the Palo Verde Valley

(in part) bounded by a line drawn as follows: Beginning at the

intersection of the Riverside-Imperial County line and the

California-Arizona State line; then, westerly and southerly along

this State line to its intersection with the north boundary line of

Township 10 South; then west along this boundary line to its

intersection with the west boundary line of Range 21 East; then

north along this boundary line to its intersection with the

Riverside-Imperial County line; then easterly along this County line

to the point of beginning.

(2) Surveillance areas. All other areas within the regulated

area.

Riverside County. That portion of Riverside County in the Blythe

and Ripley areas bounded by a line drawn as follows: Beginning at

the intersection of State Highway 62 and the Riverside-San

Bernardino County line, then east along the Riverside-San Bernardino

County line to its intersection with the California-Arizona State

line; then south along the California-Arizona State line to its

intersection with the Riverside-Imperial County line; then west

along the Riverside-Imperial County line to its intersection with

Graham Pass Road; then northeast along Graham Pass Road to its

intersection with Chuckwalla Valley Road; then west and northwest

along Chuckwalla Valley Road to its intersection with Interstate

Highway 10; then west along Interstate Highway 10 to its

intersection with State

[[Page 52210]]

Highway 177; then northeast and north along State Highway 177 to its

intersection with State Highway 62; then northeast along State

Highway 62 to the point of beginning.

(1) Restricted areas: That portion of Riverside County known as

the Palo Verde Valley (in part) bounded by a line drawn as follows:

Beginning at the intersection of the north boundary line of Township

2 South and the California-Arizona State line; then southerly and

southwesterly along this State line to its intersection with the

Riverside-Imperial County line; then westerly along this county line

to its intersection with the west boundary line of Range 21 East;

then north along this boundary line to its intersection with the

north boundary line of Township 2 South; then east along this

boundary line to the point of beginning.

(2) Surveillance areas: All other areas within the regulated

area.

New Mexico

Dona Ana County. Beginning at the intersection of the Sierra/

Dona Ana County line and Interstate 25; then south along Interstate

25 to the Texas State line; then west and south along the New

Mexico/Texas State line to the United States/Mexico boundary; then

west along the United States/Mexico boundary to the Luna/Dona Ana

County line; then north and east along the Dona Ana County line to

the point of beginning.

(1) Restricted areas: None.

(2) Surveillance areas: The entire regulated area.

Hidalgo County. Beginning at the intersection of the Arizona/New

Mexico State line and Interstate 10; then east along Interstate 10

to the Hidalgo/Grant County line; then south and east along the

Hidalgo County line to the Luna County line; then south along the

Hidalgo County line to its southernmost point; then west and north

along the Hidalgo county line to point of beginning.

(1) Restricted areas: None.

(2) Surveillance areas: The entire regulated area.

Luna County. Beginning at the intersection of the Grant/Luna

County line and Interstate 10; then east along Interstate 10 to U.S.

Highway 180; then north along U.S. Highway 180 to State Route 26;

then north along State Route 26 to State Route 27; then north along

State Route 27 to the Luna/Sierra County line; then east along the

Luna County line to the Dona Ana County line; then south along the

Luna County line to the United States/Mexico boundary; then west

along the United States/Mexico boundary to the Hidalgo County line;

then north along the Luna County line to the point of beginning.

(1) Restricted areas. None.

(2) Surveillance areas. The entire regulated area.

Sierra County. Beginning at intersection of the Luna/Sierra

County line and State Route 27; then north along State Route 27 to

State Route 152; then east along State Route 152 to Interstate 25;

then south along Interstate 25 to the Dona Ana County line; then

west and south to the Luna County line; then west along the Luna/

Sierra County line to the point of beginning; and

Beginning at the intersection of the Socorro/Sierra County line

and State Route 142; then southeast along State Route 142 to State

Route 52; then south along State Route 52 to Interstate 25; then

north along Interstate 25 to the Socorro/Sierra County line; then

west along the Socorro/Sierra County line to the point of beginning.

(1) Restricted areas. None.

(2) Surveillance areas. The entire regulated area.

Texas

El Paso County. Beginning at a point on the Rio Grande River due

east from the intersection of County Route 659 and County Route 375;

then due east along an imaginary line to County Route 659; then

north along County Route 659 to Interstate 10; then southeast along

Interstate 10 to the El Paso County line; then southwest along the

El Paso County line to the Rio Grande River; then north along the

Rio Grande River to the point of beginning.

(1) Restricted areas. None.

(2) Surveillance areas. The entire regulated area.

Hudspeth County. Beginning at the intersection of the El Paso/

Hudspeth County line and Interstate 10; then southeast along

Interstate 10 to County Route 34; then south along County Route 34

to County Route 192; then due south along an imaginary line to the

Rio Grande River; then northwest along the Rio Grande River to the

El Paso/Hudspeth County line; then north along the El Paso/Hudspeth

County line to the point of beginning.

(1) Restricted areas. None.

(2) Surveillance areas. The entire regulated area.

Sec. 301.89-4 Planting.

(a) Wheat, durum wheat, and triticale may be planted in all fields

within and outside a regulated area, except as follows:

(1) For the 1996-1997 crop season,\1\ wheat, durum wheat, and

triticale may not be planted in fields in which preharvest samples

conducted by Federal or State official tested positive for Karnal bunt;

---------------------------------------------------------------------------

\1\ The 1996-1997 crop season is that season in which wheat is

harvested in 1997.

---------------------------------------------------------------------------

(2) For the 1996-1997 crop season,\1\ wheat, durum wheat, and

triticale may not be planted in fields known to have been planted in

1995 with seed contaminated with Karnal bunt.

(b) Prior to planting, wheat seed, durum wheat seed, and triticale

seed to be planted within a regulated area must:

(1) First be sampled and test negative for Karnal bunt; then

(2) If originating within a regulated area, be treated with a

fungicide in accordance with Sec. 301.89-13.

Sec. 301.89-5 Movement of regulated articles from regulated areas.

(a) Any regulated article may be moved from a regulated area into

or through an area that is not regulated only if moved under the

following conditions:

(1) With a certificate or limited permit issued and attached in

accordance with Secs. 301.89-6 and 301.89-10;

(2) Without a certificate or limited permit, provided that each of

the following conditions is met:

(i) The regulated article was moved into the regulated area from an

area that is not regulated;

(ii) The point of origin is indicated on a waybill accompanying the

regulated article;

(iii) The regulated article is moved through the regulated area

without stopping, or has been stored, packed, or handled at locations

approved by an inspector as not posing a risk of contamination with

Karnal bunt, or has been treated in accordance with the methods and

procedures prescribed in Sec. 301.89-13 while in or moving through any

regulated area; and

(iv) The article has not been combined or commingled with other

articles so as to lose its individual identity;

(3) Without a certificate or limited permit, provided the regulated

article is a soil sample being moved to a laboratory approved by the

Administrator 2 to process, test, or analyze soil samples.

---------------------------------------------------------------------------

\2\ Criteria that laboratories must meet to become approved to

process, test, or analyze soil, and the list of currently approved

laboratories, may be obtained from the Animal and Plant Health

Inspection Service, Plant Protection and Quarantine, Domestic and

Emergency Operations, 4700 River Road Unit 134, Riverdale, Maryland

20737-1236.

---------------------------------------------------------------------------

(b) When an inspector has probable cause to believe a person or

means of conveyance is moving a regulated article, the inspector is

authorized to stop the person or means of conveyance to determine

whether a regulated article is present and to inspect the regulated

article. Articles found to be infected by an inspector, and articles

not in compliance with the regulations in this subpart, may be seized,

quarantined, treated, subjected to other remedial measures, destroyed,

or otherwise disposed of. Any treatments will be in accordance with the

methods and procedures prescribed in Sec. 301.89-13.

Sec. 301.89-6 Issuance of a certificate or limited permit.

(a) An inspector 3 or person operating under a compliance

agreement will

[[Page 52211]]

issue a certificate for the movement of a regulated article outside a

regulated area if he or she determines that the regulated article:

---------------------------------------------------------------------------

\3\ Inspectors are assigned to local offices of APHIS, which are

listed in local telephone directories. Information concerning such

local offices may also be obtained from the Animal and Plant Health

Inspection Service, Plant Protection and Quarantine, Domestic and

Emergency Operations, 4700 River Road Unit 134, Riverdale, Maryland

20737-1236, or from Karnal Bunt Project, 3658 E. Chipman Rd.

Phoenix, Arizona 85040.

---------------------------------------------------------------------------

(1) Is eligible for unrestricted movement under all other

applicable Federal domestic plant quarantines and regulations;

(2) Is to be moved in compliance with any emergency conditions the

Administrator may impose under 7 U.S.C. 150dd to prevent the artificial

spread of Karnal bunt;4 and

---------------------------------------------------------------------------

\4\ Section 105 of the Federal Plant Pest Act (7 U.S.C. 105dd)

authorizes the Secretary of Agriculture to impose emergency measures

necessary to prevent the spread of plant pests new to, or not widely

prevalent or distributed within and throughout, the United States.

---------------------------------------------------------------------------

(3)(i) Is free of Karnal bunt infestation, based on laboratory

results of testing, and history of previous infestation;

(ii) Has been grown, produced, manufactured, stored, or handled in

a manner that would prevent infestation or destroy all life stages of

Karnal bunt; or

(iii) Has been treated in accordance with methods and procedures

prescribed in Sec. 301.89-13.

(b) To be eligible for movement under a certificate, grain from a

surveillance area must test negative for Karnal bunt twice, and one of

these tests must occur at the means of conveyance or storage facility

immediately prior to movement.

(c) An inspector or a person operating under a compliance agreement

will issue a limited permit for the movement within or outside the

regulated area of a regulated article not eligible for a certificate if

the inspector deter

This text is long and has been trimmed here. Open the source document for the complete record.