# Karnal Bunt

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URL: https://www.frixlaw.com/law-library/documents/fr%3A96-25549

## Record

- **Collection:** Federal Register
- **Document type:** Rule
- **Published:** October 4, 1996
- **Citation:** 61 FR 52190

## Text

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

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A96-25549. Public record. Not legal advice.