[Federal Register Volume 61, Number 194 (Friday, October 4, 1996)]
[Rules and Regulations]
[Pages 52190-52213]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25549]



[[Page 52189]]


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Part V





Department of Agriculture





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Animal and Plant Health Inspection Service



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7 CFR Part 301



Karnal Bunt Disease; Domestic Plant-related Quarantine; Final Rule

  Federal Register / Vol. 61, No. 194 / Friday, October 4, 1996 / Rules 
and Regulations  

[[Page 52190]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 301

[Docket No. 96-016-14]


Karnal Bunt

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are establishing criteria for levels of risk for areas with 
regard to Karnal bunt and for the movement of regulated articles based 
on those risk levels, and are establishing criteria for the planting of 
seed from Karnal bunt host crops. These actions are warranted because 
they relieve unnecessary restrictions on areas regulated because of 
Karnal bunt, while guarding against the artificial spread of that 
disease. We are also making final, with some changes, the Karnal Bunt 
regulations established in a series of interim rules, and are removing 
some areas from the list of areas regulated because of Karnal bunt.

EFFECTIVE DATE: November 4, 1996.

FOR FURTHER INFORMATION CONTACT:
Mr. Mike Stefan, Operations Officer, Domestic and Emergency Operations, 
PPQ, APHIS, 4700 River Road Unit 134, Riverdale, MD 20737-1236, (301) 
734-8247.

SUPPLEMENTARY INFORMATION:

Background

    Karnal bunt is a fungal disease of wheat (Triticum aestivum), durum 
wheat (Triticum durum), and triticale (Triticum aestivum X Secale 
cereale), a hybrid of wheat and rye. The establishment of Karnal bunt 
in the United States would have significant consequences with regard to 
the export of wheat to international markets. Karnal bunt is caused by 
the smut fungus Tilletia indica (Mitra) Mundkur and is spread by 
spores. The regulations regarding Karnal bunt are set forth in 7 CFR 
301.89-1 through 301.89-14.
    On March 8, 1996, Karnal bunt was detected in Arizona during a seed 
certification inspection done by the Arizona Department of Agriculture. 
On March 20, 1996, the Secretary of Agriculture signed a ``Declaration 
of Extraordinary Emergency'' authorizing the Secretary to take 
emergency action under 7 U.S.C. 150dd with regard to Karnal bunt within 
the States of Arizona, New Mexico, and Texas. In an interim rule 
effective on March 25, 1996, and published in the Federal Register on 
March 28, 1996 (61 FR 13649-13655, Docket No. 96-016-3), the Animal and 
Plant Health Inspection Service (APHIS) established the Karnal bunt 
regulations (7 CFR 301.89-1 through 301.89-11), and quarantined all of 
Arizona and portions of New Mexico and Texas because of Karnal bunt. 
The regulations define regulated articles and restrict the movement of 
these regulated articles from the quarantined areas.
    After the establishment of the regulations, Karnal bunt was 
detected in seed lots that were either planted or stored in California. 
On April 12, 1996, the Secretary of Agriculture signed a ``Declaration 
of Extraordinary Emergency'' authorizing the Secretary to take 
emergency action under 7 U.S.C. 150dd with regard to Karnal bunt within 
California. In an interim rule effective on April 19, 1996, and 
published in the Federal Register on April 25, 1996, APHIS also 
quarantined portions of California because of Karnal bunt (61 FR 18233-
18235, Docket No. 96-016-5). In an interim rule effective on June 27, 
1996, and published in the Federal Register on July 5, 1996, we removed 
certain areas in Arizona, New Mexico, and Texas from the list of areas 
quarantined because of Karnal bunt (61 FR 35107-35109, Docket No. 96-
016-6). That list was amended in a technical amendment effective on 
July 9, 1996, and published in the Federal Register on July 15, 1996 
(61 FR 36812-36813, Docket No. 96-016-8). In an interim rule effective 
June 27, 1996, and published in the Federal Register on July 5, 1996, 
we amended the regulations to provide compensation for certain growers 
and handlers, owners of grain storage facilities, and flour millers in 
order to mitigate losses and expenses incurred because of actions taken 
by the Secretary to prevent the spread of Karnal bunt (61 FR 35102-
35107, Docket No. 96-016-7).
    In a proposed rule published in the Federal Register on August 2, 
1996 (61 FR 40354-40361, Docket No. 96-016-10), we proposed to 
establish criteria for levels of risk for areas with regard to Karnal 
bunt and the movement of regulated articles based on those risk levels, 
and to establish criteria for seed planting.
    Comments from the public regarding the interim rules and the 
proposed rule were required to be received by APHIS by September 3, 
1996. During the comment period, public forums were conducted in 
Washington, D.C.; Kansas City, MO; Phoenix, AZ; Imperial, CA; and Las 
Cruces, NM, to accept public comment on the regulations.
    We received a total of 178 comments on the interim rules and the 
proposed rule by September 3, 1996. The commenters included members of 
Congress, State departments of agriculture, agricultural associations 
and councils, local governments, the wheat industry, academia, and 
other members of the public. The information we received from 
commenters was a valuable resource in formulating this final rule. We 
consider refinement and improvement of the Karnal bunt program an 
ongoing process, and welcome data that will enable us to protect wheat-
growing areas of the United States, while causing the least possible 
disruption to affected areas.
    We discuss below each of the issues raised by the commenters. We 
first discuss those comments addressing the Karnal bunt regulations 
that were established by the series of interim rules. These regulations 
were established on an emergency basis and are currently in effect. We 
then discuss those comments that address our August 2, 1996, proposal 
to amend the Karnal bunt regulations. Based on the comments received, 
we have made a number of changes to the existing Karnal bunt 
regulations, as well as to the regulatory revisions we proposed. In 
most cases, changes that were prompted by a specific comment 
recommendation are identified with our discussion of that comment. 
Additionally, as part of our discussion of our proposed rule in this 
document, we set forth a summary of the broad changes we are making to 
the way we will classify regulated areas, and the practical 
implications of falling into a particular classification category.
    It is important to note that this final rule does not change or 
make final the interim rule made effective June 27, 1996, and published 
in the Federal Register on July 5, 1996, in which we amended the 
regulations to provide compensation for certain growers and handlers, 
owners of grain storage facilities, and flour millers in order to 
mitigate losses and expenses incurred because of Karnal bunt. We are 
still considering issues related to compensation.

Comments Addressing the Interim Rules

    Several commenters supported the provisions of the interim rules. A 
number of these, however, recommended certain additions to the 
regulations. Each of these recommendations is discussed below.

Control and Eradication of Karnal Bunt

    A number of commenters stated that, although it is possible to 
control the spread of Karnal bunt, it is impossible to eradicate it 
from the United States,

[[Page 52191]]

that no bunt or smut disease of grain crops has been eradicated, that 
Karnal bunt has likely existed in the United States for a number of 
years now, and that a program of management should be substituted for 
the current eradication program. Several commenters stated that 
focusing on the artificial spread of Karnal bunt ignores the natural 
spread of the disease, particularly from Mexico into the United States.
    As a regulatory agency, we consider eradication a reasonable first 
objective in dealing with a new quarantine pest. This position has been 
supported by various industry groups, State departments of agriculture, 
and officials involved in international trade. The Karnal bunt 
regulations are intended to prevent the artificial spread of the 
disease by minimizing the risk of spread of the causal agent to other 
wheat production areas.

Tolerance Levels for Karnal Bunt

    A number of commenters stated that the tolerance level for spores 
in grain should be a biological zero, not an absolute zero, and that 
scientists need to determine the number of spores and the conditions 
necessary to perpetuate the disease. Several commenters stated that the 
emphasis of the quarantine should be on the risk of spreading Karnal 
bunt and not on control of the spore, that non-bunted wheat should be 
certified ``free from'' Karnal bunt if no bunted kernels or only low 
levels of spores are present, and that ``free from'' status should be 
accorded to areas where no evidence exists that fields are likely to 
manifest the disease. One commenter recommended that all fields in 
which bunted kernels are not found should be released from quarantine. 
Another commenter stated that infestation should be defined in 
Sec. 301.89-1 as the presence of bunted kernels caused by Karnal bunt, 
and not include any stage of development of the fungus Tilletia indica 
(Mitra) Mundkur. One commenter stated that APHIS should remove the 
Karnal bunt quarantine, establish a commercial tolerance for Karnal 
bunt, and allow the market to provide incentive to the industry to 
minimize disease spread through price adjustments. Another commenter 
stated that APHIS should assume that any test that discovers fewer than 
ten spores is a coincidental contamination.
    We are making no changes based on these comments. APHIS does not 
use a zero tolerance approach to survey and railcar testing. Our test 
procedures, which were developed in concert with State and industry 
representatives, provide a reasonable assurance that detecting a spore 
count of 1 or more in a 50-gram sample will identify levels of Karnal 
bunt that present a risk of spreading the disease. Because it is the 
objective of the regulatory measures to prevent the further spread of 
the pathogen, it is APHIS' policy to accept the limited risk posed by 
spore counts that might be lower than this level. Although tolerance 
levels have been established as a quality factor for various fungal 
toxins that are widespread in the United States, these toxins are of 
concern only when they reach levels at which they might adversely 
affect the health of humans or animals. Therefore, their presence below 
a certain level, while detectable, is not of concern. This is not the 
case for Karnal bunt, where detectable levels present a risk of 
spreading the disease.

Characterization of Karnal Bunt

    A number of commenters disagreed with our description of Karnal 
bunt as a ``serious fungal disease.'' One commenter stated that Karnal 
bunt, at its previous worst known rates of infection of grain in the 
world, is not strong enough to do any damage to the resultant flour 
taste, smell, or color. A number of commenters stated that several 
other grain-related diseases have a greater economic impact than Karnal 
bunt, and that these diseases are allowed tolerances and are handled by 
grading techniques within the grain industry. The commenters 
recommended that such an approach be allowed for Karnal bunt. One 
commenter stated that the Biological Assessment group in APHIS, Plant 
Protection and Quarantine, has concluded that Tilletia indica 
represents a high ``Pest Risk Potential'' in the United States, as 
estimated by internationally recognized pest risk analysis procedures. 
The commenter stated that other evaluators, using the same standard as 
that used by APHIS, have judged the pest risk potential of Tilletia 
indica to be low. According to international guidelines, Pest Risk 
Assessment consists of evaluating the likelihood of a pest's 
introduction and the consequences of such an introduction. We rate the 
consequences by calculating the Pest Risk Potential according to five 
elements that rate a pest's climatic range, host range, dispersal 
potential, and economic and environmental impacts. As part of a 1995 
Karnal bunt Pest Risk Assessment, APHIS concluded that, for the United 
States, the Pest Risk Potential of the Karnal bunt fungus was high. 
This rating was objectively based on the determinations that: (1) The 
Karnal bunt fungus is able to survive in four or more hardiness zones; 
(2) the Karnal bunt fungus attacks multiple species within a single 
plant family; (3) the Karnal bunt fungus produces many spores that may 
be distributed over long distances; (4) the Karnal bunt fungus has the 
potential to cause yield loss, lower commodity values and result in 
loss of markets; and (5) the presence of the fungus might trigger 
control programs with environmental impacts.
    We acknowledge that the use of the word ``serious'' in describing 
Karnal bunt can be open to several interpretations. We believe that the 
greatest impact of the establishment of Karnal bunt is on the export of 
U.S. wheat to foreign markets, a $5 billion industry annually. Karnal 
bunt is a pest of quarantine significance throughout the world and 
jeopardizes the continued trade of U.S. wheat. However, because we 
agree that our use of the word ``serious'' has caused some confusion, 
we do not refer to Karnal bunt as a serious disease in this final rule.
    One commenter questioned why the description of Karnal bunt in the 
definitions in Sec. 301.89-1 did not describe the disease as one 
``which is new to or not widely prevalent or distributed within and 
throughout the United States.'' The commenter said such a description 
of Karnal bunt appears in the definition of Karnal bunt in Sec. 319.59, 
as established on October 13, 1983. The commenter stated that the 
modifying phrase implies that the Department acknowledged that Karnal 
bunt existed in the United States as early as 1983. We do not agree 
with the commenter's conclusion. It is true that Karnal bunt is 
described in Sec. 319.59-1 as a disease that is ``new to or not widely 
prevalent or distributed in and throughout the United States.'' 
However, that reference to Karnal bunt is included in the ``Foreign 
Quarantine Notice'' section of title 7 of the Code of Federal 
Regulations. The wording there is consistent with the statutory 
language in the United States Code (7 U.S.C. 160) which states that 
``in order to prevent the introduction into the United States of any 
tree, plant, or fruit disease or of any injurious insect, new to or not 
theretofore widely distributed throughout the United States,'' the 
Secretary of Agriculture may establish importation regulations to 
prevent such introduction. The modifying phrase ``new to and not 
heretofore widely prevalent or distributed within and throughout the 
United States'' is used in other importation regulations in 7 CFR part 
319, and it does not imply that the disease in question already exists 
in the United States.

[[Page 52192]]

Regulated Articles

    Several commenters recommended that the list of regulated articles 
in Sec. 301.89-2 be expanded. The items recommended for inclusion, the 
commenters' rationale for the additions, and our responses are as 
follows:
    Rye: One commenter stated that the 1991 APHIS Pest Risk Analysis on 
Karnal bunt includes rye (Secale cereale) as a host of the disease. We 
are making no changes based on this comment. The 1991 Pest Risk 
Analysis included rye and several species of grasses that are reported 
to demonstrate a degree of susceptibility to infection when inoculated 
(or forced) in the laboratory. Karnal bunt has not been reported on 
these species under natural conditions.
    Seeds and grain of crops other than wheat, durum wheat, and 
triticale that pass through contaminated facilities or that move out of 
a regulated area: One commenter stated that seed crops are of 
particular concern because they may be planted in fields that are 
subsequently planted with a host crop. Several other commenters stated 
that stringent restrictions should be placed on the movement of all 
seed out of quarantined areas. We are making no changes based on these 
comments. We consider the possible contamination of seed other than 
wheat, durum wheat, and triticale to pose a negligible risk. The amount 
of inoculum on non-host seed and the opportunity to infest a host would 
be small. For non-host seed moving out of a regulated area, the 
inoculum moving with the seed would originate from a field where a non-
host crop was planted and that was destined to be planted with a non-
host crop.
    Seed crops other than host crops harvested from fields infested 
with teliospores: One commenter stated that seed crops, especially 
those seed crops where soil contaminates the harvested seed, could 
become contaminated with teliospores. The commenter additionally stated 
that crops such as dry edible beans and soybeans are particularly prone 
to soil contact and contamination. We are making no changes based on 
this comment, for the same reasons cited immediately above.
    Seed crops other than host crops planted near an infected crop: One 
commenter recommended that a buffer be required to minimize the risk of 
contamination from airborne teliospores, especially if any infested 
fields will be harvested, which creates dusty conditions. Again, we 
consider the risk of the movement of the Karnal bunt causal agent with 
seed other than wheat, durum wheat, and triticale to be negligible.
    Apiary equipment placed in fields contaminated with teliospores: 
Several commenters stated that such equipment can carry contaminated 
soil, and that, additionally, there may be a risk of the bees' 
disseminating teliospores. We are making no changes based on this 
comment. We not do not consider the movement of apiaries to present a 
significant risk of spreading Karnal bunt. Hives are usually not set in 
the fields.
    Animals fed crops susceptible to Karnal bunt: Several commenters 
noted that animals that have fed on susceptible crops may not have 
passed all of the feed through their systems when moved, or may 
transport soil from infected areas. We are making no changes based on 
this comment. We consider the risk of possible contamination due to 
animal movement to be negligible. The amount of inoculum moving with 
the animal would be small, and would have little opportunity to infect 
a suitable host. In most cases, the animals would be moved to a 
stockyard, and it is not likely that the manure from the animals at the 
stockyard would be collected and distributed on a field to be planted 
with wheat. However, soil from areas where field crops are produced and 
manure from animals that have fed on untreated or raw wheat, durum 
wheat, and triticale are regulated articles.
    Nursery stock accompanied by soil from contaminated fields: One 
commenter stated that nursery stock accompanied by soil from 
contaminated fields should be regulated. We do not consider it 
necessary to make any changes based on this comment. Soil from areas 
where field crops are produced is already regulated and, under the 
Karnal bunt program, is not allowed to be moved.
    Any machinery, farm equipment, or means of conveyance that could 
move soil from areas where field crops are produced: One commenter 
cited spray and fertilizer equipment used in contaminated fields as 
potentially contaminated equipment. In establishing the list of 
regulated articles, it was our intent that any farm equipment that 
could move soil within or from the regulated area should be regulated. 
We are therefore revising the list of regulated articles at 
Sec. 301.89-2(j) of the regulations to refer to used farm tools and 
equipment.
    One commenter stated that the listing in Sec. 301.89-2 of ``soil 
from areas where field crops are produced'' as a regulated article 
should be interpreted strictly to include soil that adheres to 
propagative plant parts, including seeds. We agree with the commenter, 
and consider the regulations as written adequate to effect such 
enforcement.
    One commenter stated that ``soil'' should not be interpreted to 
include such materials as dust or road film. We believe the definition 
of soil as set forth in Sec. 301.89-1 of this final rule addresses the 
commenter's concerns and clarifies our intent. Soil is defined in the 
final rule as ``the loose surface material of the earth in which plants 
grow, in most cases consisting of disintegrated rock with an admixture 
of organic material.'' Under this definition, we do not consider dust 
or road film to be ``soil.''
    One commenter recommended that the list of regulated articles in 
Sec. 301.89-2 be modified as follows: The current listing of ``manure 
from animals that have fed on wheat, durum wheat, or triticale'' should 
be changed to ``manure from animals which have been fed untreated or 
raw wheat, durum wheat, triticale, or byproducts thereof which have 
tested positive for Karnal bunt;'' ``soil from areas where field crops 
are produced'' should be changed to ``soil from crop production fields 
proven to contain Karnal bunt;'' and ``any other product, article, or 
means of conveyance when an inspector determines that it presents a 
risk of spreading Karnal bunt due to its proximity to an infestation of 
Karnal bunt * * *.'' should be changed to ``any contaminated product, 
article, or means of conveyance when an inspector determines that 
Karnal bunt contamination exists and the conveyance presents a risk of 
spreading Karnal bunt* * *.'' We are making no changes based on this 
comment. We consider a risk to exist in the movement of each of the 
categories of the regulated articles the commenter suggested relaxing, 
and that appropriate safeguards are needed based on the level of risk. 
We do recognize that there is little risk from ``manure from animals 
that have been fed treated millfeed,'' and are adding this exemption to 
the regulations.
    The list of regulated articles in Sec. 301.89-2 includes soil from 
areas where field crops are produced. One commenter stated that this 
listing would unfairly apply to soil from areas where suspect wheat 
seed was planted, but then was destroyed and not grown to harvest. The 
commenter stated that the risk from such soil is very significantly 
less than for soil where the wheat crop was allowed to mature. In this 
final rule, we continue to consider as a regulated article the soil 
described by the commenter. We consider it necessary to regulate any 
article that presents a risk of spreading the causal agent of Karnal

[[Page 52193]]

bunt. However, we base the extent of regulation on the level of risk. 
This rule categorizes areas based on risk and imposes appropriate 
regulatory actions for each. These risk categories are discussed in 
this SUPPLEMENTARY INFORMATION under the heading ``Regulated Areas.''
    One commenter stated that quarantines imposed because of Karnal 
bunt should affect no crops other than wheat. In conducting the Karnal 
bunt program, we have focused our regulatory efforts on wheat 
production activities. However, in some cases, as with the movement of 
root crops with soil, we consider there to be sufficient risk to 
warrant regulatory activity.
    One commenter stated a connection should be made in the regulations 
between all regulated articles and Karnal bunt host crops. We do not 
agree that the rationale for regulating an article should rest solely 
on whether it had direct contact with Karnal bunt host crops. A number 
of the articles we are regulating pose a risk of spreading Karnal bunt 
because of the danger that soil on the article from the regulated area 
might transmit the Karnal bunt causal agent.
    One commenter recommended, without explanation, that several 
articles be removed from our list of regulated articles. We are not 
certain of the commenter's rationale for recommending the removal of 
the articles in question, and continue to consider it necessary to 
regulate those articles listed in Sec. 301.89-2.

Actions of Individual States

    One commenter stated that the regulations should specifically 
provide that infested articles moving under limited permit may do so 
only after concurrence by the destination State and other States 
through which the regulated article would traverse. We are making no 
changes based on this comment. As part of the Karnal bunt program, we 
are not allowing grain that tests positive for Karnal bunt to move out 
of the quarantined area. Other contaminated articles must be cleaned 
and sanitized before such movement. We are notifying destination States 
of grain that has tested negative and is moving under limited permit to 
approved mills. We do not believe there is sufficient risk involved 
with the controlled movement of these articles to warrant additional 
restrictions on their movement.
    Several commenters recommended that the Department prohibit 
individual States from imposing restrictions on Arizona agricultural 
products that, in effect, preempt APHIS standards. State regulations 
cannot preempt APHIS' regulations. While, as a practical matter, the 
Department cannot prohibit States from imposing restrictions on 
agricultural products, affected persons could assert Federal preemption 
as a legal basis for seeking relief from any State regulation that is 
inconsistent with APHIS' regulations.

Restrictions on Movement

    One commenter stated that the provisions in Sec. 301.89-5 regarding 
the issuance of a certificate or limited permit should specifically 
state that any Karnal bunt potential host crop grown on land with a 
history of infestation with Karnal bunt teliospores is not eligible for 
certification. We are making no changes based on this comment. In 
Sec. 301.89-4 of this final rule, we prohibit the planting of host 
crops in fields that tested positive and in fields planted in 1995 with 
seed known to be contaminated with Karnal bunt.
    Several commenters recommended that no commercial seed be allowed 
to leave a quarantined area under any conditions. We are making no 
changes based on this comment. The regulations already prohibit the 
movement of commercial wheat, durum wheat, and triticale seed from the 
quarantined area. We consider risk from the possible contamination of 
seed other than from host crops to be negligible. With regard to 
commercial seed, the regulations in Sec. 301.89-6 of this final rule 
set forth the criteria under which a regulated article may move from a 
regulated area, accompanied either by a certificate or a limited 
permit. Commercial seed does not meet the criteria for movement outside 
the regulated area either with a certificate or a limited permit, in 
that the commercial seed would, among other things, need to: (1) Be 
tested free of Karnal bunt; (2) have been grown, produced, 
manufactured, stored, or handled in a manner that would prevent 
infestation or destroy all live stages of Karnal bunt; or (3) have been 
treated in accordance with approved methods. Current testing and 
treatment procedures do not exist for large quantities of commercial 
seed intended for planting outside the regulated area that would ensure 
such seed could be certified free of Karnal bunt. To be eligible for a 
limited permit, the risk of the seed spreading Karnal bunt would have 
to be eliminated by the destruction of the pathogen of Karnal bunt, or 
be mitigated by specified handling, utilization, or processing. 
Commercial seed to be used for planting would not meet these criteria.
    One commenter recommended that the regulations require that any 
wheat that is to be used for seed be harvested with a fumigated combine 
and be transported in vehicles that have been fumigated, and that the 
grain be thoroughly tested for spores prior to being certified for 
planting. We are making no changes based on this comment. We have 
developed sanitization and testing protocols for seed moving within the 
area. Additionally, this final rule requires that all wheat seed to be 
planted within the regulated area be sampled and tested for Karnal 
bunt, and, for seed originating in a regulated area, treated prior to 
planting.
    A number of commenters opposed what they called a ``strict'' 
quarantine regarding Karnal bunt in the southwest United States due to 
its potential impact on the movement of germplasm, winter nurseries, 
and ``off-season'' increases for spring and winter cereals used in many 
northern States. We understand the importance of the southwest United 
States in wheat breeder research. However, we consider the movement of 
seed for planting a high risk activity and currently do not allow its 
movement outside the regulated area, except for limited quantities of 
research seed. We are allowing germplasm and research seed to move 
under conditions involving testing, treatment (described below), and 
subsequent monitoring. We will continue to work with researchers and 
industry to develop protocols and treatments that will allow movement 
of seed to resume.
    In this final rule, we are setting forth an approved treatment for 
seed used as germplasm or for research purposes. To be eligible for 
movement, the seed must be treated with a 1.5 percent aqueous solution 
of sodium hypochlorite (=30 percent household bleach) containing 2 ml. 
of Tween 20TM per liter agitated for 10 minutes at room 
temperature followed by a 15-minute rinse with clean, running water and 
then by drying, and either: (1) With 6.8 fl. oz. of Carboxin thiram (10 
percent+10 percent, 0.91+0.91 lb. ai./gal.) flowable liquid and 3 fluid 
ounces of pentachloronitrobenzene (2.23 lb. ai./gal.) per 100 pounds of 
seed; or (2) with 4.0 fluid ounces of Carboxin thiram (1.67 + 1.67 lb. 
ai./gal.) flowable liquid and 3 fluid ounces of pentachloronitrobenzene 
(2.23 lb. ai./gal.) per 100 pounds of seed.
    Several commenters urged the Department to develop specific 
protocols to outline procedures for shipment of seed within and outside 
of quarantined areas, seed treatment requirements, certification 
requirements, and the movement of germ plasm. One commenter stated that

[[Page 52194]]

this protocol should address germ plasm, foundation, registered, 
certified, and uncertified seed. We have developed protocols for 
testing, treatment, and movement of commercial seed within the 
regulated area and limited quantities of research seed out of the 
regulated area. (For more information regarding these protocols, please 
contact the individual listed in this final rule under FOR FURTHER 
INFORMATION CONTACT.) Currently, however, movement of commercial seed 
to destinations outside the regulated area is considered a high risk 
and adequate treatment and safeguard conditions have not been 
developed.
    One commenter recommended that the regulations allow seed infected 
with Karnal bunt that is not to be used for propagation to be used for 
feed, milling, or other non-propagative purposes. We agree with the 
commenter that the seed described can be safely used under certain 
conditions. We are continuing to cooperate with the industry, States, 
and export partners to develop additional options for grain testing 
positive.
    One commenter stated that because movement of grain to mills and/or 
export destinations is always to expedite the end use of the grain, 
such transport of byproducts and grain with low spore numbers should 
not be an issue. Another commenter stated that as long as wheat and 
wheat byproducts infected with Karnal bunt are segregated from other 
wheat, and the identity of the wheat and wheat byproducts is preserved 
through the marketing chain, such wheat and byproducts should be 
allowed to move to end users willing to comply with specified sanitary 
precautions. During the 1996 harvest, we were able to provide a means 
to move wheat from regulated areas with appropriate safeguards and to 
minimize the risk to other wheat producing areas. Based on survey 
information from the 1996 harvest, we are removing requirements for the 
treatment of millfeed and the sanitization of equipment for some parts 
of the regulated areas.
    One commenter stated that APHIS should in some way encourage grain 
ports to handle wheat grown in quarantined areas. Another commenter 
requested that a procedure be developed to allow wheat from Arizona to 
move to international ports. Currently, APHIS, the State of Texas, and 
the wheat industry are cooperating to move grain from quarantined areas 
to ports for export.

Treatments

    Several commenters said that no treatment for Karnal bunt should be 
listed in the regulations until efficacy data has been compiled on 
``real-life'' applications. One commenter expressed concern that the 
regulations include a treatment for millfeed when, according to the 
commenter, efficacy data for heat treatment for millfeed does not 
exist. We agree with the commenters that approval of treatments should 
be based on empirical data. The treatment options set forth in our 
regulations are based on the latest scientific literature and efficacy 
data available.
    One commenter recommended that the sodium hypochlorite treatment 
provided for in the regulations specify that the treatment solution 
must remain in contact for 15 minutes with the surface to be 
decontaminated. We are making no changes based on this comment. The 
treatment set forth in the regulations requires that the equipment or 
site not be washed down until 15 minutes have passed.
    Several commenters stated that treatment of equipment with sodium 
hypochlorite should not be included as an approved treatment, due to 
the likelihood of corrosion of the equipment being disinfected. Because 
this treatment may be corrosive to the equipment being disinfected, we 
advise in the treatment instructions to wash the equipment thoroughly 
after application in order to minimize corrosion. We are testing 
alternative, less potentially corrosive, treatments for their 
effectiveness on the pathogen. However, we have not found any less 
corrosive, effective treatment to date.
    The regulations regarding the treatment with sodium hypochlorite 
call for ``a solution of sodium hypochlorite mixed with water applied 
at the rate of 1 gallon of commercial chlorine bleach (5.2 percent 
sodium hypochlorite) mixed with 2.5 gallons of water.'' One commenter 
stated that it is possible that not all commercial chlorine bleaches 
are 5.2 percent sodium hypochlorite and that, therefore, only the final 
necessary treatment solution strength should be set forth. We agree 
with the commenter that it is the final percentage of sodium 
hypochlorite, after being mixed with water, that is important. We are 
therefore specifying in this final rule that the treatment in question 
requires wetting all surfaces to the point of runoff with a solution of 
1.5 percent sodium hypochlorite. Because we believe that most users 
will disinfect with household bleach with 5.2 percent sodium 
hypochlorite, we are retaining in the treatment description, as an 
example, the suggested mix of ``1 gallon of household chlorine bleach 
(5.2 percent sodium hypochlorite) mixed with 2.5 gallons of water.''
    One commenter recommended that a critical temperature be specified 
for treatment with sodium hypochlorite or steam, and that it be 
required that the surfaces treated be thoroughly wetted. The commenter 
also stated that the fumigation treatment in Sec. 301.89-11(a)(4) be 
revised by adding tarpaulin fumigation for small acreages. With regard 
to both the sodium hypochlorite and steam treatments, the regulations 
require the surfaces treated to be wetted thoroughly to the point of 
runoff. With regard to the sodium hypochlorite treatment, the 
temperature is not critical. However, we agree that a critical 
temperature at the point of contact should be specified for treatment 
with steam. Therefore, we are requiring in Sec. 301.89-13 of this final 
rule that, for steam treatment, a critical temperature of 170  deg.F be 
reached at the point of contact. With regard to tarpaulin fumigation, 
we are making no changes based on the comment. We are still developing 
a soil treatment with methyl bromide for the regulated area.
    One commenter recommended as a treatment for used bags, sacks, and 
containers soaking for 15 minutes in 30 percent chlorine bleach (5.2 
percent hypochlorite). We have been unable to find any literature on 
this treatment and are not endorsing it at this time. However, we do 
consider effective, and are setting forth in Sec. 301.89-14 as an 
approved treatment for bags, sacks, and containers used for infected 
grain or seed fumigation with methyl bromide at the dosage of 15 
pounds/1000 cubic feet for 96 hours.
    One commenter stated that only storage bins that have held bunted 
kernels and only combines and other equipment and means of conveyance 
found to be infested with bunted kernels should have to be sanitized. 
We disagree with the commenter, due to the risk of the spread of Karnal 
bunt by spores.
    One commenter stated that efficacy data for treatment methods 
applicable to custom harvest equipment has not been provided and, 
therefore, that custom combines used in fields infected with Karnal 
bunt should be prohibited from moving out of the quarantined area. 
Several other commenters also recommended such a prohibition, due to 
what the commenters described as the impossibility of ensuring that all 
spores on custom combines have been destroyed by the currently approved 
treatment. Several commenters recommended that the Department purchase 
a number of combines to be used, then left, in the regulated area. We 
are making no changes based on these comments. We have specified 
procedures for cleaning and sanitizing

[[Page 52195]]

equipment such as combines and consider the treatment, when properly 
monitored, to be effective.
    Several commenters stated that, although the regulations allow for 
several methods of disinfecting equipment with regard to Karnal bunt, 
fumigation with methyl bromide is the only completely effective way to 
sanitize a combine. We are making no changes based on these comments. 
We have specified procedures for cleaning and sanitizing combines, and 
believe that the treatment with sodium hypochlorite, when properly 
monitored, to be effective.
    Several commenters stated in general that available methods for 
``sanitizing'' equipment for Karnal bunt are costly and not totally 
effective. One commenter described the hot detergent solution treatment 
as ``essentially worthless.'' The commenter also stated that the need 
to moisten areas treated with methyl bromide in some cases makes such 
treatment impractical, such as in the treatment of grain elevators and 
grain augers. We are making no changes based on these comments. We set 
forth treatment options based on the best information available from 
scientists familiar with Karnal bunt control. Procedures were developed 
to facilitate the application of treatments. However, we agree that not 
all treatments are equally effective in all situations. Therefore, we 
are adding language to Sec. 301.89-13 of this final rule to provide 
that the treatment option chosen must be the one specified by an 
inspector if that treatment is deemed most effective in a given 
situation.
    One commenter stated that treatment dosage of methyl bromide 
specified in the regulations is greater than that allowed by the 
Environmental Protection Agency. The commenter urged APHIS to request 
the necessary waivers to allow the use of methyl bromide as a fumigant 
for the duration of the quarantine. We have obtained the appropriate 
exemptions and permits for all the chemicals and treatments used in the 
Karnal bunt program.
    Section 301.89-11(b) of the Karnal bunt regulations set forth as an 
approved treatment for straw/stalks/seed heads for decorative purposes 
fumigation with methyl bromide at the dosage of 15 pounds/1,000 cubic 
feet for 96 hours. One commenter stated that APHIS' import regulations 
for wheat diseases in 7 CFR 319.59 exempts from regulation ``straw 
without heads that has been processed or manufactured.'' The commenter 
stated that, for consistency and because no pest risk has been 
identified with this material, the Karnal bunt regulations should be 
revised to include this exemption. We consider the commenter's point a 
valid one. Section 319.59 exempts from regulation straw, with or 
without heads, that has been processed or manufactured for use indoors, 
such as for decorative purposes, or for use as toys. In Sec. 301.89-14 
of this final rule, we provide that straw need not be treated for 
movement outside the regulated area if it has been processed or 
manufactured prior to movement, and is intended for use indoors. 
Another commenter recommended that the dosage of methyl bromide be 5 
pounds/1,000 cubic feet, rather than 15 pounds. We have no data 
indicating that 5 pounds is an effective dosage and are making no 
changes based on this comment.
    One commenter recommended that equipment moved from a regulated 
area be allowed to do so only under limited permit, rather than under a 
certificate. Another commenter stated that, because of the difficulty 
in assuring effective decontamination of conveyances carrying infected 
articles, movement of such conveyances from quarantined areas should be 
prohibited. We are making no changes based on this comment. We have 
developed specific procedures for cleaning and sanitizing equipment and 
conveyances, and believe that, when properly monitored, the treatments 
are effective.
    Several commenters recommended that all requirements for the 
sanitization of farm equipment, conveyances, and grain elevators be 
removed from the regulations. Another commenter recommended that 
equipment coming from quarantined fields be required to be cleaned but 
not sanitized. One commenter recommended that only those articles that 
have come in contact with wheat or soil that has tested positive for 
Karnal bunt be required to be sanitized. One commenter stated that it 
was unrealistic and unachievable to restrict the movement of any 
equipment or materials that come into contact with the soil on 
contaminated fields. One commenter questioned the requirement to wash 
soil from equipment in light of what he perceived as the greater risk 
presented by windborne teliospores. Several commenters stated that, due 
to what the commenters considered the impossibility of the eradication 
of Karnal bunt, equipment moving within a quarantined area from a 
contaminated field should be required to be cleaned free of soil, but 
not be required to be sanitized. We acknowledge that the possibility of 
the windborne spread of teliospores within the regulated area can 
counteract the beneficial effects of sanitizing equipment. Because of 
the potential windborne spread of Karnal bunt, and also because of the 
possibility that equipment and means of conveyance may have been moved 
from infected fields prior to the initial detection of Karnal bunt, we 
are removing cleaning and sanitization requirements for movement within 
the regulated area, except for movement from fields that test positive 
for Karnal bunt during the 1996-97 crop season. Equipment moving 
outside the regulated area must still be cleaned and sanitized prior to 
movement. Additionally, we are still requiring the cleaning and 
sanitization of contaminated elevators, so that grain testing negative 
that is moving into the elevator remains uncontaminated.
    Several commenters recommended that custom harvesting equipment be 
prohibited from movement from a quarantined area, or, at the least, 
that an effective monitoring program be implemented to assure that only 
properly certified equipment leaves the quarantined area. We agree with 
the commenter that the movement of custom harvesting equipment must be 
closely monitored, and we have developed a system to monitor the 
sanitization and movement of equipment from the regulated area.
    In Sec. 301.89-11 of the regulations (Sec. 301.89-13 of the August 
2, 1996, proposed rule), paragraph (a)(2) lists as an approved 
treatment ``applying steam to all surfaces to the point of runoff.'' 
One commenter stated that the effectiveness of this treatment would be 
doubtful, because the regulations set forth no requirement for the 
``removal of material'' or for a minimum surface temperature. We 
disagree that the regulations do not require cleaning. Section 301.89-
11 of the regulations (301.89-13 of this final rule) requires cleaning 
by removing all soil and plant debris, followed by disinfection with 
one of the required treatments.
    In Sec. 301.89-11 of the regulations (Sec. 301.89-13 of the 
proposed rule), paragraph (a)(3) lists as an approved treatment 
``cleaning with a solution of hot water and detergent, under high 
pressure (at least 30 pounds per square inch), at a minimum temperature 
of 180  deg.F.'' One commenter stated that 30 pounds per square inch is 
not considered high pressure and that 300 pounds per square inch would 
be more appropriate. The commenter also expressed reservations about 
the effectiveness of the treatment without the use of a fungicide. We 
consider the treatment to be effective when used and monitored 
appropriately. However, in order to avoid confusion as to the meaning 
of ``high pressure,'' we are specifying only that the cleaning

[[Page 52196]]

solution must be applied with pressure of at least 30 pounds per square 
inch.
    One commenter recommended that requirements for the sanitization of 
equipment be made gradually less stringent over the 5-year period 
following the establishment of a quarantine. In our August 2, 1996, 
proposed rule, we proposed to make less stringent the cleaning and 
sanitization requirements within regulated areas, and to require 
cleaning and sanitization of equipment only when moving from a 
regulated area. In this final rule, we are requiring cleaning and 
sanitization of equipment only when moving from a regulated area, and 
in those cases where equipment is moved from a field that tests 
positive for Karnal bunt during the 1996-1997 crop season. As we obtain 
more data, we will consider other modifications to the sanitization 
requirements.

Recommended Regulatory Actions

    One commenter stated that allowing a Karnal bunt host crop to be 
mature and harvested from a field known to be infested with Karnal bunt 
teliospores or from a field planted with seed infected with Karnal bunt 
allows for the possibility of teliospores being produced in the 
resulting crop that would re-infest the soil in the field and 
potentially be blown to other fields. This commenter and several other 
commenters recommended that crops from infested fields be destroyed. We 
are making no changes based on these comments. Due to currently 
available survey techniques, we cannot determine whether a field is 
infested until the crop is sampled and tested at harvest. In this final 
rule, we are prohibiting the planting for the 1996-97 crop season of 
host crops in fields that are known to be infested.
    One commenter stated that once wheat shown to be infected is 
destroyed in the field, the field should be burned and plowed to 
destroy the spores. Then, the field should immediately undergo a soil 
test for the presence of live spores. If no live spores are found, the 
field should be considered clean and no further action should be 
necessary. We are making no changes based on this comment. There are 
scientific reports indicating that teliospores are carried on wind 
currents caused by burning, and that the eradicative measure may 
actually promote the spread of Karnal bunt. Also, we do not have an 
effective methodology for testing soil at this time.
    One commenter stated that the regulations should not allow the 
burning of sacks, bags, and containers used for infected grain or seed 
as a treatment option, due to the possibility of teliospores being 
spread by the burning. As discussed above, we agree that burning is not 
an appropriate treatment measure, and such an option is not set forth 
in the regulations.
    Several commenters stated that the ideal eradication scenario would 
be to prohibit host crop production in the regulated area for a minimum 
of 5 years. We are making no changes based on this comment. Although we 
agree that the prohibition suggested by the commenter would be an 
effective eradication technique, we believe there are other effective 
measures that are less disruptive to farmers and the wheat industry 
within the regulated area.
    One commenter requested that, in order to restore the integrity of 
grain produced in Arizona, APHIS assure the domestic industry and 
international markets that the 1996 Arizona wheat crop would be 
thoroughly tested prior to shipment. Several commenters recommended 
that no preharvest testing be done, except for the most suspicious 
fields. We consider adequate testing integral to the Karnal bunt 
program. In 1996, all grain in the Karnal bunt program areas was tested 
twice prior to movement. In 1997, under Sec. 301.89-6 of this final 
rule, all grain in regulated areas must again test negative twice 
before being moved from a regulated area, and one of these tests must 
occur at the means of conveyance or storage facility immediately prior 
to movement. We consider it necessary to test all grain moving from a 
regulated area, because some fields that will be planted with wheat in 
the 1996-97 crop season were not tested in 1996.
    One commenter recommended that, due to the possibility of spillage, 
open trucks or trailers transporting infected grain, even those covered 
with a tarpaulin, be prohibited from leaving a quarantined area. We are 
making no changes based on this comment. As noted, only grain that has 
tested negative for Karnal bunt twice is eligible for movement out of 
the regulated area. Additionally, the provisions of Sec. 301.89-6 this 
final rule regarding movement from the regulated area provide that an 
article to be moved under limited permit must be moved to a specified 
destination for specified handling, utilization, or processing. In the 
case of grain from where infested fields may occur, this means movement 
only to approved mills under specific sanitation and safeguard 
conditions.
    One commenter objected to the provision in Sec. 301.89-5(c) that 
states that an inspector shall issue blank certificates and limited 
permits to a person operating under a compliance agreement. The 
commenter requested that such documents be issued only by Federal or 
approved State plant regulatory officials. We are making no changes 
based on this comment. APHIS and State cooperators do not have the 
resources to be present when each shipment or regulated article is 
moved. However, the compliance of persons operating under compliance 
agreement is monitored through inspections of facilities and equipment, 
observation of procedures, and review and accounting of documents.

Calculation of Spore Prevalence

    One commenter stated that APHIS is incorrect in concluding that the 
detection of one spore in a railcar sample represents the presence of 
close to 2 million spores in the railcar. The commenter stated that 
subsequent tests of the railcar sometimes detect no further spores. Our 
wheat testing program is basic to determining the actions appropriate 
to controlling the spread of the Karnal bunt pathogen. We view the 
detection of Karnal bunt teliospores in a sample from a qualitative, 
not a quantitative, standpoint. We recognize that spores may not be 
evenly distributed in a railcar. Nonetheless, we consider the detection 
of teliospores as an adequate method to determine whether there is a 
risk of spread of Karnal bunt.

Management of Karnal Bunt

    Several commenters recommended that an eradication program be 
replaced with a management program to potentially include the 
following: (1) Planting clean, fungicide-treated seed; (2) requiring 
crop rotations that include non-host crops; (3) using a later planting 
date to force crop heading in central Arizona into a drier period of 
the winter; (4) applying foliar fungicides on seed fields if conditions 
indicate a risk of Karnal bunt infection; (5) implementing post-harvest 
testing of seed to detect field infections of Karnal bunt; and (6) 
using varieties of grains resistant to Karnal bunt. At this time, we 
will continue to contain and control this disease to attain our goals 
of (1) protecting other wheat producing areas of the United States, (2) 
protecting and maintaining export markets, and (3) providing as many 
options as possible to wheat producers within the impacted areas. 
However, we consider the recommendations of the commenter good 
management techniques. We are requiring in this final rule the use of 
fungicide-treated seed for planting if the seed originated in a 
regulated area and post-harvest testing. We are also examining the 
feasibility of foliar

[[Page 52197]]

fungicides and are exploring the use of more resistant varieties of 
wheat.
    One commenter stated that if widely scattered areas in the United 
States are found to have incidental Karnal bunt spores, such areas may 
need to be put under ``observation,'' ``investigation,'' or 
``restriction,'' but that ``quarantine'' may be counterproductive. 
APHIS is currently conducting activities to control and contain the 
disease within the regulated area. In addition, we are conducting a 
national survey to determine if the disease exists in other portions of 
the United States. If we find Karnal bunt in additional areas, we will 
review the available data and take the most appropriate actions 
consistent with our goals to protect other wheat growing areas, protect 
export markets, and provide as many options as possible to growers and 
industry impacted by our actions.

Non-Host Crops

    One commenter stated that the small amount of soil present on 
lettuce, cabbage, and onions poses a minimal threat of spreading spores 
to other fields. Several commenters opposed the quarantining of crops 
other than wheat, rye, and triticale. Several commenters stated that 
the production of non-host crops such as root crops, onions, and 
ornamentals should not be regulated merely because of the possibility 
of the movement of soil or soil residues. The commenter stated that the 
production of these crops poses a negligible risk of spreading Karnal 
bunt. Another commenter recommended that standards for ``free from 
soil'' be developed for the unrestricted movement of low risk crops 
from quarantine areas. We are making no changes based on these 
comments. We consider the risk of the spread of Karnal bunt through 
soil to be sufficient to require cleaning of non-host crops prior to 
movement outside the regulated area, or, alternatively, to require 
movement under limited permit to facilities that will remove the soil 
from the crops. Because cleaning root crops and other commodities is a 
normal practice prior to sale, we do not believe that handling and 
disposal of the soil in an appropriate manner will cause undue burden.
    One commenter expressed concern that the sanitization treatments 
provided will in most cases damage the fruit or vegetable crop beyond 
marketability. We are making no changes based on this comment. Under 
the regulations, fruits and vegetables need only to be free of soil. 
Typically, fruits and vegetables are cleaned at harvest or at a packing 
facility. There should be no additional damage as a result of the 
requirement to remove soil from root crops and other vegetables and 
fruit.
    One commenter stated that the regulations should state that soil 
associated with certain commodities (i.e., nursery stock, turf, etc.) 
from a positive field in which a host crop has been grown, may not be 
moved from that field unless it has been treated, tested, and found to 
be negative. However, the commenter recommended that other types of 
soil, such as soil attached to fruits or vegetables growing on top of 
the ground and soil adhering to equipment, boxes, bags, etc, as a 
result of their being set on the ground should not be regulated. We are 
making no changes based on this comment. We consider the risk 
associated with soil from a quarantined area merits regulation and 
appropriate mitigative measures.
    One commenter stated that in the case of New Mexico, where the 
commenter said growers plowed down all known wheat acreage planted with 
contaminated seed, and no Karnal bunt was detected on mature wheat, 
establishing requirements to prevent the movement of soil and plant 
debris on equipment and vegetable crops is excessive. We are making no 
changes based on this comment. We consider a risk to exist with the 
movement of soil on equipment and vegetable crops out of the regulated 
area.

Calculation of Risk

    One commenter stated that the Department should conduct a risk 
analysis on each regulated article to determine if the risk is 
``significant,'' and regulate only those articles posing a significant 
risk. Several commenters said the Department's analysis of the risk of 
a Karnal bunt outbreak from untreated millfeed showed the risk to be 
negligible. One commenter said that the Department had stated that the 
chance of Karnal bunt spreading from a quarantined area through Karnal-
bunt-negative millfeed was approximately 1 in 5,556 years, that the 
Department considers this a ``moderate'' rather than a ``significant'' 
risk, and, therefore, that millfeed should not be a regulated article. 
We are making no changes based on this comment. APHIS' estimate that 
one outbreak might occur every 5,556 years was specific to the 
situation where grain is shipped from anywhere in the quarantine area 
to a mill outside the quarantine area and the millfeed is not treated. 
This scenario was one of 17 scenarios presented by APHIS in formal risk 
assessments on Karnal bunt. According to APHIS' current guidelines, 
this constitutes a ``medium likelihood of spread'' (as opposed to a 
moderate risk). The estimate of 5,556 years--and estimates for the 
likelihood of an event in general--do not constitute a measure of 
``risk''; 5,556 years was APHIS' estimate for the likelihood that 
Karnal bunt would spread under these conditions. By definition, 
estimates of the risk incorporate both the likelihood of an event (in 
this case, spread of Karnal bunt) and the severity of the consequences 
should Karnal bunt spread (e.g., economic and environmental impacts). 
When a decision is made about what is an acceptable level of risk, both 
the likelihood of an event (e.g., spread of Karnal bunt once every 
5,556 years as a result of this particular type of shipment) and the 
severity of the consequences (e.g., loss of export markets for United 
States wheat) must be considered. The risk of each type of proposed 
action must then be considered along with (e.g., added to) the risk 
posed by other proposed or planned actions. The risk posed by these 
shipments was determined to present a level of risk that was 
unacceptable.
    One commenter stated that the potential establishment of Karnal 
bunt in an area outside the infested area from wheat grain intended for 
milling for human consumption or processing for animal consumption was 
judged by APHIS and the University of California to be remote--i.e., in 
the order of magnitude of 1 in 1 million to 1 in 5 million. We believe 
it is misleading to simplify the results of the analyses cited. The 
estimate made by the University of California (UC) was compared with 
the analogous estimate made by APHIS (i.e., Scenario No. 2C, Table 4a, 
USDA, May 28, 1996). The methodology used by UC and APHIS were similar 
in some respects but significantly different in other respects. Most 
notably, APHIS performed a probabilistic risk assessment with a 
probabilistic result (i.e., the estimate provided by the assessment was 
a probabilistic range of values for the likelihood of spread). Because 
the UC assessment was not a probabilistic assessment, only a single 
number was reported (i.e., the spread of Karnal bunt once every 1.05 
million years) and the scientific uncertainty about the biology and 
movement of Karnal bunt was not considered. APHIS' assessment accounted 
for the uncertainty regarding the biology of Karnal bunt. The estimate 
used by APHIS to make decisions regarding regulation for this type of 
shipment was, and continues to be, once

[[Page 52198]]

every 2,119 years (the 95th percentile of the estimated likelihood of 
spread). Because the UC and APHIS methodologies were different, the 
results could not be compared directly. However, UC and APHIS 
essentially reached the same conclusion using different means, and 
APHIS has not changed its estimate for the likelihood of spread.
    One commenter recommended that APHIS conduct an evaluation of the 
risk posed by Karnal bunt to the U.S. wheat industry and its 
international markets. APHIS completed a risk analysis in 1991 that 
addresses the consequences of the establishment of Karnal bunt. 
Information regarding the analysis can be obtained from the person 
listed in this final rule under FOR FURTHER INFORMATION CONTACT.

Definitions

    One commenter stated that the definition of soil in Sec. 301.89-1 
should be consistent with the definition established in the 1994 
``North American Plant Protection Organization Position Paper on Soil 
Movement.'' In that paper, soil is defined to mean ``the loose surface 
material of the earth in which plants grow, in most cases consisting of 
disintegrated rock with an admixture of organic material.'' We agree 
with the commenter and have revised the definition of soil in this 
final rule.
    One commenter stated that Sec. 301.89-1, ``Definitions,'' defines 
the terms farm tools, mechanized cultivating and mechanized harvesting 
equipment, movement, soil, and soil moving equipment in their generic 
sense, i.e., without reference to the connection they might have to 
host crops. The commenter stated that by using such definitions, the 
terms become all inclusive, even though, according to the commenter, 
equipment such as harvesting equipment specific to commodities other 
than wheat pose little risk of bearing spores of Karnal bunt. The 
commenter recommended that the definitions be revised to make such a 
connection to host crops, or, alternatively, that the term ``used'' 
that modifies certain regulated equipment in Sec. 301.89-2 be tied to 
the risk associated with host crops for Karnal bunt. We are making no 
changes based on this comment. We consider there to be a risk that the 
pathogen will be moved with soil adhering to farm equipment and tools. 
We consider cleaning and sanitization of these articles to be necessary 
prior to movement from the regulated area, and prior to movement from 
fields that test positive for Karnal bunt during the 1996-97 crop 
season.

Scientific Resources

    Several commenters stated that, in establishing the Karnal bunt 
regulations, APHIS did not sufficiently enlist the expertise of 
specialized scientific personnel. One commenter recommended that a 
representative scientific panel be appointed to advise the Department 
on modification of the quarantined areas. We disagree with the 
commenters' contention. In developing program procedures, the 
Department has solicited input from all interested parties. In 
addition, APHIS has requested that informally structured groups such as 
the Karnal bunt Science Panel meet to review and clarify technical 
issues. Also, APHIS is exploring the possibility of establishing a 
formal Karnal bunt advisory committee.

Regulated Areas

    Section 301.89-3(c) provides that the Administrator may include 
noninfected acreage within a regulated area due to its proximity to an 
infestation or inseparability from the infected locality for regulatory 
purposes. One commenter stated in general that this provision gives the 
Administrator unnecessarily broad powers, and in particular that the 
maximum regulated area in New Mexico should be those fields previously 
planted with contaminated wheat seed. We disagree. Due to the movement 
of equipment, the potential natural movement of the causal agent by 
wind, and incomplete information on seed distribution for planting, we 
consider the regulation of larger areas appropriate until additional 
survey information is available.
    Several commenters stated that areas such as Yuma County, AZ, 
should not be quarantined. One of these commenters stated that natural 
conditions in that area do not favor the establishment of Karnal bunt. 
Several commenters stated that, as of the date the comments were 
written, extensive testing in Yuma County had shown no Karnal bunt 
infestation. Several commenters questioned why Arizona was the only 
State to be quarantined in its entirety for Karnal bunt. One commenter 
requested that the quarantine of Hudspeth County in Texas be reduced to 
``more accurately reflect the affected areas.'' APHIS has revised the 
quarantine boundaries in Arizona, California, New Mexico, and Texas, 
including Hudspeth County, to include only those areas that contain 
wheat fields that are associated with contaminated wheat seed or that 
have tested positive. The Yuma area will remain within the regulated 
area because it contains fields that tested positive during the 
preharvest survey.
    Several commenters stated that the same quarantine restrictions 
have not been applied to areas with similar Karnal bunt conditions in 
different States, requested that the specific scientific standards for 
quarantine be publicly stated and applied equally, and that an 
explanation be provided of why certain areas where Karnal bunt has been 
determined to exist or that are suspect for the existence of Karnal 
bunt have not been quarantined. At any indication of Karnal bunt, APHIS 
and State cooperators respond immediately to identify potential 
infestations. APHIS has traced contaminated seed to several locations 
outside the regulated areas. In some cases, the seed had not been 
planted but was still in storage. In those cases, the seed was 
destroyed and the facilities were cleaned and sanitized. Contaminated 
seed was traced to several small research plots, where the fields were 
plowed down and fumigated. In some instances, despite extensive testing 
and traceback efforts, we have not been able to confirm that 
contaminated seed was either distributed or planted in the area in 
question. We are continuing additional monitoring activities in those 
areas. We consider such measures sufficient to ensure that Karnal bunt 
is eliminated from the site without the unnecessary imposition of a 
geographical quarantine.
    Several commenters recommended a reduction or modification of the 
quarantined area in California. According to the commenters, as of the 
date the comment was written, no samples of grain produced in the 
Imperial Valley of Imperial County, CA, had been proven to have Karnal 
bunt. The commenters recommended that the Imperial Valley be removed 
from the list of quarantined areas (with the possible exception of 
those fields known to be planted with infected seed). One commenter 
recommended that the current quarantine in Imperial County be replaced 
with a program of wheat seed inspections, fungicidal treatment of wheat 
seed, testing of outgoing shipments of wheat, and preharvest sampling. 
One commenter recommended that those townships in Imperial County where 
Karnal bunt has been found to be present be monitored during the coming 
year. The commenter stated that a formal quarantine was unnecessary 
because Karnal bunt can be dealt with in crop production and in 
marketing in the same fashion as with other smut and bunt diseases that 
occur in California. We disagree with the commenters that the Imperial 
Valley should be released from regulation. This

[[Page 52199]]

area received seed that was contaminated with Karnal bunt. In addition, 
composite samples taken from grain originating in the Imperial Valley 
have tested positive. However, we acknowledge that no individual field 
in the Imperial Valley has tested positive and are, therefore, 
categorizing the Imperial Valley as a surveillance area in this final 
rule. (Surveillance areas are discussed in more detail in this 
SUPPLEMENTARY INFORMATION under the heading ``Regulated Areas.'')
    One commenter recommended that APHIS quarantine wheat lots, rather 
than quarantine States or counties according to geographical 
boundaries. We are making no changes based on this comment. However, in 
APHIS' current program, eligibility for movement is determined by test 
results of grain from either individual fields or means of conveyance.
    One commenter recommended that the Department take responsibility 
for the movement of regulated articles out of the regulated area, and 
that States be responsible for movement within regulated areas. We are 
making no changes based on this comment. APHIS and State cooperators 
work together to provide an integrated program, because movement 
outside the regulated area is dependent on program activities conducted 
within the regulated area.
    One commenter recommended that growing areas be removed from 
regulation if they show less than 1 percent positive results in the 
pre-harvest survey. The commenter also recommended that regulated areas 
be delineated using geographic boundaries, i.e., highways, roads, and 
rivers, rather than county boundaries. We do not agree that regulation 
of an area should be dependent on whether Karnal bunt is detected in 
some specified percentage of fields tested. However, in this final 
rule, based on 1996 survey data, we have modified the regulations by 
categorizing areas based on the presence or not of fields that tested 
positive for the pathogen. The areas are regulated based on their 
relative risks. Areas with positive fields are of greater risk because 
the pathogen has been shown to exist and may be spread locally by wind 
or the movement of equipment. This would occur independently of 
whatever percentage of the fields are positive. We are using boundaries 
other than county lines to describe the regulated areas.
    Several commenters stated that, in those areas where only several 
fields have been found to be infected with Karnal bunt, only those 
fields testing positive should be quarantined, not the entire area. 
Another commenter recommended that, using traceback survey and pre-
harvest sampling results, only those areas where an infestation has 
been found should be subject to quarantine. One commenter stated that 
negative preharvest testing of seed produced in a quarantined area 
should be grounds for allowing that seed to move from the quarantined 
area. One commenter recommended that quarantined areas be limited to 
those wheat-growing areas where Karnal bunt is suspected and projected 
by APHIS. We agree with the commenters that, based on survey data, 
certain areas present a greater risk than others, and, in this final 
rule, we have created criteria for two categories of areas within the 
regulated area: (1) Restricted areas which include fields testing 
positive, and (2) surveillance areas where no fields testing positive 
are located. We discuss these areas in greater detail in this 
Supplementary Information under the heading ``Regulated Areas.'' Grain 
moving from restricted areas will continue to move under limited permit 
with safeguard conditions. Grain from surveillance areas may move under 
certificate without restriction.

Services of Inspectors

    Section 301.89-8 of the regulations sets out the procedures for 
requesting the services of an inspector by persons requiring 
certification or other services. Paragraph (a) of that section requires 
that 48 hours notice be given to the inspector before the services are 
needed. One commenter suggested that, instead of the mandated 48 hours 
notice, provisions for assembly and inspection of regulated articles be 
set through compliance agreements. We do not believe that specifics 
concerning requirements for APHIS lead-time notification are 
appropriate for a compliance agreement. However, we recognize the need 
for a quicker response time during harvest, and, therefore, are 
revising the regulations by reducing from 48 hours to 24 hours the time 
required for notification prior to the provision of APHIS services.
    Section 301.89-10 provides that the services of an inspector during 
normal business hours will be furnished by APHIS without cost, but that 
the user will be responsible for all costs and charges arising from 
services provided outside of normal business hours. One commenter 
stated that, during harvest season, ``normal business hours'' are 
virtually around the clock, and that the Department should be 
responsible for all costs and charges arising from inspection and other 
services provided at any time. During the 1996 harvest, APHIS did not 
charge for services conducted outside ``normal'' business hours. We 
expect to continue this policy for most activities in the 1997 crop 
season.

Import Requirements

    Several commenters stated that the restrictions regarding produce 
from Mexico because of Karnal bunt are less stringent than those 
established by the domestic quarantine regulations, and inquired 
whether the two sets of restrictions would be made consistent. We 
disagree with the commenters' statement. Wheat products and soil from 
Mexico are restricted entry into the United States to prevent the 
introduction of insect pests and plant diseases such as Karnal bunt.

Analysis of Economic Impact

    Several commenters stated that the Department has not published an 
assessment of the economic impact of the Karnal bunt quarantine. 
Another commenter stated that the long-term economic costs of 
maintaining the current Karnal bunt quarantine would outweigh the 
amount of foreign export business that might be temporarily lost if the 
Karnal bunt regulations were removed. We are currently in the process 
of assessing the economic impact of the Karnal bunt quarantine, and 
will publish this assessment in the Federal Register upon its 
completion.

Comment Period

    One commenter stated that the 60-day comment period provided for 
our interim rule establishing the Karnal bunt regulations allowed 
insufficient time for interested parties to compile sufficient 
information to comment. Although the comment period for the interim 
rule establishing the regulations was initially to end on May 28, 1996, 
that period was extended until September 3, 1996. We consider this 
sufficient time for interested parties to have commented on the interim 
rule.

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

    Several commenters supported our August 2, 1996, proposal.
    One commenter requested that APHIS explain the sound science upon 
which it based each provision of the proposed rule. We acknowledge the 
need to base regulatory actions on the latest scientific data 
available. The provisions of the Karnal bunt regulations are based on a 
combination of scientific data and recommendations of the Karnal bunt 
Science Panel, APHIS' experience as a regulatory agency, and standard 
regulatory procedures and systems that have proven effective in 
previous

[[Page 52200]]

programs. Sound science, coupled with environmental considerations, 
forms the basis for a risk-based, flexible regulatory system to 
accomplish APHIS' goals to (1) protect other wheat-producing areas of 
the United States, (2) protect and maintain export markets, and (3) 
provide as many options as possible for wheat producers within the 
impacted area.
    One commenter disagreed with the statement in our proposed rule 
that the purpose of the proposal was to relieve unnecessary restriction 
on areas regulated because of Karnal bunt, while guarding against the 
artificial spread of the disease. The commenter stated that the 
proposal actually expands the restriction on movement. For example, 
stated the commenter, where the regulations required the removal of 
soil from equipment that entered a field that is positive for Karnal 
bunt or that had been planted with contaminated seed, the proposed rule 
expands the cleaning requirement to any field known to be planted in 
the past 5 years with seed contaminated with Karnal bunt, and fields 
adjacent to fields in which preharvest samples tested positive. We 
agree with the commenter that, in many cases, such cleaning is 
unnecessary within the regulated area. In this final rule, we have 
modified the cleaning and sanitization requirements to require these 
measures only when equipment or conveyances are moved out of the 
regulated area, or are moved from fields that tested positive for 
Karnal bunt during the 1996-97 crop season.
    Several commenters stated that APHIS should publish in the 
regulations the terms of compliance agreements under which regulated 
articles may be moved out of regulated areas. In general, the terms of 
compliance agreements follow the provisions and treatments set forth in 
the regulations. Additional information is often provided to the 
regulated establishment concerning recordkeeping, handling of limited 
permits and certificates, local contacts, and any special instructions 
specific to the operations of the establishment. When the interim rule 
establishing the Karnal bunt regulations was promulgated, its 
provisions were general and flexible. This was because we were 
regulating a new outbreak of a disease with which we had minimal past 
experience. In this final rule, we are publishing a table of conditions 
under which areas of differing risk levels will be regulated, to inform 
growers and other members of the industry of how they will be impacted. 
Compliance agreements will be based on these regulatory conditions.
    One commenter stated that, where possible, the use of compliance 
agreements for such actions as the movement of grain, disposition of 
millfeed, and movement of equipment should be avoided. The commenter 
said that being required to sign a compliance agreement in order to 
handle a product discourages potential buyers from handling the product 
in question. We consider the use of compliance agreements to be 
beneficial to both APHIS and the person operating under the compliance 
agreement. The use of compliance agreements allows APHIS to better use 
its resources, and allows the person to handle and move regulated 
articles without the constant presence of an inspector. We believe that 
the necessity for on-site monitoring during operations and at movement 
would be more discouraging to buyers and handlers.

Risk Categories for Areas and Fields

    In Sec. 301.89-3(f) of our proposed rule, we proposed criteria by 
which fields in regulated areas would be classified into various risk 
class levels. We proposed that the Administrator would classify fields 
in regulated areas according to the following categories, and would 
notify the owner or person in possession of the field of the field's 
classification:
    1. Fields in which preharvest samples tested positive for Karnal 
bunt;
    2. Fields known to be planted in the past 5 years with seed 
contaminated with Karnal bunt;
    3. Fields adjacent to fields in which preharvest samples tested 
positive;
    4. Fields associated only through ownership, management, the 
movement of equipment, or proximity within a distinct definable area 
with fields in which preharvest samples tested positive; and
    5. Fields within a regulated area that are not fields described in 
``2'' and ``4,'' and that are part of a distinct definable area that 
includes no fields in which preharvest samples tested positive.
    A number of commenters commented on these proposed categories. Some 
of the commenters addressed the proposed categories in general; other 
commenters addressed individual categories. After reviewing the 
recommendations made by the commenters, we believe that we should 
revise our categorization of risk areas to simplify them and to make it 
easier for the owner of specific fields to know the status of those 
fields. For purposes of clarity, in the following paragraphs we will 
first explain what this revised system of categorization will consist 
of, then we will discuss comments on the system of categorization that 
we set forth in our proposed rule. We believe conducting the discussion 
of the comments in this way will allow us to respond to the comments in 
the context of the regulatory scheme that we are adopting in this final 
rule.

Regulated Areas

    In Sec. 301.89-3 of this final rule, we set forth the criteria for 
designating an area as a regulated area. These criteria are the same as 
that set forth in the proposal. Under these criteria, the Administrator 
will regulate each State or portion of a State that is infected. In 
Sec. 301.89-1 of both the proposal and this final rule, infestation 
(infected) is defined as the ``presence of Karnal bunt, or any stage of 
development of the fungus Tilletia indica (Mitra) Mundkur, or the 
existence of circumstances that make it reasonable to believe that 
Karnal bunt is present.'' In Sec. 301.89-2 of this final rule, we set 
forth a list of regulated areas.

Restricted Areas and Surveillance Areas

    In this final rule, we then divide each regulated area into two 
sub-categories. In each regulated area, all or a portion of that 
regulated area will be designated as either a ``restricted area'' or a 
``surveillance area.'' In Sec. 301.89-1 of this final rule, we define a 
restricted area as a ``distinct definable commercial wheat production 
area that includes at least one field that tested positive for Karnal 
bunt.'' A distinct definable area is defined as ``a commercial wheat 
production area of contiguous fields that is separated from other wheat 
production areas by desert, mountains, or other nonagricultural terrain 
as determined by an inspector, or, in the case of restricted areas, as 
determined by an inspector based on survey results, including the 
number of positive fields and the relative spore count of the fields 
within the area.'' In Sec. 301.89-1, we define surveillance area as a 
``distinct definable commercial wheat production area in which no 
fields have tested positive for Karnal bunt, but in which movement of 
contaminated seed has occurred.'' In Sec. 301.89-2 of this final rule, 
we set forth a list of each restricted area and each surveillance area.
    There are several practical differences between being designated a 
restricted area and being designated a surveillance area. First, grain 
from a restricted area that tests negative for Karnal bunt may move 
under limited permit from the regulated area to designated facilities 
under safeguard and sanitation conditions; grain from a surveillance 
area that tests negative for Karnal bunt may move under certificate to 
any destination without restriction.

[[Page 52201]]

Additionally, under Sec. 301.89-13(c) of this final rule, millfeed from 
grain produced in a restricted area is required to be treated, whereas 
millfeed from grain produced in a surveillance area is not required to 
be treated. However, as explained below, only certain types of fields 
will be permitted to be planted with host crops; therefore only those 
fields will be capable of producing grain to be sent for milling.
    In this final rule, each restricted area and each surveillance area 
is further divided into individual fields within those areas, as 
described in the following paragraph. Each field in a restricted area 
will fall into one of three categories. Each field in a surveillance 
area will fall into one of two categories.
    In a restricted area, each field will be designated either as (1) a 
field in which preharvest samples tested positive; (2) a field planted 
with known contaminated seed in 1995; or (3) any other field within the 
restricted area. In a surveillance area, each field will be designated 
either as (1) a field planted with known contaminated seed in 1995; or 
(2) any other field in the surveillance area.
    There is a practical effect to being designated a certain risk 
level of field. In a restricted area, in fields in which preharvest 
samples tested positive, no Karnal bunt host crops may be planted in 
the 1996-97 crop season. This same prohibition applies to fields in 
both restricted areas and surveillance areas which were planted with 
known contaminated seed in 1995. Also, as noted above, millfeed from 
grain from a field in the ``any other field'' category in a restricted 
area must be treated; millfeed from a surveillance area need not be 
treated.
    In order to help clarify our system of categorization, we have set 
forth each category we are establishing in this final rule, and the 
practical ramifications of being classified in that category, in a 
table in this final rule, as follows:

                                           Conditions for Wheat Production and Utilization in a Regulated Area                                          
--------------------------------------------------------------------------------------------------------------------------------------------------------
                   Definition       Host planting           Seed           Decontamination         Millfeed            Survey       Disposition of grain
--------------------------------------------------------------------------------------------------------------------------------------------------------
Restricted                                                                                                                                              
 area                                                                                                                                                   
Category:                                                                                                                                               
1............  Fields in which    No host planting   Not applicable...  Equipment movement    Not applicable...  Not applicable...  Not applicable.     
                preharvest         in 1996-97 crop                       outside regulated                                                              
                samples tested     season.                               area: cleaned and                                                              
                positive.                                                sanitized. Movement                                                            
                                                                         within: no                                                                     
                                                                         restrictions.                                                                  
2............  Fields planted     No host planting   Not applicable...  Equipment movement    Not applicable...  Not applicable...  Not applicable.     
                with known         in 1996-97 crop                       outside regulated                                                              
                contaminated       season.                               area: cleaned and                                                              
                seed in 1995.                                            sanitized. Movement                                                            
                                                                         within: no                                                                     
                                                                         restrictions.                                                                  
3............  All other fields   No restrictions..  Tested and, if     Equipment movement    Required, unless   Double-tested:     Movement of grain   
                within                                from regulated     outside regulated     destination        Sampled in field   testing positive   
                restricted area.                      area, treated      area: cleaned and     State controls     at harvest;        restricted; grain  
                                                      prior to           sanitized. Movement   disposition/       composite sample   testing negative   
                                                      planting.          within: no            movement.          prior to           may move under     
                                                                         restrictions.                            movement.          limited permit to  
                                                                                                                                     designated         
                                                                                                                                     facilities under   
                                                                                                                                     safeguard and      
                                                                                                                                     sanitation         
                                                                                                                                     conditions.        
Surveillance                                                                                                                                            
 area                                                                                                                                                   
4............  Fields planted     No host planting   Not applicable...  Equipment movement    Not applicable...  Not applicable...  Not applicable.     
                with known         in 1996-97 crop                       outside regulated                                                              
                contaminated       season.                               area: cleaned and                                                              
                seed in 1995.                                            sanitized. Movement                                                            
                                                                         within: no                                                                     
                                                                         restrictions.                                                                  
5............  All other fields   No restrictions..  Tested and, if     Equipment movement    Not required.....  Double-tested:     Movement of grain   
                located in                            from regulated     outside regulated                        Sampled in field   testing positive   
                definable area                        area, treated      area: cleaned and                        at harvest;        restricted; grain  
                where no fields                       prior to           sanitized. Movement                      composite sample   testing negative   
                in risk level 1                       planting.          within: no                               prior to           may move under     
                are located.                                             restrictions.                            movement.          certificate.       
                                                                                                                                     Safeguard and      
                                                                                                                                     sanitation of      
                                                                                                                                     railcars not       
                                                                                                                                     required.          
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 52202]]

Comments On Proposed Risk Categories

    We will now discuss the comments that addressed the risk categories 
we set forth in our proposal. We will first discuss those comments that 
addressed our proposed system of categorization in general. We will 
then discuss those comments that addressed specific categories set 
forth in our proposal.

Comments on Proposed Categorization in General

    The definitions in proposed Sec. 301.89-1 include a definition of 
distinct definable area. This definition reads ``a commercial wheat 
production area of contiguous fields that is separated from other wheat 
production areas by desert, mountains, or other nonagricultural terrain 
as determined by an inspector.'' One commenter stated that this 
definition does not accurately describe wheat production in the 
proposed regulated area of New Mexico, where less than 4 percent of the 
agricultural acreage is planted in wheat, and the fields are small and 
randomly dispersed. We believe we can identify distinct definable areas 
in New Mexico when appropriate. Under the criteria for classification 
set forth in this final rule, all regulated portions of New Mexico will 
at this time be classified as surveillance areas.
    One commenter stated that although the proposed rule stated that 
regulated areas would be classified according to specific risk 
categories, such classifications were not included in the proposed 
regulations. Another commenter requested that APHIS publish a map 
showing the location of fields in Arizona and the level of risk 
classification for those fields. Another commenter stated that the 
regulations should explain how risk levels are determined. As noted 
above, in this final rule, we have simplified the proposed rule by 
categorizing areas into two types--restricted and surveillance, and we 
describe the criteria for and the boundaries of each type of area. We 
have identified the location of fields that have tested positive and 
will notify growers in those areas. We are preparing maps and will 
distribute them when they are completed.
    One commenter stated that the criteria for the different risk 
levels is broad and arbitrary, and that, consequently, lenders will not 
be able to assess the risk a field presents. One commenter stated that 
the proposed rule did not make clear what practical impact 
classification of fields into different risk categories would have. As 
noted, in this final rule, we have simplified the provisions that were 
proposed by setting forth criteria for two categories of fields--
restricted and surveillance. We are also providing a table in the 
regulations that outlines the effects of being classified as a 
particular area.
    One commenter inquired whether a process would be established by 
which a field classification could be appealed. The commenter also 
inquired whether the risk classification of a field would be subject to 
change after initial classification. No appeal process has been 
established. After initial classification, changes would occur only 
when positive survey results indicate that it is appropriate.
    Several commenters expressed concern that the ``regulated'' areas 
in the proposed rule were identical to the ``quarantined'' areas in the 
current regulations, and recommended that the regulated areas be 
reduced. In this final rule, we are making certain changes to the 
existing quarantined areas. Additionally, there are significant 
differences between restricted areas as defined in this final rule, and 
surveillance areas.
    One commenter questioned whether the Department has the resources 
to regulate the different field classifications, rather than simply on 
an ``area'' level. We are confident we have sufficient resources to 
enforce the regulations. Operationally, we consider the regulatory 
scheme in this final rule to be simpler than that in our proposed rule.
    One commenter inquired whether currently quarantined areas that do 
not fit into one of the classifications described above would be 
considered not to be quarantined. As noted above, in this final rule, 
we are removing from regulation additional wheat growing areas that 
have no association with contaminated seed, We believe the remaining 
areas can be categorized.
    Several commenters recommended that only four categories of fields 
be established, as follows:
    1. Fields in which 1996 preharvest samples tested positive;
    2. Fields known positively to have been planted with contaminated 
seed since 1995;
    3. Fields in which 1996 preharvest samples tested negative; and
    4. Fields outside the 1996 regulated area. We are not adopting the 
commenter's recommended scheme, which we consider to require 
regulations essentially the same as those in effect during the 1996 
harvest. We believe that, based on survey data, we can relax 
restrictions in the coming crop year in some areas, while we gather 
more data on the extent of the infestation.
    As part of this scheme of four categories, the commenters 
recommended the following:
    Host Planting: Prohibited for 1 year in categories ``1'' and ``2;'' 
unrestricted in categories ``3'' and ``4.''
    Seed: No seed should be present in categories ``1'' and ``2;'' test 
and treat in category ``3;'' recommend treatment in category ``4.''
    Disposition of Grain: No grain should be present in categories 
``1'' and ``2;'' unrestricted disposition from categories ``3'' and 
``4.''
    Decontamination: Decontaminate equipment with soil in categories 
``1'' and ``2;'' decontaminate only equipment that came into contact 
with contaminated wheat in categories ``3'' and ``4''
    Millfeed Treatment: No requirements.
    With regard to the restrictions and requirements recommended by the 
commenters, we believe that due to the potential natural and artificial 
movement of the Karnal bunt pathogen, areas that include fields that 
test positive are a high risk, and that different levels of regulatory 
activity within areas, not only fields, is appropriate.
    One commenter recommended that the current quarantine be replaced 
with a program of ``monitored grain exchange,'' to contain three key 
elements:
    1. Require that all seed, feed, and grain be twice tested negative 
before leaving areas where there is a risk of contamination, and 
require source labeling for all grain shipped from these areas.
    2. Within the current quarantined area, classify zones according to 
three levels of risk, as follows:
    a. Zone 1: Bunted kernels have been confirmed. No grain may leave 
area, except for use as feed. All grain exceeding a specified tolerance 
is removed from distribution.
    b. Zone 2: No contamination has been found, but a risk of 
contamination exists. Allow grain to move to designated end-use sites, 
such as research facilities, certain seed replication sites, and flour 
mills.
    c. Zone 3: No contamination has been found. Allow unlimited grain 
movement once samples have been twice tested negative.
    3. Establish a multi-level tolerance based on end use. As noted 
above, we have modified the regulatory scheme we proposed. We have 
included several elements similar to those suggested by the commenter, 
including the testing twice of all grain, restricted movement of grain 
from areas that tested positive or presented a risk

[[Page 52203]]

of contamination, and unrestricted movement from areas of minimal risk.
    The provisions in Sec. 301.89-4 of the current regulations set 
forth conditions for the movement of regulated articles from 
quarantined areas. These provisions are similar to those set forth in 
Sec. 301.89-5 of the proposed rule, ``Movement of regulated articles 
from or within regulated areas.''

Comments on Specific Categories

    We now discuss comments that addressed specific categories of 
fields as set forth in our proposal.

1. Fields in Which Preharvest Samples Tested Positive for Karnal Bunt

    One commenter specifically supported this risk classification. 
Another commenter recommended that future plantings in this category be 
limited for 5 years to crops that are not hosts of Karnal bunt. Another 
commenter recommended that the regulations require that wheat be 
planted no more often than every third year in a field testing positive 
for Karnal bunt. During the 1996-97 crop season, we are prohibiting the 
planting of host crops in fields that tested positive in the 1996 
harvest testing. We will reassess this prohibition on an annual basis 
after considering new survey and scientific information.
    Several commenters stated that the proposed requirements for the 
treatment of millfeed from wheat from fields of this category are 
unnecessary, because fields that tested positive in 1996 would have no 
wheat grown on them in 1997. To eliminate any confusion, we have 
reworded the regulations to clarify that this applies only to fields 
that test positive in the future. However, we expect to find additional 
fields that test positive. Millfeed produced from grain originating 
from such positive fields will require appropriate treatment and 
handling.
    One commenter stated that if a new field tested positive for Karnal 
bunt in 1997, the grain would be heat treated, sent to a feedlot within 
the quarantined area, or handled in some other fashion that would not 
spread the disease, and there would be no millfeed. We are cooperating 
with the industry and States to develop additional options for positive 
grain, such as milling or export.
    One commenter inquired how APHIS would classify a field that tested 
positive during preharvest testing, then was harvested and tested 
negative at harvest. In such a situation, the field would be classified 
as positive for Karnal bunt.
    Several commenters objected to the proposed requirement that 
vegetable crops that are not moved to an approved processing facility 
must be cleaned of all soil and plant debris prior to movement from 
fields in this category, and also from fields in categories ``2'' and 
``3,'' as described below. The commenters stated that fresh fruits and 
vegetables are in a ``consumer market'' upon harvest and packaging, and 
therefore present no risk of spreading Karnal bunt. Most fruit and 
vegetables are cleaned prior to being sold. We are concerned with the 
handling of the soil resulting from this cleaning when the fruits and 
vegetables are moved outside the regulated area.

2. Fields Known to be Planted in the Past 5 Years With Seed 
Contaminated With Karnal Bunt

    One commenter stated that the 5-year period may be too long, based 
on a report from India that, according to the commenter, indicated that 
Karnal bunt spores can survive in the soil for only 27-45 months. One 
commenter objected to having to disinfect equipment because seed known 
to be contaminated was planted in 1994, if all lots of seed in 1995 
tested negative. Several commenters recommended that this category 
include only fields known to be planted with contaminated seed within 
the last year. We agree that the issue of spore viability requires 
further review, and are conducting such review. Due to the need for 
such review, and the absence of historical records regarding many 
fields, in this final rule, we have changed the description of fields 
of this type to include only fields planted with contaminated seed in 
1995. In addition, in the final rule, we are not requiring cleaning and 
sanitization of equipment moving within the regulated area, except from 
fields testing positive for Karnal bunt during the 1996-97 crop season.
    One commenter recommended that future plantings in this category of 
field be limited for 5 years to crops that are not hosts of Karnal 
bunt. During the 1996-97 crop season, we are prohibiting the planting 
of host crops in fields that were planted with contaminated seed in 
1995. We will reassess this prohibition on an annual basis after 
considering new survey and scientific information.
    One commenter questioned the need to clean and disinfect equipment 
moving out of the regulated area from fields of this category, stating 
that wind erosion can relocate more spores in 12 hours than equipment 
could carry in years. In order to protect other wheat growing areas of 
the United States, we consider it necessary to require cleaning and 
sanitization of equipment and conveyances moving out of a regulated 
area. However, as discussed earlier in this document, we acknowledge 
the role of wind in the local movement of the pathogen and have removed 
the requirement for cleaning and sanitization for movement within the 
regulated area, except from fields testing positive for Karnal bunt 
during the 1996-97 crop season.
    Several commenters recommended that future planting restrictions 
for fields of this category be applied only if there is direct evidence 
that the seed planted was from a contaminated source and the specific 
location of the site where it was planted can be identified. We agree 
with the commenters' recommendation and, as noted above, have redefined 
this category as fields planted in 1995 with known contaminated seed. 
This categorization will be applied only if there is direct evidence 
that the seed planted was from a contaminated source and if the 
specific location of the site where it was planted can be identified.
    Several commenters recommended that no planting restrictions be 
applied to fields in this category, and one commenter described this 
category as unrealistic. The commenter stated that unless the seeds are 
checked by DNA analysis and tested for germination, there is no 
certainty that the spores are Karnal bunt. The commenter also stated 
that the presence of a relatively small number of spores in soil may 
not mean there is significant risk when moving wheat from the area. We 
are making no changes based on these comments. The lots in question 
that were planted in 1995 were determined to be contaminated by the 
presence of bunted kernels, by standard microscopic diagnostic 
techniques involving morphometric characteristics, and/or by DNA 
analysis. We consider it necessary to prohibit planting of host crops 
in fields where contaminated seed was planted. Planting of host crops 
would allow multiplication and probable spread of the disease.
    Several commenters stated that the requirement to clean soil and 
plant debris from vegetables from this category of fields is excessive 
and should be removed. We are making no changes based on these 
comments. We consider it necessary to require that vegetable crops 
moving outside the regulated area be cleaned of all soil and plant 
debris prior to movement, or be moved under limited permit to 
processing facilities for cleaning.
    One commenter stated that if there is a prohibition against 
planting in a field in which a preharvest sample has tested positive or 
a field that has been planted within the last 5 years with

[[Page 52204]]

contaminated seed, it should also apply to such fields outside the 
regulated area. If it does not, said the commenter, the scientific 
basis for such a decision should be published. We consider our response 
to the comment discussed earlier regarding varying restrictions on 
different areas to be applicable here. As noted, APHIS has traced 
contaminated seed to several locations outside the regulated areas. In 
some cases, the seed had not been planted but was still in storage. In 
those cases, the seed was destroyed and the facilities were cleaned and 
sanitized. Contaminated seed was traced to several small research 
plots, where the fields were plowed down and fumigated. In some 
instances, despite extensive testing and traceback efforts, we have not 
been able to confirm that contaminated seed was either distributed or 
planted in the area in question. We are continuing additional 
monitoring activities in those areas. We consider such measures 
sufficient to ensure that Karnal bunt is eliminated from the site 
without the unnecessary imposition of a geographic quarantine.

3. Fields Adjacent to Fields in Which Preharvest Samples Tested 
Positive

    Several commenters recommended that this category be deleted, 
stating that no scientific justification exists for presuming that 
Karnal bunt can be easily spread from field to field due only to 
physical proximity. Alternatively, the commenters recommended that 
``adjacent'' be defined, and not mean fields separated by main roads, 
main canals, agricultural drains, and other large landmarks. Several 
commenters opposed restrictions on movement from this category of 
fields, as well as requirements for cleaning and disinfection and the 
treatment of millfeed. The proposed category of fields referred to by 
the commenters is not set forth in this final rule. All fields in an 
area that includes a field that tests positive are now classified as 
being part of a restricted area. There is a higher risk in these areas 
that the pathogen is present due to windborne spread and movement of 
equipment and means of conveyance prior to regulation.

4. Fields Associated Only Through Ownership, Management, the Movement 
of Equipment, or Proximity Within a Distinct Definable Area With Fields 
in Which Preharvest Samples Tested Positive

    Several commenters recommended that this category be deleted, 
because, according to the commenters, there is no evidence that Karnal 
bunt has been spread among fields associated as described. The 
commenters opposed the proposed requirement for the treating of 
millfeed from fields of this category. One commenter stated that APHIS 
should either state the scientific basis for regulating these fields, 
or consider these fields outside the regulated area. Although this 
category of fields is not specifically set forth in this final rule, we 
consider our response to the previous comment applicable here.
    One commenter recommended that this category should also include 
fields that are possibly associated with contaminated seed, but for 
which direct evidence is not available. The commenter cited the 
situation where a specific field in which contaminated wheat was 
planted cannot be identified because the grower did not keep records. 
In such a case, said the commenter, all fields planted to the same 
variety as the contaminated seed are suspect. The commenter stated 
that, because of the elevated risk of fields in this category, farm 
equipment, farm tools, and soil moving equipment should be required to 
be cleaned and disinfected prior to movement from fields in this 
category to locations outside the regulated area. In this final rule, 
we have modified our decontamination requirements to require cleaning 
and sanitization of farm equipment, tools, and soil-moving equipment 
prior to movement out of the regulated area, and prior to movement from 
fields testing positive for Karnal bunt during the 1996-97 growing 
seasons.
    One commenter stated that the cleaning and disinfection 
requirements for fields in categories ``1,'' ``2,'' and ``3'' should 
also apply to regulated articles from fields in categories ``4'' and 
``5.'' The commenter stated that 1996 pre-harvest testing did not 
detect the presence of Karnal bunt in all infected or contaminated 
fields, that there were reported cases where positive post-harvest 
testing followed negative pre-harvest testing, and that, because all 
fields with a history of wheat production in years prior to the 1995-96 
crop were not planted to wheat in 1995-96, there are no pre-harvest 
test results from these fields to provide evidence of area freedom from 
Karnal bunt. We agree with the commenter. This final rule requires that 
equipment and means of conveyance moved out of any regulated area be 
cleaned and sanitized. As noted above, however, we are not requiring 
cleaning for movement within the regulated area, except from fields 
testing positive for Karnal bunt during the 1996-97 crop season.

5. Fields Within a Regulated Area That are Not Fields Described in 
``2'' and ``4,'' and That are Part of a Distinct Definable Area That 
Includes No Fields in Which Preharvest Samples Tested Positive

    One commenter supported the proposed provision that millfeed from 
wheat from fields of this category need not be treated to be moved from 
a regulated area. Several commenters recommended that fields meeting 
this classification be removed from the regulated area. We are making 
no changes based on these comments. We consider it necessary to 
regulate these fields and areas because of the movement of contaminated 
equipment and seed, composite samples that tested positive in the 
areas, and the fact that many fields that were planted to wheat in 
years prior have not been sampled.

Seed For Planting

    One commenter stated that the requirements regarding planting seed 
in Sec. 301.89-4 as proposed should make clear that seed to be planted 
must first be sampled and tested negative for Karnal bunt, then be 
treated with a fungicide. The regulations as proposed set forth the 
fungicide requirement first, then the sampling and testing requirement. 
We agree that the recommended change would clarify our intent and have 
made the change in this final rule.
    One commenter stated that it would be helpful to the wheat industry 
if APHIS specified which fungicides are acceptable. We agree with the 
commenter, and have added to Sec. 301.89-13 of this final rule the 
provision that the treatment for seed must consist of either: (1) 6.8 
fl. oz. of Carboxin thiram (10 percent + 10 percent, 0.91 + 0.91 lb. 
ai./gal.) flowable liquid and 3 fluid ounces of pentachloronitrobenzene 
(2.23 lb. ai./gal.) per 100 pounds of seed; or (2) 4.0 fluid ounces of 
carboxin-thiram (1.67 + 1.67 lb. ai./gal.) flowable liquid and 3 fluid 
ounces of pentachloronitrobenzene (2.23 lb. ai./gal.) per 100 pounds of 
seed.
    One commenter asked APHIS to specify whom the Agency would allow to 
conduct the required sampling and testing. APHIS and State 
representatives conduct the sampling and testing.
    One commenter stated that the requirement in Sec. 301.89-4 for 
sampling and negative testing of seed to be planted should apply only 
to wheat seed originating within a regulated area. We disagree. We 
consider it necessary to ensure that all seed planted in the regulated 
area is free of Karnal bunt, and to be able to identify any sources of

[[Page 52205]]

contamination outside the regulated area.
    One commenter recommended that no seed be planted within a 
quarantined area unless it has been certified as having undergone the 
necessary phytosanitary requirements, and has been treated with 
antifungicides. We are making no changes based on this comment. In this 
final rule, we require that all seed to be planted within a regulated 
area be tested for the causal agent of Karnal bunt and be treated with 
a fungicide.

Millfeed

    Section 301.89-13 of the proposed rule set forth requirements for 
approved treatments for regulated articles, including millfeed. Several 
commenters stated that requirements for treatment of millfeed should 
apply only to millfeed from wheat grown in fields that have tested 
positive for Karnal bunt. APHIS is requiring millfeed to be treated if 
from grain originating in restricted areas. There is a risk of movement 
of the pathogen with wind or equipment and means of conveyance from 
fields that test positive. Many fields that will be planted in wheat in 
the 1996-97 crop season have not been tested.
    One commenter requested that the requirement that millfeed from 
quarantined areas be treated be reviewed, especially if it can be shown 
that its final destination and disposition does not present a 
significant risk for re-infection or disease spread to new areas. One 
commenter stated that APHIS should continue its policy of allowing 
States to govern millfeed movement, and should continue its policy of 
not inspecting or quarantining flour mills. We agree that final 
destination and disposition of millfeed is important in determining 
risk. During the 1996 harvest, we allowed the destination State to 
determine appropriate treatment and handling based on the intended use 
within their State. Interstate movement was still monitored and treated 
when appropriate. This final rule requires special treatment and 
handling of millfeed only when the grain originates from distinct 
definable areas that have fields that test positive. We are not 
conducting detection surveys in flour mills.
    Several commenters recommended that millfeed that results from the 
milling of wheat from clean areas within the quarantined area and/or 
wheat that has been tested and found free of teliospores should be 
allowed to move freely in commerce, and that treatment of the millfeed 
should be required only when teliospores have been detected. One 
commenter stated that it appeared that millfeed from grain from all 
areas of Arizona would have to be treated. In this final rule, we are 
not requiring millfeed to be treated if from grain originating in 
surveillance areas. The regulated areas in Arizona include several 
surveillance areas. As discussed above, we consider grain from 
restricted areas to pose a higher risk. APHIS will continue to allow 
destination States willing to accept responsibility to determine the 
appropriate treatment and handling based on the intended use within 
their States.
    One commenter objected to the requirement that millfeed be heat 
treated at 170 oF for at least 1 minute, and recommended instead 
that the treatment require only instantaneous heating to 170 oF. 
The commenter stated that the 1-minute requirement would require 
substantial capital investment and would have a negative effect on 
mills, which the commenter stated rely on high throughput rates. We are 
making no changes based on this comment. The ``1-minute'' requirement 
ensures that all surface areas are exposed to a temperature that will 
devitalize any spores present.
    One commenter stated that the requirement for heat treatment of 
millfeed should be maintained unless other effective mitigating 
measures can be identified. We agree and are retaining the heat 
treatment requirement in this final rule. However, as noted, under this 
final rule we are reducing the amount of millfeed that would have to be 
treated.
    Several commenters recommended that APHIS review the millfeed 
treatment requirements, and consider all options that reduce the risk 
of further contamination, but that may be more easily incorporated in 
existing milling processes. APHIS has reduced the millfeed treatment 
requirement and has provided alternatives for disposition in States 
willing to accept the responsibility for monitoring. We are continually 
looking for other options that are effective and less intrusive, and 
are willing to explore any ideas that may be more easily incorporated 
into existing milling processes.

Additional Comments

    One commenter requested that no areas in New Mexico be classified 
as regulated areas. The commenter recommended that no quarantines be 
placed on a field in that State unless preharvest sampling shows the 
existence of Karnal bunt. We disagree with the commenter's 
recommendation. We consider it necessary to continue to regulate these 
fields and areas because of the potential movement of contaminated 
equipment and seed prior to regulation, and the fact that many fields 
that were planted to wheat in years prior have not yet been sampled. 
However, under this final rule, all regulated areas in New Mexico will 
at this time be classified as surveillance areas, rather than as 
restricted areas.
    Section 301.89-12(b) of our proposed rule provided that vegetable 
crops be cleaned of all soil and plant debris prior to movement outside 
the regulated area, or be moved under limited permit to processing 
facilities approved by the Administrator. One commenter expressed 
concern that this requirement might be applied to fields that have not 
been contaminated with Karnal bunt. We believe that requiring that 
vegetable crops moving outside the regulated area meet the conditions 
for freedom from soil described above is necessary to protect other 
wheat production areas.
    Section 301.89-12(a) of the proposed rule sets forth cleaning and 
disinfection requirements for used mechanized cultivating equipment, 
used mechanized harvesting equipment, used farm tools, and used 
mechanized soil-moving equipment. One commenter recommended that the 
cleaning and disinfection requirements also apply to used seed 
conditioning equipment. We agree and are making the appropriate 
addition in this final rule.
    A number of commenters submitted comments that expressed general 
concerns about the economic impact of the Karnal bunt program, without 
addressing specific issues. Others expressed general criticisms of the 
way the Karnal bunt regulations were being carried out, expressed 
concern regarding the effect of the Karnal bunt regulations on 
international trade, or expressed an opinion regarding APHIS' role in 
research regarding the disease. Although we are not specifically 
addressing these comments in this final rule, we have reviewed each one 
of them carefully, and share their concerns that the Karnal bunt 
program must remain a risk-based program to prevent the artificial 
spread of Karnal bunt.

Changes to Areas Regulated Because of Karnal Bunt

    A number of commenters recommended that the areas quarantined 
because of Karnal bunt be reduced as evidence indicates which areas do 
not pose a risk of having the disease. We agree with the commenters. 
When the initial quarantined areas were established, they were 
deliberately broadly drawn due to the lack of data available at that 
time as to the extent of the infestation. Based on sampling and testing 
during the past months, we have been able to shrink the areas 
designated

[[Page 52206]]

as quarantined areas. In this final rule, we are further reducing areas 
regulated because of Karnal bunt.
    We are amending Sec. 301.89-3(e) of the regulations by removing the 
following portions of the States of Arizona, New Mexico and Texas from 
the list of quarantined areas: The entire county of Mohave, AZ, 
portions of Dona Ana and Sierra Counties, NM, and portions of El Paso 
and Hudspeth Counties, TX. These areas do not produce wheat, durum 
wheat, or triticale, or do produce wheat but we have been able to 
determine that they have no association with Karnal bunt contaminated 
seed, and, therefore, do not present a risk of being, or becoming, 
infested with Karnal bunt. In addition, we are making editorial changes 
to the description of the quarantined area in Luna County, NM, for 
clarity and consistency. The remainder of the counties listed in 
Sec. 301.89-3(e) will remain under regulation because of potential 
infestation with Karnal bunt.
    The area of Dona Ana County, NM, that will remain under regulation 
is that portion of the county bounded as follows: Beginning at the 
intersection of the Sierra/Dona Ana County line and Interstate 25; then 
south along Interstate 25 to the Texas State line; then west and south 
along the New Mexico/Texas State line to the United States/Mexico 
boundary; then west along the United States/Mexico boundary to the 
Luna/Dona Ana County line; then north and east along the Dona Ana 
County line to the point of beginning.
    The areas of Sierra County, NM, that will remain under regulation 
are those portions of the county bounded as follows: (1) Beginning at 
intersection of the Luna/Sierra County line and State Route 27; then 
north along State Route 27 to State Route 152; then east along State 
Route 152 to Interstate 25; then south along Interstate 25 to the Dona 
Ana County line; then west and south to the Luna County line; then west 
along the Luna/Sierra County line to the point of beginning; and (2) 
Beginning at the intersection of the Socorro/Sierra County line and 
State Route 142; then southeast along State Route 142 to State Route 
52; then south along State Route 52 to Interstate 25; then north along 
Interstate 25 to the Socorro/Sierra County line; then west along the 
Socorro/Sierra County line to the point of beginning.
    The area of El Paso County, TX, that will remain under regulation 
is that portion of the county bounded as follows: Beginning at a point 
on the Rio Grande River due east from the intersection of County Route 
659 and County Route 375; then due east along an imaginary line to 
County Route 659; then north along County Route 659 to Interstate 10; 
then southeast along Interstate 10 to the El Paso/Hudspeth County line; 
then southwest along the El Paso/Hudspeth County line to the Rio Grande 
River; then north along the Rio Grande River to the point of beginning.
    The area of Hudspeth County, TX, that will remain under regulation 
is that portion of the county bounded as follows: Beginning at the 
intersection of the El Paso/Hudspeth County line and Interstate 10; 
then southeast along Interstate 10 to County Route 34; then south along 
County Route 34 to County Route 192; then due south along an imaginary 
line to the Rio Grande River; then northwest along the Rio Grande River 
to the El Paso/Hudspeth County line; then north along the El Paso/
Hudspeth County line to the point of beginning.
    This action relieves unnecessary regulatory restrictions on the 
public while continuing to prevent the artificial spread of Karnal bunt 
into noninfested areas of the United States. Additionally, in this 
final rule as discussed above in this Supplementary Information, the 
areas designated as regulated areas in Sec. 301.89-3 of this final rule 
are divided into ``restricted areas'' and ``surveillance areas,'' as 
set forth in Sec. 301.89-3.

Executive Order 12866 and Regulatory Flexibility Act

    This rule has been reviewed under Executive Order 12866. This rule 
has been determined to be economically significant for purposes of 
Executive Order 12866 and, therefore, has been reviewed by the Office 
of Management and Budget.
    This action makes final with certain changes a series of interim 
rules establishing and amending regulations regarding a program to 
control and eradicate Karnal bunt in the United States, and a proposed 
rule establishing criteria for levels of risk for areas with regard to 
Karnal bunt, and criteria for seed planting and movement of regulated 
articles based on those risk levels. It does not make final an interim 
rule establishing compensation for certain growers and handlers, owners 
of grain storage facilities, and flour millers in order to mitigate 
losses and expenses incurred because of Karnal bunt. We are still 
considering issues related to compensation. This rule is being 
published on an emergency basis in order to give affected growers the 
opportunity to make planting decisions for the 1996-97 crop season on a 
timely basis. This emergency situation makes timely compliance with 
section 6, subsections (3)(B)(ii) and (3)(C), of Executive Order 12866 
impracticable. We will complete the required cost-benefit analysis as 
soon as possible and make this information available to the public. 
Further, this emergency situation makes compliance with section 603 and 
timely compliance with section 604 of the Regulatory Flexibility Act (5 
U.S.C. 603 and 604) impracticable. This rule may have a significant 
economic impact on a substantial number of small entities. If we 
determine this is so, then we will discuss the issues raised by section 
604 of the Regulatory Flexibility Act in our Final Regulatory 
Flexibility Analysis, which we will publish in a future Federal 
Register.

Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 
104-121, 5 U.S.C. Secs. 801-808)

    This rule has been designated by the Administrator, Office of 
Information and Regulatory Affairs, Office of Management and Budget, as 
a major rule under the Small Business Regulatory Enforcement Fairness 
Act of 1996 (Act). The Administrator of the Animal and Plant Health 
Inspection Service has determined, however, that there is good cause 
for making this rule effective less than 60 days after submission of 
the rule to each House of Congress and to the Comptroller General 
because a delay in the implementation of this rule would be contrary to 
the public interest. It is necessary to make this rule effective 30 
days after publication in the Federal Register in order that affected 
growers and other regulated parties can make critical planning 
decisions for the 1996-1997 crop year. Obviously, it is also essential 
to remove, as soon as possible, many other restrictions affecting 
growers and other regulated parties that are deemed unnecessary in this 
final rule. Section 808 of the Act provides that rules which would be 
exempted from the notice and comment provisions of the Administrative 
Procedure Act may be excepted from section 801(a)(1)(A), and the delay 
in the effective date for major rules under section 801(a)(3). Such 
rules may be made effective as the agency promulgating the rule 
determines.
    A 60-day or longer delay of the effective date for this final rule 
would clearly be contrary to the public interest, since it would result 
in unnecessary burdens on affected growers and other regulated parties 
who would otherwise be released from regulation or be subjected to 
lesser regulatory requirements than under the current rules. This is a 
critical time for growers in the regulated areas. These growers

[[Page 52207]]

must make their planting decisions promptly for the 1996-1997 crop 
season.

Executive Order 12372

    This program/activity is listed in the Catalog of Federal Domestic 
Assistance under No. 10.025 and is subject to Executive Order 12372, 
which requires intergovernmental consultation with State and local 
officials. (See 7 CFR part 3015, subpart V.)

Executive Order 12988

    This rule has been reviewed under Executive Order 12988, Civil 
Justice Reform. This rule: (1) Preempts all State and local laws and 
regulations that are inconsistent with this rule will be preempted; (2) 
has no retroactive effect; and (3) does not require administrative 
proceedings before parties may file suit in court challenging this 
rule.

National Environmental Policy Act

    An environmental assessment and finding of no significant impact 
have been prepared for this rule. The assessment provides a basis for 
the conclusion that the anti-fungicide and other sanitization 
treatments required under the Karnal bunt regulations do not present a 
risk of introducing or disseminating plant pests and will not have a 
significant impact on the quality of the human environment. Based on 
the finding of no significant impact, the Administrator of the Animal 
and Plant Health Inspection Service has determined that an 
environmental impact statement need not be prepared.
    The environmental assessment and finding of no significant impact 
were prepared in accordance with: (1) The National Environmental Policy 
Act of 1969 (NEPA) (42 U.S.C. 4321 et seq.), (2) Regulations of the 
Council on Environmental Quality for implementing the procedural 
provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations 
implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing 
Procedures (7 CFR part 372).
    Copies of the environmental assessment and finding of no 
significant impact are available for public inspection at USDA, room 
1141, South Building, 14th Street and Independence Avenue SW., 
Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday, 
except holidays. Persons wishing to inspect copies are requested to 
call ahead on (202) 690-2817 to facilitate entry into the reading room. 
In addition, copies may be obtained by writing to the individual listed 
under FOR FURTHER INFORMATION CONTACT.

Paperwork Reduction Act

    This rule contains no new information collection or recordkeeping 
requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
et seq.).

Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub. 
L. 104-4, establishes requirements for Federal agencies to assess the 
effects of their regulatory actions on State, local, and tribal 
governments and the private sector. Under section 202 of the UMRA, 
APHIS generally must prepare a written statement, including a cost-
benefit analysis, for proposed and final rules with ``Federal 
mandates'' that may result in expenditures to State, local, or tribal 
governments, in the aggregate, or to the private sector, of $100 
million or more in any one year. When such a statement is needed for a 
rule, section 205 of the UMRA generally requires APHIS to identify and 
consider a reasonable number of regulatory alternatives and adopt the 
least costly, more cost-effective or least burdensome alternative that 
achieves the objectives of the rule.
    This rule contains no Federal mandates (under the regulatory 
provisions of Title II of the UMRA) that may result in expenditures to 
State, local, and tribal government, in the aggregate, or to the 
private sector, of $100 million or more in any one year. Thus, this 
rule is not subject to the requirements of sections 202 and 205 of the 
UMRA.

List of subjects in 7 CFR Part 301

    Agricultural commodities, Plant diseases and pests, Quarantine, 
Reporting and recordkeeping requirements, Transportation.

PART 301--DOMESTIC QUARANTINE NOTICES

    Accordingly, 7 CFR part 301 is amended as follows:
    1. The authority citation for part 301 continues to read as 
follows:

    Authority: 7 U.S.C. 150bb, 150dd, 150ee, 150ff, 161, 162, and 
164-167; 7 CFR 2.22, 2.80, and 371.2(c).

    2. In part 301, ``Subpart--Karnal Bunt,'' Secs. 301.89-1 through 
301.89-12, is amended by revising the table of contents and 
Secs. 301.89-1 through 301.89-11, by redesignating Sec. 301.89-12 as 
Sec. 301.89-14, by and by adding new Secs. 301.89-13 and adding an 
Appendix to read as follows:

Subpart--Karnal Bunt

Sec.
301.89-1  Definitions.
301.89-2  Regulated articles.
301.89-3  Regulated areas.
301.89-4  Planting.
301.89-5  Movement of regulated articles from regulated areas.
301.89-6 Issuance of a certificate or limited permit.
301.89-7 Compliance agreements.
301.89-8 Cancellation of a certificate, limited permit, or 
compliance agreement.
301.89-9 Assembly and inspection of regulated articles.
301.89-10 Attachment and disposition of certificates and limited 
permits.
301.89-11 Costs and charges.
301.89-12 Cleaning and disinfection.
301.89-13 Treatments.
301.89-14 Compensation.

Appendix to Subpart--Karnal Bunt


Sec. 301.89-1  Definitions.

    Administrator. The Administrator, Animal and Plant Health 
Inspection Service, or any person authorized to act for the 
Administrator.
    Animal and Plant Health Inspection Service (APHIS). The Animal and 
Plant Health Inspection Service of the U.S. Department of Agriculture.
    Certificate. A document in which an inspector or a person operating 
under a compliance agreement affirms that a specified regulated article 
meets the requirements of this subpart and may be moved to any 
destination.
    Compliance agreement. A written agreement between APHIS and a 
person engaged in growing, handling, or moving regulated articles, in 
which the person agrees to comply with the provisions of this subpart 
and any conditions imposed under this subpart.
    Contaminated seed. Seed from sources in which the Karnal bunt 
pathogen (Tilletia indica (Mitra) Mundkur) has been determined to 
exist.
    Conveyances. Containers used to move wheat, durum wheat, or 
triticale, or their products, including trucks, trailers, railroad 
cars, bins, and hoppers.
    Distinct definable area. A commercial wheat production area of 
contiguous fields that is separated from other wheat production areas 
by desert, mountains, or other nonagricultural terrain as determined by 
an inspector, or, in the case of restricted areas, as determined by an 
inspector based on survey results, including the number of positive 
fields and the relative spore count of the fields within the area.
    Farm tools. An instrument worked or used by hand, e.g., hoes, 
rakes, shovels, and axes.
    Infestation (infected). The presence of Karnal bunt, or any stage 
of development of the fungus Tilletia

[[Page 52208]]

indica (Mitra) Mundkur, or the existence of circumstances that make it 
reasonable to believe that Karnal bunt is present.
    Inspector. An APHIS employee or designated cooperator/collaborator 
authorized by the Administrator to enforce the provisions of this 
subpart.
    Karnal bunt. A plant disease caused by the fungus Tilletia indica 
(Mitra) Mundkur.
    Limited permit. A document in which an inspector affirms that a 
specified regulated article not eligible for a certificate is eligible 
for movement only to a specified destination and in accordance with 
conditions specified on the permit.
    Mechanized cultivating equipment and mechanized harvesting 
equipment. Mechanized equipment used for soil tillage, including 
tillage attachments for farm tractors--e.g., tractors, disks, plows, 
harrows, planters, and subsoilers; mechanized equipment used for 
harvesting purposes--e.g., combines, cotton harvesters, and hay balers.
    Milling products and byproducts. Products and byproducts resulting 
from processing wheat, durum wheat, or triticale, including animal 
feed, waste and debris.
    Movement (moved). The act of shipping, transporting, delivering, or 
receiving for movement, or otherwise aiding, abetting, inducing or 
causing to be moved.
    Person. Any association, company, corporation, firm, individual, 
joint stock company, partnership, society, or any other legal entity.
    Premises. All structures, conveyances, or materials associated with 
a grain storage facility at a single location.
    Soil. The loose surface material of the earth in which plants grow, 
in most cases consisting of disintegrated rock with an admixture of 
organic material.
    Soil-moving equipment. Equipment used for moving or transporting 
soil, including, but not limited to, bulldozers, dump trucks, or road 
scrapers.
    State. The District of Columbia, Puerto Rico, the Northern Mariana 
Islands, or any State, territory, or possession of the United States.


Sec. 301.89-2  Regulated articles.

    The following are regulated articles:
    (a) Conveyances, including trucks, railroad cars, and other 
containers used to move wheat, durum wheat, or triticale;
    (b) Grain elevators/equipment/structures used for storing and 
handling wheat, durum wheat, and triticale;
    (c) Milling products or byproducts, except flour;
    (d) Plants, or plant parts, including grain, seed, or straw of all 
varieties of the following species:

    Wheat: Triticum aestivum;
    Durum wheat: Triticum durum; and
    Triticale: Triticum aestivum X Secale cereale;

    (e) Tilletia indica (Mitra) Mundkur;
    (f) Root crops with soil;
    (g) Soil from areas where field crops are produced;
    (h) Manure from animals that have fed on untreated or raw wheat, 
durum wheat, or triticale;
    (i) Used bags, sacks and containers;
    (j) Used farm tools and equipment;
    (k) Used mechanized cultivating equipment;
    (l) Used mechanized harvesting equipment;
    (m) Used seed conditioning equipment;
    (n) Used mechanized soil-moving equipment; and
    (o) Any other product, article or means of conveyance when:
    (1) An inspector determines that it presents a risk of spreading 
Karnal bunt due to its proximity to an infestation of Karnal bunt; and
    (2) The person in possession of the product, article, or means of 
conveyance has been notified that it is regulated under this subpart.


Sec. 301.89-3  Regulated areas.

    (a) The Administrator will regulate each State or each portion of a 
State that is infected.
    (b) Less than an entire State will be listed as a regulated area 
only if the Administrator:
    (1)(i) Determines that the State has adopted and is enforcing 
restrictions on the intrastate movement of the regulated articles 
listed in Sec. 301.89-2 that are equivalent to the movement 
restrictions imposed by this subpart; and
    (ii) Determines that designating less than the entire State as a 
regulated area will prevent the spread of Karnal bunt; or
    (2) Exercises his or her extraordinary emergency authority under 7 
U.S.C. 150dd.
    (c) The Administrator may include noninfected acreage within a 
regulated area due to its proximity to an infestation or inseparability 
from the infected locality for regulatory purposes, as determined by:
    (1) Projections of the spread of Karnal bunt along the periphery of 
the infestation;
    (2) The availability of natural habitats and host materials within 
the noninfected acreage that are suitable for establishment and 
survival of Karnal bunt; and
    (3) The necessity of including uninfected acreage within the 
regulated area in order to establish readily identifiable boundaries.
    (d) The Administrator or an inspector may temporarily designate any 
nonregulated area as a regulated area in accordance with the criteria 
specified in paragraphs (a), (b), and (c) of this section. The 
Administrator will give written notice of this designation to the owner 
or person in possession of the nonregulated area, or, in the case of 
publicly owned land, to the person responsible for the management of 
the nonregulated area. Thereafter, the movement of any regulated 
article from an area temporarily designated as a regulated area is 
subject to this subpart. As soon as practicable, this area either will 
be added to the list of designated regulated areas in paragraph (e) of 
this section, or the Administrator will terminate the designation. The 
owner or person in possession of, or, in the case of publicly owned 
land, the person responsible for the management of, an area for which 
the designation is terminated will be given written notice of the 
termination as soon as practicable.
    (e) The Administrator will classify areas within the regulated 
boundaries as either restricted areas or surveillance areas. Fields 
within each restricted area and surveillance area will be classified 
according to the following categories:
    (1) Restricted areas: A restricted area is a distinct definable 
commercial wheat production area that includes at least one field that 
tested positive for Karnal bunt. Fields within a restricted area fall 
into one of three categories:
    (i) Fields in which preharvest samples tested positive for Karnal 
bunt;
    (ii) Fields known to be planted in the 1995 with seed contaminated 
with Karnal bunt; or
    (iii) All other fields within a distinct definable area with fields 
in which preharvest samples tested positive.
    (2) Surveillance areas: A surveillance area is a distinct definable 
commercial wheat production area in which no fields have tested 
positive for Karnal bunt, but in which movement of contaminated seed 
has occurred. Fields within a surveillance area fall into one of three 
categories:
    (i) Fields known to be planted in 1995 with seed contaminated with 
Karnal bunt; or
    (ii) All other fields within a distinct definable area that 
includes no fields in which preharvest samples tested positive.
    (3) Fields in a regulated area for which the Administrator has 
given no notification of classification to the

[[Page 52209]]

owner or the person in possession of the field shall be considered to 
be fields as described in paragraph (e)(2)(ii) of this section.
    (f) The following areas are designated as regulated areas, and 
those areas are divided into restricted areas or surveillance areas as 
indicated below:

Arizona

    Cochise County. The entire county.
    (1) Restricted areas. None.
    (2) Surveillance areas. The entire regulated area.
    Graham County. The entire county.
    (1) Restricted areas. Beginning at the intersection of Highway 
70 and Black Rock Road; then due east 5 miles along an imaginary 
line to the northeast corner of Section 4 in T 5S R24E; then south 9 
miles along an imaginary line to the southeast corner of Section 16 
in T 6S R24E; then west 8 miles along an imaginary line to the 
southwest corner of Section 17 in T 6S R23E; then north 9 miles 
along an imaginary line to the northwest corner of Section 5 in T 5S 
R23E; then east along an imaginary line to the point of beginning.
    (2) Surveillance areas. All other areas within the regulated 
area.
    LaPaz County. The entire county.
    (1) Restricted areas. Beginning at the intersection of Cibola 
Road and Baseline Road; then south 2.5 miles on Cibola Road; then 
west to Cibola Lake Road; then north along Cibola Lake Road to its 
intersection with Cibola Road; then south on Cibola Road to the 
point of beginning;
    T 3N R11W; T 2N R11W, Sections 1-24;
    T 7N R11W, Sections 1-3, Sections 10-15, Sections 22-27, and 
Sections 34-36; T 7N R10W; and
    The Colorado River Indian Reservation.
    (2) Surveillance areas. All other areas within the regulated 
area.
    Maricopa County. The entire county.
    (1) Restricted areas. Beginning at the intersection of the 
northeast corner of T 4S R1E and the Maricopa/Pinal County line; 
then west along an imaginary line to the northwest corner of T 4S 
R3W; then due north along an imaginary line to the northeast corner 
of Section 24 in T 2S R4W; then due west along an imaginary line to 
the northwest corner of Section 19 in T 2S R5W; then due north along 
an imaginary line to the northwest corner of Section 19 in T 4N R5W; 
then due east along an imaginary line following Beardsley Road to 
its intersection with 40th Street; then due south on 40th Street to 
its intersection with Broadway Road; then 12 miles from this 
intersection along an imaginary line to the intersection of the 
northeast corner of section 25 in T 1S R1E and the Maricopa/Pinal 
County line; then south along this county line to the point of 
beginning;
    T 7N R10W; T 7N R9W; T 8N R9W; T 7N R8W; T 6N R8W;
    T 3N R10W; T 2N R10W, Sections 1-24;
    T 5S R10W, Sections 25-36; T 6S R10W, Sections 1-18; and
    Beginning at the intersection of Baseline Road and the Maricopa/
Pinal County line; then west along Baseline Road to its intersection 
with Bush Road; then north along Bush Road to its intersection with 
McDowell Road; then west along McDowell Road to its intersection 
with Pima Road; then south along Pima Road to its intersection with 
Price Road; then south along Price Road to its intersection with 
Baseline Road; then west along Baseline Road to its intersection 
with 40th Street; then south from this intersection along an 
imaginary line to its intersection with the Maricopa/Pinal County 
line; then south, west, and north along this county line to the 
point of beginning.
    (2) Surveillance areas. All other areas within the regulated 
area.
    Pima County. Beginning at the intersection of the Pima County 
line, the Pinal County line, and the Papago Indian Reservation 
boundary; then east along the Pima County line to its easternmost 
point; then south along the Pima County line to the Cochise and 
Santa Cruz County lines; then west along the Pima County line to the 
United States/Mexico boundary; then west along the United States/
Mexico boundary to the Papago Indian Reservation boundary; then 
north along the Papago Indian Reservation boundary to the point of 
beginning.
    (1) Restricted areas. None.
    (2) Surveillance areas. All other areas in the regulated area.
    Pinal County. The entire county.
    (1) Restricted areas. T 4S R2E; T 4S R3E; T 4S R4E; T 5S R2E; T 
5S R3E; T 5S R 4E; T 6S R2E; T 6S R3E; T 6S R 4E; T 4S R14E;
    Beginning at the Toltec junction of the Southern Pacific 
Railroad adjacent to Highway 84; then north along Signal Peak Road 
to its intersection with Kleck Road; then west on Kleck Road, which 
becomes Korsten Road; then west on Korsten Road to its intersection 
with Treckell Road; then south on Treckell Road to its intersection 
with Shedd Road; then east on Shedd Road to the point of beginning;
    Beginning at the intersection of Shay Road and Fast Track Road; 
then north 7 miles on Fast Track Road to its intersection with Arica 
Road; then west on Arica Road to its intersection with Tweedy Road; 
then south on Tweedy Road to its intersection with Shay Road; then 
east on Shay Road to the point of beginning;
    (2) Surveillance areas. All other areas within the regulated 
area.
    Yuma County. The entire county.
    (1) Restricted areas. Beginning at the intersection of 14th 
Street and Avenue 2E; then west on 14th Street to its intersection 
with Somerton Avenue; then north on Somerton Avenue to the Arizona/
California State line; then east along the State line to a point 
directly north of the intersection of Avenue 2E and County 8th 
Street; then south from this intersection along an imaginary line to 
the intersection of Avenue 2E and 8th Street; then south on Avenue 
2E to the point of beginning;
    Beginning at the intersection of I-8 and Foothill Boulevard; 
then south on Foothill Boulevard to its intersection with 12th 
Street; then west on 12th Street to its intersection with Araby 
Road; then north 6 miles on Araby Road to the southern edge of 
Section 16 of T 8S R 22W; then east to the California/Arizona State 
line; then north along the State line to Laguna Dam; then east along 
the southern shore of Mittry Lake and continue to the Yuma Proving 
Grounds boundary line; then south and then east along this boundary 
line to its intersection with Highway 95; then south along an 
imaginary line to the point of beginning; and
    Beginning on 5th Street at the Kofa junction of the Southern 
Pacific Railroad; then northwest along 5th Street to the Yuma 
Proving Grounds boundary line; then west along this boundary line to 
the intersection of Highway 95; then south along the Gila Mountains 
Range until it intersects the Barry Goldwater Air Force Range; then 
east along the Barry Goldwater Air Force Range boundary to its 
intersection with the southwest corner of Section 6 in T 8S R 13W; 
then north from that point to the point of beginning.
    (2) Surveillance areas. All other areas within the regulated 
area.

California

    Imperial County. The entire county.
    (1) Restricted areas. That portion of Imperial County known as 
the Bard-Winterhaven area bounded by a line drawn as follows: 
Beginning at the intersection of the west boundary line of Range 22 
East and the California-Arizona State line; then, north along this 
boundary line to its intersection with the All American Canal; then 
northeasterly along this canal to its intersection with the south 
boundary line of Section 25, Township 15 South, Range 23 East; then 
east along this line to its intersection with the California-Arizona 
State line; the southerly and westerly along this State line to the 
point of beginning; and
    That portion of Imperial County known as the Palo Verde Valley 
(in part) bounded by a line drawn as follows: Beginning at the 
intersection of the Riverside-Imperial County line and the 
California-Arizona State line; then, westerly and southerly along 
this State line to its intersection with the north boundary line of 
Township 10 South; then west along this boundary line to its 
intersection with the west boundary line of Range 21 East; then 
north along this boundary line to its intersection with the 
Riverside-Imperial County line; then easterly along this County line 
to the point of beginning.
    (2) Surveillance areas. All other areas within the regulated 
area.
    Riverside County. That portion of Riverside County in the Blythe 
and Ripley areas bounded by a line drawn as follows: Beginning at 
the intersection of State Highway 62 and the Riverside-San 
Bernardino County line, then east along the Riverside-San Bernardino 
County line to its intersection with the California-Arizona State 
line; then south along the California-Arizona State line to its 
intersection with the Riverside-Imperial County line; then west 
along the Riverside-Imperial County line to its intersection with 
Graham Pass Road; then northeast along Graham Pass Road to its 
intersection with Chuckwalla Valley Road; then west and northwest 
along Chuckwalla Valley Road to its intersection with Interstate 
Highway 10; then west along Interstate Highway 10 to its 
intersection with State

[[Page 52210]]

Highway 177; then northeast and north along State Highway 177 to its 
intersection with State Highway 62; then northeast along State 
Highway 62 to the point of beginning.
    (1) Restricted areas: That portion of Riverside County known as 
the Palo Verde Valley (in part) bounded by a line drawn as follows: 
Beginning at the intersection of the north boundary line of Township 
2 South and the California-Arizona State line; then southerly and 
southwesterly along this State line to its intersection with the 
Riverside-Imperial County line; then westerly along this county line 
to its intersection with the west boundary line of Range 21 East; 
then north along this boundary line to its intersection with the 
north boundary line of Township 2 South; then east along this 
boundary line to the point of beginning.
    (2) Surveillance areas: All other areas within the regulated 
area.

New Mexico

    Dona Ana County. Beginning at the intersection of the Sierra/
Dona Ana County line and Interstate 25; then south along Interstate 
25 to the Texas State line; then west and south along the New 
Mexico/Texas State line to the United States/Mexico boundary; then 
west along the United States/Mexico boundary to the Luna/Dona Ana 
County line; then north and east along the Dona Ana County line to 
the point of beginning.
    (1) Restricted areas: None.
    (2) Surveillance areas: The entire regulated area.
    Hidalgo County. Beginning at the intersection of the Arizona/New 
Mexico State line and Interstate 10; then east along Interstate 10 
to the Hidalgo/Grant County line; then south and east along the 
Hidalgo County line to the Luna County line; then south along the 
Hidalgo County line to its southernmost point; then west and north 
along the Hidalgo county line to point of beginning.
    (1) Restricted areas: None.
    (2) Surveillance areas: The entire regulated area.
    Luna County. Beginning at the intersection of the Grant/Luna 
County line and Interstate 10; then east along Interstate 10 to U.S. 
Highway 180; then north along U.S. Highway 180 to State Route 26; 
then north along State Route 26 to State Route 27; then north along 
State Route 27 to the Luna/Sierra County line; then east along the 
Luna County line to the Dona Ana County line; then south along the 
Luna County line to the United States/Mexico boundary; then west 
along the United States/Mexico boundary to the Hidalgo County line; 
then north along the Luna County line to the point of beginning.
    (1) Restricted areas. None.
    (2) Surveillance areas. The entire regulated area.
    Sierra County. Beginning at intersection of the Luna/Sierra 
County line and State Route 27; then north along State Route 27 to 
State Route 152; then east along State Route 152 to Interstate 25; 
then south along Interstate 25 to the Dona Ana County line; then 
west and south to the Luna County line; then west along the Luna/
Sierra County line to the point of beginning; and
    Beginning at the intersection of the Socorro/Sierra County line 
and State Route 142; then southeast along State Route 142 to State 
Route 52; then south along State Route 52 to Interstate 25; then 
north along Interstate 25 to the Socorro/Sierra County line; then 
west along the Socorro/Sierra County line to the point of beginning.
    (1) Restricted areas. None.
    (2) Surveillance areas. The entire regulated area.

Texas

    El Paso County. Beginning at a point on the Rio Grande River due 
east from the intersection of County Route 659 and County Route 375; 
then due east along an imaginary line to County Route 659; then 
north along County Route 659 to Interstate 10; then southeast along 
Interstate 10 to the El Paso County line; then southwest along the 
El Paso County line to the Rio Grande River; then north along the 
Rio Grande River to the point of beginning.
    (1) Restricted areas. None.
    (2) Surveillance areas. The entire regulated area.
    Hudspeth County. Beginning at the intersection of the El Paso/
Hudspeth County line and Interstate 10; then southeast along 
Interstate 10 to County Route 34; then south along County Route 34 
to County Route 192; then due south along an imaginary line to the 
Rio Grande River; then northwest along the Rio Grande River to the 
El Paso/Hudspeth County line; then north along the El Paso/Hudspeth 
County line to the point of beginning.
    (1) Restricted areas. None.
    (2) Surveillance areas. The entire regulated area.


Sec. 301.89-4  Planting.

    (a) Wheat, durum wheat, and triticale may be planted in all fields 
within and outside a regulated area, except as follows:
    (1) For the 1996-1997 crop season,\1\ wheat, durum wheat, and 
triticale may not be planted in fields in which preharvest samples 
conducted by Federal or State official tested positive for Karnal bunt;
---------------------------------------------------------------------------

    \1\ The 1996-1997 crop season is that season in which wheat is 
harvested in 1997.
---------------------------------------------------------------------------

    (2) For the 1996-1997 crop season,\1\ wheat, durum wheat, and 
triticale may not be planted in fields known to have been planted in 
1995 with seed contaminated with Karnal bunt.
    (b) Prior to planting, wheat seed, durum wheat seed, and triticale 
seed to be planted within a regulated area must:
    (1) First be sampled and test negative for Karnal bunt; then
    (2) If originating within a regulated area, be treated with a 
fungicide in accordance with Sec. 301.89-13.


Sec. 301.89-5  Movement of regulated articles from regulated areas.

    (a) Any regulated article may be moved from a regulated area into 
or through an area that is not regulated only if moved under the 
following conditions:
    (1) With a certificate or limited permit issued and attached in 
accordance with Secs. 301.89-6 and 301.89-10;
    (2) Without a certificate or limited permit, provided that each of 
the following conditions is met:
    (i) The regulated article was moved into the regulated area from an 
area that is not regulated;
    (ii) The point of origin is indicated on a waybill accompanying the 
regulated article;
    (iii) The regulated article is moved through the regulated area 
without stopping, or has been stored, packed, or handled at locations 
approved by an inspector as not posing a risk of contamination with 
Karnal bunt, or has been treated in accordance with the methods and 
procedures prescribed in Sec. 301.89-13 while in or moving through any 
regulated area; and
    (iv) The article has not been combined or commingled with other 
articles so as to lose its individual identity;
    (3) Without a certificate or limited permit, provided the regulated 
article is a soil sample being moved to a laboratory approved by the 
Administrator 2 to process, test, or analyze soil samples.
---------------------------------------------------------------------------

    \2\ Criteria that laboratories must meet to become approved to 
process, test, or analyze soil, and the list of currently approved 
laboratories, may be obtained from the Animal and Plant Health 
Inspection Service, Plant Protection and Quarantine, Domestic and 
Emergency Operations, 4700 River Road Unit 134, Riverdale, Maryland 
20737-1236.
---------------------------------------------------------------------------

    (b) When an inspector has probable cause to believe a person or 
means of conveyance is moving a regulated article, the inspector is 
authorized to stop the person or means of conveyance to determine 
whether a regulated article is present and to inspect the regulated 
article. Articles found to be infected by an inspector, and articles 
not in compliance with the regulations in this subpart, may be seized, 
quarantined, treated, subjected to other remedial measures, destroyed, 
or otherwise disposed of. Any treatments will be in accordance with the 
methods and procedures prescribed in Sec. 301.89-13.


Sec. 301.89-6  Issuance of a certificate or limited permit.

    (a) An inspector 3 or person operating under a compliance 
agreement will

[[Page 52211]]

issue a certificate for the movement of a regulated article outside a 
regulated area if he or she determines that the regulated article:
---------------------------------------------------------------------------

    \3\ Inspectors are assigned to local offices of APHIS, which are 
listed in local telephone directories. Information concerning such 
local offices may also be obtained from the Animal and Plant Health 
Inspection Service, Plant Protection and Quarantine, Domestic and 
Emergency Operations, 4700 River Road Unit 134, Riverdale, Maryland 
20737-1236, or from Karnal Bunt Project, 3658 E. Chipman Rd. 
Phoenix, Arizona 85040.
---------------------------------------------------------------------------

    (1) Is eligible for unrestricted movement under all other 
applicable Federal domestic plant quarantines and regulations;
    (2) Is to be moved in compliance with any emergency conditions the 
Administrator may impose under 7 U.S.C. 150dd to prevent the artificial 
spread of Karnal bunt;4 and
---------------------------------------------------------------------------

    \4\ Section 105 of the Federal Plant Pest Act (7 U.S.C. 105dd) 
authorizes the Secretary of Agriculture to impose emergency measures 
necessary to prevent the spread of plant pests new to, or not widely 
prevalent or distributed within and throughout, the United States.
---------------------------------------------------------------------------

    (3)(i) Is free of Karnal bunt infestation, based on laboratory 
results of testing, and history of previous infestation;
    (ii) Has been grown, produced, manufactured, stored, or handled in 
a manner that would prevent infestation or destroy all life stages of 
Karnal bunt; or
    (iii) Has been treated in accordance with methods and procedures 
prescribed in Sec. 301.89-13.
    (b) To be eligible for movement under a certificate, grain from a 
surveillance area must test negative for Karnal bunt twice, and one of 
these tests must occur at the means of conveyance or storage facility 
immediately prior to movement.
    (c) An inspector or a person operating under a compliance agreement 
will issue a limited permit for the movement within or outside the 
regulated area of a regulated article not eligible for a certificate if 
the inspector determines that the regulated article:
    (1) Is to be moved to a specified destination for specified 
handling, utilization, or processing (the destination and other 
conditions to be listed in the limited permit and/or compliance 
agreement), and this movement will not result in the artificial spread 
of Karnal bunt because Karnal bunt will be destroyed or the risk 
mitigated by the specified handling, utilization, or processing;
    (2) Is to be moved in compliance with any additional emergency 
conditions the Administrator may impose under 7 U.S.C. 150dd to prevent 
the artificial spread of Karnal bunt; and
    (3) Is eligible for movement under all other Federal domestic plant 
quarantines and regulations applicable to the regulated article.
    (d) To be eligible for movement under a limited permit, grain from 
a restricted area must test negative for Karnal bunt twice, and one of 
these tests must occur at the means of conveyance or storage facility 
immediately prior to movement.
    (e) An inspector shall issue blank certificates and limited permits 
to a person operating under a compliance agreement in accordance with 
Sec. 301.89-7 or authorize reproduction of the certificates or limited 
permits on shipping containers, or both, as requested by the person 
operating under the compliance agreement. These certificates and 
limited permits may then be completed and used, as needed, for the 
movement of regulated articles that have met all of the requirements of 
paragraph (a) or (b), respectively, of this section.


Sec. 301.89-7  Compliance agreements.

    Persons who grow, handle, or move regulated articles may enter into 
a compliance agreement \5\ if such persons review with an inspector 
each provision of the compliance agreement, have facilities and 
equipment to carry out disinfestation procedures or application of 
chemical materials in accordance with Sec. 301.89-13, and meet 
applicable State training and certification standards under the Federal 
Insecticide, Fungicide, and Rodenticide Act, as amended (7 U.S.C. 
136b). Any person who enters into a compliance agreement with APHIS 
must agree to comply with the provisions of this subpart and any 
conditions imposed under this subpart.
---------------------------------------------------------------------------

    \5\ Compliance agreements may be initiated by contacting a local 
office of Plant Protection and Quarantine, which are listed in 
telephone directories. The addresses and telephone numbers of local 
offices of Plant Protection and Quarantine may also be obtained from 
the Animal and Plant Health Inspection Service, Plant Protection and 
Quarantine, 4700 River Road Unit 134, Riverdale, Maryland 20737-
1236, or from the Karnal Bunt Project, 3658 E. Chipman Rd., Phoenix, 
Arizona 85040.
---------------------------------------------------------------------------


Sec. 301.89-8  Cancellation of a certificate, limited permit, or 
compliance agreement.

    Any certificate, limited permit, or compliance agreement may be 
canceled orally or in writing by an inspector whenever the inspector 
determines that the holder of the certificate or limited permit, or the 
person who has entered into the compliance agreement, has not complied 
with this subpart or any conditions imposed under this subpart. If the 
cancellation is oral, the cancellation will become effective 
immediately and the cancellation and the reasons for the cancellation 
will be confirmed in writing as soon as circumstances allow, but within 
20 days after oral notification of the cancellation. Any person whose 
certificate, limited permit, or compliance agreement has been canceled 
may appeal the decision, in writing, within 10 days after receiving the 
written cancellation notice. The appeal must state all of the facts and 
reasons that the person wants the Administrator to consider in deciding 
the appeal. A hearing may be held to resolve any conflict as to any 
material fact. Rules of practice for the hearing will be adopted by the 
Administrator. As soon as practicable, the Administrator will grant or 
deny the appeal, in writing, stating the reasons for the decision.


Sec. 301.89-9  Assembly and inspection of regulated articles.

    (a) Persons requiring certification or other services must request 
the services of an inspector \6\ at least 24 hours before the services 
are needed.
---------------------------------------------------------------------------

    \6\ See footnote 3.
---------------------------------------------------------------------------

    (b) The regulated articles must be assembled at the place and in 
the manner the inspector designates as necessary to comply with this 
subpart.


Sec. 301.89-10  Attachment and disposition of certificates and limited 
permits.

    (a) The consignor must ensure that the certificate or limited 
permit authorizing movement of a regulated article is, at all times 
during movement, attached to:
    (1) The outside of the container encasing the regulated article;
    (2) The article itself, if it is not in a container; or
    (3) The consignee's copy of the accompanying waybill: Provided, 
that the descriptions of the regulated article on the certificate or 
limited permit, and on the waybill, are sufficient to identify the 
regulated article; and
    (b) The carrier must furnish the certificate or limited permit 
authorizing movement of a regulated article to the consignee at the 
shipment's destination.


Sec. 301.89-11  Costs and charges.

    The services of the inspector during normal business hours will be 
furnished without cost to persons requiring the services.
    The user will be responsible for all costs and charges arising from 
inspection and other services provided outside of normal business 
hours.


Sec. 301.89-12  Cleaning and disinfection.

    (a) Used mechanized cultivating equipment, used seed-conditioning 
equipment, used mechanized harvesting equipment, used farm tools, and 
used mechanized soil-moving equipment must be cleaned and disinfected 
in accordance with Sec. 301-89-12 prior to movement from a regulated 
area and, within a regulated area, prior to movement from a field that 
tested positive for Karnal bunt during the 1996-97 crop season.

[[Page 52212]]

    (b) Prior to movement from a regulated area, vegetable crops must 
be cleaned of all soil and plant debris, or be moved under limited 
permit to processing facilities approved by the Administrator.


Sec. 301.89-13  Treatments.

    (a) All conveyances, mechanized farm equipment, seed-conditioning 
equipment, soil-moving equipment, farm tools, grain elevators and 
structures used for storing and handling wheat, durum wheat, or 
triticale required to be cleaned and disinfected under this subpart 
must be cleaned by removing all soil and plant debris and disinfected 
by one of the methods specified in paragraph (a)(1) through (a)(4). The 
treatment used must be that specified by an inspector if that treatment 
is deemed most effective in a given situation:
    (1) Wetting all surfaces to the point of runoff with a solution of 
1.5 percent sodium hypochlorite--e.g., with a solution of sodium 
hypochlorite mixed with water applied at the rate of 1 gallon of 
household chlorine bleach (5.2 percent sodium hypochlorite) mixed with 
2.5 gallons of water--and letting stand for 15 minutes. The equipment 
or site should be thoroughly washed down after 15 minutes to minimize 
corrosion; or
    (2) Applying steam to all surfaces until the point of runoff, and 
so that a critical temperature of 170  deg.F is reached at the point of 
contact;
    (3) Cleaning with a solution of hot water and detergent, applied 
under pressure of at least 30 pounds per square inch, at a minimum 
temperature of 180  deg.F; or
    (4) Fumigating with methyl bromide at the dosage of 15 pounds/1000 
cubic feet for 96 hours.
    (b) Soil, and straw/stalks/seed heads for decorative purposes must 
be treated by fumigation with methyl bromide at the dosage of 15 
pounds/1000 cubic feet for 96 hours, except that straw may move outside 
the regulated area without treatment if it has been processed or 
manufactured prior to movement, and is intended for use indoors.
    (c) Millfeed must be treated with a moist heat treatment of 
170 deg. F for at least 1 minute if the millfeed resulted from the 
milling of grain from one of the following types of fields:
    (1) Fields in which preharvest samples test positive for Karnal 
bunt during the 1996-1997 crop season; and
    (2) Fields located in a restricted area.
    (d) Seed for planting must be treated 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.
    (e) Seed used for germplasm or for research purposes 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.
    (f) Bags, sacks, and containers used for seed infected with the 
pathogen of Karnal bunt must be fumigated with methyl bromide at the 
dosage of 15 pounds/1000 cubic feet for 96 hours.
* * * * *

Appendix to Subpart--Karnal Bunt

                                            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  
                                                                         except from fields                                          designated         
                                                                         testing positive in                                         facilities under   
                                                                         the 1996-97 crop                                            safeguard and      
                                                                         season.                                                     sanitation         
                                                                                                                                     conditions         

[[Page 52213]]

                                                                                                                                                        
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.       
                                                                         except from fields                                          Safeguard and      
                                                                         testing positive in                                         sanitation of      
                                                                         the 1996-97 crop                                            railcars not       
                                                                         season.                                                     required.          
--------------------------------------------------------------------------------------------------------------------------------------------------------
Definitions:                                                                                                                                            
Distinct, definable area: A commercial wheat production area of contiguous fields that is separated from other wheat production areas by desert,        
  mountains, or other nonagricultural terrain as determined by an inspector, or in the case of restricted areas, as determined by an inspector based on 
  survey results, including the number of positive fields and the relative spore count of the fields within the area.                                   
Regulated area: The area defined in part 301.89-3; includes each State or portion of a State that is infested or associated with Karnal bunt            
  contaminated seed.                                                                                                                                    
Restricted area: A distinct, definable, commercial wheat production area that includes at least one field that tested positive for Karnal bunt.         
Surveillance area: A distinct, definable, commercial wheat production area in which no fields have tested positive for Karnal bunt, but movement of     
  contaminated seed has occurred.                                                                                                                       

    Done in Washington, DC, this 1st day of October 1996.
A. Strating,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-25549 Filed 10-1-96; 3:46 pm]
BILLING CODE 3410-34-P