[Federal Register Volume 69, Number 35 (Monday, February 23, 2004)]
[Rules and Regulations]
[Pages 8091-8097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-3807]



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  Federal Register / Vol. 69, No. 35 / Monday, February 23, 2004 / 
Rules and Regulations  

[[Page 8091]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 301

[Docket No. 02-056-2]


Karnal Bunt; Revision of Domestic Regulations

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending our Karnal bunt regulations to incorporate 
updates and improvements identified as a result of our review of their 
provisions. The changes include clarifying our method for determining 
Karnal bunt infestation and the circumstances under which a field or 
area is classified as a regulated area, as well as adding provisions 
and criteria for the release of fields or areas from regulation; 
modifying the restrictions that apply to the planting of wheat, durum 
wheat, and triticale seed originating in regulated areas; and modifying 
cleaning and disinfection requirements for certain equipment and 
storage facilities involved in the harvesting, planting, or storage of 
Karnal bunt-positive host crops or seeds, as well as providing for the 
disposal of chemically treated, spore-positive seed. These changes are 
intended to improve the clarity and effectiveness of the regulations, 
thus helping to prevent the spread of Karnal bunt within the United 
States.

EFFECTIVE DATE: March 24, 2004.

FOR FURTHER INFORMATION CONTACT: Mr. Robert Spaide, Senior Program 
Manager, Surveillance and Emergency Programs Planning and Coordination, 
PPQ, APHIS, 4700 River Road Unit 134, Riverdale, MD 20737-1236; (301) 
734-7819.

SUPPLEMENTARY INFORMATION:

Background

    Karnal bunt is a fungal disease of wheat (Triticum aestivum), durum 
wheat (Triticum durum), and triticale (Triticum aestivum X Secale 
cereale), a hybrid of wheat and rye. Karnal bunt is caused by the smut 
fungus Tilletia indica (Mitra) Mundkur and is spread primarily through 
the movement of infected seed. Some countries in the international 
wheat market regulate Karnal bunt as a fungal disease requiring 
quarantine. Therefore, in the absence of measures taken by the U.S. 
Department of Agriculture (USDA) to prevent its spread, the 
establishment of Karnal bunt in the United States could have 
significant consequences with regard to the export of wheat to 
international markets.
    The domestic quarantine and other regulations regarding Karnal bunt 
are set forth in ``Subpart--Karnal Bunt'' (7 CFR 301.89-1 through 
301.89-16, referred to below as the regulations). Among other things, 
the regulations describe articles and areas regulated for Karnal bunt; 
criteria for classifying areas or fields as regulated areas; 
requirements for planting wheat, durum wheat, and triticale in 
regulated areas; restrictions on movement of regulated articles from 
regulated areas; permitting, cleaning, disinfection, and treatment 
requirements; and requirements for growers, handlers, seed companies, 
and other entities seeking compensation from the USDA to mitigate 
losses or expenses incurred because of Karnal bunt. The regulations are 
designed to prevent the artificial spread of Karnal bunt.
    Following a review of our regulations, the Animal and Plant Health 
Inspection Service (APHIS) published in the Federal Register, on July 
8, 2003 (68 FR 40534-40541, Docket No. 02-056-1), a proposal to amend 
them to improve their clarity, transparency, and effectiveness. More 
specifically, the proposed changes included the following: Clarifying 
our method for determining Karnal bunt infestation; adding or removing 
several definitions; adding or removing certain articles from the list 
of regulated articles; clarifying the circumstances under which a field 
or area would be classified as a regulated area, as well as adding 
provisions and criteria for the release of fields or areas from 
regulation; modifying the restrictions that apply to the planting of 
wheat, durum wheat, and triticale seed originating in regulated areas; 
and modifying cleaning and disinfection requirements for mechanized 
harvesting equipment, seed conditioning equipment, and storage 
facilities involved in the harvesting, planting, or storage of Karnal 
bunt-positive host crops or seed, as well as adding a requirement for 
the disposal of chemically treated, spore-positive seed.
    We solicited comments concerning our proposal for 60 days ending 
September 8, 2003. We received nine comments by that date. The comments 
were from State governments and grain producers' associations. All of 
the commenters supported the proposed rule, but two suggested some 
modifications to certain provisions. Specifically, the commenters urged 
us to: Reconsider our decision to remove manure, soil, and milling 
products from the list of regulated articles in the existing 
regulations; clarify a provision pertaining to the regulation of grain 
elevators, equipment, and structures; modify our criteria for the 
release of a field from regulation; and develop procedures for seed 
sampling and analysis and for inspectors to use to determine whether 
certain regulated articles require disinfection. The comments are 
discussed below by topic.
    The commenters stated that manure should continue to be included on 
the list of regulated articles. It was recommended that manure from 
cattle that have been fed unprocessed Karnal bunt-positive host crops 
or cattle that have been allowed to graze in known infected fields on 
host crops that have developed past the heading stage should have to 
remain within the regulated area and that such animals should be 
subjected to a 5-day clean-out period before being moved outside a 
regulated area. The commenters suggested that because bunted kernels 
are not likely to be completely digested by cattle, the Karnal bunt 
pathogen can survive in their digestive tracts; therefore, some risk 
exists that bunted kernels could be dispersed through manure.
    We will not be making any changes to the final rule in response to 
these comments. Our decision to remove manure from the list of 
regulated articles in Sec.  301.89-2 resulted, in part, from a change 
in our regulatory goals. In 1996, manure was placed under regulation 
because the goal of the Karnal

[[Page 8092]]

bunt regulatory program at that time was eradication, and research had 
demonstrated that the Karnal bunt spore or pathogen could potentially 
be spread in manure. The 5-day clean-out period was put into practice--
though never specified in the regulations--to mitigate this potential 
risk. Since 1998, we have changed the focus of the program from 
eradication to the management of risk associated with the disease, and 
we have adopted the bunted kernel as the infestation standard.
    In addition, in contrast to the commenters, we view the risk of 
disseminating Karnal bunt through manure as very small. Cattle are 
grazed on wheat and removed from the fields prior to the soft-dough 
stage of plant growth. These cattle are not routinely fed bunted 
kernels. A review of our regulatory records for the past 2 seasons 
indicate less than 0.5 percent of the 186,500 head of cattle moved 
under limited permits from regulated areas were required to undergo the 
5-day clean-out. These cattle were subjected to the clean-out because 
they had grazed in fields that were past the soft-dough stage and that 
were within the regulated area; however, there are no records to 
confirm the presence of the disease in the fields where the cattle 
grazed. The percentage of cattle that actually grazed in infected 
fields is likely to be much lower than the 0.5 percent figure, as known 
infected fields represent a very small portion of the regulated areas 
in the United States. We believe that there is a very minimal risk of 
the spread of Karnal bunt spores through manure and an even smaller 
risk--if any--that bunted kernels may be spread that way. One commenter 
cited research indicating that 25 percent to 35 percent of healthy 
kernels pass through the ruminant digestive tract without being 
completely digested. A bunted kernel is not a healthy kernel of wheat, 
however, and the structural integrity of the former is not equivalent 
to that of the latter. Bunted kernels are very fragile and are easily 
ruptured, and, thus, are less likely than healthy grain to pass through 
the digestive tract of ruminant animals without being completely 
digested.
    The commenters also stated that soil in quantities sufficient to 
harbor bunted kernels should continue to be listed among the regulated 
articles for Karnal bunt. It was suggested that soil could not only 
contain bunted kernels but could also serve as a mechanism for 
spreading both the disease and the pathogen.
    We have not observed soil originating in regulated areas being 
moved in significant volumes. We have seen limited movement of soil 
throughout a regulated area for use as fill, road construction, and 
housing in areas. Soil moved and used in this way presents a minimal 
risk of spreading Karnal bunt. Smaller quantities of soil have also 
been permitted to move to approved laboratories for analytical 
purposes. Such movement and processing present little risk of 
disseminating the Karnal bunt pathogen. Finally, soil movement has also 
been associated with the movement of harvesting equipment. All 
equipment used to harvest bunted-kernel-positive wheat is required to 
be cleaned prior to leaving a regulated area. The cleaning process 
includes the removal of any soil on the equipment being cleaned, thus 
minimizing any pest risk associated with the movement outside of a 
regulated area of bunted kernels in soil. In addition, harvesting 
equipment that is moving across State lines usually requires cleaning 
for noxious weed seed, which also entails the removal of any soil on 
the equipment. Therefore, we will not be making any changes to the 
final rule in response to these comments.
    The commenters also stated that certain milling products or 
byproducts, such as screenings, should continue to be regulated, since 
they may present a risk of spreading Karnal bunt. Such products or 
byproducts, if produced from host crops within a regulated area, should 
have to be handled, stored, and used within the regulated area, 
according to the commenters.
    We will not be making any changes to the final rule in response to 
these comments. Bunted or damaged kernels are likely to be susceptible 
to the milling process, i.e., unlikely to survive it intact. Moreover, 
the screenings that result from the milling process are routinely used 
for animal feed. In order for the animals to receive the maximum 
benefit from this feed source, the screenings are routinely steam-
rolled or used in a pellet formulation. Both of these processes 
mitigate the risk of transmitting the Karnal bunt pathogen.
    The commenters also stated that proposed Sec.  301.89-2(b), which 
listed as regulated articles grain elevators, equipment, and structures 
used to store and handle Karnal bunt-positive host crops, needed 
clarification. It was suggested that the paragraph could be interpreted 
to apply only to those regulated articles used to store or handle 
grain, since only bunted kernels are mentioned. One commenter noted 
that proposed Sec.  301.89-12(c) addressed the cleaning and 
disinfection requirements for facilities that stored either spore-
positive seed or bunted-kernel-positive grain, suggesting that, in the 
final rule, the list of regulated articles in Sec.  301.89-2(b) should 
also include storage facilities for seed that has tested positive for 
spores.
    As noted in our definition of infestation (infected) in proposed 
Sec.  301.89-1, we regulate grain and seed according to different 
criteria. Proposed Sec.  301.89-2(b) was intended to apply only to 
articles used to store or handle grain that has tested positive for 
bunted kernels; we addressed seed conditioning equipment and storage/
handling equipment separately in proposed Sec.  301.89-2(f). To 
eliminate any possible confusion on the part of users of the 
regulations, we have decided to rearrange Sec.  301.89-2 in the final 
rule to place the provisions for grain and seed equipment adjacent to 
one another. Proposed Sec.  301.89-2(f) will become Sec.  301.89-2(c) 
in the final rule, with the remainder of the section reordered 
accordingly, and a reference to structures will be added to better 
align the paragraph with Sec.  301.89-2(b).
    The commenters generally welcomed our efforts to develop uniform 
criteria for removing fields from regulation, but took issue with some 
parts of our list of acceptable field management practices in proposed 
Sec.  301.89-3. Proposed Sec.  301.89-3 stated that a known infected 
field, as well as surrounding non-infected acreage, could be released 
from regulation if the field was no longer being used for crop 
production or if it had been subjected each year, for 5 consecutive 
years, to any one of the following management practices: Planting with 
a cultivated non-host crop; tilling once annually; or planting with a 
host crop that tests negative, through the absence of bunted kernels, 
for Karnal bunt. The commenters argued that we should eliminate tilling 
from the list because it does not prevent Karnal bunt infection if a 
crop is allowed to head. The commenters also recommended that fields 
planted with non-host crops be planted with ones that are not 
cultivated annually, such as alfalfa; that if no crop is planted in a 
regulated field during the first year of the 5-year period preceding 
deregulation, the field should be required to undergo cultivation or 
chemical fallow; and that the list of acceptable management practices 
should be expanded to include planting the field with a host crop for 
grazing, while ensuring the destruction of the crop prior to the boot 
stage, and enrolling the field in the Conservation Reserve Program.
    We will not be making any changes to the final rule in response to 
these comments. Tillage is a proven method of reducing the spore load 
in the soil. Tillage exposes spores to the

[[Page 8093]]

environment, which in turn causes the spores to deteriorate, resulting 
in a decrease of the spore load in the soil. In addition, exposing the 
spores to the surface without a host promotes ``suicidal germination'' 
of the teliospores, which also contributes to a decrease in the spore 
load. Spores germinate when the environmental conditions are favorable, 
regardless of whether there is a susceptible host plant. Suicidal 
germination reduces the spore load and the probability of infection. 
Another advantage of tilling is that it also prevents volunteer host 
material from reaching the heading stage of growth. We do not agree 
with the recommendation to plant non-host crops that are not cultivated 
annually. If a field is not cultivated annually, spore longevity is 
likely to increase. We do not believe chemical fallow should qualify as 
an independent practice during the 5-consecutive-year period, as its 
value, if any, in reducing the spore load in the soil is undetermined. 
Planting a host crop for grazing is also problematic as a management 
strategy. Many times, wheat is planted for grazing, and, depending on 
the price of wheat, the crop is allowed to mature. We do not have the 
authority to dictate what a wheat producer may plant on his farm, nor 
may we condemn or require destruction of a crop without evidence of the 
Karnal bunt pathogen. Finally, because a field enrolled in the 
Conservation Reserve Program is not likely to undergo annual tilling, 
spore longevity in the field is not likely to decrease.
    One commenter criticized the proposed rule for not stating how seed 
will be sampled and analyzed under the regulations. It was argued that 
APHIS must develop, publish, and distribute procedures for these tasks, 
adopt procedures to protect the seed supply from both bunted kernels 
and teliospores, and develop procedures to deal with seed that tests 
positive for bunted kernels or teliospores and for the facility in 
which the seed was stored and the field in which it was produced.
    We will not be making any changes to the final rule in response to 
these comments. Procedures for seed sampling and analysis do exist and 
are contained in APHIS's Karnal Bunt Manual, available on the Internet 
at http://www.aphis.usda.gov/ppq/manuals/online_manuals.html#Karnal. 
Protecting the seed supply from bunted kernels is not a concern 
because, as noted earlier, if grain tests positive for bunted kernels, 
it does not qualify as seed and could never be used as such. Procedures 
to deal with seed that tests positive for teliospores, the facility in 
which such seed was stored, and the field in which it was produced are 
contained in various places in this final rule, including Sec. Sec.  
301.89-3, 301.89-12, and 310.89-13.
    One commenter took issue with some provisions of the cleaning, 
disinfection, and disposal requirements that were contained in Sec.  
301.89-12 of the proposed rule. Proposed paragraphs (a) and (c) stated 
that an inspector may determine whether to require disinfection of 
certain regulated articles. The commenter argued that since Sec.  
301.89-12 does not include criteria for inspectors to use in making 
such determinations, APHIS needed to develop such criteria and train 
its staff in their use. The commenter also suggested that APHIS needed 
to consider pertinent environmental factors, such as soil type, depth 
of the water table, and the potential for product leaching and movement 
in the soil, in regard to the burial of chemically treated seed that 
has tested positive for Karnal bunt. Due to these and other factors, 
meeting the 24-inch minimum depth requirement for burial that is 
specified in Sec.  319.89-12(e) may not always be possible.
    We will not be making any changes to the final rule in response to 
these comments. The regulations address how APHIS will handle Karnal 
bunt-negative grain, Karnal bunt-positive grain, and seed produced in a 
regulated area. Any machinery or equipment associated with the 
production of Karnal bunt host material will fall into one of these 
three categories and be handled accordingly. Specific guidance will be 
provided in the Karnal Bunt Manual, and staff training will be given. 
Regarding the burial provision, our current practices and this 
rulemaking do reflect our consideration of the environmental factors 
cited by the commenter. We only allow burial of treated seed in 
landfills approved by the U.S. Environmental Protection Agency or on 
privately owned property with the owner's consent. We do not allow 
burial in areas that are currently cultivated or in areas subject to 
cultivation in the future. We do not allow burial of seed in areas 
where the minimum 24-inch depth is not attainable.

Miscellaneous

    Because we included tilling on our list of acceptable crop 
management practices in proposed Sec.  301.89-3, we determined that we 
needed to define the term. Section 301.89-1 of this final rule defines 
tilling as the turning of a minimum of the top 6 inches of soil.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, with the 
changes discussed in this document.

Executive Order 12866 and Regulatory Flexibility Act

    This rule has been reviewed under Executive Order 12866. The rule 
has been determined to be not significant for the purposes of Executive 
Order 12866 and, therefore, has not been reviewed by the Office of 
Management and Budget.
    This final rule is intended to improve the clarity, transparency, 
and effectiveness of our Karnal bunt regulations. This rulemaking is 
the result of a review of the regulations.
    Of the substantive changes to the regulations contained in this 
final rule, four stand out as having the potential to have the most 
economic impact: (1) Adding provisions for removing fields or areas 
from the list of regulated areas, (2) modifying seed planting 
restrictions, (3) removing animal manure from the list of regulated 
articles, and (4) modifying cleaning and disinfecting requirements for 
seed conditioning equipment. These four changes--all of which are 
expected to have a favorable impact on any affected entities--are 
discussed individually in the paragraphs that follow.

Adding Provisions for Removing Fields or Areas From the List of 
Regulated Areas

    The regulations have not contained criteria for the removal of 
fields or areas from the list of regulated areas, although we have 
removed some fields or areas from regulation in the past on a case-by-
case basis. This rule establishes uniform criteria for the removal of 
fields or areas from regulation.
    Even wheat testing Karnal bunt-negative has not been eligible for a 
phytosanitary certificate with an additional declaration if it was 
grown in fields that previously tested Karnal bunt-positive--a 
situation that adversely impacts the wheat's marketability and 
value.\1\ By allowing wheat from those fields to become eligible for 
such a certificate (if certain conditions are met), this rule will 
yield potential--and in some cases immediate--economic benefits for 
affected producers.
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    \1\ Major foreign importers will not accept wheat from the 
United States that does not have such an additional declaration. 
Furthermore, many U.S. elevators will not commingle wheat from 
previously tested positive fields with wheat destined for the export 
market.
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    In San Saba and McCulloch Counties, TX, there are approximately 28 
producers with fields that previously tested positive for Karnal bunt--
including about 8 that will be

[[Page 8094]]

immediately eligible for deregulation since they have already satisfied 
the conditions for release. It is estimated that these 28 producers 
would have received, collectively, at least about $295,000 more for 
their wheat this past crop season if it had been eligible for export--
an average of about $10,500 per producer. These dollar estimates are 
based on a price differential of at least $1.80 per bushel between 
uncertified wheat sold for animal feed and certified wheat in Texas 
sold for the export market.\2\
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    \2\ Source: George Nash (APHIS). Approximately 70 percent of the 
wheat produced in Texas is exported.
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    This final rule also has the potential to enable the approximately 
25 producers in 4 north Texas counties (Young, Throckmorton, Archer, 
and Baylor) with fields in a regulated area to recover lost revenues. 
Based on their estimated production capacity of about 81,000 bushels of 
wheat per crop season, this rule, by allowing the 25 growers to obtain 
the phytosanitary certificate with the additional declaration needed to 
market their wheat for export, has the potential to enable them to 
recover $145,000 or more in annual revenues, based on current 
prices.\3\
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    \3\ Source: Barte Smith (APHIS).
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    Growers in Arizona and California will also benefit. This rule will 
enable the approximately 67 producers in Arizona with fields that 
previously tested Karnal bunt-positive, to recover, collectively, 
revenues estimated at about $1,433,000 per year. The four producers in 
California with fields that previously tested positive stand to 
recover, collectively, about $210,000 per year in lost revenues.\4\
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    \4\ Dollar estimates are derived from data provided by Michael 
Hennessey and Cindy Umbdenstock (APHIS). Dollar estimates assume a 
price differential of $1.80/bushel between uncertified and certified 
wheat.
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Modifying Seed Planting Requirements

    The regulations have provided that wheat, durum wheat, or triticale 
that is grown in regulated areas and intended for use as seed cannot be 
planted outside those areas. Under this final rule, wheat, durum wheat, 
or triticale grown in regulated areas will be eligible for planting 
outside the regulated areas if it is tested and found free of bunted 
kernels and spores.
    Seed producers in regulated areas will benefit because they will be 
able to sell their seed outside those areas, recapturing markets that 
they had previously lost. Furthermore, by removing a disincentive for 
certified seed producers to operate in regulated areas, the rule also 
has the potential to benefit owners of seed conditioning equipment who 
operate in those areas.
    Even producers who do not sell seed outside the regulated area 
stand to benefit. In Texas, for example, it is not uncommon for 
producers to hold back a quantity of grain for use as seed in the next 
planting season. With the regulatory changes in effect, producers in 
regulated areas will be able to use their grain as seed in fields that 
they operate outside the regulated area--instead of having to purchase 
higher-priced commercial seed for use in those fields. In San Saba and 
McCulloch Counties, TX, it is estimated that 14 producers would have 
saved a total of about $60,000 this past crop season if they had been 
able to use their grain as seed in fields that they operated outside 
the regulated area.\5\ It is estimated that about half of the 
approximately 450 wheat producers in the regulated areas of northern 
Texas will benefit to at least some extent from this aspect of the 
final rule.
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    \5\ George Nash (APHIS).
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Removing Animal Manure From the List of Regulated Articles

    The regulations have listed manure from animals that have fed on 
untreated or raw wheat as a regulated article under Sec.  301.89-2. 
Although not set forth in the regulations, it has been our practice to 
require a 5-day ``clean-out'' period for livestock that have been fed 
untreated or raw wheat before the animals can be moved from the 
regulated area. During the clean-out period, livestock can be fed only 
Karnal bunt-negative wheat or a non-host crop. This final rule removes 
animal manure from the list of regulated articles in Sec.  301.89-2, 
effectively eliminating the clean-out policy.
    This aspect of the rule will benefit livestock producers, since the 
clean-out policy may compel them to switch their animals to an 
alternative, but less desirable, feed crop during the 5-day period. A 
change in feeding rations during the clean-out period can adversely 
impact weight gain, which, in turn, can adversely affect animal prices. 
In northern Texas, where this rule has the potential to have the most 
impact, it has been estimated that cattle can lose up to 20 percent of 
their weight in the first week following a feed-crop change. For a 
single head of cattle weighing 700 lbs. before clean out, therefore, 
the clean-out requirement can translate into a loss of up to $109 
(based on the current price of about $0.78/lb).
    Livestock producers will further benefit because clean-out can also 
involve gathering the animals and transporting them to a new location, 
such as a new pasture, during the 5-day period. The time and expense 
associated with gathering and transporting cattle to a new location for 
clean-out may vary among individual livestock producers, depending on 
such factors as the distance to the new location, the cost for the use 
of the new location, and the equipment needed for transport to the new 
location.
    To date in northern Texas, only a few cattle producers have had to 
clean out their animals, since most moved their animals before the 
wheat reached the soft dough stage. However, there are at least 500 
cattle producers in northern Texas who will potentially benefit from 
this aspect of the final rule, including some who move up to about 
25,000 head annually.\6\
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    \6\ Source: Barte Smith (APHIS).
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Modifying Cleaning and Disinfecting Requirements for Seed Conditioning 
Equipment

    The regulations have provided that seed conditioning equipment used 
in the production of any host crop must be cleaned and disinfected 
(using USDA-approved methods) prior to being moved from the regulated 
area. (Cleaning means the removal of all soil and plant debris, and 
disinfecting means the treatment by one of three approved methods, 
including steam and hot water and detergent.)
    Under this final rule, only seed conditioning equipment that was 
used to condition seed that was tested and found to contain spores or 
bunted kernels will have to be cleaned and disinfected prior to being 
moved from a regulated area (or prior to handling spore-negative seed).
    As a result of this rule, fewer pieces of portable seed 
conditioning equipment will have to be cleaned and disinfected. The 
affected entities will benefit, because a single cleaning and 
disinfecting is estimated to cost at least $150. However, the number of 
entities potentially affected by this aspect of the rule, and the 
potential impact on each, is unknown.

Economic Impact on Small Entities

    The Regulatory Flexibility Act requires that agencies consider the 
economic impact of their rules on small businesses, organizations, and 
governmental jurisdictions. This rule is expected to have an overall 
beneficial impact on the entities affected by the regulations, 
especially wheat producers. However, we do not expect that the rule 
will have a significant economic impact

[[Page 8095]]

on a substantial number of entities, large or small.
    Parts of three States (Texas, Arizona, and California) are 
currently regulated for Karnal bunt. In Texas, there are approximately 
285,000 agricultural acres and about 550 wheat producers under 
regulation. The equivalent figures for Arizona and California are, 
respectively, 465,000 acres (120 producers) and 105,000 acres (18 
producers).
    Wheat producers that will be affected by this rule are likely to be 
small in size, when judged by the U.S. Small Business Administration's 
(SBA's) standards. This assumption is based on composite data for 
providers of the same and similar services. In 1997, Arizona had a 
total of 6,135 farms of all types. Of those farms, 89 percent had 
annual sales that year of less than $500,000, well below the SBA's 
small entity threshold of $750,000 for wheat farms. Similarly, the 
comparable percentages of small entities for Texas (194,301 total 
farms) and California (74,126 total farms) were 98 percent and 89 
percent, respectively.
    For some of the affected entities, especially the smaller ones, the 
benefits of this rule may be substantial. However, the number of 
entities that will experience substantial benefits is expected to be 
small relative to all entities potentially affected by this rule.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action will 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12372

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

Executive Order 12988

    This final 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; (2) has no 
retroactive effect; and (3) does not require administrative proceedings 
before parties may file suit in court challenging this rule.

Paperwork Reduction Act

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

List of Subjects in 7 CFR Part 301

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

0
Accordingly, we are amending 7 CFR part 301 as follows:

PART 301--DOMESTIC QUARANTINE NOTICES

0
1. The authority citation for part 301 continues to read as follows:

    Authority: 7 U.S.C. 7701-7772; 7 CFR 2.22, 2.80, and 371.3.

    Section 301.75-15 also issued under Sec. 204, Title II, Pub. L. 
106-113, 113 Stat. 1501A-293; sections 301.75-15 and 301.75-16 also 
issued under Sec. 203, Title II, Pub. L. 106-224, 114 Stat. 400 (7 
U.S.C. 1421 note).


0
2. Section 301.89-1 is amended by removing the definitions for farm 
tools and milling products and byproducts and by adding, in 
alphabetical order, definitions for grain, hay, host crops, plant, 
seed, straw, and tilling and revising the definitions for contaminated 
seed, infestation (infected), and mechanized cultivating equipment and 
mechanized harvesting equipment to read as follows:


Sec.  301.89-1  Definitions.

* * * * *
    Contaminated seed. Seed from sources in which the Karnal bunt 
pathogen (Tilletia indica (Mitra) Mundkur) has been determined to exist 
by the presence of bunted kernels or teliospores.
* * * * *
    Grain. Wheat, durum wheat, and triticale used for consumption or 
processing.
* * * * *
    Hay. Host crops cut and dried for feeding to livestock. Hay cut 
after reaching the dough stage may contain mature kernels of the host 
crop.
    Host crops. Plants or plant parts, including grain, seed, or hay, 
of wheat, durum wheat, and triticale.
    Infestation (infected). The presence of Karnal bunt, or any 
identifiable stage of development (i.e., bunted kernels in grain, 
bunted kernels or teliospores in seed) of the fungus Tilletia indica 
(Mitra) Mundkur, or the existence of circumstances that make it 
reasonable to believe that Karnal bunt is present.
* * * * *
    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, grain buggies, trucks, swathers, 
and hay balers.
* * * * *
    Plant. Any plant (including any plant part) for or capable of 
propagation, including a tree, a tissue culture, a plantlet culture, 
pollen, a shrub, a vine, a cutting, a graft, a scion, a bud, a bulb, a 
root, and a seed.
    Seed. Wheat, durum wheat, and triticale used for propagation.
* * * * *
    Straw. The vegetative material left after the harvest of host 
crops. Straw is generally used as animal feed, bedding, mulch, or for 
erosion control.
    Tilling. The turning of a minimum of the top 6 inches of soil.

0
3. Section 301.89-2 is revised to read as follows:


Sec.  301.89-2  Regulated articles.

    The following are regulated articles:
    (a) Conveyances, including trucks, railroad cars, and other 
containers used to move host crops produced in a regulated area that 
have tested positive for Karnal bunt through the presence of bunted 
kernels;
    (b) Grain elevators/equipment/structures used for storing and 
handling host crops produced in a regulated area that have tested 
positive for Karnal bunt through the presence of bunted kernels;
    (c) Seed conditioning equipment and storage/handling equipment/
structures that have been used in the production of wheat, durum wheat, 
and triticale found to contain the spores of Tilletia indica;
    (d) Plants or plant parts (including grain, seed, and straw) and 
hay cut after reaching the dough stage of all varieties of wheat 
(Triticum aestivum), durum wheat (Triticum durum), and triticale 
(Triticum aestivum X Secale cereale) that are produced in a regulated 
area, except for straw/stalks/seed heads for decorative purposes that 
have been processed or manufactured prior to movement and are intended 
for use indoors;
    (e) Tilletia indica (Mitra) Mundkur;
    (f) Mechanized harvesting equipment that has been used in the 
production of wheat, durum wheat, or triticale that has tested positive 
for Karnal bunt through the presence of bunted kernels; and
    (g) Any other product, article, or means of conveyance when:
    (1) An inspector determines that it presents a risk of spreading 
Karnal bunt based on appropriate testing and the intended use of the 
product, article, or means of conveyance; and

[[Page 8096]]

    (2) The person in possession of the product, article, or means of 
conveyance has been notified that it is regulated under this subpart.

0
4. Section 301.89-3 is amended as follows:
0
a. In paragraph (d), by revising the fourth sentence to read as set 
forth below.
0
b. By revising paragraph (e)(3) to read as set forth below.
0
c. By redesignating paragraph (f) as paragraph (g) and adding a new 
paragraph (f) to read as set forth below.
0
d. In newly redesignated paragraph (g), by revising the introductory 
text to read as set forth below.


Sec.  301.89-3  Regulated areas.

* * * * *
    (d) * * * As soon as practicable, this area either will be added to 
the list of designated regulated areas in paragraph (g) of this 
section, or the Administrator will terminate the designation. * * *
    (e) * * *
    (3) It is a distinct definable area that contains at least one 
field that has been determined to be associated with grain at a 
handling facility containing a bunted kernel of a host crop (the 
distinct definable area may include an area where Karnal bunt is not 
known to exist but where intensive surveys are required because of the 
area's proximity to the field associated with the bunted kernel at the 
handling facility).
    (f) A field known to have been infected with Karnal bunt, as well 
as any non-infected acreage surrounding the field, will be released 
from regulation if:
    (1) The field is no longer being used for crop production; or
    (2) Each year for a period of 5 consecutive years, the field is 
subjected to any one of the following management practices (the 
practice used may vary from year to year):
    (i) Planted with a cultivated non-host crop;
    (ii) Tilled once annually; or
    (iii) Planted with a host crop that tests negative, through the 
absence of bunted kernels, for Karnal bunt.
    (g) The following areas or fields are designated as regulated areas 
(maps of the regulated areas may be obtained by contacting the Animal 
and Plant Health Inspection Service, Plant Protection and Quarantine, 
4700 River Road Unit 98, Riverdale, MD 20737-1236):
* * * * *

0
5. Section 301.89-4 is revised to read as follows:


Sec.  301.89-4  Planting.

    Any wheat, durum wheat, or triticale that originates within a 
regulated area must be tested and found free from bunted wheat kernels 
and spores before it may be used as seed within or outside a regulated 
area.


Sec.  301.89-5  [Amended]

0
6. Section 301.89-5 is amended as follows:
0
a. In paragraph (a)(3), footnote 1, by removing the words ``Domestic 
and Emergency Operations, 4700 River Road Unit 134'' and adding the 
words ``Surveillance and Emergency Programs Planning and Coordination, 
4700 River Road Unit 98'' in their place.
0
b. By removing paragraph (a)(4).

0
7. Section 301.89-6 is amended as follows:
0
a. In the introductory text of paragraph (a), footnote 2, by removing 
the words ``Domestic and Emergency Operations, 4700 River Road Unit 
134'' and adding the words ``Surveillance and Emergency Programs 
Planning and Coordination, 4700 River Road Unit 98'' in their place and 
by removing the words ``, or from the Karnal Bunt Project, 3658 E. 
Chipman Rd., Phoenix, Arizona 85040''.
0
b. By revising paragraph (b) and the introductory text of paragraph (c) 
to read as set forth below.


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

* * * * *
    (b) To be eligible for movement under a certificate, hay cut after 
the dough stage or grain from a field within a regulated area must be 
tested prior to its movement from the field or before it is commingled 
with similar commodities and must be found free from bunted kernels. If 
bunted kernels are found, the grain or hay will be eligible for 
movement only under a limited permit issued in accordance with 
paragraph (c) of this section, and the field of production will be 
considered positive for Karnal bunt.
    (c) An inspector or a person operating under a compliance agreement 
will issue a limited permit for the movement outside the regulated area 
of a regulated article not eligible for a certificate if the inspector 
determines that the regulated article:
* * * * *

0
8. Section 301.89-7 is amended by revising footnote 4 to read as 
follows:


Sec.  301.89-7  Compliance agreements.

* * * * * \4\
---------------------------------------------------------------------------

    \4\ 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, Surveillance and Emergency Program Planning and 
Coordination, 4700 River Road Unit 98, Riverdale, Maryland 20737-
1236.

0
9. Section 301.89-12 is revised to read as follows:


Sec.  301.89-12  Cleaning, disinfection, and disposal.

    (a) Mechanized harvesting equipment that has been used to harvest 
host crops that test positive for Karnal bunt based on the presence of 
bunted kernels must be cleaned and, if disinfection is determined to be 
necessary by an inspector, disinfected in accordance with Sec.  301.89-
13 prior to movement from a regulated area.
    (b) Seed conditioning equipment that was used in the conditioning 
of seed that was tested and found to contain spores or bunted kernels 
of Tilletia indica must be cleaned and disinfected in accordance with 
Sec.  301.89-13 prior to being used in the conditioning of seed that 
has tested negative for the spores of Tilletia indica or to being moved 
from a regulated area.
    (c) Any grain storage facility, including on-farm storage, that is 
used to store seed that has tested bunted-kernel or spore positive or 
grain that has tested bunted-kernel positive must be cleaned and, if 
disinfection is determined to be necessary by an inspector, disinfected 
in accordance with Sec.  301.89-13 if the facility will be used to 
store grain or seed in the future.
    (d) Conveyances used to move bunted-kernel-positive host crops, 
including trucks, railroad cars, and other containers, that have 
sloping metal sides leading directly to a bottom door or slide chute, 
are self cleaning, and will not be required to be cleaned and 
disinfected.
    (e) Spore-positive wheat, durum wheat, or triticale seed that has 
been treated with any chemical that renders it unfit for human or 
animal consumption must be disposed of by means of burial under a 
minimum of 24 inches of soil in a nonagricultural area that will not be 
cultivated or in an approved landfill.

0
10. Section 301.89-13 is revised to read as follows:


Sec.  301.89-13  Treatments.

    All conveyances, mechanized harvesting equipment, seed conditioning 
equipment, grain elevators, and structures used for storing and 
handling wheat, durum wheat, or triticale required to be cleaned under 
this subpart must be cleaned by removing all soil and plant debris. If 
disinfection is required by an inspector in addition to cleaning, the 
articles must

[[Page 8097]]

be disinfected by one of the methods specified in paragraph (a), (b), 
or (c) of this section, unless a particular treatment is designated by 
an inspector. The treatment used must be that specified by an 
inspector:
    (a) Wetting all surfaces to the point of runoff with one of the 
following 1.5 percent sodium hypochlorite solutions and letting stand 
for 15 minutes, then thoroughly washing down all surfaces after 15 
minutes to minimize corrosion:
    (1) One part Ultra Clorox brand regular bleach (6 percent sodium 
hypochlorite; EPA Reg. No. 5813-50) in 3 parts water; or
    (2) One part CPPC Ultra Bleach 2 (6.15 percent sodium hypochlorite; 
EPA Reg. No. 67619-8) in 3.1 parts water.
    (b) Applying steam to all surfaces until the point of runoff, and 
so that a critical temperature of 170 F is reached at 
the point of contact.
    (c) 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 170 F.


Sec.  301.89-14  [Removed and Reserved]

0
11. Section 301.89-14 is removed and reserved.

    Done in Washington, DC, this 17th day of February, 2004.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 04-3807 Filed 2-20-04; 8:45 am]
BILLING CODE 3410-34-P