[Federal Register Volume 74, Number 203 (Thursday, October 22, 2009)]
[Rules and Regulations]
[Pages 54431-54445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25328]
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Rules and Regulations
Federal Register
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Federal Register / Vol. 74, No. 203 / Thursday, October 22, 2009 /
Rules and Regulations
[[Page 54431]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Part 301
[Docket No. APHIS-2009-0023]
RIN 0579-AC96
Citrus Canker; Movement of Fruit From Quarantined Areas
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are amending the citrus canker regulations to modify the
conditions under which fruit may be moved interstate from a quarantined
area. We are eliminating the requirement that each lot of finished
fruit be inspected at the packinghouse and found to be free of visible
symptoms of citrus canker and removing the current prohibition on the
movement of fruit from a quarantined area to commercial citrus-
producing States. We are continuing to require fruit moved interstate
from a quarantined area to be treated with an approved disinfectant and
to be packed in a commercial packinghouse that operates under a
compliance agreement. These changes will relieve some restrictions on
the interstate movement of fresh citrus fruit from quarantined areas
while maintaining conditions that will prevent the artificial spread of
citrus canker.
EFFECTIVE DATE: October 22, 2009.
FOR FURTHER INFORMATION CONTACT: Mr. Stephen Poe, Senior Operations
Officer, Emergency and Domestic Programs, Plant Protection and
Quarantine, APHIS, 4700 River Road Unit 137, Riverdale, MD 20737-1231;
(301) 734-4387.
SUPPLEMENTARY INFORMATION:
Background
Citrus canker is a plant disease caused by the bacterium
Xanthomonas citri subsp. citri (referred to below as Xcc) that affects
plants and plant parts, including fresh fruit, of citrus and citrus
relatives (Family Rutaceae). Citrus canker can cause defoliation and
other serious damage to the leaves and twigs of susceptible plants. It
can also cause lesions on the fruit of infected plants, which render
the fruit unmarketable, and cause infected fruit to drop from the trees
before reaching maturity. The A (Asiatic) strain of citrus canker can
infect susceptible plants rapidly and lead to extensive economic losses
in commercial citrus-producing areas. Citrus canker is only known to be
present in the United States in the State of Florida.
The regulations to prevent the interstate spread of citrus canker
are contained in ``Subpart-Citrus Canker'' (7 CFR 301.75-1 through
301.75-14, referred to below as the regulations). The regulations
restrict the interstate movement of regulated articles from and through
areas quarantined because of citrus canker and provide, among other
things, conditions under which regulated fruit may be moved into,
through, and from quarantined areas for packing.
On June 30, 2009, we published in the Federal Register (74 FR
31201-31209, Docket No. APHIS-2009-0023) a proposal\1\ to amend the
regulations to modify the conditions under which fruit may be moved
interstate from a quarantined area. We proposed to eliminate the
requirement that each lot of finished fruit be inspected at the
packinghouse and found to be free of visible symptoms of citrus canker
and to remove the current prohibition on the movement of fruit from a
quarantined area to American Samoa, Arizona, California, Guam, Hawaii,
Louisiana, Commonwealth of the Northern Mariana Islands, Puerto Rico,
Texas, and the U.S. Virgin Islands. (These are the commercial citrus-
producing areas listed in Sec. 301.75-5; we refer to them in this
document as commercial citrus-producing States.)
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\1\ To view the proposed rule and the comments we received, go
to (http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2009-0023).
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We proposed to continue to require fruit moved interstate from a
quarantined area to be treated with an approved disinfectant and to be
packed in a commercial packinghouse that operates under a compliance
agreement. We proposed these changes to relieve some restrictions on
the interstate movement of fresh citrus fruit from quarantined areas
while maintaining conditions that would prevent the artificial spread
of citrus canker.
We solicited comments concerning our proposal for 60 days ending
August 31, 2009. We received 34 comments by that date. They were from
citrus producers, citrus packers, industry organizations, researchers,
and representatives of State and foreign governments. Twenty-three
commenters supported the proposed rule. Two of these commenters also
directly addressed issues raised in the remaining comments, which are
discussed below by topic.
Selection of an Option for Mitigating the Risk Associated With the
Interstate Movement of Regulated Fruit From a Quarantined Area
In a final rule\2\ effective and published in the Federal Register
on November 19, 2007 (72 FR 65172-65204, Docket No. APHIS-2007-0022),
we amended the regulations to establish new conditions for the
interstate movement of regulated fruit from an area quarantined for
citrus canker. That final rule eliminated a requirement that the groves
in which fruit to be moved interstate is produced be inspected and
found free of citrus canker. Instead, we added the packinghouse
inspection requirement mentioned earlier. We retained the other
requirements that had been in the regulations, including the
requirement that the fruit be treated with a surface disinfectant and
the prohibition on the movement of fruit from a quarantined area into
commercial citrus-producing States.
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\2\ To view the November 2007 final rule, go to (http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2007-0022).
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We established those conditions based on the conclusions of a pest
risk assessment (PRA) and risk management analysis (RMA) prepared for
the 2007 rulemaking. The PRA concluded that asymptomatic, commercially
produced citrus fruit, treated with a disinfectant and subject to other
mitigations, is not epidemiologically significant as a
[[Page 54432]]
pathway for the introduction and spread of citrus canker.
The RMA examined the risks associated with both symptomatic and
asymptomatic fruit and concluded that the introduction and spread of
Xcc into other States through the movement of commercially packed fresh
citrus fruit from quarantined areas is unlikely. In addition, the RMA
concluded that a phytosanitary inspection would ensure, with high
confidence, that few shipped fruit would have symptoms of citrus canker
disease. However, the RMA also concluded that the evidence available at
that time was not sufficient to support a determination that fresh
citrus fruit produced in an Xcc-infested grove cannot serve as a
pathway for the introduction of Xcc into new areas, thus necessitating
the prohibition on movement of fruit into commercial citrus-producing
States.
In our responses to public comments in the Background section of
the November 2007 final rule, we stated: ``If, in the future, evidence
is developed to support a determination that commercially packed citrus
fruit (both symptomatic and asymptomatic) is not an epidemiologically
significant\3\ pathway for the introduction and spread of citrus
canker, we would undertake rulemaking to amend our regulations
accordingly.''
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\3\ The term ``epidemiologically significant'' refers to the
minimum conditions required for introduction of a disease into an
unaffected area. Our judgment of whether fruit is an
epidemiologically significant pathway for disease transmission is
based on the likelihood that the fruit itself will be infected with
the disease, that the infection will occur in a way or at a level
sufficient for transmission of the disease, and that such an
infected fruit will encounter the biological conditions required for
transmission of the disease.
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Since the publication of the November 2007 final rule, two
publications have provided additional evidence regarding the potential
of fruit to serve as a pathway for the introduction and spread of
citrus canker. This new evidence addresses key uncertainties and caused
us to revisit our previous findings. The first article, by Gottwald et
al. (2009), documents research on the survival of Xcc on commercially
produced and packed citrus fruit and the likelihood that such fruit
could serve as a mechanism to spread the disease. The second article,
by Shiotani et al. (2009), documents research on the survival of Xcc on
commercially produced mandarin fruits and the likelihood of spread of
Xcc to trees from harvested mandarins.
Accordingly, we prepared updates to the PRA and RMA that had
accompanied the November 2007 final rule. The updated PRA, titled ``An
Updated Evaluation of Citrus Fruit (Citrus spp.) as a Pathway for the
Introduction of Citrus Canker Disease (Xanthomonas citri subsp.
citri)'' (March 2009), examines the information presented in Gottwald
et al. (2009) and Shiotani et al. (2009) in the context of the earlier
PRA. Based on the evidence presented in both the November 2007 PRA and
the two new publications, the updated PRA concludes that asymptomatic
fruit (treated or untreated) is not epidemiologically significant as a
pathway for introducing citrus canker. It further concludes that
symptomatic fruit subjected to a packinghouse process that includes
washing with disinfectants is also not epidemiologically significant as
a pathway for introducing citrus canker.
These conclusions led us to prepare a supplemental RMA, titled
``Movement of Commercially Packed Citrus Fruit from Citrus Canker
Disease Quarantine Area; Supplemental Risk Management Analysis'' (May
2009). The supplemental RMA takes into account the conclusions of the
updated PRA as well as the evidence and discussion presented in the
November 2007 RMA. Like the November 2007 RMA, the supplemental RMA was
submitted for peer review, in accordance with the Office of Management
and Budget's bulletin on peer review. All the materials associated with
the peer review on the supplemental RMA, including the peer reviewers'
comments and our responses, are available at (http://www.aphis.usda.gov/peer_review/peer_review_agenda.shtml). The peer
reviewers' comments were considered in developing the supplemental RMA.
The supplemental RMA concludes that multiple lines of evidence,
including, but not limited to, evidence from the two recent studies and
the November 2007 RMA, indicate that commercially packed and
disinfected fresh citrus fruit is not an epidemiologically significant
pathway for the introduction and spread of Xcc, i.e.:
Disease management practices in the grove reduce, but do
not eliminate, Xcc populations.
Commercially produced fruit harvested in areas where Xcc
exists may be visibly infected or the fruit may carry the pathogen
either on its surface or in wounds.
Citrus canker disease development between harvest and
packinghouse, via wounding for example, is not likely.
Procedures for cleaning and disinfecting fruit are
routinely applied by packinghouses.
The individual efficacy of these procedures for removing
or destroying Xcc may not be known in detail, but the effect of
packinghouse treatments reduces the prevalence of viable Xcc and
therefore the level of inoculum associated with commercially packed
fresh citrus fruit.
Packinghouse processing that includes a disinfectant
treatment further reduces amounts of Xcc inoculum on infected or
contaminated fruit.
The viability of bacteria on fruit and in lesions and
wounds diminishes after the fruit is harvested.
The viability of Xcc bacteria that survive the packing
process will further diminish during shipping.
Epiphytic populations of Xcc may aid in pathogen
dispersal, but substantial evidence indicates that bacterial
populations do not infect intact mature fruit.
Evidence indicates that wounds on harvested fruit
containing Xcc inoculum do not lead to citrus canker lesion
development, and Xcc populations generally decline rapidly, although
wounds might occasionally retain Xcc populations that decline more
slowly.
The cool temperatures at which citrus fruit are stored and
shipped and the duration of storage reduce the ability of Xcc to
reproduce and cause infection.
As a condition for successful establishment, Xcc, in
amounts sufficient to cause infection, must encounter not only an
environment with a conducive temperature, relative humidity, moisture,
and wind events for infection, but also must encounter host plant
tissue that is either at a susceptible growth stage or is wounded and
then must successfully enter this tissue.
Despite substantial international trade between Xcc-
infected and noninfected countries, there is no authenticated record of
movement of diseased fruit or seeds resulting in the introduction of
Xcc to new areas.
In light of this evidence, the supplemental RMA considered five
risk management options for the interstate movement of commercially
packed citrus fruit from areas quarantined for citrus canker:
Option 1: Allow distribution of all types and varieties of
commercially packed citrus fruit to all U.S. States, without
packinghouse treatment with a disinfectant.
Option 2: Allow distribution of all types and varieties of
commercially packed citrus fruit to all U.S. States, subject to
packinghouse treatment with an Animal and Plant Health Inspection
Service (APHIS)-approved disinfectant,
[[Page 54433]]
but without the current inspection requirement.
Option 3: Allow distribution of all types and varieties of
commercially packed citrus fruit to all U.S. States except commercial
citrus-producing States, subject to packinghouse treatment of citrus
fruit with an APHIS-approved disinfectant treatment; and, allow
distribution of all types and varieties of commercially packed citrus
fruit to all U.S. States, including commercial citrus-producing States,
subject to packinghouse treatment with an APHIS-approved disinfectant
treatment and APHIS inspection for symptoms of citrus canker.
Option 4: Allow distribution of all types and varieties of
commercially packed citrus fruit to all U.S. States other than
commercial citrus-producing States, subject to packinghouse treatment
with an APHIS-approved disinfectant.
Option 5: Leave the current regulations for the interstate
movement of citrus fruit from areas quarantined for citrus canker
unchanged.
After considering the evidence presented in the updated PRA and the
supplemental RMA and the conclusions of those documents, we determined
that currently available scientific evidence provides additional
certainty that commercially packed and disinfected fresh citrus fruit
is not an epidemiologically significant pathway for the spread of Xcc.
Therefore, no mitigations beyond treatment with an APHIS-approved
disinfectant are necessary. Accordingly, we proposed to implement
Option 2.
Several commenters acknowledged that the risk associated with the
interstate movement of regulated fruit from a quarantined area is low
but stated that, if there is any risk associated with allowing fruit to
move from areas quarantined for citrus canker into commercial citrus-
producing States, such movement should be prohibited. These commenters
stated that citrus canker has been a destructive and costly disease in
Florida, one which spurred an eradication attempt that was ultimately
unsuccessful, and that other commercial citrus-producing States do not
want to be at risk for the introduction and establishment of the
disease. One commenter recommended that we err on the side of caution
in making changes to the regulations and stated that further research
should be done before fruit from quarantined areas is allowed into
commercial citrus-producing States.
Two of these commenters proposed additional risk mitigation
measures to address the risk they perceived to be associated with fruit
moved interstate from an area quarantined for citrus canker. Both
stated that such fruit should not be allowed to move into the eight-
county Citrus Zone in south Texas. These commenters cited the
suitability of Texas' climate to citrus canker establishment (as
demonstrated by previous outbreaks of citrus canker in Texas), the
susceptibility of grapefruit (a common citrus crop in Texas) to citrus
canker, and citrus canker's effect on young citrus trees. One of these
commenters additionally requested that fruit destined for Texas
originate only from groves that have been certified as being free of
citrus canker for more than a year, based on a survey.
Another commenter, responding to some of these commenters, stated
that no agricultural trade between States and countries anywhere in the
world could be conducted if minimal risk is unacceptable and that the
proposed rule would mitigate the risks to the point that risks are
negligible.
Our goal in restricting the interstate movement of plants, plant
products, and other articles is not to achieve zero risk, which, as the
last commenter noted, cannot be achieved in agricultural trade. Rather,
we seek to impose restrictions on the interstate movement of such
articles that are commensurate with the risk they pose and that
mitigate the risk associated with their interstate movement. Based on
all the available scientific evidence, the updated PRA and supplemental
RMA concluded that commercially packed and disinfected fresh citrus
fruit is not an epidemiologically significant pathway for the
introduction and spread of Xcc. We received several comments on the two
new publications that led us to prepare the updated PRA and
supplemental RMA, as well as comments on the updated PRA and
supplemental RMA themselves. These comments are discussed in further
detail later in this document. However, they did not change our
conclusion that commercially packed and disinfected fresh citrus fruit
is not an epidemiologically significant pathway for the spread of Xcc.
Accordingly, this final rule implements Option 2 as proposed.
We are not retaining the current prohibition on the distribution of
fruit from a quarantined area to commercial citrus-producing States,
and we are not adding the additional mitigations requested by two of
the commenters. Based on our determination that fruit is not an
epidemiologically significant pathway, we have determined that those
additional mitigations are unnecessary to prevent the spread of citrus
canker via the interstate movement of fruit from quarantined areas. As
noted, it is impossible to eliminate all risk associated with the
interstate movement of fruit from quarantined areas; given the
conclusions of the updated PRA and the supplemental RMA, following the
recommendation that we prohibit the movement of fruit into commercial
citrus-producing States unless all risk is eliminated would impose an
unnecessary restriction on the movement of fruit.
Under section 412(a) of the Plant Protection Act (7 U.S.C. Sec.
7712), the Secretary of Agriculture may prohibit or restrict the
interstate movement of any plant or plant product if the Secretary
determines that the prohibition or restriction is necessary to prevent
the dissemination within the United States of a plant pest or noxious
weed. Based on our supplemental RMA, APHIS has concluded that
commercially packed citrus fruit treated with an APHIS-approved
disinfectant is not an epidemiologically significant pathway for the
dissemination of citrus canker within the United States. Accordingly,
APHIS has determined that it is not necessary to prohibit the
interstate movement of regulated fruit that is commercially packed and
treated with an APHIS-approved disinfectant from an area that is
quarantined for citrus canker in order to prevent the dissemination
within the United States of a plant pest. This determination is based
on the findings of the updated PRA and the supplemental RMA referred to
earlier in this document and our judgment that the application of the
measures we proposed will prevent the dissemination of plant pests
within the United States.
One commenter who was opposed to allowing the interstate movement
of citrus fruit from a quarantined area to commercial citrus-producing
States stated that California, a commercial citrus-producing State, is
the home of three of the most important resources of citrus germplasm
in the United States: The National Clonal Germplasm Repository for
Citrus and Dates (NCGRCD), a U.S. Department of Agriculture-
Agricultural Research Service (ARS) facility supplying budwood
worldwide; the Citrus Clonal Protection Program, University of
California-Riverside (UCR), the first citrus germplasm program in the
world supplying budwood to California, Arizona, and Texas; and the UCR
Citrus Variety Collection, perhaps the most diverse citrus collection
in the world dating back to 1907. The commenter stated that certified
disease-free budwood and a broad genetic basis for
[[Page 54434]]
variety development and improvement are the foundation of every
successful, profitable, and sustainable citrus industry in the world
and that those three germplasm resources are the only ones in the
United States (if not the world) that have not been exposed to citrus
canker or other devastating citrus diseases such as citrus greening.
The commenter stated that taking a ``calculated'' risk to expose these
invaluable resources to one of the worst citrus diseases in the world,
citrus canker, based on limited field and packinghouse practices that
will not be inspected for compliance is unacceptable. This commenter
also stated that the Florida citrus industry funded a project to
``rescue'' Florida citrus germplasm by moving it to citrus canker- and
citrus greening-free California in the NCGRCD facilities.
As we have determined that commercially packed and disinfected
fresh citrus fruit is not an epidemiologically significant pathway for
the introduction and spread of citrus canker, we do not expect that
these facilities will be exposed to citrus canker as a result of the
implementation of this final rule.
However, it should be noted that germplasm facilities are devoted
to the preservation of the germplasm within the facilities and thus are
protected against potential sources of pest and disease introduction.
Indeed, potentially infected germplasm from foreign countries is
imported into these same facilities for screening purposes, which is a
much more likely pathway for the introduction of diseases such as
citrus canker than the interstate movement of regulated fruit from a
quarantined area. Allowing citrus fruit to be moved interstate from
quarantined areas into California will not decrease the efficacy of the
biosecurity in place at these facilities.
It should also be noted that, under this final rule, packinghouses
will be inspected to ensure that they are complying with the
requirements to treat regulated fruit with an APHIS-approved
disinfectant and to ensure that the fruit is free of leaves, twigs, and
other plant parts, except for stems that are less than 1 inch long and
attached to the fruit. With regard to the other commercial fruit
production practices described in the November 2007 RMA, we assume that
commercial growers and packinghouses will continue to employ procedures
that reduce the incidence of citrus canker in their fruit, as citrus
canker lesions reduce the market value of infected fruit.
New Evidence We Considered in the Updated PRA and Supplemental RMA
Several commenters generally addressed the Gottwald et al. (2009)
and Shiotani et al. (2009) publications. We address these comments
below.
One commenter stated that the premise of both publications was to
prove that citrus canker cannot be transmitted by infected or
contaminated citrus fruit. The commenter stated that, scientifically, a
negative premise cannot be proven, and the commenter cited this as one
major flaw of these studies. Another commenter stated that Shiotani et
al. (2009) did not demonstrate that Xcc cannot be transmitted from
fruit to susceptible tissue, as it did not adequately resolve the
ability of Xcc to spread from asymptomatic fruit.
One commenter, responding to the first commenter, stated that the
two publications never set out to prove that something cannot happen
because, philosophically and scientifically, this is impossible.
However, the commenter stated, both publications soundly proclaim that
risks can very effectively, very simply, and very reliably be reduced
below any reasonable and measurable risk of transmitting citrus canker
disease.
As the last commenter states, neither of the publications concluded
that citrus canker cannot be spread by fruit. Gottwald et al. (2009)
concluded that ``harvested and packinghouse-disinfested citrus fruit
are extremely unlikely to be a pathway for Xcc to reach and infect
susceptible citrus and become established in canker-free areas.''
Shiotani et al. (2009) concluded that ``there is a low risk [of]
transmission'' of Xcc from fruit. These conclusions are consistent with
the conclusions of the updated PRA and supplemental RMA, as described
earlier.
Two commenters stated that the research in the Gottwald et al.
(2009) and Shiotani et al. (2009) publications should be tested and
retested by others who were not involved in the original research
before changing the conditions under which fruit is allowed to move
from an area quarantined for citrus canker. Three commenters stated
that a national task force consisting of scientists from citrus-
producing areas other than Florida (and besides ARS personnel) should
be assembled to address any change in current quarantine regulations
that might result in the introduction of known destructive pathogens
from known infected areas to noninfected areas (i.e., California,
Arizona, Texas, etc.).
The Gottwald et al. (2009) and Shiotani et al. (2009) publications
were produced independently, published in a peer-reviewed journal, and
came to similar conclusions regarding the epidemiological significance
of fruit as a pathway for the spread of citrus canker. Among other
topics they address, these publications provide valuable evidence
regarding the potential for Xcc to spread from infected fruit to host
plants in the field; this evidence is what prompted us to prepare the
updated PRA and supplemental RMA.
However, the updated PRA and supplemental RMA considered all the
available evidence regarding the potential of fruit to serve as an
epidemiologically significant pathway for the introduction and spread
of citrus canker, not just the evidence in those publications. The
weight of all the available evidence is what led us to the conclusion
that commercially packed and disinfected fresh citrus fruit is not an
epidemiologically significant pathway for the introduction and spread
of Xcc. We have determined that the evidence provides adequate
certainty regarding this conclusion to remove some restrictions on the
interstate movement of commercially packed and disinfected fresh citrus
fruit from an area quarantined for citrus canker.
The November 2007 PRA and RMA and the supplemental RMA prepared for
this rulemaking were all submitted for peer review in accordance with
the Office of Management and Budget's bulletin on peer review. The peer
reviewers for the November 2007 PRA and RMA and the supplemental RMA
were experts in plant pathology, phytobacteriology, and risk
assessment. The comments we received from these peer reviewers
indicated that our analysis of the available evidence regarding the
risk associated with the movement of fruit from an area quarantined for
citrus canker was sound.
It should also be noted that the authors of the Shiotani et al.
(2009) publication were not affiliated with the State of Florida in any
way, and the experiments in the Gottwald et al. (2009) publication were
conducted by an international consortium of scientists working
cooperatively and reaching the same conclusion after conducting similar
experiments in two different countries, with participants from
Argentina as well as Florida.
Gottwald et al. (2009)
We received several comments specifically addressing Gottwald et
al. (2009).
Some of the experiments included in Gottwald et al. (2009) examined
the
[[Page 54435]]
effectiveness of treatment with a disinfectant at reducing Xcc
populations on citrus fruit. One commenter stated that the disinfection
procedures significantly reduced pathogen survival but did not
completely eliminate it. The commenter stated that, considering the
large amount of fruit being shipped, even a low survival rate of the
pathogen poses a high risk for the introduction of Xcc to a disease-
free area.
This commenter also stated that the limitation of treatments in
disinfecting fruit with lesions or fruit wounds contaminated with
inoculum of the pathogen is well known. Oxidizing agents cannot
effectively remove or reduce inoculum to acceptable levels in wounded
tissue because of the natural reducing agents that occur in fruit
tissue. Furthermore, these treatments would have little or no effect on
established fruit lesions that act as reservoirs of inoculum. Thus, the
commenter stated, without any inspections, even a few lesions on fruit
would pose a high risk because the pathogen could not be eliminated
using existing disinfection practices.
Another commenter stated that one cannot in a practical sense
sterilize the surface of fruit; it would do more harm than good, and
there is no biological reason to do so. The commenter stated that there
is an inoculum threshold necessary to naturally establish citrus canker
under even the most conducive conditions (10\5\ colony-forming units
(cfu)/milliliter (ml) for intact tissue infection, 10\3\ cfu/ml for
wounded) and that fruit disinfection easily achieves the low levels of
inoculum necessary to avoid the risk of disease transmission. The
commenter stated that the concern that inoculum in wounds on fruit
could not be completely eliminated overlooks the fact that the bacteria
do not even cause an infection at the wound site, let alone become
liberated to possibly induce a lesion elsewhere.
The November 2007 RMA and the supplemental RMA both acknowledge the
fact that disinfection treatments are not completely effective against
Xcc bacteria in lesions. However, as the November 2007 RMA stated,
there is abundant evidence that shows that packinghouse disinfection
treatments destroy surface bacteria and reduce the viability of all
bacteria on fruit. We did not rely solely on the Gottwald et al. (2009)
publication in making our determination that treatment with an APHIS-
approved disinfectant is an effective mitigation against the risk of
spread of citrus canker; rather, we considered all the available
evidence regarding the effectiveness of disinfectant treatments.
In addition, other evidence indicates that bacteria that remain in
lesions after disinfection are not epidemiologically significant. For
example, Gottwald et al. (2009) provided additional evidence supporting
the conclusion that the viability of bacteria on fruit and in lesions
and wounds diminishes after the fruit is harvested and that the
viability of Xcc bacteria which survive the packing process will
further diminish during shipping.
We disagree with the first commenter that the effectiveness of
disinfectant treatment on bacteria in wounds is a concern. The second
commenter is correct to note that Xcc bacteria in wounds do not cause
infections at the wound site. As discussed in the supplemental RMA,
evidence indicates that wounds on harvested fruit containing Xcc
inoculum do not lead to citrus canker lesion development, and Xcc
populations generally decline, although wounds might occasionally
retain Xcc populations that decline more slowly.
Finally, with respect to the first commenter's concern about
elimination of bacteria, we acknowledge that the surface disinfectant
treatments approved by APHIS reduce numbers of Xcc cells to low or
undetectable levels, but do not necessarily provide complete
eradication. As the second commenter notes, complete eradication would
be impractical. In any case, it is not necessary to completely
eradicate Xcc in order to ensure that disinfected fruit is not an
epidemiologically significant pathway. While the updated PRA and
supplemental RMA conclude specifically that commercially packed and
disinfected fresh citrus fruit is not an epidemiologically significant
pathway for the introduction and spread of Xcc, it is not just the
disinfection process that makes fruit not an epidemiologically
significant pathway for Xcc, but also the biology of Xcc and the
conditions that must be fulfilled in order for Xcc transmission from
infected fruit to a host plant to occur, among other factors.
Some commenters addressed experiments in the Gottwald et al. (2009)
publication that were designed to investigate the likelihood that
citrus fruit disposed of by consumers may serve as a source of inoculum
for nearby host material. Gottwald et al. (2009) studied the
transmission of Xcc from unprocessed, infected `Ruby Red' grapefruit
and `Lisbon' lemon and packinghouse-processed `Ruby Red' grapefruit in
cull piles to `Duncan' grapefruit seedlings during natural weather
events. During the course of the experiments, citrus canker lesions did
not develop on the grapefruit seedlings (488 seedlings total)
surrounding the diseased fruit, in spite of extensive leafminer damage
present on some of the seedlings. Xcc bacteria were not detected in
assays of the foliage.
Gottwald et al. (2009) repeated the cull pile experiment to see if
transmission of Xcc from infected, unprocessed `Ruby Red' grapefruit
fruit is possible under simulated extreme wind and rain conditions.
Infected fruit were either placed in a cull pile or suspended by
vertical strings. One seedling 0 meters (m) downwind from the cull pile
became infected when subjected to the highest wind speed (25 m per
second (m/s)) and simulated rain, developing 1 lesion on a single leaf
injured by the action of the high-speed fan. The other 191 plants in
the study did not develop Xcc lesions. No Xcc lesions developed on the
192 plants placed at the same distance and subjected to the same wind
speed (0, 10, and 25 m/s with water) from Xcc-infected grapefruit
suspended from string. Xcc was recovered from 1 collection screen set
up 2 m from suspended fruit, but no Xcc was recovered from the other
144 collection screens set up at various distances (0 to 10 m) from
cull piles or suspended fruit. Gottwald et al. (2009) stated that this
cull pile experiment was ``a highly contrived situation designed to
provide every possible opportunity for dispersal of Xcc and would be
unlikely to occur in most areas, except those locations where
hurricanes or tropical storms are common occurrences.''
One commenter noted that one plant surrounding infected fruit in
cull piles did develop the disease in one of the simulated wind and
rain experiments, indicating that this pathway of transmission is
possible. The commenter stated that one might think that this level of
transmission from an infected fruit to a healthy plant is very low, but
this can be interpreted as very high under the set of conditions
established for the experiments. The commenter stated that conducting
these studies in regions where other environmental conditions exist and
with a different group of scientists may lead to a different
conclusion.
A second commenter stated that both Gottwald et al. (2009) and
Shiotani et al. (2009) demonstrate that transmission of the bacterium
is a difficult process to replicate and expressed a view that the
natural spread of the bacterium from infected fruit to host plants
remains poorly understood. The commenter stated that the cull pile
transmission experiments conducted by Gottwald et al. (2009) do not
provide conclusive
[[Page 54436]]
evidence that the risk of fruit-to-tree transmission is insignificant.
The commenter stated that these trials were conducted with little
replication and did not adequately represent weather events that are
conducive to the transmission of the bacterium, that the authors did
not demonstrate that Xcc could initiate infections under the
experimental conditions in positive controls, and that the employed
diagnostic methods were not tested in positive controls.
This commenter also noted that transmission of Xcc from infected
fruit to host plants did occur, despite each wind speed treatment being
applied for only 5 minutes. While APHIS concluded that the experimental
conditions that produced this result were ``highly contrived,'' the
commenter stated, due to the small-scale nature of this trial, small
sample sizes, short exposure times, and lack of adequate controls, the
risk of transmission under natural conditions remains feasible and
significant. The commenter concluded that the experiments by Gottwald
et al. (2009) demonstrated the ability of Xcc to be spread from
symptomatic citrus fruit.
A third commenter stated that the transmission of Xcc from infected
fruit to host plants in the simulated extreme wind and rain conditions
was probably because of mechanical contact and injury, not from
anything most people would consider as a natural transmission event.
This commenter also noted that the cull pile in that experiment was
composed of freshly picked and heavily infected fruit, not fruit that
had been graded and disinfected according to packinghouse protocol. The
commenter stated that the value of this experiment is that it
demonstrates the ``tipping point'' for canker infection from fruit. The
commenter stated that if the other commenters envision a pile of
freshly picked canker-infected grapefruit suddenly arriving in a
grapefruit orchard in Australia, Arizona, or California immediately
adjacent to susceptible plants and experiencing 25 m/s winds
accompanied by rain, the scenario is excessively imaginary. The
``tipping point,'' in this commenter's view, identifies the dangerous
conditions for shipping fresh fruit from a canker endemic area so they
can be completely avoided.
We agree with the first two commenters that it would have been
optimal to have additional replications of the experiment in which Xcc
was transmitted from infected fruit to host plants, to better determine
the rate at which transmission occurs in these conditions. However, as
noted, the conditions in the experiment in which Xcc was successfully
transmitted from infected fruit to host plants were extreme conditions,
designed (as the third commenter states) to establish whether
transmission of Xcc from infected fruit to host plants is possible, not
whether it is likely. (As the third commenter notes, Gottwald et al.
(2009) concluded that the lesion that resulted from the simulated wind
and rain cull pile experiment ``was the result of a leaf wound.'')
In the context of the other experiments Gottwald et al. (2009)
performed to assess the likelihood of fruit-to-plant transmission, and
in the context of the conditions of the experiment, including not only
the simulated extreme wind and rain conditions but also the fact that
the fruit were unprocessed and untreated and the placement of those
fruit directly adjacent to host plants, we have determined that this
one successful transmission is consistent with a determination that
commercially packed and disinfected fresh citrus fruit is not an
epidemiologically significant pathway for the introduction and spread
of Xcc, given all the available evidence about the potential for fruit
to serve as a pathway.
Although the first commenter is correct that conducting the
experiments in other environmental conditions and with another group of
scientists might lead to a different conclusion, based on the available
science regarding the transmission of citrus canker, the environmental
conditions under which these experiments were conducted are extremely
suitable to the potential transmission of citrus canker. Fruit that
were specifically selected for their high level of infection and that
were subjected to none of the packinghouse processes (including
disinfection) that are known to reduce the viability of Xcc infection
were used in attempts to infect highly susceptible grapefruit plants at
the most susceptible stage of the plants'development. The one trap
plant that was infected was placed immediately adjacent to the infected
fruit and subjected to simulated extreme wind and rain conditions that
are unlikely to occur in most areas. We have determined that it is
unlikely that studies in other regions and under other environmental
conditions would produce a greater level of transmission of the disease
from infected fruit to host plants.
We have determined that the Gottwald et al. (2009) experiments
adequately represented weather events that are conducive to the
transmission of Xcc and represented a range of weather conditions as
well. The trials were conducted both in field conditions that were not
conducive to the transmission of Xcc, in Argentina, and that were
conducive, in Florida.
It would be difficult to develop a positive control for the cull
pile experiments, as a positive control would require the successful
transmission of Xcc, which Gottwald et al. (2009) were only able to
accomplish under conditions described in the publication as ``highly
contrived.'' (It should be noted that this was not APHIS' description.)
Nevertheless, it should be noted that the authors who performed the
cull pile experiments have performed similar experiments using yard
blowers, as documented in Bock et al. (2005) and Parker et al. (2005).
These publications demonstrated that using a forced air source for wind
and hose water for rain will elicit and spread Xcc from infected
plants. In one experiment in Bock et al. (2005), the blower was run for
5 minutes, the same duration as in the 25-m/s artificial wind and rain
cull pile experiment, and bacteria were recovered from the water to
which the infected plants were exposed. Different experiments in both
papers using different durations produced the same results. We would
presume that using similar techniques to elicit and spread Xcc from
infected fruit would be effective, if fruit was an epidemiologically
significant pathway.
The commenter correctly notes that the Gottwald et al. (2009)
publication did not describe any positive controls for the immunostrips
used in the cull pile experiments to determine whether Xcc was present.
However, a personal communication with one of the authors of that
publication indicates that the experimenters did use positive controls
to confirm that the immunostrips were working properly and thus would
have indicated that Xcc was present if it had been present.
We disagree with the second commenter that the exposure times in
the cull pile experiments in Gottwald et al. (2009) were ``short.'' The
5-minute exposure time in the 25-m/s artificial wind and rain
experiment was sufficient to infect 1 test plant. The commenter also
ignores the field cull pile experiments, which each took place for
several weeks, at different times of year.
Finally, it is important to note that our determination that
commercially packed and disinfected fresh citrus fruit is not an
epidemiologically significant pathway for the introduction and spread
of Xcc does not rest solely upon the Gottwald et al. (2009) cull pile
experiments, although they do provide
[[Page 54437]]
valuable evidence supporting that determination. Rather, that
determination takes into account all the evidence considered in the
November 2007 RMA, the updated PRA, and the supplemental RMA, including
evidence about the biology of the disease, the effectiveness of
disinfectant treatment, the conditions that must be fulfilled for
disease transmission to occur, and the fact that the movement of
commercial citrus fruit has not been associated with an outbreak of the
disease anywhere in the world.
Shiotani et al. (2009)
We also received several comments specifically addressing Shiotani
et al. (2009).
One commenter stated that, in Shiotani et al. (2009), proper
positive controls proving that the polymerase chain reaction (PCR)
detection technique is working were not included in one set of
experiments. (We believe the commenter is referring to the examination
of fruit collected from a diseased commercial orchard to investigate
the survival of Xcc.)The commenter stated that the lack of controls
casts doubts on the results of this research.
The commenter correctly notes that there is no explicit discussion
of controls in the ``Materials and Methods'' section of the paper. This
does not mean that the proper controls were not used, but we cannot
verify that they were. That said, the fact that isolations and
bioassays made from the same material also yielded negative results
supports the PCR results.
One commenter stated that the Shiotani et al. (2009) experiments
used a laboratory strain of Xcc that has not been shown to be
pathogenic but, the publication stated, ``is believed to be as robust
as the wild-type.'' The commenter stated that this demonstrates
critical flaws in the experimental design and that the conclusions of
Shiotani et al. (2009) can thus not be accepted without reasonable
doubts.
The commenter quotes from the ``Discussion'' section of the
Shiotani et al. (2009) publication. In the ``Materials and Methods''
section, the authors discuss the laboratory strain in more detail: ``A
marked strain of X. citri pv. citri (KC21Rif100) that is resistant to
rifampicin was used as inoculum. This strain is a stable, spontaneously
derived mutant from strain KC21 (Shiotani et al., 2008), which has been
shown to be as pathogenic as other strains of X. citri pv. citri in
infection studies.'' We believe this information addresses the
commenter's concern.
The Shiotani et al. (2009) publication included experiments
designed to assess the potential for spread of Xcc from mature Satsuma
mandarin fruit inoculated with the marked strain of Xcc mentioned above
and suspended in polypropylene net bags in navel orange trees. One
commenter noted that, in one of the four experiments conducted, citrus
canker was transmitted from culled mandarin fruit to leaves of navel
orange trees in an orchard.
Another commenter, responding to the first commenter, noted that
the infections in that experiment were not caused by the marked strain
of Xcc but by the wild type. Citrus canker is endemic in the area where
this study was done, so a tagged strain was used. That way, the
commenter stated, the researchers have an idea where the inoculum is
coming from. The commenter stated that the fact that wild-type canker
bacteria occasionally are caught in traps or cause infection on plants
in the experiment does not undermine the conclusion in any way; in
fact, it demonstrates that conditions conducive to the transmission of
canker existed, and the marked strain on and in fruit did not
demonstrate any risks of disease transmission.
We agree with the second commenter.
One commenter stated that the Shiotani et al. (2009) publication
does not provide a high degree of confidence that transmission of Xcc
from contaminated fruit to host plants is not epidemiologically
significant. Although no transmission of Xcc was observed, the
commenter suggested that it is possible that this was due to
unexplained variables. Rainfall data were provided but no information
was provided on the growth stage of trap plants, insect presence in the
orchard, potential wounds and insect damage, spray history within the
orchard, or other significant wind and weather events. Because the
experiments were conducted in a commercial orchard, the commenter
stated, it would be expected that pest and disease management would
have been practiced at some point prior to the study.
As noted earlier, the Shiotani et al. (2009) experiments used a
marked strain of Xcc because Xcc is endemic in the area where the
experiments took place. The wild-type strain of Xcc occurred in the
orchard where the experiments took place, throughout the experiments.
This indicates that at least some plants in the orchard were at a
susceptible growth stage, and in general the transmission of Xcc
between trees in the orchard indicates that whatever unexplained
variables may have been present did not impede the normal transmission
of Xcc.
In Shiotani et al. (2009), the authors state, for the initial assay
of fruit from diseased orchards, ``No chemicals had been sprayed to
control the disease,'' addressing the commenter's concern about the
previous employment of disease control methods. Disease control is not
addressed directly for the other experiments, including the experiments
regarding the potential spread of Xcc from Satsuma mandarin fruits.
However, other statements in the publication imply that no disease
control techniques were employed in the orchard:
In September 2006, the Satsuma mandarin orchard in Saga was damaged by
typhoon No. 0613. The typhoon brought rain with strong southerly winds
with maximum speeds of 50 m/s to the orchard, which is located on a
south-facing hillside. The severe meteorological conditions of this
typhoon strongly facilitated spread of citrus canker, leading to the
highest incidence of the disease in the orchard in the last decade. ...
It is most likely that small populations of the wild strain of X. citri
pv. citri survived in the orchard. Citrus canker infection caused by
the wild strain indicated that conditions were also conducive for the
establishment and spread of the introduced KC21Rif100 strain. The
KC21Rif100 strain did not exude from lesions on Satsuma mandarin fruits
after they were discarded in an orchard in October 2006, although
conditions were conducive for the spread of X. citri pv. citri.
If disease control techniques had been employed in the orchard, we
assume that the authors would not have described the conditions as
conducive for the spread of Xcc.
These statements also indicate that information on significant wind
and water events was provided, specifically with regard to typhoon No.
0613.
Shiotani et al. (2009) did not provide any information on insect
presence or pest control in the orchard. The citrus leafminer is known
to occur in Japan, but we do not know whether it occurs in the orchard.
However, it is important to note that insects themselves are not known
to be vectors for Xcc; the presence of the citrus leafminer or another
insect in the orchard might increase the severity of canker in the
orchard, but it would not enable transmission of Xcc from infected
fruit to host plants.
The commenter stated it is likely that naturally infected tissues
have a higher
[[Page 54438]]
ability to transmit the bacterium than artificially surface-inoculated
fruit, which were used in Shiotani et al. (2009).
Shiotani et al. (2009) determined that the bacteria in the lesions
that resulted from the artificial inoculation were viable. We know of
no evidence that suggests that bacteria in natural lesions are more
effective than surface-inoculated bacteria in spreading Xcc, and the
commenter did not supply any.
The commenter stated that another limitation of the design of this
experiment is that it did not include a control group to demonstrate
tree-to-tree transmission under a similar set of conditions.
Tree-to-tree transmission was demonstrated through the incidence of
the wild-type strain of Xcc, which the publication discussed. In this
case, the wild-type strain acted as a control to show that transmission
of Xcc within the orchard was possible and did occur.
The commenter also stated that the uncertainties cited by the
commenter are acknowledged by the authors, who suggested that
conditions may have been unfavorable for spread of the bacterium.
The statement in Shiotani et al. (2009) that conditions may have
been unfavorable for disease spread referred to one replication of the
experiment. The publication goes on to note that disease spread
occurred at high levels in a subsequent replication:
In the experiments started in November 2005 and March 2006, no canker
symptoms were observed on any branches beneath the discarded fruits.
This may be because weather conditions were unfavourable for disease
spread during this period. During the experiment started on May 2006,
canker lesions were observed on leaves of navel oranges located beneath
the discarded Satsuma mandarin fruits. [hellip]The severity of the
disease was greater in 2006 than in 2005. The incidence of citrus
canker in the orchard was 36.2 percent and severity was 18.0. The high
incidence may be attributed to typhoon No. 0613 that occurred on
September 17, 2006.
In addition, it should be noted that our determination that
commercially packed and disinfected fresh citrus fruit is not an
epidemiologically significant pathway for the introduction and spread
of Xcc does not rest solely on the experiments in Shiotani et al.
(2009), although they do provide valuable evidence supporting that
determination. Rather, that determination reflected our analysis of all
the evidence considered in the November 2007 RMA, the updated PRA, and
the supplemental RMA, as discussed earlier.
Shiotani et al. (2009) also examined the survival of Xcc bacteria
on the surface of artificially inoculated fruit that were retained for
sampling. One commenter noted that viable Xcc was isolated from 3
canker lesions from 2 out of 6 Satsuma mandarin fruit (a cultivar
resistant to citrus canker), 3 months after inoculation. Given these
results, the commenter concluded that symptomatic citrus fruit (treated
or untreated) remain a potential source of inoculum.
We agree with the commenter that some viable bacteria may remain in
lesions of infected fruit. However, in those fruits, the strain
KC21Rif100 was found in only 3 of 14 lesions andat a bacterial
population lower than 3 x 10\3\ cfu per lesion. This is consistent with
one of the findings of the November 2007 RMA and the supplemental RMA,
which is that the viability of bacteria on fruit and in lesions and
wounds diminishes after the fruit is harvested. Diminishing bacterial
populations are less likely to provide adequate inoculum to incite
infection.
It should also be remembered that the fruit that were sampled and
found to have viable bacteria had been stored in protected conditions.
The fruit that were artificially inoculated and used in the experiment
regarding the potential of spread of citrus canker did not serve as
sources of citrus canker transmission, even when the lesions had just
been formed and presumably contained high levels of inoculum. The rinds
of the artificially inoculated fruits retrieved after 3 days in the
orchard did not have any viable bacteria. Finally, as noted earlier in
the discussion of Gottwald et al. (2009), other evidence indicates that
bacteria that remain on the fruit in lesions and wounds after
disinfection are not epidemiologically significant.
The commenter is correct to note that Satsuma mandarin is a
resistant variety of citrus. As noted in the supplemental RMA, the
Gottwald et al. (2009) and Shiotani et al. (2009) publications used
citrus cultivars that represented the extremes of susceptibility from
highly susceptible (grapefruit) to less susceptible varieties (lemon,
mandarins). APHIS assumes cultivars not specifically studied would fall
within this range of susceptibility and the results are therefore
applicable to all citrus cultivars. In any case, the supplemental RMA
and November 2007 RMA consider many different sources of evidence in
making the determination that the viability of bacteria on fruit and in
lesions and wounds diminishes after the fruit is harvested, not just
the Shiotani et al. (2009) publication.
One commenter noted that the authors of Shiotani et al. (2009)
state: ``It is possible that bacterial cells of KC21Rif100 strain could
not grow and colonize the surface of the contaminated fruits due to
lack of nutrients.'' The commenter stated that, considering that at
least a small percentage of fruit is always decaying during shipment
and marketing, this decayed fruit can contaminate other fruit with
nutrients that will make survival of the bacteria more likely.
The commenter provided no evidence suggesting that this would
occur, and we are aware of none. The available evidence suggests that
rotting fruit would not provide nutrients that would make survival of
Xcc bacteria more likely. For example, Fulton and Bowman (1929)
demonstrated that canker does not survive on rotting fruit. In
addition, decaying fruit would be decaying due to the presence of other
organisms, and Xcc does not compete well with other organisms, as
described in Fulton and Bowman (1929) and Leite (1990).
One commenter stated that, at the end of the Shiotani et al. (2009)
publication, the authors indicate that navel oranges are more
susceptible to canker than mandarins. The commenter stated that this
indicates that their pathogen survival studies on mandarins will not
reflect the true risk of transmission of the pathogen/disease. Two
other commenters echoed this concern and stated that, because
California's growing situation is quite different than those in the
research areas, there are serious issues about the extrapolation of
data from study of only a few varieties. Another commenter, approaching
this issue differently, suggested that restrictions on the interstate
movement of different varieties of citrus fruit could vary based on the
variety's resistance to citrus canker.
The Shiotani et al. (2009) publication does not actually state that
Satsuma mandarins are more resistant to Xcc than navel oranges,
although this is widely acknowledged to be true. In any case, as noted
earlier, the Gottwald et al. (2009) and Shiotani et al. (2009)
publications used citrus cultivars that represented the extremes of
susceptibility from highly susceptible (grapefruit) to less susceptible
varieties (lemon, mandarins). APHIS assumes cultivars not specifically
studied would fall within this range of susceptibility and the results
are therefore applicable to all citrus cultivars. The commenters did
not provide any specific reasons to question this assumption.
[[Page 54439]]
In general, although we recognize that there are limitations in
extrapolating from results achieved with Satsuma mandarins, the
Shiotani et al. (2009) provides valuable evidence supporting our
determination that commercially packed and disinfected fresh citrus
fruit is not an epidemiologically significant pathway for the
introduction and spread of Xcc. We took this evidence into account
along with the Gottwald et al. (2009) publication and the other
evidence cited in the November 2007 RMA and the supplemental RMA in
making this determination.
Other Issues in the Updated PRA and Supplemental RMA
One of the conclusions in the updated PRA is that standard
packinghouse procedures and post-harvest treatments will remove and/or
devitalize epiphytic populations of Xcc. This conclusion is echoed in
the supplemental RMA.
One commenter stated that the conclusion in the updated PRA that
Xcc has a low survival potential is in contrast to earlier research by
Golmohammadi et al. (2007), who reported that Xcc was frequently
detected on fruit with canker-like symptoms in commercial consignments
of citrus from Uruguay and Argentina into Spain. These consignments
were accompanied by phytosanitary certification stating that fruit had
been treated with postharvest bactericides, including chlorine and
sodium orthophenylphenate. The presence of Xcc on these samples was
confirmed by molecular and pathogenicity testing. Pathogenicity assays
on grapefruit leaves confirmed that Xcc cells remained viable and were
able to produce symptoms despite the application of postharvest
treatments and low temperature storage.
Both the updated PRA and the supplemental RMA addressed
Golmohammadi et al. (2007). The updated PRA and supplemental RMA state
that the results in Golmohammadi et al. (2007) indicate that
disinfection protocols are not 100 percent effective. Some samples were
only positive by PCR protocols. The authors concluded this was probably
due to the disinfection treatments, which would reduce bacterial
populations, and may induce the noncultivable state in the analyzed
lesions. They further suggested that the bacterial cells in the lesions
could be stressed after the fruit treatments (washing, disinfection,
chemical treatments, transport, and storage at low temperatures for
variable periods of time). Pathogenicity tests were successfully
conducted only by artificial laboratory inoculations; the
epidemiological significance of these results was not evaluated.
Pathogenicity tests of bacteria in the laboratory do not indicate
whether the bacteria would actually be able to infect host plants in a
field setting, where conditions are likely to be less favorable than in
a laboratory. The fact that Golmohammadi et al. (2007) concluded that
bacterial cells in the lesions could be stressed after the fruit
treatments suggests that the bacteria would not have been able to do
so, particularly given the results of the experiments Gottwald et al.
(2009) and Shiotani et al. (2009) conducted that addressed the
transmission of Xcc from infected fruit to host plants in the field.
Since Gottwald et al. (2009) and Shiotani et al. (2009) both used
untreated fruit in their experiments, and Golmohammadi et al. (2007)
concluded that packinghouse processing and disinfection treatment
further reduce the viability of the bacteria, we have determined that
the results of Golmohammadi et al. (2007) are consistent with the
determination that commercially packed and disinfected fresh citrus
fruit is not an epidemiologically significant pathway for the
introduction and spread of Xcc.
One commenter, specifically noting the detections of Xcc on fruit
with canker-like symptoms in commercial consignments of citrus from
Uruguay and Argentina into Spain, stated that standard harvesting and
packinghouse procedures may not effectively eliminate infected fruit
from the export pathway.
Both the November 2007 RMA and the supplemental RMA acknowledge
this. However, these procedures do reduce the prevalence of viable Xcc
in commercial consignments of fruit, thus bolstering the conclusion
that commercially packed and disinfected fresh citrus fruit is not an
epidemiologically significant pathway for the introduction and spread
of Xcc.
One commenter stated that the supplemental RMA claims that the
``uncertainties'' recognized in the November 2007 RMA are now answered,
but the question of additional ``uncertainties'' is completely
disregarded.
The supplemental RMA has an extensive discussion of remaining
uncertainties in the discussion of options at the end of the document.
The commenter did not identify any specific uncertainties that the
supplemental RMA did not address.
One commenter stated that, in the supplemental RMA, there is not a
single biological reference to fruit pests such as the peel miner and
to the fact that there is no scientific work/information for its impact
on diseases such as citrus canker. The supplemental RMAsimply
disregards this classic epidemiological factor under the general
assumption ``Vectors do not have a role in disease epidemiology and if
they do, it is not subject to regulation.'' The commenter stated that
this disregard of valid, researchable questions is highly disturbing.
The role of insects in citrus canker outbreaks was discussed in the
November 2007 RMA. The supplemental RMA does not recreate or revise the
entire body of evidence cited in the November 2007 RMA, but rather
builds on that body of evidence and evaluates those areas of evidence
addressed by the new research. Because none of the newer research cited
in the supplemental RMA addressed the role of insects in citrus canker
outbreaks, we did not update the discussion in the November 2007 RMA.
With regard to the issue of vectors, one commenter stated that
canker is a local lesion disease that does not invade the vascular
system and is not transmitted by sucking insects or mites, including
citrus leafminer and peel miner. The commenter stated that citrus
leafminer is not a vector for the canker bacterium.
The November 2007 RMA indicates that injuries caused by the Asian
leafminer can produce wounds that serve as infection courts in leaves
and, to a lesser extent, fruit, but the leafminer itself is not known
to be a vector for the spread of citrus canker. In the November 2007
final rule, we discussed the peel miner, stating that injuries from the
peel miner would be likely to increase the susceptibility of fruit to
infection, and increase the severity of the infection if they became
infected. In terms of overall spread of citrus canker, however, the
peel miner would not likely be as epidemiologically significant as the
Asian leafminer, since leaves of citrus trees and plants are more
susceptible to citrus canker infection than the peels of citrus fruit.
We also note that there exists no evidence indicating that the peel
miner is a vector for citrus canker, and we would presume that the peel
miner is not a vector, for the reasons cited by the second commenter.
Comments on the November 2007 RMA
The November 2007 RMA contained a discussion of the potential for
introduction and establishment of Xcc in various climatic conditions.
One commenter stated that the idea that California has unfavorable
environmental conditions for pathogen
[[Page 54440]]
establishment is simply untrue. The commenter stated that summer
monsoons commonly go through the Imperial Valley, and thunderstorms
with high winds occasionally occur in the Central Valley (both
important citrus-producing areas of California), while humidity can
reach adequate levels for canker establishment in the coastal areas of
Ventura County (lemon-producing areas).
The November 2007 RMA states: ``Using hourly wind speed and
precipitation, monthly average temperature, and annual and seasonal
precipitation data to determine the expected incidence and severity of
citrus canker if introduced into California, Borchert et al. (2007)
concluded that favorable events in California citrus growing areas
occurred `[hellip] predominantly during the winter season when
precipitation is greatest, but temperatures are less conducive for
infection activity and citrus growth. This would likely result in low
incidence and severity of citrus canker in California if the disease
were introduced[hellip]' [hellip]The `Mediterranean' climate (dry
summers) typical of most of California and the arid climate of Arizona
make [Xcc] establishment less likely in those States. However, in
microclimates with highly susceptible cultivars such as along the
California coast between San Diego and Ventura establishment is still
possible, as demonstrated by the occurrence of citrus canker disease in
Iran and the Arabian Peninsula on a highly susceptible variety of
Mexican lime.''
We acknowledge that, as the commenter stated, summer monsoons and
thunderstorms occur in California, but that is not inconsistent with
the discussion in the November 2007 RMA. The information presented by
the commenter has not led us to change the conclusions in the November
2007 RMA regarding the suitability of California's climate for the
establishment of citrus canker.
One commenter stated that we should have more solid information on
the source of previous outbreaks before making the changes we proposed.
The November 2007 RMA also analyzed the information available on
the source of previous outbreaks. It concluded, ``In summary, there is
an unfortunate lack of conclusive information regarding the origins of
previous outbreaks. Most published accounts are speculative. However,
whatever the lack of certainty may be regarding the theories of [Xcc]
introduction pathways, they all agree that trees or propagative tree
parts are most likely the original source of [Xcc] introduction.
Conclusive evidence that fresh fruit is a pathway for the introduction
of [Xcc] has never been presented.'' The November 2007 RMA also noted,
and the supplemental RMA repeated, that ``no canker outbreaks have ever
been associated with the entry of fruit into the United States or
anywhere in the world, nor has the ability of fruit to serve as a
pathway of [Xcc] dissemination ever been demonstrated in any scientific
experiment, and it seems very unlikely that fruit would be an
epidemiologically significant pathway.''
The evidence that has been developed and presented in the two
studies that prompted the preparation of the updated PRA and
supplemental RMA is consistent with the historical record on the source
of citrus canker outbreaks, which largely ties them to the movement of
infected nursery stock rather than the movement of infected fruit.
Compliance Agreements and Leaves
In addition to the requirement for treatment with an APHIS-approved
disinfectant, we proposed to retain the requirement that regulated
fruit moved interstate from an area quarantined for citrus canker be
free of leaves, twigs, and other plant parts, except for stems that are
less than 1 inch long and attached to the fruit. We proposed to retain
this requirement because other plant parts pose different risks than
fruit does; canker lesions on leaves, for example, typically have much
higher bacterial populations than canker lesions on fruit.
In the Background section of the proposed rule, we stated that,
under the proposed rule, APHIS inspectors would no longer be on site at
packinghouses to enforce the requirements for treatment and removal of
leaves, twigs, and other plant parts. We would require in our
compliance agreements with commercial packinghouses that these
activities be conducted in accordance with the regulations, and
inspections would be conducted to ensure that treatment is being
performed properly and that no leaves, twigs, or other plant parts are
being included in containers of fruit moved interstate.
Two commenters stated that eliminating mandatory inspection of
fruit to be moved interstate for visible symptoms of citrus canker
raises questions about how APHIS will assure adherence to compliance
agreement requirements.
As stated, we will continue to inspect commercial packinghouses
that pack fruit to be moved interstate to verify that they are adhering
to the requirements in the regulations, as agreed to in the compliance
agreement. These inspections will be conducted regularly. Inspectors
will check treatments to ensure that they are being performed in
accordance with the regulations (for example, verifying the pH level
and the concentration in a sodium hypochlorite treatment). Inspectors
will also open and inspect a random sample of packed boxes of fruit to
verify that the packed fruit is free of leaves, twigs, and other plant
parts. We have experience successfully enforcing compliance agreements
with similar requirements for many other domestic quarantine programs.
One commenter stated that inadvertent citrus leaves included in
packed boxes of fruit may also carry the pathogen/disease from one
location to another.
Another commenter stated that, in the very unlikely event that a
lesioned leaf would be present in a fruit load, conclusions that fruit
is not an epidemiologically significant pathway can confidently be
extended to aging and drying leaves. The commenter stated that it is
unlikely that this source of inoculum would represent any different
risk than fruit for inoculum production and disease transmission.
Although the second commenter may be correct, we have not
undertaken a thorough assessment of the risks associated with allowing
the interstate movement of leaves of regulated species from a
quarantined area. We would need to do so before allowing the interstate
movement of leaves. Therefore, we proposed to retain the requirement
discussed earlier.
The first commenter is correct that leaves could inadvertently be
moved in boxes of packed fruit. However, the requirement that fruit be
free of leaves serves to mitigate that risk, as packinghouse employees
will need to check to make sure that leaves are not inadvertently
packed so that the packinghouse will be able to pass inspections
conducted under the compliance agreements and continue to pack fruit
for interstate movement. In addition, leaves are commonly removed from
boxes of packed citrus fruit as part of commercial production
practices. Given these conditions, we have determined that it is not
necessary to provide for any further restrictions on the interstate
movement of fruit in order to prevent the inadvertent interstate
movement of leaves.
Citrus Greening
One commenter stated that we should consider ongoing research on
evaluating citrus fruit as a potential source for the
[[Page 54441]]
Asian citrus psyllid (ACP), the vector of citrus greening, to acquire
citrus greening.
Restrictions on the movement of certain articles due to the
presence of citrus greening have been put in place under separate
Federal orders; the initial order was issued on September 16, 2005, and
was last updated on September 21, 2009. The September 21, 2009, Federal
Order does not restrict the interstate movement of fruit from an area
quarantined for ACP, except to require that the fruit be cleaned using
normal packinghouse procedures. These procedures are sufficient to
remove ACP. Fruit itself has not been shown to be a potential pathway
for the spread of citrus greening.
The commenter did not cite any specific research that is ongoing
regarding ACP's ability to acquire citrus greening directly from fruit,
and we are not aware of any. However, if we determine that additional
restrictions need to be placed on the interstate movement of fruit from
areas quarantined for ACP, we would include those restrictions in a new
Federal Order or in separate citrus greening regulations, not in the
citrus canker regulations.
Illegal Movement of Nursery Stock
Section 301.75-6 of the regulations prohibits, with limited
exceptions, the interstate movement of citrus nursery stock from an
area quarantined for citrus canker. Three commenters stated that the
potential illegal movement of nursery stock was the most risky pathway
for the introduction of citrus canker into commercial citrus-producing
States other than Florida. One recommended that, given the limited
resources available to plant health regulatory programs, resources
should be concentrated on this pathway. This commenter requested
additional resources to deal with the pathway.
One stated that adoption of the proposed rule would likely increase
the illegal movement of Florida citrus nursery plants into Texas,
simply because the general public may conclude it is safe to transport
citrus nursery plants as well.
Two of the commenters stated that efforts should be undertaken to
increase public awareness of the prohibition against moving nursery
stock interstate from citrus canker quarantined areas. Both of these
commenters also requested that enforcement efforts against this illegal
movement continue; one requested increased resources for those efforts.
We agree with these commenters that the illegal movement of nursery
stock is a high-risk pathway. We have several efforts underway to
prevent the spread of citrus canker and citrus greening through the
illegal movement of nursery stock. In fiscal year 2009, we conducted
enforcement activities that included:
Monitoring of retail markets and wholesale distributors in
commercial citrus-producing States;
Monitoring the Internet for the sale and distribution of
citrus plants from quarantined areas;
Monitoring retail and wholesale establishments in States
other than commercial citrus-producing States for citrus plants and
plant products from quarantined areas; and
Conducting operations in concert with State officials at
State checkpoints to ensure that shipments moving out of Florida do not
contain plants or plant products whose movement is prohibited and that
shipments entering commercial citrus-producing States do not contain
such products.
We are also sampling nursery stock that is found moving illegally
to determine whether it is infected with a citrus disease. In all these
activities, we work with State and local agencies, and we notify them
of whatever violations we discover.
We are also conducting extensive outreach efforts regarding the
movement of nursery stock from quarantined areas. The Web site (http://www.saveourcitrus.org) provides a public clearinghouse of information
on safeguarding U.S. citrus resources and preventing the illegal
movement of citrus plants from quarantined areas. We will continue to
employ resources on enforcement and outreach as necessary and as budget
constraints allow.
We disagree with the commenter who stated that the proposed rule
would likely increase introduction of illegal Florida citrus nursery
plants into Texas. Although regulated fruit has been allowed under the
regulations to move interstate to States other than commercial citrus-
producing States, regulated nursery stock, except kumquat plants
produced under conditions designed to prevent their infection with
citrus canker, is not allowed to move interstate. Thus, the difference
between the allowable movement of regulated fruit and regulated nursery
stock already exists, and our enforcement and outreach efforts take it
into account.
International Trade
Two commenters expressed concern regarding trade issues. Both
expressed concern that the rule might result in trading partners
imposing additional restrictions on the export of citrus fruit from the
United States. One stated that we should not finalize the proposed rule
until we know that the European Union (EU) agrees with the science that
serves as a basis for the rule, citing fears of trade interruptions.
Another stated that the objective of the rule was to demonstrate to
our trading partners that there is no risk of spread of citrus canker
via fruit, thus allowing Florida to export fresh fruit to countries
that currently restrict or prohibit such importations. This commenter
stated that jeopardizing citrus-producing areas in the United States so
that Florida can trade with citrus-producing areas around the world is
unacceptable.
Regulated fruit from Florida is currently exported to other
countries, including the EU, in accordance with those countries'
regulatory requirements. We proposed to relieve restrictions on the
interstate movement of fruit from an area quarantined for citrus canker
based on our determination that commercially packed and disinfected
fresh citrus fruit is not an epidemiologically significant pathway for
the introduction and spread of citrus canker, not as part of an attempt
to reduce or remove restrictions on the exportation of Florida citrus
fruit to other countries. Other countries are not obligated to change
their requirements for the importation of plant products based on
changes in our regulations on the interstate movement of plant
products.
We are willing to have exchanges with foreign national plant
protection organizations to discuss our findings, but because we have
determined the restrictions that have been in place on the movement of
fruit from a quarantined area are no longer justified by the scientific
evidence, we are removing restrictions that are no longer warranted.
Kumquats
One commenter requested that we remove kumquats from the list of
regulated articles in Sec. 301.75-3(a), thus allowing kumquat fruits
to be moved interstate from the quarantined area with leaves and stems,
as they are commonly marketed. The commenter stated that there has not
been any citrus canker found in Pasco County, FL, where all of the
commenter's kumquats are grown, and that there has been no citrus
canker found in commercial kumquat groves. The commenter also stated
that a professor at the University of Florida's horticulture department
has stated that ``Nagami kumquats and citrus canker are
incompatible...Far
[[Page 54442]]
from acting as a host, the Nagami kumquats suppress it by causing the
inoculated tissue to die and the affected leaves to fall off.''
Although there are numerous references stating that kumquats are
highly resistant to citrus canker (see Gottwald et al. (2002) and
Francis et al. (2009)), we are aware of no references that state that
citrus canker does not infect kumquats, or that kumquats are
incompatible with citrus canker. For that reason, we list kumquat
plants and plant parts (including fruit, leaves, and stems) as
regulated articles in Sec. 301.75-3(a). If evidence is developed that
indicates that citrus canker does not infect kumquats, we will amend
the list of regulated articles accordingly.
With respect to the commenter's specific concern, we note that if
kumquats were removed from the list of articles regulated for citrus
canker, kumquat leaves would still be prohibited from moving interstate
from Florida under the September 21, 2009, Federal order on citrus
greening, which prohibits the interstate movement of plants and plant
parts other than fruit from species that are hosts of citrus greening.
Regulatory Impact Analysis
Addressing the preliminary regulatory impact analysis and initial
regulatory flexibility analysis we prepared for the proposed rule, two
commenters stated that the document devotes almost 18 pages to the
expected impacts of the proposed rule on the Florida industry. In the
2[frac12] pages addressing the expected effects for the other
commercial citrus-producing States, it is noted that APHIS expects
``the primary effect of the rule would be to preserve Florida's fresh
market in the long run.'' The commenters noted that the analysis states
that ``...a reduction in the packout rate for fresh market fruit in the
other commercial citrus-producing States due to citrus canker
infestation would likely have a larger economic impact than has been
experienced by Florida, due to their greater reliance on fresh citrus
sales, especially of oranges.'' The analysis also states that ``in the
event that citrus canker were to spread to other commercial citrus-
producing States, we do not anticipate that other commercial citrus-
producing States would find profitable alternative markets for fruit
that could not be sold on the fresh market.'' The commenters stated
that this rule change is clearly for the benefit of the Florida citrus
industry, and the interstate movement of citrus fruit from areas
quarantined for citrus canker into commercial citrus-producing States
should not be allowed as the risks to the citrus industry in other
commercial citrus-producing States are too high.
As discussed in the updated PRA and supplemental RMA, commercially
packed and disinfected fresh citrus fruit is not an epidemiologically
significant pathway for the introduction and spread of Xcc. We prohibit
the interstate movement from a quarantined area of plants and plant
products that are more likely pathways, such as grass clippings, plant
clippings, tree clippings, and nursery stock, which (as other
commenters noted) is the highest-risk pathway for the spread of citrus
canker.
We acknowledge that citrus produced in other commercial citrus-
producing States is produced primarily for the fresh market; for that
reason, protecting the appearance of the fruit is critical for citrus
production in for those States. We are committed to protecting against
the spread of citrus canker to other commercial citrus-producing
States, as evidenced by the mitigations required by the final rule for
the interstate movement of fresh fruit from quarantined areas and the
other movement restrictions in the regulations.
Consistent with the requirements of the Regulatory Flexibility Act
(RFA), our preliminary regulatory impact analysis and initial
regulatory flexibility analysis focused on any significant impacts the
proposed rule could have on small entities. We determined that
significant impacts on small entities, if they occur as a result of
this final rule, are most likely to be experienced in Florida; the
economic effects of allowing freer movement of Florida citrus are
likely to be distributed among consumers in other States, as discussed.
Miscellaneous Change
We proposed to revise the definition of commercial packinghouse in
Sec. 301.75-1 to read: ``An establishment in which space and equipment
are maintained for the primary purpose of disinfecting and packing
citrus fruit for commercial sale. A commercial packinghouse must also
be licensed, registered, or certified with the State in which it
operates and meet all the requirements for the license, registration,
or certification that it holds.''
In this final rule, we are changing the proposed definition to
indicate specifically in the second sentence that the commercial
packinghouse must be licensed, registered, or certified for handling
citrus fruit. The proposed definition could have been interpreted as
referring to any type of license, registration, or certification;
indicating that the license, registration, or certification of a
commercial packinghouse must be specifically for handling citrus fruit
provides additional specificity and clarifies the intent of the
definition.
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
change discussed in this document.
References
Bock, C. H. (2005). Effect of simulated wind-driven rain on
duration and distance of dispersal of Xanthomonas axonopodis pv. citri
from canker-infected citrus trees. Plant Disease 89:71-80.
Borchert, D., Thayer C., Brown L., Jones N., and Magarey R. (2007).
Citrus Canker Ad Hoc Project, USDA-APHIS-PPQ-CPHST-PERAL (internal
document).
Francis, M. I., Pena, A., Kostenyuk, I., Burns, J., and Graham, J.
H. (2009). HR-like resistance of kumquat (Fortunella spp.) to citrus
canker caused by Xanthomonas citri sbsp. Citri. Phytopathology 99:S36.
Fulton, H. R. & Bowman, J. J. (1929). Infection of fruits by
Pseudomonas citri. J Agric Res 39, 403-426.
Golmohammadi, M., J. Cubero, J. Pe[ntilde]alver, J. M. Quesada, M.
M. L[oacute]pez, and P. Llop. (2007). Diagnosis of Xanthomonas
axonopodis pv. citri, causal agent of citrus canker, in commercial
fruits by isolation and PCR-based methods. Journal of Applied
Microbiology 103:2309-2315.
Gottwald, T. R., Graham, J. H., and Schubert, T. S. (2002). Citrus
canker: The pathogen and its impact. Plant Health Progress.
doi:10.1094/PHP-2002-0812-01-RV.):34.
Gottwald, T., Graham, J., Bock, C., Bonn, G., Civerolo, E., Irey,
M., Leite, R., L[oacute]pez, M. M., McCollum, G., Parker, P., Ramallo,
J., Riley, T., Schubert, T., Stein, B., and Taylor, E. (2009). The
epidemiological significance of post-packinghouse survival of
Xanthomonas citri subsp. citri for dissemination of Asiatic citrus
canker via infected fruit. Crop Protection 28:508-524.
Leite Jr., R. P. (1990). Cancro citrico; prevencao e controle no
Parana. Londrina, IAPAR.
Parker, P. E., Bock, C. H., and Gottwald, T. R. (2005). Comparison
of techniques to sample Xanthomonas axonopodis pv. citri in windblown
spray. Plant Disease 89:1324-1330.
Shiotani, H., Uematsu, H., Tsukamoto, T., Shimizu, Y., Ueda, K.,
Mizuno, A. & Sato, S. (2009). Survival and dispersal of Xanthomonas
citri pv. citri from
[[Page 54443]]
infected Satsuma mandarin fruit. Crop Protection 28:19-23.
Effective Date
This is a substantive rule that relieves restrictions and, pursuant
to the provisions of 5 U.S.C. 553, may be made effective less than 30
days after publication in the Federal Register. Immediate
implementation of this rule is necessary to provide relief to those
persons who are adversely affected by restrictions we no longer find
warranted. The shipping season for Florida citrus fruit is in progress.
Making this rule effective immediately will allow interested producers
and others in the marketing chain to benefit during this year's
shipping season. Therefore, the Administrator of the Animal and Plant
Health Inspection Service has determined that this rule should be
effective upon publication in the Federal Register.
Executive Order 12866 and Regulatory Flexibility Act
This final 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.
We have prepared an economic analysis for this rule. The economic
analysis provides a cost-benefit analysis, as required by Executive
Order 12866, and an analysis of the potential economic effects of this
action on small entities, as required by the RFA. The economic analysis
is summarized below. Copies of the full analysis are available on the
Regulations.gov Web site (see footnote 1 in this document for a link to
Regulations.gov) or by contacting the person listed under FOR FURTHER
INFORMATION CONTACT.
APHIS has determined that this final rule will continue to prevent
the spread of citrus canker from quarantined areas while allowing the
interstate movement of fruit and lessening the compliance burden
associated with the fruit movement regulations. The rule will remove
the risk of lot rejection of fresh fruit intended for interstate
shipment solely because the fruit exhibits citrus canker symptoms,
thereby supporting the long-term preservation of domestic fresh fruit
markets for Florida's commercial packinghouses and growers. Fresh
citrus fruit will no longer require diversion to other uses or markets
because of citrus canker symptoms. In addition, APHIS is removing the
current prohibition on the movement of Florida's fresh citrus fruit to
other commercial citrus-producing States. We do not anticipate that
citrus production in these States will be significantly affected by
Florida's market reentry.
While the lots rejected during the 2008-09 season were successfully
diverted for processing or to fresh fruit markets within Florida or
outside the United States, affected citrus producers and commercial
packinghouses incurred revenue declines because of elimination charges
and the lower prices received due to product diversion. The cost of
producing citrus fruit intended for the fresh market is greater than
the cost of production for the processed market, where the physical
appearance of the fruit is not important.
Impact on Small Entities
The RFA requires that agencies consider the economic impact of rule
changes on small businesses, organizations, and governmental
jurisdictions. Section 605 of the RFA allows an agency to certify a
rule if the proposed rulemaking will not have a significant economic
impact on a substantial number of small entities. Following is the
factual basis for such certification in this case.
Based on the determination that fresh citrus fruit treated using an
APHIS-approved disinfectant is not an epidemiologically significant
pathway for transmission of the disease, this final rule will remove
the requirement of an APHIS inspection of fresh packed citrus intended
for the domestic market for symptoms of citrus canker disease. The
final rule will require the treatment of fresh citrus from a commercial
packinghouse with an APHIS-approved disinfectant. The final rule will
relieve prohibitions associated with the current limited permit
requirement, and allow the reentry of fresh citrus fruit from Florida
into other commercial citrus-producing States. This action is being
taken to relieve restrictions on the Florida citrus industry that we
believe are no longer warranted while continuing to prevent the spread
of citrus canker to other commercial citrus-producing States and
territories.
Florida's citrus commercial packinghouses and fresh citrus
producers comprise the industries that will be directly affected by
this final rule. The small business size standard for citrus fruit
packing, as identified by the Small Business Administration (SBA) based
upon the North American Industry Classification System (NAICS) code
115114 (Postharvest Crop Activities) is $6.5 million or less in annual
receipts. There are currently 174 commercial packinghouses in Florida
under APHIS Packinghouse Compliance Agreements, 56 of which are
registered with the Florida Department of Agriculture and Consumer
Services' Division of Fruit and Vegetables. While the classification of
all of these establishments by sales volume is not available, it is
estimated that approximately 40 of the 56 registered commercial
packinghouses are the top-grossing citrus commercial packinghouses. The
remaining packinghouses are small establishments known primarily as
gift packers. At least 95 percent of Florida fresh citrus shipments are
packed by the top 40 (23 percent) commercial packinghouses in the
State.\4\ The Fresh Shippers Report, as reported by the Citrus
Administrative Committee, details quantities of fresh citrus shipped by
the top 40 shippers each season.\5\ During the 2007-08 season, annual
sales for 14 of the top 40 shippers (35 percent) were below the SBA
size standard of $6.5 million. It is estimated that at least 82 percent
of Florida's citrus packers, including the small gift packers, will be
considered small according to the SBA size standards.
---------------------------------------------------------------------------
\4\ ``Fresh Shippers Report: 2007-08 Season Through July 31,
2008,'' Citrus Administrative Committee, August 8, 2008. (http://www.citrusadministrativecommittee.org/)
\5\ Ibid.
---------------------------------------------------------------------------
The final rule is also expected to positively affect producers of
fresh citrus in Florida currently facing an increasing number of lots
rejected at the packinghouse level each season. Packing and elimination
charges for growers are higher for fruit diverted to the within-State
or export markets, or to processing plants. In addition, fruit diverted
to processing yields lower revenues for growers who have already borne
the higher costs of producing fruit intended for the fresh market.
A majority of the Florida citrus producers that will be affected by
the final rule are small, based on 2007 Census of Agriculture data and
SBA guidelines for entities classified within the farm categories
Orange Groves (NAICS 111310) and Citrus (except Orange) Groves (NAICS
111320). SBA classifies producers in these categories with total annual
sales of not more than $750,000 as small entities. According to 2007
Census data, there were a total of 6,061 citrus farms in Florida in
2007. Of this number, 90 percent had annual sales in 2007 of less than
$500,000, which is well below the SBA's small-entity threshold of
$750,000.\6\ Any costs associated with the final rule are expected to
be minimal, especially given the producers' gains from fewer
[[Page 54444]]
rejections of fresh citrus lots destined for the domestic market.
---------------------------------------------------------------------------
\6\ Source: SBA and 2007 Census of Agriculture.
---------------------------------------------------------------------------
Producers of fresh fruit in other commercial citrus-producing
States may also be impacted by the rule to the extent that the
reintroduction of Florida fresh citrus changes the supply in these
States. However, APHIS does not anticipate significant increases in
fresh citrus supplies into these markets as a result of this final rule
as indicated by historic data on Florida fresh citrus shipments.
According to 2007 Census data, there were a total of 15,658 citrus
farms in the United States in 2007. Of this total, 329 were located in
Arizona, 7,358 in California, 884 in Hawaii, 210 in Louisiana, and 750
in Texas. In each State, at least 91 percent of all farms had annual
sales in 2007 of less than $500,000 and are classified as small
entities according to SBA guidelines.
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.
National Environmental Policy Act
An environmental assessment and finding of no significant impact
have been prepared for this final rule. The environmental assessment
provides a basis for the conclusion that the interstate movement of
citrus fruit under the conditions specified in this rule 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), as amended (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).
The environmental assessment and finding of no significant impact
may be viewed on the Regulations.gov Web site.\7\ Copies of the
environmental assessment and finding of no significant impact are also
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.
---------------------------------------------------------------------------
\7\ Go to (http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2009-0023). The environmental
assessment and finding of no significant impact will appear in the
resulting list of documents.
---------------------------------------------------------------------------
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 and 7781-7786; 7 CFR 2.22, 2.80,
and 371.3.
Section 301.75-15 issued under Sec. 204, Title II, Public Law 106-
113, 113 Stat. 1501A-293; sections 301.75-15 and 301.75-16 issued under
Sec. 203, Title II, Public Law 106-224, 114 Stat. 400 (7 U.S.C. 1421
note).
0
2. In Sec. 301.75-1, the definition of commercial packinghouse is
revised to read as follows:
Sec. 301.75-1 Definitions.
* * * * *
Commercial packinghouse. An establishment in which space and
equipment are maintained for the primary purpose of disinfecting and
packing citrus fruit for commercial sale. A commercial packinghouse
must also be licensed, registered, or certified for handling citrus
fruit with the State in which it operates and meet all the requirements
for the license, registration, or certification that it holds.
* * * * *
Sec. 301.75-4 [Amended]
0
3. Section 301.75-4 is amended as follows:
0
a. In paragraph (d)(2)(ii)(D), by removing the first sentence.
0
b. By removing paragraph (d)(6).
0
4. Section 301.75-7 is revised to read as follows:
Sec. 301.75-7 Interstate movement of regulated fruit from a
quarantined area.
(a) Regulated fruit produced in a quarantined area or moved into a
quarantined area for packing may be moved interstate with a certificate
issued and attached in accordance with Sec. 301.75-12 if all of the
following conditions are met:
(1) The regulated fruit was packed in a commercial packinghouse
whose owner or operator has entered into a compliance agreement with
APHIS in accordance with Sec. 301.75-13.
(2) The regulated fruit was treated in accordance with Sec.
301.75-11(a).
(3) The regulated fruit is free of leaves, twigs, and other plant
parts, except for stems that are less than 1 inch long and attached to
the fruit.
(4) If the fruit is repackaged after being packed in a commercial
packinghouse and before it is moved interstate from the quarantined
area, the person that repackages the fruit must enter into a compliance
agreement with APHIS in accordance with Sec. 301.75-13 and issue and
attach a certificate for the interstate movement of the fruit in
accordance with Sec. 301.75-12.
(b) Regulated fruit that is not eligible for movement under
paragraph (a) of this section may be moved interstate only for
immediate export. The regulated fruit must be accompanied by a limited
permit issued in accordance with Sec. 301.75-12 and must be moved in a
container sealed by APHIS directly to the port of export in accordance
with the conditions of the limited permit.
(Approved by the Office of Management and Budget under control
number 0579-0325)
[[Page 54445]]
Done in Washington, DC, this 15th day of October 2009.
Kevin Shea
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E9-25328 Filed 10-21-09: 8:45 am]
BILLING CODE 3410-34-S