Citrus Canker; Movement of Fruit From Quarantined Areas, 34180-34187 [X07-10621]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

[Federal Register Volume 72, Number 119 (Thursday, June 21, 2007)]
[Proposed Rules]
[Pages 34180-34187]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: X07-10621]


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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 72, No. 119 / Thursday, June 21, 2007 / 
Proposed Rules

[[Page 34180]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 301

[Docket No. APHIS-2007-0022]
RIN 0579-AC34


Citrus Canker; Movement of Fruit From Quarantined Areas

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend the citrus canker regulations to 
modify the conditions under which fruit may be moved interstate from a 
quarantined area. Under this proposed rule, we would eliminate the 
requirement that the groves in which the fruit is produced be inspected 
and found free of citrus canker, and instead require that fruit 
produced in the quarantined area be treated with a surface disinfectant 
treatment in a packinghouse operating under a compliance agreement and 
that each lot of finished fruit be inspected at the packinghouse and 
found free of visible symptoms of citrus canker. We would, however, 
retain the current prohibition on the movement of fruit from a 
quarantined area into commercial citrus-producing States. These 
proposed changes would relieve some restrictions on the interstate 
movement of fresh citrus fruit from Florida while maintaining 
conditions that would help prevent the artificial spread of citrus 
canker.

DATES: We will consider all comments regarding this proposed rule that 
we receive on or before July 23, 2007 and all comments regarding the 
information collection requirements associated with this proposed rule 
that we receive on or before August 20, 2007.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://
www.regulations.gov, select ``Animal and Plant Health Inspection 
Service'' from the agency drop-down menu, then click ``Submit.'' In the 
Docket ID column, select APHIS-2007-0022 to submit or view public 
comments and to view supporting and related materials available 
electronically. Information on using Regulations.gov, including 
instructions for accessing documents, submitting comments, and viewing 
the docket after the close of the comment period, is available through 
the site's ``User Tips'' link.
     Postal Mail/Commercial Delivery: Please send four copies 
of your comment (an original and three copies) to Docket No. APHIS-
2007-0022, Regulatory Analysis and Development, PPD, APHIS, Station 3A-
03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state 
that your comment refers to Docket No. APHIS-2007-0022.
    Reading Room: You may read any comments that we receive on this 
docket in our reading room. The reading room is located in room 1141 of 
the USDA South Building, 14th Street and Independence Avenue, SW., 
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., 
Monday through Friday, except holidays. To be sure someone is there to 
help you, please call (202) 690-2817 before coming.
    Other Information: Additional information about APHIS and its 
programs is available on the Internet at https://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT: Mr. Stephen Poe, Senior Operations 
Officer, Emergency 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 axonopodis pv. citri (referred to below as Xac) 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 aggressive 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. These regulations are 
promulgated pursuant to the Plant Protection Act (7 U.S.C. 7701 et 
seq.).
    The regulations governing the movement of regulated articles were 
first promulgated in 1984, at a time when citrus canker had very 
limited distribution within Florida. Although the regulations have been 
amended several times since then, the approach of the regulations had 
remained the same until recently, i.e., to quarantine those areas where 
the disease was found and promote eradication efforts while allowing 
the normal movement of regulated fruit and seed from those areas where 
the disease was not present.
    The exceptionally active hurricane seasons in 2004 and 2005 were 
devastating to the citrus canker eradication program. Surveys showed 
that citrus canker had become so widespread within Florida that 
approximately 75 percent of commercial groves in the State were located 
within 5 miles of a location where the disease had been detected, which 
is well within the range that the disease could be spread by future 
hurricanes or other tropical storms. With a significant portion of the 
commercial citrus acreage in the State either infected with citrus 
canker or at high risk of becoming infected, it became apparent that it 
would no longer be possible to identify and quarantine infected citrus 
acreage quickly enough to prevent further spread of the disease in 
Florida. Because of that situation, on January 10, 2006, the U.S. 
Department of Agriculture (USDA) announced that it had determined that 
the established eradication program was no longer a

[[Page 34181]]

scientifically feasible option to address citrus canker in Florida.
    In response to the widespread establishment of citrus canker in 
Florida, we published an interim rule in the Federal Register on August 
1, 2006 (71 FR 43345-43352, Docket No. APHIS-2006-0114) in which we 
amended the regulations to list the entire State of Florida as a 
quarantined area for citrus canker and amended the requirements for the 
movement of regulated articles from Florida. We also amended the 
regulations to allow regulated articles that would not otherwise be 
eligible for interstate movement to be moved to a port for immediate 
export.
    More recently, we published an interim rule in the Federal Register 
on March 22, 2007 (72 FR 13423-13428, Docket No. APHIS-2007-0032) that 
clarified and amended the citrus canker quarantine regulations to 
explicitly prohibit, with limited exceptions, the interstate movement 
of regulated nursery stock from a quarantined area. We included two 
exceptions to the prohibition. The first exception allowed calamondin 
and kumquat plants, two types of citrus plants that are highly 
resistant to citrus canker, to be moved interstate from a quarantined 
area under a protocol designed to ensure their freedom from citrus 
canker. We also continued to allow the interstate movement of regulated 
nursery stock for immediate export, under certain conditions.

Citrus Health Response Program

    In January 2006, in response to the widespread establishment of 
citrus canker in Florida, as well as other challenges to the citrus 
industry, the Animal and Plant Health Inspection Service (APHIS) 
convened key stakeholders in citrus protection and production and led a 
discussion on various options from which came the concept of a Citrus 
Health Response Program (CHRP). The CHRP is intended to improve the 
ability of the commercial citrus industry to produce, harvest, process, 
and ship healthy fruit in the presence of citrus canker. This program 
provides general guidance to all sectors of the citrus industry on ways 
to safeguard their products against citrus canker and other citrus 
pests of concern. While the CHRP is not mandatory for fruit production, 
the guidance is consistent with good production practices. Together 
with the State of Florida and other citrus producing States, their 
industries, and independent researchers, we prepared the CHRP plan, 
which is available on the Internet at https://www.aphis.usda.gov/plant_
health/index.shtml.

Pest Risk Analysis

    As we worked with States and industry to develop the CHRP, it 
became clear that the widespread presence of citrus canker in Florida 
posed a serious threat to the viability of the Florida fresh fruit 
industry. APHIS saw a need to reevaluate the regulations for the 
movement of citrus fruit to determine whether the long-standing grove 
certification and packinghouse requirements for the movement of citrus 
fruit remained scientifically justified and necessary and to determine 
whether, in light of widespread citrus canker, a program could be 
devised that would continue to allow the interstate movement of fresh 
citrus fruit from Florida and that would maintain adequate safeguards 
against the spread of citrus canker to other commercial citrus-
producing States. As part of APHIS's reevaluation, we conducted a pest 
risk assessment (PRA) titled, ``Evaluation of asymptomatic citrus fruit 
(Citrus spp.) as a pathway for the introduction of citrus canker 
disease (Xanthomonas axonopodis pv. citri).'' The PRA considered all 
available evidence associated with asymptomatic citrus fruit as a 
pathway for the introduction of citrus canker. The PRA concluded that 
asymptomatic, commercially produced citrus fruit, treated with a 
disinfectant, and subject to other mitigations, is not 
epidemiologically significant as a pathway for the introduction and 
spread of citrus canker.
    On April 6, 2006, we published a notice in the Federal Register (71 
FR 17434-17435, Docket No. APHIS-2006-0045), announcing the 
availability of the PRA. We made the PRA available for comment for 90 
days, and submitted it for peer review in accordance with USDA's 
guidelines for peer review developed in response to the Office of 
Management and Budget's peer review bulletin. We received 19 comments 
by the end of the comment period, which we also submitted to the peer 
review panel members for their consideration. We carefully considered 
the comments of the public and peer reviewers, and made revisions to 
the analysis based on concerns they raised.\1\ Even with those 
revisions, the key conclusion of the analysis remains unchanged: 
Asymptomatic, commercially produced citrus fruit, treated with a 
disinfectant, and subject to other mitigations, is not 
epidemiologically significant as a pathway for the introduction and 
spread of citrus canker.
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    \1\ The revised PRA is available on the Regulations.gov Web site 
and in our reading room (see ADDRESSES above) and may be obtained 
from the person listed under FOR FURTHER INFORMATION CONTACT.
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    However, in light of the comments by the public and peer reviewers, 
it became clear that additional analysis was necessary to apply the 
conclusions of the PRA to the situation in Florida. In order to do 
this, we needed to extend the application of the PRA to evaluate 
methods by which fruit \2\ could be produced, processed, treated, 
inspected, packaged, and shipped without resulting in the spread of 
citrus canker to commercial citrus-producing areas. (Commercial citrus-
producing areas are listed in Sec.  301.75-5 of the regulations and are 
referred to in this document as commercial citrus-producing States. 
Those States, listed in Sec.  301.75-5(a), are: American Samoa, 
Arizona, California, Florida, Guam, Hawaii, Louisiana, Northern Mariana 
Islands, Puerto Rico, Texas, and the U.S. Virgin Islands.)
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    \2\ Given the practical difficulties in ensuring that only 
asymptomatic fruit enters interstate commerce under any regulatory 
strategy--the strategy proposed in this document or the strategy 
currently in place--we refer here to host fruit in general.
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 Risk Management Analysis

    To address the considerations described above, APHIS has prepared a 
risk management analysis (RMA) titled, ``Movement of commercially 
packed fresh citrus fruit (Citrus spp.) from citrus canker (Xanthomonas 
axonopodis pv. citri) disease quarantine areas, March 2007,'' that we 
are making available for comment along with this proposed rule.\3\ The 
RMA will also be submitted for peer review, which will occur 
concurrently with the public comment period for this proposed rule. The 
RMA analyzes the potential of fresh commercially packed citrus fruit 
and associated packing material to serve as a pathway for the 
introduction and spread of citrus canker into new areas. It also 
identifies and evaluates options for regulating interstate movement 
with the goal of reducing the potential for citrus canker introduction 
and spread. The RMA extends the application of the PRA mentioned 
earlier to the citrus canker situation in Florida.
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    \3\ The RMA is available on the Regulations.gov Web site and in 
our reading room (see ADDRESSES above) and may be obtained from the 
person listed under FOR FURTHER INFORMATION CONTACT.
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    To develop the RMA, we reviewed available evidence regarding the 
biology and epidemiology of Xac and the management of citrus canker 
disease. The RMA concludes that the introduction and spread of Xac into 
other commercial citrus producing States through the movement of

[[Page 34182]]

commercially packed fresh citrus fruit is unlikely because:
     Fresh citrus fruit is produced and harvested using 
techniques that reduce the prevalence of Xac-infected fruit;
     Citrus fruit is commercially packed using techniques that 
reduce the prevalence of infected or contaminated fruit, including 
disinfectant treatment that devitalizes epiphytic contamination;
     For a successful Xac infection that results in disease 
outbreaks to occur an unlikely sequence of epidemiological events would 
have to occur;
     Reports of citrus canker disease outbreaks linked to fresh 
fruit are absent; and
     Large quantities of fresh citrus fruit shipped from 
regions with Xac have not resulted in any known outbreaks of citrus 
canker disease.
    Nevertheless, the evidence is not currently sufficient to conclude 
that fresh citrus fruit produced in a Xac-infested grove absolutely 
cannot serve as a pathway for the introduction of Xac into new areas. 
Furthermore, it is not possible to design an operationally feasible 
system that ensures only uninfected fruit moves from quarantined areas. 
Resource constraints and other practical considerations make it 
difficult to implement a grove-centered regulatory systems-approach in 
Florida that ensures full compliance with the conclusions of the 
evaluation described above. Therefore, the RMA evaluates several 
packinghouse-centered risk management options for the interstate 
movement of fresh commercially-packed citrus fruit from regions 
infested with citrus canker to regions without the disease:
     Option 1: Allow unrestricted distribution of all types and 
varieties of commercially packed citrus fruit to all U.S. States.
     Option 2: Allow distribution of all types and varieties of 
commercially packed citrus fruit to all U.S. States, subject to 
packinghouse treatment with APHIS-approved disinfectant and APHIS 
inspection of finished fruit that has completed the packinghouse 
washing, disinfection, grading, and inspection processes.
     Option 3: Allow distribution of all types and varieties of 
commercially packed citrus fruit (except tangerines) in U.S. States 
except commercial citrus-producing States. Allow distribution of 
commercially packed tangerines to all U.S. States, including commercial 
citrus-producing States. Require packinghouse treatment of all such 
citrus fruit with APHIS-approved disinfectant and APHIS inspection of 
finished fruit (all types and varieties) for citrus canker disease 
symptoms.
     Option 4: Allow distribution of all types and varieties of 
commercially packed citrus fruit in U.S. States except commercial 
citrus producing States and require packinghouse treatment of citrus 
fruit with APHIS-approved disinfectant and APHIS inspection of finished 
fruit (all types and varieties) for citrus canker disease symptoms.
     Option 5: Leave the current regulations for the interstate 
movement of citrus fruit from citrus canker quarantined areas in place 
and unchanged.
    Each option was considered within the context of available 
scientific evidence. Option 1 would allow unrestricted distribution of 
all types and varieties of commercially packed citrus fruit to all U.S. 
States. Although the available evidence suggests fresh citrus fruit is 
an unlikely pathway, that evidence is not currently sufficient to 
unequivocally conclude that fresh citrus fruit cannot serve as a 
pathway for the introduction of Xac into new areas. Therefore, 
unrestricted movement of citrus fruit from quarantine areas was 
determined not to be scientifically justified. Consequently, the more 
restrictive Options 2, 3, 4 and 5 were evaluated and Option 1 was no 
longer considered.
    The objective in designing the proposed risk management options was 
to ultimately ensure that visibly infected fruit is not shipped and 
does not reach citrus producing States. To that end, we set out to 
design an inspection protocol that would achieve the maximum level of 
sensitivity (the protocol that would allow the fewest fruit with 
visible symptoms to escape detection by the APHIS packinghouse 
phytosanitary inspection) given the constraints of operational 
feasibility.
    To assist in evaluating Options 2, 3, and 4, we prepared a 
quantitative model (Appendix 1 to the RMA) based on Florida production 
and shipping data to evaluate the efficacy of three levels of 
phytosanitary inspection in ensuring that symptomatic fruit does not 
enter commercial citrus-producing States. The three inspection levels 
were determined by preliminary estimates of PPQ's Citrus Health 
Response Program staff of inspection levels that might be operationally 
feasible. The three inspection levels evaluated were 500 fruit per lot, 
1,000 fruit per lot, and 2,000 fruit per lot. Statistically, inspection 
of 500, 1,000 fruit, or 2,000 fruit per lot will ensure, with 95 
percent confidence, that the proportion of undetected symptomatic fruit 
in a cleared lot is no more than 0.75, 0.38, and 0.19 percent, 
respectively.
    The outputs of the quantitative model were probability 
distributions. The model determined, with 95 percent confidence, that 
the total number of citrus fruit shipped from Florida to five citrus-
producing States (Arizona, California, Hawaii, Louisiana and Texas) 
over a single shipping season would be 181,283,744 or less if unlimited 
distribution is permitted. The model determined, with 95 percent 
confidence, that the number of Xac-symptomatic fruit reaching those 
five States in a single shipping season would be 633,152 or less at the 
1,000 fruit inspection levels. We anticipate that about double that 
number (approximately 1,266,304 or less) of Xac-symptomatic fruit would 
reach those States at the 500 fruit inspectional level. About half that 
number (approximately 316,576 or less) would reach those States at the 
2,000 fruit inspectional level. The model further determined with 95 
percent confidence that the number of symptomatic fruit reaching 
citrus-producing areas within those States in a single shipping season 
would be 2,135 or less at the 1,000 fruit inspectional level, about 
double that number (approximately 4270 or less) at the 500 fruit 
inspectional level and about half that number (approximately 1067 or 
less) at the 2,000 fruit inspectional level. The base level inspection 
of 1,000 fruit per lot, was adopted because it is operationally 
feasible with small adjustments to the current phytosanitary inspection 
process in Florida.
    PPQ Staff from the Melbourne, Florida office of the Citrus Health 
Response program conducted a small test of the 2,000 fruit sampling 
protocol to evaluate its operational feasibility. The study found that 
the normal complement of two inspectors at the packinghouse chosen for 
the evaluation were physically unable to achieve the 2,000 fruit per 
lot inspection level. It was estimated that the number of inspectors 
would have to have been doubled to four in order to inspect 2,000 fruit 
per lot, but the packinghouse physically had room for only two 
inspectors. Based on this test and additional input from PPQ 
operational staff, it was determined that the higher inspection level 
that achieves 95 percent confidence of detecting at least 0.19 percent 
rate of symptomatic fruit (about 2,000 fruit per lot), is only feasible 
with increased inspectional resources and/or more substantial 
modifications to the packing/phytosanitary inspection processes, and 
could be justifiable only if the risk

[[Page 34183]]

reduction benefits outweighed the cost. An inspection level of 1,000 
fruit per lot that achieves a detection rate of 0.38 percent with 95 
percent confidence was adopted because it provides the maximum level of 
detection that is operationally feasible with the phytosanitary 
inspection resources in Florida. Inspection of 500 fruit per lot was 
rejected because it did not meet the criteria of achieving the maximum 
level of detection that was operationally feasible.
    The potential for symptomatic fruit to reach citrus producing 
States, coupled with the aforementioned uncertainty regarding fruit as 
a pathway, led to the determination that additional mitigations were 
required.
    As mentioned above, Option 2 would allow distribution of all types 
and varieties of commercially packed citrus fruit to all U.S. States, 
subject to packinghouse treatment with APHIS-approved disinfectant and 
APHIS inspection of finished fruit that has completed the packinghouse 
washing, disinfection, grading, and inspection processes. Despite the 
determination that commercially packed fresh citrus fruit is an 
unlikely pathway for the introduction and spread of Xac, and a 
phytosanitary inspection that ensures, with high confidence, that a low 
level of shipped fruit has symptoms of citrus canker disease, the model 
indicates the potential for some symptomatic fruit to be shipped to 
citrus producing States. That potential for symptomatic fruit to reach 
citrus producing States coupled with the aforementioned uncertainty 
regarding fruit as a pathway led to the determination that the 
additional mitigation of limited distribution to non citrus-producing 
States only was required. Accordingly, Option 2 was no longer 
considered.
    APHIS was asked by representatives of the Florida citrus industry 
to consider regulating tangerines, which are thought to be more 
resistant to Xac infection than other citrus varieties, differently 
than other citrus fruit. Option 3 would allow for the movement of 
tangerines from Florida into all States, including commercial citrus 
producing States. In order to determine the viability of this option, 
we needed to determine whether adequate evidence was available to 
conclude that tangerines warrant different regulatory status than other 
fruit, so we reviewed published literature on tangerine varieties as 
well as grove surveys.
    Tangerines are generally grouped in the species Citrus reticulata 
and are widely regarded as less susceptible to citrus canker disease 
than other commercially grown Citrus species. But many of the 
``tangerine'' varieties grown in Florida are hybrids of C. reticulata 
with other more susceptible Citrus species. Clearly, tangerines in 
Florida are not immune to citrus canker, as APHIS records indicate 
that, during the 2005-2006 growing season grove surveys, Xac was 
detected on 274 samples from tangerine, tangor, and tangelo groves. 
APHIS pest interception data indicate that between 1985 and 2006, Xac 
was intercepted 632 times on C. reticulata fruit.
    The level of susceptibility was expressed as a continuum across 
``tangerine'' varieties rather than as a discrete immunity for all 
varieties. This creates a regulatory problem when an overlap occurs in 
the level of susceptibility expressed by, for example, a more 
susceptible tangerine variety and a more resistant non-tangerine citrus 
variety. Sufficient evidence does not exist to exclude tangerines from 
regulations applicable to other Florida citrus varieties and as such, 
Option 3 was rejected.
    Option 4 prohibits distribution of all types and varieties of 
citrus fruit, including tangerines, to citrus-producing States. Option 
4 includes all the requirements of Option 3 and further mitigates the 
risk of Xac introduction by prohibiting the distribution of all types 
and varieties of citrus fruit, including tangerines, from areas with 
citrus canker disease to U.S. commercial citrus producing States. 
Option 4 would amend the regulations by substituting a packinghouse 
inspection for the preharvest grove inspections currently required by 
the regulations.
    Option 4 takes into account the possibility that fruit may be 
transported into commercial citrus-producing States, despite the 
prohibition, and compensates for uncertainty generated by that movement 
by requiring a disinfectant treatment and phytosanitary inspection in 
addition to the distribution restriction. These measures ensure that 
even if a given shipment were illegally moved to a commercial citrus-
producing State, that shipment would have a low likelihood of 
containing symptomatic fruit.
    A packinghouse-based inspection that could ensure the same level of 
phytosanitary security as the preharvest grove survey required under 
the current regulations would be easier and potentially less costly to 
implement and enforce, and would be more reliable and less easily 
circumvented. In addition, a phytosanitary packinghouse inspection 
creates a performance standard for packed fruit that allows citrus 
producers greater flexibility to determine the most efficient and 
effective means of producing a product that will be eligible for 
interstate movement.
    Option 5 is the most restrictive option that we considered. It 
would leave the current regulations in place and unchanged, including 
the requirement for preharvest grove surveys. APHIS has concluded that 
a mandatory packinghouse treatment of citrus fruit with APHIS approved 
disinfectant and phytosanitary inspection, by APHIS, of finished fruit 
provides an effective safeguard to prevent the spread of Xac via the 
movement of commercially-packed citrus fruit, especially when combined 
with a limited distribution requirement that excludes shipment to U.S. 
citrus-producing States.
    Of the five options, we determined that Options 1, 2, and 3 are not 
viable at the present time. Those options would each allow for the 
movement of at least some types and varieties of fresh citrus fruit 
from Florida into commercial citrus-producing States. While the 
conclusions of both our PRA and RMA indicate that fresh citrus fruit is 
an unlikely pathway for citrus canker infection, we cannot conclusively 
rule out any type or variety of citrus fruit as a potential source of 
citrus canker infection at this time. In addition, the probabilistic 
model presented in our RMA document finds that if such distribution 
were to take place, fruit with symptoms of citrus canker disease could 
end up in citrus-producing States. We also determined that Options 4 
and 5 offered similar levels of phytosanitary protection, but that 
Option 4 offered some relief of restrictions for growers of citrus 
fruit in Florida while maintaining conditions that would help prevent 
the artificial spread of Xac.
    We are proposing to implement Option 4 in this document. This 
option would pair limited distribution of all types and varieties of 
citrus fruit to non-citrus-producing States with mitigations conducted 
at packinghouses operating under compliance agreements. Those 
mitigations would be the use of an approved disinfectant for all fruit 
and phytosanitary inspection.
    The approved disinfectants listed in the regulations in Sec.  
301.75-11(a) have been shown to reduce or nearly eliminate any Xac 
bacterium that may exist as a surface contaminant on citrus fruit 
moving interstate from citrus canker quarantined areas. The RMA 
discusses the efficacy of currently approved disinfectant treatments in 
the context of the scientific evidence in greater detail. Decontaminant 
treatments for fruit are required under the current regulations and 
would continue to be required under our proposal.

[[Page 34184]]

    Based on our evaluation of production and processing procedures and 
their impact on removal of citrus canker from the fresh-fruit pathway, 
along with our review of the operational feasibility of enforcing 
various mitigation measures, APHIS has concluded that the mandatory 
packinghouse inspection of processed fruit provides an effective 
safeguard against the spread of citrus canker via the movement of 
commercial citrus fruit. After consultation with operational staff, 
APHIS determined that--given the resources currently available--the 
inspection of 1,000 fruit per lot is possible without significant 
additional resources or disruptions to citrus packing operations. This 
rate of inspection is sufficient to detect, with a 95 percent level of 
confidence, lots of fruit containing 0.38 percent or more fruit with 
visible canker lesions. This determination takes into account 
operational constraints in packinghouses as well as the availability of 
APHIS inspectors. The inspection would require visual examination of 
approximately 1,000 randomly selected fruit per lot, depending on the 
size of the lot and other factors.
    We ruled out inspecting at a rate of 2,000 fruit per lot because of 
the significant disruptions to citrus packing operations in the State 
of Florida. The 1,000 fruit inspectional unit is further justified 
given the added protection provided by allowing distribution only in 
non-citrus-producing States. Even with the limited distribution 
requirement, it is necessary to require packinghouse inspection to 
ensure that very few, if any, symptomatic fruit can move out of the 
quarantined area. This added safeguard ensures that any fruit moved 
into citrus-producing States, either inadvertently or intentionally, is 
very unlikely to be symptomatic. Additionally, we ruled out inspecting 
at a rate of 500 fruit per lot because inspection at the 1,000 
inspectional rate provided a higher level of protection.
    A packinghouse phytosanitary inspection would be conducted on fruit 
immediately before shipping to provide a high level of assurance about 
the condition of the final product. Because a phytosanitary 
packinghouse inspection sets a performance standard for the packed 
fruit, it allows producers and packers greater flexibility in 
determining optimum methods for achieving that standard. Packinghouse 
phytosanitary inspections are relatively simple compared with the 
monitoring of field treatment and grove inspections.
    It is important to note that we recognize that different 
packinghouses may utilize different methods for quality control 
inspection and employ them at various points in the packing process. 
Our intention is to allow flexibility for both large and small 
packinghouses to have the ability to process, treat, pack, and ship 
fresh citrus fruit provided that all fruit, regardless of the size of 
the lot being packed, is subjected to inspection at a rate sufficient 
to detect, with a 95 percent level of confidence, lots of fruit 
containing 0.38 percent or more fruit with visible canker lesions. This 
equates to approximately 1,000 fruit per lot. We welcome comments and 
suggestions regarding the appropriate methodology and inspection level 
at packinghouses and the appropriate balance between the sensitivity of 
the inspection and the operational needs and constraints of the 
packinghouses.
    Because of the shift in emphasis from grove-freedom certification 
to packinghouse inspection and treatments, we wish to emphasize that 
only fresh citrus fruit that has been treated, inspected, and found 
free of symptoms of citrus canker and packaged in accordance with the 
proposed regulations in a packinghouse that is operating under a 
compliance agreement with APHIS would be eligible for interstate 
movement. Our proposed provisions would allow any Florida citrus 
growers, including commercial, gift fruit, and dooryard growers, to 
move their fruit interstate to non-citrus-producing States provided 
they comply with the conditions discussed in this proposed rule.

Determination by the Secretary

    Under Sec.  412(a) of the Plant Protection Act, the Secretary of 
Agriculture may prohibit or restrict the movement in interstate 
commerce of any plant or plant product if the Secretary determines that 
the prohibition or restriction is necessary to prevent the 
dissemination of a plant pest or noxious weed within the United States. 
Based on information provided in our risk assessment and risk 
management documents, we have determined that it is not necessary to 
prohibit the interstate movement of citrus fruit into non-citrus-
producing States under the conditions described in this proposed rule. 
While APHIS has concluded that commercially packed citrus fruit is an 
unlikely pathway for the introduction and spread of citrus canker, the 
remaining uncertainty about the precise level of risk associated with 
the movement of citrus fruit from a quarantined area has led us to 
maintain the current prohibition on the movement of that citrus fruit 
into citrus-producing States.

Changes to the Regulations

    This proposed rule, if adopted, would amend the citrus canker 
regulations to modify the conditions under which fruit may be moved 
interstate from a quarantined area. Under this proposed rule APHIS 
would:
     Eliminate the requirement that the groves in which the 
fruit is produced be inspected and found free of citrus canker;
     Require that fruit produced in the quarantined area be 
treated with a surface disinfectant treatment in a packinghouse 
operating under a compliance agreement;
     Require that each lot of finished fruit would be inspected 
in a packinghouse operating under a compliance agreement and found free 
of visible symptoms of citrus canker prior to interstate movement;
     Retain the current prohibition on the movement of fruit 
from a quarantined area into commercial citrus-producing States;
     Retain requirements that fruit to be moved interstate must 
be free of leaves, twigs and other plant parts, except for stems that 
are less than 1-inch long and attached to the fruit;
     Retain requirements pertaining to the treatment of 
personnel, vehicles, and equipment in groves within a quarantined area; 
and
     Require that boxes in which fruit are packed would be 
marked with a statement that fruit are being moved interstate under 
limited permit and may not be distributed in commercial citrus-
producing States listed in Sec.  301.75-5(a). Only fruit that has been 
treated, inspected, and found free of evidence of citrus canker may 
leave packinghouses in boxes marked with the limited permit stamp.
    The regulations in Sec.  301.75-7 pertain to the interstate 
movement of regulated fruit from a quarantined area. Currently, the 
regulations require that a grove be free of citrus canker prior to 
movement of any regulated fruit. To certify grove freedom, the grove 
producing the regulated fruit must have received regulated plants only 
from nurseries located outside any quarantined areas, or from nurseries 
where an inspector has found every regulated plant free of citrus 
canker on each of three successive inspections conducted at intervals 
of no more than 45 days, with the third inspection no more than 45 days 
before shipment. In addition, every tree must have been inspected by an 
inspector and the grove found free of citrus canker no more than 30 
days before the beginning of harvest. Further, in groves producing 
limes, every tree must have been

[[Page 34185]]

inspected and the grove found free of citrus canker every 120 days or 
less thereafter for as long as harvest continued. Currently, if citrus 
canker is found in a grove when the preharvest inspection is conducted, 
or at any other time beginning August 1 of the year in which the fruit 
is to be harvested and extending through the harvest season (including 
into the next calendar year), fruit from that grove is not eligible for 
interstate movement for the remainder of the harvest season.
    We are proposing to remove provisions relating to the certification 
of grove freedom from citrus canker. Instead, APHIS would focus on the 
inspection of individual lots of citrus fruit at packinghouses, as 
described earlier in this document, to ensure that regulated fruit 
moving interstate is free of symptoms of citrus canker. Specifically, 
the new provisions in Sec.  301.75-7(a)(1) would state that every lot 
of regulated fruit to be moved interstate must be inspected by an APHIS 
employee at the packinghouse for symptoms of citrus canker. Any lot 
found to contain fruit with visible symptoms of citrus canker would not 
be eligible for a limited permit to move interstate. The proposed 
regulations, as presented in this document, leave open the issue of 
allowing lots of fruit initially found to be ineligible for a limited 
permit to be reconditioned and resubmitted for inspection. Because we 
have not thoroughly examined all operational aspects of the 
reconditioning of fruit, we would like to invite comments on this 
topic.
    The number of fruit to be inspected would be the quantity that 
gives a statistically significant confidence, as discussed above, of 
detecting the disease at a level of infection to be determined by the 
Administrator. As stated previously, we intend to inspect fruit at a 
rate of inspection sufficient to detect, with a 95 percent level of 
confidence, lots of fruit containing 0.38 percent or more fruit with 
visible canker lesions. This is equivalent to 1,000 fruit per lot for 
most lots. If at some time in the future conditions warrant changing 
this rate of inspection, APHIS would provide for public participation 
in that process through the publication of a notice in the Federal 
Register.
    Because APHIS plans to focus on the inspection of individual lots, 
we would add a definition for the term lot in Sec.  301.75-1. The term 
lot would be defined as ``The inspectional unit for fruit composed of a 
single variety of fruit that has passed through the entire packing 
process in a single continuous run not to exceed a single work day 
(i.e., a run started one day and completed the next is considered two 
lots).''
    We would also require that packinghouse owners and operators 
involved with shipping citrus fruit must enter into a compliance 
agreement with APHIS in accordance with Sec.  301.75-13, ``Compliance 
agreements.'' In the compliance agreement, the owner or operator of the 
packinghouse will agree to treat fruit to be moved interstate with one 
of the approved treatments according to the procedures specified in 
Sec.  301.75-11, and to see that this fruit is packed only in boxes 
marked in accordance with the requirements in Sec.  301.75-7(a)(6). The 
compliance agreement would also contain (but not to be limited to) 
specific provisions pertaining to:
     Access to the facility, and to necessary records and 
documents by APHIS inspectors;
     Means by which lots are designated and notice of estimated 
lot sizes and run times;
     Need for notice when APHIS inspectors are not present on a 
regular basis;
     Need for notice when there are significant changes in the 
amount of fruit being packed;
     Conditions (access to fruit, lighting, safety, etc.) that 
must be met in order for APHIS inspectors to carry out the required 
inspections;
     Provisions for handling and storage of fruit, including 
provisions not allowing the movement of any part of a lot from the 
packinghouse until APHIS inspection is complete;
     Hazard-free access to decontamination areas so that APHIS 
inspectors can monitor the concentrations of chemicals used for fruit 
treatment;
     Provisions for holding fruit when packing is done at a 
time when an APHIS inspector is not present; and
     Hours of coverage for APHIS packinghouse inspections.
    The regulations already provide that any compliance agreement may 
be canceled orally or in writing by an inspector if the inspector finds 
that the person who entered into the compliance agreement has failed to 
comply with this subpart. This provision would remain in effect.
    We would retain the provision in Sec.  301.75-7(a)(4) that requires 
the fruit to be treated in accordance with Sec.  301.75-11(a), but 
would add a newly approved treatment, peroxyacetic acid, for use on 
fruit. Treatment instructions would specify that regulated fruit must 
be thoroughly wetted for at least 1 minute with a solution containing 
85 parts per million peroxyacetic acid. At the request of growers in 
Florida, we evaluated the efficacy of this treatment and determined 
that the bactericide provides treatment that is at least as efficacious 
as the currently approved bactericides listed in the regulations.
    In addition to the new inspection requirements, we would revise the 
box marking requirements currently in Sec.  301.75-7(a)(5) to clarify 
that regulated fruit may only be moved interstate with a limited permit 
and that the distribution of the fruit is limited to areas that are not 
designated as commercial citrus-producing States. Specifically, those 
proposed provisions would state that the regulated fruit must be 
accompanied by a limited permit issued in accordance with Sec.  301.75-
12. In order to be moved interstate, the regulated fruit would have to 
be packaged in boxes or other containers that are approved by APHIS and 
that are used exclusively for regulated fruit to be moved interstate. 
The boxes or other containers in which the fruit is packaged would have 
to be clearly marked with the statement ``Limited Permit: USDA-APHIS-
PPQ. Not for distribution in AZ, CA, HI, LA, TX, American Samoa, Guam, 
Northern Mariana Islands, Puerto Rico, and Virgin Islands of the United 
States.'' Those proposed provisions would also state that only fruit 
that meets all of the requirements of the section may be packed in 
boxes or other containers that are marked with the above statement. 
These additional provisions would help ensure that only fruit that has 
been handled in accordance with all of the requirements described in 
Sec.  301.75-7 will be packaged in boxes bearing the limited permit 
statement.

Miscellaneous

    In addition to the changes discussed above, we would amend the 
definitions for certificate and limited permit in Sec.  301.75-1. 
Currently, certificates and limited permits are referred to as 
``official documents.'' We would amend those definitions to indicate 
that a certificate or limited permit may be a ``stamp, form, or other 
official document.'' This proposed change would provide us with a 
greater degree of flexibility in the issuance of those documents.

Executive Order 12866 and Regulatory Flexibility Act

    This proposed rule has been reviewed under Executive Order 12866. 
The rule has been determined to be significant for the purposes of 
Executive Order 12866 and, therefore, has been reviewed by the Office 
of Management and Budget.

[[Page 34186]]

    We are proposing to amend the citrus canker regulations to modify 
the conditions under which fruit may be moved interstate from a 
quarantined area. Under this proposed rule, we would eliminate the 
requirement that the groves in which the fruit is produced be inspected 
and found free of citrus canker, and instead require that fruit 
produced in the quarantined area be treated with a surface disinfectant 
treatment in a packinghouse operating under a compliance agreement and 
that each lot of finished fruit be inspected and found free of visible 
symptoms of citrus canker. We would, however, retain the current 
prohibition on the movement of fruit from a quarantined area into 
commercial citrus-producing States. These proposed changes would 
relieve some restrictions on the interstate movement of fresh citrus 
fruit from Florida while maintaining conditions that would prevent the 
artificial spread of citrus canker.
    For this proposed rule, we have prepared an economic analysis. The 
analysis, which is summarized below, addresses economic impacts of the 
proposed new protocol for treatment and inspection of citrus fruit 
intended for the fresh market. Expected benefits and costs are examined 
in accordance with Executive Order 12866. Possible impacts on small 
entities are considered in accordance with the Regulatory Flexibility 
Act. Copies of the full analysis are available at https://
www.regulations.gov.
    Section 301.75-5 of the regulations lists the designated commercial 
citrus-producing States as American Samoa, Arizona, California, 
Florida, Guam, Hawaii, Louisiana, the Northern Mariana Islands, Puerto 
Rico, Texas, and the U.S. Virgin Islands. Of these 11 commercial 
citrus-producing States, only 4 States received fresh citrus interstate 
shipments from Florida during the 2004-05 and 2005-06 seasons: Arizona, 
California, Louisiana, and Texas. As of August 1, 2006, these four 
States no longer receive fresh citrus shipments from Florida. In this 
analysis, U.S. commercial citrus-producing States other than Florida 
are referred to as other commercial citrus-producing States.
    The overall objective of this proposed rule is to continue to 
prevent the spread of citrus canker to other commercial citrus-
producing States, while relieving restrictions on Florida citrus 
producers, namely, the requirement for interstate movement of citrus 
fruit that every tree in the grove in which the fruit is grown be 
inspected, and that the grove be found to be free of citrus canker not 
more than 30 days before the beginning of harvest. Under the proposed 
rule, the citrus fruit would be treated and inspected at the 
packinghouse prior to interstate movement. We expect the net economic 
impact of the proposed changes would be positive.
    While citrus produced in Florida is primarily intended for the 
processed market, citrus produced in California, Texas, Arizona, and 
Louisiana is largely intended for the fresh market. This proposed rule 
would continue to prohibit the movement of fresh citrus fruit from 
Florida to other commercial citrus-producing States. The proposed 
measures are designed to ensure protection of the citrus industries in 
these States from the introduction of citrus canker and the increased 
production costs and loss of fresh fruit markets that would result if 
citrus canker were to be introduced in those States.

Overview of the U.S. Citrus Industry

    The total value of U.S. citrus production rose by 16 percent from 
$2.30 billion to $2.68 billion, between the 2004-05 and 2005-06 
seasons. These gains in value reflect increased values for processed 
utilization for most varieties of citrus in the United States with the 
exception of grapefruit, which declined in overall value by 4 percent.
    Florida is the largest citrus producer in the United States, 
accounting for approximately 68 percent of U.S. production during the 
2005-06 season. California produced approximately 28 percent of the 
citrus in the United States during the same period, and production in 
Texas and Arizona comprised the remaining 4 percent. The hurricane 
season of 2004, which included 4 hurricanes that crossed Florida within 
a 2-month period, caused significant production losses to Florida's 
citrus industry and was largely to blame for the 42 percent decline of 
total utilized production in the United States between the 2003-04 and 
2004-05 seasons.
    The major citrus varieties produced in Florida are early, mid-, and 
late-season orange varieties, red and white seedless grapefruit, 
navels, early tangerines, honey tangerines, temples, and tangelos. 
Although approximately 89 percent of all Florida citrus is intended for 
the processed market, the share of production that is processed is 
highly dependent upon the variety. Approximately 95 percent of all 
Florida orange production is intended for the processing sector, 
whereas nearly 68 percent of Florida tangerine production is utilized 
on the fresh market. During the 2005-06 season, nearly 36 percent of 
Florida grapefruit production was utilized on the fresh market. During 
the previous season, the packout rate for Florida fresh grapefruit was 
approximately 58 percent, suggesting that the post-hurricane higher 
prices for fresh grapefruit led to a diversion of Florida grapefruit 
from the processing sector to the fresh market. The reduced packout 
rate for the 2005-06 season may suggest a return to a more normal fresh 
market share of about 40 percent.
    The major citrus varieties produced in California are navel and 
Valencia oranges, grapefruit, tangerines, and lemons. Approximately 73 
percent of California citrus was utilized on the fresh market during 
the 2005-06 season, including nearly 72 percent of California's oranges 
(making California the largest U.S. producer of fresh-market oranges), 
88 percent of the State's grapefruit, 75 percent of its tangerines, and 
72 percent of its lemons.
    The citrus varieties produced in Texas during the 2005-06 season 
were grapefruit, Valencia oranges, and midseason oranges. Fresh 
production accounted for approximately 67 percent of total production. 
Valencia and midseason orange production was destined primarily for the 
fresh market, accounting for 79 percent of total production. Also, 62 
percent of grapefruit production in that State was utilized on the 
fresh market.
    Arizona produces Valencia and navel oranges, grapefruit, 
tangerines, and lemons. Approximately 58 percent of Arizona citrus was 
utilized on the fresh market during the 2005-06 season, including 52 
percent of the State's orange production, 65 percent of its tangerine 
production, 55 percent of its lemon production, and all of its 
grapefruit production.
    Total and domestic shipments of Florida fresh citrus remained 
virtually unchanged during the 2005-06 season over the previous season, 
showing few signs of recovery from the dramatic decline between the 
2003-04 and 2004-05 seasons, when total and domestic shipments declined 
by 42 percent and 29 percent, respectively. Fresh grapefruit continued 
to have the largest share of total shipments of fresh Florida citrus 
including exports, while oranges accounted for the State's largest 
share of domestic shipments.

Expected Costs and Benefits

    The proposed changes described in this document are likely to 
primarily affect citrus producers and packinghouses in Florida whose 
operations rely on the interstate shipment of fresh citrus. The 
proposed changes would also affect the way resources are allocated for 
citrus canker

[[Page 34187]]

mitigation activities at both Federal and State levels.

Effects on Florida Fresh Citrus Shipments

    We expect the proposed rule to have little economic effect on the 
production of fresh citrus in Florida, but the shift from inspection 
for citrus canker in the citrus groves, tree by tree, to the inspection 
of fresh citrus fruit at the packinghouse may result in an increase in 
the quantity of citrus eventually approved for shipment interstate. As 
such, interstate shipment of fresh citrus fruit originating from groves 
previously prohibited from shipping outside of quarantined areas could 
lead to changes in market prices and increased competition. Although 
the changes to the supply of Florida fresh citrus in non-citrus-
producing States resulting from these additional shipments are expected 
to be small, we are unable to estimate the extent of any such increase 
due to lack of data. APHIS welcomes public input on the possibility of 
increased fresh citrus shipments to non-citrus producing States as a 
result of the proposed changes. Under the proposed protocol, Florida 
citrus would still be prohibited from distribution to other commercial 
citrus-producing States.

Effects on Florida Packinghouses and Citrus Growers

    Florida packinghouses are the segment of the citrus industry likely 
to be the most affected by the proposed regulations, since the focus of 
the new protocol for treatments and inspections would be shifted away 
from the citrus groves to packinghouse facilities. According to the 
proposed regulations, citrus packinghouses would be required to operate 
under an APHIS compliance agreement wherein the packinghouse operator 
agrees to meet all requirements of the regulations. The provisions in 
current Sec.  301.75-7 pertaining to the inspection of groves for 
citrus canker as a prerequisite for the interstate movement of citrus 
fruit would be remov