[Federal Register: June 21, 2007 (Volume 72, Number 119)]
[Proposed Rules]
[Page 34180-34191]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21jn07-5]

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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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[[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 http://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 http://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 http://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.
---------------------------------------------------------------------------

    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 http://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 removed. While the new regulations would indirectly
place a burden on the growers of fresh citrus to transport symptom-free
fresh citrus to packinghouses for packing, the inspection and treatment
activities that would be required would take place in the
packinghouses. A packinghouse charge to the grower for citrus that does
not meet the quality requirements is known as an elimination charge,
and is an existing industry measure for ensuring high quality, symptom-
free fruit. Table 1 outlines the average packinghouse charges for
Florida fresh citrus during the 2005-06 season.

 Table 1.--Estimated Average Total Packing charges Paid by Growers, and Elimination Charges Paid by Growers for
                             Lots That Do Not Meet Quality Requirements, 2005-06 \1\
----------------------------------------------------------------------------------------------------------------
                                     Domestic         Export                         Temples/
                                    grapefruit      grapefruit        Oranges        tangelos       Tangerines
----------------------------------------------------------------------------------------------------------------
                                                                   $/Carton \3\
                                 -------------------------------------------------------------------------------
Total packing charge \2\........          $4.016          $4.395          $4.347          $4.614          $5.469
                                 -------------------------------------------------------------------------------
                                                                     $/Box \3\
                                 -------------------------------------------------------------------------------
Drenching charge................          $0.181          $0.189          $0.181          $0.184          $0.188
Packinghouse elimination charges           0.545           0.553           0.548           0.548           0.552
Hauling charges for eliminations           0.505           0.534           0.515           0.531           0.534
----------------------------------------------------------------------------------------------------------------
Source: Ronald P. Muraro, University of Florida-IFAS, Citrus Research and Education Center, Lake Alfred, FL
  August 2006.
\1\ These packing charges are based on charges at four citrus packinghouses in the Interior production region
  and 13 citrus packinghouses in the Indian River production region.
\2\ Total packing charge refers to the charge to the grower for packed fruit, and is based upon packinghouse
  operational costs. Total packing charges are discussed in detail in the report ``Average Packinghouse Charges
  for Florida Fresh Citrus--2005-06 Season,'' (http://edis.ifas.ufl.edu).

\3\ One box is equivalent to two \4/5\-bushel cartons.

    Focusing regulatory enforcement in the packinghouse via required
treatments and inspection of fruit intended for interstate movement is
expected to be an economically efficient means of ensuring a high level
of confidence that even a small percentage of infected fruit would be
detected. Both packinghouses operating under compliance agreements with
APHIS and growers seeking to minimize elimination charges and price
discounts would have incentives to ensure that only fruit considered to
be free from citrus canker would enter a packing facility. Minimizing
the charges back to the grower associated the drenching, elimination,
hauling of fruit unsuitable for the fresh market through the practice
of grove surveys is commonly employed by growers as part of their
operations. Tree inspections, which were previously conducted by APHIS
and the Florida Department of Agriculture and Consumer Services
(FDACS), will, we believe, be conducted as self-surveys by the
industry. Given the possibility of elimination charges, growers will
apply the additional resources needed to conduct these self-surveys as
long as the benefits outweigh the costs.
    The inspection process would be largely dependent on the physical
layout of each particular packinghouse. Conditions that must be met in
order for APHIS inspectors to carry out the required inspections would
translate into additional costs to the packinghouse. Inspections would
either occur at the roll board prior to the fruit being physically
packed or after the fruit is packed. In either case, adequate lighting
would be a necessary component for the fruit inspection process. If the
inspection occurs after fruit is packed, the packinghouse would be
required to provide a table and personnel to repack the boxes after
inspection. Lot size would be determined by the packinghouse, and
varies according to the size of the packinghouse, the number of packing
lines per facility, and the varieties of fresh citrus packed. APHIS
field personnel estimate that under ideal circumstances, the inspection
of 1,000 pieces of fruit would take approximately 1 hour and 23 minutes
(approximately 5 seconds per fruit). If the lot takes longer than that
to run, the inspection is not expected to result in a delay. However, a
lot that would take less than 1 hour and 23 minutes to run the line may
be delayed by the inspection of 1,000 pieces of fruit.
    The time it would take to run a lot of fruit varies by
packinghouse, and is determined by numerous factors. It is reasonable
to assume that an average

[[Page 34188]]

time to run a lot of fruit is about 3 hours. On the average, then, the
inspection of 1,000 pieces of fruit will not result in delays.
    If a packinghouse has its own groves and packs its own fruit, lot
sizes are generally larger, and no delays should be expected.
Packinghouses that do not pack their own fruit tend to run multiple
smaller lots whose identity must be maintained to ensure proper payment
to the respective growers. These packinghouses are more likely to
experience delays caused by the inspection of 1,000 pieces of fruit.
    The decontamination of fruit, as reflected in the drenching charges
in Table 1, occurs under the existing regulations and is conducted as a
standard practice to extend shelf-life. It also is a requirement in the
FDACS/DPI compliance agreement with packers. Therefore, there is no
additional cost associated with the proposed provisions.
    APHIS requests comment on the costs that would be incurred by
packinghouses due to implementation of the proposed compliance
agreement provisions.
    The proposed compliance agreements would not present an entirely
new situation for the packinghouses. Current compliance agreements with
the State of Florida issued by the FDACS Division of Plant Industry are
required of all packinghouses that ship fresh citrus interstate. They
require the packinghouses to adhere to inspection requirements prior to
the movement of fresh citrus. According to section IIIA of the FDACS
packinghouse compliance agreement:

    Inspection of fruit for citrus canker lesions will take place
during the washing/grading process, and a designated number of
packed boxes will be required to be pulled, opened and made
available for inspection by Federal or State regulatory officials.

Effects on Public Sector Resources

    According to APHIS, 10 additional inspectors would be needed to
implement the proposed rule at a cost of $450,000 per year. The added
cost for increased inspection at the packinghouse is expected to be
offset by a reduction in certain operational expenses in other program
areas. For example, pre-harvest grove surveys would be reduced to only
those required for phytosanitary certification to certain countries.
    The State of Florida allocated approximately $10 million for the
2007 fiscal year from the Agricultural Emergency Eradication Trust Fund
to the CHRP for grove inspections (generally pre-harvest surveys),
regulatory oversight, and nursery surveys. FDACS anticipates a
reduction in field staff by 65 percent under the proposed rule, from
340 to 120 field staff members, for a cost savings of approximately
$9.9 million. We anticipate that growers would conduct their own grove
inspections, as long as the benefits outweigh the cost of resources
needed for these self-surveys.

Concluding Statement on Benefits and Costs

    The current regulations for the interstate movement for regulated
fruit from quarantined areas place several restrictions on the
interstate movement of citrus fruit from Florida, including inspections
of citrus groves to ensure that they are free of citrus canker,
preharvest inspections, treatments, and movement under limited permit.
    The proposed regulatory protocol would replace the current protocol
for the movement of citrus fruit from citrus canker quarantined areas.
A packinghouse that ships fresh citrus interstate would be required to
operate under an APHIS compliance agreement wherein the packinghouse
operator agrees to meet all requirements of the regulations.
Inspections of fresh citrus would occur at the packinghouse level. The
proposed regulations also specify treatment requirements for all
commercially packed fresh citrus. The required treatment, however, is
already employed at the top 50 packinghouses. We believe packinghouses
would adjust to the new regulations with little to no economic
hardship. Packinghouses currently face similar regulations as required
by the Florida compliance agreements for packinghouses.
    Packinghouse charges to growers for eliminations and price
discounts for fruit diverted from the fresh to the processed market are
incentives to growers to ensure fruit sent to the packinghouse for
packing is free of symptoms of citrus canker. Growers are thus highly
likely to self-survey groves as long as the benefits outweigh the cost
of the procedure. The proposed provisions would also provide the added
benefit to growers of being able to ship symptom-free fresh citrus from
groves which they were previously unable to move interstate due to the
presence of canker in the grove.
    The proposed rule would also provide opportunities for the Florida
packing industry to place in service underutilized packing equipment to
treat, pack, and have inspected, interstate shipments of non-
commercially produced citrus fruit.
    Benefits of this proposed rule may include the possibility of gains
from a larger volume of Florida shipments to consumers in non-citrus
producing States. Producers would no longer be prohibited from sending
to the packinghouses for interstate shipment fruit from citrus groves
in which citrus canker has been detected. As long as a lot of citrus
fruit is found to be symptom free upon APHIS inspection, the lot would
be considered eligible for shipment to non-citrus producing states.
Growers with infected groves would have an additional marketing option
for their fruit. Local consumers in Florida may benefit from increased
market quantities and lower prices of fresh citrus if rejected lots are
diverted to in-state fresh markets. We expect that Florida
packinghouses that wish to ship interstate would continue to do so,
should the new provisions be adopted, as long as financial benefits to
them of operating under these provisions exceed their costs.
    The additional costs of the proposed regulations to the public
sector are expected to be marginal in comparison to the benefits of a
more efficient system for fresh citrus fruit movement.

Initial Regulatory Flexibility Analysis

    The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires that
agencies consider the economic impact of rule changes on small
businesses, organizations, and governmental jurisdictions. Section 603
of the Act requires agencies to prepare and make available for public
comment an initial regulatory flexibility analysis (IRFA) describing
the expected impact of proposed rules on small entities. Sections
603(b) and 603(c) of the Act specify the content of an IRFA. In this
section, we address these IRFA requirements for this proposed rule.

Reasons for Action

    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 to prevent the spread of citrus canker via the movement of
commercial citrus fruit. Since the current regulations require groves
to be free of citrus canker in order for fruit to be eligible for
interstate movement, the changes proposed in this document are
necessary in order for the packinghouse-based treatment and inspection
protocol to be implemented.

[[Page 34189]]

Objectives of and Legal Basis for Rule

    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 at the packinghouse. 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.
    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.

Description and Estimated Number of Small Entities Regulated

    Florida's citrus packinghouses and fresh citrus producers comprise
the industries that we expect to be directly affected by the proposed
rule. The small business size standards 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. According to the County Business Patterns report for Florida
published by the U.S. Census Bureau, there were 71 post-harvest
operations in Florida in 2004. Although this publication reports the
number of employees, the number of firms by employment size, and the
annual payroll for firms included in NAICS 115114, it does not report
the distribution of annual sales for firms in this category. Neither is
information on annual sales published in the Census of Agriculture or
the Economic Census. There are at least 142 packinghouses currently
registered in Florida.\4\ While the classification of these
establishments by sales volume is not available, it is believed that
there are approximately 50 commercial citrus packinghouses and several
small establishments known as gift packers in Florida. The Fresh
Shippers Report, as reported by the Citrus Administrative Committee,
details quantities of fresh citrus shipments of the top 40 to 50
shippers of each season.\5\ That same report indicates that at least 95
percent of Florida fresh citrus shipments are packed through the top 40
packinghouses in the State. During the 2005-06 citrus season, annual
sales for 21 of the top 40 shippers (52.5 percent) were below the SBA
size standard of $6.5 million. It is estimated that at least 85 percent
of citrus packers, including small gift packers, would be considered
small according to the SBA size standards.
---------------------------------------------------------------------------

    \4\ FDACS, Division of Fruit & Vegetable Inspection (http://www.doacs.state.fl.us/fruits
).

    \5\ ``Fresh Shippers Report: 2005-06 Season Through July 31,
2006,'' Citrus Administrative Committee, August 18, 2006 (http://www.citrusadministrativecommittee.org/
).

---------------------------------------------------------------------------

    The proposed changes may also affect producers of fresh citrus in
Florida. Most, if not all, of the Florida citrus producers that would
be affected by the proposed rule are small, based on 2002 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 2002 Census data, there were a total of 7,653 citrus farms
in Florida in 2002. Of this number, approximately 94 percent had annual
sales in 2002 of less than $500,000, which is well below the SBA's
small entity threshold of $750,000.\6\ While it is likely this proposed
rule would result in higher packinghouse charges to the grower, costs
associated with the proposed rule are expected to be minimal. APHIS
invites comment on these costs.
---------------------------------------------------------------------------

    \6\ Source: SBA and 2002 Census of Agriculture.
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    Additionally, the proposed rule would provide marketing
opportunities for fresh citrus previously prohibited from interstate
shipment. APHIS invites comments on the additional costs of production
and marketing opportunities for fresh citrus that would likely result
from the implementation of this proposed rule.
    Although the proposed regulations will provide additional marketing
opportunities for fresh citrus previously prohibited from interstate
movement, adequate data is not available to measure the resulting price
effects. APHIS invites comment on the possible increase in interstate
shipment of fresh citrus and effect on fresh citrus prices that may
result from the proposed rule. Description and Estimate of Reporting,
Recordkeeping, and other Compliance Requirements.
    These considerations are discussed later in this document under the
heading ``Paperwork Reduction Act.''

Duplication, Overlap, and Conflict with Existing Rules and Regulations

    APHIS has not identified any duplication, overlap, or conflict of
the proposed rule with other Federal rules.

Regulatory Alternatives

    An in-depth discussion of the alternatives we considered in
preparing this proposed rule may be found earlier in this document
under the heading ``Risk Management Analysis'' as well as in the
accompanying full economic analysis.

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 proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. If this proposed rule is adopted: (1) All State
and local laws and regulations that are inconsistent with this rule
will be preempted; (2) no retroactive effect will be given to this
rule; and (3) administrative proceedings will not be required before
parties may file suit in court challenging this rule.

National Environmental Policy Act

    To provide the public with documentation of APHIS' review and
analysis of any potential environmental impacts associated with this
proposed domestic citrus canker program, we have prepared an
environmental assessment. The environmental assessment was prepared in
accordance with: (1) The National Environmental

[[Page 34190]]

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 may be viewed on the Regulations.gov
Web site or in our reading room. (Instructions for accessing
Regulations.gov and information on the location and hours of the
reading room are provided under the heading ADDRESSES at the beginning
of this proposed rule.) In addition, copies may be obtained by calling
or writing to the individual listed under FOR FURTHER INFORMATION
CONTACT. We invite the public to comment on the environmental
assessment. Comments on the environmental assessment may be submitted
in the same way as comments on this proposed rule (see ADDRESSES
above).

Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection or
recordkeeping requirements included in this proposed rule have been
submitted for approval to the Office of Management and Budget (OMB).
Please send written comments to the Office of Information and
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington,
DC 20503. Please state that your comments refer to Docket No. APHIS-
2007-0022. Please send a copy of your comments to: (1) Docket No.
APHIS-2007-0022, Regulatory Analysis and Development, PPD, APHIS,
Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238,
and (2) Clearance Officer, OCIO, USDA, room 404-W, 14th Street and
Independence Avenue SW., Washington, DC 20250. A comment to OMB is best
assured of having its full effect if OMB receives it within 30 days of
publication of this proposed rule.
    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.
    This proposed rule would, if adopted, require packinghouse
operators to enter into a compliance agreement with APHIS. The
compliance agreement would contain (but not 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;
     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;
     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.
    We are soliciting comments from the public (as well as affected
agencies) concerning our proposed information collection and
recordkeeping requirements. These comments will help us:
    (1) Evaluate whether the proposed information collection is
necessary for the proper performance of our agency's functions,
including whether the information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the
proposed information collection, including the validity of the
methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to
be collected; and
    (4) Minimize the burden of the information collection on those who
are to respond (such as through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology; e.g., permitting electronic
submission of responses).
    Estimate of burden: Public reporting burden for this collection of
information is estimated to average 1.25 hours per response.
    Respondents: 150.
    Estimated annual number of respondents: 1.
    Estimated annual number of responses per respondent: 1.
    Estimated annual number of responses: 150.
    Estimated total annual burden on respondents: 188 hours. (Due to
averaging, the total annual burden hours may not equal the product of
the annual number of responses multiplied by the reporting burden per
response.)
    Copies of this information collection can be obtained from Mrs.
Celeste Sickles, APHIS' Information Collection Coordinator, at (301)
734-7477.

E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to
compliance with the E-Government Act to promote the use of the Internet
and other information technologies, to provide increased opportunities
for citizen access to Government information and services, and for
other purposes. For information pertinent to E-Government Act
compliance related to this proposed rule, please contact Mrs. Celeste
Sickles, APHIS' Information Collection Coordinator, at (301) 734-7477.

List of Subjects in 7 CFR Part 301

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

    Accordingly, we propose to amend 7 CFR part 301 as follows:

PART 301--DOMESTIC QUARANTINE NOTICES

    1. The authority citation for part 301 would continue 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).

    2. In Sec.  301.75-1, the definitions for certificate and limited
permit would be amended by adding the words ``stamp, form, or other''
after the words ``An official'' and a definition of lot would be added
to read as follows:


Sec.  301.75-1  Definitions.

* * * * *
    Lot. The inspectional unit for fruit composed of a single variety
of fruit that

[[Page 34191]]

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).
* * * * *
    3. In Sec.  301.75-7, paragraphs (a)(1), (a)(2), and (a)(6) would
be revised to read as follows:


Sec.  301.75-7  Interstate movement of regulated fruit from a
quarantined area.

    (a) * * *
    (1) 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 will be ineligible for interstate movement from the
quarantined area. The number of fruit to be inspected will be the
quantity that 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 or another quantity that gives a statistically
significant confidence of detecting the disease at a level of infection
to be determined by the Administrator.
    (2) The owner or operator of any packinghouse that wishes to move
citrus fruit interstate from the quarantined area must enter into a
compliance agreement with APHIS in accordance with Sec.  301.75-13.
* * * * *
    (6) Each lot of regulated fruit found to be eligible for interstate
movement must be accompanied by a limited permit issued in accordance
with Sec.  301.75-12. Regulated fruit to be moved interstate must be
packaged in boxes or other containers that are approved by APHIS and
that are used exclusively for regulated fruit that is eligible for
interstate movement. The boxes or other containers in which the fruit
is packaged must be clearly marked with the statement ``Limited Permit:
USDA-APHIS-PPQ. Not for distribution in AZ, CA, HI, LA, TX, and
American Samoa, Guam, Northern Mariana Islands, Puerto Rico, and Virgin
Islands of the United States.'' Only fruit that meets all of the
requirements of this section may be packed in boxes or other containers
that are marked with this statement.
* * * * *
    4. In Sec.  301.75-11, paragraph (a), the introductory text would
be amended by adding the words ``at least'' after the words ``treated
in'' and a new paragraph (a)(4) would be added to read as follows:


Sec.  301.75-11  Treatments.

    (a) * * *
    (4) Peroxyacetic acid. The regulated fruit must be thoroughly
wetted for at least 1 minute with a solution containing 85 parts per
million peroxyacetic acid.
* * * * *

    Done in Washington, DC, this 18th day of June 2007.
J. Burton Eller,
Acting Under Secretary for Marketing and Regulatory Programs.
 [FR Doc. E7-12041 Filed 6-20-07; 8:45 am]

BILLING CODE 3410-34-P